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["App No.","Reference","Application Title","Status","Outcome Date","Next Review","Contact","Organisation","National Data Opt-out Status","English Confidential Patient Information","Welsh Confidential Patient Information"]
["0001",{"$f":"INDIRECT(\"A\"&A2&\"!B4\")","v":"CAG 1-06(FT3)/2013"},{"$f":"INDIRECT(\"A\"&$A2&\"!B6\")","v":"EPTOS European Transfusion Practice and Outcome Survey: An observational outcome study of transfusion practice in surgical patients (excluding cardiothoracic surgery) throughout Europe"},{"$f":"INDIRECT(\"A\"&$A2&\"!B32\")","v":"Expired"},{"$f":"INDIRECT(\"A\"&$A2&\"!B34\")","v":"2013-03-22"},{"$f":"IF(D2<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A2&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A2&\"!B35\")))","v":"N/A"},{"$f":"(INDIRECT(\"A\"&$A2&\"!B9\"))","v":"Dr Susan Mallett"},{"$f":"(INDIRECT(\"A\"&$A2&\"!B8\"))","v":"Royal Free London NHS Foundation Trust"},{"$f":"IF(INDIRECT(\"A\"&$A2&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A2&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A2&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A2&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A2&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A2&\"!B39\"))","v":""}]
["0002","CAG 1-06(FT4)/2013","A Pilot Study to Inform a MultiCentre Randomised Controlled Trial of an Impedance Threshold Device (ITD) – the ResQPOD, in Cardiac Arrest","Supported",{"$f":"INDIRECT(\"A\"&$A3&\"!B34\")","v":"2013-08-28"},{"$f":"IF(D3<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A3&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A3&\"!B35\")))","v":"2014-08-28"},"Dr John Wright","Newcastle Upon Tyne NHS Hospitals Trust",{"$f":"IF(INDIRECT(\"A\"&$A3&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A3&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A3&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A3&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A3&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A3&\"!B39\"))","v":""}]
["0003","CAG 1-06(FT5)/2013","Investigating the Safety of Medication Use in Primary Care (SAFECARE)","Supported","2013-06-11","2015-06-11","Janice Olaniyan","University of Hertfordshire","","",""]
["0004","CAG 1-06(PR6)/2013","AMICABLE Airway Management in Cardiac Arrest Study V1.1","Expired","2014-10-01","N/A","Tim Edwards","London Ambulance Service NHS Trust","","",""]
["0005","CAG 1-06(PR7)/2013","Secondary Prevention of Burns and Scalds in Children","Supported","2013-04-17","2017-04-17","Professor Alison Kemp","Cardiff University","","",""]
["0006","CAG 2-05(a)/2013","Investigating factors influencing the Infant Mortality Rate in Lincolnshire\n","Supported","2014-08-06","2015-08-06","Dr Richard Puleston","University of Nottingham","","",""]
["0013","CAG 3-03(PR3)/2013","Medical Therapy vs Intervention in Chronic Total Coronary Occlusions","Supported","2013-07-04","2014-07-04","Dr Andrew Ladwiniec","Hull and East Yorkshire Hospitals NHS Trust","","",""]
["0014","CAG 3-03(PR4)/2013","How effective are Antithrombotic Therapies in Primary PCI: HEATppci v1","Expired","2013-05-29","N/A","Dr Rod Stables","Liverpool Heart and Chest Hospital","","",""]
["0016","CAG 4-07/2013","ALSPAC Eligible Sample: Enrolment and Consent for Record Linkage\n",{"$f":"INDIRECT(\"A\"&$A10&\"!B32\")","v":"Supported"},"2014-03-26","2017-03-26","Professor John Macleod","University of Bristol","","",""]
["0017","CAG 4-09(a)/2013","Translational Research In Pulmonary Hypertension at Imperial College (TRIPHIC)","Expired","2014-11-14","N/A","Professor Martin Wilkins","Imperial College Healthcare NHS Trust","","",""]
["0018","CAG 4-09(b)/2013","Bariatric surgery and colorectal cancer","Expired","2014-01-20","N/A","Professor Mark Hull","University of Leeds","","",""]
["0019","CAG 5-03(PR1)/2013","ELN survival follow-up study","Expired","2013-07-12","N/A","Dr Charles M Oliver","University College London Hospital","","",""]
["0022","CAG 5-03(PR5)/2013","Melanoma Lifestyle Study","Expired","2013-10-08","N/A","Professor Julia Newton-Bishop","University of Leeds","","",""]
["0023","CAG 5-03(PR6)/2013","Heart Watch' Cardiac Rehabilitation: Mortality/Morbidity Audit V3.1","Supported","2013-08-01","2016-08-01","Claire Taylor","University of Hull","","",""]
["0025","CAG 5-08(b)/2013","Survival of children born with congenital heart disease","Supported","2015-07-16","2020-11-13","Professor Judith Rankin","Newcastle University","","",""]
["0026","CAG 5-08(c)/2013","A prospective surveillance study to define rates of carriage, transmission and infection by healthcare-associated pathogens in adjacent hospital and community settings","Expired","2014-02-17","N/A","Professor Sharon Peacock","University of Cambridge","","",""]
["0027","CAG 5-08(d)/2013","Cancer risks in the British rubber manufacturing industry","Supported","2014-11-17","2016-11-17","Professor Damien McElvenny","Institute of Occupational Medicine","","",""]
["0028","CAG 6-03(PR1)/2013","The QUEST Study (version 1)","Supported","2013-08-22","2014-08-22","Mr David Kirby","Luton & Dunstable University Hospital NHS Foundation Trust","","",""]
["0029","CAG 6-03(PR2)/2013","Retrospective analysis of reversible myocardial dysfunction in ICU","Expired","2013-10-24","N/A","Dr Duncan Young","Oxford University Hospitals NHS Trust","","",""]
["0030","CAG 6-03(PR3)/2013","Impact of overweight on prognosis of diabetes mellitus","Supported","2014-01-24","2016-01-24","Dr Pierluigi Costanzo","University of Hull","","",""]
["0033","CAG 7-06(a)/2013","Investigating the accuracy of current estimates of self-harm","Supported","2014-03-21","2024-03-21","Dr Becky Mars, Chief investigator","University of Bristol","","Yes","No"]
["0035","CAG 7-06(d)/2013","Reasons for Non-Participation in Physical Activity Interventions\n","Expired","2014-02-07","N/A","Sophie Attwood","University of Cambridge","","",""]
["0036","CAG 7-06(e)/2013","EpiHealth Outcomes Project The effect of maternal age, embryo cryopreservation and culture on perinatal outcomes and child health: Scottish Data Linkage Study\n",{"$f":"INDIRECT(\"A\"&$A24&\"!B32\")","v":"Supported"},"2013-10-14","2014-10-14","Professor Daniel Brison","Central Manchester University Hospitals NHS Foundation Trust","","",""]
["0041","CAG 8-03(PR8)/2013","DIAMOND-Lewy Work Package 1, version 1.0","Expired","2014-01-28","N/A","Professor John O'Brien","University of Cambridge","","",""]
["0043","CAG 9-03(PR1)/2013","Retrospective casenotes review of perinatal stroke","Expired","2014-01-24","N/A","Dr Anna Basu","Newcastle upon Tyne Hospitals NHS Foundation Trust","","",""]
["0044","CAG 9-03(PR2)/2013","The 100 Prescriptions Study","Expired","2014-08-29","N/A","Professor Tony Avery","University of Nottingham","","",""]
["0045","CAG 9-03(PR3)/2013","Arrhythmia and systemic ventricular function in atrial switch for TGA","Expired","2014-01-16","N/A","Dr John O'Sullivan","Newcastle upon Tyne Hospitals NHS Foundation Trust","","",""]
["0047","CAG 9-03(PR5)/2013","Preventable Incidents, Survival and Mortality Study 2 (PRISM2)","Expired ","2013-12-23","N/A","Dr Helen Hogan","London School of Hygiene and Tropical Medicine","","",""]
["0048","CAG 9-08(a)/2014","SLAM CAMHS CRIS linkage with DfE National Pupil Database","Expired","2014-03-10","N/A","Professor Matthew Hotopf","\nInstitute of Psychiatry\n","","",""]
["0049","CAG 9-08(b)/2013","Linkage of readmissions to birth data","Supported","2014-03-17","2024-03-17","Professor Alison Macfarlane","City, University of London","","",""]
["0050","CAG 9-08(c)/2014","MesobanK Retrospective Sample Collection","Supported","2014-05-07","2024-05-07","Professor Robert Rintoul, Lead Clinician for Cancer, Chief Investigator MesobanK ","Royal Papworth Hospital NHS Foundation Trust\n","","",""]
["0051","CAG 9-08(d)/2014","BioAID Version 1","Supported","2014-02-28","2025-02-24","Dr Mahdad Norsadeghi","\nUniversity College London\n","Applied","Yes","No"]
["0054",{"$f":"INDIRECT(\"A\"&A34&\"!B4\")","v":"CAG 10-08(b)/2014"},{"$f":"INDIRECT(\"A\"&$A34&\"!B6\")","v":"Building Blocks 2-6: parenting support to reduce maltreatment"},"Expired","2014-11-06","N/A",{"$f":"(INDIRECT(\"A\"&$A34&\"!B9\"))","v":"Dr Michael Robling"},{"$f":"(INDIRECT(\"A\"&$A34&\"!B8\"))","v":"Cardiff University"},"","",""]
["0055","CAG 10-08(c)/2014","Intergenerational and lifecourse influences on health and mortality - update","Supported","2014-05-12","2024-05-12","Professor Alissa Goodman\n","University of London","","",""]
["0057","CAG 1-03(PR1)/2014","British Childhood Cancer Survivor Study Case-Control Studies (v1.0)","Expired","2014-03-11","N/A","Prof Michael M Hawkins","The University of Birmingham","","",""]
["0058","CAG 1-03(PR2)/2014","National Child Development Study The 1958 British Birth Cohort Study","Supported","2014-07-18","2024-07-18","Professor Alissa Goodman","Institute of Education","","",""]
["0059","CAG 9-08(e)/2014","The EPIC-Norfolk prospective population study","Supported","2014-03-21","2025-03-21","Professor Nick Wareham","University of Cambridge-Addenbrooke's Hospital","Applied","Yes","No"]
["0061","CAG 1-07(a)/2014","Recall and Reoffending Outcomes of Mentally Disordered Offenders (MDOs) after Discharge from a UK Medium Secure Unit","Supported","2014-12-08","2015-12-08","Dr Lona Lockerbie","Kent and Medway NHS and Social Care Partnership Trust","","",""]
["0062","CAG 1-07(b)/2014","Yorkshire Specialist Register of Cancer in Children and Young People","Expired","2015-08-13","N/A","Dr Richard Feltbower","University of Leeds","","",""]
["0063","CAG 1-07(c)/2014","Long-term effects of whole blood and platelet donation","Supported","2014-11-19","2024-11-19","Dr Emanuele Di Angelantonio","University of Cambridge","","Yes","No"]
["0064","CAG 2-03(PR4)/2014","1970 British Cohort Study","Supported","2014-05-01","2024-05-01","Dr Alice Sullivan","Centre for Longitudinal Studies, UCL Institute of Education","","",""]
["0065","CAG 2-07(a)/2014","The AKKORD Study of Outreach in Acute Kidney Injury","Supported","2014-09-17","2015-09-17","Dr Mark Thomas","Heart of England NHS Foundation Trust","","",""]
["0067","CAG 2-07(c)/2014","Impact of earlier diagnosis of intracranial tumours in children","Expired","2014-06-25","N/A","Professor David Walker\n","University of Nottingham","","",""]
["0068","CAG 3-02(a)/2014","Long-term follow-up of ARTISTIC cervical screening trial cohort","Supported","2014-08-21","2024-08-21","Professor Julian Peto","London School of Hygiene and Tropical Medicine","","",""]
["0070","CAG 3-02(c)/2014","POEM","Supported","2014-11-19","2017-11-19","Dr James Sheehan","Royal Berkshire NHS Foundation Trust","","",""]
["0072","CAG 4-03(PR2)/2014","Prehospital Recognition of Sepsis by Ambulance Clinicians (PRoSAiC)","Expired","2014-09-09","N/A","Mr Michael Smyth","University of Warwick ","","",""]
["0073","CAG 4-03(PR3)/2014","GlyCon: Glycaemic Control of Stress Hyperglycaemia Implemented in NHS Intensive Care Units","Supported","2014-07-10","2015-07-10","Ms María del Rocío Fernández Méndez","University of Nottingham","","",""]
["0074","CAG 4-03(PR4)/2014","Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM)","Expired","2014-07-09","N/A","Professor Graham Roberts","Southampton University Hospitals NHS Foundation Trust","","",""]
["0075","14/CAG/1001","Critical Care Health Informatics Collaborative","Expired","2015-11-25","N/A","Professor Mervyn Singer","University College London","","",""]
["0076","14/CAG/1002","ALTER10 Study v1.0","Expired","2014-08-15","N/A","Dr Mark Hudson, Consultant Hepatologist","Newcastle Upon Tyne Hospitals NHS Foundation Trust","","",""]
["0077","14/CAG/1003","Improving Outcomes from Out of Hospital Cardiac Arrest: The Cardiac Arrest Individual Registry and Outcomes (CAIRO) Programme (Work Package A)","Supported","2014-09-26","2016-09-26","Professor Jonathan Benger, Consultant in Emergency Care","University Hospitals Bristol NHS Trust","","",""]
["0078","14/CAG/1005","Dynamic Risk Factors associated with Mentally Disordered Firesetting within a Mental Health Trust","Supported","2014-08-06","2015-08-06","Miss Becky Wyatt","University of Kent ","","",""]
["0079","14/CAG/1006","Millennium Cohort Study","Supported","2014-08-14","2024-08-14","Professor Emla Fitzsimons","University of London","","",""]
["0081","14/CAG/1010","Neonatal Exchange Blood Transfusion (EBT)","Supported","2014-10-21","2015-10-21","Dr Ruth Gottstein","Central Manchester University Hospitals NHS Foundation Trust","","",""]
["0084","14/CAG/1013","A feasibility study of case-finding strategies for the detection of Hepatitis B and Hepatitis C in Primary Care",{"$f":"INDIRECT(\"A\"&$A56&\"!B32\")","v":"Supported"},"2015-01-27","2016-01-27","Ms Gill Fairbairn","University of Surrey","","",""]
["0085","14/CAG/1014","Clinical presentation of enterovirus infection in children, and disease-causing enterovirus serotypes in the UK.","Expired","2014-08-12","N/A","Dr Marc Tebruegge","University Hospital Southampton NHS Foundation Trust ","","",""]
["0086","14/CAG/1015","Analysing Emergency and Urgent Care System Demand in Yorkshire and Humber: A data linkage study of pre-hospital and emergency department data.","Supported","2015-01-27","2017-01-27","Ms Suzanne Mason","University of Sheffield","","",""]
["0089","14/CAG/1018","CEMARC Longterm Outcome Study","Supported","2014-11-18","2024-11-18","Dr Laura Jones","University of Leeds","Applied","Yes","No"]
["0091","14/CAG/1020","A case-control evaluation of the NHS Bowel Cancer Screening Programme","Supported","2014-11-14","2024-11-14","Professor Stephen W. Duffy","Wolfson Institute of Preventative Medicine, Queen Mary’s, University of London","","Yes","No"]
["0093","14/CAG/1022","Decision Making with Teenagers, Parents and Clinicians","Expired","2014-11-05","N/A","Professor Myra Bluebond-Langner","University College London","","",""]
["0094","14/CAG/1023","Prehospital Risk Stratification using a Modified Thrombolysis in Myocardial Infarction (PRISM-TIMI) Score – A Medical Record Review","Expired","2014-10-03","N/A","Mr Alan Rice","St George’s, University of London ","","",""]
["0095","CR10/2014","UKAEA & AWE Epidemiology Studies in the SHIELD database","Expired","2014-10-21","N/A","Gary Bethel","Nuvia Limited","","",""]
["0096","14/CAG/1024","EVAR 1","Expired","2015-10-15","N/A","Professor Roger M Greenhalgh-Chief Investigator","Imperial College","","",""]
["0097","14/CAG/1025","CFAS Death notification of participants at HSCIC","Expired","2015-01-15","N/A","Professor Carol Brayne","University of Cambridge","","",""]
["0099",{"$f":"INDIRECT(\"A\"&A66&\"!B4\")","v":"14/CAG/1027"},{"$f":"INDIRECT(\"A\"&$A66&\"!B6\")","v":"Cluster randomised comparison of the effectiveness of 100% oxygen\nversus titrated oxygen in patients with a sustained return of\nspontaneous circulation following out of hospital cardiac arrest: a\nfeasibility study"},"Supported","2014-10-29","2015-10-29",{"$f":"(INDIRECT(\"A\"&$A66&\"!B9\"))","v":"Professor Jonathan Benger"},{"$f":"(INDIRECT(\"A\"&$A66&\"!B8\"))","v":"University Hospitals Bristol NHS FT"},"","",""]
["0100","14/CAG/1028","British Childhood Visual Impairment and Blindness Study 2 (BCVIS 2)","Supported",{"$f":"INDIRECT(\"A\"&$A67&\"!B34\")","v":"2014-11-18"},{"$f":"IF(D67<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A67&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A67&\"!B35\")))","v":"2020-10-31"},"Prof Jugnoo Rahi","University College London ",{"$f":"IF(INDIRECT(\"A\"&$A67&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A67&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A67&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A67&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A67&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A67&\"!B39\"))","v":""}]
["0101","14/CAG/1029","DECS, Diabetic Eye disease in Children Study: incidence, detection / presentation, clinical characteristics and outcomes of diabetic eye disease in childhood in the UK","Expired","2014-11-18","N/A","Prof Jugnoo Rahi","University College London ","","",""]
["0102","14/CAG/1030","Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest - Airway Management in cardiac arrest patients (AIRWAYS2)","Expired","2014-11-05","N/A","Professor Jonathan Benger","University Hospitals Bristol and Weston NHS Foundation Trust","","",""]
["0105","14/CAG/1033","Maternal Serum PAPPA levels and pregnancy outcomes","Supported","2014-12-10","2015-12-10","Dr Ashwini Bilagi","Birmingham Women’s Hospital NHS Foundation Trust","","",""]
["0106","14/CAG/1034","Collaborative European Neuro-Trauma Effectiveness Research in TBI: a prospective longitudinal observational study","Expired","2014-12-10","N/A","Dr Jonathan Coles","Cambridge University Hospitals NHS Foundation Trust","","",""]
["0107","14/CAG/1035","A Retrospective Chart Review of Deceased Patients with Mucopolysaccharidosis Type IIIB","Expired","2015-02-11","N/A","Dr Suresh Vijay","Birmingham Children's Hospital NHS Foundation Trust","","",""]
["0108","14/CAG/1036","A new combined radiological and clinical classification for pulmonary embolism using computed tomography pulmonary angiography","Expired","2014-12-17","N/A","Mr Christopher Satur","University of Keele ","","",""]
["0111","14/CAG/1039","Small Area Health Statistics Unit","Expired","2015-04-24","N/A","Paul Elliot","Imperial College London. UK Small Area Health Statistics Unit (SAHSU)","","",""]
["0112","14/CAG/1040","UCL Infection DNA Bank","Supported","2014-12-16","2024-12-16","Professor Judith Breuer","University College London","","Yes","No"]
["0115","14/CAG/1043","SOCCER (Symptoms of Colorectal Cancer Evaluation\nResearch)","Expired","2015-02-11","N/A","Dr Amanda Cross","Imperial College London","","",""]
["0116","14/CAG/1044","Predicting Response to Antipsychotic medication (STRATA)","Expired","2015-06-03","N/A","Dr James H MacCabe","KCL","","",""]
["0123","CR4/2014","Asbestos Workers Survey","Supported","2014-11-19","2024-11-19","Gillian Nicholls, Chief Investigator","Health and Safety Executive","","Yes","Yes"]
["0124","14/CAG/1007","An investigation into the role of the pharmacy team in reducing avoidable hospital readmissions","Supported","2014-11-19","2016-11-19",{"$f":"(INDIRECT(\"A\"&$A79&\"!B9\"))","v":"Miss Sarah M Upton"},"University of Huddersfield & Calderdale and Huddersfield NHS Foundation Trust (CHT)","","",""]
["0125","CAG 2-03(PR1)/2014","Understanding age inequalities and inequities in cancer diagnosis, treatment and outcomes in brain, colorectal and ovarian tumours, sarcoma and Hodgkin’s lymphoma","Expired","2015-02-06","N/A","Dr Rebecca Birch","University of Leeds","","",""]
["0126","15/CAG/0105","A prospective cohort study of clinical predictors, disease mechanisms, costs and outcomes of encephalitis in the UK","Expired","2015-03-10","N/A","Professor Tom Solomon","University of Liverpool / Liverpool Joint Research Office","","",""]
["0127","15/CAG/0001","Access to healthcare and impact on health inequalities","Expired","2015-04-13","N/A","Mrs Charlotte Kelly","University of Leeds","","",""]
["0128","15/CAG/0116","Understanding and improving the decision-making process surrounding admission to the intensive care unit","Supported","2015-04-22","2018-04-22","Mr Christopher Bassford","University Hospitals Coventry and Warwickshire","","",""]
["0129","15/CAG/0120","National investigation into suicide in children and young people","Supported","2015-05-06","2024-05-06","Professor Louis Appleby","University of Manchester","","",""]
["0130","15/CAG/0102","Surveillance of Type 2 Diabetes in children","Supported","2015-03-13","2016-03-13","Professor Julian Hamilton-Shield","University Hospitals Bristol NHS","","",""]
["0131","15/CAG/0111","Surveillance of Childhood Acute Rheumatic Fever (SCARF)","Supported","2015-04-24","2016-04-24","Dr Mary Salama","Birmingham Children's Hospital NHS Foundation Trust","","",""]
["0132","15/CAG/0115","UKCTOCS UK Collaborative Trial of Ovarian Cancer Screening","Supported","2015-04-16","2024-04-16","Professor Usha Menon","Dept of Women's Cancer, Institute for Women's Health, Institute for Women's health ,\nUCL","","",""]
["0133","15/CAG/0125","28 year followup of patients with neurotic disorder",{"$f":"INDIRECT(\"A\"&$A88&\"!B32\")","v":"Expired"},"2015-04-16","N/A","Professor Peter Tyrer","Imperial College","","",""]
["0134","15/CAG/0127","Cellular immunity to herpesvirus infection: Studies with EBV & CMV v1","Supported","2015-04-16","2024-04-16","Professor Paul Moss","University of Birmingham","Applied","Yes","No"]
["0135","15/CAG/0116","Understanding and improving the decision-making process surrounding admission to the intensive care unit","Expired","2015-04-22","N/A","Dr Christopher Bassford","University Hospitals Coventry and Warwickshire","","",""]
["0136","15/CAG/0134",{"$f":"INDIRECT(\"A\"&A91&\"!B6\")","v":"The risk of major bleeding with novel anti-platelets: A comparison of ticagrelor with clopidogrel in a real world population of patients treated for acute coronary syndrome"},"Supported","2015-05-15","2024-05-15","Dr Aleem Khand","Aintree University Hospitals NHS Foundation Trust","","",""]
["0137","15/CAG/0138","Simon Broome Familial Hypercholesterolaemia Register (MR180)","Supported","2015-06-08","2024-06-08","Professor Riyaz Patel, Professor Riyaz Patel. Professor of Cardiology","University College London","Applied","Yes","No"]
["0138","CAG 1-03(PR3)/2014","Longitudinal Study of Young People in England (LSYPE)","Supported","2014-04-17","2024-04-17","Ms Lisa Calderwood","Centre for Longitudinal Studies, UCL Institute of Education","","",""]
["0139","15/CAG/0110","Life after prostate cancer diagnosis","Expired","2015-05-15","N/A","Dr Adam Glaser","University of Leeds","","",""]
["0140","15/CAG/0136","Linkage of a military cohort study to secondary healthcare records","Expired","2015-05-29","N/A","Dr Laura Goodwin","King's College London","","",""]
["0142","15/CAG/0126","QUEST Follow Up Study","Supported","2015-06-17","2016-06-17","Prof Emily Smith","King's College London","","",""]
["0143",{"$f":"INDIRECT(\"A\"&A97&\"!B4\")","v":"15/CAG/0149"},"Breast-Screening After Radiotherapy Database - Questionnaire (BARD-Q)","Expired","2015-05-18","N/A",{"$f":"(INDIRECT(\"A\"&$A97&\"!B9\"))","v":"Dr Sacha Howell"},{"$f":"(INDIRECT(\"A\"&$A97&\"!B8\"))","v":"Manchester University & The Christie NHS Foundation Trust"},"","",""]
["0144","15/CAG/0147","Geographic and socioeconomic mapping of hepatocellular carcinoma (HCC)","Supported","2015-05-18","2016-05-18","Dr Lynsey Corless","Hull and East Yorkshire Hospitals NHS Trust","","",""]
["0146","15/CAG/0118","Validation of Risk Assessment tools in CFCAMHS","Expired","2015-06-26","N/A","Professor Jenny Shaw","University of Manchester","","",""]
["0148","15/CAG/0152","FILTR Field Triage Tool for Ruptured aneurysms","Expired","2015-07-21","N/A","Mr Alan Karthikesalingam","St Georges Hospital NHS Trust","","",""]
["0149","15/CAG/0113","Avoidable mortality from in-hospital cardiac arrest: Have interventions aimed at recognising and rescuing deteriorating patients made an impact on incidence and outcomes?","Expired","2015-07-21","N/A","Dr Helen Hogan","London School of Hygiene and Tropical Medicine","","",""]
["0150","15/CAG/0150","ERIC-PPCI","Expired","2015-08-04","N/A","Professor Derek Hausenloy","University College London","","",""]
["0151","15/CAG/0109","Brain maturation and neurodevelopmental outcome in preterm adults","Supported","2015-07-28","2016-07-28","Dr Chiara Nosarti","Institute of Psychiatry and King's College London","","",""]
["0152","15/CAG/0137","What services influence the care of people with dementia in the last year of life?","Supported","2015-08-18","2016-08-18","Dr Jennifer Todd","Princess Alice Hospice/Kingston NHS FT","","",""]
["0153","CAG 9-08(b)/2014","Linkage of readmissions to birth data","Supported","2015-08-14","2025-03-17","Professor Alison Macfarlane\n","City, University of London   ","Application considered at CAG meeting on 09/01/2014.\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 27/02/2014.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 01/11/2013.\n\n3. Provision of patient information materials. Patient information poster received.\n\n4. The application does not currently include PEDW data. \n","","Yes"]
["0154","CR2/2014","Whitehall II Study (Stress and Health Study)","Expired","2015-03-12","N/A","Professor Mika Kivimaki","University College London","","",""]
["0158","15/CAG/0169","The Role and Impact of Surgical Centralisation on Renal Cancer Survival: A Multifactorial Analysis","Expired","2015-08-24","N/A","Dr Ray Hsu","University of Cambridge","","",""]
["0159","15/CAG/0160","Acute hospital care for frail older people","Supported","2015-09-02","2017-09-02","Professor Stuart Parker","Newcastle University","","",""]
["0160","15/CAG/0151","Diabetic retinopathy in type 1 diabetes: the Winchester Cohort","Supported","2015-09-15","2016-09-15","Miss Radhika Krishnan","University Hospital Southampton NHS FT","","",""]
["0161","15/CAG/0139","Life course pathways to ageing in the MRC National Survey of Health and Development","Supported","2015-10-07","2024-10-07","Nish Chaturvedi, Director of MRC Unit for Lifelong Health and Ageing","University College London","","",""]
["0162","CR27/2014","THRIVE: Treatment of HDL to reduce the Incidence of Vascular Events\n","Supported","2015-10-07","2017-10-07","Professor Sir Rory Collins","Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU)","","",""]
["0163","15/CAG/0163","Risk modelling for quality improvement in the critically ill: making best use of routinely available data","Expired","2015-11-02","N/A","Dr David Harrison","Intensive Care National Audit & Research Centre (ICNARC)","","",""]
["0164","15/CAG/0177","An investigation of the association between substance use in adolescence and mental health using linked health data","Supported","2015-11-23","2024-09-28","Mark Mumme (ALSPAC Data Linkage Manager)","Avon Longitudinal Study of Parents and Children (University of Bristol)","Applied","Yes","Yes"]
["0165","15/CAG/0172","PUMA - Paediatric early warning system (PEWS): Utilisation and Mortality Avoidance. A prospective, mixed methods, before and after study identifying the evidence base for the core components of an effective PEWS and the development of an implementation package for implementation and use in the UK.","Supported","2015-11-04","2017-11-04","Dr Colin Powell, ","Cardiff University","","",""]
["0166","15/CAG/0154","Hospital admissions for enteral tube related issues: retrospective case note review to determine frequency, reasons and risk factors.","Expired","2015-10-26","N/A","Dr Sue Green","University of Southampton","","",""]
["0167","CR12/2014","Oxford Vegetarian Study ","Supported","2015-12-22","2024-12-22","Professor Tim Key","University of Oxford","","Yes","No"]
["0168","15/CAG/0193","ANEMONE 2819CL2002","Supported","2015-12-14","2016-12-14","Dr. Surabhi Taori","King's college Hospital NHS Foundation Trust","","",""]
["0169","15/CAG/0141","Pierre Robin Sequence national surveillance study","Supported","2015-12-22","2016-12-22","Dr Marie FA Wright","Royal Hospital for Sick Children","","",""]
["0170","15/CAG/0168","The RECENSUS Study: A Medical Chart Review of Patients with X-Linked Myotubular Myopathy (XLMTM), sponsored by Audentes Therapeutics","Expired ","2016-01-22","N/A","Professor Francesco Muntoni","UCL Institute of Child Health","","",""]
["0172","16/CAG/0022","Feasibility of an impact analysis of a clinical prediction tool to estimate the probability of abusive head trauma in children less than three years of age",{"$f":"INDIRECT(\"A\"&$A120&\"!B32\")","v":"Supported"},"2016-03-10","2017-02-25","Professor Alison Kemp","Cardiff University","","",""]
["0173","15/CAG/0164","Finding the genes that cause hypoplastic left heart syndrome (HLHS)","Expired","2016-03-30","N/A","Dr Bill Chaudhry","Institute of Genetic Medicine","","",""]
["0174","15/CAG/0165","A case study of spatiality in advanced presentation gastroesophageal cancer","Supported","2016-03-22","2017-03-22","David Richards","University of Hull","","",""]
["0175","15/CAG/0155","Magnetic Resonance Imaging to Enhance the Diagnosis of Foetal Developmental Brain Abnormalities in Utero","Supported","2016-02-26","2018-02-26","Professor Paul Griffiths","University of Sheffield","","",""]
["0176","15/CAG/0196","Tracking the Impact of Gestational Age on health, educational and economic outcomes: a longitudinal Record linkage study (TIGAR)","Expired","2016-03-23","N/A","Professor Maria Quigley","University of Oxford","","",""]
["0177","15/CAG/0203","Impact and Evaluation of a Burns Risk Assessment of Neglect and Maltreatment in Children Tool.BuRN-Tool  A multi centre study","Supported","2016-02-23","2018-02-23","Professor Alison  Kemp","Institute of Primary Care and Public Health","","",""]
["0178","15/CAG/0211","Understanding patient mortality in the month following contact with the out of hours service: a data-linkage study.","Supported","2016-02-11","2017-02-11","Dr Rebecca F R Fisher","Health Education Thames Valley","","",""]
["0179","16/CAG/0008","The management and risk of patients with personality disorder prior to suicide and homicide","Expired","2016-03-31","N/A","Professor Jennifer Shaw","The University of Manchester","","",""]
["0181","16/CAG/0029","The Empress Study Cancer diagnosis via Emergency Presentation: a case-control study","Supported","2016-04-27","2025-04-27","Professor Una Macleod","University of Hull","","Yes","No"]
["0182",{"$f":"INDIRECT(\"A\"&A129&\"!B4\")","v":"16/CAG/0017"},"Developing methods for assessing avoidable severe harm attributable to problems in care","Expired","2016-05-03","N/A","Dr Helen Hogan","London School of Hygiene and Tropical Medicine","","",""]
["0183","14/CAG/1042","BPSU facilitated study on Rickets","Supported","2014-12-22","2017-05-06","Dr Pricilla Julies","Royal Free Hospital\nChild Health Department","","",""]
["0184","14/CAG/1032","Investigating the association between IQ and Self harm","Expired",{"$f":"INDIRECT(\"A\"&$A131&\"!B34\")","v":"2016-05-18"},{"$f":"IF(D131<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A131&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A131&\"!B35\")))","v":"N/A"},"Mark Mumme, ASLPAC Data Linkage Manager","University of Bristol",{"$f":"IF(INDIRECT(\"A\"&$A131&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A131&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A131&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A131&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A131&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A131&\"!B39\"))","v":""}]
["0185","15/CAG/0175","Early life causes of adolescent depression and anxiety","Expired","2016-05-18","N/A","Mark Mumme (ALSPAC Data Linkage Manager)","Avon Longitudinal Study of Parents and Children (University of Bristol)","","",""]
["0186","15/CAG/0176","Predictors and prevalence of genital Chlamydia trachomatis infection and the impact of Chlamydia testing and treatment on sexual health outcomes","Supported","2016-05-18","2024-05-18","Mark Mumme, ALSPAC Data Linkage Manager","University of Bristol","","",""]
["0187","16/CAG/0042","Young ER follow up","Expired","2016-06-03","N/A","Dr Greg Mellor","St. George's, University of London","","",""]
["0188","15/CAG/0123","aTTom: adjuvant Tamoxifen Treatment offer more (Version 3.0)","Supported","2016-06-09","2024-06-09","Dr Sean Jennings","University of Birmingham","","",""]
["0189","16/CAG/0077","2016 Accident and Emergency Survey","Supported","2016-06-13","2017-06-13","Chris Graham","Picker Institute Europe","","",""]
["0190","16/CAG/0057","Is it possible to develop a complex intervention to improve the outcome of fall-related injuries in people with dementia?","Expired","2016-07-16","N/A","Dr Louise M Allan","Newcastle University","","",""]
["0191","16/CAG/0054","Twelve month follow up of patients who have been detained under Section 136 of the Mental Health Act, 1983","Expired","2016-06-17","N/A","Dr Simon Taylor","Derbyshire Healthcare NHS Foundation Trust","","",""]
["0192","16/CAG/0066","Hospital Alerting Via Electronic Noticeboard (HAVEN)","Supported","2016-07-04","2024-07-04","Rachel Henning, Research Coordinator","Oxford University Hospitals NHS Foundation Trust (OUH)","","",""]
["0193","16/CAG/0059","Lifestyle Risk Factors and Colorectal Cancer Screening:\nFIT Pilot Analysis and Development of a Risk-Adjusted\nPrediction Model.","Expired","2016-07-04","N/A","Jennifer Cooper","University of Warwick","","",""]
["0194","16/CAG/0048","LATTE: Long-term Anastrozole vs Tamoxifen","Supported","2016-07-19","2024-07-19","Nadia Haidar, Biospecimen Data Manager ","Queen Mary, University of London","","Yes","No"]
["0195","15/CAG/0204","Maternity-baby data study","Expired","2016-07-14","N/A","Katie Harron","Royal College of Surgeons of England","","",""]
["0196","16/CAG/0053","Prolonged Effects of Assisted reproductive technologies on the health of women and their children: a Record Linkage study for England (PEARL)","Supported","2016-07-22","2024-07-22","Claire Carson","University of Oxford","","Yes","No"]
["0197","16/CAG/0101","RESIST: Understanding the role of depression in heart disease","Supported","2016-07-29","2017-07-29","Professor Glyn Lewis (CI); Miss Samantha Lawes ","UCL","","",""]
["0198","16/CAG/0038","Risk Stratification tools to identify patients with advanced COPD","Supported","2016-07-28","2018-07-28","Professor Michael Steiner","University Hospitals of Leicester NHS Trust","","",""]
["0199","16/CAG/0091","Investigation into predictors of diagnosis in PAH patients","Expired","2016-08-16","N/A","Professor David Kiely","Sheffield Teaching Hospitals NHS Foundation Trust","","",""]
["0200","16/CAG/0095","European Network of National Schizophrenia Networks Studying Gene-Environment Interactions (EU-GEI. Work package 5: GenexEnvironment in the Prodrome","Supported","2016-08-16","2017-08-16","Prof Philip K. McGuire","Institute of Psychiatry, Psychology and Neuroscience (IoPPN) King's College London (KCL)","","",""]
["0201","16/CAG/0047","Psychological Impact of Primary Screening for HPV","Expired","2016-08-24","N/A","Dr Jo Waller","University College London","","",""]
["0202","16/CAG/0040","Validating an extended scale on the HCR-20 V3","Supported","2016-09-05","2018-09-05","Dr Phil Minoudis","East London NHS Foundation Trust","","",""]
["0203","16/CAG/0117","An extension of the Arnold Lodge Admission Cohort Reconvictions and Intervening Treatment (ALACRITy) study: 1983-2013","Supported","2016-09-16","2024-09-16","Ramani Moonsinghe, Professor of Peripoerative Medicine, Head of Research Department for Targeted Intervention","University of Nottingham","","",""]
["0204","16/CAG/0087","Epidemiology of Critical Care provision after Surgery (EpiCCS)","Supported","2016-09-16","2023-09-16","Dr S. R. Moonesinghe","University College Hospital","","",""]
["0205","16/CAG/0104","The Paediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology (PARDIE) study","Expired","2016-09-16","N/A","Dr Jon Lillie","Evelina London Children’s Hospital","","",""]
["0206","16/CAG/0081","Using Patient Data in Amyloidosis to Understand Complex Diagnosis Pathways and Treatment Patterns","Expired","2016-09-09","N/A","Dr Julian Gillmore","University College London","","",""]
["0207","16/CAG/0035","Extension of a cohort mortality study of workers with blood lead measurement to include the analysis of cancer incidence data","Expired","2016-09-19","N/A","Prof. Damien M McElvenny","Institute of Occupational Medicine","","",""]
["0208","CR11/2013","Radioiodine Treated Thyrotoxicosis Study","Expired","2016-09-19","N/A","Professor J A Franklyn","University of Birmingham","","",""]
["0209","14/CAG/1009","Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest","Supported","2014-08-26","2020-08-26","Professor Gavin Perkins","University of Warwick","","",""]
["0210","16/CAG/0092","Improving the management of drug resistant tuberculosis in the UK.","Expired","2016-09-22","N/A","Dr Helen Stagg","University College London","","",""]
["0211","16/CAG/0115","Vitamin D Study","Expired","2016-09-23","N/A","Mr Simon Bowles","Northern General Hospital","","",""]
["0212","17/CAG/0011",{"$f":"INDIRECT(\"A\"&$A159&\"!B6\")","v":"Genetic Mechanisms in Polyposis of the Bowel"},"Supported","2017-01-27","2025-01-27","Laura Butlin, Research Coordinator","Cardiff University ","Applied","Yes","Yes"]
["0213","16/CAG/0146","The Association Between HsTrop and Tachyarrhythmias: Type 1 or Type 2 MI? (STRIPE-MI)","Expired","2016-12-20","N/A","Professor Nick Curzen","University Hospital Southampton NHS FT","","",""]
["0214","16/CAG/0143","Model fidelity of early intervention services for psychosis","Expired","2017-01-05","N/A","Ms Miriam Kincaid","McGill University","","",""]
["0215","17/CAG/0015","Antibiotic Reduction and Conservation in Hospitals (ARK-Hospital)","Expired","2017-02-20","N/A","Professor Timothy Peto","Oxford University Hospitals NHS Foundation Trust","","",""]
["0216","16/CAG/0135","Use of MDCT aortic root assessment to determine valve","Expired","2016-11-03","N/A","Dr Stephen Brecker","St George's University Hospitals NHS Foundation Trust","","",""]
["0217","16/CAG/0132","Mystical seizures and salience in temporal lobe epilepsy","Expired","2016-10-11","N/A","Professor Alasdair Coles","Addenbrooke's Hospital, Cambridge University","","",""]
["0218","16/CAG/0126","Intraoperative hypotension in elder patients","Expired","2016-09-28","N/A","Dr Daniel Martin","Royal Free London NHS Foundation Trust","","",""]
["0219","16/CAG/0121","Epidemiology of Cancer after solid organ transplantation","Supported","2016-10-06","2024-10-06","Dr Adnan Sharif","University Hospitals Birmingham","","Yes","No"]
["02120","16/CAG/0120","Transcranial direct current stimulation impact on therapy","Expired","2016-10-17","N/A","Miss Margaret Sandars","School of Psychological Sciences                                                                                  Neuroscience and Aphasia Research Unit (NASU)","","",""]
["02121","16/CAG/0113",{"$f":"INDIRECT(\"A\"&$A168&\"!B6\")","v":"The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data."},"Expired","2016-10-06","N/A","Ms Belene Podmore","Phd Student/ Research Fellow","","",""]
["02122","16/CAG/0096","Therapeutic Assessment (TA) of Adolescents Presenting with Self Harm versus Standard Psychosocial Assessment and Risk Management. Randomised Controlled Trial Long-term Follow Up.","Expired","2016-12-29","N/A","Dr Dennis Ougrin","King's College London","","",""]
["02124","16/CAG/0094","Reducing misdiagnosis and antibiotic prescribing practices in hospitals: a case series review and qualitative study of diagnosis, management and treatment of urinary tract infections in adults aged over 70 years.","Expired","2016-10-14","N/A","Dr Beryl Oppenheim","University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham","","",""]
["02125","16/CAG/0093","British Paediatric Surveillance Unit (BPSU) study of deaths in children with epilepsy aged under 16 years in the UK and the Republic of Ireland.","Expired","2016-09-19","N/A","Professor Alastair Sutcliffe","Institute of Child Health","","",""]
["02128","16/CAG/0088","A feasibility randomised controlled trial of mechanical chest compression devices for in-hospital cardiac arrest.","Expired","2016-10-10","N/A","Dr Keith Couper","University of Warwick","","",""]
["02131","16/CAG/0080","The LBIH Biobank","Expired","2017-01-05","N/A","Mrs Rhiannon Clarke","The University of Liverpool","","",""]
["02132","16/CAG/0063","aTTom-Extended: Extended follow-up of patients enrolled in the Adjuvant Tamoxifen Treatment - Offer More? (aTTom) trial","Supported","2016-07-08","2024-07-08","Dr Daniel Rea","University of Birmingham","","",""]
["02133","16/CAG/0061","Childhood Disintegrative Disorder Surveillance Study","Expired","2016-10-25","N/A","Dr Michael Absoud","Evelina London Children's Hospital","","",""]
["02134","16/CAG/0060","The Two Week Wait (2WW) study - an investigation of patient non-attendance at urgent referral appointments for suspected cancer","Supported","2016-10-31","2018-10-31","Dr Peter Knapp","University of York","","",""]
["02135","16/CAG/0049","National cohort study of late effects of Hodgkin lymphoma treatment","Expired","2016-05-23","N/A","Professor Anthony J Swedlow","Institute of Cancer Research","","",""]
["02136","16/CAG/0033","The Fenland Study - Phase 2","Expired","2016-04-13","N/A","Professor Nick Wareham","MRC Epidemiology Unit, University of Cambridge\nWork Address School of Clinical Medicine","","",""]
["02137","16/CAG/0032","Analysis; NHS No, date of birth, date of death, post code, gender, occupation ethnicity, Marital status, Next of Kin, Skin Colour. [relevant for indication of cancer risk].","Supported","2016-06-21","2017-06-21","Mr Deemesh Oudit","The Christie NHS Foundation Trust","","",""]
["02138","16/CAG/0027","Estimating the burden of complications of gastrointestinal infections.","Expired","2016-11-09","N/A","Ms. Oluwaseun Esan","Department of Primary Care Health Sciences","","",""]
["02139","16/CAG/0026","Does adding a facilitated behaviour change intervention improve outcomes among people with recently diagnosed type 2 diabetes receiving intensive treatment in General Practice? The ADDITION Plus 10 year follow up study.","Expired","2016-04-08","N/A","Professor Simon Griffin","University of Cambridge, MRC Epidemiology Unit","","",""]
["02140","16/CAG/0024","ADDITION - 10 year follow up","Supported","2016-04-08","2024-04-08","Professor Simon Griffin","University of Cambridge","","Yes","No"]
["02141","16/CAG/0007","Information flow in General Practice: investigating the processing of discharge summaries to improve patient safety.","Supported","2016-02-15","2017-02-15","Professor Tony Avery","University of Nottingham","","",""]
["02142","16/CAG/0021","Effectiveness and Cost-effectiveness of 'Usual Care' versus 'Specialist Integrated Care': A Comparative Study of Hospital Discharge Arrangements for Homeless People in England.","Expired","2016-05-11","N/A","Dr Michelle Cornes","King's College London","","",""]
["02143","16/CAG/0015","Evaluating variation in special educational needs provision for children with Down syndrome and associations with emergency use of hospital care.","Expired","2016-07-05","N/A","Prof Ruth Gilbert","University College London","","",""]
["02144","16/CAG/0139","Life threatening bronchopulmonary dysplasia in infants - A rare disease BPSU survey","Expired","2016-10-11","N/A","Dr Sundeep Harigopal","The Newcastle upon Tyne Hospitals NHS Foundation Trust","","",""]
["02145","16/CAG/0131","Niemann-Pick Type C (NP-C) Patient Finder","Expired","2016-12-22","N/A","Dr Robin Lachmann","University College London Hospitals","","",""]
["02146","16/CAG/0127","Detecting and alleviating language impairments due to Traumatic Brain Injury","Expired","2017-02-09","N/A","Dr Michelle Hall","University of Manchester","","",""]
["02147","16/CAG/0124","A study to investigate the association between selective uptake of cervical cancer screening and all cause mortality.","Supported","23/11/2016-Revised 02/12/2016","2022-11-23","Prof Peter Sasieni","Queen Mary University of London","","",""]
["02148","16/CAG/0117 - Duplicate entry - see 0203","An extension of the Arnold Lodge Admission Cohort Reconvictions and Intervening Treatment (ALACRITy)","N/A","2016-09-16","N/A","N/A","N/A","","",""]
["02149","16/CAG/0114","LUCI: Long-term follow-up of urinary tract infection (UTI) in childhood and implications: an electronic record-linked cohort study.","Expired","2016-11-03","N/A","Dr Kathryn O'Brien","Cardiff University","","",""]
["02150","16/CAG/0098","THE fullPIERS RISK PREDICTION MODEL FOR WOMEN WITH PRE-ECLAMPSIA: EXTERNAL VALIDATION, RECALIBRATION AND ADDED VALUE OF A NOVEL BIOMARKER (PLACENTAL GROWTH FACTOR)","Expired","2016-12-02","N/A","Dr. Manu Vatish","University of Oxford","","",""]
["02151","16/CAG/0072","TargetCOPD: A randomised controlled trial of targeted case finding for COPD versus routine practice in primary care.","Expired","2016-06-03","N/A","Dr. Rachel Jordan","The University of Birmingham","","",""]
["02152","16/CAG/0043","British Association of Dermatologists Biologic Interventions Register.","Supported","2016-03-24","2025-09-25","Ian Evans (Programme Manager)","The University of Manchester","","Yes","Yes"]
["02153","16/CAG/0013","A comparison of risk scores in consecutive, unselected chest pain presentations with suspected acute coronary syndrome in the era of high sensitive Troponin.","Expired",{"$f":"INDIRECT(\"A\"&$A195&\"!B34\")","v":"2016-01-25"},{"$f":"IF(D195<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A195&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A195&\"!B35\")))","v":"N/A"},"Dr Aleem Khand, Consultant Cardiologist & Chief Investigator for the project ","Aintree University Hospital",{"$f":"IF(INDIRECT(\"A\"&$A195&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A195&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A195&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A195&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A195&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A195&\"!B39\"))","v":""}]
["02154","16/CAG/0025","Extension of the Partnerships in Care Research Database","Expired","29/07/2016","N/A","Professor Conor Duggan","Calverton Hill Hospital","","",""]
["02155","16/CAG/0157","Case-control study for Campylobacter in the under 5s","Supported","2015-12-02","2017-12-02","Professor Sarah J O'Brien","University of Liverpool","","",""]
["02156","CAG 5-03 (PR3)/2013","Mortality outcome in the London COPD cohort","Expired","2014-01-07","N/A","Professor Jadwiga Wedzicha","University College London","","",""]
["02157","15/CAG/0103","Behçet’s syndrome in children and young people in the United Kingdom","Expired","2015-05-15","N/A","Dr Clare Pain","Alder Hey Children's NHS Foundation Trust","","",""]
["02158","CR20/2014","CAERPHILLY ISCHAEMIC HEART DISEASE STUDY SPEEDWELL STUDY - LONGITUDINAL STUDY OF ISCHAEMIC HEART DISEASE EARLY LIFE ORIGINS OF INSULIN RESISTANCE\nMORTALITY AND CANCER IN CHRISTS HOSPITAL SCHOOL COHORT","Supported","2015-05-20","2024-05-20","Professor Yoav Ben-Shlomo","University of Bristol","","",""]
["02159","CR38/2014","ADDITION - Cambridge","Supported","2015-04-09","2024-04-09","Dr Nick J Wareham","University of Cambridge","","",""]
["02160","CAG 2-07(c)/2013","The Pesticide Users’ Health Study: Nervous system, eye, respiratory and skin disease among certified pesticide users.","Supported","2015-01-22","2025-01-22","Gillian Nicholls, Chief Investigator","Health and Safety Executive","Applied","Yes","No"]
["02161","15/CAG/0179","West Midlands Regional Children's Tumour Registry","Expired","2016-10-24","N/A","Miss Helen Curry","Birmingham Children's Hospital NHS Foundation Trust","","",""]
["02162","16/CAG/0156","UK FOCSS","Expired","2017-01-30","N/A","Professor Usha Menon","Department of Women's Cancer, Institute for Women's Health, UCL","","",""]
["2163","16/CAG/0149","Measuring inequalities in the access to and utilisation of genetic and genomic services across the Collaboration for Leadership in Applied Health Research and Care North West Coast Region [CLAHRC NWC","Supported","2017-03-13","2018-03-13","Mrs Sikhanyisiwe Nhamburo","University of Central Lancashire","","",""]
["2164","17/CAG/0033","Prospective observational study of the long term hazards of anti-TNF therapy in rheumatoid arthritis.","Supported","2017-03-13","2025-03-13","Professor Kimme Hyrich","The University of Manchester","Applied","Yes","No"]
["02165","16/CAG0142","Epidemiology of Coeliac Disease in Southern Derbyshire","Supported","2016-10-11","2017-10-11","Dr Geoffrey K T Holmes","Royal Derby Hospital","","",""]
["02166","15/CAG/0182","Understanding the Nature and Frequency of Avoidable Significant Harm in Primary Care (Phase 2)","Expired","2016-04-11","N/A","Professor Anthony J Avery","University of Nottingham","","",""]
["02167","17/CAG/0012","Cancer survival trends in the United Kingdom","Expired","2017-03-09","N/A","Professor Michel P Coleman","London School of Hygiene & Tropical Medicine","","",""]
["02169","17/CAG/0029","Surveillance of invasive Listeria infections in infants under 90 days of age","Expired","2017-03-20","N/A","Dr Stefania Vergnano","Royal Bristol Children Hospital","","",""]
["02170",{"$f":"INDIRECT(\"A\"&A211&\"!B4\")","v":"17/CAG/0025"},"Liver transplantation as treatment for patients with hepatocellular carcinoma; a study using existing electronic data.","Supported","2017-03-20","2024-03-20","Mr David Wallace","London School of Hygiene and Tropical Medicine","","Yes","No"]
["02171","16/CAG/0064","The UK Renal Registry: a research database","Supported","2017-03-07","2025-03-07","Dr Zoe Plummer, Senior Project Manager (Research and Operations), The Renal Association ","North Bristol NHS Trust","Applied","Yes","Yes"]
["02172","17/CAG/0010","NRCT Research Database V1.0","Supported","2017-03-28","2023-03-28","Professor Jane Green","Cancer Epidemiology Unit (University of Oxford)","","",""]
["02173","CAG 2-03(PR2)/2014","Mental Disorder & Cancer care: a data linkage study in south London II","Expired","2014-09-12","N/A","Professor Robert Stewart","Kings College London","","",""]
["02174","17/CAG/0031","ReMLap","Expired","2017-04-13","N/A","Dr Julian Sonksen","Dudley Group NHS FT","","",""]
["02175","17/CAG/0034","The Nuclear Community Charity Fund Chromosomal Study","Expired","2017-04-13","N/A","Dr Rhona M Anderson","Brunel University London","","",""]
["02176","17/CAG/0020","Clinical and Biological factors associated with relapse and length of survival following relapse in UK neuroblastomas","Supported","2017-05-02","2024-05-02","Professor Deborah Tweddle","Wolfson Childhood Cancer Research Centre, Northern Institute for Cancer Research, Newcastle University","","",""]
["02177","17/CAG/0018","Implementation of a Telephone-Based Case Management Intervention for Patients at risk of High Emergency Department Utilisation in the English NHS",{"$f":"INDIRECT(\"A\"&$A218&\"!B32\")","v":"Supported"},"2017-05-04","2024-05-04",{"$f":"(INDIRECT(\"A\"&$A218&\"!B9\"))","v":"An Nguyen, Head of Analytics "},{"$f":"(INDIRECT(\"A\"&$A218&\"!B8\"))","v":"Nuffield Trust (sponsored by HealthNavigator)"},"","",""]
["02178","17/CAG/0013","Do Patients with Social Deprivation present late with Dementia?","Expired","2017-05-08","N/A","Dr Richard Barnes","Merseycare NHS Trust","","",""]
["02179","17/CAG/0060","Evaluation of the Recommended Summary Plan for Emergency Care and Treatment (RESPECT)","Supported","2017-06-09","2021-06-09","Professor Gavin Perkins","University of Warwick","","",""]
["02180","17/CAG/0044","S-AVANT. Follow-up to the AVANT study up to 8 and 10 years (median follow-up) in patients with colon carcinoma.","Supported","2017-06-09","2018-06-09","Dr Stephen Falk","University Hospitals Bristol","","",""]
["02181","17/CAG/0063","REFLECT: Recovery Following Intensive Care Treatment","Expired","2017-06-09","N/A","Mrs Sarah Vollam","University of Oxford","","",""]
["02182","17/CAG/0058","National Chronic Kidney Disease Audit","Supported","2017-06-12","2024-06-12","Dr Spiros Denaxas","Univeristy College London","","",""]
["02183",{"$f":"INDIRECT(\"A\"&A224&\"!B4\")","v":"17/CAG/0036"},"Real-World Primary Biliary Cholangitis (PBC) patient pathways in South East England","Supported","2017-06-20","2018-06-20","Dr Marinos Pericleous","Royal Surrey County Hospital","","",""]
["02184",{"$f":"INDIRECT(\"A\"&A225&\"!B4\")","v":"17/CAG/0097"},"SEARCH - A population based study of genetic predisposition to ovarian cancer","Supported","2017-06-23","2024-06-23","Valerie Rhenius, Research Assistant","University of Cambridge","","",""]
["02185",{"$f":"INDIRECT(\"A\"&A226&\"!B4\")","v":"17/CAG/0087"},"Pilot Study for the Tight-K Study","Supported","2017-06-26","2018-06-26","Dr Ben O’Brien","Barts Health NHS Trust","","",""]
["02186","17/CAG/0028","Professional decision making around next generation clinical genetics","Supported","2017-06-28","2018-06-28","Professor Adam Hedgecoe","Cardiff University","","",""]
["02187","17/CAG/0092","Evaluation of Prosthetic Joint infection (PJI) After Total Knee Replacement (TKR): Is the Assessment of Plasma Viscosity (PV) as Reliable as the Erythrocyte Sedimentation Rate (ESR)?","Expired","2017-06-29","N/A","Mr Andrew Toms","University of Exeter Medical School","","",""]
["02188","17/CAG/0098","SEARCH: A population based study of genetic predisposition to endometrial cancer","Supported","2017-06-30","2024-06-30","Valerie Rhenius, Research Assistant","University of Cambridge","","",""]
["02189","16/CAG/0118","A Study of the Natural History of Renal Disease in TSC2/PKD1 Contiguous Gene Deletion Syndrome.","Supported","2017-04-12","2024-04-12","Dr Iris Egner","Cardiff University","","Yes","Yes"]
["02190","17/CAG/0101","Acute Day Units as Crisis Alternatives to Residential Care (AD-CARE) Work package 3","Expired","2017-07-06","N/A","Professor David Osborn","University College London","","",""]
["02191","17/CAG/0103",{"$f":"INDIRECT(\"A\"&$A232&\"!B6\")","v":"West Midland's Regional Children's Tumour Registry"},"Supported","2017-07-06","2024-07-06","Dr Martin English","Birmingham Children's Hospital NHS Foundation Trust","Applied","Yes","No"]
["02192","17/CAG/0093","Hodgkin Lymphoma Survivorship Questionnaire Study","Expired","2017-07-25","N/A","Dr Aislinn Macklin-Doherty","Institute of Cancer Research, University of London","","",""]
["02193","17/CAG/0024","Analysing Emergency and Urgent Care System Demand in Yorkshire and Humber: A data-linkage study of pre-hospital, emergency department and out of hours service data","Expired","2017-04-19","N/A","Professor Suzanne Mason","University of Sheffield","","",""]
["02194","17/CAG/0094","The assessment of risk and safety in mental health services","Supported","2017-08-18","2024-08-18","Dr Nav Kapur","University of Manchester","Applied","Yes","Yes"]
["02195",{"$f":"INDIRECT(\"A\"&A236&\"!B4\")","v":"16/CAG/0147"},"Understanding the police response to vulnerability and risk","Expired","2017-01-27","N/A","Dr Katharine Ford","Public Health Wales","","",""]
["02196","17/CAG/0082","Do specialist cancer services for teenagers and young adults (TYA) add value?","Supported","2017-08-21","2024-08-21","Dr Rachel Taylor","University College London Hospitals NHS Foundation Trust","","",""]
["02197","17/CAG/0076","The Invasive Dentistry – Endocarditis Association (IDEA) Study: A Study of the link between invasive dental procedures and critical medical events including infective endocarditis, myocardial infarction, stroke, pulmonary embolus and spontaneous pre-term birth.","Expired","2017-09-27","N/A","Professor Martin H. Thornhill","The University of Sheffield\nAcademic Unit of Oral & Maxillofacial Medicine & Surgery","","",""]
["02198","17/CAG/0119","Steps Towards Increasing Bowel Cancer Screening Uptake","Expired","2017-10-10","N/A","Anastasia Tsipa","University of Leeds","","",""]
["02199","17/CAG/0164","A case-control study to investigate transmission routes for sporadic STEC infections in England","Expired","10/10/2017","N/A","Dr Paul Hunter","Norwich Medical School, University of East Anglia","","",""]
["02200","17/CAG/0144","PPH Butterfly","Expired","2017-10-17","N/A","Professor Andrew Weeks","University of Liverpool","","",""]
["02201","17/CAG/0021","Pregnancy after kidney donation in living donor transplantation: a retrospective case-control study.","Expired","2017-10-17","N/A","Professor Nizam Mamode","Guy's & St Thomas's Foundation NHS trust and Kings College London","","",""]
["02202","16/CAG/0122","Long term follow up of asymptomatic carotid surgery trial (acst-1)","Expired","2016-10-26","N/A","Dr Rebecca Llewellyn-Bennett","University of Oxford","","",""]
["02203","17/CAG/0158","Managing the risk of self-inflicted death to support a psychologically safe and rehabilitative criminal justice pathway","Expired","2017-10-24","N/A","Professor Jenny Shaw","University of Manchester","","",""]
["02204","17/CAG/0166","Using Guthrie cards for a serosurveillance study of maternally-derived antibody against Group B Streptococcus (GBS)","Expired","2017-10-27","N/A","Dr Mehring Le Doare","Imperial College London","","",""]
["02205","17/CAG/0133","Data quality on shared information","Expired","2017-11-02","N/A","Dr Pablo Millares-Martin","University of Sheffield","","",""]
["02206","17/CAG/0182","Safety and Feasibility Evaluation of Tourniquets for Total Knee Replacement Study","Expired","2017-11-06","N/A","Mr Peter D H Wall","CSRI","","",""]
["02207","17/CAG/0180","MR865 (Whitehall Study)","Supported","2017-11-15","2024-11-15","Professor Robert Clarke","Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU)","Applied","Yes","No"]
["02208",{"$f":"INDIRECT(\"A\"&A249&\"!B4\")","v":"17/CAG/0107"},"WMUK Rory Morrison Registry","Supported","2017-11-22","2023-11-22","Dr. Shirly D'Sa","UCLH","","",""]
["02209","17/CAG/0162","GP Reminders for Bowel Scope Screening non-Participants","Expired","2017-11-30","N/A","Dr Yasemin Hirst","University College London","","",""]
["02210","17/CAG/0055","CRIS Linkage with DWP Employment and Benefits Data","Expired","2017-12-01","N/A","Professor Matthew Hotopf","Maudsley NIHR Biomedical Research Centre","","",""]
["02211","17/CAG/0176","A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneursyms: The UK Complex Aneurysm Study (UK-COMPASS).","Supported","2017-12-13","2024-12-13","Professor Srinivasa Rao Vallabhaneni","Royal Liverpool and Broadgreen University Hospitals NHS Trust","","Yes","No"]
["02212","17/CAG/0191","DETERMINE-PD","Expired","2017-12-08","N/A","Dr Louise Allan","Newcastle University","","",""]
["02213","17/CAG/0156","Rectal Cancer Oncological Complete Response Database (OnCoRe)","Supported","2017-12-14","2024-12-14","Professor Andrew Renehan","Christie NHS Foundation Trust","","Yes","No"]
["02214",{"$f":"INDIRECT(\"A\"&A255&\"!B4\")","v":"17/CAG/0177"},"Exploring DNA methylation as an initiating event in childhood cancers","Expired","2017-12-19","N/A","Dr Jill A McKay","Newcastle University","","",""]
["02215","17/CAG/0165","Evaluation of the sensitivity and specificity of the Wessex Trauma Network trauma unit bypass tool in predicting major trauma, with suggestions for modifications to assist pre-hospital clinicians in appropriate triage and transport.","Supported","2017-12-20","2018-12-20","Ms Eleanor Freshwater","University Hospitals Southampton","","",""]
["02216","17/CAG/0171","Testing a diagnostic aid for hip dysplasia in primary care","Expired","2017-12-20","N/A","Professor Andreas Roposch","Great Ormond Street Hospital for Children","","",""]
["02217","16/CAG/0145","An investigation of decision making around treatment escalation","Expired","2017-02-06","N/A","Professor Alison Richardson","University Hospital Southampton NHS Foundation Trust (UHSFT)","","",""]
["02218","16/CAG/0102","Health literacy and its relationship with process and outcomes in people undergoing dialysis or with a kidney transplant","Expired",{"$f":"INDIRECT(\"A\"&$A259&\"!B34\")","v":"2017-04-10"},{"$f":"IF(D259<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A259&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A259&\"!B35\")))","v":"N/A"},"Chris Watson","University of Cambridge Department of Surgery",{"$f":"IF(INDIRECT(\"A\"&$A259&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A259&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A259&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A259&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A259&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A259&\"!B39\"))","v":""}]
["02219","17/CAG/0151","A randomised trial of expedited transfer to a cardiac arrest centre for non-ST elevation out-of-hospital cardiac arrest (ARREST)","Supported","2018-01-04","2025-01-04","Professor Simon R Redwood","St Thomas’ Hospital","","Yes","No"]
["02220","17/CAG/0159","Predicting flow to high-acuity services from 111: Data analysis plan","Expired","2018-01-08","N/A","Dr Michael Hallsworth","Behavioural Insights Team Ltd","","",""]
["02221",{"$f":"INDIRECT(\"A\"&A262&\"!B4\")","v":"17/CAG/0199"},"The use of artificial nutrition and hydration at the end of life in acute stroke - a feasibility study","Expired","2018-01-10","N/A","Dr Helen S Jones","Lancashire Teaching Hospitals NHS Foundation Trust","","",""]
["02222","CR13/2014","Haemostatic Factors of Coronary Heart Disease","Expired","2015-03-13","N/A","Professor Stephen Humphries","Royal Free & University College Medical School","","",""]
["02223","18/CAG/0007","Evaluating alternative protocols for identifying and managing patients with familial hypercholesterolaemia: cost-effectiveness analysis with qualitative study","Expired","2018-01-26","N/A","Professor Nadeem Qureshi","University of Nottingham","","",""]
["02224","17/CAG/0205","MAPPING Study","Expired","2018-01-26","N/A","Professor Andrea Rockall","Imperial Healthcare NHS Trust","","",""]
["02225","17/CAG/0081","UK Women's Cohort Study - HES","Supported","2018-02-02","2025-02-02","Professor Janet E. Cade","University of Leeds","","Yes","No"]
["02226","17/CAG/0167","Prevalence and Investigation of Laboratory Diagnosed Anaemia in Secondary Care","Expired","2018-02-02","N/A","Dr James Plumb","University of Southampton","","",""]
["02227","17/CAG/0206","The relationship between body composition, tumour activity, functional activity and survival in patients with advanced cancer","Supported","2018-07-02","2019-07-02","Dr Barry Laird","University of Glasgow","","",""]
["02228","18/CAG/0003","FAST- Febuxostat versus Allopurinol Streamlined Trial A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia","Supported","2018-02-09","2025-02-09","Professor Thomas MacDonald","University of Dundee","","Yes","No"]
["02229","18/CAG/0002","Trajectories of diabetes related health measures (from linked lab data) and subsequent health and educational outcomes","Supported","2018-02-09","2025-02-09","Dr Robert French","Cardiff University","Applied","Yes","No"]
["02230","18/CAG/0010","Prevention of Fall Injury Trial","Expired","2018-02-15","N/A","Professor Sarah Lamb","University of Warwick","","",""]
["02231","17/CAG/0189","Surveillance of Incidence of first time diagnosis of Early Onset Depression in children aged 3-13 years the United Kingdom and Republic of Ireland (EOD-UK & ROI)","Expired","2018-02-15","N/A","Dr Aditya Sharma","Northumberland Tyne and Wear NHS Trust","","",""]
["02232",{"$f":"INDIRECT(\"A\"&A273&\"!B4\")","v":"18/CAG/0005"},"Using Guthrie cards for a serosurveillance study of maternally-derived antibody against pertussis","Expired","2018-02-27","N/A","Dr Kirsty Le Doare","Public Health England","","",""]
["02233","17/CAG/0198","Long term outcomes of functional neurological symptoms in children","Expired","2018-02-28","N/A","Dr Rob Forsyth","Newcastle upon Tyne Hospitals NHS Foundation Trust","","",""]
["02234","18/CAG/0021","The incidence of hydroxychloroquine retinopathy in England a prospective case-finding study.","Expired","2018-03-01","N/A","Miss Srilakshmi Sharma","Oxford University Hospitals NHS Trust","","",""]
["02235","17/CAG/0187","The Street Triage Project V1","Supported","2018-03-02","2019-03-02","Miss Rivka Smith","University of Sheffield","","",""]
["02236","17/CAG/0114","Understanding homicide against family carers: Expanding the focus from individual- to contextual-relational factors-A Phase II Analysis","Supported","2018-03-02","2019-03-02","Mr Andy Brown","Mersey Care NHS Trust","","",""]
["02237","18/CAG/0012","Exploring collaborative working in adult intellectual (learning) disability services","Expired","2018-03-02","N/A","Miss Madeleine Tremblett","University of Plymouth","","",""]
["02238","17/CAG/0173","An evaluation of the impact of the MedEye System in one U.K. Hospital Trust","Expired","2018-03-05","N/A","Dr Sarah Slight","Newcastle University","","",""]
["02239","17/CAG/0188","Improving the Diagnosis and Management of neurodegenerative dementia of the Lewy body type in the NHS (DIAMOND-Lewy). Work package 1 Review (WP1R) - Reviewing the impact of the assessment toolkit on diagnosis of Lewy body dementia.","Expired","2018-03-13","N/A","Professor John O'Brien","University of Cambridge","","",""]
["02240","17/CAG/0032","Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study","Supported","2017-03-15","2019-03-15","Dr Daniel Prieto-Alhambra","NDORMS, University of Oxford","","",""]
["02241",{"$f":"INDIRECT(\"A\"&A282&\"!B4\")","v":"15/CAG/0208"},"PEPS Data Linkage Study","Supported","2016-05-27","2017-05-27","Professor Mary McMurran","University of Nottingham","","",""]
["02242","18/CAG/0050","The DESiGN Trial Detection of small for gestational age fetus (SGA) – a cluster randomised controlled trial to evaluate the effect of the Growth Assessment Protocol (GAP) programme","Expired","2018-03-21","N/A","Dr Dharmintra Pasupathy","King's College London and Guy's & St Thomas' NHS Foundation Trust","","",""]
["02243","16/CAG/0136","Personalised Risk assessment in Febrile illness to Optimise Real-life Management across the European Union (PERFORM)","Expired","2017-01-11","N/A","Professor Michael Levin","Imperial College Healthcare Trust","","",""]
["02244","17/CAG/0204","CRIS Linkage wtih the Office for National Statistics Census Data",{"$f":"INDIRECT(\"A\"&$A285&\"!B32\")","v":"Expired"},"2018-03-23","N/A",{"$f":"(INDIRECT(\"A\"&$A285&\"!B9\"))","v":"Dr Jayati Das-Munshi"},{"$f":"(INDIRECT(\"A\"&$A285&\"!B8\"))","v":"Office for National Statistics and the South London and Maudsley NHS Foundation Trust (SLaM)"},"","",""]
["02245","17/CAG/0172","Expanded Access of Blincyto® in Patients with Acute Lymphoblastic Leukaemia: A Retrospective Observational Study","Supported","2018-03-28","2019-03-28","Professor Adele Fielding","OXON Epidemiology","","",""]
["02246","18/CAG/0043","Predictive biomarkers for more effective targeted therapy of colorectal cancer patients with anti-EGFR antibodies","Supported","2018-04-06","2019-04-06","Dr Sharadah Essapen","Royal Surrey County NHS Foundation Trust","","",""]
["02247","17/CAG/0001","Infective endocarditis after valve replacement: outcomes after surgical and transcatheter valve implantation and the impact of the NICE 2008 guidelines on prosthetic valve endocarditis","Expired","2017-02-10","N/A","Dr Bernard Prendergast","Guy’s and St Thomas’ NHS Foundation Trust","","",""]
["02248",{"$f":"INDIRECT(\"A\"&A289&\"!B4\")","v":"16/CAG/0138"},"Genetic analysis of ovarian granulosa cell tumours","Expired","2017-04-19","N/A","Dr Esther Moss","University Hospitals of Leicester","","",""]
["02249","18/CAG/0059","Evaluating the effect of Community Mental Health services on the lives of people with mental health problems in England over a time of economic insecurity","Expired","17/04/2018","N/A","Dr Peter W Smith","Administrative Data Research Centre at the University of Southampton","","",""]
["02250","17/CAG/0155","Investigation of Aneurysm Repair Decision Aid (ARDA) for Management of Abdominal Aortic Aneurysms: Safety Validation and Impact Assessment.","Supported","2017-10-25","2020-10-25","Professor S.R. Vallabhaneni","Royal Liverpool and Broadgreen University Hospitals NHS Trust","","",""]
["02251","18/CAG/0038","A randomised controlled trial to evaluate invitation to community-based low dose computed tomography (LDCT) screening for lung cancer versus usual care in a targeted population at risk.","Supported","2018-04-20","2024-04-20","Dr Matthew Callister","The University of Leeds","","",""]
["02252","18/CAG/0057","Hospice-led innovations for end of life care","Supported","2018-04-20","2019-04-20","Mr Giles Colclough","NHS England and Hospice UK","","",""]
["02253","18/CAG/0049","Using primary care to increase uptake of the Bowel Scope Screening Programme in Yorkshire: evaluating paper and telephone based interventions","Supported","2018-05-01","2020-05-01","Dr Lesley McGregor","University College London","","",""]
["02254","18/CAG/0031","Unexplained visual loss following silicone oil removal in patients presenting with retinal detachment in the United Kingdom: results of a prospective surveillance study","Expired","2018-05-03","N/A","Ms Haifa Madi,","County Durham and Darlington NHS Foundation Trust","","",""]
["02255","17/CAG/0016","Patient Reported Outcome Measures for Neurological Conditions","Expired","2017-05-24","N/A","Dr J Hewitt","Aneurin Bevan University Health Board","","",""]
["02256","18/CAG/0041",{"$f":"INDIRECT(\"A\"&$A297&\"!B6\")","v":"Liverpool Lung Project"},"Supported","2018-05-10","2024-05-10","Professor John K Field","University of Liverpool","","",""]
["02257",{"$f":"INDIRECT(\"A\"&A298&\"!B4\")","v":"17/CAG/0054"},"Life and Bladder Cancer: The Yorkshire Cancer Research Bladder Cancer Patient Reported Outcomes Survey","Expired","2017-05-05","N/A","Professor James Catto","University of Sheffield","","",""]
["02258","18/CAG/0008","Sight-threatening chemical injury study in association with the British Ophthalmological Surveillance Unit","Expired","2018-05-15","N/A","Dr Nicola Cronbach","Buckinghamshire Healthcare NHS Trust","","",""]
["02259","18/CAG/0006","A Prospective Study of Acute Severe Poisonings In Children","Expired","2018-10-15","N/A","Dr Elizabeth Starkey","Derby Hospitals NHS Foundation Trust","","",""]
["02260","18/CAG/0060","European Prospective Investigation into Cancer and Nutrition, Oxford cohort (formerly \"the Royal College of General Practitioners/Imperial Cancer Research Fund Diet, Hormones and Health Study\")Known as EPIC- Oxford","Expired","2018-05-15","N/A","Professor Timothy Key","University of Oxford","","",""]
["02261","17/CAG/0096","SEARCH: A population based study of pre-disposition to breast cancer","Supported","2017-06-21","2024-06-21","Valerie Rhenius, Research Assistant","University of Cambridge","","",""]
["02262","17/CAG/0186","REACH Pregnancy Circles: An individual-level randomised controlled trial of group antenatal care","Supported","2018-05-18","2024-05-18","Angela Harden, Professor of Health Sciences (Chief Investigator)","University of East London","","",""]
["02263","18/CAG/0025","Improving Prediction of Outcome in Out of Hospital Cardiac Arrest Patients - The King's Out of Hospital Cardiac Arrest Registry (KOCAR)","Supported","2018-05-18","2019-05-18","Professor Philip MacCarthy","King's College Hospital","","",""]
["02264","18/CAG/0028","Mixed methods evaluation of the Getting it Right First Time programme: improvements to NHS orthopaedic care in England","Expired","2018-05-30","N/A","Dr Helen Barratt","University College London","","",""]
["02265",{"$f":"INDIRECT(\"A\"&A306&\"!B4\")","v":"18/CAG/0004"},"Transient patella dislocation and mode of early mobilisation","Supported","2018-05-31","2019-05-31","Dr Bamikole Ogunwale","Heart of England NHS Foundation Trust","","",""]
["02266","18/CAG/0044","Long Term follow up of the ASCO Trial into Electronic Records (LATER)","Supported","2018-06-04","2024-06-04","Professor Peter Sever, Chief Investigator","Imperial College London","","",""]
["02267","18/CAG/0054","Lung cancer screening study using low dose CT to support the development of blood tests for early cancer detection","Supported","2018-06-05","2024-06-05","Professor Samuel Janes","University College London","","",""]
["02268","18/CAG/0015","Improving diagnosis and management in dementia with Lewy bodies using the CPFT Research Database (CRATE)","Supported","2018-06-13","2024-06-13","Professor John O'Brien","University of Cambridge (on behalf on the Cambridgeshire and Peterborough NHS Foundation Trust)","","",""]
["02269","18/CAG/0056","Retinoblastoma gene mutations and risk of secondary primary tumours","Supported","2018-06-15","2024-06-15","Dr Zerrin Onadim, Head of Retinoblastoma Genetic Screening Unit","Barts Health NHS Trust","","",""]
["02270","18/CAG/0040","The eLIXIR project/ eLIXIR: Early Lifecourse data Cross-Linkage in Research: a Multidisciplinary partnership - linked data for research into maternal and child health","Supported","2018-06-15","2024-06-15","Professor Robert J Stewart","Maudsley NIHR Biomedical Research Centre","","",""]
["02271","18/CAG/0070","Renal Replacement Anticoagulant Management","Expired","2018-06-21","N/A","Dr Peter Watkinson","Intensive Care National Audit & Research Centre (ICNARC)","","",""]
["02272","17/CAG/0048","Long-term follow-up of the East London Sickle Cell Disease Neonatal Cohort","Supported","2017-09-07","2024-09-07","Dr Paul Telfer","Royal London Hospital ","","",""]
["02273",{"$f":"INDIRECT(\"A\"&A314&\"!B4\")","v":"CR17/2014"},"EPIDEMIOLOGICAL STUDY OF BRCA1 AND BRCA2\nMUTATION CARRIERS","Supported","2015-03-31","2024-06-13","Professor Antonis Antoniou, Chief investigator ","University of Cambridge","","",""]
["02274","18/CAG/0029","The effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)- a four arm randomised controlled trial","Expired","2018-06-29","N/A","Professor Derek Yellon","University College London","","",""]
["02275","18/CAG/0080","Development and Validation of Barts Heart Centre Surgical Infection Risk (B-SIR) Tool to Predict Surgical Site Infection After Cardiac Surgery","Expired","2018-07-06","N/A","Mrs Rosalie Magboo","Barts Health NHS Trust","","",""]
["02276","18/CAG/0087","A critical evaluation of community based integrated care policy","Expired","2018-07-09","N/A","Ms. Hannah Kendrick","University of Essex","","",""]
["02277","18/CAG/0082","Breast Cancer (BC) Predict - Providing breast cancer risk as part of the national breast cancer screening programme: building an evidence base on benefits and harms to inform a decision to implement","Expired","2018-07-13","N/A","Professor Gareth Evans","University of Manchester","","",""]
["02278","18/CAG/0071","Avoiding Cardiac Toxicity in lung cancer patients treated with curative-intent radiotherapy to improve survival","Supported","2018-07-13","2024-07-13","Dr Kevin Franks","Leeds Teaching Hospitals NHS Foundation","","Yes","No"]
["02279","18/CAG/0090","What changes in Medium Secure Care? A long term follow up study of outcomes, care, supervision and patients' experiences.","Expired","2018-07-13","N/A","Dr Ruth Bagshaw","Abertawe Bro Morgannwg Health Board","","",""]
["02280",{"$f":"INDIRECT(\"A\"&A321&\"!B4\")","v":"18/CAG/0084"},"Household transmission of Cryptosporidium in NW England and Wales, 2018-19: Risk factors and likely mechanisms for secondary spread.","Expired","2018-07-20","N/A","Dr Rob Christley","University of Liverpool","","",""]
["02281","18/CAG/0113","British Paediatric Surveillance Study of Food Protein Induced Enterocolitis Syndrome (FPIES) presenting to Paediatricians in the UK and Republic of Ireland","Expired","2018-07-20","N/A","Dr Gary Hylton Stiefel","University Hospitals of Leicester NHS Trust","","",""]
["02282","18/CAG/0066","United Kingdom Childhood Cancer Study","Supported",{"$f":"INDIRECT(\"A\"&$A323&\"!B34\")","v":"2018-07-24"},{"$f":"IF(D323<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A323&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A323&\"!B35\")))","v":"2024-07-24"},"Professor Eve Roman","University of York",{"$f":"IF(INDIRECT(\"A\"&$A323&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A323&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A323&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A323&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A323&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A323&\"!B39\"))","v":""}]
["02283","18/CAG/0085","Investigating the use of ‘frailty’ on death certificates and admission information- a retrospective case note analysis","Expired","2018-07-30","N/A","Dr Margaret M. Dunham","Sheffield Hallam University","","",""]
["02284","18/CAG/0094","The ACUTE (Ambulance CPAP: Use, Treatment Effect and Economics) feasibility study: A pilot randomised controlled trial of prehospital CPAP for acute respiratory failure","Expired","2018-08-28","N/A","Gordon Fuller","University of Sheffield","","",""]
["02285","18/CAG/0014","Mechanisms of Change in Psychological Therapy","Expired","2018-08-28","N/A","Iona Symington","Royal Holloway University of London","","",""]
["02286","18/CAG/0102","HES and NICOR data linkage for cardiac failure population analysis","Expired","2018-08-29","N/A","Emily Kwong, Clinical Engineer","Kings College London","","",""]
["02287","18/CAG/0091","Connected Bradford Linked Education and Healthcare Research Database","Supported","2018-09-03","2024-09-03","John Wright","Bradford Institute for Health Research - Bradford NHS Foundation Trust","","",""]
["02288","18/CAG/0052","BPSU survey of severe Chronic Fatigue Syndrome/Myalgic Encephalopathy","Expired","2018-09-04","N/A","Esther Crawley","University of Bristol and Royal United Hospitals Bath NHS Foundation Trust","","",""]
["02289","18/CAG/0111","Detection Dementia from Retinal Morphology: a Big Data Machine Learning based Retrospective Case-Control Study","Supported","2018-09-13","2022-09-13","Mr Pearse Keane","Moorfields Eye Hospital NHS Foundation Trust","","",""]
["02290","18/CAG/0105","The Incidence, Management and Early Outcome of Congenital Ichthyosis","Expired","2018-09-14","N/A","Professor Celia Moss","Birmingham Women’s And Children’s NHS Foundation Trust","","",""]
["02291",{"$f":"INDIRECT(\"A\"&A332&\"!B4\")","v":"18/CAG/0100"},"HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease","Supported","13/09/2018","2024-09-13","Louise Bowman","University of Oxford","","Yes","No"]
["02292","18/CAG/0124","Automated Cancer Diagnosis and Prognosis Using Digital Images","Supported","2018-09-24","2024-09-24","Dr Nicolas Orsi","University of Leeds","","",""]
["02293","17/CAG/0051","Head or Heart Database","Expired","2018-10-12","N/A","Ruth E. Gilbert","University College London","","",""]
["02294","18/CAG/0126","Connected Health Cities: Data linkage of urgent care data","Supported","2018-10-25","2024-04-19","Dr Rosie Gough, Project Manager ","University of Sheffield","","Yes","No"]
["02295","18/CAG/0189","Helicobacter pylori Screening Study: a randomised stomach cancer prevention trial","Supported","2018-10-26","2024-10-26","Professor Joan Morris, chief Investigator        ","Queen Mary, University of London","","",""]
["02296","18/CAG/0153","The POOL study: Establishing the safety of waterbirth for mothers and babies: A cohort study with nested qualitative component.","Supported","2018-11-02","2024-11-02","Julia Sanders","Cardiff University","","Yes","Yes"]
["02297","17/CAG/0145","Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience from 2009 to 2015","Supported","2017-09-07","2024-09-07","Simon Eccleshall, Chief Investigator","Norfolk and Norwich University Hospital NHS Foundation Trust","","Yes","No"]
["02298",{"$f":"INDIRECT(\"A\"&A339&\"!B4\")","v":"16/CAG/0134"},"Follow-up of the Hertfordshire Cohort Study through Hospital Episode Statistics","Expired","2017-04-11","N/A","Professor Elaine Dennison, Professor of Musculoskeletal Epidemiology","University of Southampton","","",""]
["02299","CR28/2014","Study of a Birth Cohort from Hertfordshire","Supported","2015-08-17","2024-08-17","Professor Elaine Dennison, Professor of Musculoskeletal Epidemiology","MRC Epidemiology Resource Centre, Southampton General Hospital","","",""]
["02300","18/CAG/0178","DEveloping a Complex Intervention for DEteriorating Patients using Theoretical Modelling (DECIDE study)","Expired","2018-11-07","N/A","Mr Duncan J Smith","City, University of London","","",""]
["02301","18/CAG/0145","Synergy between PCI with TAXUS and Cardiac Surgery: SYNTAX Extended Survival (SYNTAXES)","Expired","2018-11-08","N/A","Prof Nicholas Curzen","University Hospital Southampton NHS Foundation Trust","","",""]
["02302","18/CAG/0119","Comprehensive Patient Records (CPR) for Cancer Outcomes: A feasibility studyWorkstream 5: Patient Reported Outcome Measures (PROMs)","Expired","2018-11-08","N/A","Dr Geoff Hall","University of Leeds","","",""]
["02303","18/CAG/0159","Housing, family and environmental risk factors for hospital admissions in children","Supported","2018-11-09","2024-11-09","Dr Pia Hardelid","University College London","Applied","Yes","No"]
["02304","17/CAG/0129","Critically ill children and young people: do national Differences in access to Emergency Paediatric Intensive Care and care during Transport affect clinical outcomes and patient experience? The DEPICT study","Expired","2017-09-26","N/A","Dr Padmanabhan Ramnarayan","NIHR","","",""]
["02305",{"$f":"INDIRECT(\"A\"&A346&\"!B4\")","v":"18/CAG/0171"},"Epidemiological studies of the Porton Down veterans: a ten-year update of mortality and cancer incidence","Supported","2018-11-16","2024-11-16","Professor Nicola T Fear","King’s College London, University of Oxford and University of Lancaster ","Applied","Yes","No"]
["02306","18/CAG/0112","Understanding the mental health needs of mothers involved in family court cases: A research study exploring linkage between family court and mental health data","Expired","2018-11-20","N/A","Professor Ruth Gilbert","South London and Maudsley NHS Foundation Trust and King's College London Institute of Psychiatry","","",""]
["02307","18/CAG/0151","Prevalence of hip femoroacetabular impingement (FAI) syndrome in the general population","Supported","2018-11-20","2019-11-20","Dr Rita Patel","University of Bristol","","",""]
["02308","17/CAG/0052","NETS2HD-Six year outcomes for children with Hirschsprung's Disease","Expired","2017-05-18","N/A","Dr Benjamin Allin","Oxford University","","",""]
["02309","18/CAG/0152","Evaluation of patient access to medical test result services in general practice.","Expired","2018-11-28","N/A","Dr Gemma Lasseter","University of Bristol","","",""]
["02310","17/CAG/0078","Barts Health-NICOR - Extended Use of Data V1.1 2017","Expired","2017-06-29","N/A","James Chal, NICOR Chief Operating Officer","Barts Health NHS Trust","","",""]
["02311","18/CAG/0175","Do Invasive Dental Procedures Cause Prosthetic Joint Infections (PJI)? - The PJI Study","Expired","2018-12-04","N/A","Professor Martin H. Thornhill","University of Sheffield","","",""]
["02312","18/CAG/0156","The Distribution of Highly Sensitive Troponin in the Critically Unwell and Associated Mortality - The DIGNITY Study","Supported","2018-12-04","2024-12-04","Dr Jonathan Hinton, Cardiology Registrar","University Hospital Southampton NHS Foundation Trust ","","Yes","No"]
["02313",{"$f":"INDIRECT(\"A\"&A354&\"!B4\")","v":"18/CAG/0177"},"Evaluation of the medium to long term impact of commercial open-group behavioural weight loss programmes on body weight and diabetes risk in adults with overweight and obesity.","Supported","2018-12-10","2024-12-10","Dr Amy Ahern, Chief Investigator","University of Cambridge","Applied","Yes","No"]
["02314","17/CAG/0160","The HOME Study: A study comparing two different ways of looking after older people in hospitals to see if we can improve how quickly they go home.","Expired","2017-10-25","N/A","Prof Michael Sharpe","University of Oxford","","",""]
["02315","14/CAG/1041","Missed Diagnostic Opportunities","Expired","2015-03-09","N/A","Professor Stephen Campbell",0,"","",""]
["02316","15/CAG/0131","Integrate","Expired","2015-07-21","N/A","Professor Sarah J O’Brien",0,"","",""]
["02317","15/CAG/0140","Preceding paraneoplastic encephalitis in ovarian cancer","Expired","2015-09-08","N/A","Miss Kit Yi Wong","University of Birmingham","","",""]
["02318","15/CAG/0156","A randomised controlled trial to test the effectiveness of GP-based text-message reminders to facilitate uptake of colorectal cancer screening in London","Expired","2015-08-12","N/A","Dr Christian von Wagner","University College London (UCL)","","",""]
["02319","15/CAG/0157","Case-control study for Campylobacter in the under 5s","Expired","2015-12-02","N/A","Professor Sarah J O'Brien",0,"","",""]
["02320","15/CAG/0184","Young people with Attention Deficit Hyperactivity Disorder (ADHD) in transition from children’s services to adult services (CATCh-uS): a mixed methods project using national surveillance, qualitative and mapping studies.","Supported","2015-11-03","2016-11-03","Professor Tamsin Ford","University of Exeter Medical School","","",""]
["02321","15/CAG/0192","Outcomes of adolescents transitioning from children's ADHD services","Expired","2016-02-05","N/A","Dr Louise Theodosiou","Central Manchester University Hospitals NHS Foundation Trust","","",""]
["02322","15/CAG/0195","The DESiGN Trial Detection of small for gestational age fetus (SGA) – a cluster randomised controlled trial to evaluate the effect of the Growth Assessment Protocol (GAP) programme","Expired","2016-05-09","N/A","Dr Dharmintra Pasupathy","King’s College London","","",""]
["02323","15/CAG/0205","Use of a frailty index in end of life care","Expired","2016-03-14","N/A","Professor Barbara Hanratty","Newcastle University","","",""]
["02324","16/CAG/0016","The Survey of the Mental Health of Children and Young People 2016","Supported","2016-06-30","2018-06-30","Helen Henderson","NatCen Social Research","","",""]
["02325","16/CAG/0125","Does Learning to Perform Surgery on Cadavers Lead to Better Surgeons and Safer Patients?","Expired","2017-02-27","N/A","Dr Hannah James","University of Warwick","","",""]
["02326","16/CAG/0133","Incidence of infectious disease in BME groups using Onomap","Expired","2017-04-05","N/A","Dr Daniel Thomas","Public Health Wales","","",""]
["02327","17/CAG/0009","Risk factors for influenza-related complications in children","Expired","2017-06-06","N/A","Dr Kay Wang","University of Oxford","","",""]
["02328","16/CAG/0142","Epidemiology of coeliac disease in Southern Derbyshire","Supported","11/10/2016","2017-10-11","Dr Holmes","Derby Teaching Hospitals NHS FT","","",""]
["02329","17/CAG/0040","Incidence Study of Birdshot Retinochoroidopathy in the UK V1","Supported","2017-03-23","2018-03-23","Mr Mark Westcott","Moorfields Eye Hospital","","",""]
["02330","17/CAG/0069","Early identification of necrotising enterocolitis (NEC) in preterm infants","Supported","2017-06-06","2018-06-06","Miss Megan Greasley","Sheffield Teaching Hospitals NHS Trust","","",""]
["02331","17/CAG/0075","Incidence of JLSE in CYP and their access to care in the UK and ROI","Expired","2017-08-04","N/A","Dr Hanna Lythgoe","University of Liverppol","","",""]
["02332","17/CAG/0083","Is the Current Threshold for Diagnosis of \"Abnormality\", including non-ST Elevation Myocardial Infarction, using Raised Highly Sensitive Troponin Appropriate for a Hospital Population? The CHARIOT Study","Supported","2017-05-19","2025-05-19","Dr Jonathan Hinton","University Hospitals Southampton","Applied","Yes","No"]
["02333","17/CAG/0105","Cardiovascular markers of ischaemic stroke risk: a registry of stroke patients, their associated risk factors and cardiovascular investigations","Expired","2017-09-21","N/A","Dr Muzahir H Tayebjee","Leeds Teaching Hospitals NHS Trust","","",""]
["02334","17/CAG/0106","NICE Fit","Supported","2017-06-26","2018-06-26","Mr Muti Abulafi",0,"","",""]
["02335","17/CAG/0116","The incidence, presentation, treatment, and motor outcomes of essential infantile esotropia in the UK","Expired","2017-09-19","N/A","Mr Patrick Watts","Cardiff and Vale University Health Board","","",""]
["02336","17/CAG/0117","Prevalence and characteristics of fractures in preterm infants presenting to Accident and Emergency: A retrospective study.","Supported","2017-10-27","2018-10-27","Ms Liting Tong","University of Sheffield","","",""]
["02337","17/CAG/0126","Surveillance of Severe Microcephaly in the UK and Ireland (SSM-UKI)","Supported","2017-09-08","2024-09-08","Dr Rachel L Knowles","University College London Great Ormond Street Institute of Child Health","","",""]
["02338","17/CAG/0161","Epidemiological surveillance of Fetal Alcohol Syndrome in the United Kingdom and the Republic of Ireland in children under 16 years of age","Expired","2017-11-27","N/A","Dr Kathryn Johnson","Leeds Teaching Hospitals NHS Trust","","",""]
["02339","17/CAG/0169","Investigating an organ donation intervention in primary care: A single-practice feasibility study.","Expired","2017-12-08","N/A","Miss Catrin P Jones","University of Bedfordshire","","",""]
["02340","CAG 2-05(b)/2013","Pandemic Influenza Triage in the Emergency Department","Expired","2013-08-29","N/A","Professor Steve Goodacre","University of Sheffield","","",""]
["02341","CAG 2-07(b)/2014","The prevalence of patterned cutaneous injuries in child maltreatment","Supported","2015-02-20","2016-02-20","Professor Alison Kemp","Cardiff University ","","",""]
["02342","CAG 2-07(a)/2013","Developing effective strategies to reduce unscheduled care in\nchronic disease: Validation of a “red flag” system that identifies patients who are at risk of becoming frequent users of unscheduled care","Supported","2013-11-01","2015-11-01","Dr Tom Chan","University of Surrey","","",""]
["02343","CAG 2-07(b)/2013","The assessment of institutional violence and aggression: an evaluation of the predictive accuracy of five risk assessment tools","Expired","2013-06-28","N/A","Professor Jane Ireland","Ashworth High Secure Hospital","","",""]
["02344","CAG 5-03 (PR2)/2013)","United Kingdom Immune Thrombocytopenia Registry","Supported","2013-07-16","2016-07-16","Umesh Doobaree","Barts Health NHS Trust","","",""]
["02345","CAG 6-03(PR4)/2013","Comparing psoriasis treatments and care pathways using routine data","Supported","2013-11-11","2014-11-11","Professor Simon de Lusignan","University of Surrey","","",""]
["02346","CAG 7-06(b)/2013","Decision making for children with high risk brain tumours","Expired","2013-12-18",{"$f":"IF(D387<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A387&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A387&\"!B35\")))","v":"N/A"},"Professor Myra Bluebond-Langner","University College London",{"$f":"IF(INDIRECT(\"A\"&$A387&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A387&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A387&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A387&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A387&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A387&\"!B39\"))","v":""}]
["02347",{"$f":"INDIRECT(\"A\"&A388&\"!B4\")","v":"18/CAG/0180"},"LAUNCHES QI: Linking AUdit and National datasets in Congenital HEart Services for Quality Improvement","Supported","2018-11-30","2024-11-30","Dr Christina Pagel","University College London","","Yes","No"]
["02348","18/CAG/0182","UK Prospective Diabetes Study (UKPDS) Legacy Study: long term follow-up of participants into electronic health records","Supported","2018-12-20","2024-12-20","Professor Rury R. Holman","University of Oxford","","Yes","No"]
["02349","18/CAG/0024","Pregnancy Outcome Prediction Study: Transgenerational and Adult Review","Supported","2018-12-21","2024-12-21","Professor Gordon C S Smith","University of Cambridge","Applied","Yes","No"]
["02350","18/CAG/0181","Cost effectiveness modelling for adaptive liver surveillance in uveal melanoma patients screened with Magnetic Resonance Image or Ultrasound using the Liverpool Uveal Melanoma Prognosticator Online (LUMPO).","Expired","2018-12-21","N/A","Professor SE Coupland","University of Liverpool","","",""]
["02351","18/CAG/0118","HPV primary testing in cervical cancer screening: using behavioural science to understand anxiety and attendance","Expired","2019-01-07","N/A","Dr Jo Waller","University College London","","",""]
["02352","18/CAG/0176","Take home naloxone Intervention Multicentre Emergency setting feasibility trial (TIME)","Expired","2019-01-07","N/A","Helena Emery - Research Officer","Swansea University","","",""]
["02353","18/CAG/0013",{"$f":"INDIRECT(\"A\"&$A394&\"!B6\")","v":"Evaluating the real-world implementation of the Family Nurse Partnership in England: a data linkage study"},{"$f":"INDIRECT(\"A\"&$A394&\"!B32\")","v":"Expired"},{"$f":"INDIRECT(\"A\"&$A394&\"!B34\")","v":"2019-01-11"},"N/A",{"$f":"(INDIRECT(\"A\"&$A394&\"!B9\"))","v":"Dr Katie Harron"},{"$f":"(INDIRECT(\"A\"&$A394&\"!B8\"))","v":"University College London"},"","",""]
["02354","18/CAG/0207","Defining delirium and its impact in Parkinson’s Disease (DELIRIUM-PD)","Expired","2019-01-11","N/A","Dr Alison Yarnall","Newcastle University","","",""]
["02355",{"$f":"INDIRECT(\"A\"&A396&\"!B4\")","v":"18/CAG/0142"},"A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast, Ovarian & Endometrial Cancer","Supported","2019-01-21","2025-01-21","Valerie Rhenius, Research Assistant","University of Cambridge","","Yes","No"]
["02356","18/CAG/0199","The effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage: A pilot cluster randomised trial.","Expired","2019-01-22","N/A","Dr Laura Green","Queen Mary University of London","","",""]
["02357","18/CAG/0200","Longitudinal study of pelvic floor dysfunction, and its relationship with childbirth (ProLong20+)","Expired","2019-01-29","N/A","Professor Suzanne Hagen","Glasgow Caledonian University","","",""]
["02358","18/CAG/0202","Emergency Medical Dispatcher recognition of maternity emergencies using the International Academy Medical Priority Dispatch System: a mixed methods study","Expired","2019-01-28","N/A","Professor Rachael Fothergill","London Ambulance Service NHS Trust (LAS)","","",""]
["02359","18/CAG/0203","Not Intervening as a form of care: an ethnographic study of palliative care","Expired","2019-01-28","N/A","Professor Simon Cohn","LSTHM","","",""]
["02360","19/CAG/0004","Follow up of young people treated in CAEDS 2009-2014.Longitudinal Follow Up of Eating Disorder Treatment (L-FED)","Expired","2019-01-29","N/A","Dr Catherine Stewart","South London and Maudsley NHS Foundation Trust","","",""]
["02361","19/CAG/0013","Cerebrovascular accident and Acute coronary syndrome and Peri-operative Outcomes Study","Expired","2019-01-29","N/A","Professor Iain K Moppett","University of Nottingham","","",""]
["02362","18/CAG/0164 Duplicate entry - see 02364","02364 - Use and impact of the pre-hospital 12-lead electrocardiogram in the primary PCI era. Mixed method study (PHECG-2)","N/A","00:00:00","N/A","N/A","N/A","","",""]
["02363",{"$f":"INDIRECT(\"A\"&A404&\"!B4\")","v":"18/CAG/0184"},"Using National Congenital Heart Diseases Audit data to explore the impact of non-medical risk factors on late post-operative outcomes for children with complex congenital heart defects.","Supported","2019-02-15","2025-02-15","Dr Katherine L Brown","Great Ormond Street Hospital for Children NHS Foundation Trust","Applied","Yes","No"]
["02364","18/CAG/0164","Use and impact of the pre-hospital 12-lead electrocardiogram in the primary PCI era. Mixed method study (PHECG-2)","Expired","2019-02-15","N/A","Professor Tom Quinn","Faculty of Health, Social Care and Education, Kingston University & St George's, University of London","","",""]
["02365","18/CAG/0184 - Duplicate entry see 02363","Using National Congenital Heart Diseases Audit data to explore the impact of non-medical risk factors on late post-operative outcomes for children with complex congenital heart defects","N/A","2019-02-15","N/A","Dr Katherine L Brown","Great Ormond Street Hospital for Children NHS Foundation Trust","","",""]
["02366","19/CAG/0011","British Ophthalmic Surveillance Unit: National Surveillance of the Incidence of Fungal Keratitis in the United Kingdom","Expired","2019-02-19","N/A","Professor Matthew Burton","London School of Hygiene & Tropical Medicine","","",""]
["02367","18/CAG/0206","Dose Reductions in Palliative Lung Cancer following an episode of Neutropenia","Expired","2019-02-26","N/A","Mr Khuram Moaz Ahmad Amini","The Rotherham Foundation Trust","","",""]
["02368","19/CAG/0006","How have electronic prescribing and medication administration systems transformed pharmacists’ communication in an inpatient setting? A multi-site observational study","Expired","2019-02-26","N/A","Professor Bryony Dean Franklin","UCL School of Pharmacy","","",""]
["02369","19/CAG/0018","Understanding the health needs of mothers involved in family court case: A research study exploring linkage between family court and health data","Expired","2019-03-08","N/A","Professor Ruth Gilbert","University College London","","",""]
["02370","19/CAG/0012","Long-term outcomes in Hirschsprung's and anorectal malformations","Supported","2019-03-13","2025-03-13","Mr Colin Baillie","Alder Hey Children’s NHS Foundation Trust","","Yes","No"]
["02371",{"$f":"INDIRECT(\"A\"&A412&\"!B4\")","v":"18/CAG/0186"},"Angiography-based functional assessment of coronary artery disease in patients with aortic stenosis: predictive prognostic value in patients undergoing TAVI","Expired","2019-03-28","N/A","Dr Fernando Macaya-Ten ","King´s College Hospital ","","",""]
["02372","18/CAG/0125","Predicting recovery and treatment responses in post-stroke aphasia","Expired","2019-03-29","N/A","Dr Thomas M. H. Hope ","University College London ","","",""]
["02373","18/CAG/0078","Prospective epidemiological surveillance of Retinal Dialysis in the United Kingdom: Incidence, demographics and clinical features","Expired","2019-03-26","N/A","Miss Pallavi Tyagi ","NHS Greater Glasgow and Clyde ","","",""]
["02374","19/CAG/0014","Anticipatory Prescribing in Terminal Care Study (APT Study)","Expired","2019-03-25","N/A","Dr Stephen Barclay ","University of Cambridge ","","",""]
["02375","18/CAG/0185","At-Risk Registers Integrated into primary care to Stop Asthma crises in the UK (ARRISA-UK): A pragmatic cluster randomised trial with nested economic and process evaluations examining the effects of integrating at-risk asthma registers into primary care with internet-based training and support","Expired","2019-04-08","N/A","Professor Andrew Wilson","University of East Anglia","","",""]
["02376","19/CAG/0024","The Sub30 feasibility study of a pre-hospital extra-corporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 minutes of collapse in patients with refractory out-of-hospital cardiac arrest.","Expired","2019-04-09","N/A","Dr Simon Finney","St Bartholomew's Hospital","","",""]
["02377",{"$f":"INDIRECT(\"A\"&A418&\"!B4\")","v":"19/CAG/0048"},"Patient perceived outcomes after Sub-acromial Decompression surgery #1","Expired","2019-04-11","N/A","Dr Mark Pinnington ","University of Liverpool","","",""]
["02378","18/CAG/0168","Clinical outcomes of a PPS program undertaken in a large UK cohort","Supported","2019-04-05","2024-04-05","Dr Hamish MacLachlan","St George's University of London","","Yes","No"]
["02379","19/CAG/0008 ","Determination of genetic, transcriptomic and proteomic pharmacological targets for the treatment of ovarian cancer","Expired","2019-04-18","N/A","Dr Nicolas M Orsi, Clinical Lecturer","Leeds Teaching Hospitals NHS Trust","","",""]
["02380","19/CAG/0049","ECG Parameters predicting Adverse Events in Congenital Heart Disease","Expired","2019-04-23","N/A","Dr Louise Coats, Clinical Intermediate Fellow and Honorary Consultant Adult Congenital Heart Disease","Newcastle University","","",""]
["02381","19/CAG/0040","Translational Research in Pulmonary Hypertension at Imperial College (TRIPHIC","Supported","2019-04-26","2024-04-26","Professor Martin R Wilkins\nCentre for Pharmacology & Therapeutics\nICTEM Building, Hammersmith Hospital\nDu Cane Road, London\nW12 0HS","Imperial College Healthcare NHS Trust","Applied","Yes","No"]
["02382","18/CAG/0205","International Surgical Outcomes Study: Long-term survival","Supported","2019-05-14","2024-05-14","Professor Rupert Pearse\nProfessor of Intensive Care Medicine","Queen Mary University of London","","Yes","No"]
["02383",{"$f":"INDIRECT(\"A\"&A424&\"!B4\")","v":"18/CAG/0195"},"Does surgery for asymptomatic carotid stenosis reduce the long term risk of dementia, stroke, death and other important health outcomes? Extended UK post-trial follow-up of the Asymptomatic Carotid Surgery Trial (ACST-1). Phase 2","Supported","2019-05-15","2021-05-15","Professor Alison Halliday, Professor of Vascular Surgery","University of Oxford","","",""]
["02384","19/CAG/0060","Lancashire ANCA Vasculitis and Glomerulonephritis Study","Supported","2019-05-24","2024-05-24","Dr Kina Bennett, Research Operations Manager","Lancashire Teaching Hospitals NHS Foundation Trust","","",""]
["02385","19/CAG/0056","Using Health Informatics to Improve Neurological Services","Expired","2019-05-30","N/A","Professor Hedley Emsley - Professor of Clinical Neuroscience","Lancashire Teaching Hospitals NHS Foundation Trust","","",""]
["02386","19/CAG/0046","Deciphering AMD by deep phenotyping and machine learning - PINNACLE retrospective study","Expired","2019-05-30","N/A","Professor Andrew Lotery","University of Southampton","","",""]
["02387","19/CAG/0053",{"$f":"INDIRECT(\"A\"&$A428&\"!B6\")","v":"Myeloproliferative neoplasms Associated SplanChnic vein Thrombosis: Mascot Registry"},"Expired","2019-06-13","N/A","Dr Malika Sekhar, Consultant Haematologist","University College Hospitals London NHS Trust","","",""]
["02388","19/CAG/0061","Salford Kidney Study","Supported","2019-06-14","2020-06-14","Professor Philip Kalra","Salford Royal NHS Foundation Trust","","",""]
["02389","19/CAG/0042 ","Anti-thyroid Drug (ATD) Study","Expired","2019-06-26","N/A","Bijay Vaidya","Royal Devon and Exeter NHS Trust","","",""]
["02390",{"$f":"INDIRECT(\"A\"&A431&\"!B4\")","v":"17/CAG/0050"},"Educational Outcomes in Children Born after ART","Supported","2019-07-03","2024-07-03","Professor Alastair G Sutcliffe","University College London Institute of Child Health","","",""]
["02391","19/CAG/0054","An evaluation of knee arthroplasty fixation in an evolving challenging population","Supported","2019-07-17","2024-07-17","Dr Hasan Mohammad ","University of Oxford","","Yes","No"]
["02392","19/CAG/0092","The ‘OxMIV’ violence risk assessment tool: an external validation study in patients referred to Early Intervention in Psychosis services using routine documentation in Electronic Patient Records.","Expired","2019-07-25","N/A","Dr Daniel A Whiting - NIHR Doctoral Research Fellow","University of Oxford","","",""]
["02393","19/CAG/0077","Enhanced surveillance of neonatal herpes simplex disease in UK and Irish infants less than 90 days of age.","Supported","2019-07-26","2024-07-26","Dr Katy Fidler, Chief Investigator, Senior Clinical Lecturer in Paediatrics &\nHonorary Consultant in Paediatric Infectious Diseases, Brighton & Sussex Medical School and Royal Alexandra Children’s Hospital.\n","Royal Alexandra Children’s Hospital, Brighton & Sussex University Hospitals NHS Trust","","",""]
["02394","19/CAG/0043","Telephone triage of critical illness using NHS Pathways","Expired","2019-08-02","N/A","Professor Suzanne Mason","University of Sheffield","","",""]
["02395","19/CAG/0035","Updating cancer survival index trends for England and Wales to 2016","Supported","2019-08-05","2024-08-05","Professor Michel Coleman - Professor of Epidemiology and Vital Statistics ","London School of Hygiene and Tropical Medicine","","",""]
["02396","19/CAG/0117 (Replacement of PIAG 4-05(e)/2007)","IMS Health and HES Data Linkage","Supported","2019-11-19","2024-11-19","Ms Hassy Dattani, Data Controller","IQVIA Ltd.","","",""]
["02397","19/CAG/0119 ","MATTS (Major Trauma Triage Tool Study)","Expired","2019-08-22","N/A","Dr Gordon Fuller, NIHR Clinical Lecturer in Emergency Medicine ","University of Sheffield","","",""]
["02398",{"$f":"INDIRECT(\"A\"&A439&\"!B4\")","v":"19/CAG/0082"},"Feasibility cohort study: Serum mid-luteal progesterone versus ultrasound for monitoring first-cycle clomifene citrate.","Expired","2019-09-06","N/A","Dr Heather Garthwaite - Academic GP Registrar","University of Sunderland ","","",""]
["02399","19/CAG/0129","Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA).","Expired","2019-09-09","N/A","Professor SR Vallabhaneni - Prof of Vascular Surgery","Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust","","",""]
["02400","19/CAG/0148","Parents' and children's informed and voluntary consent to heart surgery","Expired","2019-09-02","N/A","Professor Katy Sutcliffe","University College London","","",""]
["02401","19/CAG/0088 ","Realist Evaluation of Pressure Ulcer Risk Assessment Instruments in Clinical Practice: Theory Testing","Expired","2019-08-30","N/A","Dr Susanne Coleman - NIHR Post-doc Research Fellow","University of Leeds","","",""]
["02402","19/CAG/0135 (Previously PIAG 4-06(FT2)/2006)","Derby Monitoring Study of Self-harm","Supported","2019-09-04","2025-02-20","Jennifer Ness, Lead Health Services Researcher ","Derbyshire Healthcare NHS Foundation Trust","","Yes","No"]
["02403","19/CAG/0110","Investigating all-cause mortality in the substance misuse treatment population","Expired","2019-09-18","N/A","Ms Jenny Ness - Lead Health Services Researcher","Derbyshire Healthcare NHS Foundation Trust","","",""]
["02404","19/CAG/0072","Validation of a novel scoring system to predict inpatient mortality in exacerbations of Chronic Obstructive Pulmonary Disease requiring assisted ventilation with supplementary longitudinal assessment of quality of life and other patient-centred outcomes over one year.","Supported","2019-09-18","2020-09-18","Professor Stephen Bourke - Consultant Respiratory Physician","Northumbria Healthcare NHS Foundation Trust","","",""]
["02405","19/CAG/0136","Acute Leukemia in Pregnancy Registry Study","Expired","2019-09-18","N/A","Dr Judith Cohen, Director, Hull Health Trials Unit / ICAHR Information Governance Lead\n","Hull and East Yorkshire Hospitals NHS Trust","","Yes","Yes"]
["02406","19/CAG/0105 Duplicate entry - see 02409","Partners at Care Transitions (PACT): Improving patient experience and safety at transitions of care - Assessing the feasibility of using the PACT intervention to improve safety and experience of the transition process in a randomised controlled trial setting.","N/A","N/A","N/A","N/A","N/A","","",""]
["02407","19/CAG/0112","Assessment of the de-identification algorithm in UKCRIS","Expired","2019-09-24","N/A","Mr Mike Denis","University of Oxford","","",""]
["02408",{"$f":"INDIRECT(\"A\"&A449&\"!B4\")","v":"19/CAG/0114"},"Evaluation of adults admitted to hospital with community acquired pneumonia and non-cystic fibrosis bronchiectasis: a multicentre, retrospective observational cohort study.","Expired","2019-09-18","N/A","Dr Alice M. Turner - Reader in Respiratory Medicine / Honorary Consultant Respiratory Physician","University Hospitals Birmingham NHS Foundation Trust","","",""]
["02409",{"$f":"INDIRECT(\"A\"&A450&\"!B4\")","v":"19/CAG/0105"},"Partners at Care Transitions (PACT): Improving patient experience and safety at transitions of care - Assessing the feasibility of using the PACT intervention to improve safety and experience of the transition process in a randomised controlled trial setting.","Expired","2019-09-24","N/A","Professor Rebecca Lawton - Professor, Psychology of Healthcare","University of Leeds","","",""]
["02410","19/CAG/0129 Duplicate entry - see 02399","Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA).","N/A","N/A",{"$f":"IF(D451<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A451&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A451&\"!B35\")))","v":"N/A"},"N/A","N/A",{"$f":"IF(INDIRECT(\"A\"&$A451&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A451&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A451&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A451&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A451&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A451&\"!B39\"))","v":""}]
["02411",{"$f":"INDIRECT(\"A\"&A452&\"!B4\")","v":"19/CAG/0139"},"The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)","Supported","2019-10-07","2024-10-07","Professor Jane Daniels - Professor of Clinical Trials, University of Nottingham","University of Nottingham","","Yes","Yes"]
["02412",{"$f":"INDIRECT(\"A\"&A453&\"!B4\")","v":"19/CAG/0033"},"A multi-point survey to investigate the incidence and outcome of patients who doctors or nurses feel are unlikely to leave hospital alive from intensive care and the rate of agreement between doctors and the bedside nurse","Expired","2019-10-09","N/A","Dr Richard Innes - Consultant Intensive Care\nTaunton and Somerset NHS Trust\nMusgrove park\nTaunton\nTA15DA","Taunton and Somerset NHS Foundation Trust","","",""]
["02413","19/CAG/0027","A diagnostic evaluation of malaria detection in patients presenting to the emergency department - a large teaching hospital retrospective cohort study","Expired","2019-10-10","N/A","Dr Charles Reynard - Academic Clinical Fellow, Honorary lecturer in Cardiovascular sciences","Manchester University NHS Foundation Trust","","",""]
["02414","19/CAG/0132","Frequency of observations (FOBS)","Expired","2019-10-11","N/A","Professor Jim Briggs","University of Portsmouth","","",""]
["02415","19/CAG/0101","Oxford Cerebrovascular Research Database","Supported","2019-10-14","2024-10-14","Dr Alastair Webb","University of Oxford","","Yes","No"]
["02416","19/CAG/0125","The Incidence and epidemiology of Eyelid Melanoma in the UK","Supported","2019-10-14","2020-10-14","Dr John Bladen - Consultant Ophthalmologist","Kings College NHS Foundation Trust","","",""]
["02417","19/CAG/0111","Cambridge Blood and Stem Cell Biobank","Supported","2019-10-10","2024-10-10","Dr Elizabeth Joanna Baxter, Senior Research Associate","University of Cambridge","","Yes","No"]
["02418",{"$f":"INDIRECT(\"A\"&A459&\"!B4\")","v":"19/CAG/0096"},"A randomised pilot study of a pharmacist-led retrospective review of prescribing by general practitioners in training (REVISiT) intervention","Expired ","2020-11-01","N/A","Dr Richard Knox, Clinical Associated Professor","University of Nottingham","","",""]
["02419","19/CAG/0108","Utility of biomarkers for ovarian cancer risk assessment in primary care: a pilot study",{"$f":"INDIRECT(\"A\"&$A460&\"!B32\")","v":"Expired"},{"$f":"INDIRECT(\"A\"&$A460&\"!B34\")","v":"2019-11-05"},"N/A",{"$f":"(INDIRECT(\"A\"&$A460&\"!B9\"))","v":"Dr Emma Crosbie, NIHR Clinician Scientist, Senior Lecturer & Honorary Consultant Gynecological Oncologist"},{"$f":"(INDIRECT(\"A\"&$A460&\"!B8\"))","v":"University of Manchester"},"","",""]
["02420","19/CAG/0115","Suspected Stroke Clinical and radiological data base (SSCRaD)","Supported","2019-10-28","2024-10-28","Dr Jordan Colman ","Ashford and St Peter's NHS Foundation Trust","","Yes","No"]
["02421","19/CAG/0172","A POPULATION BASED STUDY OF GENETIC PREDISPOSITION AND GENE-ENVIRONMENT INTERACTIONS IN ENDOMETRIAL CANCER","Supported","2019-10-29","2024-10-29","Valerie Rhenius, Research Assistant","University of Cambridge","","Yes","No"]
["02422","19/CAG/0146","The TIGHT-K STUDY. Dysrhythmias on the cardiac\nintensive care unit - does maintenance of high-normal\nserum potassium levels matter?","Supported","2019-11-05","2024-11-05","Prof Benjamin O'Brien, Professor of Perioperative Medicine / Consultant in Intensive Care Medicine and Cardiac Anaesthesia\n","Barts Health NHS Trust","","Yes","No"]
["02423","19/CAG/0086","Pre-operative CPEX and 90-day mortality after oeosphagectomy","Expired","2020-11-05","N/A","Professor Andrew Hart","Norfolk and Norwich University Hospitals NHS Foundation Trust","","",""]
["02424","19/CAG/0150","Long-term vascular complications in young people with childhood-onset type 1 diabetes","Supported","2019-11-12","2024-11-12","Dr Loredana Marcovecchio","University of Cambridge","","Yes","No"]
["02425",{"$f":"INDIRECT(\"A\"&A466&\"!B4\")","v":"19/CAG/0104"},"OPTIPREM: Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation in England using national data, qualitative research and economic analysis.","Supported","2019-11-07","2024-11-07","Dr T Pillay, Clinical Lead Neonatologist, Royal Wolverhampton NHS Trust","Royal Wolverhampton NHS Trust","","",""]
["02426","19/CAG/0160","BRCOH - Evaluation of the NHS Breast Screening Programme","Supported","2019-03-17","2024-03-17","Professor Stephen Duffy, Professor of Cancer Screening ","Queen Mary University of London","","",""]
["02427","19/CAG/0118","The Orchid Research Tissue Bank - Collection of Genito-urinary tissue","Supported","2019-11-08","2024-11-08","Professor Daniel Berney (Principal Investigator for The Robert Lane Tissue Bank) ","Barts Health NHS Trust","Applied","Yes","No"]
["02428","18/CAG/0204","When to suspect Cauda Equina Syndrome in patients presenting to the Emergency Department with back pain","Expired","2019-01-29","N/A","Mrs Rosalie Alpine","University of Birmingham","","",""]
["02429","19/CAG/0191","Glucocorticoid induced adrenal suppression in the UK and Ireland","Expired","2019-11-19","N/A","Dr Tim Cheetham","Newcastle University","","",""]
["02430","19/CAG/0094","A national mixed methods study to evaluate whether out of hospital oral anticoagulation programs for children and young people with congenital heart disease are safe, high quality and effective.","Supported","2019-11-15","2022-11-15","Ms Liz Smith, Lead Advanced Nurse Practitioner \nRoom D3008, Level 3, West Link, \nGreat Ormond Street NHS Foundation Trust. \n34 Great Ormond Street, London\nWC1N 3JH\nTel: 0207 405 9200 ext 5955\nEmail: liz.smith@gosh.nhs.uk","Great Ormond Street Hospital for Children NHS Foundation Trust","","",""]
["02431","19/CAG/0144","Infections in Oxfordshire: a Research Database (IORD)","Supported","2019-10-07","2024-10-07","Professor Ann Sarah Walker, Professor of Medical Statistics and Epidemiology","University of Oxford","","",""]
["02432","19/CAG/0173","Critical illness related cardiac arrest (CIRCA): an investigation of the incidence and outcome of cardiac arrest within Intensive Care Units in the United Kingdom.","Supported","2019-11-15","2024-11-15","Dr Matt Thomas, Consultant in Intensive Care Medicine","North Bristol NHS Trus","Applied","Yes","Yes"]
["02433","19/CAG/0019","Button Batteries: The unintentional ingestion, inhalation or insertion of button batteries in children requiring removal or attempted removal","Supported","2019-11-18","2020-11-18","Dr Suvradeep Basu, Paediatric Emergency Medicine Fellow","Leeds Teaching Hospitals NHS Foundation Trust","","",""]
["02434",{"$f":"INDIRECT(\"A\"&A475&\"!B4\")","v":"19/CAG/0023 "},"Naevoid Melanoma: Prognosis between two subtypes","Expired","2019-12-03","N/A","Professor Martin Cook, Consultant Histopathologist","Royal Surrey County Hospital ","","",""]
["02435","19/CAG/0164","Investigation of gender mortality differences in children admitted to UK Paediatric Intensive Care Units","Supported","2019-11-21","2024-11-19","Professor Bianca De Stavola","University College London Great Ormond Street Institute of Child Health ","Applied","Yes","No"]
["02436","19/CAG/0183","Are children with a history of Cleft Palate and/or Lip from a non-English language speaking homes more susceptible to atypical speech sound errors at 3 and 5 years old?","Expired","2019-11-22","N/A","Miss Sophie Bourne","University of Sheffield ","","",""]
["02437","19/CAG/0185","Understanding Multidisciplinary approaches and Parental Input in perinatal mortality Review  ","Expired","2019-12-04","N/A","Mrs Joanne R W Dickens","University of Leicester ","","",""]
["02438","19/CAG/0190","A prospective surveillance study of conservatively managed children with end-stage kidney disease in the United Kingdom and Republic of Ireland. ","Supported","2019-12-02","2024-12-02","Lucy Plumb, Chief Investigator of study, Paediatric clinical research fellow ","UK Renal Registry, UK Kidney Association ","Applied","Yes","Yes"]
["02439","19/CAG/0166","HPS2-THRIVE trial legacy study: long-term follow-up of participants using electronic health records","Supported","2019-12-06","2024-12-06","Professor Jane Armitage, Professor of Clinical Trials and Epidemiology","University of Oxford","","Yes","Yes"]
["02440","19/CAG/0167","SEARCH trial legacy study: long-term follow-up of participants using electronic health records","Supported","2019-12-06","2024-12-06","Professor Jane Armitage, Professor of Clinical Trials and Epidemiology","University of Oxford","","Yes","Yes"]
["02441","19/CAG/0059","National Early Inflammatory Arthritis Audit Research Database","Supported","2019-12-06","2024-08-14","Dr James Galloway, Senior Lecturer and Honorary Consultant","Kings College Hospital","Applied","Yes","Yes"]
["02442",{"$f":"INDIRECT(\"A\"&A483&\"!B4\")","v":"19/CAG/0149"},"Mammographic Predictors of Cancer Recurrence after Breast Conservation and Adjuvant Endocrine Therapy","Supported","2019-12-06","2024-12-06","Dr Kulsam Ali Project Manager","University of Dundee","","Yes","Yes"]
["02443","19/CAG/0131","Systems research into child-centred medical education v1.0","Expired","2019-12-06","N/A","Professor Timothy Dornan","Queen’s University Belfast","","",""]
["02444","18/CAG/0141","CLASSIFYING STRUCTURE AND JOINT FEATURES IN EXTREMITIES USING STATISTICAL LEARNING METHODS TO ASSIST DIAGNOSIS","Supported","2019-12-09","2024-12-09","Mariam Al-Laith, Clinical Project Manager","Imperial College London","","Yes","No"]
["02445","19/CAG/0201","The PREDICT Study","Expired","2019-12-10","N/A","Mr Karl Charlton","North East Ambulance Service NHS Foundation Trust","","",""]
["02446","19/CAG/0065","Causes of sixth nerve palsies in children: a retrospective study","Expired","2019-12-19","N/A","Mr. James Self, Paediatric Ophthalmology Consultant","University Hospitals Southampton NHS Foundation Trust","","",""]
["02447","19/CAG/0079","International Breast Cancer Intervention Study (IBIS-I) - Epidemiological Cohort Study.","Supported","2019-04-22","2024-04-22","Nadia Haidar. Biospecimens Data Manager","Queen Mary University of London","","",""]
["02448","19/CAG/0002","Outcome of resuscitated term babies with no heart rate detected at 10 minutes of age.","Supported","2019-12-16","2024-12-16","Dr Gemma Sullivan, Neonatal Grid Specialist Trainee","NHS Lothian","","Yes","Yes"]
["02449",{"$f":"INDIRECT(\"A\"&A490&\"!B4\")","v":"19/CAG/0217"},"Risk-stratified screening for breast cancer: modelling natural history and screening strategies","Expired","2019-12-18","N/A","Professor Nora Pashayan - Professor of Applied Cancer Research","University College London","","",""]
["02450",{"$f":"INDIRECT(\"A\"&A491&\"!B4\")","v":"19/CAG/0220"},"Linked de-identified research database for congenital\nanomaly outcomes","Expired","2019-12-19","N/A","Professor Joan K Morris","St George’s University of London","","",""]
["02451",{"$f":"INDIRECT(\"A\"&A492&\"!B4\")","v":"19/CAG/0221"},{"$f":"INDIRECT(\"A\"&$A492&\"!B6\")","v":"Association between tumour amphiregulin, epiregulin and epidermal growth factor receptor (EGFR) expression and response to anti-EGFR agents in colorectal cancer"},"Expired","2019-12-20","N/A","Professor Philip Quirke - Professor of Pathology and Data Analytics","University of Leeds","","",""]
["02452",{"$f":"INDIRECT(\"A\"&A493&\"!B4\")","v":"19/CAG/0162"},{"$f":"INDIRECT(\"A\"&$A493&\"!B6\")","v":"Accuracy, impact and cost-effectiveness of prehospital clinical early warning scores for adults with suspected sepsis"},"Expired","2020-01-13","N/A","Professor Steve Goodacre","University of Sheffield","","",""]
["02453","19/CAG/0198","Evaluation of an aid to diagnosis for congenital dysplasia of the hip in general practice: controlled trial randomised by practice","Supported","2020-01-13","2025-01-13","Professor Andreas Roposch","Great Ormond Street Hospital for Children NHS Foundation Trust","Applied","Yes","No"]
["02454","18/CAG/0179","IMproving the practice of foetal heartrate MOnitoring with cardiotocography for safer childbirth","Expired","2018-10-29","N/A","Professor Mary Dixon-Woods - Director of THIS Institute, Health Foundation Professor of Healthcare Improvement Studies","University of Cambridge","","",""]
["02455","19/CAG/0219","Epidemiology of Pancreatic Cancer Using Longitudinal Electronic Health Record Data","Expired","2020-01-17","N/A","Dr Abu Zafer M Dayem Ullah Senior Health Data Science Specialist                \n","Queen Mary University of London","","",""]
["02456","15/CAG/0005","Research to identify measures of quality and safety of healthcare","Expired","2015-07-30","N/A","Professor Paul Aylin","Imperial College London","","",""]
["02457","19/CAG/0226","The SAFER Trial: Screening for Atrial Fibrillation with ECG to Reduce stroke - a randomised controlled trial","Expired","2020-01-17","N/A","Professor Jonathan Mant - Professor of Primary Care Research","University of Cambridge","","",""]
["02458","19/CAG/0084","Developing Diagnostic and Prognostic Algorithms Using Digital Pathology and Artificial Intelligence","Supported","2020-01-22","2025-01-22","Professor Emad Rakha, Professor of Breast Cancer Pathology","University of Nottingham","","Yes","No"]
["02459","19/CAG/0170","Evaluating the effectiveness, and cost-effectiveness, of a pharmacist-led IT-based intervention (PINCER) when widely implemented in general practices to reduce the prevalence of patient exposure to hazardous prescribing, and the incidence of serious harm","Expired","2020-01-23","N/A","Professor Anthony J Avery - Professor of Primary Health Care","University of Nottingham","","",""]
["02460","20/CAG/0010","Pulmonary Hypertension (PH) population characterisation and epidemiological analysis","Expired","2020-01-23","N/A","Professor David Kiely - Consultant Respiratory Physician, Director of the Sheffield Pulmonary Vascular Disease Unit (SPVDU)","Sheffield Teaching Hospitals NHS Foundation Trust, IQVIA and Janssen","","",""]
["02461","19/CAG/0161","CRYOSTAT-2: A multi-centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation","Supported","2020-01-28","2023-01-28","Professor Karim Brohi - Chair of Trauma Science - Queen Mary's University of London","Queen Mary University of London and NHS Blood and Transplant","","",""]
["02462","20/CAG/0003","Study of cancer risks in ataxia telangiectasia heterozygotes","Supported","2020-02-03","2025-02-03","Professor A.M.R. Taylor - Professor of Cancer Genetics","University of Birmingham","","Yes","No"]
["02463","19/CAG/0224","Health Pathfinder: An evaluation of health-based domestic abuse interventions","Expired","2020-02-03","N/A","Mrs Nanya Coles - Research Manager","SafeLives","","",""]
["02464","19/CAG/0228","Impact & acceptability of 10-year risk at breast cancer screening v1","Expired","2020-02-04","N/A","Dr Lorna McWilliams, Research Fellow ","University of Manchester","","",""]
["02465","19/CAG/0209","Advanced cardiovascular risk prediction in the acute care setting","Supported","2020-02-05","2025-02-05","Dr Charles Reynard","University of Manchester ","Applied","Yes","No"]
["02466","19/CAG/0189","Bart’s Gynae Tissue Bank","Supported","2020-02-07","2024-02-07","Dr Michelle Lockley","Bart’s Cancer Institute at the Queen Mary University of London","","",""]
["02467","19/CAG/0163","Developing new care pathways for women at low risk of breast cancer","Expired","2020-02-11","N/A","Professor David French - Professor of Health Psychology","University of Manchester","","",""]
["02468","19/CAG/0154","The CANDID study: Understanding how to improve making, communicating and recording a medical (differential) diagnosis in the acute care setting through institutional, legal and ethical drivers.","Expired","2020-02-17","N/A","Dr Zoe Fritz - Consultant Physician","University of Cambridge","","",""]
["02469","18/CAG/0201","Retinal injuries resulting from handheld laser devices: Incidence and epidemiology","Expired","2020-02-17","N/A","Dr Ruth Darbyshire - ST3 Specialty Registrar Ophthalmology","Leeds Teaching Hospitals NHS Foundation Trust","","",""]
["02470","19/CAG/0197","Vaccination timeliness in preterm infants","Supported","2020-02-17","2021-02-17","Miss Helen Sisson","University of Hull","","",""]
["02471","19/CAG/0211","Improving the effectiveness of cancer multidisciplinary team meetings (MDTMs) in Surrey and Sussex","Expired","2020-02-18","N/A","Dr Cath Taylor - Reader in Healthcare Workforce Organisation and Wellbeing","University of Surrey","","",""]
["02472","19/CAG/0230",{"$f":"INDIRECT(\"A\"&$A513&\"!B6\")","v":"Advanced analytics in primary care: provision of actionable information for quality improvement for antibiotic reduction, care advice and medication safety (ACTION)"},"Expired","2020-03-10","N/A","Professor Tjeerd van Staa","University of Manchester","","",""]
["02473","19/CAG/0208","Aetiology, timing and risk factors for tuberculosis-associated deaths in London: a retrospective, case-control study","Supported","2020-03-10","2024-03-10","Dr Jessica Barrett","London North West University Healthcare NHS Trust","","",""]
["02474","19/CAG/0187","Multifrequency Bioimpedance in the Early Detection of Lymphoedema after Axillary Surgery","Expired","2020-03-10",{"$f":"IF(D515<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A515&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A515&\"!B35\")))","v":"N/A"},"Hayley Brooks, Clinical Trials Manager            ","University of Manchester",{"$f":"IF(INDIRECT(\"A\"&$A515&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A515&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A515&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A515&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A515&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A515&\"!B39\"))","v":""}]
["02475","19/CAG/0225","Raised intracranial pressure following intracerebral haemorrhage: association with survival and physiological variables","Expired","2020-03-10","N/A","Dr Adrian Parry-Jones","Salford Royal NHS Foundation Trust","","",""]
["02476","20/CAG/0028","Small Area Health Statistics Unit Research Database","Supported","2020-03-24","2024-03-24","Professor Paul Elliott","Imperial College London ","","",""]
["02477","19/CAG/0230","Advanced analytics in primary care: provision of actionable information for quality improvement for antibiotic reduction, care advice and medication safety (ACTION)","Expired","2020-03-10","N/A","Professor Tjeerd van Staa","University of Manchester","","",""]
["02478","19/CAG/0208","Aetiology, timing and risk factors for tuberculosis-associated deaths in London: a retrospective, case-control study","Supported","2020-03-10","2021-03-10","Dr Jessica Barrett","London North West University Healthcare NHS Trust","","",""]
["02479","19/CAG/0187","Multifrequency Bioimpedance in the Early Detection of Lymphoedema after Axillary Surgery","Supported","2020-03-10","2021-03-10","Professor Nigel Bundred","Manchester University NHS Foundation Trust","","",""]
["02480","19/CAG/0225","Raised intracranial pressure following intracerebral haemorrhage: association with survival and physiological variables","Supported","2020-03-10","2021-03-10","Dr Adrian Parry-Jones","Salford Royal NHS Foundation Trust","","",""]
["02481","20/CAG/0049","PREDICT Study: RaDaR and UKRR Linked Dataset","Supported","2020-04-29","2024-04-22","Dr Kate Bramham","King's College Hospital ","","",""]
["02482","20/CAG/0050","What is the prevalence of distal surface caries (DSC) in the lower second molar when screening patients with bitewing radiographs: A multi-center study","Expired","2020-05-12","N/A","Dr Verena Toedtling","University of Manchester","","",""]
["02483","19/CAG/0195","STRETCHED: Strategies to Manage Emergency Ambulance Telephone Callers With Sustained High Needs - An Evaluation Using Linked Data","Supported","2020-05-27","2024-05-27","Professor Alan J Watkins","Swansea University","","Yes","Yes"]
["02484","19/CAG/0227","Oral Health, Dental Care and Aspiration History of Tube Fed Patients","Expired","2020-05-27","N/A","Dr Frankie Soldani","Bradford Community NHS Trust","","",""]
["02485","20/CAG/0001","Functional outcomes In Trauma (FIT) Study","Supported","2020-05-27","2024-05-27","Professor Peter Giannoudis","Leeds Teaching Hospitals NHS Foundation Trust","","",""]
["02486","20/CAG/0020","Healthcare Usage of Bariatric/Metabolic Surgery","Expired","2020-06-03","N/A","Professor Francesco Rubino","King’s College London ","","",""]
["02487","20/CAG/0009","The Cambridge Cohort - Mammography East-Anglia Digital Imaging Archive (CC-MEDIA)","Supported","2020-06-11","2024-06-11","Professor Fiona J Gilbert","University of Cambridge","","Yes","No"]
["02488","19/CAG/0196","Evaluating prescribing safety indicators embedded in computerised clinical decision support software OptimiseRx","Supported","2020-06-17","2024-06-17","Professor Niels Peek","University of Manchester","","Yes","No"]
["02489","19/CAG/0050","Service User Perspectives of the Transition from Medium Security to Lower Security and Community Services",{"$f":"INDIRECT(\"A\"&$A530&\"!B32\")","v":"Supported"},{"$f":"INDIRECT(\"A\"&$A530&\"!B34\")","v":"2020-06-23"},"2021-06-23",{"$f":"(INDIRECT(\"A\"&$A530&\"!B9\"))","v":"Rebecca Dalby"},{"$f":"(INDIRECT(\"A\"&$A530&\"!B8\"))","v":"Nottinghamshire NHS Foundation Trust"},"","",""]
["02490","20/CAG/0015","Clinical outcome modelling of rapid dynamics in acute stroke with joint-detail, remote, body motion analysis","Supported","2020-06-21","2024-06-21","Dr Yee Mah","King's College Hospital NHS Foundation Trust","","",""]
["02491","20/CAG/0039","Phenotyping individuals with elevated mean pulmonary arterial pressure and elevated pulmonary vascular resistance in the United Kingdom","Supported","2020-06-21","2024-06-21","Dr Gerry Coghlan","Royal Free London NHS Foundation Trust","Applied","Yes","No"]
["02492","19/CAG/0109","Suicide by middle-aged men","Supported","2019-07-29","2024-07-29","Professor Louis Appleby","University of Manchester","","",""]
["02493","19/CAG/0194","Identifying models of care to improve outcomes for older people with emergency and urgent care needs.","Expired","2020-06-23","N/A","Professor Simon Conroy","University of Leicester ","","",""]
["02494","20/CAG/0013","Correlates of cognitive changes in epilepsy","Supported","2020-06-23","2024-06-24","Ms J de Tisi, Data Manager ","University College London Institute of Neurology","","",""]
["02495","19/CAG/0223","TwinsUK: Phenotypic enrichment of the TwinsUK cohort through linkage to electronic health records and other databases.","Supported","2020-06-25","2024-06-25","Dr Claire Steves","King's College London","","",""]
["02496","20/CAG/0034","Detecting clinical deterioration in respiratory hospital patients using machine learning","Supported","2020-06-29","2024-06-29","Dr Sherif Gonem (Consultant Respiratory Physician)","University of Nottingham ","","",""]
["02497","20/CAG/0055","Can clinical and biochemical variables be used innovatively to improve risk modelling of mortality in patients undergoing emergency abdominal surgery?","Expired","2020-07-01","N/A","Mr Alexander Darbyshire","Portsmouth Hospitals NHS Foundation Trust ","","",""]
["02498","20/CAG/0007","Professional work in austere healthcare in the UK- the case of physiotherapy.","Expired","2020-07-01","N/A","Professor Stephen Timmons","University of Nottingham ","","",""]
["02499","20/CAG/0021","Breast Reconstruction: InvestigatinG long-term clinical and cost-effectiveness in tHe National MasTectomyand BrEast Reconstruction Audit cohort","Expired","2020-07-03","N/A","Miss Shelley Potter","University of Bristol ","","",""]
["02500","19/CAG/0192","IgG4-related Orbital Disease (IgG4-ROD): A Surveillance Study","Supported","2020-07-06","2024-07-06","Samantha Hunt,Ophthalmologist","University Hospitals Bristol NHS Foundation Trust ","","",""]
["02501","20/CAG/0072","How effective and cost-effective is water fluoridation for adults? A 10-year retrospective cohort study","Expired","2020-07-07","N/A","Professor Iain Pretty ","University of Manchester ","","",""]
["02502","20/CAG/0079","Long-term safety of cabergoline in hyperprolactinaemia","Supported","2020-06-26","2021-06-20","Dr Craig Stiles","Queen Mary University of London ","","",""]
["02503","20/CAG/0035","Safety INdEx of Prehospital On Scene Triage (SINEPOST): The derivation and validation of a risk prediction model to support ambulance clinical transport decisions on scene","Expired","2020-07-14","N/A","Professor Suzanne Mason","University of Sheffield","","",""]
["02504","20/CAG/0029","Incidence of Chronic Recurrent Multifocal Osteomyelitis (CRMO) in the United Kingdom (UK) and Republic of Ireland (ROI)","Supported","2020-07-12","2024-07-12","Dr Chenqu Suo","Cambridge University Hospitals NHS Foundation Trust","","",""]
["02505","20/CAG/0027","Congenital Heart Audit: Measuring Progress In Outcomes Nationally","Supported","2020-07-12","2024-07-12","Professor Sonya Crowe, Co-PI of CHAMPION and Professor of Operational Research ","University College London","","",""]
["02506","20/CAG/0031","Self-management and support programme for COPD (EDGE2)","Expired","2020-07-16","N/A","Professor Andrew Farmer","University of Oxford","","",""]
["02507","20/CAG/0054","Screening for Hypertension in the INpatient Environment (SHINE): A Diagnostic Accuracy Cohort Study","Expired","2020-07-16","N/A","Professor Peter Watkinson","Oxford University NHS Foundation Trust","","",""]
["02508","19/CAG/0207","Survival of people with screen-detected heart failure (ECHOES-Survive)","Supported","2020-07-22","2024-07-22","Professor Richard Hobbs, General Practitioner and Head of Department","University of Oxford","","Yes","No"]
["02509","19/CAG/0205","A large randomised assessment of the relative cost-effectiveness of different classes of drugs for Parkinson’s disease","Expired","2020-07-23","N/A","Dr Carl Clarke","University of Birmingham","","",""]
["02510","20/CAG/0030","Optimal management of lymphoedema: do attitudes towards body weight and experiences of practitioners and patients affect patient engagement and guideline adherence?","Expired","2020-07-24","N/A","Dr Rhian Noble-Jones","University of Glasgow","","",""]
["02511","20/CAG/0012","A Retrospective Cohort Study of Treatment Outcomes Among Adult Patients with Refractory or Relapsed Follicular Lymphoma","Expired","2020-07-24","N/A","Dr Piers Patten","King's College Hospital NHS Foundation Trust","","",""]
["02512","19/CAG/0182","National Joint Registry – Research Database","Supported","2020-07-24","2024-07-24","Alyson Ottley, Research and Governance Programme Manager ","Healthcare Quality Improvement Partnership","","",""]
["02513","19/CAG/0210","Discovery and Analysis Of Novel Biomarkers In Urological Diseases (DIAMOND STUDY)","Supported","2020-07-15","2024-07-15","Professor Vincent Gnanapragasam","University of Cambridge","","Yes","No"]
["02514","20/CAG/0045","An evaluation of a water fluoridation scheme in Cumbria: A population based comparative cohort study of systemic and topical fluoride exposure","Supported","2020-07-20","2024-07-20","Tanya Walsh","University of Manchester","","",""]
["02515","20/CAG/0033","An anthropological study of the early detection of cancer","Expired","2020-08-03","N/A","Dr Ignacia Arteaga, Research Associate","Cambridge University NHS Foundation Trust","","",""]
["02516",{"$f":"INDIRECT(\"A\"&A557&\"!B4\")","v":"20/CAG/0046"},{"$f":"INDIRECT(\"A\"&$A557&\"!B6\")","v":"An evaluation of a water fluoridation scheme in Cumbria: population based comparative cohort studies of topical fluoride exposure alone"},"Supported","2020-08-03","2024-08-03","Tanya Walsh","University of Manchester","","",""]
["02517","20/CAG/0038","The C3 Study - Version 1 (The short and long-term cardiovascular consequences of critical illness: The C3 Study)","Supported","2020-08-10","2024-08-10","Dr Robert Hatch","Oxford University Hospitals NHS Foundation Trust","","",""]
["02518","20/CAG/0063","A population-based comprehensive lymphoma registry","Supported","2020-09-02","2024-09-02","Dr Mark Bishton","Nottingham University Hospitals NHS Trust","","",""]
["02519","20/CAG/0086",{"$f":"INDIRECT(\"A\"&$A560&\"!B6\")","v":"YouScreen: A pragmatic implementation feasibility clinical trial of offering HPV self-sampling to cervical screening non-attenders within the NHS cervical screening programme in England"},"Expired","2020-08-27","N/A","Dr Anita Lim","King's College London","","",""]
["02520","19/CAG/0214","Understanding the scale and nature of avoidable harm in prison healthcare (Phases 2 & 3: Case note review and qualitative interviews)","Supported","2020-04-07","2025-04-07","Professor Jennifer Shaw","University of Manchester","Applied","Yes","No"]
["02521","20/CAG/0097","Breast Cancer Metastasis","Supported","2020-09-13","2024-09-13","Professor Clare Isacke","Institute of Cancer Research (ICR)","","Yes","No"]
["02522","20/CAG/0071","Birmingham and Lambeth Liver Evaluation Testing Strategies - 10 Year Follow Up","Expired","2020-09-15","N/A","Professor Richard Lilford ","University Hospitals Birmingham NHS Foundation Trust","","",""]
["02523","20/CAG/0073","Assessing the cancer risks due to occupational exposure to styrene","Supported","2020-09-15","2024-09-15","Prof. Damien McElvenny","Institute of Occupational Medicine (IOM)","Applied","Yes","No"]
["02524","20/CAG/0044","Revision Hip and Knee Replacement: Evaluation of Clinical, Psychological and Surgical Outcomes","Supported","2020-09-10","2024-11-21","Professor Andrew Price","Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford","Applied","Yes","No"]
["02525","20/CAG/0002","Investigating the incidence of radiation-related cancer following endovascular aortic aneurysm repair compared to open aneurysm repair","Supported","2020-09-11","2024-09-11","Professor Bijan Modarai, KCL Chair of Vascular Surgery","King's College London (KCL)","Applied","Yes","No"]
["02526","20/CAG/0069","C&I CRIS Linkage with HES and Mortality","Supported","2020-09-14","2024-09-14","Professor David Osborn","University College London","","",""]
["02527","20/CAG/0096","Royal Free HIV Cohort Study","Supported","2020-09-16","2024-09-16","Dr Fiona Lampe","University College London","","",""]
["02528","20/CAG/0051","Exploring the impact of mental health services in reducing suicide risk for those accused of online sexual offences against children within the Cleveland area.","Expired","2020-09-16","N/A","Dr Paul Cooper","Tees, Esk and Wear Valleys NHS Foundation Trust","","",""]
["02529","20/CAG/0088","Antihypertensive Treatment in Elderly Multimorbid Patients: a pilot study","Expired","2020-10-01","N/A","Professor Kazem Rahimi, Associate Professor of Cardiovascular Medicine ","University of Oxford","","",""]
["02530","20/CAG/0084","PIONEER: The UK Health Data Research Hub for Acute Care","Supported","2020-09-28","2024-09-28","Professor Elizabeth Sapey ","University Hospitals Birmingham NHS Foundation Trust","","Yes","No"]
["02531","20/CAG/0078","Accuracy of using crown rump length measurements in dating pregnancies","Supported","2020-09-29","2024-09-29","Dr Linden Stocker","University Hospital Southampton NHS Foundation Trust","","",""]
["02532","20/CAG/0103","UK National Haemophilia Research Registry","Supported","2020-09-30","2024-09-30","Professor Charles Hay","United Kingdom Haemophilia Doctors Organisation ","","",""]
["02533","20/CAG/0057","PEARL s251 Sensitive Health Records Template (Incidence of psychosis and measures of psychotic experiences within the ALSPAC)","Supported","2020-10-04","2024-10-04","Mark Mumme (ALSPAC Data Linkage Manager) ","Avon Longitudinal Study of Parents and Children (University of Bristol) ","","Yes","No"]
["02534","20/CAG/0087","Research database for Cambridgeshire & Peterborough NHS FT (CPFT)","Supported","2020-10-04","2024-10-04","Dr Rudolf Cardinal","Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) ","","Yes","No"]
["02535","20/CAG/0110","Understanding the epidemiology in the transition from neonatal to paediatric care: a data linkage study","Expired","2020-09-29","N/A","Dr Sarah Seaton","University of Leicester","","",""]
["02536","20/CAG/0064","Health, education and social outcomes of children with visual impairment and blindness (VI/SVIBL)","Supported","2020-10-08","2024-10-08","Professor Jugnoo Rahi","University College London","","Yes","No"]
["02537","20/CAG/0122","The Prognostic Performance of the Enhanced Liver Fibrosis Test in UK Patients with Chronic Liver Disease Assessed 20 Years After Recruitment to the EUROGOLF study (EVenti)","Expired ","2020-10-12","N/A","Prof. William Rosenberg","Royal Free London NHS Foundation Trust","","",""]
["02538","20/CAG/0068","South London and Maudsley NHS Foundation Trust CRIS data linkage with the National Pupil Database","Supported","2020-10-08",{"$f":"IF(D579<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A579&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A579&\"!B35\")))","v":"2024-10-08"},"Dr Johnny Downs","King's College London",{"$f":"IF(INDIRECT(\"A\"&$A579&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A579&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A579&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A579&\"!B38\"))","v":"Yes"},{"$f":"IF(INDIRECT(\"A\"&$A579&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A579&\"!B39\"))","v":"No"}]
["02539","20/CAG/0081",{"$f":"INDIRECT(\"A\"&$A580&\"!B6\")","v":"Predicting vascular complications in diabetes"},"Supported","2020-10-13","2024-10-13","Dr Charles Gutteridge","Barts Health NHS Trust","Applied","Yes","No"]
["02540","20/CAG/0125","A population based study of genetic predispositions and gene-environment interactions in colorectal cancer - SEARCH Colorectal","Supported","2020-10-20","2024-10-20","Valerie Rhenius, Research Assistant","University of Cambridge","","Yes","No"]
["02541","20/CAG/0126","A Population-based Study of Genetic Predisposition to Cancer (SEARCH) (Oesophageal Cancer, Pancreatic Cancer, Brain tumours, Non-Hodgkins, Lymphoma, Melanoma, Kidney Cancer, Bladder cancer - SEARCH Multi","Supported","2020-10-20","2024-10-20","Valerie Rhenius, Research Assistant","University of Cambridge","","Yes","No"]
["02542","20/CAG/0133","Yorkshire Specialist Register of Cancer in Children and Young People","Supported","2020-10-22","2024-10-22","Dr Richard Feltbower, Professor of Epidemiology","University of Leeds","Applied","Yes","No"]
["02543","20/CAG/0104","POST-BOX: Consensus-building a post-partum haemorrhage kit using citizen science (Workpackage 1)","Expired","2020-10-29","N/A","Professor Mary Dixon-Woods","THIS Institute, University of Cambridge","","",""]
["02544","20/CAG/0120","Incidence of Avoidant/Restrictive Food Intake Disorder (ARFID) in children and young people presenting to secondary care in the UK and Ireland","Supported","2020-11-04","2024-11-04","Dr Dasha Nicholls, Reader in Child Psychiatry","Imperial College London","","Yes","Yes"]
["02545","19/CAG/0188","A population based study of genetic predisposition and gene-environment interactions in prostate cancer in East Anglia, Trent and West Midlands: SEARCH Prostate","Supported","2020-11-05","2024-11-05","Valerie Rhenius, Research Assistant","University of Cambridge","","Yes","No"]
["02546","19/CAG/0171","A population based study of genetic predisposition and gene-environment interactions in breast cancer: SEARCH breast","Supported","2020-11-11","2024-11-11","Valerie Rhenius, Research Assistant","University of Cambridge","","Yes","No"]
["02547","18/CAG/0188","Road Traffic Injury – Analytics for Integrated Data (RTI-AID)","Supported","2020-11-13","2021-11-13","Professor Ara Darzi","Imperial College London","","",""]
["02548","20/CAG/0148 (previously 18/CAG/0007)","Evaluating alternative protocols for identifying and managing patients with familial hypercholesterolaemia: cost-effectiveness analysis with qualitative study","Expired","2018-01-26","N/A","Professor Nadeem Qureshi","University of Nottingham & University of York","","",""]
["02549","20/CAG/0123","REadmission And Cardiovascular ouTcomes following Acute Myocardial Infarction in England and Wales (REACT-AMI)","Supported","2020-11-27","2024-11-27","Professor Mamas Mamas, Professor in Cardiology","Keele University Clinical Trials Unit","","Yes","Yes"]
["02550","20/CAG/0106","The SUFFICE CoV-Study","Expired","2020-11-17","N/A","Mrs Jody Ede","Oxford University Hospitals NHS Foundation Trust","","",""]
["02551","20/CAG/0080","Investigating whether elevated C-reactive protein is associated with probable depression in paediatric Chronic Fatigue","Supported","2020-11-20","2024-11-20","Professor Esther M Crawley","University of Bristol","","Yes","No"]
["02552","20/CAG/0099","Promoting vision-related quality of life (QoL): first stage development of a model for intervention from the evidence of what matters most to visually impaired children and their families","Expired","2020-11-23","N/A","Professor Jugnoo S Rahi","University College London Great Ormond Street Institute of Child Health","","",""]
["02553","20/CAG/0095","Gender-specific outcomes post transcatheter aortic valve implantation","Supported","2020-12-03","2024-12-02","Dr Ghada Mikhail, Consultant Cardiologist","Imperial College Healthcare NHS Trust","","",""]
["02554","20/CAG/0121","Strengthening the Implementation and Operationalisation of ‘Open Disclosure’ with Women and Families After Unexpected Harm in NHS Maternity Care: DISCERN study","Expired","2020-11-30","N/A","Professor Jane Sandall, Professor of Social Sciences and Women's Health","King's College London","","",""]
["02555","20/CAG/0147","Global Consortium Study of Neurological Dysfunction in COVID 19 - paediatric substudy ","Expired","2020-12-04","N/A","Dr Hari Krishnan, Consultant Paediatric Intensivist","Birmingham Women's and Children's NHS Foundation Trust","","",""]
["02556","20/CAG/0137","Best Care for Abdominal Emergencies - The BCAE Study.  A retrospective single, centre cohort study of patients with intestinal emergencies","Supported","2020-12-08","2024-12-08","Mr Simon K C Toh, Consultant Surgeon","Portsmouth Hospitals NHS Trust","Applied","Yes","No"]
["02557","20/CAG/0136","A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus standard care using a mixed methods approach: NightLife","Supported","2020-12-11","2024-12-11","Professor James Burton, Professor of Renal Medicine","University of Leicester","","Yes","Yes"]
["02559","20/CAG/0143","CTSU clinical trial follow-up service with NHS Digital to provide de-identified follow-up data for use in the EBCTCG breast cancer meta-analyses","Supported","2020-12-03","2022-12-03","Professor Robert Hills, Professor of Medical Statistics, NDPH","University of Oxford","Applied","Yes","No"]
["02560","14/CAG/1012","Critical Care Health Informatics Collaborative",{"$f":"INDIRECT(\"A\"&$A600&\"!B32\")","v":"Supported"},"2015-11-25","2024-11-25",{"$f":"(INDIRECT(\"A\"&$A600&\"!B9\"))","v":"Professor Mervyn Singer"},{"$f":"(INDIRECT(\"A\"&$A600&\"!B8\"))","v":"University College London"},"","Yes","No"]
["02561","20/CAG/0138","Avon Community Acquired Pneumonia Study (Avon CAP): A Pan-Pandemic Acute Lower Respiratory Tract Disease Surveillance Study","Supported",{"$f":"INDIRECT(\"A\"&$A601&\"!B34\")","v":"2020-12-01"},"2024-12-01","Professor Adam Finn, Professor of Paediatrics","University of Bristol","","Yes","No"]
["02562","20/CAG/0149","Yorkshire & Humberside Haematology Network Register","Supported","2020-12-17","2024-12-17","Professor Eve Roman","University of York","","Yes","No"]
["02563","19/CAG/0127","CRIS Linkage with the HIV and AIDS Reporting System","Expired","2020-01-17","N/A","Dr Margaret Heslin","South London and Maudsley NHS Foundation Trust","","",""]
["02564","20/CAG/0157","The Oxford Risk Factors And Non-invasive imaging Study: ORFAN","Supported","2021-01-07","2025-01-07","Professor Charalambos Antoniades, Professor of Cardiovascular Medicine","University of Oxford","","Yes","Yes"]
["02565","20/CAG/0113","Heart Protection Study Long-term Follow-up: A randomised study of the effects on mortality and morbidity of HMG CoA reductase inhibitors and of antioxidant vitamins in a wide range of people at high risk of coronary heart disease","Supported","2021-01-06","2025-01-06","Professor Rory Collins","University of Oxford","","Yes","Yes"]
["02566","20/CAG/0127","Admissions far away from home or to adult wards - understanding the impact of current practices for accessing inpatient care for adolescents with mental health difficulties: a surveillance study","Expired","2021-01-08","N/A","Dr Kapil Sayal","University of Nottingham","","",""]
["02567","21/CAG/0010","Peritoneal Mesothelioma Retrospective Sample Collection \n(Short title: Peritoneal Mesothelioma TMA)","Supported","2021-01-29","2025-01-29","Professor Stefan Marciniak, Consultant Physician, Professor of Respiratory Science","Royal Papworth Hospital NHS Trust (MesobanK database)","Applied","Yes","No"]
["02568","20/CAG/0107","Childhood outcomes after perinatal brain injury: a population-based linkage study  ","Expired","2021-01-28","N/A","Dr Philippa Rees","University College London Great Ormond Street Institute of Child Health (UCL GOS ICH)","","",""]
["02569","21/CAG/0008","Clinical Practice Research Datalink (CPRD)","Supported","2021-02-08","2025-02-08","Dr Puja Myles, Director of Clinical Practice Research Datalink ","MHRA","","Yes","Yes"]
["02570","20/CAG/0144","Follow-up of the QUEST Cohort - Wave 3 Additions","Expired","2021-02-03","N/A","Professor Emily Simonoff, Professor & Head of Department of Child & Adolescent Psychiatry","King's College London","","",""]
["02571","21/CAG/0017","Outcomes of Patients who survived Treatment on an Intensive Care unit for COVID-19 in England and Wales: a retrospective cohort study ","Supported","2021-02-25","2025-02-25","Dr Peter Watkinson, Associate Professor of Intensive Care Medicine","University of Oxford","","Yes","Yes"]
["02572","21/CAG/0029","BOSU Study on Newly Presenting Visual Loss Secondary to myopic maculopathy","Supported","2021-02-26","2022-02-26","Mr Ajay Kotagiri, Consultant Opththalmologist","South Tyneside and Sunderland NHS Foundation Trust","","",""]
["02573","21/CAG/0030","Experiences of gestational trophoblastic disease: reconciling cancer, pregnancy and loss","Expired","2021-03-02","N/A","Dr Emily Ross, Research Fellow","The University of Sheffield","","",""]
["02574","21/CAG/0012","Expression and Reception of Gratitude in Healthcare: Analytical Ethnography","Expired","2021-03-04","N/A","Professor Anne Marie Rafferty","King's College London","","",""]
["02575","20/CAG/0017","Effectiveness of Differing Psychotherapies Offered in a Specialist Psychotherapy Service – a benchmarking study","Expired","2021-03-10","N/A","Dr Stephen Kellett","University of Sheffield","","",""]
["02576","19/CAG/0047","Development and validation of a risk assessment tool for self-harm in prisoners","Supported","2021-03-10","2025-03-10","Professor Seena Fazel, Professor of Forensic Psychiatry","University of Oxford","","Yes","No"]
["02577","21/CAG/0033","Risk of Aneurysm Rupture Study (ROAR)","Supported","2021-03-17","2024-03-17","Mr Diederik Bulters, Consultant Neurosurgeon","University Hospitals Southampton NHS Foundation Trust","","Yes","Yes"]
["02578","21/CAG/0044","UK Longitudinal Linkage Collaboration (Study to NHS identifier flow v1)","Supported","2021-03-29","2024-07-01","Mr Andy Boyd","University of Bristol","","Yes","No"]
["02579","20/CAG/0100","Study of lung transplant in cystic fibrosis through linkage between the UK Cystic Fibrosis Registry and the UK Cardiothoracic Transplant Registry","Supported","2021-03-31","2022-03-31","Professor Ruth Keogh","London School of Hygiene & Tropical Medicine","","",""]
["02580",{"$f":"INDIRECT(\"A\"&A620&\"!B4\")","v":"21/CAG/0003"},{"$f":"INDIRECT(\"A\"&$A620&\"!B6\")","v":"Transforming research with routinely collected linked clinical data using an umbrella ethics and governance approach at Newcastle Hospitals"},"Supported","2021-03-25","2024-03-25","Professor Miles Witham","Newcastle upon Tyne Hospitals NHS Foundation Trust","","",""]
["02581","19/CAG/0215","Fractional Flow Reserve versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes: a developmental clinical study of management guided by coronary angiography combined with fractional flow reserve (FFR) measurement versus management guided by coronary angiography alone(standard care) in patients with non-ST elevation MI","Supported","2021-04-01","2025-04-01","Dr Colin Berry","University of Glasgow","Applied","Yes","No"]
["02582","21/CAG/0021","Increasing cervical cancer screening uptake in Yorkshire: Testing the effectiveness of a behaviour change intervention in deprived and non-deprived populations","Expired","2021-03-30","N/A","Prof Daryl O'Connor","University of Leeds","","",""]
["02583","20/CAG/0141","Conversation analytic (CA) study of prognostic decision-making within palliative multi-disciplinary team (MDT) meetings","Expired","2021-04-06","N/A","Prof Patrick Stone, Chair in Palliative Medicine","University College London","","",""]
["02584","21/CAG/0025","Retrospective Review of the Use of Simplex High Viscosity Bone Cement for Joint Arthroplasty\n(Short title: Simplex Cement)","Expired","2021-04-06","N/A","Prof Andrew Toms, Consultant Orthopaedic Surgeon","Royal Devon & Exeter NHS Foundation Trust","","",""]
["02585","21/CAG/0036","Identification of Specific Low-Uptake Population Segments in Breast Cancer Screening","Expired","2021-04-23","N/A","Professor Ara Darzi, Co-Director of Institute of Global Health Innovation, Professor of Surgery","Imperial College London","","",""]
["02586","21/CAG/0022","The use of telephone based digital triage in urgent care provision and the associated patient service use and health outcomes: A routine data analysis study before and during the Covid-19 pandemic","Expired","2021-04-12","N/A","Dr H Atherton, Associate Professor","University of Warwick","","",""]
["02587","21/CAG/0026","High intensity treatment at the end of life in children with cancer: retrospective, national,data linkage study","Supported","2021-04-16","2025-04-16","Professor Lorna K Fraser","University of York","Applied","Yes","No"]
["02588","21/CAG/0042","The Wynn Database - Metabolic Risk Factors and Mortality v1.0","Supported","2021-04-26","2024-04-26","Professor Nick Oliver","Imperial College London","","",""]
["02589",0,0,0,"00:00:00","N/A",0,0,"","",""]
["02590","21/CAG/0040","Welsh Study of Mothers and Babies. Examining the association between cardiac echogenic foci at the 18-20 week antenatal fetal anomaly scan and cardiac disease in early childhood: An electronic record-linked cohort study. Sub-study 1: Obtaining scan images for further classification of the cardiac echogenic foci","Expired","2021-05-13","N/A","Dr Lisa Hurt, Senior Lecturer","Cardiff University","","",""]
["02591","21/CAG/0001","Optimum Patient Care Research Database (OPCRD)","Supported","2021-05-20","2022-05-20","Professor David Price","Optimum Patient Care Research Database (OPCRD)","","",""]
["02592","21/CAG/0061","British Paediatric Surveillance Study of Neonatal Stroke in the United Kingdom and the Republic of Ireland presenting/diagnosed in babies in the first 90 days of life","Supported","2021-05-27","2024-05-27","Dr Don Sharkey","University of Nottingham","","Yes","Yes"]
["02593","21/CAG/0054","A cluster randomised controlled trial to assess the effectiveness and cost-effectiveness of the ‘Your Care Needs You’ intervention to improve safety and experience of care transitions","Supported","2021-05-28","2024-05-28","Professor Rebecca Lawton, Professor in Psychology of Healthcare","Bradford Institute for Health Research (based at Bradford Teaching Hospitals NHS Foundation Trust)","Applied","Yes","No"]
["02594","21/CAG/0060","A pan cancer programme of tumour typing (version 1)","Supported","2021-05-28","2024-05-28","Dr Nicolas Orsi","Leeds Teaching Hospitals NHS Trust","","",""]
["02595","21/CAG/0070","The DAMPen-D study: Improving the Detection, Assessment, Management, and Prevention of Delirium in Hospices - Co-design and feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care","Expired","2021-06-14","N/A","Dr Mark Pearson, Senior Lecturer in Implementation Science","University of Hull","","",""]
["02596","18/CAG/0187","Project to Enhance ALSPAC through Record Linkage (PEARL): Phenotypic enrichment of the ALSPAC original parent/carer (G0) cohort through linkage to primary care electronic patient records and other databases.","Supported","2021-06-17","2024-06-17","Professor John Macleod, Professor in Clinical Epidemiology and Primary Care","ALSPAC, University of Bristol","","",""]
["02597",{"$f":"INDIRECT(\"A\"&A637&\"!B4\")","v":"21/CAG/0035"},"ABC Discover (Molecular Phenotyping of Breast Cancer)","Supported","2021-06-21","2022-06-21","Dr Paul Skipp","University of Southampton","","",""]
["02598","21/CAG/0077","Classification of breast cancer for personalised therapy","Expired","2021-06-21","N/A","Professor Emad A Rakha","University of Nottingham","","",""]
["02599","21/CAG/0063","The Impact of introducing real time feedback on ventilation rate and volume by ambulance clinicians in out of hospital cardiac arrest","Expired","2021-06-22","N/A","Mr Karl Charlton","North East Ambulance Service NHS Foundation Trust","","",""]
["02600","21/CAG/0081","neoWONDER: Neonatal Whole Population Data linkage to improving long-term health and wellbeing of preterm and sick babies","Supported","2021-06-22","2024-06-22","Dr Cheryl Battersby, Clinical Senior Lecturer and Honorary Consultant Neonatologist","Neonatal Data Analysis Unit (NDAU), Imperial College London","","",""]
["02601","21/CAG/0062","Barts Haemato-Oncology Research Tissue Bank (HOTB)","Supported","2021-06-23","2024-06-23","Coleen Colechin, Senior Operations Manager","Barts Cancer Institute, Queen Mary University of London","","",""]
["02602","21/CAG/0056","A randomized, controlled trial to assess the clinical utility of a multi-cancer early detection (MCED) test for population screening in the United Kingdom (UK) when added to standard of care","Expired","2021-06-23","N/A","Graham Cheetham, Senior Director Clinical Operations","Grail Bio UK Ltd & King's College London (KCL)","","",""]
["02603",{"$f":"INDIRECT(\"A\"&A643&\"!B4\")","v":"21/CAG/0093"},"Facilitating access to online NHS primary care services - current experience and future potential (Di-Facto)","Expired","2021-07-01",{"$f":"IF(D643<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A643&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A643&\"!B35\")))","v":"N/A"},"Professor John Campbell","University of Exeter",{"$f":"IF(INDIRECT(\"A\"&$A643&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A643&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A643&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A643&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A643&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A643&\"!B39\"))","v":""}]
["02604",{"$f":"INDIRECT(\"A\"&A644&\"!B4\")","v":"21/CAG/0067"},"Derivation and narrow validation of a clinical decision rule for paramedics to triage older adults with a traumatic brain injury \nShort title: Clinical Decision Rule for TBI in Older adults (CEREBRAL)","Expired","2021-07-20","N/A","Mr Jack Barrett, Research Paramedic","South East Coast Ambulance Service NHS Foundation Trust","","",""]
["02605",{"$f":"INDIRECT(\"A\"&A645&\"!B4\")","v":"21/CAG/0089"},"Evaluating the integration of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) into primary care and its impact on patient treatment and care\nShort title: ReSPECT in primary care","Expired","2021-07-21","N/A","Professor Anne Slowther, Professor of Clinical Ethics","University of Warwick","","",""]
["02606","21/CAG/0009",{"$f":"INDIRECT(\"A\"&$A646&\"!B6\")","v":"Motor Neuron Disease Register for England, Wales and Northern Ireland"},"Supported","2021-02-23","2025-04-14","Professor Ammar Al-Chalabi, Consultant Neurologist & Head of Basic and Clinical Neuroscience at KCL","Kings College London","","Yes","Yes"]
["02607","21/CAG/0066","Improving outcomes in Advanced Colorectal Tumours: The IMPACT I Project. Assessing multidisciplinary team management and referral patterns of patients with locally advanced and recurrent rectal cancer in the UK \nShort title:(IMPACT I)","Supported","2021-06-26","2022-06-26","Miss Deena Harji","University of Newcastle","","",""]
["02608","21/CAG/0078","Cancer Survivorship Studies","Supported","2021-07-28","2024-07-28","Professor Michael M Hawkins","Institute of Applied Health Research - the University of Birmingham","","Yes","Yes"]
["02609","21/CAG/0076","Configuration and utilisation of clinical pathways by patients who attend A&E in suicidal crisis","Expired","2021-07-29","N/A","Dr Pooja Saini ","Liverpool John Moores University","","",""]
["02610","21/CAG/0049","Do Safe and Well Visits delivered by the Fire and Rescue service reduce falls and improve quality of life among older people?  A randomised controlled trial (FIREFLI)","Expired","2021-07-20","N/A","Mrs Sarah Cockayne","Department of Health Sciences, University of York","","",""]
["02611","21/CAG/0102","Barts Myocardial Infarction with Non-Obstructed Coronary Arteries Registry","Supported","2021-07-30","2024-07-30","Dr. Daniel A Jones","Queen Mary, University of London","","",""]
["02612","21/CAG/0020","The effect of age at first invitation for breast screening in the NHS Breast Screening Programme in England and Wales (AFBSS)","Supported","2021-08-10","2024-08-10","Dr Isobel Barnes","University of Oxford","Applied","Yes","Yes"]
["02613","21/CAG/0098","Paediatric Intensive Care Audit Network (research application)","Supported","2021-08-10","2024-08-10","Professor Richard Feltbower","University of Leeds","","",""]
["02614","21/CAG/0043","Barts Cancer Institute Breast BioBank","Supported","2021-08-11","2024-08-11","Coleen Colechin, Senior Operations Manager ","Barts Cancer Institute","","Yes","No"]
["02615","21/CAG/0108","What clinical outcomes are associated with the ‘joint care’ for teenagers and young adults with cancer?\nShort title: BRIGHTLIGHT_2021","Supported","2021-08-24","2024-08-24","Dr Rachel Taylor","University College London","","Yes","Yes"]
["02616","21/CAG/0137","IBIS-II-O: Long term observational follow up of previous participants of the IBIS-II studies: DCIS and Prevention","Supported","2021-08-25","2024-08-25","Nadia Haidar","Wolfson Institute for Cancer Prevention","","Yes","Yes"]
["02617","21/CAG/0071","Congenital Hypothyroidism with Gland in Situ: establishing risk factors and outcomes using population-based data linkage methods","Supported","2021-09-07","2024-09-07","Dr Pia Hardelid","UCL Great Ormond Street -Institute of Child Health","","Yes","No"]
["02618","21/CAG/0088","Barts Structural Interventional Registry (BSIR)","Supported","2021-09-07","2024-09-07","Dr Michael Mullen","Barts Health NHS Trust","","Yes","No"]
["02619","21/CAG/0106","TRIM: What Triage model is safest and most effective for the management of 999 callers with suspected COVID-19? A linked outcome study","Supported","2021-09-02","2024-09-02","Professor Alan Watkins","Swansea University","","Yes","No"]
["02620","21/CAG/0104","Enhancing Pre-hospital Chest Pain Telephone-triage Using a Prediction Model","Supported","2021-09-15","2024-09-15","Professor Richard Body","Manchester University NHS foundation Trust","","",""]
["02621","21/CAG/0099","Governing parental opioid use: a relational ethnography\nShort title: The Relations Study_v1.0","Supported","2021-09-15","2022-09-15","Professor Anne Whittaker","University of Stirling ","","",""]
["02622","19/CAG/0200","The PROFILE Study- Germline genetic profiling: correlation with targeted prostate cancer screening and treatment.","Expired","2020-06-25","N/A","Professor Rosalind Eeles","The Institute of Cancer Research","","",""]
["02623","21/CAG/0111","Barts Cancer Research Tissue Bank (CTB)","Supported","2021-09-24","2024-09-24","Coleen Colechin, Senior Operations Manager ","Barts Cancer Institute, Queen Mary University of London","","",""]
["02624","21/CAG/0048","Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy","Supported","2021-09-28","2024-09-28","Professor Nicholas James","Institute for Cancer Research","","",""]
["02625","21/CAG/0064","How are assessment tools and chronologies used by health and social care professionals in England to identify child neglect?","Expired",{"$f":"INDIRECT(\"A\"&$A665&\"!B34\")","v":"2021-10-05"},"N/A","Mrs Monica Duman","Oxford Brookes University","","",""]
["02626","21/CAG/0131","Confirming ongoing nasogastric tube position – an analysis of practice and outcomes between the UK and Australia ","Expired","2021-10-08","N/A","Dr Christine Elizabeth Weekes","University College London Hospital NHS Foundation Trust ","","",""]
["02627","21/CAG/0126","A retrospective cohort study to investigate body composition and survival in metastatic breast cancer","Supported","2021-10-11","2024-10-11","Dr Ellen Copson ","University of Southampton","","",""]
["02628","20/CAG/0112","Ethnic Density and Psychosis in a British Pakistani Population: an investigation using data from the East Lancashire Early Intervention Service","Expired","2021-09-24","N/A","Dr Ross White","University of Liverpool ","","",""]
["02629","21/CAG/0120","NHS England Hepatitis C Virus Case Finding in Primary Care Pilot (HepCAPP)","Expired","2021-10-08","N/A","Professor Matthew Hickman","University of Bristol","","",""]
["02630","21/CAG/0135","Clinical management of Patients with Malignant Bowel Obstruction: A Multi-centre retrospective Cohort Study","Expired","2021-10-15","N/A","Mr Michael Patterson","University of Hull","","",""]
["02631","21/CAG/0127","The Oxford Vascular Study: a population-based study of the incidence and outcome of stroke, transient ischaemic attack, acute coronary syndromes and peripheral vascular events\nShort title: OxVasc","Supported","2021-10-21","2024-10-21","Professor Peter Rothwell","University of Oxford","","Yes","No"]
["02632","21/CAG/0058","Evaluation of Homeless Health Peer Advocacy: an analysis of secondary data\nShort title: HHPA evaluation: Secondary analyses of Hospital Episodes Statistics","Expired","2021-10-25","N/A","Professor Lucy Platt, Professor of Public Health Epidemiology","London School of Hygiene & Tropical Medicine","","",""]
["02633","20/CAG/0056","PEARL s251 Sensitive Health Records Template (Maternal smoking during pregnancy and intellectual disability)","Supported","2020-09-17","2024-09-17","Mark Mumme (ALSPAC Data Linkage Manager)","University of Bristol","","Yes","No"]
["02634","21/CAG/0095 ","IMplementation of the Preterm Birth Surveillance PAthway: a RealisT evaluation (including a realist literature scope)","Expired","2021-11-08","N/A","Professor Jane Sandall, Professor of Social Science and Women's Health","King’s College London ","","",""]
["02635","21/CAG/0097 ","PARADISE: Predicting AF after Cardiac Surgery - A Clinical Prediction Rule for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","Supported","2021-11-09","2024-11-09","Dr Peter Watkinson","University of Oxford","","",""]
["02636","21/CAG/0160","Secondary/additional findings in the 100,000 Genomes Project: disease manifestation, impacts on recipients and healthcare utilisation ","Supported","2021-11-18","2024-11-18","Dr Elizabeth Ormondroyd, Senior Researcher","University of Oxford","","",""]
["02637","21/CAG/0114","Trends in the Prevalence and Complexity of Children with a Life-limiting or Life-threatening condition in Wales","Supported","2021-11-25","2025-01-02","Professor Lorna Fraser","University of York","Applied","Yes","Yes"]
["02638","21/CAG/0164","Recovery, Renewal and Reset of Services to Disabled Children","Supported","2021-12-03","2024-12-03","Professor Lindsay Pennington","Newcastle University","","Yes","No"]
["02639","21/CAG/0123","RE-BLEED: A digital platform for identifying bleeding patients – a feasibility study","Supported","2021-12-09","2024-12-09","Professor Peter Watkinson, Chief Investigator","University of Oxford","","Yes","No"]
["02640","21/CAG/0128","Investigating the role of play experiences in paediatric hospital settings","Expired","2021-12-10","N/A","Professor Paul Ramchandani","University of Cambridge","","",""]
["02641","21/CAG/0177","Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency hip fracture care Delivery","Supported","2021-12-10","2024-11-22","Professor Helen Snooks","Swansea University","Applied","Yes","Yes"]
["02643","21/CAG/0123 Duplicate entry - see 02639",{"$f":"INDIRECT(\"A\"&$A682&\"!B6\")","v":"RE-BLEED: A digital platform for identifying bleeding patients – a feasibility study"},"N/A","N/A","N/A","N/A","N/A","","",""]
["02644","21/CAG/0128","Investigating the role of play experiences in paediatric hospital settings","Supported","2021-12-10","2022-12-10","Professor Paul Ramchandani, Professor of Play in Education, Development and Learning & Honorary Consultant Child and Adolescent Psychiatrist","University of Cambridge","","",""]
["02645","21/CAG/0177 Duplicate entry - see 02641","Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency hip fracture care Delivery","N/A","N/A","N/A","N/A","N/A","","",""]
["02646","21/CAG/0173","Establishing the burden of vaccine preventable acute lower respiratory tract infections in primary care, UK: Avon-CAP GP2","Supported","2021-12-21","2024-12-21","Professor Adam Finn, Professor of Paediatrics","University of Bristol","Applied","Yes","No"]
["02647","22/CAG/0004","Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people","Expired","2021-12-10","N/A","Dr Michelle Willicombe, Senior Clinical Lecturer","Imperial College London","","",""]
["02648","21/CAG/0182","PriDem: Best Practice in Primary Care Led Dementia Support","Expired","2021-12-23","N/A","Dr Sarah Griffiths, PriDem Study Manager         ","University College London","","",""]
["02649","21/CAG/0133",{"$f":"INDIRECT(\"A\"&$A688&\"!B6\")","v":"Mortality and morbidity outcomes after aorto-vascular surgery in patients with Marfan Syndrome: A UK experience "},{"$f":"INDIRECT(\"A\"&$A688&\"!B32\")","v":"Supported"},"2021-12-23","2024-12-23",{"$f":"(INDIRECT(\"A\"&$A688&\"!B9\"))","v":"Prof Julie Sanders - Director Clinical Research (Barts), Clinical Professor (QMUL) "},{"$f":"(INDIRECT(\"A\"&$A688&\"!B8\"))","v":"Barts Health NHS Trust"},"","Yes","Yes"]
["02650","21/CAG/0175","Peer support Observational Ethnography – Theory in Context (POETIC) Study","Expired","2022-01-07","N/A","Professor Mike Slade, Professor of Mental Health Recovery and Social Inclusion","University of Nottingham","","",""]
["02651","20/CAG/0101","FFRCT In Stable Heart disease & CTA Helps Improve Patient care and Societal costs","Supported","2021-01-28","2025-01-28","Dr Timothy Fairbairn, Consultant Cardiologist, Honorary Lecturer,","Liverpool Heart and Chest Hospital NHS Foundation Trust","Applied","Yes","No"]
["02652","21/CAG/0176","What Are the Organisational And Cultural Issues That Affect the Maintenance of Safety During The Management Of High Security Forensic Patients Outside of the High Secure Setting","Expired","2022-01-25","N/A","Professor Stephen Timmons, Professor of Health Services Management","University of Nottingham","","",""]
["02653","21/CAG/0113","A comprehensive assessment of peri-prosthetic fractures associated with the CPT® stem in a large teaching hospital over 16 years","Supported","2022-01-24","2024-01-24","Mr Andrew Manktelow, Orthopaedic Consultant ","Nottingham University Hospitals NHS Trust","","",""]
["02654",{"$f":"INDIRECT(\"A\"&A693&\"!B4\")","v":"22/CAG/0017"},"Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe): a multi-centre randomised controlled trial","Expired","2022-01-31","N/A","Dr Gordon McGregor, Chief Investigator ","University of Warwick","","",""]
["02655","21/CAG/0149","Legacies and Futures: Gestational Parents' Experiences with Vulnerability and Resilience as it Influences Parent and Neonatal Health","Expired","2022-01-31","N/A","Dr. David Frost, Associate Professor of Social Psychology","University College London","Applied","Yes","No"]
["02656","21/CAG/0132","Evaluating the health inequality effects of the Best Practice Tariff for hip fracture","Supported","2022-02-10","2024-02-10","Professor Susan Griffin","University of York","","",""]
["02657","22/CAG/0021","The South London Stroke Register: Improving the lives of stroke survivors with data. (SLSR)","Supported","2022-02-16","2025-02-16","Iain Marshall, Chief Investigator","King's College London","Applied","Yes","No"]
["02658","21/CAG/0155","Using patient records to identify potential participants for the fourth National Survey of Sexual Attitudes and Lifestyles (Natsal-4)","Supported","2022-02-16","2025-02-16","Professor Pam Sonnenberg","University College London","","Yes","Yes"]
["02659","21/CAG/0121","Long-term risk of cancer and general health outcomes in women who underwent assisted reproductive technology in Great Britain, 1991-2010: a data linkage study ","Supported","2022-02-18","2024-02-18","Professor Alastair Sutcliffe, Professor of General Paediatrics","UCL Institute of Child Health","","Yes","No"]
["02660","22/CAG/0010","The Integration and Analysis of Data Using ARtificial InTelligence to Improve Patient Outcomes with Thoracic Diseases","Supported","2022-02-23","2025-02-23","Professor Fergus Gleeson, Consultant Radiologist","Oxford University","","Yes","No"]
["02661","22/CAG/0012","Using linked secondary and primary care electronic health records to evaluate opioid utilisation and safety","Supported","2022-03-01","2025-03-01","Dr Meghna Jani, NIHR Clinician Scientist and Honorary Consultant Rheumatologist","University of Manchester","","Yes","No"]
["02662",{"$f":"INDIRECT(\"A\"&A701&\"!B4\")","v":"21/CAG/0148"},"Postoperative vasopressor usage: a prospective observational study. Relation to Perioperative Atrial Fibrillation (AF)","Expired","2022-03-15","N/A","Professor Ingeborg Welters","University of Liverpool","Applied","Yes","Yes"]
["02663","22/CAG/0040","A Surveillance Study of Congenital and Hospitalized Neonatal Varicella in the United Kingdom & Portugal (NEOPOX)","Supported","2022-03-21","2024-03-21","Dr Kate Jordan","UK Health Security Agency","","Yes","Yes"]
["02664","22/CAG/0042","A long-term prospective cohort study on the effects of smoking and prophylactic aspirin on all-cause mortality in male British doctors","Supported","2022-03-21","2025-03-21","Professor Peter Rothwell, Action Research Professor of Neurology/Consultant Neurologist","University of Oxford","","Yes","No"]
["02665","22/CAG/0031","Magnetic Foreign Body Ingestion in Children (MAGNETIC): a prospective surveillance study","Expired","2022-03-23","N/A","Professor Nigel J Hall, Associate Professor of Paediatric Surgery","University Hospital Southampton NHS Foundation Trust","","",""]
["02666","22/CAG/0003","Emergency Medical Services Streaming Enabled Evaluation In Trauma","Expired","2022-03-22","N/A","Professor Cath Taylor, Professor of Healthcare Workforce Organisation and Wellbeing","University of Surrey","","",""]
["02667","22/CAG/0051","Our Future Health","Supported","2022-03-29","2025-03-29","Jackie Shears, Lead for NHS and Data ","Our Future Health Ltd","Applied","Yes","No"]
["02668",{"$f":"INDIRECT(\"A\"&A707&\"!B4\")","v":"22/CAG/0068"},"Childhood outcomes after perinatal brain injury: a population-based linkage study  ","Supported","2022-04-08",{"$f":"IF(D707<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A707&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A707&\"!B35\")))","v":"2025-01-28"},"Dr Philippa Rees","University College London & Imperial College London",{"$f":"IF(INDIRECT(\"A\"&$A707&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A707&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A707&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A707&\"!B38\"))","v":"Yes"},{"$f":"IF(INDIRECT(\"A\"&$A707&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A707&\"!B39\"))","v":"No"}]
["02669","22/CAG/0009","Early detection of bladder cancer in Yorkshire: Feasibility assessments for implementing a targeted study in populations with high disease specific mortality risk","Supported","2022-03-31","2024-03-31","Professor James Catto, Professor in Urological Surgery","University of Sheffield","","",""]
["02670","22/CAG/0006","Developing a digital handover application for paramedics to provide a personalized approach to pre-hospital stratification for OOHCA – the RAPID-MIRACLE study","Supported","2022-03-31","2024-08-14","Dr. Nilesh Pareek","King's College London","","Yes","No"]
["02671","22/CAG/0002","Assembling the Data Jigsaw in Greater Manchester: improving MSK research to advance patient care and inform patient policy using linked primary and secondary care data ","Supported","2022-04-26","2024-04-26","Professor Will Dixon, Professor of Digital Epidemiology","University of Manchester","","Yes","No"]
["02672","22/CAG/0032","A Foucauldian discourse analysis of clinicians' language regarding standards of care in the current socio-political NHS context","Expired","2022-05-03","N/A","Miss Kristina Argustaite","Surrey and Borders Partnership NHS Foundation Trust","","",""]
["02673",{"$f":"INDIRECT(\"A\"&A712&\"!B4\")","v":"22/CAG/0036"},"Cardiovascular morbidity and mortality in Liothyronine-treated patients: a linked record cohort study ","Supported","2022-05-04","2024-05-04","Professor Colin Dayan, Professor of Clinical Diabetes and Metabolism","Cardiff University","","",""]
["02674","22/CAG/0065","Comorbidities and outcomes of patients with chronic pancreatitis: a single centre cohort study","Supported","2022-05-09","2024-05-09","Dr Aloysious Aravinthan, Chief Investigator","Nottingham University Hospitals NHS Trust","","",""]
["02675","22/CAG/0059 (Previously CR2/2014)","The Whitehall II Study","Supported","2022-05-10","2024-05-10","Professor Mika Kivimaki, Chair of Social Epidemiology, Whitehall II Study Director","University College London","Applied","Yes","Yes"]
["02676",{"$f":"INDIRECT(\"A\"&A715&\"!B4\")","v":"18/CAG/0158"},"The Northern Region Young Persons' Malignant Disease Registry","Supported","2022-05-05","2024-05-05","Dr Richard McNally","Newcastle University","","",""]
["02677",{"$f":"INDIRECT(\"A\"&A716&\"!B4\")","v":"21/CAG/0050"},"Suicide in former service personnel: rates, antecedents, and prevention","Supported","2021-06-17","2024-06-16","Professor Navneet Kapur, Head of Suicide Research","University of Manchester","","",""]
["02678","22/CAG/0071","CompreHensive GeriAtRician led MEdication Review (CHARMER) - Work Package 3 Feasibility Trial","Supported","2022-05-20","2024-05-20","Megan Pritchard","University of Leicester","Exempt","Yes","No"]
["02679","22/CAG/0034","Artificial Intelligence Stress Echo (FINESSE) ","Supported","2022-05-30","2024-05-30","Professor Attila Kardos","Milton Keynes University Hospital NHS Foundation Trust","","",""]
["02680",{"$f":"INDIRECT(\"A\"&A719&\"!B4\")","v":"21/CAG/0169"},"DECLINE: Decisions against curative treatment for lung cancer in eligible patients","Expired","2022-06-09","N/A","Dr Manpreet Bains","University of Nottingham","","",""]
["02681","22/CAG/0071","CompreHensive GeriAtRician led MEdication Review (CHARMER) - Work Package 3 Feasibility Trial","Supported","2022-05-20","2023-05-20","Megan Pritchard","University of Leicester","","",""]
["02682","22/CAG/0066","A pragmatic trial of an Artificial intelligence DRiven appOInTment maNagEment SyStem","Supported","2022-06-15","2024-06-15","Professor Nicola Thomas","London South Bank University","","",""]
["02683","22/CAG/0072","Epidemiology and Outcome from Out of Hospital Cardiac Arrest (Research application)","Supported","2022-06-15","2024-06-15","Professor Gavin Perkins, Director Warwick Clinical Trials Unit","University of Warwick","","Yes","Yes"]
["02684",{"$f":"INDIRECT(\"A\"&A723&\"!B4\")","v":"22/CAG/0070"},"Implementation of an artificial intelligence module on the online imaging portal MYO-Share for guiding the diagnosis of muscle diseases","Supported","2022-06-24","2024-06-24","Professor Jordi Diaz-Manera, Professor of Neuromuscular Diseases ","Newcastle University","","",""]
["02685",{"$f":"INDIRECT(\"A\"&A724&\"!B4\")","v":"22/CAG/0001"},{"$f":"INDIRECT(\"A\"&$A724&\"!B6\")","v":"RECAP  (Remote  Covid  Assessment  in  Primary  Care):  a learning  system  approach  to  develop  an  early  warning scorefor use by primary care practitioners"},"Supported","2022-07-01","2024-07-01","Professor Brendan Delaney","Imperial College London","","Yes","No"]
["02686","21/CAG/0159","UK-REACH:    United    Kingdom    Research    Study into Ethnicity And COVID-19 outcomes in Healthcare workers","Supported","2022-07-01","2024-07-01","Dr Manish Pareek","University of Leicester","","Yes","Yes"]
["02687","21/CAG/0122","Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses - PRINCIPLE","Expired","2022-07-01","N/A","Professor Christopher Butler","University of Oxford","","",""]
["02688","21/CAG/0004","Neonatal Complications of Coronavirus Disease (COVID-19) Study","Supported","2022-07-01","2024-07-01","Professor Jennifer Kurinczuk","University of Oxford","","Yes","No"]
["02689","21/CAG/0156","Understanding SARS-CoV-2 infection, immunity and its duration in care home staff and residents in the UK (VIVALDI STUDY)","Expired","2022-07-01","N/A","Professor Laura Shallcross","University College London","","",""]
["02690","21/CAG/0180","National COVID-19 Chest Imaging Database (NCCID)","Supported",{"$f":"INDIRECT(\"A\"&$A729&\"!B34\")","v":"2022-07-01"},"2024-07-01","Mr Dominic Cushnan","NHS England","","",""]
["02691","21/CAG/0125","ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infection","Supported","2022-07-01","2024-07-01","Professor Calum Semple","University of Liverpool","","Yes","Yes"]
["02692","21/CAG/0117","CCP-Cancer UK: Clinical Characterisation Protocol for Severe Emerging Infections in the UK (CCP-UK) – a prospective companion study for patients with Cancer and COVID-19","Supported","2022-07-01","2024-07-01","Professor Carlo Palmieri","University of Liverpool","","",""]
["02693","22/CAG/0026","Covid impact on RSV Emergency Presentations: BronchStart","Supported","2022-07-01","2024-07-01","Professor Damian Roland","University Hospitals of Leicester NHS Foundation Trust","","Yes","No"]
["02694","21/CAG/0157","CVD-COVID-UK/COVID-IMPACT: UK-wide linked routine healthcare data to address the impact of cardiovascular diseases and other health conditions and health-related risk factors on COVID-19 and the impact of COVID-19 on cardiovascular diseases and other health conditions.","Supported","2022-07-01","2024-07-01","Professor Cathie Sudlow","Health Data Research UK","","",""]
["02695","21/CAG/0144","Risk of COVID-19 related hospital admission and death in cancer patients in Greater Manchester - GM-COVID CANCER","Expired","2022-07-01","N/A","Kate Wicks","The Christie NHS Foundation Trust","","",""]
["02696","22/CAG/0097","AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment","Supported","2022-07-01","2024-07-01","Babitha Jeevith/ Project Manager","University of Southampton and the University of Liverpool","","",""]
["02697","22/CAG/0082","PANORAMIC - Platform Adaptive trial of NOvel antiviRals for eArly treatMent of covid-19 In the Community","Supported","2022-07-01","2024-07-01","Professor Christopher Butler","University of Oxford","","",""]
["02698",{"$f":"INDIRECT(\"A\"&A737&\"!B4\")","v":"22/CAG/0089"},"\nOutcomes of Early Psoriatic Arthritis in a UK nation-wide cohort","Supported","2022-07-07","2024-09-01","Dr William Tillet","Royal United Hospitals Bath NHS Foundation Trust ","","",""]
["02699",{"$f":"INDIRECT(\"A\"&A738&\"!B4\")","v":"22/CAG/0022"},"\nPatterns of Multiple Long-Term Vascular Conditions: A pilot study","Supported","2022-07-07","2024-07-07","Dr Abdel Douiri ","Kings' College London","","",""]
["02700",{"$f":"INDIRECT(\"A\"&A739&\"!B4\")","v":"22/CAG/0064"},"\nBuilding an understanding of Ethnic minority people’s Service Use Relating to Emergency care for injuries (BE SURE)","Supported","2022-07-07","2024-07-07","Dr Ashrafunnesa Khanom","Swansea University","","",""]
["02701",{"$f":"INDIRECT(\"A\"&A740&\"!B4\")","v":"22/CAG/0078"},"EXTEND study – Needs Assessed Care for Early Psychosis","Supported","2022-07-26","2024-07-26","Professor Belinda Lennox","University of Oxford","","",""]
["02702",{"$f":"INDIRECT(\"A\"&A741&\"!B4\")","v":"22/CAG/0118"},"NICOR - Extended Use of Data V1.1 2017","Supported","2022-07-26","2024-06-28","Professor Nick Linker","NHS England & NHS Improvement","","",""]
["02703",{"$f":"INDIRECT(\"A\"&A742&\"!B4\")","v":"22/CAG/0019"},"CUREd+: Centre for Urgent and Emergency Care Research Database - refresh","Supported","2022-07-26","2024-07-26","Professor Suzanne Mason ","University of Sheffield","","",""]
["02704",{"$f":"INDIRECT(\"A\"&A743&\"!B4\")","v":"22/CAG/0075"},"Clinical and Radiographic outcomes of reverse shoulder arthroplasty performed with 36-mm CoCrMo vs 40-mmcross-linked UHMWPE glenospheres at minimum 2-years follow-up.","Supported","2022-07-26","2024-07-26","Prof Ian Trail","Wigan and Leigh NHS Foundation Trust","","Yes","No"]
["02705",{"$f":"INDIRECT(\"A\"&A744&\"!B4\")","v":"22/CAG/0073 "},"Kidney disease and mental health: Bridging the gap ","Supported","2022-08-02","2024-05-14","Dr Kate Bramham","Weston Education Centre","","",""]
["02706",{"$f":"INDIRECT(\"A\"&A745&\"!B4\")","v":"22/CAG/0076 "},"Suicide by patients in contact with drug and alcohol services in the year prior to death","Supported","2022-08-03","2025-01-05","Professor Jennifer Shaw","University of manchester","Applied","Yes","No"]
["02707",{"$f":"INDIRECT(\"A\"&A746&\"!B4\")","v":"22/CAG/0092 "},{"$f":"INDIRECT(\"A\"&$A746&\"!B6\")","v":"Establishing evidence to inform culturally competent mental health services (EVOLVE)"},"Supported","2022-08-09","2024-08-09","Dr Yu Fu","Population Health Sciences Institute","","Yes","No"]
["02708",{"$f":"INDIRECT(\"A\"&A747&\"!B4\")","v":"22/CAG/0102"},"Exploring use and implementation of rehabilitation prescriptions for individuals admitted to UK major trauma centres: a mixed-methods study","Expired","2022-08-16","N/A","Dr Jade Kettlewell","University of Nottingham","","",""]
["02709",{"$f":"INDIRECT(\"A\"&A748&\"!B4\")","v":"22/CAG/0099"},"ABATED -Automated Brain Image Analysis for Timely and Equitable Dementia Diagnosis","Supported","2022-08-03","2024-08-03","Dr Charles Marshall","Queen Mary University of London/Barts Health NHS Trust/East London Foundation Trust","","Yes","No"]
["02710",{"$f":"INDIRECT(\"A\"&A749&\"!B4\")","v":"22/CAG/0086"},"The Norfolk Arthritis Register (NOAR)","Supported","2022-08-05","2024-08-05","Professor Alexander Macgregor","University of East Anglia","","",""]
["02711",{"$f":"INDIRECT(\"A\"&A750&\"!B4\")","v":"22/CAG/0094 "},"Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Diagnostics. (Short title:RID-TB:Dx","Supported","2022-08-26","2024-08-26","Professor Ibrahim Aboubakar","University College London","","",""]
["02712",{"$f":"INDIRECT(\"A\"&A751&\"!B4\")","v":"22/CAG/0095"},"UK Early Life Cohort Feasibility Study","Supported","2022-08-24","2024-08-24","Professor Lisa Calderwood","University College London","","",""]
["02713",{"$f":"INDIRECT(\"A\"&A752&\"!B4\")","v":"22/CAG/0088"},"Evaluating  ICON:  A  mixed  methods  study  to  assess  the impact  of  the  ICON  programme  on  coping  strategies  for carersof crying babies, and rates of abusive head trauma in infants aged under one year.","Supported","2022-08-25","2024-08-25","Doctor Mark Lyttle","Bristol Royal Hospital for Children","Applied","Yes","No"]
["02714",{"$f":"INDIRECT(\"A\"&A753&\"!B4\")","v":"22/CAG/0103"},"Supporting the NHS Long Term Plan: An evaluation of the implementation   and   impact   of   NHS-funded   tobacco dependence services","Supported ","2022-09-07","2024-09-07","Professor Eileen FS Kaner","Newcastle University","","Yes","No"]
["02715",{"$f":"INDIRECT(\"A\"&A754&\"!B4\")","v":"22/CAG/0119"},"Cluster JIA-uveitis research database","Supported","2022-09-08","2024-09-08","Professor Kimme Hyrich","University of Manchester","","Yes","No"]
["02716",{"$f":"INDIRECT(\"A\"&A755&\"!B4\")","v":"22/CAG/0080"},"Cancer  incidence  and  mortality  in  a  cohort  of  women treated for subfertility in Oxfordshire and West Berkshire","Supported","2022-09-09","2024-09-09","Dr Michael Murphy","Universityof Oxford","","",""]
["02717",{"$f":"INDIRECT(\"A\"&A756&\"!B4\")","v":"22/CAG/0055 "},"Near Fatal Asthma in Children and Young People","Supported","2022-09-23","2024-09-23","Professor Steve Cunningham","University of Edinburgh","","",""]
["02718",{"$f":"INDIRECT(\"A\"&A757&\"!B4\")","v":"22/CAG/0062"},"A Study of Cardiovascular Events iN Diabetes –PLUS ","Supported","2022-09-26","2024-09-26","Dr David Preiss","University of Oxford ","","Yes","No"]
["02719",{"$f":"INDIRECT(\"A\"&A758&\"!B4\")","v":"22/CAG/0039"},"An  investigation into  effective Antimicrobial Stewardship (AMS)  Strategies  during  a  pandemic  (COVID-19)  in  an acute care setting","Expired","2022-09-29","N/A","Dr Zoe Aslanpour","School of Life and Medical Sciences","","",""]
["02720",{"$f":"INDIRECT(\"A\"&A759&\"!B4\")","v":"22/CAG/0123 "},"A single-centre, retrospective cohort study of CT head pathologies in infants and toddlers presenting to ED due to head injury from an accidental fall","Supported","2022-10-07","2024-10-07","Mr Jayaratnam Jayamohan","Oxford University HospitalNHS Foundation Trust","","Yes","No"]
["02721",{"$f":"INDIRECT(\"A\"&A760&\"!B4\")","v":"22/CAG/0093"},"Emerging  eviDence  on  the  impact  of  COVID-19  on  mental  hEalth sErvices  and  health  inequalities  in  highly  dePrived  communities (DEEP","Expired","2022-10-05","N/A","Dr Ge Yu","Newcastle University","","Yes","No"]
["02722",{"$f":"INDIRECT(\"A\"&A761&\"!B4\")","v":"22/CAG/0049"},"LOng   COvidMultidisciplinary   consortium:   Optimising Treatments and servIces across the NHS (LOCOMOTION)","Supported","00:00:00","2024-10-12","Mr Thomas Osborne, Research Project Manager","University of Leeds","","Yes","Yes"]
["02723",{"$f":"INDIRECT(\"A\"&A762&\"!B4\")","v":"22/CAG/0106"},"The BCIS Out of Hospital Cardiac Arrest Pilot Registry","Supported","2022-10-17","2024-10-17","Dr Thomas Keeble","Mid and South Essex NHS Foundation Trust","","Yes","No"]
["02724",{"$f":"INDIRECT(\"A\"&A763&\"!B4\")","v":"22/CAG/0122 "},"ROC-oN: Radiotherapy for Oropharyngeal Cancer and impact on Neurocognition","Expired","2022-10-18","N/A","Dr Louise Murray","University of Leeds","","",""]
["02725",{"$f":"INDIRECT(\"A\"&A764&\"!B4\")","v":"22/CAG/0124 "},"Feasibility  of  an  artificial  intelligence  system to  improve the quality and efficiency of breast cancer screening","Supported","2022-10-20","2024-10-20","Professor Lord Darzi","Imperial College London","Applied","Yes","No"]
["02726",{"$f":"INDIRECT(\"A\"&A765&\"!B4\")","v":"22/CAG/0112"},"Randomised  trial  of  the  clinical  and  cost  effectiveness  of  a supraglottic   airway   device   versus   intubation   during   in-hospital cardiac arrest","Supported","2022-10-31","2024-10-31","Professor Jonathan Benger","University of the West of England ","","Yes","Yes"]
["02727",{"$f":"INDIRECT(\"A\"&A766&\"!B4\")","v":"22/CAG/0131"},"STandardising pAthways for diagnosing hypeRtension using routine healLthcare data: an InvestiGation of the Health and economic ouTcomes: STARLIGHT, Version 1.0","Supported","2022-11-04","2024-11-04","Dr Laura Armitage","University of Oxford","","Yes","No"]
["02728",{"$f":"INDIRECT(\"A\"&A767&\"!B4\")","v":"22/CAG/0038"},{"$f":"INDIRECT(\"A\"&$A767&\"!B6\")","v":"Twins’ Early Development Study (TEDS) Medical Record Linkage "},"Supported","2022-11-18","2024-11-18","Thalia C Eley","King’s College London","Applied","Yes","No"]
["02729",{"$f":"INDIRECT(\"A\"&A768&\"!B4\")","v":"22/CAG/0125 "},"Management of Patients with Chronic Liver Disease Admitted to Hospital as an Emergency","Supported","2022-11-22","2024-11-22","William Bernal","King's College Hospital NHS Foundation Trust","Applied","Yes","No"]
["02730",{"$f":"INDIRECT(\"A\"&A769&\"!B4\")","v":"22/CAG/0149"},"Progression of Diabetic Retinopathy from referral to treatment or vision loss: External Validation, update and net clinical benefit of a Multivariable Prediction Model","Supported","2022-12-02","2024-12-02","Dr Nicola Adderley Head of Research Governance & Integrity Research Strategy and Services Division ","University of Birmingham","Applied","Yes","No"]
["02731",{"$f":"INDIRECT(\"A\"&A770&\"!B4\")","v":"22/CAG/0127"},"Turning6 - A Clinical and Neurodevelopmental follow up of EPIPEG participants at 60 months","Supported","2022-12-02","2023-12-02","Professor Helen Cross (Chief Investigator) ","UCL GOS Institute of Child Health and Young Epilepsy (The National Centre for Young People with Epilepsy)","","",""]
["02732",{"$f":"INDIRECT(\"A\"&A771&\"!B4\")","v":"22/CAG/0144"},"Randomised Evaluation of SOdium dialysate Levels on Vascular Events","Supported","2022-12-07",{"$f":"IF(D771<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A771&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A771&\"!B35\")))","v":"2024-12-07"},"Mrs Lisa French ","University College London",{"$f":"IF(INDIRECT(\"A\"&$A771&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A771&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A771&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A771&\"!B38\"))","v":"Yes"},{"$f":"IF(INDIRECT(\"A\"&$A771&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A771&\"!B39\"))","v":"No"}]
["02733",{"$f":"INDIRECT(\"A\"&A772&\"!B4\")","v":"22/CAG/0146"},"Evaluating Behavioural Science Informed Messaging on Cervical Cancer Screening Catch-up","Supported","2022-12-09","2024-12-09","Dr Gaby Judah Lecturer in Behavioural Sciences ","Big Data Analytical Unit (BDAU), Imperial College London","Applied","Yes","No"]
["02734",{"$f":"INDIRECT(\"A\"&A773&\"!B4\")","v":"23/CAG/0006"},"Birmingham   and   Lambeth   Liver   Evaluation   Testing Strategies -10 Year Follow Up","Expired","2022-12-16","N/A","Professor Richard Lilford","University of Birmingham","","",""]
["02735",{"$f":"INDIRECT(\"A\"&A774&\"!B4\")","v":"22/CAG/0165 "},"Shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of an intervention to promote regular, asymptomatic testing in care home staff.","Expired","2022-12-19","N/A","Professor Laura Shallcross","University College London","","",""]
["02736",{"$f":"INDIRECT(\"A\"&A775&\"!B4\")","v":"22/CAG/0160"},"National Prospective Cohort Study and Surveillance of Sympathetic Ophthalmia in the United Kingdom","Supported","2022-12-19","2024-12-19","Mr Mahiul MK Muqit ","Moorfields Eye Hospital NHS Foundation Trust","","Yes","Yes"]
["02737",{"$f":"INDIRECT(\"A\"&A776&\"!B4\")","v":"19/CAG/0044"},"Evaluating the two-week wait referral system for bowel cancer","Expired","2021-06-17","N/A","Professor Michel Coleman","London School of Hygiene and Tropical Medicine","","",""]
["02738",{"$f":"INDIRECT(\"A\"&A777&\"!B4\")","v":"22/CAG/0166"},"How Do Healthcare Professionals Recognise and Respond to Deconditioning? A mixed-methods synthesis and consensus","Expired","2022-12-30","N/A","Professor Adam L Gordon, Professor of the Care of Older People ","University of Nottingham","","Yes","No"]
["02739",{"$f":"INDIRECT(\"A\"&A778&\"!B4\")","v":"22/CAG/0156"},"General Health Outcomes in Subfertile Men: a UK register-based cohort study","Supported","2023-01-05","2024-01-05","Professor Alastair G Sutcliffe, Professor of General Paediatrics","UCL Institute of Child Health","","",""]
["02740",{"$f":"INDIRECT(\"A\"&A779&\"!B4\")","v":"22/CAG/0168"},"Opioid use after surgery in opioid-naive patients: a qualitative study","Expired","2023-01-16","N/A","Dr Fausto Morell-Ducos, Chief Investigator ","University College London ","","",""]
["02741","22/CAG/0147","A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease (FDG-PET Study): RAPID","Supported","2023-01-11","2025-01-11","Professor John Radford","The University of Manchester","Applied","Yes","No"]
["02742","22/CAG/0154","Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care: UK-ROX","Supported","2023-01-12","2025-01-12","Professor Daniel Martin","University of Plymouth","Applied","Yes","No"]
["02743","22/CAG/0145 ","Safety and Efficacy of Managing Acute Heart Failure without Hospital Admission (SAFE v6.0) ","Supported","2023-01-16","2024-01-16","Dr Kenneth Wong  ","Blackpool Teaching Hospitals NHS Foundation Trust","","",""]
["02744","22/CAG/0105","Improving patient outcome in the 'hotzone' during a major incident: a mixed methods medical research approach","Supported","2023-01-20","2025-01-20","Dr Claire Park, Chief Investigator  ","Barts Health NHS Trust","","Yes","No"]
["02745","22/CAG/0174","UNderstanding the Causes of hyperglycaemia in pRegNancy","Supported","2023-01-20","2024-01-20","Dr Sara Louise White, Chief Investigator","King's College London","","",""]
["02746","22/CAG/0157","Do  we  miss  a  common  subset  of Primary  Aldosteronism  in which  there  is  cyclical  or  exaggerated  diurnal  variation  in secretion?","Supported","2023-01-24","2024-01-24","Dr Yun Ni Lee, student researcher","Queen Mary University of London","","",""]
["02747","23/CAG/0016 ","How are people with motor neuron disease (MND) are supported by their clinical teams to make decisions about gastrostomy feeding tube: a multiple case study","Expired","2023-01-27","N/A","Mr Sean White ","Sheffield Teaching Hospitals NHS Foundation Trust ","","",""]
["02748","22/CAG/0141","Do patients with autoimmune hepatitis (AIH) have an excessive incidence of cardio- and cerebrovascular disease and is this related to corticosteroid treatment?\n\n","Supported","2023-01-30","2025-01-30","Dr Jemima Clarke  ","Sheffield Teaching Hospitals NHS Foundation Trust \n","Applied","Yes","No"]
["02749","23/CAG/0010","The SHIPS Study: Sharing Information at the Primary / Secondary care interface – improving patient care by ensuring that GPs get the information they need when someone is discharged from hospital","Supported","2023-01-30","2024-01-30","Dr Lucy Pocock","University of Bristol ","","",""]
["02750","23/CAG/0003","PRemature Infant Outcome Risk study – PRIOR ","Supported","2023-02-02","2025-02-02","Professor Don Sharkey","University of Nottingham","","Yes","Yes"]
["02751","22/CAG/0130 ","ELUCIDate: ELUcidate long-term consequences of Childhood Infections using administrative and research Data ","Supported","00:00:00","2025-02-02","Dr Katharine Looker","University of Bristol","","Yes","No"]
["02752","22/CAG/0141","Do patients with autoimmune hepatitis (AIH) have an excessive incidence of cardio- and cerebrovascular disease and is this related to corticosteroid treatment?","Supported","2023-01-30","2024-01-30","Dr Jemima Clarke ","Sheffield Teaching Hospitals NHS Foundation Trust","","",""]
["02753","22/CAG/0135 ","UK Genetic Prostate Cancer Study ","Supported","2022-11-21","2024-11-21","Professor Rosalind Eeles ","The Institute of Cancer Research ","","Yes","No"]
["02754","22/CAG/0096","The use of machine learning to identify patients with rapidly declining chronic kidney disease","Supported",{"$f":"INDIRECT(\"A\"&$A793&\"!B34\")","v":"2023-02-15"},"2024-02-15","Dr Umanath (Nitin) Bhandary  ","Royal Berkshire NHS Foundation Trust","","",""]
["02755","23/CAG/0004","Using AI and Data Analysis to Better Predict Cardiovascular Disease","Supported","2023-03-06","2024-03-06","Dr Stephen J White Reader in Cardiovascular Pathology ","Manchester Metropolitan University","","",""]
["02756","22/CAG/0140","Exploring the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London.","Supported","2023-03-06","2024-04-06","Mr Pushpsen Joshi, Research Governance Manager","University College London","","",""]
["02757","23/CAG/0015 ","Flatiron Health UK Oncology Real-World Database v2.0","Supported","2023-03-20","2025-03-20","Dr Arunan Sujenthiran","Flatiron Health UK Ltd.","","Yes","No"]
["02758","22/CAG/0158","Investigation into sex-specific differences in mortality and complications following elective abdominal aortic aneurysm repair and association with pre-operative co-morbid status","Supported","2023-03-20","2024-03-20","Professor Janet Powell ","Imperial College London","","",""]
["02759","23/CAG/0017 ","Application of the Clinithink Natural Language Processing tool and Machine Learning methods to Clinical Notes for the Screening of Lung Cancer","Expired","2023-03-27","N/A","Dr John Conibear","Barts Health NHS Trust","","",""]
["02760","23/CAG/0002","Haematological inflammatory markers and survival in \nmesothelioma","Supported","2023-03-22","2024-03-22","Dr Claire Vella, Consultant Respiratory Physician with a special interest in Lung Cancer ","University Hospitals of Leicester NHS Trust","","",""]
["02761","23/CAG/0012","Utilising data linkage to investigate the health impact of carrier status for common genetic disorders","Expired","2023-04-03","N/A","Dr Andrew Fry ","Cardiff University","","",""]
["02762",{"$f":"INDIRECT(\"A\"&A801&\"!B4\")","v":"23/CAG/0032"},{"$f":"INDIRECT(\"A\"&$A801&\"!B6\")","v":"Natural language processing of histopathology reports"},"Supported","2023-04-06","2024-04-06","Dr Adam P. Levine, NIHR Academic Clinical Lecturer in Histopathology","University College London","","",""]
["02763",{"$f":"INDIRECT(\"A\"&A802&\"!B4\")","v":"23/CAG/0034 "},"Precision Treatment Strategies in Multiple Sclerosis Using Next-generation Machine Learning","Supported","2023-04-06","2024-04-06","Dr Arman Eshagh, NIHR Advanced Fellow","University College London","","",""]
["02764",{"$f":"INDIRECT(\"A\"&A803&\"!B4\")","v":"22/CAG/0120"},"A Retrospective Follow-up of Two Services for High Risk Offenders with Personality Disorder","Supported","00:00:00","2024-04-13","Dr Celia Taylor ","East London NHS Foundation Trust","","",""]
["02765",{"$f":"INDIRECT(\"A\"&A804&\"!B4\")","v":"23/CAG/0021"},"CSOR: Children’s Surgery Outcome Reporting Research Database v1.0","Supported","00:00:00","2025-04-17","Professor Marian Knight ","National Perinatal Epidemiology Unit, University of Oxford","","Yes","No"]
["02766",{"$f":"INDIRECT(\"A\"&A805&\"!B4\")","v":"21/CAG/0092"},"Pre-hospitAl RAndomised trial of MEDICation route in out-of-hospital cardiac arrest (PARAMEDIC3)","Supported","2021-07-22","2024-07-22","Professor Gavin Perkins","University of Warwick","","",""]
["02767",{"$f":"INDIRECT(\"A\"&A806&\"!B4\")","v":"23/CAG/0041 "},"Management of Patients with Chronic Liver Disease \nAdmitted to Hospital as an Emergency: MAP-CLD Social \nScience (CAG)\r","Supported","2024-04-21","2025-04-21","Professor Will Bernal, Professor of Liver Critical Care Medicine","Kings Healthcare NHS Foundation Trust","","",""]
["02768",{"$f":"INDIRECT(\"A\"&A807&\"!B4\")","v":"23/CAG/0020"},"Early behaviour predicting adherence to Continuous \nPositive Airway Pressure therapy in patients with \nObstructive Sleep Apnoea: a growth mixture modelling \nanalysis\r","Supported","2023-04-26","2024-04-26","Dr S. Amanda Sathyapala","Imperial College London","","",""]
["02769",{"$f":"INDIRECT(\"A\"&A808&\"!B4\")","v":"23/CAG/0005"},"A randomised controlled trial of no routine gastric residual monitoring to guide enteral feeding in paediatric intensive care units.","Supported","2023-05-12","2024-05-12","Professor Lyvonne Tume, Professor of Critical Care Nursing","Edge Hill University\r","","Yes","Yes"]
["02770",{"$f":"INDIRECT(\"A\"&A809&\"!B4\")","v":"23/CAG/0036 "},"re-clinical biomarker analyses for Gastrointestinal and Hepato\u0002pancreatobiliary disease: cancers and inflammatory disorders\r","Supported","2023-05-26","2024-05-26","Dr Abhik Mukherjee","The University of Nottingham ","","",""]
["02771",{"$f":"INDIRECT(\"A\"&A810&\"!B4\")","v":"22/CAG/0170 "},"Greater Manchester Care Record Research Database","Supported","2023-05-30","2024-05-30","Mr Matt Hennessey","NHS Greater Manchester Integrated Care ","","",""]
["02772",{"$f":"INDIRECT(\"A\"&A811&\"!B4\")","v":"22/CAG/0150"},"United Kingdom Register of Stored Ovarian and Testicular Tissue","Supported","2023-05-26","2024-05-26","Professor Adam W Glaser ","University of Leeds","","",""]
["02773",{"$f":"INDIRECT(\"A\"&A812&\"!B4\")","v":"23/CAG/0082 "},"The Prognostic Performance of the Enhanced Liver Fibrosis Test in UK Patients with Chronic Liver Disease Assessed 20 Years After Recruitment to the EUROGOLF study (EVenti)","Supported","2023-06-15","2024-10-12","Pushpsen Joshi Research Governance Manager ","University College London","","Yes","No"]
["02774",{"$f":"INDIRECT(\"A\"&A813&\"!B4\")","v":"23/CAG/0055 "},"Understanding patient uptake and experience of interpreter services in primary care","Supported","2023-06-20","2024-06-20","Dr Georgia Black, Reader in Health Services Research","Queen Mary University of London","","",""]
["02775",{"$f":"INDIRECT(\"A\"&A814&\"!B4\")","v":"23/CAG/0029"},"Catch-up Screen: A urine test for cervical screening","Supported","2023-06-07","2024-06-07","Ms Clare Gilham, Assistant Professor ","London School of Hygiene & Tropical Medicine","","",""]
["02776",{"$f":"INDIRECT(\"A\"&A815&\"!B4\")","v":"23/CAG/0044"},"Optimisation of the FAST MRI protocol: an evaluation of what makes a good breast MRI through detailed analysis of scans from multiple NHS sites contributing to the FAST MRI Programme","Supported","2023-06-16","2024-06-16","Dr Katherine Klimczak ","North Bristol NHS Trust","","",""]
["02777",{"$f":"INDIRECT(\"A\"&A816&\"!B4\")","v":"23/CAG/0072 "},"Listen2Baby - Improving monitoring of the baby during \nuncomplicated labour: a study using experience-based \nco-design","Supported","2023-06-23","2024-06-23","Associate Professor Rachel Rowe, Senior Health Services Researcher\n","University of Oxford ","","",""]
["02778",{"$f":"INDIRECT(\"A\"&A817&\"!B4\")","v":"23/CAG/0007"},"A UK-wide study of paediatric-onset chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) epidemiology, clinical presentation and outcomes.","Supported","2023-06-22","2024-06-22","Professor Michael PT Lunn, Consultant Neurologist and Clinical Lead for Neuroimmunology and CSF Laboratory, Institute of Neurology","The National Hospital for Neurology and Neurosurgery, part of the University College London Hospitals NHS Foundation Trust","","",""]
["02779",{"$f":"INDIRECT(\"A\"&A818&\"!B4\")","v":"23/CAG/0052"},"The health effects of police diversion for drug-involved suspects","Supported","2023-06-29","2024-06-29","Professor Sir Alex Stevens","The University of Kent","","",""]
["02780",{"$f":"INDIRECT(\"A\"&A819&\"!B4\")","v":"23/CAG/0068"},"Maximising the value of the Caerphilly Prospective Study (CaPS)","Supported","2023-06-30","2024-06-30","Professor Yoav Ben-Shlomo","University of Bristol","","",""]
["02781",{"$f":"INDIRECT(\"A\"&A820&\"!B4\")","v":"23/CAG/0046 "},"Thames Valley and Surrey (TVS) sub national secure data environment (SNSDE) programme ","Supported","2023-06-30","2024-06-30","Mr David Walliker","Oxford University Hospitals NHS Foundation Trust ","","",""]
["02782",{"$f":"INDIRECT(\"A\"&A821&\"!B4\")","v":"23/CAG/0056"},"How to improve communication from GPs to hospital specialists at the point of referrals?","Supported","2023-06-27","2024-06-27","Dr Shan   He, NIHR In-Practice Fellow ","University of Cambridge","","",""]
["02783",{"$f":"INDIRECT(\"A\"&A822&\"!B4\")","v":"23/CAG/0073"},"CompreHensive GeriAtRician led MEdication Review (CHARMER) - Work Package 4 Definitive Trial","Supported","2023-07-06","2024-07-06","Professor David Wright, Co-Chief Investigator","University of Leicester","","Yes","No"]
["02784",{"$f":"INDIRECT(\"A\"&A823&\"!B4\")","v":"23/CAG/0083 "},"Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy","Supported","2023-07-14","2024-07-14","Dr Kyriakos Lobotesis","Imperial College Healthcare NHS Trust","","",""]
["02785",{"$f":"INDIRECT(\"A\"&A824&\"!B4\")","v":"23/CAG/0081"},"Remote monitoring in virtual wards for acutely unwell patients being managed and treated on an ambulatory care pathway: feasibility study","Supported","2023-07-14","2024-07-14","Professor Andrew Farmer","University of Oxford","","Yes","No"]
["02786",{"$f":"INDIRECT(\"A\"&A825&\"!B4\")","v":"23/CAG/0019 "},"CLEOPATRAA Trial - Breast cancer molecular typing and grading trial","Supported","2023-07-13","2024-07-13","Dr Nicolas Orsi","Leeds Teaching Hospitals NHS Trust","","Yes","No"]
["02787",{"$f":"INDIRECT(\"A\"&A826&\"!B4\")","v":"23/CAG/0051"},"Retrospective analysis of real-world evidence on the use of glycopyrronium bromide in children under 3 years of age with sialorrhea ","Supported","2023-07-17","2024-07-17","Dr Louise Bracken","Alder Hey Children's NHS Foundation Trust (and Proveca Ltd)","","",""]
["02788",{"$f":"INDIRECT(\"A\"&A827&\"!B4\")","v":"22/CAG/0090"},"ISIS 2 Second International Study of Infarct Survival: Legacy Database","Supported","2022-07-04","2024-07-04","Prof Rory Collins\r","University of Oxford (Nuffield Department of Population Health) ","","Yes","No"]
["02789",{"$f":"INDIRECT(\"A\"&A828&\"!B4\")","v":"23/CAG/0064"},"Stroke Audit Machine Learning","Supported","2023-07-31","2024-07-31","Dr Michael Allen, Senior Modeller ","University of Exeter College of Medicine and Health ","","",""]
["02790",{"$f":"INDIRECT(\"A\"&A829&\"!B4\")","v":"22/CAG/0129 "},"Assessment, Management and Outcomes for children and young people referred to a National Gender Identity Development Service","Supported","2023-08-10","2024-08-10","Professor Tim Doran","University of York","","",""]
["02791",{"$f":"INDIRECT(\"A\"&A830&\"!B4\")","v":"23/CAG/0047"},"A randomised controlled phase III trial of a novel behavioural intervention for primary care teams to promote the earlier diagnosis of cancer (ThinkCancer!)","Supported","2023-08-22","2024-08-22","Professor Clare Wilkinson","Bangor University","","Yes","Yes"]
["02792",{"$f":"INDIRECT(\"A\"&A831&\"!B4\")","v":"23/CAG/0068"},"Maximising the value of the Caerphilly Prospective Study (CaPS)","Supported","2023-09-11","2024-09-11","Professor Nick Reynolds","University of Bristol","","",""]
["02793",{"$f":"INDIRECT(\"A\"&A832&\"!B4\")","v":"23/CAG/0067"},"An evaluation of the clinical efficacy and risk profile of routine spinal operations performed in the National Health Service","Supported","2023-09-12","2024-09-12","Dr Hasan Mohammad","Queen Mary University of London","","",""]
["02794","23/CAG/0088","Community based continuity of midwifery care models for women living in areas of ethnic diversity and social disadvantage","Supported","2023-09-13","2024-09-13","Professor Jane Sandall, Chief Investigator\n","King’s College London","","",""]
["02795","23/CAG/0086","Transforming Ovarian Cancer diagnostic pathways (TranSforming Ovarian caNcer diAgnosTic pAthways - SONATA)","Supported","2023-09-20","2024-09-20","Professor Sudha S Sundar","University of Birmingham","","",""]
["02796","22/CAG/0173","Preservation of the Boyd Orr Cohort Database Version 1 (CAG)","Supported","2023-09-21",{"$f":"IF(D835<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A835&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A835&\"!B35\")))","v":"2024-09-21"},"Professor Richard Martin, Chief Investigator ","University of Bristol",{"$f":"IF(INDIRECT(\"A\"&$A835&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A835&\"!B37\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A835&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A835&\"!B38\"))","v":""},{"$f":"IF(INDIRECT(\"A\"&$A835&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A835&\"!B39\"))","v":""}]
["02797","23/CAG/0089","Hospitalisation decision-making in Primary Care: How do, and how should clinicians approach decisions regarding hospital admission for those living with frailty or who could be near the end of their life?","Supported","2023-09-22","2024-09-22","Mr Adam Taylor","University of Bristol","","",""]
["02798","23/CAG/0080","eLIXIR Research Tissue Bank/Database","Supported","2023-09-26","2024-09-26","Dr Cally Gill, Tissue Bank Manager ","King’s College London - Department of Women and Children's Health","","",""]
["02799","23/CAG/0099","Defining delirium and its impact in Parkinson’s Disease (DELIRIUM-PD)","Supported","2023-09-22","2024-09-22","Dr Alison Yarnall, Clinical Fellow/Honorary Consultant","Newcastle upon Tyne Hospitals Foundation Trust","","",""]
["02800","23/CAG/0094","NSIGHT-2: Mechanistic Studies into Pregnancy Complications and their Impact on Maternal and Child Health","Supported","2023-09-22","2024-09-22","Professor Rachel Tribe, Professor of Maternal and Perinatal Sciences","King’s College London and Guy’s and St Thomas’ NHS Foundation Trust are joint data controllers","","",""]
["02801","22/CAG/0104","Peripheral arterial disease, High blood pressure and Aneurysm Screening Trial -A cluster randomised trial of screening men for peripheral arterial disease, high blood pressure and abdominal aortic aneurysm vs screening men for abdominal aortic aneurysm","Supported","2022-08-06","2024-08-06","Professor Matthew Brown   ","University of Leicester","","",""]
["02802","23/CAG/0060","Kid’s Environment and Health Cohort","Supported","2023-10-03","2024-10-03","Dr Pia Hardelid","UCL Great Ormond Street Institute of Child Health","","Yes","No"]
["02803",{"$f":"INDIRECT(\"A\"&A842&\"!B4\")","v":"23/CAG/0150"},{"$f":"INDIRECT(\"A\"&$A842&\"!B6\")","v":"Intimate partner violence"},"Supported","2023-10-20",{"$f":"IF(D842<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A842&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A842&\"!B35\")))","v":"2024-10-20"},"Dr Rebecca Lacey ","ALSPAC (University of Bristol) ","Applied","Yes","No"]
["02804",{"$f":"INDIRECT(\"A\"&A843&\"!B4\")","v":"23/CAG/0100"},"GP Management After Transition Events (GP-MATE) - Developing an intervention to assist older patients’ communication with their GP practice after discharge from hospital in order to improve patient safety","Supported","2023-10-16",{"$f":"IF(D843<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A843&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A843&\"!B35\")))","v":"2024-10-16"},"Dr Rachel Spencer","University of Warwick ","Applied","Yes","No"]
["02805",{"$f":"INDIRECT(\"A\"&A844&\"!B4\")","v":"23/CAG/0138"},"A qualitative investigation of a novel Parkinson’s Disease Hub: an integrated multidisciplinary service for patients with Parkinson’s and related disorders with rapidly declining condition or unmet palliative needs ","Supported","2023-10-31",{"$f":"IF(D844<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A844&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A844&\"!B35\")))","v":"2024-10-31"},"Dr Elisabeth Grey","University of Bristol ","Applied","Yes","No"]
["02806",{"$f":"INDIRECT(\"A\"&A845&\"!B4\")","v":"23/CAG/0155 "},"CAG Overarching Application for Oxford Vaccine Group (OVG) Studies","Supported","2023-11-08",{"$f":"IF(D845<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A845&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A845&\"!B35\")))","v":"2024-11-08"},"Professor Sir Andrew Pollard","University of Oxford","Applied","Yes","No"]
["02807",{"$f":"INDIRECT(\"A\"&A846&\"!B4\")","v":"23/CAG/0157 "},"Young people's barriers to mental health services","Supported","2023-11-10",{"$f":"IF(D846<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A846&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A846&\"!B35\")))","v":"2024-11-10"},"Dr Corine Driessens, Senior Research Fellow ","ALSPAC (University of Bristol)","Applied","Yes","No"]
["02808",{"$f":"INDIRECT(\"A\"&A847&\"!B4\")","v":"23/CAG/0161 "},"The link between questionnaire-reported disordered eating and eating disorder medical diagnosis","Supported","2023-11-10",{"$f":"IF(D847<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A847&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A847&\"!B35\")))","v":"2024-11-10"},"Dr Helen Bould, Consultant Senior Lecturer, Bristol Medical School (PHS), ","ALSPAC (University of Bristol)   ","Applied","Yes","No"]
["02809",{"$f":"INDIRECT(\"A\"&A848&\"!B4\")","v":"23/CAG/0075 "},"A Multi-Center Registry of Cardiovascular Magnetic Resonance Data for Research, Education, and Quality Control Purposes","Supported","2023-11-14",{"$f":"IF(D848<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A848&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A848&\"!B35\")))","v":"2024-11-14"},"Professor Alistair Young","Guy's and St Thomas NHS Foundation Trust ","Applied","Yes","No"]
["02810",{"$f":"INDIRECT(\"A\"&A849&\"!B4\")","v":"23/CAG/0139"},"Retrospective cohort study of professional footballers in England ","Supported","2023-11-14",{"$f":"IF(D849<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A849&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A849&\"!B35\")))","v":"2024-11-14"},"Prof Damien McElvenny ","Institute of Occupational Medicine ","Applied","Yes","Yes"]
["02811",{"$f":"INDIRECT(\"A\"&A850&\"!B4\")","v":"23/CAG/0090 "},"King's College London Cardiovascular Diseases Database ","Supported","2023-11-09",{"$f":"IF(D850<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A850&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A850&\"!B35\")))","v":"2024-11-09"},"Dr Nilesh Pareek, Chief Investigator","King's College Hospital NHS Trust ","Applied","Yes","No"]
["02812",{"$f":"INDIRECT(\"A\"&A851&\"!B4\")","v":"23/CAG/0141 "},"Kings College Hospital Liver Intensive Therapy Unit Research Database","Supported","2023-11-09",{"$f":"IF(D851<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A851&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A851&\"!B35\")))","v":"2024-11-09"},"Professor William Bernal, Chief Investigator","King's College Hospital NHS Foundation Trust ","Applied","Yes","No"]
["02813",{"$f":"INDIRECT(\"A\"&A852&\"!B4\")","v":"23/CAG/0156 "},"Development of Pathways for the Diagnosis and Management of Latent Tuberculosis Infection in Wales ","Supported","2023-11-10",{"$f":"IF(D852<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A852&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A852&\"!B35\")))","v":"2024-11-10"},"Dr Emma Thomas-Jones","Public Health Wales  ","Applied","Yes","Yes"]
["02814",{"$f":"INDIRECT(\"A\"&A853&\"!B4\")","v":"23/CAG/0133 "},"Co-producing an Ambulance Trust national fatigue risk management system for improved Staff And Patient Safety (CATNAPS) ","Supported","2023-11-22",{"$f":"IF(D853<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A853&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A853&\"!B35\")))","v":"2024-11-22"},"Professor Kristy Sanderson, Chair in Applied Health Research ","University of East Anglia ","Applied","Yes","No"]
["02815",{"$f":"INDIRECT(\"A\"&A854&\"!B4\")","v":"23/CAG/0176"},"An Anthropological Study of the Role of Music in the Diagnosis and Treatment of Psychotic Disorders","Supported","2023-12-05",{"$f":"IF(D854<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A854&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A854&\"!B35\")))","v":"2024-12-05"},"Dr Iza Kavedzija","University of Cambridge","Exempt","Yes","No"]
["02816",{"$f":"INDIRECT(\"A\"&A855&\"!B4\")","v":"23/CAG/0140"},"Suicide Prevention in Probation","Supported","2023-12-05",{"$f":"IF(D855<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A855&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A855&\"!B35\")))","v":"2024-12-05"},"Laura Pope","University of Manchester","Applied","Yes","Yes"]
["02817",{"$f":"INDIRECT(\"A\"&A856&\"!B4\")","v":"23/CAG/0143"},"Development of the International Stillbirth Alliance Perinatal Death Classification System for Ending Preventable Stillbirths and Neonatal Deaths in Data-Rich Settings","Supported","2023-12-06",{"$f":"IF(D856<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A856&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A856&\"!B35\")))","v":"2024-12-06"},"Professor Elizabeth Draper","University of Leicester","Applied","Yes","Yes"]
["02818",{"$f":"INDIRECT(\"A\"&A857&\"!B4\")","v":"23/CAG/0069"},"A study examining the outcomes of blood transfusions where \"least incompatible blood\" has been issued due to the rarity of available red cell units ","Supported","2023-12-07",{"$f":"IF(D857<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A857&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A857&\"!B35\")))","v":"2024-12-07"},"Dr Tom Bullock","NHS Blood and Transplant ","Applied","Yes","No"]
["02819",{"$f":"INDIRECT(\"A\"&A858&\"!B4\")","v":"23/CAG/0134"},"VIVALDI Social Care Database ","Supported","2023-12-07",{"$f":"IF(D858<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A858&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A858&\"!B35\")))","v":"2024-12-07"},"Professor Laura Shallcross","University College London ","Applied","Yes","No"]
["02820",{"$f":"INDIRECT(\"A\"&A859&\"!B4\")","v":"23/CAG/0096 "},"Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial","Supported","2023-10-26",{"$f":"IF(D859<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A859&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A859&\"!B35\")))","v":"2024-10-26"},"Dr Sarah Bell (Chief Investigator)","Cardiff and Vale University Local Health Board and Cardiff University ","Applied","Yes","No"]
["02821",{"$f":"INDIRECT(\"A\"&A860&\"!B4\")","v":"23/CAG/0062"},"Exploring determinants of pregnancy intention and relationships between pregnancy intention and outcome using routine data","Supported","2023-12-13",{"$f":"IF(D860<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A860&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A860&\"!B35\")))","v":"2024-12-13"},"Dr Jennifer Hall","University College London ","Applied","Yes","No"]
["02822",{"$f":"INDIRECT(\"A\"&A861&\"!B4\")","v":"23/CAG/0148 "},"Aspirin Esomeprazole Chemoprevention Trial – EXtension Long-term Clinical Study : A cohort follow up of a phase III randomised study of Aspirin and Esomeprazole Chemoprevention in Barrett’s Metaplasia","Supported","2023-12-15",{"$f":"IF(D861<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A861&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A861&\"!B35\")))","v":"2024-12-15"},"Professor Janusz Jankowski, Chief Investigator","University College London","Applied","Yes","Yes"]
["02823",{"$f":"INDIRECT(\"A\"&A862&\"!B4\")","v":"23/CAG/0178 "},"Genetics of neurodevelopmental traits and disorders in ALSPAC","Supported","2023-12-19",{"$f":"IF(D862<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A862&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A862&\"!B35\")))","v":"2024-12-19"},"Prof Matthew Hurles, Head of Human Genetics","University of Bristol (ALSPAC)","Applied","Yes","No"]
["02824",{"$f":"INDIRECT(\"A\"&A863&\"!B4\")","v":"24/CAG/0021 "},"National cohort study of late effects of Hodgkin lymphoma treatment\n","Supported","2023-05-23",{"$f":"IF(D863<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A863&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A863&\"!B35\")))","v":"2024-05-23"},"Professor David Cunningham, Consultant Medical Oncologist, Head of Gastro Intestinal Unit/ Lymphoma. ","The Royal Marsden NHS Foundation Trust","Applied","Yes","Yes"]
["02825",{"$f":"INDIRECT(\"A\"&A864&\"!B4\")","v":"23/CAG/0098 "},"Epidemiological Surveillance of Deterioration Of Sight Caused By Delay In Review Or Treatment in the UK: Frequency and morbidity ","Supported","2024-01-09",{"$f":"IF(D864<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A864&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A864&\"!B35\")))","v":"2025-01-09"},"Ms Rashmi Mathew","Moorfields Eye Hospital NHS Foundation Trust ","Applied","Yes","No"]
["02826",{"$f":"INDIRECT(\"A\"&A865&\"!B4\")","v":"23/CAG/0177 "},"Investigating potential health and health equality impacts of planning deregulation: The case of permitted development housing in England","Supported","2024-01-10",{"$f":"IF(D865<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A865&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A865&\"!B35\")))","v":"2025-01-10"},"Professor Benjamin Clifford ","University College London","Applied","Yes","No"]
["02827",{"$f":"INDIRECT(\"A\"&A866&\"!B4\")","v":"23/CAG/0096"},"DUPLICATE ENTRY Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial","Duplicate entry","00:00:00",{"$f":"IF(D866<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A866&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A866&\"!B35\")))","v":"N/A"},"Dr Sarah F Bell, Consultant Anaesthetist","Cardiff and Vale University Local Health Board and Cardiff University","Applied","Yes","Yes"]
["02828",{"$f":"INDIRECT(\"A\"&A867&\"!B4\")","v":"23/CAG/0162"},"Database of UK recipients of pituitary-derived human growth hormone","Supported","2024-01-17",{"$f":"IF(D867<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A867&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A867&\"!B35\")))","v":"2025-01-17"},"Dr Gargi Banerjee","University College London","Applied","Yes","No"]
["02829",{"$f":"INDIRECT(\"A\"&A868&\"!B4\")","v":"23/CAG/0093 "},"Natural Experiment of the impact of supervised Opiate Agonist Therapy (OAT) consumption on drug related harm and treatment outcomes","Supported","2024-01-18",{"$f":"IF(D868<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A868&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A868&\"!B35\")))","v":"2025-01-18"},"Professor Matthew Hickman, Professor of Public Health and Epidemiology","Bristol Medical School","Applied","Yes","No"]
["02830",{"$f":"INDIRECT(\"A\"&A869&\"!B4\")","v":"24/CAG/0016"},"Collaboration on Prevent In-Place Extremism Referrals ","Supported","2024-01-30",{"$f":"IF(D869<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A869&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A869&\"!B35\")))","v":"2025-01-30"},"Dr Nicola Fowler ","Birmingham and Solihull Mental Health Foundation Trust","Applied","Yes","No"]
["02831",{"$f":"INDIRECT(\"A\"&A870&\"!B4\")","v":"23/CAG/0182 "},{"$f":"INDIRECT(\"A\"&$A870&\"!B6\")","v":"Suicide crisis and self-harm attendance at A&E in autistic children and young people"},"Supported","2024-02-02",{"$f":"IF(D870<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A870&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A870&\"!B35\")))","v":"2025-02-02"},"Dr Pooja Saini","Liverpool John Moores University ","Applied","Yes","No"]
["02832",{"$f":"INDIRECT(\"A\"&A871&\"!B4\")","v":"23/CAG/0181 "},"Does living by the coast negatively impact palliative and end-of-life care outcomes? An explanatory sequential mixed methods study exploring the inequality of provision and access to palliative care in a coastal region ","Supported","2024-02-01",{"$f":"IF(D871<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A871&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A871&\"!B35\")))","v":"2025-02-02"},"Dr  Abigail  Hensley","Norfolk And Norwich University Hospitals NHS Foundation Trust ","Applied","Yes","No"]
["02833",{"$f":"INDIRECT(\"A\"&A872&\"!B4\")","v":"24/CAG/0023 "},"Stroke and atrial fibrillation (AF) with a focus on prevalent and incident stroke and/or AF in one area of North West England, and associated clinical risk factors, multimorbidity, time trends, and outcomes, and development and evaluation of clinical risk models and dynamic changes in stroke risk","Supported","2024-02-13",{"$f":"IF(D872<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A872&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A872&\"!B35\")))","v":"2025-02-13"},"Associate Professor Andrew Hill ","Mersey & West Lancashire teaching hospitals NHS Trust","Applied","Yes","No"]
["02834",{"$f":"INDIRECT(\"A\"&A873&\"!B4\")","v":"24/CAG/0017"},"CRIS Linkage with the Police National Computer (PNC)","Supported","2024-02-14",{"$f":"IF(D873<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A873&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A873&\"!B35\")))","v":"2025-02-14"},"Dr Johnny Downs ","South London and Maudsley NHS Foundation Trust","Applied","Yes","No"]
["02835",{"$f":"INDIRECT(\"A\"&A874&\"!B4\")","v":"24/CAG/0029"},"Parenting and children’s behavioural problems: Micro- and macro-processes at play in the context of intervention ","Supported","2024-02-22",{"$f":"IF(D874<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A874&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A874&\"!B35\")))","v":"2025-02-22"},"Dr Jon Heron, Associate Professor","University of Bristol (ALSPAC) ","Applied","Yes","No"]
["02836",{"$f":"INDIRECT(\"A\"&A875&\"!B4\")","v":"24/CAG/0030"},"Mapping Neurodevelopmental Trajectories for Adult Psychiatric Disorder: A focus on Autism and Psychosis","Supported","2024-02-22",{"$f":"IF(D875<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A875&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A875&\"!B35\")))","v":"2025-02-22"},"Professor Anthony David (CI), Professor of Mental Health Director & Sackler Chair","University of Bristol (ALSPAC) ","Applied","Yes","No"]
["02837",{"$f":"INDIRECT(\"A\"&A876&\"!B4\")","v":"24/CAG/0002 "},"MyWay IQ (MWIQ); safety and efficacy testing of a diagnosis and precision medicine tool for diabetes management.","Supported","2024-02-26",{"$f":"IF(D876<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A876&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A876&\"!B35\")))","v":"2025-02-26"},"Dr Nicholas Conway","MyWay Digital Health Ltd ","Applied","Yes","No"]
["02838",{"$f":"INDIRECT(\"A\"&A877&\"!B4\")","v":"24/CAG/0006 "},"Evaluating the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire: A cluster randomised GP pilot trial Picture ","Supported","2024-02-26",{"$f":"IF(D877<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A877&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A877&\"!B35\")))","v":"2025-02-26"},"Dr Charlotte Kelly","University of Hull ","Applied","Yes","No"]
["02839",{"$f":"INDIRECT(\"A\"&A878&\"!B4\")","v":"24/CAG/0025 "},"West Midlands Sub National Secure Data Environment","Supported","2024-02-16",{"$f":"IF(D878<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A878&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A878&\"!B35\")))","v":"2025-02-16"},"Dr Elizabeth Sapey","University Hospitals Birmingham NHS Foundation Trust ","Applied","Yes","No"]
["02840",{"$f":"INDIRECT(\"A\"&A879&\"!B4\")","v":"24/CAG/0011"},"Pre-hospital Research and Audit Network (PRANA)",{"$f":"INDIRECT(\"A\"&$A879&\"!B32\")","v":"Supported"},{"$f":"INDIRECT(\"A\"&$A879&\"!B34\")","v":"2024-03-05"},{"$f":"IF(D879<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A879&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A879&\"!B35\")))","v":"2025-03-05"},{"$f":"(INDIRECT(\"A\"&$A879&\"!B9\"))","v":"Dr Philip Hyde"},{"$f":"(INDIRECT(\"A\"&$A879&\"!B8\"))","v":"University Hospital Southampton"},{"$f":"IF(INDIRECT(\"A\"&$A879&\"!B37\")=0,\"\",INDIRECT(\"A\"&$A879&\"!B37\"))","v":"Applied"},{"$f":"IF(INDIRECT(\"A\"&$A879&\"!B38\")=0,\"\",INDIRECT(\"A\"&$A879&\"!B38\"))","v":"Yes"},{"$f":"IF(INDIRECT(\"A\"&$A879&\"!B39\")=0,\"\",INDIRECT(\"A\"&$A879&\"!B39\"))","v":"Yes"}]
["02841","23/CAG/0110","Royal Hospital for Neuro-disability (RHN) patients Database","Supported","2024-03-05","2025-03-05","Benedikt von Thungen","Sanome Limited ","Applied","Yes","No"]
["02842","24/CAG/0033","North West Sub National Secure Data Environment: Cheshire and Merseyside ICB","Supported","2024-03-06","2025-03-06","Mrs Helen Duckworth","Cheshire and Merseyside ICB","Applied","Yes","No"]
["02843","24/CAG/0036","Can performing extra tests on non-diagnostic biopsy samples avoid the need for further invasive biopsies in people with suspected cancer of the lung lining?","Supported","2024-02-28","2025-02-28","Professor Nick A Maskell","North Bristol NHS Trust","Applied","Yes","No"]
["02844","24/CAG/0005 ","PremPath: Improving the optimisation and stabilisation of the preterm infant","Supported","2024-02-29","29/02/2025","Professor Nicola Mackintosh ","University of Leicester ","Applied","Yes","No"]
["02845","23/CAG/0151","The UK Colorectal Cancer Intelligence Hub","Supported","2024-03-05","2025-03-05","Professor Eva JA Morris\r","University of Oxford\r","Applied","Yes","Yes"]
["02846",{"$f":"INDIRECT(\"A\"&A885&\"!B4\")","v":"22/CAG/0111 "},{"$f":"INDIRECT(\"A\"&$A885&\"!B6\")","v":"Research database for Biliary Atresia (England & Wales)"},"Supported","00:00:00",{"$f":"IF(D885<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A885&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A885&\"!B35\")))","v":"2025-03-06"},"Professor Mark Davenport, Chief Investigator ","Kings College Hospital NHS Foundation Trust","Applied","Yes","No"]
["02847",{"$f":"INDIRECT(\"A\"&A886&\"!B4\")","v":"24/CAG/0013"},{"$f":"INDIRECT(\"A\"&$A886&\"!B6\")","v":"Wessex sub national secure data environment (SNSDE) programme"},"Supported","2024-03-14",{"$f":"IF(D886<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A886&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A886&\"!B35\")))","v":"2025-03-14"},"Prof. Christopher Kipps\r","University Hospital Southampton NHS Foundation Trust","Applied","Yes","No"]
["02848",{"$f":"INDIRECT(\"A\"&A887&\"!B4\")","v":"24/CAG/0043"},{"$f":"INDIRECT(\"A\"&$A887&\"!B6\")","v":"Geriatric Medicine, Care and the End of Life: Appreciating Clinical Uncertainty in the Acute Care of Older Adults"},"Supported","2024-03-15",{"$f":"IF(D887<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A887&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A887&\"!B35\")))","v":"2025-03-15"},"Mr Luke Stalley, Doctoral Researcher","University of St. Gallen\r","Applied","Yes","No"]
["02849",{"$f":"INDIRECT(\"A\"&A888&\"!B4\")","v":"23/CAG/0180 "},{"$f":"INDIRECT(\"A\"&$A888&\"!B6\")","v":"An analysis of the malignancy risk following Gamma Knife Stereotactic Radiosurgery"},"Supported","2024-03-21",{"$f":"IF(D888<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A888&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A888&\"!B35\")))","v":"2025-03-21"},"Mr Julian Cahill","Sheffield Teaching Hospitals NHS Foundation Trust","Applied","Yes","No"]
["02850",{"$f":"INDIRECT(\"A\"&A889&\"!B4\")","v":"24/CAG/0015 "},{"$f":"INDIRECT(\"A\"&$A889&\"!B6\")","v":"The Rituals of Integrated Working: Promoting and Improving Integrated Care"},"Supported","2024-03-22",{"$f":"IF(D889<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A889&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A889&\"!B35\")))","v":"2025-03-22"},"Dr Jenelle Clarke ","University of Kent","Applied","Yes","No"]
["02851",{"$f":"INDIRECT(\"A\"&A890&\"!B4\")","v":"24/CAG/0034"},{"$f":"INDIRECT(\"A\"&$A890&\"!B6\")","v":"North West Sub National Secure Data Environment: Greater Manchester ICB"},"Supported","2024-03-27",{"$f":"IF(D890<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A890&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A890&\"!B35\")))","v":"2025-03-27"},"Matt Hennessey","NHS Greater Manchester Integrated Care Board (ICB)","Applied","Yes","No"]
["02852",{"$f":"INDIRECT(\"A\"&A891&\"!B4\")","v":"24/CAG/0026"},{"$f":"INDIRECT(\"A\"&$A891&\"!B6\")","v":"Covid impact on RSV Emergency Presentations: BronchStart"},"Supported","00:00:00",{"$f":"IF(D891<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A891&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A891&\"!B35\")))","v":"2025-03-28"},"Professor Will Dixon","University Hospital of Leicester NHS Trust","Applied","Yes","No"]
["02853",{"$f":"INDIRECT(\"A\"&A892&\"!B4\")","v":"24/CAG/0057"},{"$f":"INDIRECT(\"A\"&$A892&\"!B6\")","v":"NHS Bristol, North Somerset, South Gloucestershire Integrated Care Board (BNSSG ICB) "},"Supported","2024-04-11",{"$f":"IF(D892<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A892&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A892&\"!B35\")))","v":"2025-04-11"},"Dr Charlie Kenward ","NHS Bristol, North Somerset, South Gloucestershire Integrated Care Board (BNSSG ICB) ","Applied","Yes","No"]
["02854",{"$f":"INDIRECT(\"A\"&A893&\"!B4\")","v":"24/CAG/0045 "},{"$f":"INDIRECT(\"A\"&$A893&\"!B6\")","v":"Evaluating the impact of artificial intelligence triage in online consultations to reduce delays in urgent and emergency primary care: a qualitative process evaluation "},"Supported","2024-04-10",{"$f":"IF(D893<>\"Supported\",\"N/A\",IF(INDIRECT(\"A\"&$A893&\"!B35\")=0,\"\",INDIRECT(\"A\"&$A893&\"!B35\")))","v":"2025-04-10"},"Dr Benjamin Brown ","The University of Manchester ","Applied","Yes","No"]

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[]
[]
["Application Number","0001"]
["Reference","CAG 1-06(FT3)/2013"]
["Other Refs"]
["Application Title","EPTOS European Transfusion Practice and Outcome Survey: An observational outcome study of transfusion practice in surgical patients (excluding cardiothoracic surgery) throughout Europe"]
["Application Summary","This research application from the Royal Free London NHS Foundation Trust detailed a European study of pre-operative transfusion practice with the aim of describing difference in transfusion practices throughout Europe and correlating with perioperative outcomes.\nSupport was requested to allow data to be collected on all patients over the age of 18 years undergoing elective or emergency surgery who received one or more units of packed red blood cells during the intraoperative period. Each patient would be followed up at 30 days by the local principal investigators who would be consultant anaesthetists.  Anonymised data would be extracted on a case report form and sent to the Chief Investigator."]
["Applicant Organisation Name","Royal Free London NHS Foundation Trust"]
["Contact Name","Dr Susan Mallett"]
["Address","Pond Street"]
[null,"London"]
[null," "]
["Postcode","NW3 2QG"]
["Telephone","02077940500"]
["Email","susan.mallett@nhs.net"]
["Medical Purposes","□","preventative medicine"]
[null,"Y","medical diagnosis"]
[null,"□","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Consecutive patients (aged 18+) admitted to participating centres undergoing elective non cardiac surgery or emergency (non trauma) surgery over a three month period commencing from March 2013 who receive at least one red cell transfusion during the intraoperative period.  Total cohort size 1500 in UK, 10,000 internationally."]
["Description of confidential patient information used","No patient identifiable data will be used for analysis and the \neCRF that is sent to the ESA clinical trials unit is anonymised.\n"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2013-03-22"]
["Next Review Date","N/A"]
["Notes","The CAT acknowledged the end of support in a letter to the applicant dated 30 September 2014, but the register was not updated in error.  End closure report not requested.\n\nApplication considered at CAG meeting on 18/04/2013.\nConditions of support\n\n1. Provision of the patient information notice to be displayed at hospital sites.\n2. Confirmation of a favourable REC opinion.\n3. Confirmation of satisfactory security arrangements. Please note there has been a change to the security review process. Please review the following link (http://www.nigb.nhs.uk/s251/forms) which sets out the change, and please follow the guidance given. If you have any queries over this, please contact the Exeter Helpdesk. You can contact the Exeter helpdesk on 01392 251289 or exeter.helpdesk@nhs.net"]

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[]
[]
["Application Number","0002"]
["Reference","CAG 1-06(FT4)/2013"]
["Other Refs"]
["Application Title","A Pilot Study to Inform a MultiCentre Randomised Controlled Trial of an Impedance Threshold Device (ITD) – the ResQPOD, in Cardiac Arrest"]
["Application Summary","This research application from Newcastle Upon Tyne Hospitals NHS Trust detailed a pilot randomised control trial to test the long term benefits of the ResQPOD impedance threshold device. This would inform and test the feasibility of a larger, adequately powered study.\nSupport was requested to allow a research paramedic to be assigned within the North East Ambulance Service who would collect information on patients following the intervention and use this to obtain follow up details about the patient’s treatment. Where a patient survived and was admitted to hospital, identifiable data would be collected to allow consent, or assent from relatives where the patient lacked capacity, to be obtained within 48 hours of admission. No identifiable data would need to be retained if it was established that a patient had died prior to admission."]
["Applicant Organisation Name","Newcastle Upon Tyne NHS Hospitals Trust"]
["Contact Name","Dr John Wright"]
["Address","Emergency Department, Royal Victoria Infirmary"]
[null,"Queen Victoria Road"]
[null,"Newcastle upon Tyne"]
["Postcode","NE1 4LP"]
["Telephone","01912336161"]
["Email","john.wright@nuth.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18+ with unexpected cardiorespiratory arrest in the absence of trauma, known terminal illness or other external cause such as self-harm and primary cardiac origin not suspected. Resuscitation attempt in accordance with normal NEAS policy"]
["Description of confidential patient information used","name, NHS number, date of birth, date of death, postcode, address, gender"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","North East Ambulance NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2013-08-28"]
["Next Review Date","2014-08-28"]
["Notes","Application considered at CAG meeting on 18/04/2013.\nSpecific conditions of support\n\n1. Favourable opinion from REC Received 18/01/2013.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 04/07/2013. \n"]

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[]
[]
["Application Number","0003"]
["Reference","CAG 1-06(FT5)/2013"]
["Other Refs"]
["Application Title","Investigating the Safety of Medication Use in Primary Care (SAFECARE)"]
["Application Summary","This research application from the University of Hertfordshire detailed a study which aimed to carry out a review of patient notes within six GP practices and pharmacies in order to review prescribing errors and meet the following objectives:\n \n1) To characterise existing systems of error identification, reporting and recording at PCT and primary healthcare organisation (general practice and community pharmacy) levels, \n2)  to assess the safety culture of primary healthcare organisations, \n3) to develop primary care definition of prescribing errors and their categories, \n4) to determine prevalence and types of prescribing errors in general practice, and to assess dispensing accuracy in community pharmacies, and \n5) to design, implement and evaluate a practical error preventing intervention for primary healthcare organisations, in the UK.\n \nThe applicant requested support to allow a researcher to access 600 patient records within GP practices and 2000 prescribing records from community pharmacies in order to extract de-identified data only. Confirmation of Information Governance Toolkit compliance and Caldicott Guardian approval required from each site prior to access to any data from that site.\n\n"]
["Applicant Organisation Name","University of Hertfordshire"]
["Contact Name","Janice Olaniyan"]
["Address","Department of Pharmacy"]
[null,"School of Medical and Life Sciences"]
[null," "]
["Postcode","AL10 9AB"]
["Telephone","01707283359"]
["Email","gbemisoye@yahoo.com"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Two general practices in each PCT (three purposively sampled PCTs Bedfordshire, Luton, and\nHarrow) holding electronic patient clinical medical records, and with secured space for confidential review of patients' medical records.  Two community pharmacies located within a 2mile radius of the selected general practices, and who can provide some space for the reviewers to shadow the responsible pharmacist's interventions on prescription errors.\nElectronic records of patients aged 65 years and over and children 0-12 years; patients who have been registered with the general practice for at least 12 months to data collection; patients who have had at least one prescription item in the 12 months to data collection."]
["Description of confidential patient information used","NHS number, date of birth, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Hertfordshire"]
["Status","Supported"]
[]
["Outcome Date","2013-06-11"]
["Next Review Date","2015-06-11"]
["Notes","Application considered at CAG meeting on 18/04/2013\n\nConfirmation of Information Governance Toolkit compliance and Caldicott Guardian approval required from each site prior to access to any data from that site. Sites that have provided this will be listed below.                                                                                 Luton CCG                                                                                                                              Bedfordshire CCG                                                                                                                 Harrow CCG\n\nSpecific conditions of support\n\n1) Confirmation of a favourable REC opinion. Received\n\n2) Confirmation of satisfactory security arrangements. Please note that as access is taking place on NHS sites it has been confirmed by the security review team that you should provide IG toolkit references for those sites along with confirmation from the Caldicott Guardian that your research is being undertaken in line with their IG toolkit return prior to accessing data at each site. This information will then be reviewed by the security review team who will confirm if this is satisfactory for the purposes of your application.\n\n3) Please ensure that the patient information poster reflects that University staff will be accessing patient records. An updated poster was provided which detailed access to patient records.\n\n"]

{"sheet":"A0004","index":4,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0004"]
["Reference","CAG 1-06(PR6)/2013"]
["Other Refs"]
["Application Title","AMICABLE Airway Management in Cardiac Arrest Study V1.1"]
["Application Summary","This research application from London Ambulance Services NHS Trust, detailed a study to evaluate the influence of airway management strategies on survival and quality of life where successful pre-hospital resuscitation had taken place.  Support was requested to allow a researcher, employed by London Ambulance Services NHS Trust, access to contact details and survival status in order to contact the patient and seek consent and complete quality of life questionnaires. \n"]
["Applicant Organisation Name","London Ambulance Service NHS Trust"]
["Contact Name","Tim Edwards"]
["Address","Clinical Audit & Research Unit"]
[null,"8-20 Pocock Street"]
[null,"London"]
["Postcode","SE1 0BW"]
["Telephone","07941048411"]
["Email","t.edwards@herts.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"□","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18+ who have suffered out of hospital cardiac arrest, achieve return of\nspontaneous circulation, are diagnosed with ST elevation Myocardial Infarction, and are transferred directly to a regional Heart Attack Centre.  Cohort size 220."]
["Description of confidential patient information used","name, NHS number, date of birth, date of death, postcode, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Hertfordshire"]
["Status","Expired"]
[]
["Outcome Date","2014-10-01"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 18/04/2013"]

{"sheet":"A0005","index":5,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0005"]
["Reference","CAG 1-06(PR7)/2013"]
["Other Refs"]
["Application Title","Secondary Prevention of Burns and Scalds in Children"]
["Application Summary","This research application from the University of Cardiff described a study to evaluate a risk assessment tool designed to assess childhood burns and direct to appropriate care. The application was for the pilot study only.  The application followed on from a previous PIAG approval which was obtained in order to establish the risk assessment tool, PIAG 4-05(i)/2008 Thermal injuries in children - Version 1.  The application requested approval to access data in relation to patients under the age of 16 who have presented with scalds and non-scald burns at emergency departments over a 12 month period over 3 NHS Trusts. Clinical staff would complete a data collection form on behalf of the research team who would then use identifiable details to request further information from other services such as health visitors, social workers, school nurses and children centres. Name, hospital or NHS number and date of birth would be collected in order to carry out linkages. Identifiable data items would be removed from the database once linkages were complete.\n\n"]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Professor Alison Kemp"]
["Address","Institute of Primary Care and Public Health"]
[null,"4 Floor, Neuadd Meirionnydd"]
[null,"Heath Park, Cardiff"]
["Postcode","CF14 4YS"]
["Telephone","02920 687143"]
["Email","kempam@cardiff.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"Y","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children aged 0-16 who attend minor injuries unit, A&E or burns unit with thermal injury"]
["Description of confidential patient information used","name, NHS number, date of birth, postcode, gender"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University"]
["Status","Supported"]
[]
["Outcome Date","2013-04-17"]
["Next Review Date","2017-04-17"]
["Notes","Application considered at CAG meeting on 18/04/2013.\n\nSpecific conditions of support\n\n1. Confirmation of a favourable opinion from REC. Received.\n\n2. Confirmation of satisfactory security review. It was noted that the IG toolkit had been reviewed in relation to another application from the same chief investigator and that data would be processed in the same environment.\n\n3. It was noted that there was an international element to the study, if any data is to be shared with other countries, it should be ensured that this is not in identifiable format.\n"]

{"sheet":"A0006","index":6,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0006"]
["Reference","CAG 2-05(a)/2013"]
["Other Refs"]
["Application Title","Investigating factors influencing the Infant Mortality Rate in Lincolnshire\n"]
["Application Summary","This research application from the University of Nottingham set out details of a case control study to investigate factors affecting the infant mortality rate within premature babies in Lincolnshire. The study was commissioned in response to NHS Lincolnshire raising concerns over the infant mortality rate within the county over the last few years.  Researchers from the University requested access to records of deceased babies only, born between the two gestational ages within Lincolnshire, or born outside of Lincolnshire where the mother would usually be resident in the county. Date of birth, date of death, deprivation score and ethnicity of baby would be extracted for analysis purposes. \n"]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Dr Richard Puleston"]
["Address","School of Community Health Sciences, Clinical Sciences Building"]
[null,"City Hospital, Hucknall Road"]
[null,"Nottingham"]
["Postcode","NG5 1PB"]
["Telephone","01158231812"]
["Email","richard.puleston@nottingham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"Y","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Babies born to mothers normally resident in Lincolnshire beyond 22 weeks and 6 days gestation and prior to 37 weeks gestation who die within the first month after birth and were either born and cared for outside of the United Lincolnshire Hospitals NHS Trust or were transferred from there after birth for intensive care treatment."]
["Description of confidential patient information used","date of birth, date of death, postcode, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Nottingham"]
["Status","Supported"]
[]
["Outcome Date","2014-08-06"]
["Next Review Date","2015-08-06"]
["Notes","Application considered at CAG meeting on 19/04/2013.\n\nSpecific conditions of support\n\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 17 December 2014.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here; http://www.hra.nhs.uk/hra-confidentiality-advisory-group/cag-application-process/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed 30 July 2014.\n\n3. Given the importance of the issue, members requested that a report should be submitted in 3 months’ time to provide an update on the progress of the study.\n"]

{"sheet":"A0013","index":7,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0013"]
["Reference","CAG 3-03(PR3)/2013"]
["Other Refs"]
["Application Title","Medical Therapy vs Intervention in Chronic Total Coronary Occlusions"]
["Application Summary","This research application from Hull and East Yorkshire Hospitals NHS Trust detailed a study which aimed to determine whether there was a difference in mortality between patients who have had a chronically occluded coronary artery (CTO) who have an attempt at angioplasty to the vessel with those electively treated conservatively. Around 2000 patients treated at Castle Hill Hospital would be included.  Access was requested to follow up data from NICOR and the Health and Social Care Information Centre in relation to patient outcomes after 5 years which would then be linked to data collected locally. The researcher undertaking the work was part of the clinical care team for patients at Castle Hill Hospital.\n"]
["Applicant Organisation Name","Hull and East Yorkshire Hospitals NHS Trust"]
["Contact Name","Dr Andrew Ladwiniec"]
["Address","Department of Cardiology, Castle Hill Hospital"]
[null,"Cottingham"]
[null,"East Yorkshire"]
["Postcode","HU16 5JQ"]
["Telephone","07949012478"]
["Email","andrew.ladwiniec@hyms.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Consecutive patients (>18 years) who underwent coronary angiography between 1st January 2002 and 31st December 2007 and were found to have a vessel which had been blocked for a least 3 months (a CTO), with no forward flow down the vessel when dye is injected down it (TIMI grade 0 flow).  Total cohort size 1192."]
["Description of confidential patient information used","name, NHS number, hospital number, date of birth, date of death, gender"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Hull & East Yorkshire Hospitals NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2013-07-04"]
["Next Review Date","2014-07-04"]
["Notes","Application considered at CAG meeting on 14/06/2013.\nSpecific conditions of support\n\n1. Favourable opinion from REC Received 30 April 2013\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 25 June 2013\n"]

{"sheet":"A0014","index":8,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0014"]
["Reference","CAG 3-03(PR4)/2013"]
["Other Refs"]
["Application Title","How effective are Antithrombotic Therapies in Primary PCI: HEATppci v1"]
["Application Summary","This research application from the Liverpool Heart and Chest Hospital detailed a study which aimed to compare two drugs used to prevent blood clotting during Primary Percutaneous Coronary Intervention (PPCI) to determine if there is any difference in their use in the treatment of heart attacks and reducing complications of treatment such as bleeding.  Patients undergoing PPCI at Liverpool Heart and Chest Hospital over a period of 24 months would be included within the trial. Patients would be followed up for 28 days to determine any difference between the two groups for heart attacks, additional angioplasty procedures, stroke and death. Support was requested to allow access to follow up data for those patients who died prior to consent being sought.\n"]
["Applicant Organisation Name","Liverpool Heart and Chest Hospital"]
["Contact Name","Dr Rod Stables"]
["Address","Liverpool"]
[null," "]
[null," "]
["Postcode","L14 3PE"]
["Telephone","0151 600 1489"]
["Email","rod.stables@lhch.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Acute myocardial infarction patients (aged 18+) activating the primary percutaneous\ncoronary intervention pathway. Total cohort size 1800."]
["Description of confidential patient information used","name, NHS number, hospital number, GP registration, date of birth, date of death, postcode, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Liverpool Heart and Chest Hospital"]
["Status","Expired"]
[]
["Outcome Date","2013-05-29"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 14/06/2013"]

{"sheet":"A0016","index":9,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0016"]
["Reference","CAG 4-07/2013"]
["Other Refs","ECC 9-02/2013"]
["Application Title","ALSPAC Eligible Sample: Enrolment and Consent for Record Linkage\n"]
["Application Summary","This application from the University of Bristol detailed accessing contact details in relation to the eligible cohort in order to write to them and seek consent to participate in the Avon Longitudinal Study of Parents and Children.\nClass 3 and 6 support was requested to allow access to contact details.\n\nSupport was requested to allow researchers access address details from the Health and Social Care Information Centre in order to invite the eligible cohort to consent to their data being linked."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor John Macleod"]
["Address","Canynge Hall"]
[null,"39 Whatley Road"]
[null,"Bristol"]
["Postcode","BS8 2PS"]
["Telephone","0117 3313935"]
["Email","john.macleod@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children of all women who were pregnant, while resident in three NHS Health Districts in and around Bristol, with a estimated date of delivery between 1st April 1991 and 31st December 1992"]
["Description of confidential patient information used","name, address, postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Supported"]
[]
["Outcome Date","2014-03-26"]
["Next Review Date","2017-03-26"]
["Notes","Reviewed at 14 June 2013 meeting.\nSpecific conditions of support\n\n1. This support is to access contact details in relation to the eligible cohort in order to write to them and seek consent only.  Contact details of those not responding must be securely destroyed and these details and any information derived from them must not be used for further record linkage.  Confirmed that no identifiable data would be retained in relation to those who do not respond\n\n2. Please provide final copies of the patient information leaflets. Submitted.\n\n3. A favourable opinion from a Research Ethics Committee. Confirmed.\n\n4. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 30/12/2013.\n"]

{"sheet":"A0017","index":10,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0017"]
["Reference","CAG 4-09(a)/2013"]
["Other Refs","Application has been replaced with a revised CAG reference 19/CAG/0040"]
["Application Title","Translational Research In Pulmonary Hypertension at Imperial College (TRIPHIC)"]
["Application Summary","This application from Imperial College Healthcare NHS Trust detailed the establishment of a research database for use in research projects into pulmonary vascular disease. Data from established datasets within Imperial College and at the HSCIC would be linked and pseudonymised to be used for research purposes. Approximately 2000 patients had been referred to the National Pulmonary Hypertension Service at Imperial over the last decade and the database would include all these patients. The application detailed linking the following datasets:\n1) The Integrated Computerised Hospital Information System (ICHIS)\n2) Internal Communication Environment (ICE)\n3) The cardiopulmonary exercise testing data \n4) Lung function database\n5) The National Pulmonary Hypertension Audit (NPHA) database\nA recommendation for class 1 and 4 support was requested to allow the Database Manager access to all retrospective information held in local databases and from the NPHA database. NPHA data would be accessed via the Health and Social Care Information Centre (HSCIC) and linked to mortality data from ONS.  Access was requested to NHS number, Hospital number, date of birth and date of death in order to carry out linkages\n\n"]
["Applicant Organisation Name","Imperial College Healthcare NHS Trust"]
["Contact Name","Professor Martin Wilkins"]
["Address","Hammersmith Hospital"]
[null,"Du Cane Road"]
[null,"London"]
["Postcode","W12 0HS"]
["Telephone","0208 383 2049"]
["Email","m.wilkins@imperial.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients within existing datasets defined above.  Cohort size c. 2000."]
["Description of confidential patient information used","name, address, postcode, NHS number, date of birth, date of death, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Imperial College Healthcare NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-11-14"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 14/06/2013.\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee, including confirmation of whether an amendment is now required if vulnerable groups are to be approached. The applicant confirmed that they did not anticipate that many potential participants would be unable to provide consent for themselves and that where necessary a REC amendment would be submitted rather than excluding these groups. REC opinion confirmed 10/09/2013.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission.  Confirmed 30/05/2013.\n\n3. Further efforts should be made to carry out patient involvement, including the addition of patient members on the TRIPHIC steering committee; this should be reported at annual review stage.\n\n4. Please consider whether linkages could be undertaken using NHS number only; progress in relation to this should be reported at annual review stage.\n\n5. Please ensure any onward disclosure is managed in line with the Hospital Episode Statistics (HES) protocol.\n"]

{"sheet":"A0018","index":11,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0018"]
["Reference","CAG 4-09(b)/2013"]
["Other Refs"]
["Application Title","Bariatric surgery and colorectal cancer"]
["Application Summary","This application from the University of Leeds set out details of a study to confirm whether the risk of colorectal cancer increased after bariatric surgery.  The study proposed to use existing health datasets and established methodology to compare the incidence of colorectal cancer in a cohort of patients who had undergone bariatric surgery and a cohort of obese patients who had not undergone bariatric surgery.  A recommendation for class 2, 4 and 5 support was requested to cover access to existing Hospital Episode Statistics (HES) and National Cancer Data Repository (NCDR) datasets for the purpose of linkage. Access was requested to NHS number, date of birth, date of death, postcode and sex.\n"]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Mark Hull"]
["Address","Leeds Institute of Molecular Medicine"]
[null,"St James's University Hospital"]
[null,"Leeds"]
["Postcode","LS9 7TF"]
["Telephone","0113 206 8958"]
["Email","m.a.hull@leeds.ac.uk"]
["Medical Purposes","Y","preventative medicine"]
[null,"Y","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with a diagnosis of obesity (defined using ICD10 code E66) and/or who underwent bariatric surgery (defined by NICE-approved ICD10 codes G3033) between April 1997 and December 2010."]
["Description of confidential patient information used","name, NHS number, postcode, date of birth, date of death, sex"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Leeds"]
["Status","Expired"]
[]
["Outcome Date","2014-01-20"]
["Next Review Date","N/A"]
["Notes","All data has been deleted.\n\nThe research was published in a scientific journal. \nAravani A, Downing A, Thomas JD, Lagergren J, Morris EJA, Hull MA. Obesity surgery and risk of colorectal and other obesity-related cancers: An English population-based cohort study. Cancer Epidemiol 2018;53:99-104 \n\nApplication considered at CAG meeting on 14/06/2013\n\nSpecific conditions of support\n\n\n1. Favourable opinion from Research Ethics Committee. Confirmed.\n\n2. Please confirm data linkage arrangements as soon as possible. Confirmed that confidential patient information would be processed on the ENCORE system within Public Health England. Confirmation of satisfactory security arrangements received on 21 November 2013.\n\n3. Please provide further information in relation to public involvement which has been undertaken and any consultation regarding the use of data as part of this. Details of consultation with the WLSinfo Leeds support group were provided on the 30 September 2013.\n"]

{"sheet":"A0019","index":12,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0019"]
["Reference","CAG 5-03(PR1)/2013"]
["Other Refs"]
["Application Title","ELN survival follow-up study"]
["Application Summary","This application from University College London Hospital detailed a study to assess 3 year survival data in a group of patients who have undergone an emergency laparotomy (EL). Access was requested to data collected as part of a national audit of perioperative care which was currently held locally at NHS sites and mortality data from the Health and Social Care Information Centre (HSCIC). Access was requested to name, hospital number, NHS number and date of birth in order to send to the HSCIC and flag patients on the NHS Central Register. Mortality data would be provided to the applicant every 3 months until April 2014 in a pseudonymised format.\n"]
["Applicant Organisation Name","University College London Hospital"]
["Contact Name","Dr Charles M Oliver"]
["Address","Surgical Outcomes Research Centre"]
[null,"237-245 Euston Road"]
[null,"London"]
["Postcode","NW1 2BU"]
["Telephone","07973227338"]
["Email","matt.oliver@uclh.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 18 years or over, undergoing expedited/ urgent or emergency surgery via a midline upper or lower abdominal incision"]
["Description of confidential patient information used","name, NHS number, hospital number, date of birth, postcode, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London Hospital"]
["Status","Expired"]
[]
["Outcome Date","2013-07-12"]
["Next Review Date","N/A"]
["Notes","Expired\n\nThe controller confirmed in July 2022, that the study was closed in 2014. Applicants were unable to secure approvals from each of the individual hospitals. The study was therefore abandoned.  2 sites did submit data, which were deleted in 2014. There were no benefits, given that the study was abandoned.\n\nApplication considered at CAG meeting on 08/08/2013.\nSpecific conditions of support\n\n1. Favourable opinion from REC Received \n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 9 July 2013\n3. Please confirm what activities will be undertaken to ensure that reasonable efforts are made to inform the cohort in line with the Data Protection Act 1998.  It was confirmed on 11 July 2013 that details of the study would be published on the ELN network, Health Services Research Centre and National Emergency Laparotomy Audit websites, and the project would be discussed with the National Emergency Laparaotomy Audit/Royal College of Anaesthetists Patient Liaison Group.\n4. Please ensure that full dates of birth and death are destroyed once the necessary calculations have taken place using this data.  Confirmed 10 July 2013\n"]

{"sheet":"A0022","index":13,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0022"]
["Reference","CAG 5-03(PR5)/2013"]
["Other Refs"]
["Application Title","Melanoma Lifestyle Study"]
["Application Summary","This application from the University of Leeds set out the purpose of a study which was part of a programme of work looking at lifestyle and genetic factors affect the risk of melanoma returning after treatment, with a particular focus on the effect of vitamin D.  A recommendation for class 1, 3 and 6 support was requested to allow the project manager to identify patients at one site for the purpose of identifying patients in order for the clinical care team to then seek consent to take part in the study.  Access was requested to histology reports, digital medical records, case note records or results databases to eligible participants at one site in Leeds.\n"]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Julia Newton-Bishop"]
["Address","St James's University Hospital"]
[null,"Beckett Street"]
[null,"Leeds"]
["Postcode","LS9 7TF"]
["Telephone","0113 2064573"]
["Email","j.a.newton-bishop@leeds.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18+ diagnosed with melanoma.  Cohort size 892."]
["Description of confidential patient information used","name, NHS number, hospital number, date of birth, date of death, postcode, sex, hair colour, hospital of recruitment"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Leeds Teaching Hospitals NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2013-10-08"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 08/08/2013"]

{"sheet":"A0023","index":14,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0023"]
["Reference","CAG 5-03(PR6)/2013"]
["Other Refs"]
["Application Title","Heart Watch' Cardiac Rehabilitation: Mortality/Morbidity Audit V3.1"]
["Application Summary","This research application from the University of Hull set out a study to determine patient\noutcomes following participation in the Heart Watch cardiac rehabilitation programme, and the\nimpact of exercise on cardiorespiratory fitness, through linking the programme’s existing\ndataset to mortality and morbidity data. All participants gave consent for the cardiac\nrehabilitation programme and to have their clinical exercise and supervised training data\nroutinely collected and used for research purposes.  A recommendation for class 1, 4, 5 and 6 support was requested to cover access to mortality and morbidity data from medical records at Leeds Teaching Hospitals’ NHS Trust in order to extract and pseudonymise data. Where mortality data was not available from the NHS Trust GP practices would be contacted. Data would be analysed at Leeds Metropolitan University.  Access was requested to name, date of birth, date of death and postcode in order to carry out linkages, once linkages had taken place all personal identifiable information would be removed and only the original data custodian at Leeds Metropolitan University (LMU) would retain the key to identification of the original participants’ data."]
["Applicant Organisation Name","University of Hull"]
["Contact Name","Claire Taylor"]
["Address","Department of Sport, Health and Exercise Science"]
[null,"Cottingham Road"]
[null,"Hull"]
["Postcode","HU6 7RX"]
["Telephone","07747 006051"]
["Email","c.taylor@2012.hull.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adults aged 47-98 with previous diagnosis of cardiovascular disease.  Total cohort 1030."]
["Description of confidential patient information used","name, date of birth, date of death, postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Hull"]
["Status","Supported"]
[]
["Outcome Date","2013-08-01"]
["Next Review Date","2016-08-01"]
["Notes","Application considered at CAG meeting on 08/08/2013.\nSpecific conditions of support\n\n\n1. Favourable opinion from REC Received\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 5 July 2013\n\n3. Please provide patient information materials for display at Leeds Teaching Hospitals NHS Trust, these should include information in relation to opting out of the study.  Received 22 July 2013\n\n4. Please amend the consent form for prospective participants of the programme to ensure that future data collection is undertaken on a consented basis.  Received 22 July 2013\n"]

{"sheet":"A0025","index":15,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0025"]
["Reference","CAG 5-08(b)/2013"]
["Other Refs"]
["Application Title","Survival of children born with congenital heart disease"]
["Application Summary","This research application from Newcastle University set out a study to determine survival for all children with congenital heart disease and examine predictors of survival using demographic data.  A recommendation for class 1, 4 and 6 support was requested to provide BINOCAR data to the Health and Social Care Information Centre (HSCIC) and a linked BINOCAR and ONS dataset to the Regional Maternity Survey Office (RMSO) at Newcastle upon Tyne Hospitals Trust.  The aim was for the RMSO to carry out survival analysis and provide a pseudonymised dataset to Newcastle University.  Access was requested to name, date of birth and postcode in order for the HSCIC to link BINOCAR data to mortality data."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Professor Judith Rankin"]
["Address","Institute of Health and Society"]
[null,"Baddiley-Clark Building"]
[null,"Newcastle"]
["Postcode","NE2 4AX"]
["Telephone","0191 222 6686"]
["Email","judith.rankin@ncl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All live born cases of congenital heart disease (ICD 10: Q2026), notified to the seven participating British Isles Network of Congenital Anomaly Registers (BINOCAR) between the inception of the register to 31st Dec 2010"]
["Description of confidential patient information used","name, date of birth, postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle University"]
["Status","Supported"]
[]
["Outcome Date","2015-07-16"]
["Next Review Date","2020-11-13"]
["Notes","Application considered at CAG meeting on 08/08/2013.\nSpecific conditions of support\n\n1. Confirmation of a favourable Research Ethics Committee opinion. Received 7 August 2013.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here; http://www.hra.nhs.uk/hra-confidentiality-advisory-group/cag-application-process/ and contact Exeter.helpdesk@nhs.net with any queries.\n\n3. Please provide further information regarding how reasonable efforts will be made to inform the cohort of the processing of confidential patient information.\n"]

{"sheet":"A0026","index":16,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0026"]
["Reference","CAG 5-08(c)/2013"]
["Other Refs"]
["Application Title","A prospective surveillance study to define rates of carriage, transmission and infection by healthcare-associated pathogens in adjacent hospital and community settings"]
["Application Summary","This research application from the University of Cambridge set out a prospective surveillance study to define rates of carriage, transmission and infection by healthcare-associated pathogens in adjacent hospital and community settings, using a combination of epidemiological investigation and bacterial genome sequencing.  The proposed study would include approximately 65,000 patients admitted to Addenbrooke’s Hospital over a one year period and 251 residents admitted to a specified nursing home during the same period.  A recommendation for class 4 and 6 support was requested for a research nurse to access records of those patients admitted to Addenbrooke’s and found to be infected.  Identifiable data was requested in order to track patients admitted to both the hospital and the nursing home and remove duplicate entries.  Access was requested to name, NHS number, hospital number and date of birth in order to carry out data linkage."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Sharon Peacock"]
["Address","Box 157, Addenbrooke's Hospital"]
[null,"Hills Road"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223 336845"]
["Email","estee.torok@addenbrookes.nhs.uk    sjp97@medschl.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult inpatients at Addenbrooke's Hospital or specified nursing home tested for MRSA, C. difficile, MDR GNB, or VRE carriage or infection "]
["Description of confidential patient information used","name, NHS number, hospital number, date of birth"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cambridge University Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-02-17"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 08/08/2013\n\n1. The application is approved, in order to allow data in relation to the patients admitted to Addenbrooke’s Hospital, subject to compliance with the standard and specific conditions of approval.\n2. The collection of data in relation to the nursing home patients is not approved as consent appears to be feasible.\n\nExpired-02 September 2015 \n"]

{"sheet":"A0027","index":17,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0027"]
["Reference","CAG 5-08(d)/2013"]
["Other Refs"]
["Application Title","Cancer risks in the British rubber manufacturing industry"]
["Application Summary","This research application from the Institute of Occupational Medicine set out a study to determine whether specific chemicals used within the rubber manufacturing process increase the risk of cancer.  A recommendation for class 1, 4 and 6 support was requested in order to flag approximately 40,000 workers, who were aged 35 or over in 1967 and worked in the rubber industry, on the NHS Central Register and receive updates from the Health and Social Care Information Centre (HSCIC) in relation to cancer and deaths.  The Institute of Occupational Medicine (IOM) would receive data from the Health and Safety Executive in relation to workers who took part in an original study undertaken by the HSE predecessor in 1967. They would then pass demographic data to the HSCIC who would use this to trace the cohort and provide identifiable data to IOM.  Access was requested to central register data including name, NHS number, date of birth and date of death to allow linkages to take place.\nAmendment 24/06/2015: A notification was submitted to the CAT highlighting a change to the Chief Investigators organisation and that the analysis of pseudonymised data would now take place at the University of Bristol rather than the University of Manchester. It was noted that a condition of the original approval was that the dataset disclosed to the University of Manchester should include month and year of birth and death only. It was confirmed by the applicant that on transfer to the University of Bristol the data would be anonymised in the same way. Therefore there would be no amendment to organisations having access to confidential patient information under the Regulations."]
["Applicant Organisation Name","Institute of Occupational Medicine"]
["Contact Name","Professor Damien McElvenny"]
["Address","Research Avenue North"]
[null,"Riccarton"]
[null,"Edinburgh"]
["Postcode","EH14 4AP"]
["Telephone","0131 449 8085"]
["Email","damien.mcelvenny@iom-world.org"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","40,000 rubber industry workers aged 35 or over in 1967"]
["Description of confidential patient information used","name, NHS number, date of birth, date of death"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Manchester"]
["Status","Supported"]
[]
["Outcome Date","2014-11-17"]
["Next Review Date","2016-11-17"]
["Notes","Application considered at CAG meeting on 08/08/2013.\nSpecific conditions of support\n\n1. Favourable opinion from REC Received 30/07/2013\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here; http://www.hra.nhs.uk/hra-confidentiality-advisory-group/cag-application-process/ and contact Exeter.helpdesk@nhs.net with any queries.\n\n3. Please provide a confirmation of support from the Information Custodian.\n\n4. Please contact relevant trade unions to inform them of the study and seek any feedback in relation to the study. Please provide further details of a plan to carry this out prior to final approval and report any feedback at annual review stage.\n\n5. The dataset disclosed to the University of Manchester should include month and year of birth and death only. \n"]

{"sheet":"A0028","index":18,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0028"]
["Reference","CAG 6-03(PR1)/2013"]
["Other Refs"]
["Application Title","The QUEST Study (version 1)"]
["Application Summary","This research application from Luton & Dunstable University Hospital Foundation NHS Trust\nset out the purpose of assessing the effectiveness of the current sepsis care pathway and the\nimpact of adding an additional clinical test (the procalcitonin point of care test) to the pathway.\nA recommendation for class 1, 5 and 6 support was requested to cover access to data on 100\ndeceased adult patients across two chosen sites (50 per site) who had attended A&E with\nsuspected sepsis.  Access was requested to date of birth, date of death, postcode, gender and ethnicity"]
["Applicant Organisation Name","Luton & Dunstable University Hospital NHS Foundation Trust"]
["Contact Name","Mr David Kirby"]
["Address","Lewsey Road"]
[null,"Luton"]
[null," "]
["Postcode","LU4 0DZ"]
["Telephone","01582 497065"]
["Email","david.kirby@ldh.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 deceased adult patients across two chosen sites (50 per site) who had attended A&E with\nsuspected sepsis."]
["Description of confidential patient information used","date of birth, date of death, postcode, gender, ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Luton & Dunstable University Hospital NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2013-08-22"]
["Next Review Date","2014-08-22"]
["Notes","Application considered at CAG meeting on 03/10/2013.\nSpecific conditions of support\n\n\n1. Favourable opinion from REC  Received 24 June 2013.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here; http://www.hra.nhs.uk/hra-confidentiality-advisory-group/cag-application-process/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed 30 July 2013.\n"]

{"sheet":"A0029","index":19,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0029"]
["Reference","CAG 6-03(PR2)/2013"]
["Other Refs"]
["Application Title","Retrospective analysis of reversible myocardial dysfunction in ICU"]
["Application Summary","This research application from Oxford University Hospitals NHS Trust set out the purpose of a\nretrospective analysis of repeated heart ultrasound outcomes performed in general ICU\npopulation in order to characterise the natural history and outcomes of patients experiencing\nheart impairment. The study aims to develop a greater understanding about whether the\ncondition affects wider critically ill patients. A recommendation for class 1, 4 and 6 support was requested in order for the research team within John Radcliffe Hospital to identify patients\nwho had serial heart ultrasounds whilst in the ICU and assess changes in heart function during\nthe course of critical illness. Access was requested to the ICU patient monitoring database,\nlocal data collected for national ICU audit programme (ICNARC) and the heart ultrasound\ndatabase. The ICU patient monitoring database would be extracted for all patients admitted to\nthe ICU from January 2008 to June 2013 and linked to the ultrasound database. Where\npatients were identified as having serial ultrasounds clinical data would be extracted from the\npatient monitoring database and local ICNARC data.  Access was requested to name, date of birth, hospital number and gender."]
["Applicant Organisation Name","Oxford University Hospitals NHS Trust"]
["Contact Name","Dr Duncan Young"]
["Address","Kadoorie Centre, Level 3"]
[null,"John Radcliffe Hospital, Headley Way"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865 220621"]
["Email","duncan.young@ndcn.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients admitted to the Adult Intensive Care Unit at the John Radcliffe Hospital between 1/1/2008 and 1/06/2013 who had more than one echocardiographic ultrasound examination of their heart during their stay in Intensive Care"]
["Description of confidential patient information used","name, date of birth, hospital number, gender"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Expired"]
[]
["Outcome Date","2013-10-24"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 03/10/2013.\n\nSpecific conditions of support\n1. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 10 September 2013.\n2. Confirmation of suitable security arrangements via IG Toolkit submission.  Confirmed 08 May 2013.\n3. Please amend the patient information materials to ensure that they give patients a clear opportunity and mechanism for objection if they do not wish their data to be included in the study. It was confirmed that the patient information materials would be updated in December 2013. Please ensure that copies of the amended materials are submitted to CAG.\n4. Please ensure that information in relation to this specific activity is made available to living patients, in line with the fair processing requirements of the Data Protection Act 1998, for example through publication on the Trust website. It was confirmed that information in relation to the study would be included on the OUH Trust website.\n5. Please provide more details concerning patient and public engagement with respect to this application, including more details in relation to attendees at the public meeting mentioned in the application. Details were provided of the attendees at the public meeting in August 2011. It was also confirmed that the project would be brought to the attention of the local ICU patient group.\n"]

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[]
[]
["Application Number","0030"]
["Reference","CAG 6-03(PR3)/2013"]
["Other Refs"]
["Application Title","Impact of overweight on prognosis of diabetes mellitus"]
["Application Summary","This research application from the University of Hull set out the purpose of establishing a\nresearch database which would be used to assess the relationship between obesity,\ncardiovascular disease and mortality in diabetes mellitus and address issues that might have\naccounted for inconsistent results in previous studies. A recommendation for class 1, 4 and 6\nsupport was requested to cover access to a database including approx. 12,000 patients’ data\nheld at the diabetes out-patient clinic at Hull and East Yorkshire Trust for the purpose of data\nextraction and linkage to ONS mortality data.  Access was requested to name, NHS number, date of birth, date of death and postcode."]
["Applicant Organisation Name","University of Hull"]
["Contact Name","Dr Pierluigi Costanzo"]
["Address","Daisy Building"]
[null,"Castle Hill Hospital, Cottingham Road"]
[null,"Hull"]
["Postcode","HU16 5JQ"]
["Telephone","01482 875875"]
["Email","pierluigicostanzo83@gmail.com"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patient database at diabetes out-patient clinic at Hull and East Yorkshire Trust (12,000 patients)"]
["Description of confidential patient information used","name, NHS number, date of birth, date of death, postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Hull"]
["Status","Supported"]
[]
["Outcome Date","2014-01-24"]
["Next Review Date","2016-01-24"]
["Notes","Application considered at CAG meeting on 03/10/2013.\nSpecific conditions of support\n\n1. Favourable opinion from REC  Received 08/07/2013.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission.  Confirmed 24/07/2013.\n\n3. Please ensure that all identifiable data is retained separately from clinical information and that identifiers are kept no longer than necessary once linkages have been established.\n\n4. Please provide details of plans to raise awareness of the activity and copies of any patient information materials. \n"]

{"sheet":"A0033","index":21,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","0033"]
["Reference","CAG 7-06(a)/2013"]
["Other Refs"]
["Application Title","Investigating the accuracy of current estimates of self-harm"]
["Application Summary","This application from the University of Bristol set out the purpose of a study to carry out data linkage of ALSPAC and Hospital Episode Statistics (HES) data in order to enhance understanding in relation to the accuracy of current estimates of self-reported self-harm in the community and the long term risk of hospital admission for self-harm.  It was intended that the findings would have potential value for health policy by raising awareness about the importance of self-harm and would lead to greater prioritisation of preventative measures.  A recommendation for class 1, 4 and 6 support was requested in order to access HES data in relation to self-harm episodes of non-responders.\n"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Dr Becky Mars, Chief investigator"]
["Address","Population Health Sciences"]
[null,"Bristol Medical School, Oakfield House"]
[null,"Oakfield Grove, Bristol"]
["Postcode","BS8 2BN"]
["Telephone","0117 3310165"]
["Email","becky.mars@bristol.ac.uk"]
["Medical Purposes","Y","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ALSPAC enrolled cohort: Hospital admitted selfharm"]
["Description of confidential patient information used","NHS number, date of birth, district level postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Supported"]
[]
["Outcome Date","2014-03-21"]
["Next Review Date","2024-03-21"]
["Notes","Amendment supported 09 November 2023 to extend the study to include data from primary care, to extend the duration of ‘s251’ support until 30 September 2025, and to change the chief investigator from Professor David Gunnell to Dr Becky Mars\n\nApplication considered at CAG meeting on 04/10/2013.\nSpecific conditions of support\n1. Favourable opinion from REC  Received 08/07/2013.\n2. Confirmation of suitable security arrangements via IG Toolkit submission.  Confirmed 24/07/2013.\n3. Please ensure that all identifiable data is retained separately from clinical information and that identifiers are kept no longer than necessary once linkages have been established.\n4. Please provide details of plans to raise awareness of the activity and copies of any patient information materials. \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0035","index":22,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0035"]
["Reference","CAG 7-06(d)/2013"]
["Other Refs"]
["Application Title","Reasons for Non-Participation in Physical Activity Interventions\n"]
["Application Summary","This application from the University of Cambridge set out the purpose of a study to determine the reasons that non-responders to a preceding trial gave for turning down the opportunity to take part.  A ‘profiling’ study would be conducted alongside these interviews and would involve analysis of non-responders data from GP practices.  A recommendation for class 1, 2 and 6 support was requested to cover access to data relating to non-responders, including unit-level postcode."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Sophie Attwood"]
["Address","Institute of Public Health"]
[null,"Forvie Site, Robinson Way"]
[null,"Cambridge"]
["Postcode","CB2 0SR"]
["Telephone","01223 769192"]
["Email","ska32@medschl.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adults aged 40-74 invited to participate in health check programme by their GP practice who have not responded"]
["Description of confidential patient information used","postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Expired"]
[]
["Outcome Date","2014-02-07"]
["Next Review Date","N/A"]
["Notes","Approved for access to data at the following GP surgeries: Acorn Surgery, Riverside Practice, Roman Gate, Old Telephone Exchange Practice"]

{"sheet":"A0036","index":23,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0036"]
["Reference","CAG 7-06(e)/2013"]
["Other Refs"]
["Application Title","EpiHealth Outcomes Project The effect of maternal age, embryo cryopreservation and culture on perinatal outcomes and child health: Scottish Data Linkage Study\n"]
["Application Summary","This application from Central Manchester University Hospitals NHS Foundation Trust set out the purpose of a study aiming to assess the role of parental ages, IVF treatment method, in-vitro culture and embryo freezing on neonatal health and subsequent growth in IVF-conceived babies, adjusting for known confounders.  A recommendation for support was requested to cover access to the Human Fertility and Embryology Authority (HFEA) Research Register by Informatics Services Division in Scotland who would undertake linkage to health information routinely held by NHS Scotland and provide a de-identified extract to the applicant."]
["Applicant Organisation Name","Central Manchester University Hospitals NHS Foundation Trust"]
["Contact Name","Professor Daniel Brison"]
["Address","Department of Reproductive Medicine"]
[null,"St Mary's Hospital"]
[null,"Oxford Road, Manchester"]
["Postcode","M13 9WL"]
["Telephone","01612766612"]
["Email","daniel.brison@manchester.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All IVF treatments in the period from the start of data collection in August 1991 to 30/9/2009 producing singleton or twin live births from fresh or frozen embryos. Within this timeframe, the children born as a result of these treatments will currently be aged between 3 or 4 and 22."]
["Description of confidential patient information used","name, NHS number, hospital number, date of birth, sector level postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Central Manchester University Hospitals NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2013-10-14"]
["Next Review Date","2014-10-14"]
["Notes","Application considered at CAG meeting on 04/10/2013"]

{"sheet":"A0041","index":24,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0041"]
["Reference","CAG 8-03(PR8)/2013"]
["Other Refs"]
["Application Title","DIAMOND-Lewy Work Package 1, version 1.0"]
["Application Summary","This research application from the University of Cambridge set out the purpose of a study to improve the recognition and diagnosis of Lewy Body Dementia (LBD) through development of a new assessment tool, and to improve patient management and outcomes with respect to the same condition through development of an evidence based toolkit for clinicians.  A recommendation for class 1, 3 and 6 support was requested to cover access to the records of 1,800 adult patients at NHS Trusts in North East England and East Anglia with a diagnosis of dementia or Parkinson’s disease, in order to screen these records for LBD and contact the subset of patients with LBD to seek consent for inclusion in further research.  It was expected that this subset would be approximately 480 patients.\nAmendment 02.04.15-Authorisation was sought to retain patient contact details, including name, hospital number and full address for a temporary period of time. This was to avoid duplication between different services within the same NHS Trust. Patients who had opted out of the study may potentially be re-contacted about taking part in it."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor John O'Brien"]
["Address","Addenbrooke's Hospital"]
[null,"Hills Road"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223 760682"]
["Email","john.obrien@medschl.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1800 adult patients with diagnosis of dementia or Parkinson’s disease"]
["Description of confidential patient information used","name, NHS number, hospital number, date of birth, address, postcode, telephone number, gender"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Expired"]
[]
["Outcome Date","2014-01-28"]
["Next Review Date","N/A"]
["Notes","Only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nThis study provided important and much needed information on the extent to which Lewy body dementia is diagnosed in the UK, at much lower rates than expected, showing that many cases remain undiagosed.\n\nFindings have been published.\nhttps://pubmed.ncbi.nlm.nih.gov/29448953/\n\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee.  Received 22/11/2013.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 17/01/2014.\n"]

{"sheet":"A0043","index":25,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0043"]
["Reference","CAG 9-03(PR1)/2013"]
["Other Refs"]
["Application Title","Retrospective casenotes review of perinatal stroke"]
["Application Summary","This research application from Newcastle upon Tyne Hospitals NHS Foundation Trust set out the purpose of a study to obtain information about presentation, management and current care pathways in perinatal stroke.  This included the ways in which babies born at term and premature babies presented with perinatal stroke, the range in age at which a diagnosis was made, variation in management including investigations and referrals for therapy and other specialist services, and outcome.  A particular focus was whether the infants developed cerebral palsy and whether term and preterm infants differed in their rates of developing hemiplegic cerebral palsy.  A recommendation for class 1, 5 and 6 support was requested to cover access by one researcher to case notes of patients suffering from perinatal stroke within a 10 year period (2000-2009) at 4 hospitals in the Northern region with neonatal intensive care units.  Access was requested to name, hospital number and date of birth.  It was noted that only date of birth would be extracted.\n"]
["Applicant Organisation Name","Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Contact Name","Dr Anna Basu"]
["Address","Sir James Spence Institute, Royal Victoria Infirmary"]
[null,"Queen Victoria Road"]
[null,"Newcastle upon Tyne"]
["Postcode","NE1 4LP"]
["Telephone","0191 2821375"]
["Email","anna.basu@ncl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","case notes of patients suffering from perinatal stroke within a 10 year period (2000-2009) at 4 hospitals in the Northern region with neonatal intensive care units"]
["Description of confidential patient information used","name, hospital number, date of birth"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-01-24"]
["Next Review Date","N/A"]
["Notes","Support no longer required as of 31 December 2018.\n\nApplication considered at CAG meeting on 09/01/2014.\n\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 13/01/2014.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission Confirmed 31/07/2013 \n\n3. Any objections by patients, or where appropriate patients’ parents, to processing of their data should be upheld.  Confirmed 09/12/2013\n\n4. Please ensure that reasonable attempts are made to inform patients of the project, for example by displaying patient information in hospitals which can be referred to if the patient/parent is still in contact with the hospital.   Confirmed 09/12/2013\n"]

{"sheet":"A0044","index":26,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0044"]
["Reference","CAG 9-03(PR2)/2013"]
["Other Refs"]
["Application Title","The 100 Prescriptions Study"]
["Application Summary","This research application from the University of Nottingham set out the purpose of a research study to assess error rates in prescribing by GP registrars, following on from similar work on behalf of the General Medical Council.  A recommendation for class 1, 5 and 6 support was requested to cover access by a CCG-employed pharmacist to notes of 1,000 GP patients in the East Midlands, in order to assess the appropriateness of the most recent 100 prescriptions issued by each of 10 GP registrars recruited to the study. Access was requested to patient records on GP practice sites in order to extract anonymised data.\n\n"]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Tony Avery"]
["Address","Division of Primary Care, Room D1417, University of Nottingham Medical School"]
[null,"Queen's Medical Centre"]
[null,"Nottingham"]
["Postcode","NG7 2UH"]
["Telephone","0115 823 0422"]
["Email","tony.avery@nottingham.ac.uk      richard.knox@nottingham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1,000 GP patients in the East Midlands"]
["Description of confidential patient information used","Access to GP records"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Nottingham"]
["Status","Expired"]
[]
["Outcome Date","2014-08-29"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 09/01/2014.\n\nSpecific conditions of support\n1. Favourable opinion from Research Ethics Committee. Confirmed.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 18/08/2014.\n3. Provision of patient information materials and confirmation that these will be distributed at a local level. Confirmed\n"]

{"sheet":"A0045","index":27,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0045"]
["Reference","CAG 9-03(PR3)/2013"]
["Other Refs"]
["Application Title","Arrhythmia and systemic ventricular function in atrial switch for TGA"]
["Application Summary","This research application from Newcastle upon Tyne Hospitals NHS Foundation Trust set out the purpose of a study to assess local management of arrhythmia and systemic ventricular dysfunction, in patients who had undergone an atrial switch operation for transposition of the great arteries.  A recommendation for class 5 and 6 support was requested to cover access by one researcher, formerly a member of the local care team, to records of patients who were alive in 1985 and had undergone this procedure at the Freeman Hospital.  Access was requested to name, hospital number, date of birth, date of death and gender.\n\n"]
["Applicant Organisation Name","Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Contact Name","Dr John O'Sullivan"]
["Address","Department of Congenital Cardiology"]
[null,"Freeman Hospital"]
[null,"Newcastle upon Tyne"]
["Postcode","NE7 7DN"]
["Telephone","01912448296"]
["Email","john.o'sullivan@nuth.nhs.uk     iain.matthews@nuth.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","patients who were alive in 1985 and underwent atrial switch operation for transposition of the great arteries at the Freeman Hospital"]
["Description of confidential patient information used","name, hospital number, date of birth, date of death, gender"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-01-16"]
["Next Review Date","N/A"]
["Notes","The data controller confirmed in January 2023 that the application can be expired.\n\nApplication considered at CAG meeting on 09/01/2014.\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 23/12/2013\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission Confirmed 31/07/2013\n\n3. Confirmation that reasonable efforts would be made to inform data subjects of the uses of their data and provision of any patient information materials to be used. Confirmed that posters in relation to use of data would be displayed within consulting rooms.\n\n4. Consultation with patients to test the acceptability of accessing data without consent. Details of a consultation exercise with 20 patients testing acceptability of proposals was provided, all patients confirmed that they were supportive of the activity.\n"]

{"sheet":"A0047","index":28,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0047"]
["Reference","CAG 9-03(PR5)/2013"]
["Other Refs","14CAG1023 Rice - PRISM-TIMI Score"]
["Application Title","Preventable Incidents, Survival and Mortality Study 2 (PRISM2)"]
["Application Summary","This application from the London School of Hygiene and Tropical Medicine set out the purpose of a Department of Health sponsored study to identify avoidable deaths in English hospitals and to compare these with each participating site’s Hospital Standardised Mortality Ratio (HSMR) score in order to assess the HSMR’s own reliability as an indicator of avoidable deaths.  This followed on from the national report on hospital mortality by Sir Bruce Keogh earlier in 2013.  It was noted that this was also a repeat and extension of a prior approved application, ECC 3-06(c)/2009.  A recommendation for class 1, 5 and 6 support was requested to cover access by researchers to retrospective case notes of 100 deceased patients each at 24 NHS Trusts in England, in order to extract pseudonymised data.  Access was requested to NHS number, hospital number, date of birth, date of death, date of admission and date of discharge.\n"]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Dr Helen Hogan"]
["Address","Department of Health Services Research and Policy"]
[null,"15-17 Tavistock Place"]
[null,"London"]
["Postcode","WC1H 9SH"]
["Telephone","020 7958 8293"]
["Email","helen.hogan@lshtm.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 deceased patients at each of 24 NHS Trusts in England (2,400 patients total)"]
["Description of confidential patient information used","NHS number, hospital number, date of birth, date of death, date of admission, date of discharge"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Expired "]
[]
["Outcome Date","2013-12-23"]
["Next Review Date","N/A"]
["Notes","Physicians conducted reviews of records of patients who had died in an index period. The reviews took place on hospital sites. Only anonymous patient information was extracted onto a review form. No identifiable patient information left the hospital site.\n\nThis study extended the first PRISM study to another 24 NHS hospital Trusts with an additional 2400 reviews undertaken on the notes of patients dying during hospital care. The enlarged study did not strengthen the findings of the first PRISM study in terms of a robust estimate of avoidable deaths and the range of causes of those deaths it also helped to develop the approach to clinician-led reviews of deaths. This learning subsequently fed into the design of a national programme of reviews of deaths by hospital doctors which was introduced across the NHS.\n\n\nApplication considered at CAG meeting on 09/01/2014.\nSpecific conditions of support\n\n1. Favourable opinion from REC. Received 10/09/2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 19/09/2014.\n3. Confirmation that the retention period of confidential patient information is 6 months. Confirmed 02/10/2014.\n"]

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[]
[]
["Application Number","0048"]
["Reference","CAG 9-08(a)/2014"]
["Other Refs"]
["Application Title","SLAM CAMHS CRIS linkage with DfE National Pupil Database"]
["Application Summary","This application from Kings College London set out the purpose of linking and anonymising child and adolescent mental health (CAMHS) clinical data from the South London and Maudsley NHS Foundation Trust (SLAM) Biomedical Research Centre (BRC) Case Register Interactive Search (CRIS) system and educational performance data from Department of Education (DfE) National Pupil Database (NPD).\n\nAll children aged between 5 and 17 who were referred to CAMHS services between January 2008 and December 2013, (approx 35,000) would be included in order to aid health and education policy makers by providing information on the frequency and characteristics of children referred to CAMHS.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover DfE access to demographic data only from CAMHS.\n\n"]
["Applicant Organisation Name","\nInstitute of Psychiatry\n"]
["Contact Name","Professor Matthew Hotopf"]
["Address","Kings College London\n"]
[null,"Weston Education Centre\n"]
[null,"Cutcombe Road\n"]
["Postcode","SE5 9RJ"]
["Telephone"]
["Email","johnny.downs@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children aged between 5 and 17 who were referred to CAMHS services between January 2008 and December 2013"]
["Description of confidential patient information used","Access was requested to first name, last name, date of birth and address."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","South London and Maudsley NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-03-10"]
["Next Review Date"]
["Notes","Applicant confirmed in June 2023 that ‘s251’ support can be expired, as all identifiable patient information held without consent under this support has been pseudonymised.\n\nWith regards to public benefit, applicants have published and presented on preliminary findings on educational predictors of self-harm and the educational patterns that signal children with depression. Results have been provided and discussed with local providers and commissioners, which has highlighted the gaps in their current understanding of mental health needs and patterns in their areas. For example, presentations of the work to the South East London Sustainability and Transformation Partnership, lead to a number of discussions on how the public health data on self-harm were a significant underestimate compared to the data. Applicants continue to develop results from the linked data which are helping shape policy. A next phase of work is planned to examine how applicants can provide predictive models on liability for ADHD, ASD and other neuropsychiatric disorders.\n\nApplication considered at CAG meeting on 09/01/2014.\n\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 25 February 2014.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Arrangements at DfE confirmed as satisfactory on 13 November 2013.\n\n"]

{"sheet":"A0049","index":30,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0049"]
["Reference","CAG 9-08(b)/2013"]
["Other Refs","CAG 9-08(b)/2014"]
["Application Title","Linkage of readmissions to birth data"]
["Application Summary","This application from City, University of London set out the purpose of creating a research database which could be accessed by other researchers using the Office of National Statistics Virtual Microprocessor Laboratory (ONS VML). The database would be used for analyses relating to inequalities in the outcome of pregnancy and inform maternity service users about the outcome of midwifery, obstetric and neonatal care.\n\nA recommendation for class 4, 5 and 6 support was requested to cover access to birth and death registration data, HES maternity data, PEDW data and Wales Child Health System data.\nThe application sought to amend an existing application, PIAG 2-10(g)/2005 National Gestational Age Statistics, to include HES records of babies and mothers admitted or readmitted to hospitals in England in the first year following birth and PEDW records of babies admitted or readmitted in the first year following birth. Linkages would take place with the HSCIC and ONS.\n"]
["Applicant Organisation Name","City, University of London"]
["Contact Name","Professor Alison Macfarlane"]
["Address","City, University of London"]
[null,"1, Myddelton Street"]
[null,"London"]
["Postcode","EC1R 1UW"]
["Telephone","0207 040 5832"]
["Email","A.J.Macfarlane@city.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","babies and mothers admitted or readmitted to hospitals in England in the first year following birth"]
["Description of confidential patient information used","Access was requested to date of birth, date of death and postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Office of National Statistics"]
["Status","Supported"]
[]
["Outcome Date","2014-03-17"]
["Next Review Date","2024-03-17"]
["Notes","Application considered at CAG meeting on 09/01/2014.\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 27/02/2014.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 01/11/2013.\n\n3. Provision of patient information materials. Patient information poster received.\n\n4. The application does not currently include PEDW data. \n"]

{"sheet":"A0050","index":31,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0050"]
["Reference","CAG 9-08(c)/2014"]
["Other Refs"]
["Application Title","MesobanK Retrospective Sample Collection"]
["Application Summary","This application from Papworth Hospital NHS Foundation Trust set out the purpose of carrying out a retrospective biospecimen collection to be undertaken to gather formalin fixed paraffin embedded samples from approximately 1000 patients with proven mesothelioma. Tissue samples would then be used to prepare tissue microarrays (TMAs) to provide a valuable resource for researchers working in the area of mesothelioma.\nA recommendation for class 1, 4 and 6 support was requested to cover access to data in relation to samples of mesothelioma tumours from 10 Pathology departments throughout the UK (around 100 patients). Support was requested to allow the transfer of confidential patient information in relation to deceased patients to NHS staff at Papworth Hospital NHS Trust. This identifiable data would then be used to request data from the National Cancer Registration Service.\n\n"]
["Applicant Organisation Name","Royal Papworth Hospital NHS Foundation Trust\n"]
["Contact Name","Professor Robert Rintoul, Lead Clinician for Cancer, Chief Investigator MesobanK "]
["Address","Royal Papworth Hospital NHS Foundation Trust\n"]
[null,"Papworth Road\n"]
[null,"Cambridge Biomedical Campus, Cambridge\n"]
["Postcode","CB2 0AY"]
["Telephone","01223 639 582   "]
["Email","robert.rintoul@nhs.net"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with samples of mesothelioma tumours from 10 Pathology departments throughout the UK (around 100 patients)"]
["Description of confidential patient information used","name, NHS number, date of birth, date of death."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Papworth Hospital NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2014-05-07"]
["Next Review Date","2024-05-07"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source National Cancer Registration and Analysis Service (NCRAS)\n\nApplication considered at CAG meeting on 09/01/2014.\nSpecific conditions of support\n1. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed.\n"]

{"sheet":"A0051","index":32,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","0051"]
["Reference","CAG 9-08(d)/2014"]
["Other Refs","CAG 9-08(d)/2013"]
["Application Title","BioAID Version 1"]
["Application Summary","This application from University College London set out the purpose of establishing a registry of 10,000 episodes in unselected adult infectious diseases across the major biomedical research centres (emergency department or acute admissions unit) within the NHS. Confidential patient information would be linked with samples that would be used to investigate the patient’s genetic profile.\nA recommendation for class 3 and 6 support was requested to allow researchers access to confidential patient data in order to approach patients for consent across 5 centres. Consent would be obtained whilst the patient was still in hospital.\n"]
["Applicant Organisation Name","\nUniversity College London\n"]
["Contact Name","Dr Mahdad Norsadeghi"]
["Address","Gower Street\n"]
[null,"London\n"]
[]
["Postcode","WC1E 6BT"]
["Telephone"]
["Email","saadia.rahman@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","10,000 episodes in unselected adult infectious diseases across the major biomedical research centres (emergency department or acute admissions unit) within the NHS. "]
["Description of confidential patient information used","Access was requested to name, address, date of birth, date of death, hospital number."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Supported"]
[]
["Outcome Date","2014-02-28"]
["Next Review Date","2025-02-24"]
["Notes","Application considered at CAG meeting on 09/01/2014.\n\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee, including specific views in relation to the issue about approaching next of kin highlighted above. Confirmed 18 February 2014. The REC raised no concerns relating to who would approach the next-of-kin as long as it was handled sensitively.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 13 December 2013.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0054","index":33,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0054"]
["Reference","CAG 10-08(b)/2014"]
["Other Refs"]
["Application Title","Building Blocks 2-6: parenting support to reduce maltreatment"]
["Application Summary","This application from Cardiff University set out the purpose of following up a cohort of 1562 women and children until child reaches age of 6 in order to assess whether Family Nurse Partnership (FNP) reduces maltreatment of children."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Michael Robling"]
["Address","Cardiff University"]
[null,"7th Floor, Neuadd Meirionnydd"]
[null,"Heath Park, Cardiff"]
["Postcode","CF14 4YS"]
["Telephone",2920687177]
["Email","roblingmr@cardiff.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants, ages 0 - 30 years"]
["Description of confidential patient information used","Name, NHS number, GP registration and postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University"]
["Status","Expired"]
[]
["Outcome Date","2014-11-06"]
["Next Review Date","N/A"]
["Notes","Application Expired\n\nApplicant confirmed in August 2022 that ‘s251’ support no longer required, as no confidential patient information is retained. \n\nWith regards to public benefit, results add to the evidence base of this international programme, and will inform both UK and beyond policy decisions.\n\nApplication considered at CAG meeting on 06/03/2014\nAmendment request 22/04/2015-The amendment requested support to allow tracing at the HSCIC for those women who withdrew from the trial so that they could be sent further information in relation to follow up and allow data collection in line with the original approval.\nSpecific conditions of support\n\n\n1. Favourable opinion from a Research Ethics Committee. Received 18/03/2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 20/10/2014.\n3. Submission of final copy of patient information letter once available. Submitted.\n4. Confirmation whether it would be possible to include patients that were engaged with FNP but not currently part of the study. It was confirmed that FNP supervisors in West England would be contacted so that FNP graduates could be consulted about the project.\n                                                                                                                                  \nAmended update 24/8/2016: \nIn response to the HSCIC requirements for fair processing, the applicant has produced a new letter for participants to better inform them what will happen to their data. This is to be published on the website and sent to withdrawn participants. The letter is provided for review, and approval is requested to enable the applicant to access HSCIC data.\n2. In order to fully answer the secondary outcome set out in the Protocol – to assess subsequent pregnancies in trial participants – abortion data is to be requested from the DoH. This would enable subsequent pregnancies to be calculated using self-report, HES data and abortion data, allowing an important outcome to be measured."]

{"sheet":"A0055","index":34,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0055"]
["Reference","CAG 10-08(c)/2014"]
["Other Refs"]
["Application Title","Intergenerational and lifecourse influences on health and mortality - update"]
["Application Summary","This application from the Institute of Education from the University of London set out the purpose of carrying out further follow up in longitudinal study examining the influence of indicators of health and growth in one generation on the health and growth of the preceding or subsequent generation.\nA recommendation for class 4 and 6 support was requested to cover access to details of cancer registration and mortality from ONS for 18,454 parent cohort members. The cohort members had already been flagged at ONS.\nAccess was requested to cancer registration and mortality data from ONS including name, NHS number, date of birth and date of death."]
["Applicant Organisation Name","University of London"]
["Contact Name","Professor Alissa Goodman\n"]
["Address","Institute of Education\n"]
[null,"University of London\n"]
[null,"20 Bedford Way\n\n\n"]
["Postcode","WC1H"]
["Telephone"]
["Email","P.Shepherd@ioe.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","18,454 parent cohort members"]
["Description of confidential patient information used","name, NHS number, date of birth and date of death."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of London"]
["Status","Supported"]
[]
["Outcome Date","2014-05-12"]
["Next Review Date","2024-05-12"]
["Notes","22 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – cancer registration and ONS mortality data\n\nApplication considered at CAG meeting on 06/03/2014\nSpecific conditions of support\n\n\n1. Favourable opinion from a Research Ethics Committee. Received 18/03/2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 20/10/2014.\n3. Submission of final copy of patient information letter once available. Submitted.\n4. Confirmation whether it would be possible to include patients that were engaged with FNP but not currently part of the study. It was confirmed that FNP supervisors in West England would be contacted so that FNP graduates could be consulted about the project.\n\n"]

{"sheet":"A0057","index":35,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0057"]
["Reference","CAG 1-03(PR1)/2014"]
["Other Refs"]
["Application Title","British Childhood Cancer Survivor Study Case-Control Studies (v1.0)"]
["Application Summary","This application from the University of Birmingham set out the purpose of establishing case-control studies as an extension of the British Childhood Cancer Survivor Study (BCCSS) cohort (Ref: ECC 2-02(f)/2011 - 13/04/2011). The BCCSS is a long-term follow-up (i.e. cohort) study of adult survivors of childhood cancer. The nested case-control studies will focus on the risks of adverse health outcomes, including, but not limited to, cardiac disease, cerebrovascular disease, and subsequent primary neoplasms after childhood cancer and quantify the extent to which these risks are related to previous radiotherapy and chemotherapy given to treat childhood cancer. Approximately 50-70% of all cases and 15-20% of all controls included in the case-control studies are deceased. Medical records of deceased cases and controls would be accessed without consent and consent would not be sought from a legal representative. This submission has been recognised under Proportionate Review Criteria 2 - access to deceased patient data."]
["Applicant Organisation Name","The University of Birmingham"]
["Contact Name","Prof Michael M Hawkins"]
["Address","School of Health & Population Sciences\n"]
[null,"Public Health Building, The University of Birmingham"]
[null,"BIRMINGHAM"]
["Postcode","B15 2TT"]
["Telephone"]
["Email","m.m.hawkins@bham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"□","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Details of those previously diagnosed with childhood cancer (aged 0-15 yrs) in Britain have been ascertained through the population-based National Registry of Childhood Tumours at the University of Oxford."]
["Description of confidential patient information used","Full name, NHS number, Hospital ID, GP Registration, Date of Birth, Date of Death and Postcode and clinical information."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","The University of Birmingham"]
["Status","Expired"]
[]
["Outcome Date","2014-03-11"]
["Next Review Date","NA"]
["Notes","Study completed on 31/03/2019. End of study declared. Processing of CPI is complete. Data controller confirmed support can be expired, and expired on 02 June 2023.\n\nApplication considered at CAG meeting on 10/04/2014\nProvisional approval 11 March 2014.\nSpecific conditions of support\n\n1. Favourable opinion from REC. Confirmed.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 02/06/2014\n"]

{"sheet":"A0058","index":36,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0058"]
["Reference","CAG 1-03(PR2)/2014"]
["Other Refs"]
["Application Title","National Child Development Study The 1958 British Birth Cohort Study"]
["Application Summary","This application is for the National Child Development Study (NCDS), the second of Britain’s world renowned national longitudinal birth cohort studies. It follows all those born in one week in 1958 through the course of their lives, charting the effects of experiences in early life on outcomes and achievements later on. Since 1958 information has been gathered from the cohort on eight occasions. Over time, the scope of enquiry has broadened from a strictly medical focus at birth, to encompass physical and educational development at the age of seven, physical, educational and social development at the ages of eleven and sixteen, and then to include economic development and other wider factors at ages 23, 33, 42, 46 and 50. The age 55 study is currently in the field. Future sweeps of the study are planned to take place every five years.\n \nThe ongoing success of the study depends on maintaining contact with as many study members as possible. Support is requested for two activities which will support this endeavour:\n1) To supply the HSCIC with lists of ‘untraced' cohort members in order that they can be matched with GP registrations and new addresses supplied. These matched individuals will be contacted and invited to continue participating in the study.\n2) To continue to receive notifications from the HSCIC of deaths, embarkations (i.e. emigrations) and exits/entry from the NHS which are used for both tracing and research purposes."]
["Applicant Organisation Name","Institute of Education"]
["Contact Name","Professor Alissa Goodman"]
["Address","Centre for Longitudinal Studies, Institute of Education"]
[null,"20 Bedford Way"]
[null,"LONDON"]
["Postcode","WC1H 0AL"]
["Telephone"]
["Email","a.goodman@ioe.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study is following all those born in Great Britain in one particular week in March 1958."]
["Description of confidential patient information used","Name, NHS Number, date of birth, full address, postcode, date of death and cause of death."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Institute of Education"]
["Status","Supported"]
[]
["Outcome Date","2014-07-18"]
["Next Review Date","2024-07-18"]
["Notes","14 August 2023 - change in data processor from NHS Digital to NHS England regarding address data, and notifications of deaths and embarkations.\n\nAmendment supported 14 August 2023 to receive mortality data from NHS England, including fact, date and cause of death, for everyone who has ever participated in the study, including those who have withdrawn from the study (except where patients have withdrawn from the study and stop usage of their data)\n\n22 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – GP registration, demographics, embarkations (i.e. emigrations) and exits/entry from the NHS,  and ONS mortality data\n\nOctober 2020 – support extended to add IPSOS Mori as a data processor, to provide the entire cohort to NHS Digitial in order for address to be return and notification of an update to electornic storage arrangements at UCL.\n\nOctober 2020 – support to extend to three additional data processors (Copyprint, NatCen and Kantar Public).\n\nApplication considered at CAG meeting on 10/04/2014\nSpecific conditions of support:\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 6 May 2014.\n2. The retention period of identifiable data be reduced to 100 years. It was specified after further correspondence that the retention of unconsented identifiable data could be held up to 100 years with the regular review of the continued need to hold such data and consideration of its destruction. Prior to the retention of identifiable data, beyond 100 years, an external review should be sought from CAG or its contemporary equivalent."]

{"sheet":"A0059","index":37,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0059"]
["Reference","CAG 9-08(e)/2014"]
["Other Refs"]
["Application Title","The EPIC-Norfolk prospective population study"]
["Application Summary","The European Prospective Investigation into Cancer, Nutrition and Chronic Disease in Norfolk (EPICNorfolk) is a population of 25,639 men and women aged 4079 years resident in Norfolk originally recruited between 19931997 as part of a ten country half a million participant collaboration focussing primarily on lifestyle and cancer with the intention and capacity from the outset to examine broader determinants of health and chronic disease. The study was\napproved by the then Norfolk and Norwich Research Ethics committee and ethics approval has been updated throughout the years with new applications for all further participant contacts. All participants attending the baseline health examination provided signed informed consent at inception of the study agreeing to provide lifestyle and health data and biological samples for this study and access to medical records, and again provided signed informed consent for each further attendance at two follow up examinations in 19972000 and in 20062011.\nThey have also completed postal mailed questionnaires. The participants have been followed up to present for health outcomes. The wealth of lifestyle and biological information available collected over two decades of follow up in participants together with the ability to ascertain a large number of relevant health outcomes including mortality by cause, cancer incidence,incident chronic conditions including cardiovascular disease, arthritis, osteoporosis and fractures, functional health including objective cognitive function, physical performance and frailty and visual health and subjective well being means the study is well placed to identify major health issues in an ageing population, determinants and interventions to improve health and prevent disease. There have been over 500 publications from this study, extensive\nparticipant involvement including a Participants Advisory Panel, and results have informed Department of Health public health initiatives, NICE and other clinical and public health policies and guidelines."]
["Applicant Organisation Name","University of Cambridge-Addenbrooke's Hospital"]
["Contact Name","Professor Nick Wareham"]
["Address","University of Cambridge"]
[null,"School of Clinical Medicine Box 285"]
[null,"Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223330315"]
["Email","nick.wareham@mrc-epid.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Female: 40-70 years\n25,639 individuals from the general population in Norfolk\n"]
["Description of confidential patient information used","Access was requested to name, NHS number, date of birth, postcode, gender and occupation. \nAccess to HES data                                                                                                             Amemdment submitted August 2016 for access to Mental Health Data set from HSCIC and data from secondary and tertiary care services, registries and other health data sources (including those held by the Norfolk and Suffolk Foundation Trust)"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Ms Denise Pinto-denise.pinto@admin.cam.ac.uk"]
["Status","Supported"]
[]
["Outcome Date","2014-03-21"]
["Next Review Date","2025-03-21"]
["Notes","30 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), GP data, Office for National Statistics (ONS) mortality data, cancer registration data & National Diabetes Audit (NDA) data\n\n21 March 2022 - Amendment supported\nAmendment supported to include National Diabetes Audit (from NHS Digital) as a data source.\n\nApplication considered at CAG meeting on 09 January 2014.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee (including all patient information leaflets) Confirmed 05/03/2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 02/02/2014\n3. Those participants who have not responded to recent requests should be contacted and informed that their data is still being used and given the opportunity to object prior to further data collection from GP records, HES and in relation to cancer registration. It was confirmed that all remaining participants in EPIC-Norfolk study whether they have or have not responded to recent requests have been posted a brochure about the study which informs them that their data are still used and they are being followed up through medical records. There was an address and FREEPHONE number to contact the study.\n4. Those participants who frequently respond should be informed and given an opportunity to object at the time of next contact. See response to 2 above. In addition, all future contacts with the whole cohort will have each time explicit reference to the continuing use of medical records including GP records, HES and cancer registration and the opportunity to object. Another mailing would be sent this year.\n5. Updated address and mortality data should be requested from the HSCIC to ensure that there is the best possible opportunity that information will reach patients. Updated address and mortality data would be requested from the HSCIC.\n\nAmendment August 2016                                                                                                                     An amendment was submitted requesting permission to extend the approval to allow access to Mental Health Data set from HSCIC and data from secondary and tertiary care services, registries and other health data sources (including those held by the Norfolk and Suffolk Foundation Trust). This was to allow follow up on dementia and cognitive impairment endpoints, which are not recorded in the data sources that are available to the study under the current approvals.  We also requested access to consultant letters that contain relevant health outcome data that is not always included in hospital records.\nConditions                                                                                                                       Support was recommended on the condition that further information was included in the public engagement material so that it was clear to participants that mental health would also be extracted and that opt out was a clear option. (to report back at annual review) "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0061","index":38,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0061"]
["Reference","CAG 1-07(a)/2014"]
["Other Refs"]
["Application Title","Recall and Reoffending Outcomes of Mentally Disordered Offenders (MDOs) after Discharge from a UK Medium Secure Unit"]
["Application Summary","This application from Kent and Medway NHS and Social Care Partnership Trust set out the purpose of a project to provide an examination of factors that influence recall and reoffending rates in mentally disordered offenders (MDOs), to allow for the targeting of resources both prior to discharge and upon discharge."]
["Applicant Organisation Name","Kent and Medway NHS and Social Care Partnership Trust"]
["Contact Name","Dr Lona Lockerbie"]
["Address","Kent and Medway NHS and Social Care Partnership Trust"]
[null,"Trevor Gibbens Unit, Hermitage Lane"]
[null,"Maidstone, Kent"]
["Postcode","ME16 9PH"]
["Telephone","01622 723107"]
["Email","lona.lockerbie@kmpt.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants aged 18 to 90 years"]
["Description of confidential patient information used","Name and date of birth"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Kent and Medway NHS and Social Care Partnership Trust"]
["Status","Supported"]
[]
["Outcome Date","2014-12-08"]
["Next Review Date","2015-12-08"]
["Notes","Application considered at CAG meeting on 10/04/2014.\nConditions of support\n\n1. Please confirm that identifiable NHS data will not be retained by the police. Confirmed\n\n2. Confirmation of satisfactory Information Governance toolkit return.  Confirmed 10/06/2014.\n"]

{"sheet":"A0062","index":39,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0062"]
["Reference","CAG 1-07(b)/2014"]
["Other Refs"]
["Application Title","Yorkshire Specialist Register of Cancer in Children and Young People"]
["Application Summary","This application from the University of Leeds set out the purpose of establishing a research database that would include all individuals aged <30 years diagnosed with a malignant tumour whilst resident in the former Yorkshire and Humber SHA region from 1974 to present day. The database would be used to carry out a programme of epidemiological and applied health research investigating incidence, survival and aetiology of cancer occurring in children and young people."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Richard Feltbower"]
["Address","University of Leeds"]
[null,"Division of Epidemiology and Biostatistics"]
[null,"Worsley Building, Clarendon Way, Leeds "]
["Postcode","LS2 9JT"]
["Telephone","0113 343 4841"]
["Email","R.G.Feltbower@leeds.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","cohort of patients drawn from the Yorkshire Specialist Register of Cancer in Children and Young People.\nAll individuals aged under 30 years diagnosed with a malignant (or benign central nervous system) tumour whilst resident in the area contiguous with the former Yorkshire and the Humber SHA region which existed between 1 July 2006 and 31 March 2013."]
["Description of confidential patient information used","Our work programme for the Yorkshire Register includes an existing research interest and approval to provide linked HES and primary care data. This is to facilitate analyses examining hospital activity and the risks of comorbidities occurring both before and after diagnosis of cancer. Sensitive, identifiable data are needed in order to link electronic HES inpatient\nand outpatient information and primary care data to the cohort of patients drawn from the Yorkshire Specialist Register of Cancer in Children and Young People. Our epidemiological and health services research programme necessitates the use of individual records of NHS activity to examine health usage and in particular describe late effects of cancer treatment in a comprehensive manner suitable for peer review publication."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Leeds"]
["Status","Expired"]
[]
["Outcome Date","2015-08-13"]
["Next Review Date","N/A"]
["Notes","Support continuing under application reference 20/CAG/0133\n\n18 October 2019 – Amendment supported to enable linkage of the Yorkshire Specialist Register of Cancer in Children and Young People to information held by the Department for Education, the Department of Work and Pensions, and Public Health England to enable wider analysis of the impact of childhood cancer to be undertaken. The patients’ full name, date of birth, sex and postcode will be shared with DfE, DWP and PHE in order to facilitate the these linkages.\n\nThe following conditions of support were placed on the outcome of the amendment and feedback is required within six months from the date of this outcome. 01 June 2020 - conditions confirmed as met\n1. Feedback following the planned further patient and public involvement is to be submitted.\n2. The following changes to the poster need to be made;\na. The information given about the study needs to be simplified.\nb. Clear information that patients can opt-out and how to do so needs to be provided.\n3. The three Patient Information leaflets need to be revised as follows;\na. Age appropriate language needs to be used.\nb. The content of each document should to be tailored to ensure they are appropriate to the intended audience.\nc. Clear information that patients can opt-out and how to do so needs to be provided.\n4. A simpler way of finding information on the cancer register on the University of Leeds website needs to be devised.\n\nApplication considered at CAG meeting on 10/04/2014.\nSpecific conditions of support\n1. Continuing satisfactory annual IG Toolkit submission maintained for the duration of this approval\n2. Scope of approval to cover relevant childhood and young adult cases, under the age of 30 years, diagnosed with a malignant (or benign central nervous system) tumour whilst resident in the area contiguous with the former Yorkshire and the Humber SHA region which existed between 1 July 2006 and 31 March 2013.\n3. Provision of approved patient information leaflet incorporating changes indicated on patient objection to be provided to CAG once approved by the REC. \n4. Future annual review reports should be included as part of the overarching Public Health England annual review report submissions (to be provided no later than 12 months from date of final approval). It was advised that discussions take place with Public Health England to ensure this is appropriately incorporated.  \n5. Status of patient involvement activities to be reported against at time of next annual review. \n"]

{"sheet":"A0063","index":40,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0063"]
["Reference","CAG 1-07(c)/2014"]
["Other Refs"]
["Application Title","Long-term effects of whole blood and platelet donation"]
["Application Summary","This application from the University of Cambridge set out the purpose of establishing a large population research dataset involving blood donors enrolled with NHS Blood and Transplant. Data from NHS Blood and Transplant (NHSBT) would be linked to variety of health data. The project aims to evaluate claims about the possible risk and benefits of frequent blood donation. The application detailed a pilot activity only at this stage."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Emanuele Di Angelantonio"]
["Address","University of Cambridge Department of Public Health and Primary Care"]
[null,"Strangeways Research Laboratory"]
[null,"Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone",1223748659]
["Email","ed303@medschl.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants aged 18 years and above"]
["Description of confidential patient information used","Participant's Hospital Episode Statistic data as well as Office for National Statistics death records from 2002 onwards\n"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Supported"]
[]
["Outcome Date","2014-11-19"]
["Next Review Date","2024-11-19"]
["Notes","5 February 2024 - change in data processors from NHS Digital to NHS England, regarding data source - civil registration mortality data. \n\nRegister updated Feb 2017\n\nApplication considered at CAG meeting on 10/04/2014.\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 25/09/2014.\n2. Consent must be obtained for prospective data collection and members advised that patient information leaflets should be updated to ensure that users of NHSBT were fully informed of the potential uses of data.\n3. Support is for the pilot activity and to link to HES-ONS linked data only, additional applications should be made for further linkages.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0064","index":41,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0064"]
["Reference","CAG 2-03(PR4)/2014"]
["Other Refs"]
["Application Title","1970 British Cohort Study"]
["Application Summary","This application is for the 1970 British Cohort Study, which is the third of Britain’s world renowned national longitudinal birth cohort studies. It follows all those born in a particular week in 1970 throughout their lives, charting the effects of events and circumstances in early life on outcomes and achievements later on. The study is run by the Centre for Longitudinal Studies (CLS), at the Institute of Education, University of London and funded by the Economic and Social Research Council.\n\nSince 1970 there have been eight attempts to gather information from the whole cohort. Over time, the scope of enquiry has broadened from a medical focus at birth, to encompass physical and educational development at the age of five, physical, educational and social development at the ages of ten and sixteen, and then to include economic development and other wider factors at ages 26, 30, 34, 38 and 42. Future sweeps of the study will take place every 45 years.\n\nThe ongoing success of the study depends on maintaining contact with as many study members as possible. The purpose of this application is to request Section 251 support for two activities which will support this endeavour.\n1) To supply the HSCIC with lists of ‘untraced' cohort members in order that they can be matched with GP registrations and new addresses supplied. These matched individual would then be contacted and invited to continue their participation in the study.\n2) Receive notifications from the HSCIC which inform us of deaths, embarkations (i.e. emigrations) and exits/entry from the NHS which are used for both tracing and research purposes.\nAmendment 25 June 2015: The amendment is approved in relation to the changes in data controller and processor, subject to compliance with the standard and specific conditions of approval.\nAmendment 25 June 2015: The amendment is conditionally approved in relation to Age 46 Survey, subject to compliance with the standard and specific conditions of approval.\nAmendment 15 December 2015: The applicant submitted an amendment request to advise of a change in data controller and that the invitation letters to the patient cohort will be sent by an external contractor which had been appointed since the original application was submitted. \nThe applicant noted that as of the 2nd December 2014, the Institute of Education (IOE) joined with University College London (UCL) as a single faculty school, to be known as the UCL Institute of Education. The applicant confirmed that the data controller for the 1970 British Cohort Study was UCL. \nThe applicant confirmed that the original application did not state who would send the invitations but had now contracted an external supplier as a Data Processor to carry out the survey fieldwork for the Age 46 survey. Invitations will be sent to study members (including those who have been traced via the NHSCR) asking them to participate in the Age 46 survey – these invitations will be sent via letter and email and will be sent by National Centre for Social Research (NatCen).   \nThe applicant also confirmed that Nurse Interviewers working for NatCen would visit consenting study members in their home in order to conduct an interview and a range of assessments and measurements. \n"]
["Applicant Organisation Name","Centre for Longitudinal Studies, UCL Institute of Education"]
["Contact Name","Dr Alice Sullivan"]
["Address","Centre for Longitudinal Studies"]
[null,"UCL Institute of Education"]
[null,"20 Bedford Way, London\n"]
["Postcode","WC1H 0AL"]
["Telephone","0207 6126661"]
["Email","a.sullivan@ioe.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study is following all those born in Great Britain in one particular week in April 1970."]
["Description of confidential patient information used","Name, NHS number, date of birth, full address and postcode."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","UCL Institute of Education"]
["Status","Supported"]
[]
["Outcome Date","2014-05-01"]
["Next Review Date","2024-05-01"]
["Notes","14 August 2023 - change in data processor from NHS Digital to NHS England regarding address data, and notifications of deaths and embarkations.\n\nAmendment supported 14 August 2023 to receive mortality data from NHS England, including fact, date and cause of death, for everyone who has ever participated in the study, including those who have withdrawn from the study (except where patients have withdrawn from the study and stop usage of their data)\n\n24 April 2023 - change in data processor from NHS Digital to NHS England, regarding GP registrations, addresses, deaths, and embarkation data.\n\nOctober 2020 – support extended to add IPSOS Mori as a data processor, to provide the entire cohort to NHS Digitial in order for address to be return and notification of an update to electornic storage arrangements at UCL.\n\nOctober 2020 – support to extend to two additional data processors (NatCen and Kantar Public).\n\nThis application was considered on 7 April 2014.\n\nSpecific conditions of support\n1. Confirmation of suitable security arrangements via IG Toolkit submission, Confirmed 1 May 2014.\n\n12 August 2021 - amendment supported to allow the 1970 British Cohort Study to receive mortality data, including patients’ cause of death, from NHS Digital\n\n"]

{"sheet":"A0065","index":42,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0065"]
["Reference","CAG 2-07(a)/2014"]
["Other Refs"]
["Application Title","The AKKORD Study of Outreach in Acute Kidney Injury"]
["Application Summary","This application from Heart of England NHS Foundation Trust set out the purpose of a study to assess the impact of an outreach service. Data was requested in relation to a group of intervention and control patients identified by the same laboratory and treated at Birmingham Heartlands Hospital, Solihull Hospitals and Good Hope Hospital."]
["Applicant Organisation Name","Heart of England NHS Foundation Trust"]
["Contact Name","Dr Mark Thomas"]
["Address","Heart of England NHS Foundation Trust"]
[null,"Birmingham Heartlands Hospital"]
[null,"Birmingham"]
["Postcode","B9 5SS"]
["Telephone",1214243156]
["Email","Mark.thomas@heartofengland.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Femail aged 18yrs and above"]
["Description of confidential patient information used","Name, date of birth, Hospital ID, NHS number, postcode and date of death."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Heart of England NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2014-09-17"]
["Next Review Date","2015-09-17"]
["Notes","Application considered at CAG meeting on 15/05/2014.\nSpecific conditions of support\n\n1. Favourable opinion from a research ethics committee. Confirmed 12 June 2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 16 September 2014.\n"]

{"sheet":"A0067","index":43,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0067"]
["Reference","CAG 2-07(c)/2014"]
["Other Refs"]
["Application Title","Impact of earlier diagnosis of intracranial tumours in children"]
["Application Summary","This application from the University of Nottingham set out the purpose of a study to investigate the role of a symptom awareness campaign (Headsmart) in reducing delays and improving outcomes. An evaluation of the impact in population health would be undertaken by examining annual changes in survival in children and young adults with intracranial tumour and investigating the relationship between diagnostic delay, survival and prevalence of functional deficits such as vision impairment.\nA recommendation for class 4, 5 and 6 support was requested to cover access to data from the cancer registry in relation to patients aged 0-24 who had been diagnosed with an intracranial tumour. This data would then be supplemented with data on primary (CPRD)\nand secondary care presentations, specialist referrals, neuroimaging and vision impairment. Data would be processed at the London School of Hygiene and Tropical Medicine (LSHTM)."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor David Walker\n"]
["Address","University of Nottingham\n"]
[null,"Children’s Brain Tumour Research Centre\n"]
[null,"Queen’s Medical Centre, Nottingham\n"]
["Postcode","NG7 2UH"]
["Telephone","0115 823 0632"]
["Email","david.walker@nottingham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 0-24 who had been diagnosed with an intracranial tumour."]
["Description of confidential patient information used","Access was requested to NHS number, date of birth, date of death and postcode."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Nottingham University Hospitals NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-06-25"]
["Next Review Date","N/A"]
["Notes","Expired on 15/11/2018\n\nApplication considered at CAG meeting on 16/05/2014.\nSpecific conditions of support\n1. Favourable opinion from a research ethics committee. Received.\n2. Confirmation of suitable security arrangements via IG Toolkit submission for those organisations processing identifiable data. Confirmed for LSHTM on 29/05/2014.\n"]

{"sheet":"A0068","index":44,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0068"]
["Reference","CAG 3-02(a)/2014"]
["Other Refs","IRAS: 153311"]
["Application Title","Long-term follow-up of ARTISTIC cervical screening trial cohort"]
["Application Summary","The ARTISTIC trial compared cytology with and without HPV testing among 24,510 women attending for routine cervical screening in 2001-04. This project is an epidemiological follow-up based on their history of HPV infection and cytological abnormality, irrespective of their initial random allocation. Women were followed to 2009 through the two local participating cytology laboratories for cytology and histology. Additional linkages to Open Exeter and pathology reports were now required in order to obtain complete cytological follow-up by linkage to NHS cervical screening call-recall records."]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Professor Julian Peto"]
["Address","NCDE"]
[null,"Keppel Street"]
[null,"London"]
["Postcode","WC1E 7HT"]
["Telephone","02079272632"]
["Email","julian.peto@lshtm.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","24510 women aged 20-64 undergoing routine cervical screening in 2001-4 were originally recruited if they agreed for their LBC cervical samples to be tested for HPV infection, to be followed for 2 screening rounds of cytology and HPV testing, and to be randomised for the HPV results to the revealed or concealed. Passive follow-up will be restricted to women with known NHS number."]
["Description of confidential patient information used","NHS number, date of birth, date of death, post code."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Supported"]
[]
["Outcome Date","2014-08-21"]
["Next Review Date","2024-08-21"]
["Notes","01 August 2023 - change in data processor from NHS Digital to NHS England regarding cancer registrations, ONS Mortality data, and linkage to Open Exeter records regarding full cervical screening\n\nAmendment Request (Approved 12/1/2018)\nSupport is in place for the applicants to flag for current patient status on cancer registrations and death data via NHS Digital and ONS and linkage vis NHS Digital to Open Exeter records to obtain full cervical screening history. This amendment requests an extension to flag patients with locally collected cervical screening records from histology, virology and cytology laboratories and data from colposcopy clinics.\n\nApplication considered at CAG meeting on 16/05/2014.\nSpecific conditions of support\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 07/07/2014\n2. Confirmation of a favourable opinion from a research ethics committee. Confirmed.\n3. Confirmation of what efforts will be made to inform participants in line with the comments above. Confirmed that details would be made available on LSHTM website and further details of this would be provided in September 2014.\n"]

{"sheet":"A0070","index":45,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0070"]
["Reference","CAG 3-02(c)/2014"]
["Other Refs"]
["Application Title","POEM"]
["Application Summary","This application from Royal Berkshire NHS Foundation Trust set out the purpose of a study to determine the factors that lead to failure to assess pain and provide timely pain relief and to assess the adequacy of pain management in consecutive patients presenting to emergency departments within the Thames Valley with confirmed breaks or dislocations to either the arms or legs. The data may highlight factors associated with failure to provide timely pain relief in the population."]
["Applicant Organisation Name","Royal Berkshire NHS Foundation Trust"]
["Contact Name","Dr James Sheehan"]
["Address","Royal Berkshire NHS Foundation Trust"]
[null,"London Road"]
[null,"Reading"]
["Postcode","RG1 5AN"]
["Telephone"]
["Email","James.sheehan@royalberkshire.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants"]
["Description of confidential patient information used","Access to hospital ID and postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Royal Berkshire NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2014-11-19"]
["Next Review Date","2017-11-19"]
["Notes","Amendment request 30/12/2016\nNew sites were to be added for data collection – since the study was adopted onto the NIHR Portfolio, other sites had expressed an interest in providing information for the study, and a larger sample size was required due to the development of new outcome measures (reflecting new information from the pilot study) Procedures for data processing remained the same.\nFollowing on from the addition of new sites, an extra step was proposed to the data flow, to enable the sponsor site to query incomplete or inaccurate data. Different sites would now be finishing data collection at different times, and the data checking was more effective the sooner it was completed following data collection. Therefore, sites that had already completed data collection would send their database to the Royal Berkshire Hospital for review. Incomplete or anomalous data would be recorded and a list of data queries returned to the sites for review. After receiving from each site the final ‘completed database’ within 8 weeks of data queries being sent, identifiable information would be removed                                                           Specific conditions of support 30/12/2016\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Provided via email from John Brent, HSCIC on 7 July 2016.\n2. Confirmation of a favourable opinion from a Research Ethics Committee. Letter provided by the applicant on 23 December 2016                                                                                      Application considered at CAG meeting on 16/05/2014.\n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed for Royal Berkshire Hospital 11 November 2014.\n3. Confidential patient information must not be disclosed to the University of Reading until confirmation of satisfactory security arrangements is provided.\n4. Please submit copies of posters once available. \n5. Please provide a signed or electronically validated copy of the IRAS application form. Submitted\n\n"]

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[]
[]
["Application Number","0072"]
["Reference","CAG 4-03(PR2)/2014"]
["Other Refs"]
["Application Title","Prehospital Recognition of Sepsis by Ambulance Clinicians (PRoSAiC)"]
["Application Summary","This application from the University of Warwick is to produce a ‘tool’ to allow ambulance staff/paramedics to identify patients with sepsis so that they can be prioritised for treatment on reaching the Emergency Department. The data will be obtained retrospectively only from the West Midlands Ambulance Service NHS Foundation Trust and University Hospital North Staffordshire NHS Foundation Trust, the applying body being Warwick Medical School, Clinical Trials Unit."]
["Applicant Organisation Name","University of Warwick "]
["Contact Name","Mr Michael Smyth"]
["Address","Warwick Clinical Trials Unit"]
[null,"Gibbett Hill Rd"]
[null,"Coventry"]
["Postcode","CV4 7AL"]
["Telephone","02476528039"]
["Email","m.a.smyth@warwick.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult patients aged 18 and above attending emergency department by ambulance for a medical cause"]
["Description of confidential patient information used","Name, hospital number, date of birth, gender and unit level postcode."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Warwick "]
["Status","Expired"]
[]
["Outcome Date","2014-09-09"]
["Next Review Date","N/A"]
["Notes","All patient identifiers were deleted by November 2014.\n\nPatient identifiable data were used in this study to link ambulance and hospital data sets. The combined datasets were used to develop the SEPSIS score to identify patients at risk of death from sepsis. This score has been tested in subsequent studies, but has not yet been used in clinical practice.\n\nApplication considered at CAG meeting on 19/06/2014.\n\nSpecific conditions of support\n\n1. Provision of patient information leaflets that reference patients’ right to opt-out of their data being included within this project. Received 1 August 2014.\n2. Receipt of a fully authorised/signed NIGB Form based on the draft form submitted as part of the application with confirmation that there have been no further changes to the NIGB form other than the authorisations of the Declarations. Received 1 August 2014.\n3. Confirmation that West Midlands Ambulance Service NHS Foundation Trust includes the use of data for research purposes within their ICO Data Protection Registration prior to the start of the research activity. Received 1 August 2014.\n4. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here. Confirmed 1 August 2014.\n"]

{"sheet":"A0073","index":47,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0073"]
["Reference","CAG 4-03(PR3)/2014"]
["Other Refs"]
["Application Title","GlyCon: Glycaemic Control of Stress Hyperglycaemia Implemented in NHS Intensive Care Units"]
["Application Summary","This application from the University of Nottingham set out the purpose of a retrospective review of medical records and anonymised data extraction from seven sites based a selection of patients identified from the Intensive Care National Audit & Research Centre database.\n\nRecords will include observation charts, patients’ notes, and the Case Mix Programme (CMP) database of the Intensive Care National Audit & Research Centre (ICNARC), among others. Data collected will include baseline characteristics, data about glycaemic monitoring and treatment, and outcome data. The primary outcome measure will be the effectiveness of the methods for glycaemic control implemented, measured as the proportion of time spent within the glycaemic range 4-10 mmol/L. Secondary outcomes will be other measures of effectiveness, efficiency and safety. The degree of staff adherence to the specific recommendations of the protocols will also be explored.\n\nThe main aim of GlyCon is to explore the associations between the methods for glycaemic control of stress hyperglycaemia implemented in 7 NHS ICUs of a network of ICUs, and the time that their patients spend within pre-specified glycaemic ranges."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Ms María del Rocío Fernández Méndez"]
["Address","B33, Postgraduate Office, B Floor, Medical School"]
[null,"The University of Nottingham, Queen's Medical Centre"]
[null,"Nottingham"]
["Postcode","NG7 2HA"]
["Telephone","07435 368265"]
["Email","ntxmdf@nottingham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients satisfying all of the following criteria will be included in the study:\n* Age: 18 and above years old;\n* Level 3 of care, defined as need for either advanced respiratory support alone, or support of at least two organ systems;\n* Length of stay in ICU of at least 48 hours;\n* Having had at least one glycaemic measurement above 10 mmol/L during the first 24h of admission. \nPatients satisfying any of the following criteria will be excluded from the study:\n* Pregnant women;\n* Patients with any of the following primary or secondary reasons for admission: Cardiac Surgery; Diabetic Ketoacidosis and Hyperosmolar Coma (diabetic emergencies); insulinoma and islet cell transplant."]
["Description of confidential patient information used","NHS number, hospital number, date of birth (as age), date of death (as survival time from admission), ethnicity, admission and discharge dates and sex."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Nottingham"]
["Status","Supported"]
[]
["Outcome Date","2014-07-10"]
["Next Review Date","2015-07-10"]
["Notes","Application considered at CAG meeting on 19/06/2014.\nHealth Research Authority approval decision\n\nThe Health Research Authority, having considered the advice from the Confidentiality Advisory Group as set out below, has determined the following:\n\n1. The application is approved, subject to compliance with the standard and specific conditions of approval.\n\nThis letter should be read in conjunction with the outcome letter dated 19 May 2014.\n"]

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[]
[]
["Application Number","0074"]
["Reference","CAG 4-03(PR4)/2014"]
["Other Refs"]
["Application Title","Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM)"]
["Application Summary","This application from Southampton University Hospitals NHS Foundation Trust set out the purpose of tracing current names and addresses of members of the EuroPrevall and the Cork BASELINE birth cohorts. The EuroPrevall birth cohort (‘The prevalence, cost and basis of food allergy in Europe’) enrolled 12,049 new-borns between 2005 and 2010 in nine countries and traced development of food allergy over the first 30 months of life; the Cork BASELINE birth cohort (‘Babies After SCOPE: Evaluating the Longitudinal Impact using Neurological and Nutritional Endpoints’) enrolled approximately 2000 new-borns between 2008 and 2011 and traced health status over the first 24 months.\n\nContact will be made regarding a clinical follow-up to re-assess the cohorts at 5-10 years of age. Follow up is comprised of collecting data on family background and allergic diseases through online questionnaires, clinical investigation with a focus on skin status, skin prick testing, determination of specific Immunoglobulin against common food and inhalant allergens, and collection of DNA. Suspicion of food allergy is further evaluated with standardized double-blind, placebo-controlled food challenges. All data will be stored in the Allergelab database to facilitate complex data analysis in a professionally networked environment.\n\nThe main goal of this project is to trace new onset of food allergy and clinical evolution of already established food allergy, determining frequencies and patterns of tolerance development. Influence of environmental and behavioural factors (e.g. diet, feeding practices) will be investigated. Secondary outcomes cover asthma, allergic rhinitis and eczema. This application covers the follow up of the UK part of the Europrevall cohort."]
["Applicant Organisation Name","Southampton University Hospitals NHS Foundation Trust"]
["Contact Name","Professor Graham Roberts"]
["Address","Southampton University Hospitals NHS Foundation Trust"]
[null,"Southampton General Hospital, Tremona Road"]
[null,"SOUTHAMPTON"]
["Postcode","SO16 6YD"]
["Telephone","023 8120 6160"]
["Email","g.c.roberts@soton.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All participants of the two birth cohorts EuroPrevall and BASELINE are the target population."]
["Description of confidential patient information used","Name, NHS number, hospital number, Date of Birth and unit level postcode."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Southampton University Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-07-09"]
["Next Review Date","N/A"]
["Notes","Identifiable patient information was used to contact potential participants in a follow up of a birth cohort. Where they did not consent to be involved their information was destroyed.\n\nThe CAG approved process allowed us to contact more of the original cohort thereby increasing the numbers included in the follow up. With greater follow up, the data and findings are much more impactful.\n\nApplication considered at CAG meeting on 19/06/2014.\n\n1. Favourable opinion from REC Received 12/06/2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 02/07/2014.\n"]

{"sheet":"A0075","index":49,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0075"]
["Reference","14/CAG/1001"]
["Other Refs"]
["Application Title","Critical Care Health Informatics Collaborative"]
["Application Summary","This application detailed the establishment of a research database including clinical, laboratory and demographic data in relation to all patients admitted to Adult Critical Care Units across 5 NHS Trusts.\nAn application for support under class 1, 2, 4 and 6 was received to allow access to data from hospital systems and Hospital Episode Statistics (HES) data from the Health and Social Care Information Centre (HSCIC)."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Mervyn Singer"]
["Address","University College London"]
[null,"Wolfson Institute of Biomedical Research"]
[null,"Gower Street"]
["Postcode","WC1E 6BT"]
["Telephone","0207 679 6714"]
["Email","m.singer@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data will be collected automatically from all patients on the participating critical care units. The data will be extracted from existing databases"]
["Description of confidential patient information used","NHS number, date of birth, postcode and gender were requested in order to carry out linkages to HES data."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2015-11-25"]
["Next Review Date","N/A"]
["Notes","Now operating under CAG reference 14/CAG/1012\n\n01 November 2019: Amendment supported to add the following two new data sources into the scope of the application activity: Royal Marsden NHS Foundation Trust and University Hospitals Bristol NHS Foundation Trust. These sites would disclose the same dataset, including items of confidential patient information, into the research database as was currently supported for the wider five named sites providing data. \n\nApplication was initial considered at CAG meeting on 19/06/2014.\nThis application was considered again on 28 August 2014."]

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[]
[]
["Application Number","0076"]
["Reference","14/CAG/1002"]
["Other Refs"]
["Application Title","ALTER10 Study v1.0"]
["Application Summary","This application from Newcastle Upon Tyne Hospitals NHS Foundation Trust detailed a study to identify the significance of a minimally abnormal result of a liver blood test and to identify if this abnormality was associated with an increased risk of mortality due to liver disease of cardiovascular disease at 10 years. In addition, the study hoped to identify whether a minimally abnormal result of a liver blood test was associated with an increased incidence of significant liver disease, type 2 diabetes and cardiovascular disease.\n\nAmendment 16/07/2015-An amendment request was submitted to extend the duration of the study until 31st December 2015. It was noted that due to unexpected delays data analysis will not be complete before the original annual review date of 31st July 2015.\n\nAmendment 09/06/2016 - An amendment request was submitted to extend the duration of the study until 31st December 2016. It was noted that due to unexpected delays data analysis will not be complete before the annual review date of 31st July 2016."]
["Applicant Organisation Name","Newcastle Upon Tyne Hospitals NHS Foundation Trust"]
["Contact Name","Dr Mark Hudson, Consultant Hepatologist"]
["Address","Newcastle Upon Tyne Hospitals NHS Foundation Trust"]
[null,"Freeman Hospital, Freeman Road, High Heaton,"]
[null,"Newcastle upon Tyne"]
["Postcode","NE7 7DN"]
["Telephone","01912137244"]
["Email","mark.hudson@nuth.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged from 18yrs with incidental finding of minimally deranged ALT in a community\nsetting."]
["Description of confidential patient information used","Name, NHS number, date of birth and date of death would be used to carry out data linkage. Date of birth and death would be retained for analysis purposes."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle Upon Tyne Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-08-15"]
["Next Review Date","N/A"]
["Notes","Expired\n\nCI has retired and the data controller has confirmed in July 2022 that there is no processing of Confidential patient information.    \n\nApplication considered at CAG meeting on 19/06/2014.\nSpecific conditions of support\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 06/08/2014\n2. Confirmation of a favourable Research Ethics Committee opinion. Received 20/05/2014.\n3. Submission of patient information posters and confirmation of arrangements for provision of information to patients, including methods available to object to processing of confidential patient information. Submitted 04/07/2014\n4. Confirmation that GPs will be informed where data is to be collected from GP records. Confirmed.\n"]

{"sheet":"A0077","index":51,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0077"]
["Reference","14/CAG/1003"]
["Other Refs"]
["Application Title","Improving Outcomes from Out of Hospital Cardiac Arrest: The Cardiac Arrest Individual Registry and Outcomes (CAIRO) Programme (Work Package A)"]
["Application Summary","This application from University Hospitals Bristol NHS Trust detailed a research programme designed to monitor and improve patient care from initial ambulance response to cardiac arrest through to hospital discharge and beyond. A comprehensive patient registry, the CAIRO database, would be established to allow linkages to be made from different data sources and to track each cardiac arrest patient from initial collapse through to hospital discharge.\nAmendment approved March 2015  to allow 1) In-hospital research nurses to identify eligible patients, 2) inclusion of retrospective patients who experienced OHCA at any time from confirmation of original REC and CAG approvals and 3) full postcode would be required for linkage purposes.\nAmendment approved 29/07/2015-Amendment to the CAG form: \nThe applicant submitted an amendment request to change details specified within the application, in particular question 45. The applicant requested to add further details to note that it should not be stated that the data stored on University computers will be encrypted, as these data are stored securely on the University server, and will have had all identifiers removed apart from study ID, age, date of death and postcode of OHCA. The applicant added that it should not be possible to identify patients from this data in this context. Data at rest is unencrypted; however, all data in motion is encrypted using SSL.\nAmendments to the protocol (these changes also impact upon various questions within the CAG form)\nSection 4.3.2 \nThe applicant submitted an amendment to the text for the fourth exclusion criteria to clarify what the applicant would do if it is not possible to identify whether or not the OHCA definitely occurred within the North Division of SWAST for example, if a postcode was not available for the incident. \nSections 4.5.2, 5.6, 9.2, 9.5 \nThe applicant submitted an amendment to the text within these sections to clarify that the applicant would only approach survivors that were admitted to one of the 3 hospitals that will be participating in this feasibility study (Bristol Royal Infirmary, Royal United Hospital Bath or Southmead Hospital). The resources would not be available to assess capacity, approach and carry out follow-up for patients who have an OHCA within the eligible geographical area but are subsequently admitted to a different hospital. The initial data collected for these patients will be retained, but no follow-up data will be collected. \nSection 5.3.1 – Table 2 and 5.6 \nThe applicant submitted an amendment to provide clarification regarding which data will be collected for patients that are deceased prior to the study team being able to approach them. \nSection 5.6 \nThe applicant submitted an amendment to include a clause regarding patients who are discharged for palliation. These patients (or their consultees) would not be approached about the study; and again, the initial data collected for these patients would be retained, but no follow-up data would be collected. The applicant considers that it would unnecessary and potentially distressing for the patient and/or their family/friends at an already difficult time. \nSection 11.2.1 \nThe applicant submitted an amendment to add a sentence to clarify that age on day of OHCA, date of death and postcode of OHCA would be transferred to the University of Bristol IT system for analysis, but it should not be possible to identify patients from this data in this context. "]
["Applicant Organisation Name","University Hospitals Bristol NHS Trust"]
["Contact Name","Professor Jonathan Benger, Consultant in Emergency Care"]
["Address","University Hospitals Bristol NHS Trust"]
[null,"Emergency Department, Bristol Royal Infirmary"]
[null,"Bristol"]
["Postcode","BS2 8HW"]
["Telephone","0117 3424363"]
["Email","jonathan.benger@UHBristol.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Access name, NHS number, hospital ID, date of birth and date of death."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University Hospitals Bristol NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2014-09-26"]
["Next Review Date","2016-09-26"]
["Notes","Application considered at CAG meeting on 19/06/2014.\nSpecific conditions of support\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 10/06/2014.\n2. Confirmation of favourable Research Ethics Committee opinion. Confirmed 24 June 2014.\n3. Confirmation of retention period for identifiable data in relation to deceased patients. Identifiable data would be retained for 2 years.\n"]

{"sheet":"A0078","index":52,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0078"]
["Reference","14/CAG/1005"]
["Other Refs"]
["Application Title","Dynamic Risk Factors associated with Mentally Disordered Firesetting within a Mental Health Trust"]
["Application Summary","This application from the University of Kent set out the purpose of a research study which aimed to establish which dynamic risk factors are associated with firesetting recidivism. The results of the study would provide information to aid professionals in the short term assessment of future firesetting behaviours."]
["Applicant Organisation Name","University of Kent "]
["Contact Name","Miss Becky Wyatt"]
["Address","School of Psychology, Keynes College"]
[null,"University of Kent"]
[null,"Canterbury"]
["Postcode","CT2 7NP"]
["Telephone"," 01227 827821"]
["Email","bw269@kent.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Mentally Disordered individuals aged 18 - 99 years\nThe inclusion criteria for the firesetting group are:\n1. The incident form must name a perpetrator (i.e. associated patient) of the deliberate incident of firesetting within the\nincident form.\n2. A date of birth of the patient must be documented within the KMPT IRIS incident form. In the absence of a date of\nbirth, an NHS number will be recorded.\n3. Must have one month of clinical information/data that the researcher is able to extract dynamic variables from.\nTherefore, some incidents recorded within a community setting will have to be excluded. Ideally the patient will have\ndaily progress notes written by a member of the nursing team. The progress notes will include detailed information\nabout dynamic variables that may have been present.\nThe inclusion criteria for the non firesetting control group:\n1. Must have been named as a perpetrator (i.e. associated patient) of the antisocial incident (i.e. incident of violence,selfharm,\nAWOL, use of alcohol/substance) within the incident form.\n2. A date of birth of the perpetrator must be documented within the KMPT IRIS incident form. In the absence of a date of\nbirth, an NHS number will be recorded.\n3. Must have one month of clinical information/data that the researcher is able to extract dynamic variables from.\nTherefore, some incidents recording within a community setting will have to be excluded. Ideally the patient will have\ndaily progress notes written by a member of the nursing team. The progress notes will include detailed information\nabout dynamic variables that may have been present."]
["Description of confidential patient information used"," Name, NHS number and date of birth."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Kent"]
["Status","Supported"]
[]
["Outcome Date","2014-08-06"]
["Next Review Date","2015-08-06"]
["Notes","Application considered at CAG meeting on 19/06/2014.\nSpecific conditions of support\n\n\n1. Favourable opinion from REC. Confirmed 25/06/2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here. Confirmed 10/06/2014\n3. Confirmation that further information about the study would be displayed on hospital website. Confirmed 21/07/2014\n4. Confirmation regarding who will have access to identifiable data. Confirmed that the chief investigator and one research assistant, employed by KMPT, would have access.\n"]

{"sheet":"A0079","index":53,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0079"]
["Reference","14/CAG/1006"]
["Other Refs"]
["Application Title","Millennium Cohort Study"]
["Application Summary","This application from the University of London set out the purpose of carrying out tracing via the Health and Social Care Information Centre for the Millennium Cohort Study (MCS; a continuing, multi-disciplinary, longitudinal study of some 19,000 subjects born in 2000/2001."]
["Applicant Organisation Name","University of London"]
["Contact Name","Professor Emla Fitzsimons"]
["Address","Centre for Longitudinal Studies, Institute of Education"]
[null,"20 Bedford Way"]
[null,"London"]
["Postcode","WC1H 0AL"]
["Telephone","02076126900"]
["Email","e.fitzsimons@ioe.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," A random sample of all of those born in England and\nWales between 1 September 2000 and 31 August 2001 who had previously been recurited into the study."]
["Description of confidential patient information used","1) Tracing via the NHS Central Registry\nIf granted support, CLS would periodically supply the HSCIC with a list of the cohort members who are currently 'untraced' so that these could be matched with GP registrations on the NHS Central Registry so that their addresses could be supplied to us. We would then use these addresses to contact individuals and invite them to reengage with the study.\n2) Notifications from the HSCIC\nStudy members are flagged on the NHS Central Registry and the HSCIC currently send notifications to CLS which inform us of deaths, exits from and entry to the NHS and embarkations (e.g. emigrations). We understand that recent changes in the law mean that Section 251 support will be required for us to continue to receive these notifications\nwithout the consent of study members. This information is required so as to prevent us from continuing to attempt to make contact with study members who have died or moved out of the UK."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of London"]
["Status","Supported"]
[]
["Outcome Date","2014-08-14"]
["Next Review Date","2024-08-14"]
["Notes","14 August 2023 - change in data processor from NHS Digital to NHS England regarding address data, and notifications of deaths and embarkations.\n\nAmendment supported 14 August 2023 to receive mortality data from NHS England, including fact, date and cause of death, for everyone who has ever participated in the study, including those who have withdrawn from the study (except where patients have withdrawn from the study and stop usage of their data)\n\nOctober 2020 – support extended to add NatCen and Kantar Public as a data processor, to provide the entire cohort to NHS Digitial in order for address to be return and notification of an update to electronic storage arrangements at UCL.\n\nOctober 2020 – support to extend to two additional data processors (IPSOS Mori and Copyprint).\n\nApplication considered at CAG meeting on 19 June 2015.\nSpecific conditions of support\n\n1. Please ensure that parents and children are informed (through annual letters, websites or other means) about follow up of address and data of death with clear means of registering any objection. Confirmed.\n\n2. Tracing via the HSCIC should take place only where individuals cannot be traced using the pupil database. Confirmed.\n\n3. Linkage to DWP data should only be with specific consent from individuals. Confirmed.\n\n4. Confirmation of suitable security arrangements via IG Toolkit submission. 31 March 2014.\n\n5. Confirmation of a favourable REC opinion letter. 17 June 2014\n\n12 August 2021 - amendment supported to allow the Millennium Cohort Study to receive mortality data, including patients’ cause of death, from NHS Digital. \n"]

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[]
[]
["Application Number","0081"]
["Reference","14/CAG/1010"]
["Other Refs"]
["Application Title","Neonatal Exchange Blood Transfusion (EBT)"]
["Application Summary","Exchange blood transfusion is an emergency treatment for a very high or rapidly rising jaundice level that is not responding to treatment with phototherapy (UV light treatment). Due to a decreased incidence of haemolytic disease of the newborn, fewer exchange transfusions are now performed. There is concern that the expertise of doctors in performing this procedure is declining. Hence, it is important to establish what the current incidence, difficulties and risks of this relatively uncommon procedure are. NHS Blood and Transplant (NHSBT) also support this study as it will help inform future decisions as to the best way to provide red blood cells for neonatal exchange blood transfusion."]
["Applicant Organisation Name","Central Manchester University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Ruth Gottstein"]
["Address","Consultant Neonatologist"]
[null,"Central Manchester University Hospitals NHS Foundation Trust"]
[null,"NICU, St Mary’s Hospital, Oxford Road, Manchester"]
["Postcode","M13 9WL"]
["Telephone","0161 276 6857"]
["Email","Ruth.Gottstein@cmft.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Newborn infants from 0 - 28 days undergoing a neonatal exchange blood transfusion"]
["Description of confidential patient information used","NHS and hospital numbers, date and time of birth, date of death (if applicable), sex and ethnicity, gestational age and birth weight"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Central Manchester University Hospitals NHS Foundation Trust "]
["Status","Supported"]
[]
["Outcome Date","2014-10-21"]
["Next Review Date","2015-10-21"]
["Notes","Application considered at CAG meeting on 30/06/2014\n\nSpecific conditions of support\n\n1. The provision of a listing of the retention period for all identifiers. It was confirmed that data would be retained until publication to ensure that checks could be carried out. This could be for up to 4 years.\n2. Confirmation that participant objections will be respected and how this will be performed. Confirmed, revised public information leaflet provided.\n3. Favourable opinion from REC. Received 09/06/2014.\n4. Confirmation of suitable security arrangements via IG Toolkit submission for Section 251 purposes. Confirmed 11/07/2014.\n"]

{"sheet":"A0084","index":55,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0084"]
["Reference","14/CAG/1013"]
["Other Refs"]
["Application Title","A feasibility study of case-finding strategies for the detection of Hepatitis B and Hepatitis C in Primary Care"]
["Application Summary","This application from the University of Surrey set out the purpose of a study which aimed to compare three testing strategies compared to usual viral hepatitis testing practice in primary care (GP practices).\nA recommendation for class 1, 4 and 6 support was requested to cover access to confidential patient information from GP practice records by a researcher in order to help with patient identification for the study. MIQUEST queries would be set up to allow the extraction of pseudonymised data for follow up purposes only and a researcher may require access in order to set this up. This would be undertaken only where necessary and requested by GP practices and where possible only pseudonymised data would be provided to the applicant.\nWhere GP practices required help from the researcher to follow-up patients after tests had been completed, it was confirmed patients that would be informed of this and asked for consent. This would be by written or verbal consultation between the GP and patient.\nApproximately 565 patients would be included across 10 GP practices."]
["Applicant Organisation Name","University of Surrey"]
["Contact Name","Ms Gill Fairbairn"]
["Address","\nResearch and Enterprise Support"]
[]
[null,"Guildford, Surrey"]
["Postcode","GU2 7XH"]
["Telephone"]
["Email","s.mathew@surrey.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\nfrom 18 years"]
["Description of confidential patient information used","Access was requested to GP records on GP practice sites to allow identification of patients to invite for testing."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","g.fairbairn@surrey.ac.uk"]
["Status","Supported"]
[]
["Outcome Date","2015-01-27"]
["Next Review Date","2016-01-27"]
["Notes","Application considered at CAG meeting on 24/07/2014.\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee Confirmed 25/09/2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 29/12/2014.\n"]

{"sheet":"A0085","index":56,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0085"]
["Reference","14/CAG/1014"]
["Other Refs"]
["Application Title","Clinical presentation of enterovirus infection in children, and disease-causing enterovirus serotypes in the UK."]
["Application Summary","This application from University Hospital Southampton NHS Foundation Trust was for a retrospective study of existing microbiological and clinical data to capture the spectrum of clinical presentation of enterovirus infections in children who have received care at the University Hospital Southampton (UHS) NHS Foundation Trust and describe any associations between enterovirus serotype and clinical presentation. The Applicant also sought to compare local serotype data with national serotype data provided by Public Health England."]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust "]
["Contact Name","Dr Marc Tebruegge"]
["Address","Academic Unit of Clinical & Experimental Sciences, Faculty of Medicine"]
[null,"Tremona Road, Hampshire"]
[null,"Southampton"]
["Postcode","SO16 6YD"]
["Telephone","02381204989"]
["Email","m.tebruegge@soton.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants of 18 years"]
["Description of confidential patient information used","Hospital number, gender and clinical information."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University Hospital Southampton NHS Foundation Trust "]
["Status","Expired"]
[]
["Outcome Date","2014-08-12"]
["Next Review Date","N/A"]
["Notes","All information was taken from the patient files anonymously. The paper is published and contains no identifiable information.\n\nThe paper is published and cited by 35 papers: de Graaf H, Pelosi E, Cooper A, Pappachan J, Sykes K, MacIntosh I, Gbesemete D, Clark TW, Patel SV, Faust SN, Tebruegge M. Severe Enterovirus Infections in Hospitalized Children in the South of England: Clinical Phenotypes and Causative Genotypes. Pediatr Infect Dis J. 2016 Jul;35(7):723-7. \n\nApplication considered at CAG meeting on 28/08/2014.\nSpecific conditions of support\n\n1. Favourable opinion from REC. Confirmed 18/06/2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 08/07/2014.\n"]

{"sheet":"A0086","index":57,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0086"]
["Reference","14/CAG/1015"]
["Other Refs"]
["Application Title","Analysing Emergency and Urgent Care System Demand in Yorkshire and Humber: A data linkage study of pre-hospital and emergency department data."]
["Application Summary","This research application from the University of Sheffield described a study which aimed to utilise routine NHS data from a number of providers of emergency and urgent care in Yorkshire and Humber. The application described linking the data to provide a coherent picture of emergency and urgent care demand for a period of 12 months. The data would be used to map the use of emergency and urgent care services in order to identify pattern of service use and outcome by different patient and demographic groups to identify groups of patients who currently utilised emergency and urgent care services in different ways and who may benefit from an alternative approach to care.\nA request for class 4 and 6 support was made to allow the disclosure of confidential patient information from Yorkshire Ambulance Service and Emergency Department and inpatient Patient Administration System data to researchers within the University of Sheffield"]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Ms Suzanne Mason"]
["Address","Professor of Emergency Medicine"]
[null,"Regent Court, 30 Regent Street"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone","0114 222 0694"]
["Email","s.mason@sheffield.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\n16-100 years - amended 02/02/2017 to include children"]
["Description of confidential patient information used","Confidential patient information from the Yorkshire Ambulance Service and a number of NHS Trusts was requested in relation to patients using services over a 12 month period.\nName, postcode, NHS number, date of birth and date of death were requested in order to carry out linkages. It was confirmed that all identifiers were required in order to carry out linkages across ambulance data as limited data is recorded"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Prof Simon Heller\ns.heller@sheffield.ac.uk"]
["Status","Supported"]
[]
["Outcome Date","2015-01-27"]
["Next Review Date","2017-01-27"]
["Notes","Amendment request 02/02/2017\nThe amendment request was to extend the scope of the project to include children. The data items and methodology would remain the same.                                                                       Specific conditions of support 02/02/2017\n1. Patient notifications should be revised to ensure they are accessible to young patients. The updated patient notifications should be provided to the CAG at annual review along with details of any public involvement work that has been carried out.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Version 13 confirmed reviewed and published as satisfactory.\n3. Confirmation of a favourable opinion from a Research Ethics Committee.\nReviewed documents\nAmendment Request form 20 January 2017                                                                                                            Application considered at CAG meeting on 28/08/2014\nSpecific conditions of support\n1. Favourable opinion from Research Ethics Committee. Confirmed 15/09/2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed xx\n3. Fair processing information should be displayed on the Trust websites in relation to the data collection. Confirmation that a brief description of project would be added to Yorkshire Ambulance Trust website.\n4. Date of death should be reduced to month and year only for analysis purposes. Confirmed.\n5. It was advised that incident number should be replaced with another unique reference number within the dataset retained for analysis. Confirmed, an amended flowchart was submitted.\n"]

{"sheet":"A0089","index":58,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","0089"]
["Reference","14/CAG/1018"]
["Other Refs"]
["Application Title","CEMARC Longterm Outcome Study"]
["Application Summary","This application from the University of Leeds set out the purpose of performing a long-term\nfollow up of the Clinical Evaluation of Magnetic Resonance imaging in Coronary heart\ndisease (CEMARC) study cohort by collecting outcome data for this cohort for a period of\n10 years."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Laura Jones"]
["Address","Advanced Imaging Centre, Gilbert Scott Building (Floor A),"]
[null,"Great George Street Entrance, Leeds General Infirmary,"]
[null,"Great George Street, Leeds"]
["Postcode","LS1 3EX"]
["Telephone","0792 1121 815"]
["Email","L.M.Jones@Leeds.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants: 35 years and above"]
["Description of confidential patient information used","NHS number, date of birth, date of death, gender and ethnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Leeds"]
["Status","Supported"]
[]
["Outcome Date","2014-11-18"]
["Next Review Date","2024-11-18"]
["Notes","17 August 2023 - change in data processor from NHS Digital to NHS England regarding data source Hospital Episode Statistics (HES).\n\nApplication considered at CAG meeting on 02/10/2014.\nSpecific conditions of support\n\n1. Favourable opinion from REC Received 29/08/2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 10/09/2014.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0091","index":59,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","0091"]
["Reference","14/CAG/1020"]
["Other Refs"]
["Application Title","A case-control evaluation of the NHS Bowel Cancer Screening Programme"]
["Application Summary","This application from the Wolfson Institute of Preventative Medicine, Queen Mary’s, University of London outlined a case review of patients invited to the English Bowel Screening Programme (healthy and colorectal cancer patients) for two years from January 2012, to identify the effect of the current bowel screening programme on incidence of advanced primary colorectal cancer. Confidential patient information would be used to link ONS, Cancer registries, National Cancer Data Repository (NCDR) and Health and Social Care Information Centre (HSCIC) data into the study database."]
["Applicant Organisation Name","Wolfson Institute of Preventative Medicine, Queen Mary’s, University of London"]
["Contact Name","Professor Stephen W. Duffy"]
["Address","Queen Mary University of London"]
[null,"Wolfson Institute of Preventive Medicine Room 008"]
[null,"Barts and The London School of Medicine and\nDentistry, Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone",2078823535]
["Email","s.w.duffy@qmul.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants, ages 60 - 89"]
["Description of confidential patient information used","NHS number, Date of Birth, Date of Death, Post Code, Ethnicity"]
["S251 Class(es)","Y","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Wolfson Institute of Preventative Medicine, Queen Mary’s, University of London"]
["Status","Supported"]
[]
["Outcome Date","2014-11-14"]
["Next Review Date","2024-11-14"]
["Notes","29 March 2023 - change in data processor from Public Health England (PHE) and NHS Digital to NHS England, regarding data sources Office for National Statistics (ONS) mortality data, and cancer registry data.\n\n05 April 2019 – Amendment supported to extend the duration of support under the Regulations to 31 December 2023\n\nApplication considered at CAG meeting on 02/10/2014.\nSpecific conditions of support\n1. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here; http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries.\n2. Confirmation of the arrangements for the fair processing of data that specifically references that data may be used for research purposes and provides both an opportunity for individuals to object to this and that also outlines the process to be followed to respect such requests.\n3. Confirmation of arrangements for fair processing information to be provided to the control group in relation to the above condition.\n4. A Favourable Opinion from a Research Ethics Committee. Confirmed 01/08/2014.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0093","index":60,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0093"]
["Reference","14/CAG/1022"]
["Other Refs"]
["Application Title","Decision Making with Teenagers, Parents and Clinicians"]
["Application Summary","This application from University College London set out the purpose of a research study which aimed to understand how teenagers (13-19 years old), families and health care professionals’ experience in decision making regarding care and treatment."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Myra Bluebond-Langner"]
["Address","Louis Dundas Centre, Institute of Child Health"]
[null,"University College London Institute of Child Health,"]
[null,"30 Guildford Street, London"]
["Postcode","WC1N 1EH"]
["Telephone",2079052781]
["Email","bluebond@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Female aged 13 - 85 years"]
["Description of confidential patient information used","Confidential patient information including name would be collected by a researcher at multidisciplinary meetings in relation to discussions about patients between clinicians.\nPatient name was requested in order to identify eligible patients and seek consent."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2014-11-05"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that support for this project can be ended.\n\n04/04/2019: amendment supported to extend the duration of support under the Regulations to 31 December 2023\n\nApplication considered at CAG meeting on 02/10/2014.\nSpecific conditions of support\n\n\n1. Favourable opinion from REC and confirmation that the ethics and requirement for the attendance of the researcher at the initial consultation had been considered. Assurance from the REC will be sought from the Confidentiality Advice Team and must be provided prior to support being confirmed. This assurance was provided on 15/10/2014 and the REC favourable opinion letter. \n2. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here. Confirmed\n3. Please confirm whether in order to minimise the amount of confidential patient information disclosed to the researcher, clinical teams could let researchers know when relevant patient would be discussed so the researcher would not have to attend the meeting where other patients who were not eligible were discussed. It was confirmed that, where possible, clinical teams would let the researcher know when/ at what meetings relevant patients will be discussed. The researcher would not attend those meetings where no relevant patient will be discussed, and will leave meetings once relevant patients have been discussed.\n"]

{"sheet":"A0094","index":61,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0094"]
["Reference","14/CAG/1023"]
["Other Refs"]
["Application Title","Prehospital Risk Stratification using a Modified Thrombolysis in Myocardial Infarction (PRISM-TIMI) Score – A Medical Record Review"]
["Application Summary","This application from St George’s, University of London set out the purpose of determining whether using a novel prehospital risk stratification tool (The Modified Thrombolysis in Myocardial Infarction Risk Score) is better than the current methods used by paramedics in the London Ambulance Service at assessing the severity of a heart attack that a patient is suffering."]
["Applicant Organisation Name","St George’s, University of London "]
["Contact Name","Mr Alan Rice"]
["Address","Faculty Health, Social Care and Education"]
[null,"St George’s, University of London"]
[null,"Tooting, LONDON"]
["Postcode","SW17 0RE"]
["Telephone",2087252800]
["Email","alan.rice@sgul.kingston.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Potential Non ST Elevation Acute Coronary Syndrome patients aged 18 years and above who have attended The Heart Hospital or University College Hospital (ED) and coded as \"Cardiac Chest Pain (ACS)\", seen by a London Ambulance Service (LAS) paramedic between 04/03/2013 and 01/09/2014 where there is a LAS prehospital ECG available for review, which was the primary method of convey to hospital. Amendment received in February 2015 to extend data collection 04/03/13 - 31/12/14."]
["Description of confidential patient information used","Name, date of birth, gender and date of admission"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","St George’s, University of London "]
["Status","Expired"]
[]
["Outcome Date","2014-10-03"]
["Next Review Date"]
["Notes","Anonymised at data extraction and linkage document has been deleted.\n\nThis project gave better understanding of prehospital risk scoring in this group of patients.\n\n\nApplication considered at CAG meeting on 22/09/2014.\nSpecific conditions of support\n\n1. Favourable opinion from REC. Received 10/09/2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 19/09/2014.\n3. Confirmation that the retention period of confidential patient information is 6 months. Confirmed 02/10/2014.\n"]

{"sheet":"A0095","index":62,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0095"]
["Reference","CR10/2014"]
["Other Refs"]
["Application Title","UKAEA & AWE Epidemiology Studies in the SHIELD database"]
["Application Summary","This application from Nuvia Ltd, on behalf of Public Health England as data controller, set out the purpose of a project to assemble and store data collected for the monitoring of workers for internal contamination by radionuclides. The cohort comprised the entire workforce past and present of the United Kingdom Atomic Energy Authority (UKAEA) and its recent successor organisations, RSRL and DSRL, together with the workforce of the Atomic Weapons Establishment (AWE) up to 1982."]
["Applicant Organisation Name","Nuvia Limited"]
["Contact Name","Gary Bethel"]
["Address","Nuvia Ltd., The Library"]
[null,"Harwell Oxford, Didcot, Oxfordshire"]
[null,"Didcot, Oxfordshire"]
["Postcode","OX11 0RL"]
["Telephone",1235514904]
["Email","Gary.Bethel@nuvia.co.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The entire workforce past and present of the United Kingdom Atomic Energy Authority (UKAEA) and its recent successor organisations, RSRL and DSRL, together with the workforce of the Atomic Weapons Establishment (AWE) up to 1982."]
["Description of confidential patient information used"," Home addresses,employment start and finish dates, establishment, job grade and social status, radiation dose data from external sources of ionising radiation, and followup, including date and cause of death, emigration dates and cancer\nregistry data."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Nuvia Ltd"]
["Status","Expired"]
[]
["Outcome Date","2014-10-21"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in 2021 that support no longer required, as from October 2021, processing of confidential patient information without consent has been completed and Nuvia no longer hold the data.  A data destruction certificate has been sent to NHS Digital.  \n\nIn terms of public benefit, data from the SHIELD database was used for significant studies on the health effects of exposure to low doses of ionising radiation.  The latest study with European collaborators was one of the first to look at the effects of internal contamination.  Overall, this resulted in 25 publications in the scientific literature and has influenced the setting of radiation protection standards by policy makers.  \n\nApplication considered at CAG meeting on  17 March 2014\nSpecific conditions of support\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission Confirmed 12/09/2013\n2. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 11/11/2014.\n3. Patient addresses should be destroyed as soon as possible, please confirm timescales in relation to this prior to final support. Confirmed that home address would be deleted after flagging was complete and we have confirmed that the correct person has been flagged. \n4. Continued efforts should be made to review the retention period of identifiable data and this should be reported at annual review.\n"]

{"sheet":"A0096","index":63,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0096"]
["Reference","14/CAG/1024"]
["Other Refs"]
["Application Title","EVAR 1"]
["Application Summary","The EVAR trial 1 was the world’s first trial comparing open repair (OR) versus endovascular aortic repair (EVAR) for abdominal aortic aneurysms by random allocation to one or the other treatment option. The trial has reported up to 10 years of follow up. In the first 6 years EVAR was ahead of OR in terms of aneurysmrelated mortality, however at 6 years\nno benefit remained for one or the other surgical method. Within this follow up period 27 secondary ruptures of the excluded aneurysm have occurred and it is highly probable that the early aneurysm related mortality benefit of EVAR is lost as a result of these EVAR late sac ruptures. We identified device migration downwards and excess aortic neck kinking as well as defined leaks (so called type I, type 2 and type 3 with sac expansion to be associated with these late EVAR secondary original aortic or \"sac\" ruptures. We observed until September 2009 that secondary sac ruptures continue to occur after EVAR and so it is very possible\nthat open repair could be superior to EVAR within another 5 years of follow up. This may well affect cost effectiveness\nand patient follow up."]
["Applicant Organisation Name","Imperial College"]
["Contact Name","Professor Roger M Greenhalgh-Chief Investigator"]
["Address","Imperial College"]
[null,"Charing Cross Hospital"]
[null,"Fulham Palace Road, London"]
["Postcode","W6 8RF"]
["Telephone","02033117316"]
["Email","r.greenhalgh@imperial.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Ms Becky Ward-becky.ward@imperial.ac.uk "]
["Status","Expired"]
[]
["Outcome Date","2015-10-15"]
["Next Review Date","N/A"]
["Notes","Section 251 support was requested to obtain HES data, which was never obtained, and the study proceeded on the legal basis of consent to follow up the patients. \n\nApplication considered at CAG meeting on 29 September 2014\n\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee Confirmed\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed \n"]

{"sheet":"A0097","index":64,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0097"]
["Reference","14/CAG/1025"]
["Other Refs"]
["Application Title","CFAS Death notification of participants at HSCIC"]
["Application Summary","The Cognitive Function and Ageing Study (CFAS) is a large population based epidemiological study which began in 1990 involving people aged over 65 in six centres of Britain including Liverpool, Newcastle, Nottingham, Oxford, Cambridge and Gwynedd.\nOver 18,000 people were initially recruited to the study and conducted over 48,000 computer based interviews over a 20+ year period that has increased our knowledge on the onset, course and risk factors for dementia and related conditions in the older population as well as healthy and frail ageing. Participants who consented to take part in the study signed consent forms allowing the study access to their GP and other medical records, for the remaining unconsented sample, section 60 approval was granted in Nov 2003.\nParticipants were flagged and traced with the Office for National Statistics (ONS) in order that the study be informed of the date and cause of death of participants.\nAs systems have evolved the access to medical records forms which participants signed are no longer deemed sufficient by the HSCIC who have requested the study reconsent all participants which is not practicable for many reasons including the advanced ages of participants, potential lack of capacity, inevitable attrition and lack of resources required for such an undertaking. The study has been informed if we do not receive permission from the Confidentiality Advisory Group (CAG) all data previously received will have to be deleted and will render 20+ years of publicly funded research unusable. The participants gave their consent to participate in a longitudinal study and gave permission for access to medical records in good faith not anticipating future changes to governance arrangements. We request approval to continue to receive the death notifications from HSCIC and to be allowed to retain the data previously received for continuing analysis.\n\nAmendment 16/07/2016 - The amendment detailed a change to data flows. The original application had stated that identifiable data would be stored at the MRC Biostatics unit Cambridge. However the MRC Biostatics unit is becoming an external partner with the University of Cambridge and therefore the data will come under the clinical governance of the University of Cambridge. CFAS identifiable data will therefore be moved in to the Research Secure Data Holding service at the Clinical School, University of Cambridge."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Carol Brayne"]
["Address","Institute of Public Heath, Forvie Site"]
[null,"School of Clinical Medicine"]
[null,"University of Cambridge "]
["Postcode","CB2 2SR"]
["Telephone","01223 330334"]
["Email","carol.brayne@medschl.cam.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Generic Health relevance\nDementias and Neurodegenerative diseases\nMale and female participants\n89-110 years"]
["Description of confidential patient information used","Death certification including the following information:\nName in full (including maiden name where appropriate), Sex, Date of Birth and Place,\nDate of death and Place, Cause of death, ICD10 codes, NHS number."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge "]
["Status","Expired"]
[]
["Outcome Date","2015-01-15"]
["Next Review Date"]
["Notes","Applicant confirmed in June 2023 that ‘s251’ support for this application can be expired, as All identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the ‘s251’ support has allowed applicants to increase our knowledge of ageing and continue to provide beneficial evidence to the NHS, policy makers and the general public regarding ageing and dementia. \n\nApplication considered at CAG meeting on 02/10/2014\n\nSpecific conditions of support\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 09/01/2015.\n2. Confirmation of favourable Research Ethics Committee opinion. Received 29/09/2014.\n3. Please ensure the deletion of identifiable data in relation to deceased patients or confirm why it is important or more appropriate to retain identifiable data in relation to the deceased at this time. Confirmed on 28 October 2014 that when notified of a death the identifiable information is no longer required and will be removed from the administrative database. This information will have already been removed from the full analysis datasets.\n"]

{"sheet":"A0099","index":65,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0099"]
["Reference","14/CAG/1027"]
["Other Refs"]
["Application Title","Cluster randomised comparison of the effectiveness of 100% oxygen\nversus titrated oxygen in patients with a sustained return of\nspontaneous circulation following out of hospital cardiac arrest: a\nfeasibility study"]
["Application Summary","This application from University Hospitals Bristol NHS FT set out the purpose of collecting data\nfrom 40 paramedics (randomly allocated on a 1:1 basis between those patients who have 100%\noxygen or titrated oxygen to a target SpO2 94-98%) regarding patients (aged 18 years or over)\nwho have sustained a return of spontaneous circulation (ROSC) for longer than 2 minutes\nfollowing a non-traumatic out of hospital cardiac arrest (OHCA). Traditionally, patients who have\nsuffered OHCA have been given unrestricted, 100% oxygen following ROSC on the basis that\nthey have profound tissue hypoxia that requires rapid correction. However, recent ambulance\nservice guidelines have proposed the titration of oxygen to a SpO2 of 94-98%, as expert opinion\nsuggests that this may be superior to 100% oxygen.\nProposed outcome measures for a subsequent main study include survival and quality of life at\nhospital discharge and 3 and 6 months following OHCA, length of hospital stay and intensive care\nunit stay, cognitive function and additional data to support a cost effectiveness analysis. These\nwill be assessed in this feasibility study and feasibility outcome measures will include the\ncompleteness of these data. The Applicant will base the methodology on a previous OHCA trial\n(REVIVE-Airways; Benger et al. 2013) successfully completed in the same ambulance service."]
["Applicant Organisation Name","University Hospitals Bristol NHS FT"]
["Contact Name","Professor Jonathan Benger"]
["Address","University Hospitals Bristol NHS Foundation Trust"]
[null,"Upper Maudlin Street"]
[null,"Bristol"]
["Postcode","BS2 8HW"]
["Telephone",1173421498]
["Email","jonathan.benger@uwe.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants, ages 18 and above"]
["Description of confidential patient information used","Name, NHS number, hospital number, date of birth, date of death, gender and district level of postcode), data\nrelating to the cardiac arrest (including response time, bystander CPR, initial rhythm and\ntreatment given), time of ROSC, and whether sustained, airway management during OHCA, and\nfollowing ROSC, ability to achieve a reliable SpO2 trace, SpO2 during transport and on arrival at\nhospital, use of 100% versus titrated oxygen after sustained ROSC, device used for ventilation\n(self-inflating bag or automatic ventilator), whether the patient arrived at hospital with a palpable\npulse, any complications or problems encountered, ability to comply with allocated study group\nand staff feedback."]
["S251 Class(es)","Y","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University Hospitals Bristol NHS FT"]
["Status","Supported"]
[]
["Outcome Date","2014-10-29"]
["Next Review Date","2015-10-29"]
["Notes","Application considered at CAG meeting on 20 October 2014\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 29 October 2014.\n2. Receipt of a letter of support from the Caldicott Guardian at the NHS organisation from which data is to be accessed. Confirmed 24 November 2014.\n3. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 7 November 2014.\n"]

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[]
[]
["Application Number","0100"]
["Reference","14/CAG/1028"]
["Other Refs"]
["Application Title","British Childhood Visual Impairment and Blindness Study 2 (BCVIS 2)"]
["Application Summary","This application from University College London set out the purpose of the first national epidemiological study to determine the incidence, mode/context of detection, determinants/risk factors, management and short term health and social outcomes of all-cause visual impairment and blindness in childhood (ie across the full spectrum of visual disability as per the WHO international classification)."]
["Applicant Organisation Name","University College London "]
["Contact Name","Prof Jugnoo Rahi"]
["Address","University College London"]
[null,"Life Course Epidemiology and Biostatistics"]
[null,"30 Guilford Street, London"]
["Postcode","WC1N 1EH"]
["Telephone",2079052250]
["Email","j.rahi@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants, 0 - 18 years"]
["Description of confidential patient information used","NHS number, birth, postcode, gender and ethnicity and clinical data."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London "]
["Status","Supported"]
[]
["Outcome Date","2014-11-18"]
["Next Review Date","2020-10-31"]
["Notes","Application considered at CAG meeting on 3 November 2014\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 12/11/2014.\n2. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 14/11/2014.\n                                                                                                                          Amendment 22/07/16                                                                                                      The request was for the research team to assist some consultants in completing the data\ncollection forms on their behalf, to reduce the workload for the consultants. The research team\nwould travel to the hospital in question and transcribe data from the routinely collected\nophthalmology notes to the data collection forms. This will be arranged under the supervision\nand with assistance from their clinical teams. This would ensure that there was no missing data,\nwhich would have an impact on the validity of the findings since this is a rare condition of public\nhealth importance and national surveillance is the only means of achieving an unbiased dataset.\nThe amendment would not involve gaining access to any data other than those which the\nclinicians would themselves have returned had they completed the data collections forms solely\nby themselves.\nIn addition to this the research team requested support to use NHS numbers retained for\ngovernance purposes in order to carry out follow-up in order to ascertain longer-term outcomes\nof visual impairment. This would be subject to approvals for each use of the data.\n"]

{"sheet":"A0101","index":67,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0101"]
["Reference","14/CAG/1029"]
["Other Refs"]
["Application Title","DECS, Diabetic Eye disease in Children Study: incidence, detection / presentation, clinical characteristics and outcomes of diabetic eye disease in childhood in the UK"]
["Application Summary","This application from University College London set out the purpose of a national study of childhood diabetic eye disease (retinopathy/cataract) and diabetes-related visual disability, investigating variations (eg by age, gender, ethnicity), clinical characteristics, patterns of detection and short term outcomes. Information about newly diagnosed children will be collected from their managing ophthalmologists and reported to the long-established British Ophthalmic Surveillance Unit (BOSU), which has facilitated key recent national studies of childhood eye disorders. "]
["Applicant Organisation Name","University College London "]
["Contact Name","Prof Jugnoo Rahi"]
["Address","University College London"]
[null,"Life Course Epidemiology and Biostatistics"]
[null,"30 Guilford Street, London"]
["Postcode","WC1N 1EH"]
["Telephone",2079059200]
["Email","j.rahi@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," NHS number, date of birth, postcode, gender and ethnicity and clinical data."]
["Description of confidential patient information used","Male and female participants: 0 - 18 years"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London "]
["Status","Expired"]
[]
["Outcome Date","2014-11-18"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, study findings have informed delivery of the UK’s National Diabetic Screening Programme, NICE guidelines on the management of diabetes in children and young people and the information provided to affected children/young people and their families by clinicians on risks of sight impairment due to diabetes.\n\n\nApplication considered at CAG meeting on 3 November 2014\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 12/11/2014.\n2. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 14/11/2014.\n"]

{"sheet":"A0102","index":68,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0102"]
["Reference","14/CAG/1030"]
["Other Refs","IRAS Project ID: 159391, REC reference: 14/SC/1219"]
["Application Title","Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest - Airway Management in cardiac arrest patients (AIRWAYS2)"]
["Application Summary","This application from University Hospitals Bristol NHS Foundation Trust set out the purpose reviewing patient confidential information regarding patients who have had an out of hospital cardiac arrest (OHCA) to establish the most effective method by ambulance staff to restore breathing: the placement of a breathing tube (intubation) or by the insertion of a supraglottic airway device (SAD)."]
["Applicant Organisation Name","University Hospitals Bristol and Weston NHS Foundation Trust"]
["Contact Name","Professor Jonathan Benger"]
["Address","University Hospitals Bristol NHS Foundation Trust"]
[null,"Emergency Department"]
[null,"Bristol Royal Infirmary, BRISTOL"]
["Postcode","BS2 8HW"]
["Telephone","0117 3421498"]
["Email","jonathan.benger@uhbw.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants; 18 years and above"]
["Description of confidential patient information used","NHS number, hospital number, date of birth, date of death, postcode, ethnicity."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University Hospitals Bristol NHS Foundation Trust "]
["Status","Expired"]
[]
["Outcome Date","2014-11-05"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the trial found no significant difference between tracheal intubation (TI) and the i-gel supraglottic airway device (SGA) in functional outcome at hospital discharge or 30 days after an out-of-hospital non-traumatic cardiac arrest in adults. However, some important differences were noted in the secondary and pre-specified sensitivity analyses. \n\nThe findings have also provided immediate and direct impact on clinical practice. International resuscitation guidelines have been updated in light of the trial’s findings. UK NHS Ambulance Trusts have reviewed their use of TI, and it is no longer considered an essential skill for all front line paramedics, though TI is retained by more specialist practitioners where the skill can be adequately governed and maintained. As TI is a more resource-intensive skill, the finding that SGA did not result in significantly different outcomes has also had important implications for ambulance resource utilisation. \n\n\nConditionally supported - 07 August 2020:\nNew conditions in letter sent. The following sets out the updated specific conditions of support applied against this application reference.\n\n1. All staff at University Hospitals Bristol NHS Foundation Trust that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\nAmendment Request (approved 15/6/2018)\nThis amendment requested support to extend the duration of support to enable confidential patient information to be retained for an additional period of six months from the date which the study database is locked in May 2018.\n\nAmendment Request (approved 9/2/2018)\nThis amendment requested support to follow-up all patients enrolled in the AIRWAYS2 trial, through linkage with the HES dataset held by NHS Digital.\nSupport was requested to allow the disclosure of NHS number, Date of Birth, Surname, Forename, Gender and Postcode from the trial team at University Hospitals Bristol NHS Foundation Trust to NHS Digital, to be linked with the HES datasets (A&E, Inpatients, Critical care and Outpatients). HES data will be returned to the trial team by NHS Digital as a spreadsheet linked by patient identifiers. The trial team at University Hospitals Bristol NHS Foundation Trust will link the information to the study database. The trial team create a pseudonymised dataset and transfer this to the Nuffield Department of Population Health at the University of Oxford who will undertake analysis.\nIt was acknowledged that support was in place for the retention of confidential patient information until all study data had been validated and the trial database locked. The applicants confirmed that the HES linkage would be undertaken prior to the database lock, as confidential patient information was required to facilitate linkage. It was anticipated that this would be completed in early 2018.\n\nApplication considered at CAG meeting on 3 November 2014.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 13 October 2014.\n2. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 11 November 2014.\n\n"]

{"sheet":"A0105","index":69,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0105"]
["Reference","14/CAG/1033"]
["Other Refs"]
["Application Title","Maternal Serum PAPPA levels and pregnancy outcomes"]
["Application Summary","This application from Birmingham Women’s Hospital NHS Foundation Trust set out the purpose of time limited access to perform data linkages of hospital records prior to the anonymisation of the study dataset."]
["Applicant Organisation Name","Birmingham Women’s Hospital NHS Foundation Trust"]
["Contact Name","Dr Ashwini Bilagi"]
["Address","Birmingham Women's Hospital NHS Trust"]
[null,"Mindelsohn Way"]
[null,"Birmingham"]
["Postcode","B15 2TG"]
["Telephone",7886436045]
["Email","AXB1030@student.bham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female participants only"]
["Description of confidential patient information used"," NHS number, hospital number, date of birth, district level postcode "]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Birmingham Women’s Hospital NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2014-12-10"]
["Next Review Date","2015-12-10"]
["Notes","Application considered at CAG meeting on 1 December 2014\n\nSpecific conditions of support\n\n1. The applicant should seek advice from the Information Commissioner's Office in relation to the fair processing of data specifically for this application and consider the suggestion of the CAG in relation to providing information in key community health settings. Confirmed 10/12/2014. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 13/11/2014.\n3. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 12/12/2014.\n"]

{"sheet":"A0106","index":70,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0106"]
["Reference","14/CAG/1034"]
["Other Refs"]
["Application Title","Collaborative European Neuro-Trauma Effectiveness Research in TBI: a prospective longitudinal observational study"]
["Application Summary","This application from Cambridge University Hospitals NHS Foundation Trust set out the purpose of accessing confidential patient information to produce an anonymised data registry."]
["Applicant Organisation Name","Cambridge University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Jonathan Coles"]
["Address","Cambridge University Hospitals NHS Foundation Trust"]
[null,"University Division of Anaesthesia, Box 93, Addenbrooke's Hospital"]
[null,"Hills Road, Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223 217889"]
["Email","jpc44@wbic.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants 16 years and above"]
["Description of confidential patient information used","Age (in years), date of injury, sex, American Society of Anaesthesiologists Physical Status Score, anticoagulant therapy, injury severity score, type of injury, location of incident (home, street, public place, work, sports field), date and date of CT, CT results, pre-hospital care details, date and time of arrival to hospital, admission level (ward, ICU), GCS score, pupil response, blood pressure, oxygen saturation, treatment procedures in study centre, discharge status (mortality), discharge destination, principle cause of death (if appropriate), duration of survival."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cambridge University Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2014-12-10"]
["Next Review Date","N/A"]
["Notes","Only anonymised patient information was extracted/received.\n\nCENTER-TBI (https://www.center-tbi.eu) includes a prospective observational Core Study and a Registry, supported by extensive profiling of participating centres to inform comparative effectiveness research (CER) analysis. The Core Study collected granular data from over 4500 patients in Europe and Israel and an additional 1200 in Australia and India. The Registry collected basic data on all patients presenting with TBI, aiming to assess representativeness of the Core Study and to analyse effects of structural parameters (e.g. organisational) in greater numbers (recruitment: 22,772 patients). CENTER-TBI is part of the International Initiative on TBI Research (InTBIR - http://intbir.nih.gov/). Research results are being widely disseminated to patients, health care professionals and policy makers, and have already resulted in over 200 peer-reviewed manuscripts in the scientific literature. Importantly, though CENTER-TBI officially closed at the end of March 2021 after a project duration of 7 1/2 years, our data, imaging, and biosample repositories continue to be open for the scientific business of improving our understanding and management of TBI. These resources, particularly when combined with those in partner InTBIR studies, will continue to deliver outputs that will help to improve patient outcomes in TBI. Ongoing meta-analyses between CENTER-TBI and its sister study in the US, TRACK-TBI, are already providing novel insights and vital confirmation of results. CENTER-TBI and InTBIR have established productive global networks of researchers and research institutions, who will use the legacy of CENTER- TBI to improve patient care and injury prevention globally for many years to come.\n\nApplication considered at CAG meeting on 1 December 2014\n\nSpecific conditions of support\n\n1. The poster to be corrected to refer to the “Confidentiality Advisory Group” rather than the Confidentiality Advisory Board. Confirmed 16/12/2014.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 22/12/2014.\n3. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed for Sheffield Teaching Hospitals NHS Foundation Trust on 05/12/2014 and United Hospitals of Birmingham NHS Foundation Trust on 09/12/2014.\n"]

{"sheet":"A0107","index":71,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0107"]
["Reference","14/CAG/1035"]
["Other Refs"]
["Application Title","A Retrospective Chart Review of Deceased Patients with Mucopolysaccharidosis Type IIIB"]
["Application Summary","This application from Birmingham Children's Hospital NHS Foundation Trust on behalf of INC Research UK Ltd set out the purpose of carrying out a source data verification of the anonymised data that has been collected for this study."]
["Applicant Organisation Name","Birmingham Children's Hospital NHS Foundation Trust"]
["Contact Name","Dr Suresh Vijay"]
["Address","Birmingham Childrens Hospital NHS Foundation Trust"]
[null,"Steelhouse Lane"]
[null,"Birmingham"]
["Postcode","B4 6NH"]
["Telephone",1213339907]
["Email","suresh.vijay@bch.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants - no lower or upper age limits apply."]
["Description of confidential patient information used","Month and year of birth, gender, month and year of death, cause of death, patient demographics, clinical information, results of diagnostic tests, treatments for MPS\nIIIB, clinical chemistry and haematology tests, anthropometric data, radiology results, supportive interventions/medications and autopsy findings."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Birmingham Children's Hospital NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2015-02-11"]
["Next Review Date"]
["Notes","Only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nThis study provided useful information on the natural history of this rare disorder for which, even to this day there is no effective treatment available. The\ninformation obtained from this study will help design clinical trials to assess new treatments being developed.\n\n\nApplication considered at CAG meeting on 17 November 2014\n\nSpecific conditions of support\n\n1. Letter of support from the Caldicott Guardian. Received 06/01/2015.\n2. Favourable opinion from a Research Ethics Committee. Received 06/01/2015.\n3. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 11/02/2015.\n"]

{"sheet":"A0108","index":72,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0108"]
["Reference","14/CAG/1036"]
["Other Refs"]
["Application Title","A new combined radiological and clinical classification for pulmonary embolism using computed tomography pulmonary angiography"]
["Application Summary","This application from the University of Keele set out the purpose of reviewing radiology images, report and patient notes of patients who have a massive pulmonary embolism. Data will be collected and analysed in an anonymised format to establish a new classification based upon the radiology images and other relevant patient\ninvestigations. The new classification will be developed for clinical practice to \naid the direction of patient treatment and long term follow up"]
["Applicant Organisation Name","University of Keele "]
["Contact Name","Mr Christopher Satur"]
["Address","Consultant Cardiothoracic Surgeon"]
[null,"The Royal Stoke University Hospital"]
[null,"Newcastle Road, STAFFORDSHIRE"]
["Postcode","ST 4 6QG"]
["Telephone","01782 715444"]
["Email","christopher.satur@uhns.nhs.uk "]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Female participants: 18 years and above"]
["Description of confidential patient information used","Access was requested to hospital number, gender, age, co-morbidities, clinical presentation and imaging findings."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Keele"]
["Status","Expired"]
[]
["Outcome Date","2014-12-17"]
["Next Review Date","N/A"]
["Notes","Closure Form received dated 14/07/2016                                                                             No informaiton is being processed under support as at 14/07/2016                                                             Application considered at CAG meeting on 1 December 2014\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Received 1 December 2014.\n2. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 7 January 2015.\n"]

{"sheet":"A0111","index":73,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0111"]
["Reference","14/CAG/1039"]
["Other Refs"]
["Application Title","Small Area Health Statistics Unit"]
["Application Summary","This application from Imperial College London set out a request for continued support for a research database covering England and Wales, the database would be mainly used by studies focusing on environmental health risks. The original application specified that support would be required for the funding period of 5 years, as the funding period had been extended the application requested an extension to the initial support provided.\nA recommendation for class 1, 2, 3, 4, 5 and 6 support was requested to cover access to the following datasets:\n• ONS Births and Still births\n• ONS Cancer Incidence\n• Welsh Cancer Intelligence and Surveillance Unit.\n• ONS Mortality\n• National Congenital Anomaly Register (NCAR from ONS)\n• Local Congenital Anomaly registries affiliated with BINOCAR [CARIS (Wales), Glasgow Register of Congenital Anomalies, Merseyside and Cheshire Congenital Anomaly Survey, North Thames (West) Congenital Malformation Register, Northern Congenital Abnormality Survey (NORCAS), Oxfordshire Congenital Anomaly Register (OXCAR), Scottish Congenital Anomaly Register (SCAR), East Midlands & South Yorkshire Congenital Anomaly Register (formerly Trent), West Midlands Congenital Anomaly Register, Wessex Antenatally Detected Anomalies Register (WANDA), National Downs Syndrome Cytogenetic Register (NDSCR)\n• Terminations grounds “E” (that there is a substantial risk that if the child were born it would suffer from such physical\n• or mental abnormalities as to be seriously handicapped)\n• NN4B – currently expecting data for 20062011\n• (data arrival expected November 2014).\n• HES Inpatients\n• HES A+E – current holdings\n• HES ONS mortality link – current holdings\n• NCCHD (National Community Child Health Database)\nAmendment 10/07/2015: CAG original approval had covered the SAHSU application but not unlimited data linkages. The applicant had been asked to come back when undertaking specific projects which required additional linkages. It was noted that the applicant confirmed that they will be using the approved methodology agreed at the CAG meeting.\nAn amendment was requested in order to link between the ONS births registrations (enhanced with NN4B variables) and ONS mortality records to be able to analyse infant mortality as an outcome for two studies (12/LO/0566 and 12/LO/0567) covered by HRA - 14/CAG/1039 – Section 251 support; (supersedes NIGB - ECC 2-06(a)/2009). The applicant confirmed that approval would be sought from NRES and ONS (the data provider) before carrying out any linkage."]
["Applicant Organisation Name","Imperial College London. UK Small Area Health Statistics Unit (SAHSU)"]
["Contact Name","Paul Elliot"]
["Address","Department of Epidemiology and Biostatistics"]
[null,"Imperial College London, School of Public Health"]
[null,"St Mary's Campus, Norfolk Place, London"]
["Postcode","W2 1PG"]
["Telephone","020 7594 3328"]
["Email","p.elliott@imperial.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Access was requested to address, postcode, NHS number, date of birth and date of death."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Imperial College, London"]
["Status","Expired"]
[]
["Outcome Date","2015-04-24"]
["Next Review Date","N/A"]
["Notes","24 March 2022 - Support Expired - Now operating under reference 20/CAG/0028\nA new application was submitted in January 2020 following the 5th year of Ref 14/CAG/1039 which has since been superseded with CAG Ref 20/CAG/0028 (IRAS 219598, Small Area Health Statistics Unit).  This was given support on 24 March 2020.\n\nApplication considered at CAG meeting on 11/12/2014.\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed.\n2. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed\n3. Please ensure that you continue to explore with others the feasibility of an exit strategy from and reduction of the use of confidential patient information without consent. This should be reported on at the next annual review stage. \n4. Please ensure that a patients and public section of the SAHSU website is created and includes information in relation to the data being processed and methods to enable patient objection.\n"]

{"sheet":"A0112","index":74,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","0112"]
["Reference","14/CAG/1040"]
["Other Refs"]
["Application Title","UCL Infection DNA Bank"]
["Application Summary","This application is for the establishment of a new tissue bank to undertake research to analyse the genetic basis for infections and potentially the interactions with non-communicable diseases at a later point. It is intended that both a microbial and human DNA would be analysed. The tissue bank will include residual diagnostic samples, held anonymised for retrospective samples and linked with hospital numbers for prospective samples. The disclosure of confidential patient information will be limited to instances where further collection or investigation of patient records is requested by researchers, having identified samples of interest. Consent will be sought to complete any such further analysis and support was requested for project researchers to be given patient details to seek consent for further analysis and samples to be collected, after the patient had been first approached about this by their clinician."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Judith Breuer"]
["Address","Division of Infection and Immunity"]
[null,"Cruciform Building"]
[null,"Gower Street, London"]
["Postcode","WC1E 6BT"]
["Telephone",2031082130]
["Email","j.breuer@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Access was requested to clinical data, name, address, date of birth, gender and hospital number"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Supported"]
[]
["Outcome Date","2014-12-16"]
["Next Review Date","2024-12-16"]
["Notes","31\tJanuary 2023 – Annual review supported and new condition applied: \n1.\tA new refreshed CAG application should be submitted within three months, to supersede 14/CAG/1040.\n\nThis application was considered at the CAG meeting on 11 December 2014.\n\nSpecific conditions of support\n\n1. Patients should be approached by a member of their care team in clinic and not directly by researchers.\n2. Researchers should only have access to patient details three weeks after the patient's clinician has sent the letter to enable the patient to opt-out of being further contacted.\n3. Favourable opinion from a Research Ethics Committee.\n4. Confirmation of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 21 February 2014.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0115","index":75,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0115"]
["Reference","14/CAG/1043"]
["Other Refs"]
["Application Title","SOCCER (Symptoms of Colorectal Cancer Evaluation\nResearch)"]
["Application Summary","This application from Imperial College London set out the purpose of utilising data\nregarding non-consented patients (“registered only”) to determine whether a whole colon investigation, either via a colonoscopy, CT colonography or barium enema is necessary for all patients with symptoms suggestive of colorectal cancer (CRC) and for which patients flexible\nsigmoidoscopy might suffice. This study seeks therefore to confirm whether or not the\npresence of a specific combination of symptom(s) can reliably be used to inform if a\ncancer is located in the upper or lower part of the bowel and therefore whether patients\nwith particular symptoms can be safely investigated by flexible sigmoidoscopy rather than\nexamination of the whole bowel.\nA recommendation for class 1, 4 and 6 support was requested to cover the process of\nextracting and anonymising the information, link patient identifiable information obtained\nfrom more than one source and to allow access to an authorised user for the above\npurposes.\nIt was noted that this application for support only related to those non-consented patients\nwho had registered for the study and for various reasons were no randomised.\n"]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Dr Amanda Cross"]
["Address","Imperial College London"]
[null,"Cancer Screening and Prevention-Research Group"]
[null,"Room 505, Medical School Building, St Mary's Campus, Norfolk Place"]
["Postcode","W2 1PG"]
["Telephone","02075943401 /3338"]
["Email","amanda.cross@imperial.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with symptoms suggestive of colorectal cancer, referred to hospital\nfor whole colon investigation.\nMale and female participants\n55-No upper age limit"]
["Description of confidential patient information used","Access was requested to name, NHS number, date of birth, address and postcode."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","laura.turner@imperial.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-02-11"]
["Next Review Date","N/A"]
["Notes","May 2022 - Support Expired\nApplicant confirmed May 2022 that they do not retain any confidential patient information without consent in the archived SOCCER database and files, and therefore ‘s251’ support no longer required. \n\nRegarding public benefit, the results showed that for patients with certain bowel cancer symptoms, flexible sigmoidoscopy can be a clinically effective investigation and it is likely that very few upper large bowel cancers would be missed. The potential cost savings for the NHS require further analysis.\n \nThe study’s findings will be used to inform endoscopy guidelines – both in the UK and internationally – that advise doctors on the best tests for their patients. The findings will help ensure that patients receive the tests that most benefits them, and also generate efficiency savings for health services.\n\nApplication considered at CAG meeting on 5 January 2015.\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 18 April 2013.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed.\n"]

{"sheet":"A0116","index":76,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0116"]
["Reference","14/CAG/1044"]
["Other Refs"]
["Application Title","Predicting Response to Antipsychotic medication (STRATA)"]
["Application Summary","This application from King’s College London set out the purpose of seeking up to date\ncontact details of participants who participated in previous studies to seek their consent\nfor a new study to develop predictors of treatment response in psychosis.\nPsychosis is a serious mental illness which has a highly variable outcome. Some patients\nrecover while others suffer a chronic course that severely compromises their capacity to\nmeet the demands of everyday life (Milev, Ho, Arndt, & Andreasen, 2005).\nThe term ‘Outcome’ refers to the long term trajectory of illness. For example, a classic\ndefinition of outcome is symptom severity in response to antipsychotic treatment.\nAccordingly, up to 30% of patients diagnosed with schizophrenia fail to respond to two\nantipsychotics after adequate trials – such patients are defined as having treatment\nresistant schizophrenia. Schizophrenia is estimated to cost £11.8 billion per year in\nEngland; some of this cost includes non-responsive treatment, which consumes 25-50%\nof the total NHS mental health budget and can lead to very high social care costs and lost\nproductivity.\nThe aim of this project is to establish the extent to which genes influence clinical outcome\nin psychosis. Clinical outcome will be assessed in ~1,000 patients up to 8 years after their\nfirst presentation with psychosis. Participants of past psychosis studies will be recontacted\nto avoid a selection bias towards chronic samples if recruited prospectively and long term\nresponse outcome is known. A summary approach to genetic information capture will rely\non polygenic scoring methodologies and pathway analysis.\nA recommendation for class 2, 3 and 5 support was requested to cover access to obtain\nand use information about use information about part or present geographical location, to\nselect and contact patients to seek their consent and to allow access to an authorised\nuser for one or more of the above purposes."]
["Applicant Organisation Name","KCL"]
["Contact Name","Dr James H MacCabe"]
["Address","Department of Psychosis Studies"]
[null,"PO63, 16, De Crespigny Park"]
[null,"London"]
["Postcode","SE5 8AF"]
["Telephone",2078480757]
["Email","james.maccabe@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants 18-65 years old"]
["Description of confidential patient information used","Access was requested to name, NHS number, hospital number, GP registration, date of birth and date of death, current and past addresses and post code."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","KCL-keith.brennan@kcl.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-06-03"]
["Next Review Date","N/A"]
["Notes","Study finished recruitment on 9/5/2017 wherein all identifiable information held without consent was deleted.\n\nApplication considered at CAG meeting on 5th January 2015.\nSpecific conditions of support\n\n1. Favourable opinion from REC Received 16th February 2015\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 2nd June 2015\n"]

{"sheet":"A0123","index":77,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","0123"]
["Reference","CR4/2014"]
["Other Refs"]
["Application Title","Asbestos Workers Survey"]
["Application Summary","This application from the Health & Safety Laboratory set out the purpose of a study to monitor the long-term health of asbestos workers and help to determine whether the 1969 Asbestos Regulations were effective in reducing the risk of asbestos-related ill-health."]
["Applicant Organisation Name","Health and Safety Executive"]
["Contact Name","Gillian Nicholls, Chief Investigator"]
["Address","HSE Science and Research Centre"]
[null,"Harpur Hill"]
[null,"BUXTON"]
["Postcode","SK17 9JN"]
["Telephone","020 3028 1967"]
["Email","Gillian.Nicholls@hse.gov.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All licensed asbestors workers"]
["Description of confidential patient information used","Access to mortality and cancer data including name, address, date of birth and NHS number"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Health & Safety Laboratory"]
["Status","Supported"]
[]
["Outcome Date","2014-11-19"]
["Next Review Date","2024-11-19"]
["Notes","Amendment support 20 November 2023 to change the Chief investigator from Lucy Darnton to Gillian Nicholls\n\n27 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources; Demographics/PDS, Civil Registrations – Deaths, and cancer registration data.\n\nAmendment supported 15 February 2023 to change the Chief investigator from Dr Anne-Helen Harding to Ms Lucy Darnton\n\n09 October 2020 - Amendment conditionally supported\nAmended the data flow to enable the follow-up of participants’ when a participant moves between England/Wales and Scotland, to allow the disclosure of NHS number from: \n\no NHS digital to the Health and Safety Executive Laboratory, \no Health and Safety Executive Laboratory to National Records of Scotland (NRS)\no National Records of Scotland (NRS) to the Health and Safety Executive Laboratory\no Health and Safety Executive Laboratory to NHS Digital\n\nand to update study documentation.\n\nSpecific conditions of support:\n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold: Confirmed:\n\nThe NHS Digital 2018/19 DSPT review for Health and Safety Executive Laboratory was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 29 September 2020). Please note the updated specific condition of support below.\n\nAll staff at Health and Safety Executive Laboratory that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support.\n\nAmendment Request (approved - 18/01/2018)\n\nThe Health and Safety Laboratory (HSL) was previously an agency of the Health and Safety Executive (HSE, the legal entity and data controller for the application activity). HSL has now become an integral part of the HSE and is now referred to as HSE Buxton or HSE’s laboratory. As such, the HSL can no longer be considered a separate data processor. The amendment requested a change to the data processor for the application activity to the Health and Safety Executive, with HSE Buxton as the location of the data processing.\nThe applicants further explained that, as part of the integration and the wider IT Infrastructure changes that are required to facilitate the above, the information which is held for this project will need to change location. It was clarified that this would affect all study data, including information received from NHS Digital.\n\nApplication considered at CAG meeting on 27/01/2015\n\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 01 September 2014.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 22 October 2014.\n3. Please continue to seek consent in order to access cancer and mortality data from those individuals attending medical examinations.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A0124","index":78,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0124"]
["Reference","14/CAG/1007"]
["Other Refs"]
["Application Title","An investigation into the role of the pharmacy team in reducing avoidable hospital readmissions"]
["Application Summary","This application from the University of Huddersfield & Calderdale and Huddersfield NHS Foundation Trust (CHT) detailed the development of an evidence base for pharmacy interventions in reducing hospital readmissions."]
["Applicant Organisation Name","University of Huddersfield & Calderdale and Huddersfield NHS Foundation Trust (CHT)"]
["Contact Name","Miss Sarah M Upton"]
["Address","W2/47, School of Applied Sciences"]
[null,"University of Huddersfield,"]
[null,"Queensgate, Huddersfield"]
["Postcode","HD1 3DH"]
["Telephone",1484472296]
["Email","u0867424@hud.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants 18 years and above"]
["Description of confidential patient information used","NHS numbers of patients discharged/readmitted"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Huddersfield & Calderdale and Huddersfield NHS Foundation Trust (CHT)"]
["Status","Supported"]
[]
["Outcome Date","2014-11-19"]
["Next Review Date","2016-11-19"]
["Notes","Application considered at CAG meeting on 19 June 2014\n\nSpecific conditions of support\n\n1. Please confirm the sample size. Between 1000 and 2000 patients.\n\n2. Please confirm that the patient information leaflet will include details of how to register a patient’s objection to the use of data. Confirmed 21 October 2014. \n\n3. Favourable opinion from REC Received 17 July 2014.\n\n4. Confirmation of suitable security arrangements via IG Toolkit submission. Received 17 September 2014.\n"]

{"sheet":"A0125","index":79,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0125"]
["Reference","CAG 2-03(PR1)/2014"]
["Other Refs"]
["Application Title","Understanding age inequalities and inequities in cancer diagnosis, treatment and outcomes in brain, colorectal and ovarian tumours, sarcoma and Hodgkin’s lymphoma"]
["Application Summary","This application from the University of Leeds set out the purpose of a study which aimed to use routine health data to quantify and understand the influence of age on the incidence, tumour characteristics, diagnosis, treatment, survival and outcomes of a number of cancers at a population level.\nThe application detailed linking a number of datasets; cancer registry, HES and pathology and treatment information, at the NCRS Northern and Yorkshire offices. It was confirmed that any datasets taken off site would be fully anonymised.\nA recommendation for class 2, 4, 5 and 6 support was requested to cover access to date of birth, date of death, postcode and NHS number. All identifiers would be removed once all linkages had taken place."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Rebecca Birch"]
["Address","Cancer Epidemiology Group, Level 6,"]
[null,"\nBexley Wing, St James’s University Hospital"]
[null,"Leeds"]
["Postcode","LS9 7TF"]
["Telephone","01132068974"]
["Email","\nr.j.birch@leeds.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants-0-110 years old"]
["Description of confidential patient information used","Name, NHS Number, Date of birth, Date of death, Postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","c.e.skinner@leeds.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-02-06"]
["Next Review Date","N/A"]
["Notes","The data has been irreversibly anoymised.\n\nThe study outcomes were published in a paper.\n\nBirch, Rebecca J., et al. \"Rectal cancer in old age–is it appropriately managed? Evidence from population-based analysis of routine data across the English national health service.\" European Journal of Surgical Oncology 45.7 (2019): 1196-1204\n\nAmendment request 23/11/2016\nThe amendment proposed to add an additional cancer to be included in the data linkage. The research questions, methodologies and data security principles would remain the same. By adding an additional diagnostic code, breast cancer would be included as an additional site. This site was included for its high incidence of treatments such as hormone and combination treatments, which would enable the research team to better carry out their analysis.                                                                                                    \n\nSpecific conditions of support\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed that confidential patient information would be processed on the ENCORE system within Public Health England.\n2. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 8 September 2016."]

{"sheet":"A0126","index":80,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0126"]
["Reference","15/CAG/0105"]
["Other Refs","11/EM/0442/80945"]
["Application Title","A prospective cohort study of clinical predictors, disease mechanisms, costs and outcomes of encephalitis in the UK"]
["Application Summary","Encephalitis is inflammation of the brain substance most often caused by a virus or by the body's immune response it is one of the most important types of brain infection. It has a devastation impact on those affected. For the numbers affected, the costs to the NHS and society are disproportionally large, because of the nature of brain damage caused.\nPatients with encephalitis do not do very well in the NHS. The early symptoms are often subtle, so the patient is told there is nothing wrong with them. When they finally get to hospital the management is often poor. The consequencesof the disease are not properly understood, so getting the long term help needed is difficult. With this research study we are aim to study the clinical predictors of encephalitis and of poor outcome, better understand those outcomes in terms of cognitive function, quality of life and costs and ultimately develop the means of\nintervening to improve patient outcome.This study is for anyone who is suspected of having encephalitis from the ages of one month old and above in hospitals across England, Scotland and Wales. The study will be looking at medical notes to see if there is any pattern to the presenting features of encephalitis and to see what treatment has been given. It will try to understand the disease mechanisms by studying patient samples. There are sub studies looking into the quality of life and costs that patients incur. In a selected group of patients we will conduct interviews about their experience and also neuropsychology assessments to see how the brain is functioning after being unwell."]
["Applicant Organisation Name","University of Liverpool / Liverpool Joint Research Office"]
["Contact Name","Professor Tom Solomon"]
["Address","University of Liverpool"]
[null,"Liverpool Joint Research Office, 3 Brownlow Street"]
[null,"2nd Floor Block D Waterhouse Building"]
["Postcode","L69 3GL"]
["Telephone"]
["Email","tsolomon@liv.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Prospective study: all patients meeting suspected encephalitis criteria as\nset out below.\nRetrospective study: all patient diagnosed has having had encephalitis\nMale and female participants \nNo upper age limit"]
["Description of confidential patient information used","Access was requested to medical records in relation to deceased patients from hospital sites to a researcher from the University of Liverpool. The researcher would undertake a review of medical records onsite and extract relevant clinical information onto the clinical record form."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Liverpool"]
["Status","Expired"]
[]
["Outcome Date","2015-03-10"]
["Next Review Date","N/A"]
["Notes","Only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete. \n\nThe findings of this study help clinicians to consider autoimmune encephalitis at an earlier stage in the illness and start immunomodulatory treatments earlier leading to improved outcomes. \n\nApplication considered at CAG meeting on 19/02/2015.\nSpecific conditions of support\n\n1. In line with the comments above, please confirm the age group included within the study. It was confirmed that all age groups would be included.\n2. Favourable opinion from a Research Ethics Committee.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed.\n"]

{"sheet":"A0127","index":81,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0127"]
["Reference","15/CAG/0001"]
["Other Refs"]
["Application Title","Access to healthcare and impact on health inequalities"]
["Application Summary","The NHS is going through a process of changing where certain patients access healthcare services. This study will investigate the relationship between distance/ transport accessibility to healthcare services and health inequalities. It focuses on patients with Rheumatoid Arthritis and Osteoarthritis. The study includes: a systematic review, case study of West Yorkshire Healthcare facilities, analysis of secondary data using econometrics and scenario testing. Key\noutputs will provide the NHS with robust recommendations on the impact of distance/ transport accessibility to healthcare services on health inequalities and recommendations on minimising health inequalities from the policy of centralisation."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Mrs Charlotte Kelly"]
["Address","Leeds Institute of Health Sciences"]
[null,"Leeds"]
[]
["Postcode","LS2 9LJ"]
["Telephone"]
["Email","c.e.kelly@leeds.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The patients in the study have either Rheumatoid Arthritis or Osteoarthritis\nor may have both.\nMale&Female\n18-No upper age limit"]
["Description of confidential patient information used","Access was requested to HES and PROMs datasets from HSCIC and data from the English Longitudinal Study of Ageing from NatCen. Datasets would include postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Faculty Research Ethics and Governance Administrator\ngovernanceethics@leeds.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-04-13"]
["Next Review Date","N/A"]
["Notes","All processing activities have been completed and a data destruction certificate issued and sent to NHS Digital on the 26th of November 2018.  See attached evidence provided to NHS Digital that all source files and files created as part of the research were destroyed in line with NHS Digital policy.\n\nThe study applied for CAG approval to allow the calculation of travel times and distances from patients’ home postcode to the hospital that they attended for their hip or knee replacements using the NHS Digital hospital episode statistics datasets.  The study was able to show that in some cases such as rural areas the distances and travel times by postcode were significantly different when compared to using the population weighted lower super output areas centroid as the starting point.  The key output from using this data is Dr Charlotte Kelly’s PhD Thesis - Quality of life is a matter of distance.  A study investigating the association between transport accessibility to healthcare and health inequalities for patients with rheumatoid arthritis and osteoarthritis.  This is available from https://etheses.whiterose.ac.uk/24766/   The methods developed within this study are now being applied to the area of cancer to focus on differences in health outcomes for cancer patients based on where they live and the journeys to healthcare that they need to make.\n\nApplication considered at CAG meeting on 15/01/2015.\nSpecific conditions of support\n\n1. The applicant should explore whether it would be feasible to provide relevant training to HSCIC staff to allow them to apply the relevant software on their behalf and utilise this option if available. A letter from the HSCIC was provided confirming that this would not be feasible.\n2. Favourable opinion from a Research Ethics Committee. Confirmed.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed\n"]

{"sheet":"A0128","index":82,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0128"]
["Reference","15/CAG/0116"]
["Other Refs"]
["Application Title","Understanding and improving the decision-making process surrounding admission to the intensive care unit"]
["Application Summary","This application from University Hospitals Coventry and Warwickshire NHS Trust set out the purpose of investigating how clinical decisions are made in the best interests of the patient to determine admission into ICU or palliative care and how the process of assessment can be improved. The applicant would be observing the process across six hospitals to establish current practice and evaluation through interviews with ICU doctors, referral activity to ICU and family views on how the decisions should be made. For part of this study, consent would be obtained.\nA recommendation for class 1 and 6 support was requested to cover access to allow an authorised user for one or more of the purpose of extracting and anonymising the information."]
["Applicant Organisation Name","University Hospitals Coventry and Warwickshire"]
["Contact Name","Mr Christopher Bassford"]
["Address","Consultant in Intensive Care Medicine"]
[null,"University Hospital"]
[null,"Clifford Bridge Road"]
["Postcode","CV2 2DX"]
["Telephone","07967 014919"]
["Email","Christopher.Bassford@uhcw.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Access was requested to allow disclosure of confidential patient information for the purpose of anonymisation. This would include work package 3 where access to health records will be required in order to extract anonymised data within 3 NHS Trusts. Work package 4 will require a research nurse to identify the health records of a consecutive series of patients where a referral to ICU was received and to extract information for anonymisation within 5 NHS Trusts."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","ceri.jones@uhcw.nhs.uk"]
["Status","Supported"]
[]
["Outcome Date","2015-04-22"]
["Next Review Date","2018-04-22"]
["Notes","The data controller has confirmed that support for this study can end.\n\nApplication considered at CAG meeting on 26/03/2015.\nSpecific conditions of support \n1. Favourable opinion from a Research Ethics Committee. Confirmed 18th February 2015\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 21st April 2015\n"]

{"sheet":"A0129","index":83,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0129"]
["Reference","15/CAG/0120"]
["Other Refs","IRAS project ID: 159134, REC reference: 15/NW/0184"]
["Application Title","National investigation into suicide in children and young people"]
["Application Summary","Suicide rates in children are low compared to other age groups. However, there are important reasons for regarding a study of suicides in this group as a priority. Firstly, they are of major public interest, particularly when they appear to occur in clusters or to follow a “copycat” pattern. Secondly, public concern over child suicide often focuses on the role of internet sites or social media, but there is relatively little information on the part these factors play. Thirdly, suicide is one of the main causes of mortality in young people. Fourthly, although there are relatively few suicides in young teenagers, suicide rates are agedependent and the numbers increase markedly into the late teens and early 20s. Inquiry data show that 6070\nsuicides occur per year in people aged under 18, 150160 in those aged under 20, and\n500 per year in those aged 25 and under. There is, however, no current national investigative process focussing specifically on suicide in children and young people and no system nationally for reporting suicide trends or recommending priorities for prevention specifically in this age group. A multi agency designed study combining available sources of information on cases of suicide and probable suicide (open verdict) in those aged 20 and under would provide the depth and range of information at an individual level not yet available. Data will be analysed from a range of health and nonhealth sources including coroners inquest reports, Serious Case Reviews, CDOP files, NHS investigations into Serious Untoward Incidents, fatal investigation reports by the Prisons and Probation Ombudsman, Independent Police Complaints Commission reports, and Inquiry data on those in contact with mental health services. Data will be extracted from these sources onto a standardised database for aggregated analysis. An annual report on numbers, trends, antecedents and messages for prevention is proposed."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Louis Appleby"]
["Address","University of Manchester"]
[null,"Centre for Mental Health and Safety, Jean McFarlane Building"]
[null,"Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone","0161 275 0714 "]
["Email","ncish@manchester.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants- Age limit-10-20"]
["Description of confidential patient information used","Access was requested to name, postcode, date of birth, date of death and place of death."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Ms Lynne McCrae-fmhsethics@manchester.ac.uk"]
["Status","Supported"]
[]
["Outcome Date","2015-05-06"]
["Next Review Date","2024-05-06"]
["Notes","Amendment Request 01/03/2017\nThe amendment requested permission to extend the study end date from the current date of 31st March 2017 to 30th June 2017. This additional time would be used to write up the study findings.\nThe amendment also requested an administrative change to the lead R&D contact.\nConfidentiality Advice Team advice\nThe Confidentiality Advice Team agreed that the amendment request was aligned with the principles of the original approval. It was acknowledged that the extension to the study end date did not involve any additional data processing and was only requested to enable additional time to write-up the study findings.\nConfidentiality Advice Team conclusion\nIn line with the considerations above, the Confidentiality Advice Team determined that the minimum criteria under the Regulations appeared to have been met for this amendment, and therefore advised recommending support to the Health Research Authority.                   \n                                                                                                                                  Amendment update 02 September 2016:                                                                       The amendment request was to extend the data collection to Wales, Scotland and Northern Ireland (separate applications to be made to Scotland and N. Ireland) in order to allow a more comprehensive and detailed exploration of the characteristics of young people who die by suicide and the antecedents of suicide (e.g. role of frontline services and risk recognition). This proposed extension to the study was documented in the original, approved version of the study protocol (Version 1: 09/02/2015)."]

{"sheet":"A0130","index":84,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0130"]
["Reference","15/CAG/0102"]
["Other Refs"]
["Application Title","Surveillance of Type 2 Diabetes in children"]
["Application Summary","This study will investigate the incidence and associations of Type 2 diabetes developing in children and young people under 17 years of age in the UK and Republic of Ireland. Until recently Type 2 diabetes was not a clinical problem in children or adolescents, being a condition seen almost exclusively in adults. However there is growing evidence that\nthe increase in childhood obesity has resulted in cases of Type 2 diabetes being seen relatively frequently in childhood. This study will repeat a survey conducted in 2004/5 using the same methodology that identified 68 children and adolescents diagnosed over a 12 month period. We believe the numbers will have increased since then.\nType 2 diabetes is linked with greatly increased ill health in adulthood and the outcome is worse in those developing the disease at an early age. So it is important to identify, treat and manage these children as soon as possible. Furthermore, there are some anecdotal reports from UK clinics and studies from the USA and Europe suggesting that some young people with Type 2 diabetes are poor attenders at clinic and have a tendency not to take their medication\nas prescribed. This BPSU approved study will also allow us to estimate the current incidence and whether it has increased since ten years ago. It will also allow us to examine current treatment modalities and whether there is truly a problem to delivering optimal care for this group of patients."]
["Applicant Organisation Name","University Hospitals Bristol NHS"]
["Contact Name","Professor Julian Hamilton-Shield"]
["Address","Bristol Royal Hospital for Children"]
[null,"Upper Maudlin Street"]
[null,"Bristol"]
["Postcode","BS2 8AE"]
["Telephone","0117 342 0183"]
["Email","j.p.h.shield@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children aged between 0-14 with newly diagnosed acute pancreatitis\nMale and female participants-0 years-17 years old"]
["Description of confidential patient information used","We will be seeking minimal identifier information in order to help with the deduplicating\nof case reports. This\ninformation will be held separately from the clinical data.\nNHS/CHI number\nDate of birth\nSex\nEthnicity"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Birgit.Whitman@bristol.ac.uk"]
["Status","Supported"]
[]
["Outcome Date","2015-03-13"]
["Next Review Date","2016-03-13"]
["Notes","Confidentiality Advisory Group advice from meeting 30 January 2015\n\nSpecific conditions of support \n1. Support only applies to data generated in England and Wales.\n2. Favourable opinion from a Research Ethics Committee - Confirmed 9 December 2014.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 13 March 2015\n"]

{"sheet":"A0131","index":85,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0131"]
["Reference","15/CAG/0111"]
["Other Refs"]
["Application Title","Surveillance of Childhood Acute Rheumatic Fever (SCARF)"]
["Application Summary","This application from Birmingham Children's Hospital NHS Foundation Trust set out the purpose of utilising the BPSU surveillance methodology to ascertain a dataset to assess the epidemiology for the surveillance of childhood acute rheumatic fever (SCARF). Clinicians participating within the BPSU reporting mechanism will be reporting cases of incidence to the BPSU office. The BPSU office will notify the lead investigator and the research team will send a proforma consisting of specified identifiers and associated clinical data to the clinicians to complete and return. The identifiers will be kept separately from the clinical data for case verification and to de-duplicate the dataset. The applicant also requested support to utilise the specified identifiers for the purposes of linking with Hospital Episode Statistics (HES) data to ensure cases have not been missed. \n\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover access to an authorised user for the process of extracting and anonymising data, to obtain and use information about past or present geographical location, to link patient identifiable information obtained from one or more sources and also for auditing, monitoring and analysing patient care and treatment.\n\n"]
["Applicant Organisation Name","Birmingham Children's Hospital NHS Foundation Trust"]
["Contact Name","Dr Mary Salama"]
["Address","Birmingham Children's Hospital NHS Foundation Trust"]
[null,"Steelhouse Lane"]
[null,"Birmingham"]
["Postcode","B4 6NH"]
["Telephone","01213338179"]
["Email","mary.salama@bch.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Acute Rheumatic fever- Male and femaile participants-0 years-16 years old"]
["Description of confidential patient information used","We will need details of clinical presentation and course of illness in addition to treatment and outcome. There will also be spme aspects of past health recorded and details of blood and other investigations susch as echocadiograms."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Mr Richard Lynn, Royal College of Paediatrics and Child Health"]
["Status","Supported"]
[]
["Outcome Date","2015-04-24"]
["Next Review Date","2016-04-24"]
["Notes","This application was considered at the precedent set CAG meeting held on 27 February 2015.\n\nSpecific conditions of support \n\n1. Support only applies to data generated in England and Wales. \n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 26 February 2015.\n \n"]

{"sheet":"A0132","index":86,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0132"]
["Reference","15/CAG/0115"]
["Other Refs"]
["Application Title","UKCTOCS UK Collaborative Trial of Ovarian Cancer Screening"]
["Application Summary","This research trial is based on the premise that screening detect ovarian cancer at an early stage may reduce the number of deaths. Large studies performed by the research team during the last decade have refined two methods of screening. One method uses ultrasound scanning, similar to the scanning used in pregnancy, to assess the size and texture of the ovaries. The second method involves measurement of a substance called CA 125, which is released in large amounts into the circulation in ovarian cancer. Using these tests it seems likely that over 80% of women with ovarian cancer can be identified before they have symptoms. There is some evidence that screening may improve the survival of women with ovarian cancer, but there is a need to perform a very large trial in order to see whether screening definitely saves lives. This study will involve 200,000 women in the UK, of which half will be screened every year for 6 screens and half followed up without screening. Of the 100,000 women who will be screened 50,000 will be screened with ultrasound and 50,000 with the CA 125 test. To accurately assess the value of screening the study needs to be a randomised trial. This means that if a woman agrees to take part, the decision about whether she is screened and if so with which test, is a random decision. Women who agree to participate will take part at 12 collaborating centres around the UK and the study will take 10 years to complete. The end of the study will provide information about how many lives ovarian cancer screening can save, how much this will cost, how women feel about being screening and the complications of screening. This information will be used to make a decision about whether an NHS national screening programme for ovarian cancer should be introduced.\n\nThe main reason support was sought was with regards to release of ONS cancer and death registration data and HES data both for the primary purpose of identifying incidence of ovarian and fallopian tubal cancer and secondarily for research into other cancers and diseases. The trial was conceived in 1999 and ethical approval obtained in Nov 2000. The first women were recruited in April 2001 and informed consent sought for the participants. Based on this permission was given for flagging with Office on National Statistics which is ongoing and for release of HES data between 2000 - 2010.The HSCIC has refused to release further data as their view is that the consent materials do not give enough information to participants about the data sharing or processing involving the HSCIC and that the consent is now out of date.\n"]
["Applicant Organisation Name","Dept of Women's Cancer, Institute for Women's Health, Institute for Women's health ,\nUCL"]
["Contact Name","Professor Usha Menon"]
["Address","MRC Clinical Trials Unit, University College London"]
[null,"90 High Holborn"]
[null,"London"]
["Postcode","WC1V 6LJ"]
["Telephone","020 767 04927 "]
["Email","u.menon@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Post menopausal asymptomatic, health women aged 50-74. Female participants only"]
["Description of confidential patient information used","Name, NHS number, Date of birth, postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Dr Jatinderpal Kalsi   j.k.kalsi@ucl.ac.uk\n "]
["Status","Supported"]
[]
["Outcome Date","2015-04-16"]
["Next Review Date","2024-04-16"]
["Notes","24 April 2023 - change in data processor from NHS Digital to NHS England, regarding data sources National Cancer Registration and Analysis Service (NCRAS), and ONS mortality data.\n\n25/03/2019:  Amendment supported to enable follow-up of the patient cohort directly with the National Cancer Registration Service at Public Health England and via the Patient Episodes Dataset Wales (PEDW) dataset at NHS Wales Informatics Service.                                                                                                                                                                                                                                                                                                                  Application considered at CAG meeting on 13 March 2015.\nSpecific conditions of support \n\n1. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 19th March 2015\n"]

{"sheet":"A0133","index":87,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0133"]
["Reference","15/CAG/0125"]
["Other Refs"]
["Application Title","28 year followup of patients with neurotic disorder"]
["Application Summary","The classification and management of anxiety, depressive and personality disorders are among the most pressing concerns of both primary care and psychiatric services, but the component of personality disorder is almost always ignored, despite growing evidence that it predicts the outcome of treatment better than almost any other variable. About one in four of all patients with anxiety and depression have sufficient personality pathology to be described as having a personality disorder (originally lumped together as neurotic disorder) and these not only have a worse outcome but their health service costs are much greater than those with no personality disorder. At present NICE and other guidelines do not take into account comorbid personality disturbance in making recommendations for treatment. The proposed study, which completes the long term assessment of a cohort of anxious and depressed patients seen before treatment was allocated in a randomised trial, also has recorded personality status before treatment, and differences in outcome by personality status were shown after two years, and are expected to be at least as great in the longterm. The importance of environmental factors in determining better or worse outcome in those with initial personality disturbance will also be examined as these may be more important than the effects of specifictreatments."]
["Applicant Organisation Name","Imperial College"]
["Contact Name","Professor Peter Tyrer"]
["Address","Imperial College"]
[null,"Centre for Mental Health"]
[null,"St Dunstan's Road, London"]
["Postcode","W6 8RP"]
["Telephone","02073861233"]
["Email","p.tyrer@imperial.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants"]
["Description of confidential patient information used","Access was requested to obtain current contact details from the Health and Social Care Information Centre (HSCIC) for individuals who were previously consented/enrolled within the study but for whom contact information is no longer accurate and to also obtain date of death and cause of death data to complete the overall study. The applicant would need to submit name and date of birth to HSCIC and the applicant will receive address, GP registration, date of death and cause of death from HSCIC."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","becky.ward@imperial.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-04-16"]
["Next Review Date","N/A"]
["Notes","All identifiers have been permanently deleted.    Support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.   No further processing of confidential patient information is taking place.\n\nThe study has led to twenty-five original articles and one book.  These publications have pointed out that our current treatments for common mental illness in the form of neurosis have largely failed despite short-term gains as, in the long-term, outcome of these conditions is poor. Further work has established that changes in the environment are more important than ones provided by medical professionals. The associated work on personality disorder in the Nottingham Study has led to the main author (Peter Tyrer) chairing the World Health Organisation Reclassification of Personality Disorder Group.  The data from the study were used to help the group decide on a radical new classification that has been shown to be superior to its predecessor and is now the official world classification (since January, 2022).\n\nThis application was considered at the Precedent Set CAG meeting held on 27 March 2015.\nSpecific conditions of support \n1. Remove identifiers from dataset for patients who had not consented or provided a response. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 15th May 2014\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 4th December 2014\n\n"]

{"sheet":"A0134","index":88,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","0134"]
["Reference","15/CAG/0127"]
["Other Refs"]
["Application Title","Cellular immunity to herpesvirus infection: Studies with EBV & CMV v1"]
["Application Summary","We are studying the way in which the human immune system, particularly a type of white blood cell known as a Tlymphocyte, normally controls infection caused by two human herpes viruses, Epstein−Barr virus (EBV) and cytomegalovirus (CMV). These viruses infect many people and persist for life under the control of the immune system. In the vast majority of cases infection is asymptomatic, but can be life−threatening in immunosuppressed patients. However in some cases primary infection of immunocompetent people is associated with an identifiable acute clinical syndrome, infectious mononucleosis (IM), more commonly known as glandular fever. We wish to make a detailed study of the immune response to EBV and CMV in patients with acute primary infection and in long−term healthy virus carriers. This information will help in the development of future treatments of virus−associated disease in immunosuppressed patients."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Professor Paul Moss"]
["Address","University of Birmingham"]
[null,"Vincent Drive"]
[null,"Birmingham "]
["Postcode","B15 2TT"]
["Telephone",1214144491]
["Email","a.pachnio@bham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Infectious Mononucleosis patients\nMale and female participants\n16 years old-no upper age limit"]
["Description of confidential patient information used","We will receive the following confidential/sensitive patient information from hospital haematology labs for IM patients identified by a positive 'monospot' test (without prior consent from the patient):\nResults of the ‘monospot’ test (used to identify IM patients) and whole blood counts from the initial diagnostic sample\nPatient's name\nPatient's date of birth\nPatients' GP\nAll the above will be destroyed if we do not subsequently receive permission (via the GP) to contact the patient regarding the study.\nFollowing verbal consent given to the GP by the patient we may then receive the following information:\nFull postal address\nTelephone number\nAll the above would be destroyed if the patient does not subsequently complete a written consent form at the time of first sample donation.\nFollowing written consent from the patient we may also receive:\nInformation regarding the timing and nature of the first symptoms which led to GP consultation (acquired via questionnaire completed by the donor at the time of first sample donation)."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Dr Sean Jennings"]
["Status","Supported"]
[]
["Outcome Date","2015-04-16"]
["Next Review Date","2024-04-16"]
["Notes","Amendment Request (Approved 26/10/2018)\nThe amendment seeks a duration extension to the support recommended under the Regulations to 31 June 2023. The amendment also confirmed that the extended study duration was now funded by the Medical Research Council.\n\nApplication considered at CAG meeting on 30/04/2015.\nSpecific conditions of support \n1. Favourable opinion from a Research Ethics Committee. (Confirmed 12th January 2015)\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed 5th March 2015)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0135","index":89,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0135"]
["Reference","15/CAG/0116"]
["Other Refs"]
["Application Title","Understanding and improving the decision-making process surrounding admission to the intensive care unit"]
["Application Summary","This application from University Hospitals Coventry and Warwickshire NHS Trust set out the purpose of investigating how clinical decisions are made in the best interests of the patient to determine admission into ICU or palliative care and how the process of assessment can be improved. The applicant would be observing the process across six hospitals to establish current practice and evaluation through interviews with ICU doctors, referral activity to ICU and family views on how the decisions should be made. For part of this study, consent would be obtained. "]
["Applicant Organisation Name","University Hospitals Coventry and Warwickshire"]
["Contact Name","Dr Christopher Bassford"]
["Address","University Hospitals Coventry and Warwickshire"]
[null,"General Critical Care Unit"]
[null,"Clifford Bridge Road"]
["Postcode","CV2 2DX"]
["Telephone","02476964000"]
["Email","christopher.bassford@uhcw.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\n18 years old-no upper age limit"]
["Description of confidential patient information used","Access was requested to allow disclosure of confidential patient information for the purpose of anonymisation. This would include work package 3 where access to health records will be required in order to extract anonymised data within 3 NHS Trusts. Work package 4 will require a research nurse to identify the health records of a consecutive series of patients where a referral to ICU was received and to extract information for anonymisation within 5 NHS Trusts. "]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","ceri.jones@uhcw.nhs.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-04-22"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that support for this study can end."]

{"sheet":"A0136","index":90,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0136"]
["Reference","15/CAG/0134"]
["Other Refs"]
["Application Title","The risk of major bleeding with novel anti-platelets: A comparison of ticagrelor with clopidogrel in a real world population of patients treated for acute coronary syndrome"]
["Application Summary","Following the recent PLATO trial, ticagrelor has been recommended in ESC and NICE guidelines for the treatment of acute coronary syndromes. The ACS guidelines at Aintree University Hospital and within Mersey Network were recently altered; with Ticagrelor replacing the previously recommended clopidogrel in 2012/13. There have been concerns raised of potential increased bleeding risk with ticagrelor in a “real world” population given its more potent antiplatelet effect. The PLATO trial did not show any statistically significant difference in overall bleeding between clopidogrel and ticagrelor. There was however an increase incidence of non CABG related major bleeding and the average age of\nsubjects within the study was 10 years younger than the mean age of ACS patients in the UK. Also there were a higher proportion of men compared to women than would be seen in UK demographic data. One may therefore postulate that the incidence of bleeding with ticagrelor in a “real world” population, including more high risk patients, may be higher. We intend to compare the incidence of bleeding with ticagrelor and clopidogrel used for treatment of ACS amongst patients at five hospitals within the Mersey network; Aintree University Hospital, Royal Liverpool University Hospital,Warrington, Whiston and Chester Hospitals. Data will be collected retrospectively. We aim to collect data on the last 2500 patients receiving clopidogrel for ACS as a new prescription prior to the change in guidelines. We will then collect data on a similar number of patients given ticagrelor after the change in guidelines for the same indication. We intend to collect data using patient's paper and electronic case notes. We will also intend to access mortality data from a national registry. We will not be contacting patients directly or influencing management in any way. In this regard it is an\nobservational study."]
["Applicant Organisation Name","Aintree University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Aleem Khand"]
["Address","University Hospital Aintree"]
[null,"Lower Lane"]
[null,"Liverpool"]
["Postcode","L9 7AL"]
["Telephone",1925665272]
["Email","aleem.khand@aintree.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants-\nLower age limit: 18\nUpper age limit: 120\n"]
["Description of confidential patient information used","We intend to access combined Office of National Statistics and Hospital Episode Statistics data on mortality for survival\nrates in our study. We intend to submit list of patients for mortality data. We will only be requesting the following data :\nany death, date of death, and cause of death as per death certificate. Also will request data on hospital admissions in\nfollow up period that coded for bleeding event."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Paula Harlow-Aintree University Hospital"]
["Status","Supported"]
[]
["Outcome Date","2015-05-15"]
["Next Review Date","2024-05-15"]
["Notes","30 May 2023 - change in data processor from NHS Digital to NHS England, regarding data source Hospital Episode Statistics (HES).\n\nAmendment supported 30 May 2023 to;\n\n•\tinclude an additional purpose of ‘validating metrics that are used to calculate the bleeding vs reinfarction risk when placing patients on anti-platelet medications (such as ticagrelor and clopidogrel)’,\n\n•\tto allow Liverpool University Hospitals NHS Foundation Trust to disclose confidential patient information to NHS England to undertake further linkage with Hospital Episode Statistics (HES), and for the flow back to the applicant, \n\n•\tinform CAG that a pseudonymised dataset will be disclosed to Liverpool heart and Chest hospital (LHCH) for analysis,\n\n•\tto clarify that Aintree University Hospital and The Royal Liverpool Hospital Trusts have now merged to form Liverpool University Hospitals NHS Foundation Trust (LUHFT),\n\n•\tand to extend the duration of ‘s251’ support until January 2024\n"]

{"sheet":"A0137","index":91,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","0137"]
["Reference","15/CAG/0138"]
["Other Refs","REC reference: 08/H0308/276"]
["Application Title","Simon Broome Familial Hypercholesterolaemia Register (MR180)"]
["Application Summary","This application from University College London set out the purpose of continuing the development of a research database and associated epidemiological study to investigate risk factors in Familial Hypercholesterolemia patients. The study will assess the extent to which the prognosis has improved due to the increase in availability and effectiveness of the lipid-modifying drug therapy and also the increased rate in which patients are identified and treated. The applicant had previously obtained support with the condition that newly registered patients would prospectively consent for flagging via the NHS Central Register. From this period, consent forms were in place and mortality data was provided both for those who had consented and also those who were registered prior to the adoption of the consent model. The applicant would like to continue receiving mortality data; however, the Health and Social Care Information Centre (HSCIC) Data Access Advisory Group (DAAG) had advised that the applicant should seek s251 support approval from CAG for the cohort who were registered prior to the consent forms being in place."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Riyaz Patel, Professor Riyaz Patel. Professor of Cardiology"]
["Address","University College London, Institute of Health Informatics"]
[null,"403 222 Euston Rd"]
[null,"London, United Kingdom"]
["Postcode","NW1 2DA"]
["Telephone","020 354 95332 "]
["Email","riyaz.patel@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Identifying data as in part A question 11. Sensitive data held on the database includes ethnic group and physical health data.\nThe register was established in 1981 and includes patients with Familial Hypercholesterolaemia recruited from participating lipid clinics. Data collected is on medical history, family history, treatments, genetic mutations, lifestyle information, lipids, blood pressure and body mass index. Information on mortality up to 2011 is also held on the database. We wish to obtain further mortality data from HSCIC up to the current date in order to update previously published analysis. The identifiable data from these patients is stored and processed in a safe haven environment."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Professor Graham J Hart PhD FMedSci, UCL School of Life and Medical Sciences"]
["Status","Supported"]
[]
["Outcome Date","2015-06-08"]
["Next Review Date","2024-06-08"]
["Notes","This application was considered at the CAG meeting held on 4th June 2015.\n\nSpecific conditions of support \n\n1. Provide feedback on the development and implementation of patient notification at annual review submission\n2. Favourable opinion from a Research Ethics Committee. Confirmed 11th November 2008\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC on 26th March 2015.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0138","index":92,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[35,1,35,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[13,1,13,4],[7,1,7,4],[8,1,8,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[9,0,11,0],[10,1,10,4],[9,1,9,4],[12,1,12,4],[11,1,11,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0138"]
["Reference","CAG 1-03(PR3)/2014"]
["Other Refs"]
["Application Title","Longitudinal Study of Young People in England (LSYPE)"]
["Application Summary","The Longitudinal Study of Young People in England (LSYPE) also known as 'Next Steps' to the cohort was previouslymanaged and funded by the Department of Education (DfE) from 2004 until 2012. In 2013, the Economic and Social Research Council (ESRC) took over the funding of the study and management transferred to the Centre for Longitudinal Studies (CLS), at the Institute of Education, University of London. The initial LSYPE study took place in 2004 with young people in Year 9 (aged 13/14 years), with the cohort beingcontacted annually until 2010. The next survey (wave 8) will take place in 2015 when the cohort will be 24/25 years old.This next wave will continue to collect information on the lives of the cohort such as their education, employment, economic circumstances, family life, physical and emotional health and wellbeing,social participation and attitudes. The ongoing success of the study depends on maintaining contact with as many study members as possible, particularly as there has been a long period where no contact has been made with the cohort. The purpose of this application is to request Section 251 support for two activities which will support this endeavour.\n1)We wish to supply the HSCIC with lists of cohort members in order that they can be matched with GP registrations and new addresses supplied. We would then contact these matched individuals and invite them to continue participating in the study.\n2) We would like to receive notifications from the HSCIC which inform us of deaths, embarkations (i.e. emigrations) and exits/entry from the NHS which are used for both tracing and research purposes. We currently receive these notifications on other projects and will be applying for Section 251 support to continue to receive these notifications\nwithout explicit consent from study members.\nAmendment request-25/06/2015\nIt was noted that one external supplier had been appointed as Data Processor to carry out the survey fieldwork and associated mailings for the LSYPE Age 25 survey. The National Centre for Social Research (NatCen) had been contracted to carry out: (1) Email and postal mailings to LSYPE cohort members about the study. (2) Interviews with LSYPE cohort members. Upon completion of these activities, the data files will be securely deleted from NatCen systems. Note: These activities were covered in the original application, but the Data Processor had not been appointed at that time.\nAn amendment was submitted to request an additional data processor (NatCen) with no change to the purposes, data sources, data items or data flows.\n"]
["Applicant Organisation Name","Centre for Longitudinal Studies, UCL Institute of Education"]
["Contact Name","Ms Lisa Calderwood"]
["Address","UCL Institute of Education"]
[null,"Centre for Longitudinal Studies"]
[null,"20 Bedford Way"]
["Postcode","WC1H 0AL"]
["Telephone"]
["Email","l.calderwood@ioe.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\n0-150 years"]
["Description of confidential patient information used","1) GP registrations and addresses from the Health and Social Care Information Centre (HSCIC) so that individuals could be contacted and invited to continue participating in the study.\n2)  Notification from the HSCIC of deaths, embarkations (i.e. emigrations) and\nexits/entry from the NHS\n"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","UCL Institute of Education"]
["Status","Supported"]
[]
["Outcome Date","2014-04-17"]
["Next Review Date","2024-04-17"]
["Notes","14 August 2023 - change in data processor from NHS Digital to NHS England regarding address data, and notifications of deaths and embarkations.\n\nAmendment supported 14 August 2023  to receive mortality data from NHS England, including fact, date and cause of death, for everyone who has ever participated in the study, including those who have withdrawn from the study (except where patients have withdrawn from the study and stop usage of their data)\n\n30 March 2023 - change in data processor from NHS Digital to NHS England, regarding ONS mortality data, embarkations, and address details\n\nOctober 2020 – support extended to add NatCen, Kantar Public and IPSOS Mori as a data processor, to provide the entire cohort to NHS Digitial in order for address to be return and notification of an update to electornic storage arrangements at UCL.\n\nApplication considered at CAG meeting on 18 February 2014 \nSpecific conditions of support\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 02 April 2014.\n\n2. Confirmation of favourable Research Ethics Committee opinion. Confirmed.\n\n3. Provision of final version of patient information materials which must include reference to ongoing data collection from the HSCIC. A web link would be provided to participants at the next mailing which would include information in relation to ongoing data collection from the HSCIC.\n\n12 August 2021 - amendment supported to allow the Next Steps Study to receive mortality data, including patients’ cause of death, from NHS Digital.\n"]

{"sheet":"A0139","index":93,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0139"]
["Reference","15/CAG/0110"]
["Other Refs"]
["Application Title","Life after prostate cancer diagnosis"]
["Application Summary","This application describes a research study which aims to:\n• describe the health-related quality of life (HRQL) of men with prostate cancer using qualitative (interview) and quantitative (survey) methods; \n• explore if and how their HRQL is associated (cross-sectional) or is predicted by (longitudinal) disease, treatment and/or patient characteristics with a view to inform health care policy and service delivery to better meet the needs of such men and their families;\n• describe levels of patient empowerment and undertake preliminary exploration of the interaction between empowerment and HRQL."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Adam Glaser"]
["Address","University of Leeds"]
[null,"Consultant Paediatric & Adolescent Oncologist"]
[null,"Level 5, Clinical Sciences Building,St James's University Hospital"]
["Postcode","LS9 7TF"]
["Telephone",1132066523]
["Email","a.glaser@nhs.net"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from NCRS in relation to men diagnosed with prostate cancer between 01/04/2012 and 31/03/2014 and a second cohort diagnosed at a later date.  \n"]
["Description of confidential patient information used","Name and address are requested to send patient surveys"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Leeds- governance-ethics@leeds.ac.uk\n"]
["Status","Expired"]
[]
["Outcome Date","2015-05-15"]
["Next Review Date","N/A"]
["Notes","Application expired 31/03/2019. University of Leeds confirmed that this application reference is no longer processing confidential patient information without consent. The legal support in place to allow relevant information to be processed without consent is expired\n\nThis application was considered at the CAG meeting held on 26 March 2015.\n\nSpecific conditions of support \n1. Confirmation as to whether it is a retrospective study only, if any of the cohort was still receiving treatment, members had advised that further efforts should be made at a local level to inform participants of the disclosure of data and the mechanisms established to enable opt-out of the survey. The applicant confirmed that it was a retrospective study which invited participants who had been diagnosed 15-39 months previously, some of whom may still be undergoing treatment. Patients will not be newly diagnosed but they may be having ongoing follow up or treatment, including maintenance treatment and relapse therapy. The applicant also confirmed the steps which will be undertaken to ensure that participants are informed of the disclosure of data and the mechanisms established to enable opt-out of the survey.\n2. Telephone interviews were not included as part of this support, as prior consent would be in place.\n3. Confirmation regarding what data and identifiers would be retained, for what purpose and duration of retention. The applicant confirmed that confidential patient information would only be retained by the survey provider for the time required to complete the survey activity and data anonymisation for each cohort. During this time, participant identifiers will be stored on the survey provider’s secure hard drives until completion of the fieldwork period, after which it will be confidentially deleted using a designated secure software programme. Only the response data will be retained for 15 years following the completion of the study, in accordance with research governance requirements and data protection laws.\n4. Confirmation that disease and treatment information will only be extracted from the NCRS to send to the analysis centres, for the patients who had returned the questionnaires and registered their consent. The data in relation to non-responders would have demographic details only. The applicant confirmed that data released from the National Cancer Registration System relating to non-responders will contain demographic data only.\n5. Favourable opinion from a Research Ethics Committee. Confirmed 20th February 2015.\n6. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 28th August 2014.\n"]

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[]
[]
["Application Number","0140"]
["Reference","15/CAG/0136"]
["Other Refs"]
["Application Title","Linkage of a military cohort study to secondary healthcare records"]
["Application Summary","There are a number of factors about the UK military which could put them at a greater risk of physical health problems and mortality than the general population. There are very high levels of alcohol use and drinking is an accepted part of military culture. In addition, military personnel are more likely to experience stressful events than the general population, particularly during deployment. The King’s Centre for Military Health Research (KCMHR) cohort study was set up to look at a representative sample of UK military personnel, and collected data on mental health, alcohol use and deployment experiences. Identifying the future healthcare needs of military personnel and veterans is a current priority for the UK government.\nHowever, the current datasets that are available to look at use of healthcare services (and the reasons why) do not identify whether or not an individual is in the military. This study will be able to identify military personnel in existing NHS datasets for England, Wales and Scotland that include secondary healthcare records, by linking to the KCMHR cohort data. This will provide information on approximately 10,000 military personnel and on the health problems for\nwhich they most commonly seek help. We will be able to identify whether physical health conditions or accidents and injuries are most common. A further aim for the study will be to look at whether we can predict if an individual is likely to be admitted to, or visit hospital, for a physical health condition or an accident or injury, by using the information from the KCMHR cohort about how much alcohol they drink and whether they have a mental health problem. We will also be able to look at the costs to the NHS resulting from high levels of alcohol use and mental health problems within the military."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Laura Goodwin"]
["Address","King's College London"]
[null,"Psychological Medicine, Weston Education Centre"]
[null,"10 Cutcombe Road, Denmark Hill"]
["Postcode","SE5 9RJ"]
["Telephone",2078485425]
["Email","laura.goodwin@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Generic Health Relevance, Male and female participants, 18-75 years old"]
["Description of confidential patient information used","The confidential personal identifiers that are required for the data linkage will be provided by KCMHR to the HSCIC, ISD and SAIL. The sensitive information from the healthcare records that will be used includes full dates of admission and discharge, which are required for the time to event analyses. Geographical data has also been requested, but only at the level of government office region, so there is no risk that patients could be identifiable from this level of geography.The sensitive data to be analysed from the cohort data, include childhood adversity, alcohol misuse and mental health. These data have already been collected and KCMHR have published widely using these outcomes. Participants have been informed of the outcomes of these studies through dissemination on the website and through newsletters. The findings on mental health prevalence and associations have been published in academic papers and have been disseminated widely through the UK and international media. The work from the KCMHR cohort is used to provide prevalence estimates for the UK military. The data on alcohol misuse has also been published in a number of academic papers and these findings have been covered by the UK press (including a recent BBC interview) and participants will also be aware of this data through newsletters. There has been much discussion in the media (independent of KCMHR) regarding the potential health consequences of the high levels of alcohol misuse in the UK military. It should therefore not be a surprise to participants that these research questions would be investigated. However, we will ensure that there is fair processing of the linked data that will be used to answer research questions on the longer term consequences of alcohol misuse. We will do this by disseminating information to participants on the aims and research questions for this study and on the methodology that will be used. Participants will be informed that they can request to be withdrawn from the data linkage."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","King's College London"]
["Status","Expired"]
[]
["Outcome Date","2015-05-29"]
["Next Review Date","N/A"]
["Notes","Application considered at CAG meeting on 30/04/2015.\nApproved for a period of 12 months.\n\nThe identifiable information required for the data linkage had been deleted by the HSCIC (England) and SAIL (Wales), in line with one of our conditions.\n\nSpecific conditions of support.\n\n1. Sufficient time must be allowed by the applicant to ensure that information on the proposed activity is provided in advance to the cohort, using all reasonable communication methods available, to enable time for review and any objections to be made. This must take place prior to any data flowing to the HSCIC / SAIL.\n\n2. Data generated in Scotland is excluded from the scope of this approval due to the restrictions of the Health Service (Control of Patient Information) Regulations 2002, and an alternative legal basis should be identified to link with this data.\n\n3. Favourable opinion from the Research Ethics Committee or REC confirmation to be provided that a specific amendment is not required for this non-consented activity. It was confirmed by the REC that a further amendment would not be necessary.\n\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Published v12 assessment available on IGT website. \n\n5. Once linkages have been undertaken between the data from the military cohort study and secondary healthcare records, an end closure report should be submitted no later than 12 months following final approval, confirming that the HSCIC and SAIL have deleted all relevant information and there is no further processing of identifiable information taking place under support.  \n\n"]

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[]
[]
["Application Number","0142"]
["Reference","15/CAG/0126"]
["Other Refs"]
["Application Title","QUEST Follow Up Study"]
["Application Summary","ASD Spectrum Disorder (ASD) is a severe and lifelong developmental disability affecting about 1% of children and characterized by pervasive impairments in social communication and stereotyped and restricted interests. In addition to these core symptoms, 70-90%\nof young children with ASD have significant additional psychiatric disorders that impair their everyday functioning and reduce quality of life for themselves and their families.\nIn 2007-2008 our team recruited 277 families from two London health districts (Lewisham and Bromley) with children aged 48 years diagnosed with ASD (the “QUEST” study). We ascertained the prevalence, severity, impact and pervasiveness of a wide range of emotional and behavioural problems by parent and teacher report. Parents reported an overall prevalence of emotional and behaviour problems of more than 70%, including hyperactivity and inattention,\nfears and worries, oppositional behaviour and rages, sleep problems, sensory problems and self injury.Teachers reported similar rates.However, research shows that only ~20% of these children are expected to go on to develop severe and often entrenched maladaptive behaviours problems so severe that they jeopardize the core elements of ordinary childhood experience: living with their families, attending local schools and participating in community activities. Relatively little is known about the factors that predict which children will go on to develop severe maladaptive behaviour. This is an important clinical and public health question because early identification would allow professionals to target resources and interventions to the most needy children and families. Therefore in this current study we wish to followup the QUEST children now that they are aged 10 to 14 years old to identify the personal, family and wider environmental risk/protective factors that later predict severe maladaptive behaviour in adolescence. We will then further follow these children up again in two years’ time to determine which children have persistent severe maladaptive behaviour and to determine which factors were predictive. The present application deals with the first wave of followup data collection at 10-14 years (time 2). For the third time point data collection we will seek a major amendment when the assessment battery is decided following the current proposed follow up study."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Prof Emily Smith"]
["Address","Institute of Psychiatry, King's College London"]
[null,"Child and Adolescent Psychiatry Building"]
[null,"De Crespigny Park"]
["Postcode","SE5 8AF"]
["Telephone","020 7708 5800"]
["Email","emily.simonoff@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Autism Spectrum Disorder\n10-14 years old"]
["Description of confidential patient information used","The NHS Personal Demographics Service will be used to match up names and NHS numbers to the families’ contact\ndetails (telephone numbers and addresses). We already have records of the NHS numbers of the children in the study,\ngiven to us by the parents for research purposes, so these can be used for this purpose."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","King's College London"]
["Status","Supported"]
[]
["Outcome Date","2015-06-17"]
["Next Review Date","2016-06-17"]
["Notes","Application considered at CAG meeting on 27th March 2015"]

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[]
[]
["Application Number","0143"]
["Reference","15/CAG/0149"]
["Other Refs"]
["Application Title","Breast-Screening After Radiotherapy Database - Questionnaire (BARD-Q)"]
["Application Summary","Women who have had radiotherapy to the upper chest under the age of 36 as treatment for Hodgkin Lymphoma are at a higher risk of developing secondary breast cancer. We want to look at whether women who are at higher risk are having annual breast screening according to the national breast cancer screening protocol. We would also like to know what the reasons behind possible deviations from the protocol are. We invite women to participate who have\npreviously attended a national risk review for secondary breast cancer in 2003/4 at the Christie and the Royal Marsden. The Cancer Registry North West will supply us with date of death so we can exclude any patients who have died. We will then send questionnaires to eligible women, asking them about their breast screening frequency and if they have had any issues gaining screening appointments. Following the return of the questionnaires, we will contact breast screening centres to verify screening and dates. Our analysis will concentrate on looking at the percentage of women who had issues with their screening and reasons behind the issues."]
["Applicant Organisation Name","Manchester University & The Christie NHS Foundation Trust"]
["Contact Name","Dr Sacha Howell"]
["Address","Manchester University & The Christie NHS Foundation Trust"]
[null,"550 Wilmslow Road"]
[null,"Manchester"]
["Postcode","M20 4BX"]
["Telephone","0161 446 8347"]
["Email","Sacha.howell@christie.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Hodgkin Lymphoma\nFemale participants only\n0-36 years old\n"]
["Description of confidential patient information used","The project team will need NHS numbers, address and date of death of all potential participants. We will need address and date of death to be able to send out questionnaires to eligible participants. We will need NHS numbers to be able to get the address and date of death, and to ask breast screening centres for screening frequency of patients."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","john.radford@manchester.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-05-18"]
["Next Review Date","N/A"]
["Notes","Study ended on 31 October 2017.   \n\nAccess  was  requested  to  obtain  current  contact  details  from  Cancer  Registry  North West, Public Health England (PHE) for individuals who  were consented participants of the previous questionnaire but for whom contact information is no longer accurate. The  applicant  was  also  seeking  for  support  in  order  for  PHE to  extract  date  of  death from the Cancer Analysis System (CAS) to ensure that the questionnaire and associate materials are not sent through the post to deceased patients and to also complete the overall study. The applicant would need to submit a list of the previous participant’s NHS  numbers  to  Cancer  Registry  North  West,  PHE  and  the  applicant  would  receive name,  NHS  number,  Hospital  ID  number,  date  of  birth,  date  of  death  and  patient  full address and postcode.\n\nThis study indicated that although high risk patients are internally motivated to engage with screening, inconsistencies within the national programme are having a detrimental impact on patient care and as a consequence, second cancers may be missed or diagnosed late.  It was evident from our study population that there were discrepancies with the care delivered within the two regions; including variations in appointment time intervals, imaging modalities and attitudes to screening.  Indeed, the largest proportion of issues with screening focussed around delays or missed appointments; a nationalised database may streamline the care moving forward for this patient group.\n\nAmendment request 07/12/2016\nAlthough the applicant had anticipated screening eligible subjects against the Cancer Analysis System via the Cancer Registration Service (NCRS) North West to exclude those who had died and to access an up to date postal address, they had later discovered that addresses were only recorded at the time of diagnosis.\nThe amendment requested was to access updated vital status and postal address data using the SPINE system. One of the research team, Dr Kate Vaughan, held an honorary PHE contract and had access to work within the section 251 office at NCRS North West. She also held an honorary NHS contract and would be provided access to SPINE by The Christie NHS Foundation Trust.                                                                                                               Specific conditions of support 07/12/2016\n1. Confirmation of suitable security arrangements via IG Toolkit submission.\n2. Confirmation of a favourable opinion from a Research Ethics Committee.                                                                                                                                                                        This application was considered at the Precedent Set meeting held on 22 May 2015.\nSpecific conditions of support \n\n1. Members requested clarification as to how long the applicant was intending to retain the Date of Birth identifier and the justification for the retention period. Applicant confirmed Date of Birth identifier will only be used to extract correct patient and up to date address. Once this activity had been completed, the applicant will destroy the identifier. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 8th June 2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Health and Social Care Information Centre (HSCIC) confirmed 23rd March 2015\n"]

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[]
[]
["Application Number","0144"]
["Reference","15/CAG/0147"]
["Other Refs"]
["Application Title","Geographic and socioeconomic mapping of hepatocellular carcinoma (HCC)"]
["Application Summary","HCC is an increasingly common malignancy with very poor survival. Our recent analysis of the population served by Hull and East Yorkshire hospitals (HEY) showed that approximately 2/3 of patients diagnosed with HCC did so on a background of chronic liver disease.The development of chronic liver disease is usually associated with one or more of obesity, alcohol excess and viral hepatitis, all of which are thought to be more common in areas of deprivation. It follows that the development of HCC may also show variation according to social and environmental factors.\nWork by others has previously identified geographical variation in overall cancer incidence in East Yorkshire, but we have no data on liver cancer specifically, or the potential factors driving the variation (e.g. socioeconomic deprivation, access to healthcare, environmental factors etc.). Furthermore, although there is existing North American literature on geographical variation in liver cancer, nobody has examined this in the United Kingdom, where differences in healthcare and welfare provision may impact outcomes. The project has the following aims: To use and build on our existing database of HCC in the HEY population to map geographical/postcode incidence of HCC in Hull and East Yorkshire. To examine and analyse the possible factors associated with variation (industry, pollution, socioeconomic status, access to healthcare etc.)\nTo determine whether HCC incidence is linked or correlates with other cancer diagnoses within a postcode. Whether HCC has a different mode of presentation according to postcode (e.g. more or less advanced, potentially curable etc.) Ultimately, the results of this work should highlight areas of increased cancer prevalence and describe the possible mechanisms. This offers the opportunity to focus early intervention/prevention or surveillance strategies on areas with the greatest need, thereby improving survival in this underrepresented patient group."]
["Applicant Organisation Name","Hull and East Yorkshire Hospitals NHS Trust"]
["Contact Name","Dr Lynsey Corless"]
["Address","Hull Royal Infirmary"]
[null,"Anlaby Road"]
[null,"Hull"]
["Postcode","HU3 2JZ"]
["Telephone",1482816698]
["Email","lynsey.corless@hey.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Hepatocellular carcinoma\nMale and female participants-18-99 years old"]
["Description of confidential patient information used","All patients in our geographical area with a diagnosis of liver cancer are discussed and logged at the regional hepatobiliary MDT (of which the Chief Investigator is a member).\nThe MDT registry can be searched by diagnosis, and this information is also available through the trusts information governance department. We will request details for all liver cancer cases over the past 5 years. We (the MSc student and the chief investigator) will collect patient/disease data (e.g. age, comorbidity, tumour characteristics, treatment, outcome, smoking, BMI, alcohol intake) and their postcode. The majority of this information will be available on the hospital trust electronic results/records system.There may be pieces of data not available in the hospital (e.g. smoking history, comorbidity) and where there are gapsin the dataset, we would approach GP surgeries to supply missing information from their record. If the data is still not available, it will not be collected in any other way. No approach will be made to patient or relatives at any time. Casenote numbers will be used to access clinical details (e.g. tumour type, treatment and outcome) and this access will mean that the trial team see the name/address of the patient, however this will not be logged or recorded. We will have a master list and we will assign a unique identifier to each casenote number on this master document. This will be kept in our research department server in the trust in a password protected document. The only demographic information recorded on the dataset form will be unique identifier, age and postcode, i.e. it will not be possible to identify patients by looking at the final data collection form. Only the MSc student and the Chief Investigator will access the patient data. No other parties are involved. All patient identifiable informtion will be removed prior to mapping"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Hull and East Yorkshire Hospitals NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2015-05-18"]
["Next Review Date","2016-05-18"]
["Notes","This application was considered at the precedent set meeting held on 22 May 2015. \nSpecific conditions of support \n1. The committee would like to see consultation with a HCC patient/carer group if such exists. Evidence of support from British Liver Trust provided\n2. Favourable opinion from a Research Ethics Committee. Confirmed 16/06/2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 16/06/2015\n"]

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[]
[]
["Application Number","0146"]
["Reference","15/CAG/0118"]
["Other Refs"]
["Application Title","Validation of Risk Assessment tools in CFCAMHS"]
["Application Summary","Mental Health and Criminal Justice Practitioners are frequently required to predict and make decisions about how to manage different levels of risk posed by individuals, both to themselves and to others; recently this expectation has been extended to those working with children and young people. Subsequently risk assessment tools have been developed that assess both risk and protective factors, and research is required to see how well these new tools support clinicians in making decisions about risk. In particular, when used with children and young people who have mental health issues, and use services in the community, which is a group\nthat has the potential to be high risk because of lack of formal supervision, and has been neglected by previous research. This research will use four risk assessment tools, that include protective factors which look specifically at those areas which make it less likely that a person will engage in risky behaviour, developed for use with children and young people. These assessment tools will be used with the current caseload of the 10 NHS funded Community Forensic Child and Adolescent Mental Health Teams in England. They will then be followed up over 6 and 12 months to measure their ability to predict violence, in addition to other high risk behaviours such as self harm, suicide and substance misuse. It is anticipated that this research will make an important contribution to the knowledge about risk assessment in\nchildren and young people in contact with forensic community mental health services. It will also promote the development of a standard risk assessment schedule to improve the communication of information."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Jenny Shaw"]
["Address","University of Manchester"]
[null,"Centre for Mental Health and Risk,"]
[null,"Jean McFarlane Building, Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone",1612750730]
["Email","jennifer.j.shaw@manchester.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","This research uses a prospective cohort study of up to 250 children and young people. Male and female participants-12-18 years old"]
["Description of confidential patient information used","In order to undertake each of the violence risk assessment tools being validated in this research, it is anticipated that each participants case files will be accessed paying particular interest to referral letters, initial assessments, court reports, records of clinical team meetings and reports produced by members of the clinical and criminal justice team members."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","James.K.Power@manchester.ac.uk"]
["Status","Expired"]
[]
["Outcome Date","2015-06-26"]
["Next Review Date","N/A"]
["Notes","CAG support was sought for a PhD student, who subsequently withdraw from the PhD programme and the activity never commenced.   \n\nApplication considered at CAG meeting on 26/03/2015.\nSpecific conditions of support \n\n1. Please ensure that the consent form is consistent and submit the final version. Submitted.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 23 April 2015.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed \n"]

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[]
[]
["Application Number","0148"]
["Reference","15/CAG/0152"]
["Other Refs"]
["Application Title","FILTR Field Triage Tool for Ruptured aneurysms"]
["Application Summary","An Abdominal Aortic Aneurysm (AAA) is a diseased weakening of the body’s largest artery and is a significant healthcproblem accounting for 8000 deaths/year in the UK. Aneurysm rupture (rAAA) is fatal without surgery, and surgery itself is high risk. For patients with rAAA, swift transport to specialist care is vital. Unfortunately 41% of rAAA are initially misdiagnosed. This introduces potentially harmful delay before patients are given definitive care. We have designed a simple software score that improves diagnostic accuracy for rAAA to 83%. Our software score uses 10 basic parameters such as age, gender, and blood pressure to predict how likely it is that the patient is suffering from a ruptured aneurysm based on their symptoms. We have incorporated this score into smartphone software for paramedics to use. the software requires propsective observational study in order to confirm its validity and obtain feedback on its clinical feasibility. This initial study WILL NOT affect patient transfers,it is merely designed to test the software and to see how accurate its predictions would have been had been utilised."]
["Applicant Organisation Name","St Georges Hospital NHS Trust"]
["Contact Name","Mr Alan Karthikesalingam"]
["Address","4th Floor St James Wing"]
[null,"St Georges Hospital NHS Trust"]
[null,"Blackshaw Road"]
["Postcode","SW17 0QT"]
["Telephone","02087256426"]
["Email","alankarthi@gmail.com"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with acute abdominal pain, back pain or collapse who do not have\nconfirmed myocardial infarction, stroke or major trauma. Male and female participants\nLower age limit: 18\n\n"]
["Description of confidential patient information used","Access was requested to NHS number, name, date of birth and postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","St George's Healthcare NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2015-07-21"]
["Next Review Date","NA"]
["Notes","Data controller confirmed support can be expired, as of 02 June 2023.\n\nApplication considered at CAG meeting on 19/06/2015.\nSpecific conditions of support \n\n1. The removal of the identifiers should be completed within twelve months. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 20th January 2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC on 21st July 2015.\n"]

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[]
[]
["Application Number","0149"]
["Reference","15/CAG/0113"]
["Other Refs","IRAS project ID: 139667, REC reference: 15/SW/0151"]
["Application Title","Avoidable mortality from in-hospital cardiac arrest: Have interventions aimed at recognising and rescuing deteriorating patients made an impact on incidence and outcomes?"]
["Application Summary","A substantial proportion of patients who experience a cardiac arrest in hospital have shown signs of deterioration for up to eight hours before the event which have not been identified or acted upon by staff. Once a patient has experienced an arrest, their outcomes are very poor with only 15% leaving hospital alive. With around 20,000 cardiac arrests in NHS hospitals each year, a substantial number of subsequent deaths might be avoided if deterioration was identified earlier. A number of interventions aimed at improving the recognition and care of acutely ill patients have been put in place over the last few years. After taking into account differences in patient mix, variation in the way these services have been implemented is likely to be a major reason for the variation in cardiac arrest rates and outcomes found across the 60% of English hospitals participating in the National Cardiac Arrest Audit (NCAA). The aim of this research is to determine the association between different services aimed at identification of patients at risk of deterioration and their subsequent management and wardbased cardiac arrest rates and outcomes. In the first phase of the study we will review research evidence on the effectiveness of services,gather information on how such services have been implemented in 20 hospitals, selected because of the different approaches they have taken. Using information gathered from both phases we will carry out a survey to map interventions across all hospitals participating\nin the NCAA. We will then investigate which combinations of services are associated with the lowest cardiac arrest rates and best outcomes. We will also look at how arrest rates and outcomes have changed over time in hospitals as new services have been introduced.\nIdentifying key interventions that improve outcomes will enable hospital managers, clinicians and policy makers to raise standards of care for all patients at risk of deterioration and reduce avoidable mortality."]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Dr Helen Hogan"]
["Address","London School of Hygiene and Tropical Medicine"]
[null,"Department of Health Services Research and Policy"]
[null,"15-17 Tavistock Place"]
["Postcode","WC1H 9SH"]
["Telephone","020 7958 8293"]
["Email","helen.hogan@lshtm.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult patients who have contributed to data in the National Cardiac Arrest\nAudit, the Spotlight study and the ICNARC Case Mix Programme.\nMale and female participants\n18-100 age limit"]
["Description of confidential patient information used","The following items will be requested:\nFrom HES\nPatient Information\nAge in years\nSex\nEthnicity\nIndex of Multiple Deprivation (IMD by decile)\nrural urban indicator\nEpisode information: From one year before to one year after the index admission\nDiagnosis and operative codes\nDate of admission\nSource of admissions\nMethod of admission\nDate of death\nDate of interventions\nDate of discharge\nStart and end date of spells\nDestination after discharge\nAugmented critical care period data\nOrganisation\nSUS system codes\nHospital and Trust code\nPurchaser (CCG)\nFrom ONS:\nDate of death\nPrimary and additional causes of death"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Expired"]
[]
["Outcome Date","2015-07-21"]
["Next Review Date","N/A"]
["Notes","Amendment (Approved - 14/09/2018)\nThe amendment requested an extension to the end date of the study, which was now identified as 30 September 2019, in order to facilitate completion of the final analysis for the study.\n\nAmendment (Approved - 10/10/2017)\nThe amendment requested an extension to the end date of the study, which was now identified as 30 September 2018. The request was not an extension to the required duration of support.\n30 September 2019 - Support Expired\nThe study closed in 2019 with all pseudonymized data related to the study destroyed in September 2019.\n\nThis study provided evidence that implementation of the National Early Warning Score into hospitals did have an impact on reduction of in-hospital cardiac arrests. This effect was likely to be through a combination of earlier recognition of deterioration and also identifying patients who would be more suitable to an end of life pathway rather than active resuscitation.\n\nAmendment Request 03/01/2017\nThe amendment requested an extension to the end date of the study, which was now identified as 31 May 2017. The request was not an extension to the required duration of support.        \n\nApplication considered at CAG meeting on 26/03/2015.\nSpecific conditions of support \n1. The members requested clarification regarding which organisation will be retaining date of death, the retention period and for what purpose is it to be retained. Applicant provided clarification that the date of death identifier would be retained for the duration of three months in order to carry out checks/data cleansing. The identifier will be retained at the London School of Hygiene and Tropical Medicine during this period.  \n2. Provide patient information materials. Applicant provided patient information leaflet and it was noted that the patient notification material had reviewed by the REC and received favourable opinion. \n3. Favourable opinion from a Research Ethics Committee. Confirmed 3rd June 2015 \n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC. \n"]

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[]
[]
["Application Number","0150"]
["Reference","15/CAG/0150"]
["Other Refs"]
["Application Title","ERIC-PPCI"]
["Application Summary","This application from University College London Hospitals NHS Foundation Trust (UCH) set out the purpose of a study to investigate whether remote ischaemic conditioning (RIC) can increase survival and prevent the onset of heart failure in patients undergoing a specific type of heart attack known as ST elevation MI or STEMI. The study would also review whether RIC will reduce the amount of damage to the heart muscle during the heart attack thereby, preserving the pump action of the heart. The applicant confirmed that the direct clinical care team will identify eligible patients for the study and will enter month and year of birth against a study ID number within the study database. The clinical care team would provide the patient with information materials and seek to obtain consent or note dissent to take part within the study on behalf of the research team to access confidential patient information. \n\nA recommendation for class 1 and 6 support was requested to permit access to an authorised user to extract and anonymise confidential patient information. \n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Derek Hausenloy"]
["Address","University College London"]
[null,"The Hatter Cardiovascular Institute"]
[null,"67 Chenies Mews"]
["Postcode","WC1E 6HX"]
["Telephone","0203 447 9894"]
["Email","d.hausenloy@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with suspected Stelevated Myocardial Infarction being treated with\nPrimary PCI. Male and female participants-Lower age limit 18"]
["Description of confidential patient information used","The applicant was seeking s251 support to access medical records of the deceased patients who had not consented, to extract and anonymise confidential patient information. The applicant would require access to date of birth, date of death, gender and ethnicity. "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2015-08-04"]
["Next Review Date","N/A"]
["Notes","02 July 2019 - Support Expired \nEnd study report submitted 2 July 2019 with no storage of identifiers after the study. \n\n04 August 2015 - Application Supported\n1. Favourable opinion from a Research Ethics Committee. Confirmed 22nd June 2015\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 30th July 2015.\n"]

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[]
[]
["Application Number","0151"]
["Reference","15/CAG/0109"]
["Other Refs"]
["Application Title","Brain maturation and neurodevelopmental outcome in preterm adults"]
["Application Summary","This application from the Institute of Psychiatry and King's College London set out a study to define patterns of brain growth which made an individual at risk of poor outcome, as well as those that were associated with developmental resilience. The application detailed that in the future this information would enable the development of treatments to reduce or prevent long-term disability in people born very prematurely (VP). The cohort of individuals included had been taking part in a follow-up study from birth to age 19 and they are now between the age of 27 and 32 years.\nA recommendation for class 3 and 6 support was requested to cover access to current contact details from the Health and Social Care Information Centre (HSCIC) for individuals who were previously consented within the project but for whom contact information were no longer accurate. The applicant stated that if this method would not be deemed as acceptable, the study team would like to obtain support for GP address in order to contact the relevant surgery and ask the practice staff to forward a letter to the patient regarding the study and the desire to re-contact them."]
["Applicant Organisation Name","Institute of Psychiatry and King's College London"]
["Contact Name","Dr Chiara Nosarti"]
["Address","Institute of Psychiatry and King's College London"]
[null,"Department of Psychosis Studies"]
[null,"De Crespigny Park, Denmark Hill"]
["Postcode","SE5 8AF"]
["Telephone",2078480133]
["Email","c.nosarti@iop.kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Very premature birth (<33 weeks completed gestation)\nMale and female participants\nLower age limit: 28\nUpper age limit: 36"]
["Description of confidential patient information used","Access was requested to address and GP registration from the HSCIC."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Institute of Psychiatry and King's College London"]
["Status","Supported"]
[]
["Outcome Date","2015-07-28"]
["Next Review Date","2016-07-28"]
["Notes","Application was considered at the precedent set CAG meeting held on 13 March 2015.\n\n1. Please confirm how long identifiable information will be retained for those individuals that do not provide consent. It was confirmed that if an individual indicated that they did not wish to participate the information would be delated immediately; if no reply was received the information would be deleted within 42 days. No further data linkages would be requested for those individuals who did not respond.\n2. Please ensure that if further contact is to be made to those who don’t respond this is clear within the letter and that a reply slip to allow objection is included.\n3. In line with advice above, please ensure that consent to obtain contact details in future is provided if you intend to contact individuals again.\n4. Favourable opinion from a HRA Research Ethics Committee. Confirmed\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 21 July 2015."]

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[]
[]
["Application Number","0152"]
["Reference","15/CAG/0137"]
["Other Refs"]
["Application Title","What services influence the care of people with dementia in the last year of life?"]
["Application Summary","This application from Princess Alice Hospice/Kingston NHS Foundation Trust set out the purpose to assess what services influence the end of life care for people with dementia. It was detailed within the application that Princess Alice hospital has seen a year on year increase in people with dementia being referred for Specialist Palliative care (SPC) a multidisciplinary approach to provide total care for patients with progressive advanced disease and their families and referral seems to occur late in the illness trajectory. However little is known about the end of life provision for these patients. This study aims to build a detailed picture of the last year of a patient’s life and what service do or could influence their care.\nThis will be a retrospective study in 2 NHS Trusts and the Hospice to explore the everyday lives of 20 people with dementia in the last year of life. Data will be collected from deceased patient’s medical notes over the last 12 months and interviews will take place with their carers. Clinicians involved in the care of patients will identify the deceased patients and carers and act as “professional consultee” to ensure carer suitability to be contacted. The researchers have contracts with the trusts to access the health records they hold to obtain the necessary data. Each study participant will be assigned a unique number at the site of data retrieval. Analysis between the trust data and hospice data will occur at the hospice but both sources of data will have been assigned the identification number at the site of origin and no identifiable information will be removed from either site.\nA recommendation for class 1 and 4 support was requested to cover access from Trusts hospital records and data within hospice records by the research team."]
["Applicant Organisation Name","Princess Alice Hospice/Kingston NHS FT"]
["Contact Name","Dr Jennifer Todd"]
["Address","Princess Alice Hospice/Kingston NHS FT"]
[null,"West End Lane"]
[null,"Esher, Surrey"]
["Postcode","KT10 8NA"]
["Telephone",1372461818]
["Email","jennifertodd@pah.org.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants"]
["Description of confidential patient information used","Access was requested to date of birth and date of death for data linkage."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Princess Alice Hospice/Kingston NHS FT"]
["Status","Supported"]
[]
["Outcome Date","2015-08-18"]
["Next Review Date","2016-08-18"]
["Notes","Application considered at CAG meeting on 04/06/2015.\nSpecific conditions of support:\n1. Favourable opinion from a Research Ethics Committee.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries."]

{"sheet":"A0153","index":104,"n_rows":40,"n_cols":3,"rows_kept":40,"cut":false,"hidden":false,"merged":[[23,0,29,0],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[23,2,23,4],[15,0,20,0],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[15,2,15,4],[7,1,7,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[37,2,37,4],[38,2,39,4],[8,1,8,4],[14,1,14,4],[31,1,31,4],[13,1,13,4],[12,1,12,4],[32,1,32,4],[34,1,34,4],[35,1,35,4],[36,1,36,4],[21,1,21,4],[30,1,30,4],[22,1,22,4],[33,1,33,4]]}
[]
[]
["Application Number","0153"]
["Reference","CAG 9-08(b)/2014"]
["Other Refs","CAG 9-08(b)/2013"]
["Application Title","Linkage of readmissions to birth data"]
["Application Summary","This application from City, University of London set out the purpose of creating a research database which could be accessed by other researchers using the Office of National Statistics Virtual Microprocessor Laboratory (ONS VML). The database would be used for analyses relating to inequalities in the outcome of pregnancy and inform maternity service users about the outcome of midwifery, obstetric and neonatal care.\nA recommendation for class 4, 5 and 6 support was requested to cover access to birth and death registration data, HES maternity data, PEDW data and Wales Child Health System data.\nThe application sought to amend an existing application, PIAG 2-10(g)/2005 National Gestational Age Statistics, to include HES records of babies and mothers admitted or readmitted to hospitals in England in the first year following birth and PEDW records of babies admitted or readmitted in the first year following birth. Linkages would take place with the HSCIC and ONS."]
["Applicant Organisation Name","City, University of London   "]
["Contact Name","Professor Alison Macfarlane\n"]
["Address","City, University of London   \n"]
[null,"1, Myddelton Street\n"]
[null,"London"]
["Postcode","EC1R 1UW"]
["Telephone","0207 040 5832"]
["Email","A.J.Macfarlane@city.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","babies and mothers admitted or readmitted to hospitals in England in the first year following birth"]
["Description of confidential patient information used","Access was requested to date of birth, date of death and postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Office of National Statistics"]
["Status","Supported"]
[]
["Outcome Date","2015-08-14"]
["Next Review Date","2025-03-17"]
["Notes","Please see register entry for CAG 9-08(b)/2013 - this is a duplicate entry"]
[null,"Application considered at CAG meeting on 09/01/2014.\nSpecific conditions of support\n\n1. Favourable opinion from Research Ethics Committee. Confirmed 27/02/2014.\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 01/11/2013.\n\n3. Provision of patient information materials. Patient information poster received.\n\n4. The application does not currently include PEDW data. \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0154","index":105,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0154"]
["Reference","CR2/2014"]
["Other Refs"]
["Application Title","Whitehall II Study (Stress and Health Study)"]
["Application Summary","This application from University College London set out the purpose of a study to explore the relationship between socio-economic status and cardiovascular disease by examining the inter-relationships between contextual, biological, psychosocial and behavioural factors. Measures included blood pressure, blood sugar, blood lipid levels, height, weight, cardiovascular tests, walking speed, lung function, questions about diet, and five tests of mental functioning.\n\nA recommendation for class support was requested to cover access to mortality data from the NHS Central Register, maintained by the Health and Social Care Information Centre (HSCIC).  A cohort of 10,308 patients was flagged at the HSCIC.\n\nThis study had previously accessed data under the NHS Central Register (ECC 2-04(c)/2010) application. Amendment approved July 2015 - The amendment request detailed access to Hospital Episode Statistics data and Mental Health Minimum Dataset (MHMDS) data in order  to estimate the contribution of midlife inflammatory, vascular, and metabolic factors to chronic disease, depression, cognitive impairment and functional health in later life, assess whether the adoption of healthy lifestyle even at older ages modifies functional trajectories, and also develop multi-factorial predictive algorithms, like those developed for cardiovascular diseases, to facilitate early identification of adverse ageing outcomes\n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Mika Kivimaki"]
["Address","Whitehall II Study"]
[null,"Dept. Epidemiology & Public Health, UCL"]
[null,"1-19 Torrington Place, London"]
["Postcode","WC1E 6BT"]
["Telephone"]
["Email","m.kivimaki@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Whitehall II is a closed occupational cohort. At recruitment in 1985 it included 10,308 participants, all employees of the British Civil Service; 3,413 women and 6,895 men. To date the cohort has been subject to 11 data collection waves, six of which have involved clinical measurements. "]
["Description of confidential patient information used","Data from the HSCIC in relation to mortality, cancer registration, HES and MHMDS. Individuals were already flagged with the HSCIC and data provided would include NHS number to allow linkage to cohort data."]
["S251 Class(es)","□","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Medical Research Council (MRC):\ncorporate@headoffice.mrc.ac.uk\n"]
["Status","Expired"]
[]
["Outcome Date","2015-03-12"]
["Next Review Date"]
["Notes","10 May 2022 - Support Expired\nApplication was superseded on 10 May 2022 by 22/CAG/0059.\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed \n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed\n3. Please continue to inform and remind participants that information in relation to their mortality is accessed on an ongoing basis.\n4. Support will not extend to situations where a participant has objected to their data being processed as part of the study.\n"]

{"sheet":"A0155","index":106,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0155"]
["Reference","CR8/2014"]
["Other Refs"]
["Application Title","South London Stroke Register"]
["Application Summary","This application from King’s College London set out the purpose of a register of first stroke events occurring in residents of a defined area of South London corresponding to northern Lambeth and northern Southwark.\n\nA recommendation for class support was requested to cover access to mortality data from the NHS Central Register,  at the Health and Social Care Information Centre.  A cohort of 4,800 patients was flagged at the HSCIC  It was noted that the cohort was projected to continue to grow by approximately 250 patients per year, data in relation to these patient .\n\nThis study had previously accessed data under the NHS Central Register (ECC 2-04(c)/2010) application.\n"]
["Applicant Organisation Name","Kings College London"]
["Contact Name","Professor Charles Wolfe"]
["Address","Department of Public Health Sciences"]
[null,"Kings College London"]
[null,"Capital House, 42 Weston Street"]
["Postcode","SE1 3QD"]
["Telephone"]
["Email","charles.wolfe@kcl.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort consists of all patients recruited to the register since 1995 (approximately 4800 patients). "]
["Description of confidential patient information used","The continued receipt of mortality data from the HSCIC was requested."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Northern and Yorkshire NHS R&D Programme in Cardiovascular Disease and Stroke, Guy's and St Thomas' Hospitals Charitable Foundation, The Stroke Association, NIHR Programme Grant and HQIP"]
["Status","Supported"]
[]
["Outcome Date","2015-01-29"]
["Next Review Date","2016-01-29"]
["Notes","Specific conditions of support\n\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here. Confirmed 31/07/2014.\n\n2. Confirmation of favourable REC opinion. Received 23/08/2013\n\n3. Please continue to seek consent from patients attending follow up appointments for their mortality to be accessed from the HSCIC. Correspondence with patients who do not attend appointments should remind patients that mortality data will be accessed from the HSCIC.\n"]

{"sheet":"A0156","index":107,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0156"]
["Reference","CR38/2014"]
["Other Refs"]
["Application Title","ADDITION - Cambridge"]
["Application Summary","This application from University of Cambridge requested support in order to access mortality data from the Data Access Request Service at the Health and Social Care Information Centre (HSCIC). Date and cause of death was required for analysis purposes and name and address information would be use in order to keep in touch with ADDITION participants.\nThe study aims are to evaluate the effectiveness and cost-effectiveness of a stepwise screening programme for type 2 diabetes and intensive multi –factorial treatment in people with screen detected diabetes in English general practice. A cohort of 135,825 patients was flagged at the Health and Social Care Information Centre and consent had been obtained from patients for inclusion within the ADDITION study.\n"]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Nick J Wareham"]
["Address","MRC Epidemiology Unit"]
[null,"Hills Road"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone"]
["Email","nick.wareham@mrc-epid.cam.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","In the screening phase of the study, 135,852 people aged 40-69 were identified from 60 practices across the East of England. 35,297 were identified at high risk of undiagnosed siabetes, 33.539 were invited for an initial blood test, 24,654 attended for blood tests and 867 people were diagnosed with type 2 disabetes and agreed to take part in the treatment phrase of the study."]
["Description of confidential patient information used","Continued receipt of mortality information was requested from the HSCIC."]
["S251 Class(es)","□","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Supported"]
[]
["Outcome Date","2015-04-09"]
["Next Review Date","2019-04-09"]
["Notes","Specific conditions of support\n1. Favourable opinion from REC Received 14 October 2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 23 March 2015\n"]

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[]
[]
["Application Number","0157"]
["Reference","CR20/2014"]
["Other Refs"]
["Application Title","Caerphilly Ischaemic Heart Disease Study, Speedwell Study - Longitudinal Study Of Ischaemic \nHeart Disease, Early Life Origins Of Insulin Resistance Mortality And Cancer In Christs Hospital School Cohort  \n"]
["Application Summary","This application from University of Bristol requested support in order to access mortality and cancer data from the Data Access Request Service (DARS) at the Health and Social Care Information Centre (HSCIC). This application included four individual research projects: Caerphilly Prospective Study (CaPS), Speedwell study (Speed), Barry Caerphilly Growth study (BCG) and CHS study. \n\nMortality data, including date and cause of death, cancers and GP registration was requested. Name and date of birth would be used to link to HSCIC data.\n"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Department of Social Medicine"]
["Address","Canynge Hall"]
[null,"39 Whatley Road"]
[null,"Bristol"]
["Postcode","BS8 2PS"]
["Telephone"]
["Email","y.ben-shlomo@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","This varies by individual study:CaPS 2,959 subjects\nSpeed 2, 348 subjects, BCG 679 subjects, CHS 1,410 subjects"]
["Description of confidential patient information used","Support was requested for continued access to mortality, cancer and GP registration data from the HSCIC.  Name and date of birth would be used to carry out linkages."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","MRC, Cancer Research UK, Alzheimer's Society, British Heart Foundation, DH, Diabetes UK, British Lung Foundation"]
["Status","Supported"]
[]
["Outcome Date","2015-05-20"]
["Next Review Date","2020-05-20"]
["Notes","Specific conditions of support\n\n1. Follow the pseudonymised method as detailed within your application form as an appropriate mechanism to exit from using confidential patient information. An update is required at Annual Review Stage. \n2. Please ensure that information in relation to the processing is available on the University website and that if future contact is planned the information sent to patients includes details of data disclosed from the HSCIC.\n3. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 18th May 2015\n4. Provide confirmation of how you are intending to proceed with the IGT submission to the Confidentiality Advice Team by 1st May 2015.Confirmed as per specific condition 2. \n"]

{"sheet":"A0158","index":109,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0158"]
["Reference","15/CAG/0169"]
["Other Refs","IRAS project ID: 185885, REC reference: 15/EM/0340"]
["Application Title","The Role and Impact of Surgical Centralisation on Renal Cancer Survival: A Multifactorial Analysis"]
["Application Summary","This application from the University of Cambridge set out the purpose of a research study which aimed to link data from HES, ONS and Cancer Registries in order to answer five specific questions. First, how has nephrectomy practice in England evolved in the past few years in response to regionalisation? Second, what role does service reconfiguration play in changing renal cancer outcomes? Third, what is the relationship between case volume and outcome in nephrectomy, from short to long term and how does treatment in a high volume centre alter an individual’s outcome compared to treatment in a lower volume centre? Fourth, what are the interactions between treatment setting, patient background and tumour characteristics in predicting renal cancer survival and mortality? Finally, how does understanding the volume outcome relationship in nephrectomy change the current paradigm on renal cancer service and risk prediction model?\n\nA recommendation for class 1, 5 and 6 support was requested to cover access to confidential patient information from Public Health England in relation to patients undergoing a nephrectomy between 1998 and 2013 (approx. 112,000 patients)\n"]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Ray Hsu"]
["Address","Department of Surgery, University of Cambridge "]
[null,"Box 202, Level E9, Addenbrooke’s Hospital"]
[null,"Hills Road, Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone",7910301224]
["Email","raycjhsu@gmail.com"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Renal cell carcinoma managed with surgical intervention.\nMale and female participants\nLower age limit: 18-No upper age limit"]
["Description of confidential patient information used","Access was requested to a dataset including date of death and date of birth."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Expired"]
[]
["Outcome Date","2015-08-24"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in 2023 that ‘s251’ support can be expired from October 2021 as all identifiable patient information held without consent under this support has been anonymised.\n\nIn terms of public benefit, the study has resulted in publications and presentations and has increased our understanding on how surgical volume in the management of kidney cancer can impact on patient survival. This knowledge will be useful and will need to be considered for any future service planning relating to the management of kidney cancer, both in the UK and abroad.\n\n09 October 2020 - Amendment supported to extend the end date of the study to 07 October 2021.\n\n06 January 2020 – Amendment supported to extend the end date of the study to 07 October 2020.\n\nAmendment Request (Approed 26/10/2018)\nThis amendment requested an extension to the duration of support in place for the application activity. The project had been originally approved for a two year period; however, the applicants explained that due to delay in obtaining the required data from Public Health England, analysis of the full dataset did not commence until January 2017, which was a 1.5 year delay on the original timeframe.\nThe amendment requested a one-year extension to the application of support under the Regulations for the use of potentially identifiable data from Hospital Episode Statistics and the National Cancer Data Repository. It was confirmed that all required data had already been extracted and received.\n\nSpecific conditions of support\n1. Further efforts should be made to inform patients about this specific use of data, please ensure that information is displayed on the University and other relevant websites and that consultation with patient groups takes place. Please provide confirmation in relation to how this will be achieved. Information in relation to the study would be displayed on the Department of Urology website and on the Cambridge Urology website once developed. The study had been reviewed by two UK charities, The Urology Foundation and Addenbrooke’s Charitable Trust, who agreed to support and fund the study. Further patient consultation took place within local clinics and the comments received evidenced support for the study and use of data.\n2. Please ensure that identifiers are destroyed at the earliest opportunity. It was confirmed that identifiers would be destroyed at the earliest opportunity.\n3. Please confirm that the scope of the application is as described above. The application scope was confirmed to cover the disclosure of confidential patient information to the University of Cambridge only.\n4. Favourable opinion from a Research Ethics Committee. Confirmed\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. V12 confirmed as satisfactory March 2015.\n"]

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[]
[]
["Application Number","0159"]
["Reference","15/CAG/0160"]
["Other Refs"]
["Application Title","Acute hospital care for frail older people"]
["Application Summary","This application from the University of Newcastle set out the purpose of conducting an epidemiological cohort study to investigate and provide high quality evidence to support the delivery of Comprehensive Geriatric Assessment (CGA) on a hospital wide basis. The purpose of the study is to investigate how CGA is defined and recognised, how and in what form is CGA currently organised and delivered within the UK, who receives CGA and to identify the benefits.\nThe applicant was seeking s251 support in order for confidential patient identifiers collected from previous studies by the Newcastle University, Nottingham University and Southampton University, to be disclosed to the Health and Social Care Information Centre (HSCIC) for the purpose of data linkage to create HES IDs for HES data held by the Nuffield Trust. The HSCIC was to forward the HES IDs and an unique identifier to the Nuffield Trust  in order for the Nuffield Trust to link HES data to the clinical data using the unique identifier for each patient.  The applicant also specified the intention to pursue pseudonymisation at source for the purpose of linking clinical data sets with social care data. The applicant had been informed by the Confidentiality Advice Team (CAT) that s251 support would not cover social care data and the applicant confirmed that separate discussions with social care was currently taking place.\n"]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Professor Stuart Parker"]
["Address","Newcastle University"]
[null,"Institute of Health & Society"]
[]
["Postcode","NE1 7RU"]
["Telephone"]
["Email"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Older people with and without frailty.\nMale and female participants\nLower age limit: 18-120"]
["Description of confidential patient information used","Data from specified universities in relation to NHS Number, name, date of birth, address and postcode are requested to flow to the HSCIC for the purpose of data linkage. The HSCIC will forward pseudonymised data to the Nuffield Trust."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle Joint Research Office"]
["Status","Supported"]
[]
["Outcome Date","2015-09-02"]
["Next Review Date","2017-09-02"]
["Notes","Amendment request 16/01/2017\nThe start of the study had been delayed while the Nuffield Trust obtained the Information Governance toolkit.\nThe request was to extend the initial permission by one year to allow for the late commencement of the study. No other changes were to be made.\nSpecific conditions of support \n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 5 January 2017 – reviewed score of 92% published on the website.\n2. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 5 January 2017                                                                                                                                  This application was considered at the CAG meeting held on 9th July 2015.  \n\n1. Provide justification for the purpose of utilising date of birth for data linkage. It was advised by HSCIC that date of birth would be required to obtain optimal linkage.\n2. Provide clarification as to whether identifiers would be retained for seven years. It was confirmed that identifier would not be retained once linkage undertaken, will be retained within original study databased.\n3. Submit an action plan detailing implementation deadlines of the patient and public involvement workstream. It was confirmed that two half-day workshops with a total of approximately 12 PPI volunteers would be arranged and that these would be held Jan/Feb 2016 and June/July 2016. Reports in relation to these workshops would be submitted at annual review stage.\n4. Provide confirmation that patient notification will be added to university sites where the previous studies were conducted. Confirmed. A copy of the patient information leaflet was also submitted (see comments below).\n5. Provide clarification regarding the mechanisms for patients to opt-out. It was confirmed that opt out would be possible at a local level via the study lead at the specific site or via the study team.\n6. Favourable opinion from a Research Ethics Committee. Confirmed 17 July 2015. \n7. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC in May 2015.\n\n\n"]

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[]
[]
["Application Number","0160"]
["Reference","15/CAG/0151"]
["Other Refs"]
["Application Title","Diabetic retinopathy in type 1 diabetes: the Winchester Cohort"]
["Application Summary","This application from University Hospital Southampton NHS Foundation Trust set out the purpose of conducting an epidemiological cohort study to investigate diabetic eye disease in patients with type 1 diabetes. The applicant would review how the prevalence relate to the duration of the type 1 diabetes, how the prevalence relate to other risk factors such as smoking, blood pressure and renal function and also the risk of progression of diabetic retinopathy in this type 1 diabetic cohort over period the period of the study. The applicant confirmed that the Winchester cohort includes 750 patients with type 1 diabetes who attended the specialist diabetes clinic service provided by former Winchester and Eastleigh Healthcare Trust and were registered on the Diamond Diabetes Database. The applicant was seeking s251 support in order to collect further data on this cohort from Southampton Diabetic Eye Screening Programme (SDESP) and health records from University Hospital Southampton NHS Foundation Trust."]
["Applicant Organisation Name","University Hospital Southampton NHS FT"]
["Contact Name","Miss Radhika Krishnan"]
["Address","University Hospital Southampton NHS FT"]
[null,"Southampton Eye Unit"]
[null,"Southampton General Hospital, Tremona Road, Southampton"]
["Postcode","SO16 6YD"]
["Telephone"]
["Email","radhika.krishnan@uhs.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\nLower age limit: 12\nUpper age limit: 100"]
["Description of confidential patient information used","Access was requested to NHS number. The applicant would be required access to following data classes:\n Gender\n Truncated Postcode\n Age\n Age at death\nAccess would also be required to age at diagnosis, smoking status, blood pressure, HbA1C, diabetic retinopathy screening dates, age at screening, retinopathy grade, maculopathy grade, visual acuity, laser treatment, presence of cataract and outcomes of screening visits."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Southampton General Hospital-Joshua.Lovejoy@uhs.nhs.uk"]
["Status","Supported"]
[]
["Outcome Date","2015-09-15"]
["Next Review Date","2016-09-15"]
["Notes","This application was considered at the precedent set CAG meeting held on 19 June 2015.\nSpecific conditions of support\n1. Clarification regarding the retention of the NHS number and justification for the period specified. Applicant provided sufficient clarification on 17th July 2015.\n2. Clarification that information about the project will appear on local website and any objections received from patients would be respected. Applicant provided sufficient clarification on 17th July 2015.\n3. Favourable opinion from a Research Ethics Committee. Confirmed [3rd September 2015]\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC on 26th June 2015."]

{"sheet":"A0161","index":112,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0161"]
["Reference","15/CAG/0139"]
["Other Refs"]
["Application Title","Life course pathways to ageing in the MRC National Survey of Health and Development"]
["Application Summary","This application from The Medical Research Council (MRC), Unit for Lifelong Health and ageing at University College London (UCL) sets out the purpose of support to allow continued data flows in relation to cancer registry and mortality data from the Health and Social Care Information Centre (HSCIC).\nA recommendation for class 4 and 6 support was requested to cover access to cancer registry, mortality and HES data from the HSCIC."]
["Applicant Organisation Name","University College London"]
["Contact Name","Nish Chaturvedi, Director of MRC Unit for Lifelong Health and Ageing"]
["Address","MRC Unit for Lifelong Health and Ageing, UCL"]
[null,"1-19 Torrington Place"]
[null,"London"]
["Postcode","WC1E 7HB"]
["Telephone","020 7679 9431"]
["Email","n.chaturvedi@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\nLower age limit: 68-Upper age limit: 72"]
["Description of confidential patient information used","Access was requested to Name, NHS number and Date of Birth in order to carry out linkage."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Supported"]
[]
["Outcome Date","2015-10-07"]
["Next Review Date","2024-10-07"]
["Notes","Amendment Request (Approved - 14/12/2017)\nIn order to obtain equivalent information for medical research on the remainder of the cohort ( (for those who have not consented), the purpose of this amendment was to seek section 251 approval for:\n1) A new data flow for the provision of address details in order to re-contact study members who have been lost to follow up and had not originally consented to linkage with cancer registry and mortality data.\nThis was requested in order to avoid bias to the results, due to loss of participants to follow-up. Obtaining address details will enable the applicant, where possible, to re-contact the study members who had not previously refused and who had been lost to follow-up, to invite them to continue participating in the study, as well as inviting them to consent to future participation.\n2) NHS Digital to link identifiable information provided from the NSHD research team to HES data, for participants who could not be contacted.\nIn a similar vein, NSHD has collected much of its data from birth through to early childhood and early adulthood before participants were lost to follow-up. For study members who remain lost to follow up and have not been contacted section 251 support is sought as linkage to additional routine data items such as HES, will allow us to make full use of data that had previously been collected.\n\nThis application was considered at the precedent set meeting held on 08 May 2015.\nConditions of support:\n1. Members queried what provisions had been made to allow objection and agreed that reassurances in relation to how this would be managed should be provided. Confirmed 14/7/2015\n2. Favourable opinion from a Research Ethics Committee. Confirmed 14/7/2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 21/09/2015"]

{"sheet":"A0162","index":113,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0162"]
["Reference","CR27/2014"]
["Other Refs"]
["Application Title","THRIVE: Treatment of HDL to reduce the Incidence of Vascular Events\n"]
["Application Summary","This application from the Clinical Trial Service Unit at the University of Oxford requested support in order to access mortality and cancer notification data from the Data Linkage Service (DLS) at the Health and Social Care Information Centre (HSCIC).\n\nThe study aims included long term follow up of the HPS2-THRIVE trial participants comprised of 25,000 (8,000 patients in UK). Long term follow up would allow beneficial or harmful effects that were not apparent during the scheduled study period to be investigated. A cohort of around 8,000 patients was flagged.\n"]
["Applicant Organisation Name","Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU)"]
["Contact Name","Professor Sir Rory Collins"]
["Address","Nuffield Department of Population Health"]
[null,"University of Oxford"]
[]
["Postcode"]
["Telephone","07920 506 689"]
["Email","tim.sprosen@ndph.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","8,035 participants from 88 sites in the UK plus 10,932 from China and 6,706 from Scandinavia, giving a total of 25,673 with a history of circulatory problems."]
["Description of confidential patient information used"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-10-07"]
["Next Review Date","2017-10-07"]
["Notes","Specific conditions of support\n\n1. Favourable opinion from REC. Received 06 October 2015\n2. Please ensure that information in relation to the processing is available on the University website and that if future contact is planned the information sent to patients includes details of data disclosed from the HSCIC.\n3. The recommendation for support covers access to mortality and cancer data from the HSCIC only.\n4. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 80% version 12 \n5. Provision of an annual review to be provided to the CAG no later than 11 months from date of this letter\n"]

{"sheet":"A0163","index":114,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0163"]
["Reference","15/CAG/0163"]
["Other Refs","REC Reference: 15/WA/0256, IRAS ID: 172505"]
["Application Title","Risk modelling for quality improvement in the critically ill: making best use of routinely available data"]
["Application Summary","This application from the Intensive Care National Audit & Research Centre (ICNARC) sets out the purpose of conducting an epidemiologic study to understand the risk factors for, and the consequences of critical illness leading to improvement in risk models used to underpin national clinical audits for adult general critical care, cardiothoracic critical care and in-hospital cardiac arrest by utilising data linkage with other routinely collected data sources. The patient cohort would include patients admitted to an adult critical care unit or experiencing an in-hospital cardiac centre in NHS Hospitals in England and Wales for the period between 1st April 2009 to 31st March 2015. \nThe applicant was seeking s251 support in order to disclose confidential patient information to the Health and Social Care Information Centre (HSCIC) and also for the HSCIC to carry out data linkage activity to link datasets from Case Mix Programme (CMP), the National Cardiac Arrest Audit (NCAA), National Diabetes Audit, UK Renal Registry and National Adult Cardiac Audit with Mortality data from the Office for National Statistics and also HES Data from the HSCIC. \nA recommendation for class 2, 4 and 6 support was requested to allow access to an authorised user for the purpose of obtaining and using information about past or present geographical location and to link patient identifiable information obtained from more than one source.\n"]
["Applicant Organisation Name","Intensive Care National Audit & Research Centre (ICNARC)"]
["Contact Name","Dr David Harrison"]
["Address","Intensive Care National Audit & Research Centre (ICNARC)"]
[null,"Napier House"]
[null,"24 High Holborn"]
["Postcode","WC1V 6AZ"]
["Telephone"]
["Email","david.harrison@icnarc.org"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\nLower age limit: 28"]
["Description of confidential patient information used","Access was requested to NHS Number, date of birth, gender, ethnicity, postcode and date of death for patients admitted to an adult critical care unit or an in-hospital cardiac centre within NHS Hospitals in England and Wales for the period between 1st April 2009 to 31st March 2015. \nThe dataset will also include date of admission, all other dates within the dataset and hospital names which will all be anonymised in the subsequent dataset.\nThe committee had requested clarification on two aspects before being able to advise support.\n1. Enhance patient notification on ICNARC website and the other organisations involved within the project. (provided to members)\n2. Provide onward disclosure policy and associated documentation (provided to members)\n"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Intensive Care National Audit & Research Centre (ICNARC)"]
["Status","Expired"]
[]
["Outcome Date","2015-11-02"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed that ‘s251’ support can be expired from 23 December 2022, as all identifiable patient information held without consent under this support has been pseudonymised, and linkage keys between the study database and the audit databases have been destroyed.\n\nIn terms of public benefit, the study has improved the risk prediction models that are used in the national clinical audits for adult critical care (the Case Mix Programme) and in-hospital cardiac arrest (the National Cardiac Arrest Audit). \n\n21 March 2022 - Amendment supported\nAmendment supported to extend the duration of support under the Regulations to 31 December 2022.\n\n28 September 2021- Amendment supported to extend the duration of support under the Regulations to 31 December 2021 \n\n21 October 2020 - Amendment supported to extend the duration of support under the Regulations to 31 July 2021.\n\n08 July 2019 – Amendment supported to extend the duration of support to 31 December 2019. \n\nAmendment Request (Approved 12/7/2018)\nDue to delays in processing of the application to NHS Digital for data linkage with HES and ONS data and to access data from the National Adult Cardiac Surgery Audit the research study is running behind schedule. The amendment sought an extension to support up to 31 December 2018.\nThe amendment will allow the objectives of the project to be achieved. Without this extension, the proposed project would not be able to be completed.\n\nAmendment (27/4/2017):\nDue to delays in processing of the application to NHS Digital for data linkage with HES and ONS data, the research study is running with an 11-month delay. The study funder (NIHR Health Services & Delivery Research Programme) has therefore recently approved an extension to the project with a revised end date of 30 June 2018. As such, the amendment is to extend the duration to 30 June 2018.\nThe amendment will allow the objectives of the project to be achieved. Without this extension, much of the proposed project would not be able to be completed.\nConfidentiality Advisory Group advice\nThis request was considered by the Confidentiality Advice Team, where it was agreed that the request appeared reasonable. The rationale for the duration was noted to be caused by delays in processing of the application by NHS Digital.\nThe applicant has an up to date Information Governance Toolkit, and the annual review is in place.\nConfidentiality Advisory Group conclusion\nIn line with the considerations above, the Confidentiality Advice Team agreed that the minimum criteria under the Regulations appeared to have been met for this amendment, and therefore advised recommending support to the Health Research Authority.\n\nThe CAG meeting was held on 06 August 2015\nSpecific conditions of support \n1. Patient Notification on ICNARC website and on the websites of the other organisations involved within the project. Confirmed 1 October 2015\n2. Favourable opinion from a Research Ethics Committee. Confirmed 17 July 2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 14 May 2015\n"]

{"sheet":"A0164","index":115,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0164"]
["Reference","15/CAG/0177"]
["Other Refs"]
["Application Title","An investigation of the association between substance use in adolescence and mental health using linked health data"]
["Application Summary","This application from the University of Bristol detailed the linkage of information relating to the health, education, benefits and earning and criminal convictions for the Avon Longitudinal Study of Parents and Children (ALSPAC) cohort (around 14000 individuals).\nPermission to access medical records without consent (ref:ECC 1-05(b)/2012) has already been obtained for ALSPAC participants who did not respond to the consent campaign. One condition of this approval was that mental health data would be excluded from any data extracts unless subsequently approved by the committee on a study specific basis.\nFor this current project, the researchers wish to extend this approval to extract data on mental health from Hospital Episode Statistics (HES), GP records, and the Mental Health and Learning Disabilities Dataset. This would allow them to investigate the association between self-reported substance use in adolescence and diagnosed mental health difficulties, particularly depression, anxiety and psychosis.\nThese data would be linked to de-identified ALSPAC data, for all those young people with a history of participation in ALSPAC and who have not explicitly withdrawn from the study or denied consent for record linkage to their health records. The study will examine the associations between mental health and the three most commonly used substances: tobacco, cannabis and alcohol.\nA request for class 1, 4 and 6 support was made to enable the extraction of confidential patient information without consent from a number of sources, including:\n1. Primary care data held by general practices; This data would be provided by NWIS and linked by the Secure Anonymous Data linkage (SAIL) system at Swansea University.\n2. HSCIC - Hospital Episode Statistics (HES); Mental health data\n3. HSCIC - MHLDDS – Mental Health and learning disabilities dataset"]
["Applicant Organisation Name","Avon Longitudinal Study of Parents and Children (University of Bristol)"]
["Contact Name","Mark Mumme (ALSPAC Data Linkage Manager)"]
["Address","ALSPAC"]
[null,"Oakfield House"]
[null,"Oakfield Grove"]
["Postcode","BS8 2BN"]
["Telephone","0117 3310033"]
["Email","mark.mumme@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ALSPAC-enrolled cohort: mental health difficulties\nMale and female participants\nLower age limit: 22 years\nUpper age limit: 25 years"]
["Description of confidential patient information used","NHS number, date of birth and postcode were requested to allow the linkage of data using services provided by the HSCIC and NHS Wales Informatics Service (NWIS). Only pseudonymised data which included a unique reference number (ALSPAC ID) for each individual would be available to the applicant."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Supported"]
[]
["Outcome Date","2015-11-23"]
["Next Review Date","2024-09-28"]
["Notes","This application was considered at the CAG meeting held on 17 September 2015.\nSpecific conditions of support\n1. Confirmation requested that the study would be included on the website. Confirmed 07/10/2015\n2. Confirmation was requested that if a newsletter was regularly provided to the participants that this signpost to information on the website. Confirmed 07/10/2015\n3. Confirmation was required that information about the exclusion of sexual and mental health data from the original study had not yet been provided to participants. Confirmed 07/10/2015\n4. Favourable opinion from a Research Ethics Committee. Confirmed 07/10/2015\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 07/10/2015"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","0165"]
["Reference","15/CAG/0172"]
["Other Refs"]
["Application Title","PUMA - Paediatric early warning system (PEWS): Utilisation and Mortality Avoidance. A prospective, mixed methods, before and after study identifying the evidence base for the core components of an effective PEWS and the development of an implementation package for implementation and use in the UK."]
["Application Summary","This application from Cardiff University and the South East Wales Trials Unit sets out the purpose to develop an evidence based paediatric track and trigger tool, in order to evaluate its feasibility and potential effectiveness in predicting deterioration and triggering timely interventions, identify the contextual features and factors necessary to ensure successful implementation and normalisation. Researchers will observe staff, who may have sight of patient documentation such as observation charts, to record how vital signs are recorded and how patient deterioration is recognised and acted upon. \n\nThe applicant sought support in order for members of the research team to undertake observations of members of the clinical care team, whereby they may be privy to confidential patient information and also to access patient medical records at 4 NHS hospital sites to extract anonymised data.\n"]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Colin Powell, "]
["Address","Department of Child Health"]
[null,"School of Medicine, Cardiff University"]
[null,"Children’s Hospital of Wales, Heath Park, Cardiff"]
["Postcode","CF14 4XN"]
["Telephone",2920748732]
["Email","PowellC7@cf.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\n37 Weeks gestational age-18 years"]
["Description of confidential patient information used","Access was requested to name, NHS number, date of birth, post code, medical details (predominantly observation charts)."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University"]
["Status","Supported"]
[]
["Outcome Date","2015-11-04"]
["Next Review Date","2017-11-04"]
["Notes","Application considered at the precedent set CAG meeting held on 31 July 2015.  \nConditions of support:\n1.  The wording with regard to opt out should be consistent between the Patient Information Leaflet and the poster specifying which hospital staff the patient should approach.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 21/09/2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 21/09/2015\n\n"]

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[]
[]
["Application Number","0166"]
["Reference","15/CAG/0154"]
["Other Refs"]
["Application Title","Hospital admissions for enteral tube related issues: retrospective case note review to determine frequency, reasons and risk factors."]
["Application Summary","People who are unable to eat and drink enough to meet their nutritional needs may have a tube inserted into their stomach or small intestine so liquid feed and water can be given. The number of people living at home receiving nutrition through a tube into their stomach or small intestine (enteral tube feeding) is increasing. Problems can occur with the tube, which result in the need for a person to be admitted to hospital. It is not clear how frequently this occurs or whether some admissions can be avoided.\nThis application from the University of Southampton aims to review records of hospital admissions for enteral tube related problems to identify how often admission for tube related problems occurs and the reasons for admission. The study will also identify whether there are any patient characteristics which make hospital admission more likely. The study protocol was divided into two parts for clarity on the aspects requiring approval under the regulations.\nPart 1.\nAll patients undergoing enterostomy tube insertion in the year 2012 will be identified from the Patient Administration System in two acute NHS Hospital Trusts in England. Additionally all patients discharged with a nasoenteric feeding tube in situ in the year 2012 in the same Trust will be identified. Data will be extracted from the Inpatient Patient Administration System by a Clinical Informatics Database Manager in one Trust and authorised personnel in the other Trust. Data extracted will be anonymised by the use of a unique identifier prior to access by the chief investigator. Support would not be required for this aspect of the study\nPart 2.\nThe dietetic records of all patients identified as having an enterostomy tube inserted in 2012 or discharged with a nasoenteric feeding tube in situ will be identified by the Nutrition and Dietetics Department and their records reviewed by the researcher. Extracting data from the dietetic records will give the researcher access to patient identifiable information as the records are paper, although the researcher will not extract and record any information that will enable the patient to be identified. The researcher is also part of the normal care team for some patients in one Trust. Approval under the regulations would be required for access to the dietetic records by the researcher.\nData will also be extracted from Hospital Episode Statistics (HES) or the Secondary Uses Service (SUS) however this will be anonymised before the researcher receives it."]
["Applicant Organisation Name","University of Southampton"]
["Contact Name","Dr Sue Green"]
["Address","University of Southampton"]
[null,"Faculty of Health Sciences, Level A, South Academic Block MP11"]
[null,"Southampton General Hospital, Tremona Road, "]
["Postcode","SO16 6YD"]
["Telephone","023 8077 7222 Ext: 3864"]
["Email","S.M.Green@soton.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with gastrostomy tubes inserted in 2012 and patients discharged\nfrom hospital with nasoenteral tubes in 2012.Male and female participants.18-No upper age limit"]
["Description of confidential patient information used","Access was requested to date of birth, date of death and postcode.\nThis application had been referred to full CAG review following initial consideration via the precedent set process. The application was referred because members had queried whether a practical alternative existing through effective the de-identification of records by the direct care team."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Southampton"]
["Status","Expired"]
[]
["Outcome Date","2015-10-26"]
["Next Review Date","N/A"]
["Notes","This application was considered at the CAG meeting held on 06 August 2015. \n1. Reassurance should be provided by the applicant that data will only be extracted from the PAS by those with legitimate access to the data. Confirmed 15/09/2015\n2. Study information should be displayed within the Trusts and patients informed of mechanisms to opt out of secondary uses of their data at every opportunity. Confirmed 15/09/2015\n3. Favourable opinion from a Research Ethics Committee. Confirmed 23/10/2015\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 11/09/2015\n"]

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[]
[]
["Application Number","0167"]
["Reference","CR12/2014"]
["Other Refs"]
["Application Title","Oxford Vegetarian Study "]
["Application Summary","This application from the University of Oxford set out a cohort study of 11,000 men and women to study the incidence of cancer and causes of death in vegetarians compared to non-vegetarians. It was confirmed that follow up until 2020 was planned. \nA recommendation for class support was requested to cover access to cancer and mortality data from the NHS Central Register, maintained by the Data Access Request Service (DARS) at the Health and Social Care Information Centre.\n"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Tim Key"]
["Address","Richard Doll Building, Roosevelt Drive"]
[null,"Cancer Epidemiology Unit"]
[null,"University of Oxford,Oxford"]
["Postcode","OX3 7LF "]
["Telephone"]
["Email","tim.key@ceu.ox.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","6000 vegetarians and 5000 non-vegetarians"]
["Description of confidential patient information used"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Supported"]
[]
["Outcome Date","2015-12-22"]
["Next Review Date","2024-12-22"]
["Notes","17 July 2023 - change in data processor from NHS Digital to NHS England, regarding cancer and mortality data.\n\n15 June 2021 - Amendment supported:\nSupport provided to continue processing of existing data until 31 December 2023 to continue analyses, plus other minor changes to the protocol.\n\nAmendment request 22/03/2017\nThe amendment request was submitted in response to the following advice from CAG as part of the original support:\n‘The applicant was advised to explore the feasibility of receiving pseudoynmised information only in relation to the cohort. The applicant was asked to discuss with NHS Digital and confirm whether this would be possible at annual review stage’. The applicant had discussed this possibility with NHS Digital and agreed that this would be implemented. During the same review of the request for data, NHS Digital had asked for further clarification from CAG, as follows:\n‘The s251 covers the supply of mortality and cancer data, but doesn't state that identifiable data will be transferred to NHS Digital to allow participants to be flagged’.\nThe applicant was therefore requesting confirmation that this data transfer was supported by CAG.                                                                                                                                          Specific conditions of support\n\n1. Favourable opinion from REC. Received 09/December 2015\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0168","index":119,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0168"]
["Reference","15/CAG/0193"]
["Other Refs"]
["Application Title","ANEMONE 2819CL2002"]
["Application Summary","Fidaxomicin an antibiotic licenced to treat Clostridium difficile infection (CDI). In the initial clinical trials of this drug, patients with Inflammatory Bowel Disease, severe and life threatening CDI were excluded. In addition, there is limited data available on the clinical response and safety of this drug on patients with renal or hepatic impairment and in pregnancy. However, it is likely that post licencing, this drug may have been used in the above patient groups. Hence, the Sponsor has proposed a retrospective, observational, multicentre drug utilisation study in Europe based on secondary use of data derived from medical records\n\nThis research application from Kings College Hospital will be looking at a minimum of 192 adult patients in the UK, identified from the pharmacy records of the study sites, who were prescribed Fidaxomicin during the country specific eligibility period. Research team members/Local site staff allocated to the study by each site, will review the medical records of all identified patients at a participating site to confirm eligibility and collect the relevant data of all eligible patients as outlined in the study protocol. The researchers believe that considering all eligible patients at the site, and randomizing a subgroup (max of 50 patients enrolled per site), will eliminate selection bias. Pre-specified data points included in the medical records from the patient’s hospital admission up to 30 days after the last dose of Fidaxomicin (the patient’s observational period) will then be collected. The data will then be pseudonymised at the individual study sites before being entered into the study database for analysis.\n\nS251 Support is requested to allow disclosure of identifiable patient information from the pharmacy and medical records at the hospital to the research staff. .\n\nA recommendation for class 5 support was requested for auditing, monitoring and analysing patient care and treatment.\n"]
["Applicant Organisation Name","King's college Hospital NHS Foundation Trust"]
["Contact Name","Dr. Surabhi Taori"]
["Address","3rd Floor Cheyne wing"]
[null,"Denmark Hill"]
[null,"London"]
["Postcode","SE5 9RS"]
["Telephone",2032994361]
["Email","surabhi.taori@nhs.net"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with concomitant inflammatory bowel disease (IBD), fulminant or\nlife threatening CDI, severe renal impairment, moderate or severe hepatic\nimpairment and pregnant patients and any other patients that were\nprescribe fidaxomicin.\nMale and female participants\nLower age limit: 18 years old"]
["Description of confidential patient information used","Access was requested to Hospital ID number, date of death, postcode, gender, ethnicity and data on hospital admissions and treatments."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"□","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Astellas Pharma Global Development, Inc."]
["Status","Supported"]
[]
["Outcome Date","2015-12-14"]
["Next Review Date","2016-12-14"]
["Notes","This application was considered at the precedent set CAG meeting held on 25 September 2015. The application was considered via the Precedent Set process under criteria 4 - Time limited access to undertake record linkage and to pseudonymise the data.\nSpecific conditions of support \n1. Please provide satisfactory evidence of public engagement and patient notification, including clear patient information sheets and the process for patient objection. Confirmed 8/11/2015\n2. Please provide an explanation of your understanding of the direct care team and why the definition appears to be inconsistent in your application. Confirmed 8/11/2015\n3. Favourable opinion from a Research Ethics Committee. Confirmed 11/12/2015\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 8/12/2015\nAs the above conditions have been accepted and/or met, this letter provides confirmation of final approval. I will arrange for the register of approved applications on the HRA website to be updated with this information.\n"]

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[]
[]
["Application Number","0169"]
["Reference","15/CAG/0141"]
["Other Refs"]
["Application Title","Pierre Robin Sequence national surveillance study"]
["Application Summary","This application from NHS Lothian NHS Foundation Trust set out the purpose of utilising the BPSU surveillance methodology and notifications to members of the Royal College for Paediatrics and Child Health (RCPCH), to provide a dataset to assess the epidemiology of Pierre Robin Sequence (PRS) within the UK and Ireland and how these cases are managed within hospitals. The study will involve inclusion of PRS on the “Orange Card” for a 13 month period. Clinicians participating within the BPSU reporting mechanism will be informing cases of incidence to the BPSU office. The BPSU office notify the lead investigator and the research team will send a questionnaire consisting of specified identifiers and associated clinical data to the clinicians to complete and return. A second questionnaire will be sent to clinicians 1 year after the initial report to collect clinical information about each child’s progress and health over the first year of life. The identifiers will be kept separately from the clinical data for case verification and to de-duplicate the dataset.\nPatient initials, date of birth, hospital number and postcode will be requested to allow for identification of case duplication, calculation of regional incidences of PRS and accurate ages of affected infants. In order to protect confidentiality, data collection questionnaires are structured so that the front page, which contains information only essential for case verification and deduplication, can be separated from the remaining pages that contain clinical research data.\nA recommendation for class 1, 2, 4, 5, and 6 support was requested to cover access to an authorised user for the process of extracting and anonymising data, to obtain and use information about past or present geographical area, for linking patient identifiable information obtained from more than one source and also for auditing, monitoring and analysing patient care and treatment."]
["Applicant Organisation Name","Royal Hospital for Sick Children"]
["Contact Name","Dr Marie FA Wright"]
["Address","Department of Paediatric Respiratory Medicine"]
[]
[null,"Edinburgh"]
["Postcode","EH9 1LF"]
["Telephone"]
["Email","016047261480"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants\n0-12 years old"]
["Description of confidential patient information used","Access was requested to patient initials, date of birth, hospital number and postcode."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-12-22"]
["Next Review Date","2016-12-22"]
["Notes","This application was considered at the precedent set CAG meeting held on 22 May 2015.The application was considered via the Precedent Set process under criteria 6 - Applicants utilising the British Paediatric Surveillance Unit (BPSU) methodology.\n1. The committee requested view of the text to be displayed on the web site. Confirmed 20/10/2015\n2. Favourable opinion from a Research Ethics Committee. Confirmed 21/12/2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 23/09/2015\n"]

{"sheet":"A0170","index":121,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[33,1,33,4],[34,1,34,4],[30,1,30,4],[31,1,31,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0170"]
["Reference","15/CAG/0168"]
["Other Refs"]
["Application Title","The RECENSUS Study: A Medical Chart Review of Patients with X-Linked Myotubular Myopathy (XLMTM), sponsored by Audentes Therapeutics"]
["Application Summary","This retrospective medical chart review (RECENSUS) of approximately 70-100 XLMTM patients will provide further knowledge about the clinical manifestations and recorded medical management of XLMTM and potentially inform the design of future therapeutic intervention studies. Patient records from approximately 70-100 subjects (with at least 50 deceased and 20 living) may be reviewed at approximately 10-12 clinical sites in the US and Europe with 2 of these in the England. XLMTM is a disease that presents at birth, children as young as 1 day of age may be included in the research database. Some patients die shortly after birth, while some (milder and rarer cases) may live into their teens. Few XLMTM patients live into adulthood.\nA CRA (Clinical Research Associate) trained in GCP (Good Clinical Practice) at each hospital will identify potential participants that meet the inclusion criteria. A search of electronic medical records and/or paper medical records system may also be used to identify potential participants.\nSupport is requested to provide access to the personal patient information held in the medical records by the research team in order to determine if potential participants meet study entry criteria.\nDue to limited number of XLMTM patients (a rare and often fatal disease) available and the difficulty in reaching and getting a response from authorized legal representative(s) of deceased patients, support is also requested for the disclosure of identifiable patient data for deceased patients for this study. Data extracted from medical records will be entered into a secure, password protected anonymous electronic database. No identifiable data will be transferred outside the EEA\nA recommendation for class 2, 5 and 6 support was requested to obtain and use information about past and present geographical location, for auditing, monitoring and analysing patient care and treatment and to allow access to an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","UCL Institute of Child Health"]
["Contact Name","Professor Francesco Muntoni"]
["Address","Dubowitz Neuromuscular Centre and MRC Centre for Neuromuscular Diseases"]
[null,"UCL Institute of Child Health"]
[null,"30 Guilford Street"]
["Postcode","WC1N 1EH"]
["Telephone",2079052111]
["Email","f.muntoni@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","XLinked\nMyotubular Myopathy (XLMTM)\nMale participants only\nNo upper age limit\n"]
["Description of confidential patient information used","Access to date of birth, date of death and country of birth are requested to allow for identification of cases by the research team."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Audentes Therapeutics, Inc."]
["Status","Expired "]
[]
["Outcome Date","2016-01-22"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that support for this study can be expired.  \n\nThis application was considered at the precedent set CAG meeting held on 31 July 2015.\n\n1. Please ensure that you restrict identifiers going outside the EEA to anonymous data e.g only month and year of birth and death. Confirmed 25/08/2015\n2. Favourable opinion from a Research Ethics Committee. Confirmed 14/07/2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission."]

{"sheet":"A0172","index":122,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[19,2,19,4],[20,2,20,4],[8,1,8,4],[27,2,27,4],[13,1,13,4],[14,1,14,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[35,1,35,4],[30,1,30,4],[31,1,31,4],[21,1,21,4],[22,1,22,4],[33,1,33,4],[34,1,34,4],[28,2,28,4],[29,2,29,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4]]}
[]
[]
["Application Number","0172"]
["Reference","16/CAG/0022"]
["Other Refs","16/WA/0003"]
["Application Title","Feasibility of an impact analysis of a clinical prediction tool to estimate the probability of abusive head trauma in children less than three years of age"]
["Application Summary","This application from Cardiff University set out the purpose of assessing the Feasibility of using an impact analysis tool to predict abuse. Abusive Head Trauma is the leading cause of death and disability in young children who have suffered abuse; however it can be difficult to tell if a head injury is the result of abuse. The researchers have created a tool to facilitate clinicians in this judgement. They will collect:\n1. The probability assessment provided by the tool;\n2. The probability assessment of the clinician pre and post use of the tool [with consent of the clinician];\n3. The child protection decisions of the clinician pre and post use of the tool [with consent of the clinician, s251 is not sought for this]; and\n4. Whether the child was deemed abused or not.\nSupport for activities 2 and 3, above, was not requested.\nThe researchers will identify cases by attending child protection and radiology peer review meetings. The notes will then be consulted to discover the six clinical indicators the tool uses as the basis for its prediction (seizure, apnoea, long-bone fracture, rib fracture. Head/neck bruising, and retinal haemorrhages). These cases will be given a study identifier and the link between study identifier and NHS number will be retained separately by the CI to allow data-linkage for follow-up.\nClinicians will then be approached to take part in the study. If they agree they will be asked to make an assessment pre and post use of the tool, and what their child protection decisions are pre and post use of the tool.\nThe research student will follow up each case to determine abuse/non-abuse. This will be determined by the decision of the multidisciplinary assessment conducted by the clinicians, social workers, police, and other relevant agencies at a strategy meeting, case conference, or child death case review meeting. These outcomes will be determined from the children’s case notes or child protection peer review meeting. Abuse will also be confirmed if witnessed or admitted to. Where abuse is not suspected (and therefore no multidisciplinary assessment meeting is held), the clinician will be followed up after six months to determine if they have any child protection concerns – unless there is an independently witnessed accidental injury or confirmed underlying organic disease. Follow up data will be obtained from health visitor records.\nIn addition, they will collect quantitative process data (e.g. the number of eligible patients) and qualitative process data (e.g. researcher observations, structured field notes arising from informal conversations and stakeholder organisations.)\nA recommendation for class 1 and 6 support was requested to cover the activity specified in the application."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Professor Alison Kemp"]
["Address","5th floor, Neuadd Meirionnydd"]
[null,"Heath Park"]
[null,"Cardiff"]
["Postcode","CF14 4YS"]
["Telephone",2920687150]
["Email","KempAM@cardiff.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","0—3 year olds presenting with head injury"]
["Description of confidential patient information used","NHS number, name, DoB."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University"]
["Status","Supported"]
[]
["Outcome Date","2016-03-10"]
["Next Review Date","2017-02-25"]
["Notes","Amendment - Approved (17/8/2017)\n\nResearchers now wished to address the issue that not all children with abusive head trauma would receive neuroimaging due to radiation concerns, resulting in these cases being missed – conversely, some children may undergo neuroimaging where this is not clinically indicated, exposing them to unnecessary radiation. New guidelines had recently been put in place at the study site regarding which children should undergo CT scan. The researcher wished to evaluate the guidelines looking at previous records for children who had undergone neuroimaging.\nThe researcher therefore requested additional access to medical notes in order to identify children who had undergone a CT scan, and to review the CT scan to establish whether the scan would have been recommended by the guidelines and whether they were clinically indicated.\n\nThis application was considered at the CAG meeting held on 25 February 2016\n\n1. An update on patient and public involvement to be included in the first annual review submitted to CAG. Confirmed, letter dated 15 March 2016\n2. CAG receipt of a favourable opinion from a Research Ethics Committee. Received, letter dated 21 January 2016\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission.. Confirmation received by e-mail dated 24 November 2015, version 12, 97%\n"]

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[]
[]
["Application Number","0173"]
["Reference","15/CAG/0164"]
["Other Refs","15/NE/0311"]
["Application Title","Finding the genes that cause hypoplastic left heart syndrome (HLHS)"]
["Application Summary","This application from the University of Newcastle sets out the purpose of conducting an observational and case note review study to identify genes that cause hypoplastic left heart syndrome (HLHS). The study would include identifying specific families with strong heritance of HLHS and congenital heart disease in several family members and analysing their genes for common patterns. The applicant confirmed that the clinical care team at Newcastle Upon –Tyne Hospitals NHS Foundation Trust, will identify living and deceased patients eligible for this study. The clinical care team will approach the patients to invite them to the study at an appropriate time and the patients will be able to contact the research team directly or via their clinicians. The applicant was seeking s251 support for the purpose of accessing deceased patient’s medical records to extract anonymised clinical data. \n\nA recommendation for class 1 and 6 support was requested to allow access to an authorised user for the purpose of extracting and anonymising the confidential patient information."]
["Applicant Organisation Name","Institute of Genetic Medicine"]
["Contact Name","Dr Bill Chaudhry"]
["Address","Newcastle University"]
[null,"Central Parkway"]
[]
["Postcode","NE1 3BZ"]
["Telephone"]
["Email","bill.chaudhry@ncl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Hypoplastic Left Heart Syndrome, Lower Age 12 Weeks gestational age, no upper limit."]
["Description of confidential patient information used","The sex, pre or postnatal age at time of scan(s), anatomical structures seen on the scan are the main study details.\nWe will check notes to exclude genetic syndromes in the proband which would exclude from our study and determine the eventual outcome (termination of pregnancy or continuation). We will look at the surgical operation record (if carried\nout) in case an important anatomical detail has been recored."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-03-30"]
["Next Review Date","N/A"]
["Notes","This application was considered at the precedent set CAG meeting held on 17 July 2015. The application was considered via the Precedent Set process under criteria 3 - where applicants are accessing data on-site to extract anonymised data.\n\nThe request for support was to check NHS records of deceased patients to identify if they actually had a robust diagnosis of hypoplastic left heart syndrome and if there was evidence within their NHS records that they might be important in understanding the heritability of this condition. Through an initial list of possible patients with this condition requested from the Newcastle Hospitals NHS Trust it became clear that there were no patients that had hypoplastic left heart syndrome that had not been already contacted through an open approach and consent process. Thus, no data was kept under this Section 251 permission and only the cohort of patients that have consented to be within the Finding Genes in HLHS study have anonymised information stored.\n\nThe research team have been able to ensure that they have assessed all possible participants who would be able to progress this study and that families with important information have not been missed, whilst ensuring that undue distress was not inadvertently applied to them. This means that the large number of families who consented to enter the Finding Genes in HLHS study are an accurate representation of the condition and the study will be able to draw solid conclusions from the analysis of their anonymised data.\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 24 December 2015\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC on 16th July 2015."]

{"sheet":"A0174","index":124,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[19,2,19,4],[20,2,20,4],[8,1,8,4],[27,2,27,4],[13,1,13,4],[14,1,14,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[30,1,30,4],[31,1,31,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[33,1,33,4],[34,1,34,4],[28,2,28,4],[29,2,29,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4]]}
[]
[]
["Application Number","0174"]
["Reference","15/CAG/0165"]
["Other Refs"]
["Application Title","A case study of spatiality in advanced presentation gastroesophageal cancer"]
["Application Summary","This application from University of Hull describes a case study of cancer of the gullet (gastroesophageal cancer, GOC). GOC presents an interesting case for study, as certain attributes are very commonly associated with sufferers, such as advancing age, male gender, smokers and those with higher alcohol intake, as well as those from lower socioeconomic groups. This project will use a case study approach to map and analyse patients' environments against these common attributes, so that maps can be produced according to underlying population demographics and to analyse how the environment plays a part in stage of presentation.  \n\nA search of the disease register database held by the National Cancer Intelligence Network (NCIN) at Public Health England will be undertaken to yield all patients with histologically confirmed GOC who presented to the Queens Centre Castle Hill Hospital, during the period 1999 2013. ONS lifestyle survey data from this period will be used to develop the weighted map of the region. ONS population data from 2010 census will be used to determine age and sex of postcode level data, so that incidences may be weighted accordingly. Data from the Environmental Systems Research Institute, the geographical underpinning map datasets, will be used for the purposes of cartography and mapping the appropriate geographical catchment area.\n\nAll data will be held within the geographic information system for purposes of analysis. This will be stored in an encrypted format and only accessible to the researcher and her academic supervisors.\n\nA recommendation for class 2 support was requested to cover access to confirmed GOC diagnosis, histological type, Interventions, GP registration, patients Date of Birth, age, gender, date of presentation to cancer specialist services and date of death where this has occurred."]
["Applicant Organisation Name","University of Hull"]
["Contact Name","David Richards"]
["Address","PVC office, Room 005"]
[null,"Ground Floor, VENN building University of Hull "]
[]
["Postcode","HU67RX"]
["Telephone"]
["Email","david.richards@hull.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Gastroesophageal cancer C15 & C 16 histologically\nconfirmed  - Male and female participants, 18 to 150 Years "]
["Description of confidential patient information used","Data from NCIN in relation to GOC will be accessed including confirmed GOC diagnosis, histological type, Interventions, GP registration, patients DOB, age, gender, date of presentation to cancer specialist services and date of death where this has occurred.  Other data sources rely upon non identifying ONS census data, which will be applied geographically, to produce a map which identifies areas where populations exhibit GOC relevant demographics."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Hull"]
["Status","Supported"]
[]
["Outcome Date","2016-03-22"]
["Next Review Date","2017-03-22"]
["Notes","This application was considered at the CAG meeting held on 06 August 2015. \n\n1. The applicant is requested to clarify that this is a multi-centre study. Confirmed 18/08/2015\n2. The applicant is requested to clarify the retention of identifiers beyond 5 years post PHD and what can be done to reduce primary risks post collection.\na) What conversion into a less identifiable form can take place prior to analysis? Confirmed 18/08/2015\nb) What does the applicant intend to do to reduce identifiability of data prior to publication? Confirmed 18/08/2015\n3. Increased patient notification. What can the researcher do to encourage NCIN for increased notification on the website. Confirmed 18/08/2015\n4. The applicant should address what definition of anonymous data is being used (Sweeney K and quasi anonymous data). Confirmed 18/08/2015\n5. Favourable opinion from a Research Ethics Committee. Confirmed 2/09/2015\n6. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 17/03/2016"]

{"sheet":"A0175","index":125,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[19,2,19,4],[20,2,20,4],[8,1,8,4],[27,2,27,4],[13,1,13,4],[14,1,14,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[30,1,30,4],[31,1,31,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[33,1,33,4],[34,1,34,4],[28,2,28,4],[29,2,29,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4]]}
[]
[]
["Application Number","0175"]
["Reference","15/CAG/0155"]
["Other Refs","15/YH/0398"]
["Application Title","Magnetic Resonance Imaging to Enhance the Diagnosis of Foetal Developmental Brain Abnormalities in Utero"]
["Application Summary","This application from the Academic Unit of Radiology in Sheffield outlines the purpose of the Meridian study and its 2-3 year follow up to find out if magnetic resonance imaging (MRI) improves the accuracy of diagnosis of fetal brain abnormalities. The study had recruited 750 pregnant women identified during routine second trimester ultrasound screening (i.e. between 18+0 and 21+6 weeks gestation). The sociological aspects of the research will examine patients’ views of care, including overall satisfaction with care, acceptability of in utero Magnetic Resonance in the process of prenatal diagnosis, and the impact of in utero MR on decision making. The inclusion of an in-depth qualitative study of health professional perspectives alongside patient perspectives will also allow for a more comprehensive understanding of the utility of in utero MR in this setting. All participants had been provided with a patient information sheet describing the study and the consent form to be signed.\n\nThe 2-3 year follow up study will follow up the children of the MERIDIAN cohort when they are aged 2- 3 years. The research team have prior consent to contact the families regarding future studies about their child's development. However to avoid causing emotional upset the HSCIC patient tracking system will be used to check that the child is still alive before the parents are approached. NHS number and, for verification purposes, date of birth will be provided to the HSCIC to allow them to link the cohort with the Patient Tracking service. The date of death and cause of death of the children born from the Meridian study will be returned to the research team, allowing bereaved parents to be excluded from further contact and providing valuable information for the prognostic aspect of the follow-up study, particularly where the cause of death is related to brain development."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Paul Griffiths"]
["Address","Academic Department of Radiology"]
[null,"Royal Hallamshire Hospital"]
[null,"Sheffield"]
["Postcode","S10 2JF"]
["Telephone","0114 2712587"]
["Email","P.Griffiths@Sheffield.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study had recruited 750 pregnant women identified during routine second trimester ultrasound screening (i.e. between 18+0 and 21+6 weeks gestation)."]
["Description of confidential patient information used","NHS number and DOB "]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Sheffield Teaching Hospitals NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2016-02-26"]
["Next Review Date","2018-02-26"]
["Notes","This application was considered at the precedent set CAG meeting held on 19 June 2015.\n\n1. S251 support is limited to list cleaning purposes only. For future studies there is the practicable alternative at this stage of seeking consent to retain identifiers in order to pass them in the future to HSCIC for list cleaning/updating purposes. The applicant should be reminded that as the subjects of this study move towards being adults they will need to give their own consent to this study.\n2. The application should be amended to make clear why S251 support is required and Q6 should be ticked to include participants who are children. Confirmed 17/12/2015\n3. Members requested greater clarity on the need to retain identifiers for 5 years Confirmed 17/12/2015\n4. Favourable opinion from a Research Ethics Committee. Confirmed 4/09/2015\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 16/02/2016\n6. As the above conditions have been accepted and/or met, this letter provides confirmation of final approval. I will arrange for the register of approved applications on the HRA website to be updated with this information."]

{"sheet":"A0176","index":126,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[33,1,33,4],[34,1,34,4],[30,1,30,4],[31,1,31,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0176"]
["Reference","15/CAG/0196"]
["Other Refs","REC: 15/SW/0294, IRAS: 183510"]
["Application Title","Tracking the Impact of Gestational Age on health, educational and economic outcomes: a longitudinal Record linkage study (TIGAR)"]
["Application Summary","This application from University of Oxford set out the purpose of the overall aim of the study to investigate the effect of gestational age at birth on health, educational and economic outcomes up to age 11 years.\n\nTIGAR will use information about all children born in England during 2005/2006 (about one million). Information on the children will be obtained from: birth records; records of hospital admissions or outpatient visits up to age 10 years and primary school records (e.g. SATs results, special educational needs). The information from these sources will be linked together by independent organisations, which will make the data completely anonymous before sending it to the TIGAR team for analysis. \n\nSupport is requested to allow the disclosure of confidential patient information from;\n• The HSCIC to the Office for National Statistics (ONS)\n• The ONS to the Education Data Division \n• The TIGAR team to access patient confidential information within the ONS VML – this is for validation purposes\n\nA recommendation for class 1, 2, 4 and 6 support was requested."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Maria Quigley"]
["Address","University of Oxford"]
[null,"Univeristy of Oxford Old Road Campus"]
[null,"Headington, Oxford"]
["Postcode","OX3 7LF"]
["Telephone","01865 (2)89725 "]
["Email","maria.quigley@npeu.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","TIGAR will use information about all children born in England during 2005/2006 (about one million)."]
["Description of confidential patient information used","child name, sex, date of birth and most recent postcode"]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Expired"]
[]
["Outcome Date","2016-03-23"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the study has advanced the understanding of how being born early can affect a child's health and their progress at school.  research findings also provide a useful costing resource for future economic evaluations focusing on preventive and treatment strategies for babies born preterm.  \n\n\n18 June 2020 - Amendment supported to extend the end date of the research from 30 June 2020 to 30 June 2022 and to clarify that the analysis of confidential patient information will take place within the Office for National Statistics safe haven.\n\nAmendment Request (Approved - 11/01/2018)\nThe amendment request sought support for a revised lay summary, which fulfils the patient notification requirements. Revisions had been made at the request of NHS Digital in order to more clearly set out the patient’s right to objection. Wider administrative changes were made to the document to accurately reflect previously supported amendments which were made to the study.\n\nAmendment Request (Approved - 18/05/2018)\nThe application sought an extension to the duration of support until 30 June 2020.\nThe applicants further explained that, due to delays in the release of pseudonymised data from ONS to the University of Oxford, the analysis of the pseudonymised data would begin at the ONS in London, pending the approval of data release. The applicants explained that this decision had been taken as the project was behind schedule. Some additional administrative changes were notified which included a change to project staffing and replacement of references to ‘ONS Virtual Microprocessor Laboratory (VML)’ with‘ONS Secure Research Service (SRS)’, due to recent name change.\n\nAmendment Request (Approved - 8/11/2017)\nThe original application requested transfers of data from ONS to the research team for validation on two occasions.\nThis request was for a third data transfer to enable another check to be carried out. The reason for this additional phase of checking was that the research team who undertook the initial linkage from which the TIGAR data was extracted, did not have time to check the matching of the children’s data before their research funds ran out. Full details and a data flow diagram were provided.\n\nApproval (12/5/2017) - Approved\nThe applicant was investigating health and educational outcomes associated with premature birth. They had requested identifiable information for linkage, and anonymised data for analysis.\n\nAlthough initially the need to include information about deaths was not recognised, the applicant had later discovered that in order to avoid confounding survival analysis and regression models, they would need to know which children had died and approximately when the death occurred. This information would be used to create a censoring variable based on the age in months at which the child died, to enable accurate calculations to be made – for example, a child who died at 3 months old would only be at risk of hospital admission for pneumonia before 3 months.\n\nAccess would be requested to age of death in months, to be used in survival and regression analyses and to exclude these children from linkage to school data, where they died before starting school.\n\nNotes: \nThis application was considered at the CAG meeting held on 26 November 2015. \n1. A Health Research Authority Research Ethics Committee favourable opinion letter: Received 23/12/2015\n2. Support is provided for the following aspects only. The flow of confidential patient information between; \na. The HSCIC to the Office for National Statistics (ONS) (including the linked HES maternity data)\nb. The ONS to the Education Data Division (this file will contain patient confidential information)\nc. The Education Data Division to pass confidential patient information back to ONS  - please see below for exclusion.\nd. The TIGAR team to access patient confidential information within the ONS VML (for validation purposes)\n\n3. Support excludes the following three aspects;\na. ONS to pass information they hold about births to the HSCIC \nb. the HSCIC to process the ONS births information\nc. Education Data Division to pass education data to ONS\n4. Confirmation that further information about opt out will be made available to participants, how and when this will be done. Confirmed 23/12/2015\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. This is required for ONS and the Education Data Division as well as for this project at the University of Oxford. Please see security review requirement section of the HRA website:http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmation received 23/12/2015                                                                                           "]

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[]
[]
["Application Number","0177"]
["Reference","15/CAG/0203"]
["Other Refs","15/WA/0259"]
["Application Title","Impact and Evaluation of a Burns Risk Assessment of Neglect and Maltreatment in Children Tool.BuRN-Tool  A multi centre study"]
["Application Summary","This research application from Cardiff University set out the purpose of the application to develop and test a Clinical Prediction Tool for use in the Emergency Departments (ED)/MIU’S (Minor Injury Units) and Burns Units to help identify features that may be significant when considering if a burn or scald is due to neglect or maltreatment. A further aim was to conduct a before and after study to evaluate the acceptability, efficacy and accuracy of the BuRNtool to identify maltreatment when implemented into clinical practice in Emergency Departments, Minor injury Units and Burns Units. Finally, a further aim was to identify if a version of the tool can be developed for use by child protection professionals.\n\nThe target range for this study are those aged 16 years and under. It was stated that patterns/types of thermal injury are unique to the developing child and it is vital that any safeguarding concerns are addressed especially in the younger children who are not able to verbalise what has happened to them.\n\nA recommendation for class 1 and 6 support was requested to achieve the activities specified within the application and to enable a specific research nurse access to identifiable information. The applicant confirmed that the selection of feasibility study in the application was done in error, the application is for all sites."]
["Applicant Organisation Name","Institute of Primary Care and Public Health"]
["Contact Name","Professor Alison  Kemp"]
["Address","4th Floor Neuadd Meirionnydd"]
[null,"Heath Park, Cardiff "]
[]
["Postcode","CF14 4YS"]
["Telephone",2920687143]
["Email","KempAM@cardiff.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Those children less than 16 years of age who attend the Emergency\nDepartment/ Minor injury unit or Burns unit with a Thermal injury. Male and female participants. 1 days to 16 Years"]
["Description of confidential patient information used","Name, NHS No (no longer required as of 22/10/2018), postcode at sector level to enable deprivation scoring (and to identify child's local authority as of 22/10/18), gender, ethnicity and date of birth. Address will be collected in cases where name and DOB are not sufficient identifiers (as of 22/10/18)."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University"]
["Status","Supported"]
[]
["Outcome Date","2016-02-23"]
["Next Review Date","2018-02-23"]
["Notes","Amendment (Approved - 22/10/2018)\nThe amendment is seeking to change the items of confidential patient information processed for the purposes of the application activity. The following changes are proposed:\n1. NHS Number is no longer required,\n2. Postcode (already collected) will be used to identify the child’s local authority,\n3. In cases where name and date of birth (both already collected) were not sufficient to identify an individual child within the local authority system, address (not currently collected) will be used.\n\nAmendment (Approved - 11/09/2017)\nThe request was for a 2-year extension to the activity, due to additional funding which would enable the tool to be assessed within a wider variety of settings.\n\nAmendment Request 10/02/2017\nThe amendment seeks approval for the applicants to receive the full postcode to allow accurate calculation of deprivation scoring. The initial application was approved to allow access to postcode at sector level to enable deprivation scoring; however, the applicants have subsequently identified that the postcode should have been requested at unit level to ensure accuracy of this calculation. The applicants advised that this would involve entering the full postcode into an excel spreadsheet to enable the deprivation score to be calculated; however, it was clarified that only the deprivation score (not the postcode) would be entered into the research database. The applicants advised that if they were unable to calculate an accurate deprivation score, this would prevent the opportunities that a targeted burn/scald prevention scheme could offer.\n\nSpecific Conditions of Support 10/02/2017\n1. Confirmation of suitable security arrangements via IG Toolkit submission. (Confirmed - Version 13, 2015/16 showing a self-assessed score of 97% which has been reviewed and published as satisfactory).\n2. Confirmation of a favourable opinion from a Research Ethics Committee. (Confirmed – Substantial Amendment 1 – Approved 28/10/2016).\n\nThis application was considered at the CAG meeting held on 26 November 2015. \nSpecific Conditions of Support\n1. Favourable opinion from a Research Ethics Committee. Received 21/12/2015\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. This is needed for REDCap and the site the research nurse will be based at. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed"]

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[]
[]
["Application Number","0178"]
["Reference","15/CAG/0211"]
["Other Refs","15/WA/0259"]
["Application Title","Understanding patient mortality in the month following contact with the out of hours service: a data-linkage study."]
["Application Summary","This application from the Oxford Health NHS foundation trust set out the purpose to establish the proportion of patients dying in Oxfordshire over a year who were assessed by the Oxfordshire out of hours service (run by Oxford Health NHS foundation trust) in the four weeks prior to their death and to evaluate whether there are clinical and demographic features which could help distinguish patient subgroups at higher risk of death within 4 weeks of contact with the out of hours service.\n\nBy linking mortality data from the Health and Social Care Information Centre with OOH records for Oxfordshire all people who have died in Oxfordshire in a 12 month period can be identified. The researchers can then establish whether these people had made contact with the OOH service in the four weeks before their death and the proportion of people who contacted the service. Using the OOH electronic record will allow demographic and clinical information to be recorded on this group, such as age, social deprivation, and the outcome of the contact with the OOH service. Researchers will also look specifically at those patients who did not contact the service due to end of life issues.\n\nThere is currently no integrated feedback system regarding patient deaths between local GP practices, the out of hours service and hospitals in the Oxfordshire region. One potential repercussion of this is that the proportion of patients who make contact with the out of hours service and who die within four weeks of that contact remains unknown. It is also unclear why these patients die, and whether it is possible to identify any particularly high risk subgroups of patients making contact with the out of hours service.\n\nS251 support is requested to allow the disclosure of NHS numbers, dates of birth and dates and cause of death for all patients dying within Oxfordshire on a 12 month basis, expected to be around 7,000 patients. Data from the HSCIC will be cross-referenced with the Oxfordshire out of hours electronic medical record to identify patients seen by the Oxfordshire out of hours service within four weeks of their death. Sub sector level postcode will enable an evaluation with indices of deprivation. NHS numbers will be replaced with study identification numbers and all information relating to patients who had not seen the OOH service within 4 weeks of their death will be securely deleted as soon as linkage is complete.\n\nA recommendation for class 1, 2, 4, 5, and 6 support was requested to cover access to an authorised user for the process of extracting and anonymising the information, to obtain and use information about past or present geographical location, for linking patient identifiable information obtained from more than one source, and for auditing, monitoring and analysing patient care and treatment."]
["Applicant Organisation Name","Health Education Thames Valley"]
["Contact Name","Dr Rebecca F R Fisher"]
["Address","Department of Primary Care Health Sciences"]
[null,"Radcliffe Observatory Quarter, Woodstock Road"]
[null,"Oxford"]
["Postcode","OX2 6GG"]
["Telephone","07882372166"]
["Email","rebecca.fisher@phc.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Expected to be around 7,000 patients"]
["Description of confidential patient information used","NHS numbers, D.O.B AND dates and cause of death for all patients dying within Oxfordshire on a 12 month basis."]
["S251 Class(es)","□","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Supported"]
[]
["Outcome Date","2016-02-11"]
["Next Review Date","2017-02-11"]
["Notes","Confidentiality Advisory Group sub-committee meeting 04 December 2015.\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 23/12/2015\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 8/2/2016"]

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[]
[]
["Application Number","0179"]
["Reference","16/CAG/0008"]
["Other Refs","15/NW/0766"]
["Application Title","The management and risk of patients with personality disorder prior to suicide and homicide"]
["Application Summary","This application from The University of Manchester set out the purpose of this study which was to inform clinical policy and practice by recommending safety improvements which may reduce patient suicide and homicide by people with personality disorder.\n\nRecommendations were to be highlighted in a report and were to form part of the NCISH toolkit for use throughout the service.\n\nThe study aims were to:\nDescribe the characteristics of patients with PD who died by suicide or committed homicide.\nExamine the care pathway for patients with PD who died by suicide or committed homicide.\nExamine the extent to which care received adhered to NICE guidelines for personality disorder.\nEvaluate the quality of risk management intervention (assessment, planning and implementation of risk plans) in the 3 months prior to death or homicide.\nA mixed methodology was to be used to examine the care and risk management of patients with personality disorder (PD) who had died by suicide in 2012/13 or were convicted of homicide in 2010-2013 in the UK. Cases were to be identified from the existing National Confidential Inquiry into Suicide and Homicide by People with Mental Illness [NCISH] database. (PIAG 4-08(d)/2003)). \n\nAdditional information was to be obtained through a number of data sources, such as a web based survey, medical records, focus groups with clinical teams across the UK, and interviews with support and representatives groups for patients with PD.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to allow the study's participating organisations to correctly locate the medical records held on the participants, and for access to their medical records in order to extract information.\nSpecifically; The study was to receive data from the following sources:\n1) Service providers: Medical records of the individuals in cases included in the study.\n2) Data from the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness cases of people in contact with mental health services in the 12 months prior to their death\nOther aspects of the project listed in the application did not require support as consent was to be obtained and were therefore not part of this request:\n3) Responses from the Web based survey\n4) Transcripts of the focus groups with clinicians\n5) Transcripts of the telephone interviews with patient group representatives"]
["Applicant Organisation Name","The University of Manchester"]
["Contact Name","Professor Jennifer Shaw"]
["Address","RM 2.317"]
[null,"Jean McFarlane Building"]
[null,"Oxford Rd"]
["Postcode","M13 9PL"]
["Telephone","0161 275 0700"]
["Email","jennifer.j.shaw@manchester.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Suicides by patients with PD that occurred between 1st January 2012 and 31st December 2013  \nConvictions for homicides by patients with PD between 1st January 2010 and 31st December 2013. "]
["Description of confidential patient information used","Date of birth, date of death, post code, gender and ethnicity is to be retained for analysis."]
["S251 Class(es)","Y","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Manchester"]
["Status","Expired"]
[]
["Outcome Date","2016-03-31"]
["Next Review Date","N/A"]
["Notes","All identifiers have been removed and analysed data is anonymised.\n\nKey messages: \n\n•\tThere is no clinical justification for patients with personality disorder to be excluded from care. This is a high need, vulnerable group who require appropriate and timely access to mental health care specific care arrangements to reduce the risk of self-harm. \n\n•\tA diagnosis of personality disorder itself is part of the problem. The term continues to be used internationally partly because the diagnosis is required for admin or legal purposes. Work with patients is needed to identify a new way of formulating their experiences and difficulties.  \n\n•\tStability of care is required in the service, with a focus on preventing rather than responding to crises. \n\n•\tIt is crucial that psychological treatments such as DBT and MBT are available and continual supportive care is provided by mainstream staff while patients are waiting to be treated.\n\n•\tSafer prescribing of psychotropic medications that could be used in fatal overdose is needed. Clinicians should be aware of the potential risks of prescribing these drugs long-term.\n\n•\tStaff are currently not sufficiently trained to support and manage patients with personality disorder. Skilled staff should be available in all mental health services. Although not examined in this study, it would be valuable if training were extended to GP’s and primary care mental health teams to increase understanding of the illness.\n\n•\tPatients with PD often have complex needs including comorbid substance misuse. Substance misuse and mental health services should work closely to manage clinical risk. \n\n•\tWhen specialist services and therapies were accessed by patients they were found to be good. \n\n•\tFormer patients are an under-used resource and should have involvement in staff training, advocacy and peer support where possible. \n\nImproving safety does not have to mean excessive burden on existing capacity and resources. These patients are already receiving care, but for many this is in a disorganised and costly way which compromises safety. \n\n\nThis application was considered at the Confidentiality Advisory Group meeting 14 January 2016\n\n1. Confirmation that date of birth and date of death for the analysis would be reduced to either month and year or age. Or provide justification why this is not possible. Confirmed 4th February 2016. Date of birth and death should be converted to age only in the database and should not held.\n2. To put a process in place to manage patient objections. Confirmed 4th February 2016. Any discussions in stage 1 of the objections process cannot be deemed to be pressurising candidates to allow their data to be processed.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed."]

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[]
[]
["Application Number","0181"]
["Reference","16/CAG/0029"]
["Other Refs","15/NW/0766"]
["Application Title","The Empress Study Cancer diagnosis via Emergency Presentation: a case-control study"]
["Application Summary","This application from University of Hull set out the purpose of a case-control study into colorectal and lung cancer. This involves an investigation of the emergency presentation pathway in order to identify and understand the reasons for this type of presentation. In particular the researchers are asking:\n\n Are there differences in the pathway to diagnosis between patients who are diagnosed during an emergency presentation compared to those who are referred to hospital by their GP through the usual UK fast track system – the two-week-wait pathway (2WW)?\n\n What are the characteristics and primary health care experiences of patients with colorectal and lung cancers who are diagnosed as a result of emergency presentation, compared to those diagnosed through the 2WW referral system?\n\nThe research will also consider patients’ socio-economic status.\nSome patients will have died quite quickly after presentation. The researchers therefore sought support to include the medical records data (hospital and general practice) for the patients who have died."]
["Applicant Organisation Name","University of Hull"]
["Contact Name","Professor Una Macleod"]
["Address","Hull York Medical School"]
[null,"The University of Hull"]
[null,"Hull"]
["Postcode","HU6 7RX"]
["Telephone"]
["Email","una.macleod@hyms.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with histologically confirmed primary colorectal cancer and\npatients with histologically confirmed primary lung cancer, or if no histology\nexists, radiologically confirmed primary lung cancer. Male and Female, 18 Years onwards"]
["Description of confidential patient information used","Name, NHS number, Hospital ID number, GP registration, Date of birth, Date of death, & Postcode."]
["S251 Class(es)","Y","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Hull"]
["Status","Supported"]
[]
["Outcome Date","2016-04-27"]
["Next Review Date","2025-04-27"]
["Notes","09 September 2019: Amendment supported to change the data storage arrangements for the trial by the University of Hull (Hull Health Trials Unit) as processor for the application activity. The University of Leeds was removed as a processor.\n\nThis application was considered at the Confidentiality Advisory Group meeting 17 March 2016.\n1. An update on patient and public involvement to be included in the first annual review submitted to CAG. Confirmation received, e-mail dated 22 April 2016\n2. CAG receipt of a favourable opinion from a Research Ethics Committee. Received, letter dated 03 June 2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Received 18 April 2016"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A0182","index":131,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0182"]
["Reference","16/CAG/0017"]
["Other Refs","15/NW/0941"]
["Application Title","Developing methods for assessing avoidable severe harm attributable to problems in care"]
["Application Summary","This application from the London School of Hygiene and Tropical Medicine set out the purpose of this study to test if it was feasible to identify high risk patients using routine data, identify a pool of such patients from 5 different hospitals and retrieve case notes to undertake a review to confirm whether patient harm has occurred. If the applicant can show this route works then it will pave the way for much larger validation studies.\n\nRecent studies using retrospective case record reviews (RCRR) have demonstrated that a proportion of hospital deaths are avoidable. However, the amount of (severe) harm caused by health care may reflect a greater quality of care problem.\n\nThe researchers were to first draw up a list of the types of severe harm that occur based on previous research, information from routine reports to the NHS National Reporting and Learning System and the opinions of clinical experts and patients. Next, ways of using existing routine health and social care databases to identify those patients who suffered severe harm as a result of their hospital in-patient care will be developed.\n\nFinally the researchers will develop and test how they will determine which of these incidents of severe harm was due to poor quality care and could, therefore, have been avoided. This was to be done by detailed review of the patients' case records by experienced doctors trained to undertake this task. This would also provide information on the hospital factors that contributed to the event.\n\nIt was expected that this research will guide NHS England in their approach to monitoring severe harm in health care and complement the emerging measure of avoidable hospital mortality (section 5c NHS Outcomes Framework 2014/15)."]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Dr Helen Hogan"]
["Address","Keppel Street"]
[null,"London"]
[]
["Postcode","WC1E7HT"]
["Telephone"]
["Email","helen.hogan@lshtm.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants,  18 Years and over\n\n\n"]
["Description of confidential patient information used","Local hospital IDs that HSCIC provide to the Nuffield Trust."]
["S251 Class(es)","Y","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Expired"]
[]
["Outcome Date","2016-05-03"]
["Next Review Date","N/A"]
["Notes","All processing of Confidential Patient Information has ended - 22/8/2017\n\nAmendment Request 27/01/2017\nThe amendment requests an extension to the end date of the project to be in line with the revised grant end date of 30 June 2017. The request was not a duration extension to the time period for which support is requested.\n\nSpecific Conditions of Support 27/01/2017\n1. Confirmation of suitable security arrangements via IG Toolkit submission. (Received – London School of Hygiene & Tropical Medicine, Version 13 2015/16, Reviewed Grade Satisfactory at 78%)\n2. Confirmation of a favourable opinion from a Research Ethics Committee. (Pending)                                                                                                             This application was considered at the Confidentiality Advisory Group meeting 11 February 2016.\n\n1. Draft letter and patient information which was to go to participants to inform them about the project and advise how they can opt out of the further use of their data. Confirmed 07/04/2016\n\n2. Confirm a check would be put in place before attempting to contact participants. Confirmed 07/04/2016\n\n3. Confirmation of the dates for the case note reviews and whether this has already taken place. Confirmed 09/03/2016 – this is to take place between April and July 2016\n\n4. Confirm what is meant by GP data, where and how this is to be accessed, the legal basis for access and the purpose it was to be used for. Support is not requested for this, no disclosure is taking place 09/03/2016\n\n5. Review question 45 of the application form and correct if needed. Corrected 09/03/2016\n\n6. Favourable opinion from a Research Ethics Committee. Provided 29/04/2016\n\n7. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 28/01/2016."]

{"sheet":"A0183","index":132,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0183"]
["Reference","14/CAG/1042"]
["Other Refs","14/LO/2221"]
["Application Title","BPSU facilitated study on Rickets"]
["Application Summary","This application from Royal Free London NHS FT set out the purpose of completing a surveillance study to investigate nutritional rickets caused by vitamin D deficiency presenting to secondary care.\n\nRickets is unique to growing children and adolescents and occurs when growing bones do not develop adequately. As a result the child’s bones soften which can lead to distressing short and long term consequences. These include pain, delayed walking, deformed limbs in need of surgical correction, or difficulty with child bearing. The disease can be recognised in children and adolescents by specific clinical signs and/or bone x-rays.\n\nRickets is the commonest childhood complication of vitamin D deficiency (VDD) and is caused by a lack of dietary calcium or problems with the supply or use of vitamin D inside the body. Rickets can also be caused by the lack of phosphate, from the loss of kidneys or from genetic problems.\n\nCurrently there is little data on the number of rickets cases and the last national UK survey of rickets was conducted in 1945. The limited data that is available to date shows that VDD in the UK is steadily increasing. The knowledge of population based data will allow us to follow trends of the disease in different populations over time. The data will also help to provide evidence for the supplementation of vitamin D.\n\nAs a disease that can be identified by specific clinical and radiological signs, the number of new cases (incidence) and treatment of rickets in the UK can be monitored and evaluated. In the recent Chief Medical Officer’s (CMO) report 2012, Dame Sally Davies recommends investment to be made into universal and targeted vitamin schemes and whether the approaches are cost effective. This project aims to estimate the incidence of nutritional rickets presenting to secondary care and to identify and describe the presentation, management and known risk factors."]
["Applicant Organisation Name","Royal Free Hospital\nChild Health Department"]
["Contact Name","Dr Pricilla Julies"]
["Address","Pond Street"]
[]
[]
["Postcode","NW3 2QG"]
["Telephone"]
["Email","p.julies@nhs.net"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Total international sample size (including UK): 330"]
["Description of confidential patient information used","NHS number, Hospital ID no., Date of birth, Date of death, sector level postcode ethnicity and gender."]
["S251 Class(es)","Y","Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"□","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Royal College of Paediatrics and Child Health"]
["Status","Supported"]
[]
["Outcome Date","2014-12-22"]
["Next Review Date","2017-05-06"]
["Notes","Amendment Request (Approved 18/11/2017)\nThe amendment requested additional data linkage with HES data managed by NHS Digital in\norder to improve case ascertainment.\n\nThis application was considered at the Sub Committee Meeting 15 December 2014.\n1. Confirmation as to when the requested CAG support will cease (when identifiable data will no longer be processed). Confirmed that data will be processed for 12 months after collection period has ended, whereupon CAG support will no longer be required, 18/05/16."]

{"sheet":"A0184","index":133,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0184"]
["Reference","14/CAG/1032"]
["Other Refs","10/H1010/70"]
["Application Title","Investigating the association between IQ and Self harm"]
["Application Summary","This application from the University of Bristol set out the purpose of linking HES and\nGP record data in order to conduct a study to determine a more accurate estimate\nof the association between IQ and self-harm among adolescent and to investigate\nhow non-response and under-reporting in questionnaires affects estimates of this\nassociation.\n\nA recommendation for class 1, 4 and 6 support was requested to cover disclosure\nof confidential patient information including NHS number and date of birth from GP\nrecords and Health and Social Care Information Centre to the NHS Wales\nInformatics Service. Linkage would then be undertaken to ALSPAC data using the\nmethodology approved within the overarching ALSPAC application (ECC 1-\n05(b)/2012)."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Mark Mumme, ASLPAC Data Linkage Manager"]
["Address","Oakfield House"]
[null,"Oakfield Grove"]
[null,"Bristol"]
["Postcode","BS8 2BN"]
["Telephone","0117 331 0033 "]
["Email","mark.mumme@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ALSPAC enrolled cohort: hospital admitted self-harm,A&E attendances for self-harm.\n\nMale and Female,  21 to 24 years"]
["Description of confidential patient information used","NHS number and date of birth and Health and Social Care Information Centre to the NHS Wales Informatics Service."]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Expired"]
[]
["Outcome Date","2016-05-18"]
["Next Review Date","N/A"]
["Notes","Expired from 's251' support\n\nApplicant confirmed July 2022 that the data request was never processed, and therefore no confidential patient information ever processed without consent. No ‘s251’ support required as research now unable to go ahead. \n \nThe applicant confirmed there has been no public benefit, as no data received, grant now expired and research unable to be started/completed. \n\n\n\nThis application was considered at the Confidentiality Advisory Group CAG meeting 11 December 2014.\nSpecific Conditions of Support\n1. Postcode should not be disclosed and deprivation score should be used instead. Confirmed 21/12/2015\n2. The linked dataset should only be retained for the duration of the specific project. Confirmed 21/12/2015\n3. Favourable opinion from a Research Ethics Committee. Confirmed 21/12/2015\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 21/12/2015"]

{"sheet":"A0185","index":134,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0185"]
["Reference","15/CAG/0175"]
["Other Refs","10/H1010/70"]
["Application Title","Early life causes of adolescent depression and anxiety"]
["Application Summary","This application details using linked electronic patient records in order to establish\nthe prevalence of adolescent depression and anxiety to investigate early life causes\n(maternal smoking and binge drinking in pregnancy) of these. Access to information\nabout GP-recorded depression and anxiety, identified using a specific set of Read\ncodes, is requested. These are based on a recent study validating a number of\nalgorithms to identify adults with depression and anxiety from GP records."]
["Applicant Organisation Name","Avon Longitudinal Study of Parents and Children (University of Bristol)"]
["Contact Name","Mark Mumme (ALSPAC Data Linkage Manager)"]
["Address","Oakfield House"]
[null,"Oakfield Grove"]
[null,"Bristol"]
["Postcode","BS8 2BN"]
["Telephone","0117 331 0033 "]
["Email","mark.mumme@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from GPs in relation to mental health of ALSPAC enrolled cohort"]
["Description of confidential patient information used","NHS number and date of birth. "]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Expired"]
[]
["Outcome Date","2016-05-18"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2022 that ‘s251’ support could be expired as it was confirmed that all identifiable data has been pseudonymised, and the applicants have no way to re-identify. \n\nWith regards to public benefit, it is important that ALSPAC continues to collect information on as full and representative a sample of originally enrolled individuals who have not explicitly opted-out of linkage as possible. This will maximise statistical power, minimise participant bias and avoid exclusion of marginalised and ‘hard to reach’ groups for sub-studies such as this one.\nThis sub-study is an example of one of the many projects that have benefited by using ALSPAC linked health records and s251 support. This project has now concluded following publication and dissemination of results and findings.\n\n06 February 2020 – Amendment Supported to amend the data items requested from participating GP practices. The applicants intend to collect additional mental health and other GP data, with the aim of developing understanding of the relationship between ALSPAC-recorded depression and anxiety and GP recorded depression and anxiety.\n\nThis application was considered at the Confidentiality Advisory Group meeting 17 September 2015.\nSpecific Conditions of Support\n1. Favourable opinion from a Research Ethics Committee. Confirmed\n2. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed"]

{"sheet":"A0186","index":135,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0186"]
["Reference","15/CAG/0176"]
["Other Refs","10/H1010/70"]
["Application Title","Predictors and prevalence of genital Chlamydia trachomatis infection and the impact of Chlamydia testing and treatment on sexual health outcomes"]
["Application Summary","This application from University of Bristol set out the purpose to determine what\nproportion of young people are tested for Chlamydia as part of the National\nChlamydia Screening Programme and whether the risk of the main morbid\nsequelae of Chlamydia information (pelvic inflammatory disease, ectopic pregnancy\nand reduced fertility) are effectively reduced by testing and treatment. The project\ndetails the linkage of health care records of the ALSPAC enrolled cohort in order to\ndetermine this.\n\nIt was noted that support had been provided to link data in relation to the enrolled\ncohort (ALSPAC), however this excluded data in relation to mental and sexual\nhealth as this was considered to be more sensitive and therefore require a higher\nlevel of justification for individual projects. The applicant had been required to\nsubmit a new application if access to these classes of information was necessary."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Mark Mumme, ALSPAC Data Linkage Manager"]
["Address","Oakfield House"]
[null,"Oakfield Grove"]
[null,"Bristol"]
["Postcode","BS8 2BN"]
["Telephone","0117 331 0033 "]
["Email","mark.mumme@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ALSPAC enrolled cohort: sexual health.  Male and Female 22 - 25 Years"]
["Description of confidential patient information used","Data from GPs and HSCIC in relation to sexual health of\nALSPAC enrolled cohort. NHS number and date of birth."]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Supported"]
[]
["Outcome Date","2016-05-18"]
["Next Review Date","2024-05-18"]
["Notes","This application was considered at the Confidentiality Advisory Group meeting 17 September 2015\nSpecific Conditions of Support\n1. Confirmation requested that the study would be included on the website. Confirmed\n27/11/2015\n2. Confirmation was requested that if a newsletter was regularly provided to the\nparticipants that this signpost to information on the website. Confirmed 27/11/2015\n3. Confirmation was required that information about the exclusion of sexual and mental\nhealth data from the original study had not yet been provided to participants.\nConfirmed 27/11/2015\n4. Favourable opinion from a Research Ethics Committee. Confirmed 27/11/2015\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\nConfirmed 27/11/2015"]

{"sheet":"A0187","index":136,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0187"]
["Reference","16/CAG/0042"]
["Other Refs"]
["Application Title","Young ER follow up"]
["Application Summary","This application from St Georges, University of London set out the purpose to identify individuals who have died and the causes of death from a database of approximately 4500 individuals who underwent voluntary cardiac screening with a medical questionnaire and ECG through a program organised by the charity Cardiac Risk in the Young (CRY).\n\nThe purpose of the database is to look for an association between sudden death and particular feature's on an individual's ECG. These features are known as the early repolarisation pattern (ERP). ERP has been shown to be more common in people who have suffered a cardiac arrest and has been associated with an increased risk of sudden death in large populations of middle-aged individuals. However, it is seen commonly in young healthy people and its significance in this group is unknown. An application to the Health and Social Care Information Centre (HSCIC) for ONS data has been submitted by the applicant to identify those individuals who have died and date and cause of death.\n\nAll individuals whose data is included have signed a consent form stating \"I do agree that data from these tests [ECG] will be held on a database ... and can be used anonymously for research purposes.\" The consent form is accompanied by a comprehensive information sheet that explains the potential role for such research. This is further supported by regular paper-based literature and on-line publicity and information from CRY supplied to all participants and the charity's supporters."]
["Applicant Organisation Name","St. George's, University of London"]
["Contact Name","Dr Greg Mellor"]
["Address","Cardiovascular Sciences Department"]
[null,"Cranmer Terrace"]
[null,"London"]
["Postcode","SW17 0QT"]
["Telephone"]
["Email","gregmellor@nhs.net"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","4500 individuals who underwent cardiac screening with a medical questionnaire and electrocardiogram (ECG) in England and Wales"]
["Description of confidential patient information used","Name, GP registration, Postcode, date of birth, date of death and cause of death."]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","St. George's, University of London"]
["Status","Expired"]
[]
["Outcome Date","2016-06-03"]
["Next Review Date","NA"]
["Notes","Data controller confirmed support can be expired as of 02 June 2023.\n\nAmendment Request (Approved 12/1/2018)\nThe amendment requested an extension to the duration of support through to January 2020. It was clarified that extension was required due to an unexpected delay in receiving the required data from NHS Digital, as the initial data access request had not yet been completed.\n\nThis application was considered at the Confidentiality Advisory Group sub-committee meeting 11 March 2016.\n\n1. Would participants be re-consented to include linkage with HSCIC and ONS? Confirmed 20/05/2016\n2. If the applicant will not re-consent participants but rely on section 251 support, will principle 1 of the DPA be fulfilled by the applicant doing their best to inform subjects via privacy notices that linkage will occur and inform them of how they may 'opt out'? Confirmed 20/05/2016\n3. Does the use of the word pseudonymise mean there would be no data released to researchers other than those working in the applicants department? Confirmed 20/05/2016\n4. Which fields would be stripped out and would the applicant be allocating a project number to identify individual cases and allow linkage? Confirmed 20/05/2016\n5. Will only aggregated data be released to researchers or will patient level data also be released? Confirmed 20/05/2016\n6. Would the applicant consider separating the identifiers and clinical data into separate databases? Confirmed 20/05/2016\n7. Has an exit strategy been considered and if so when could identifiers be removed? Confirmed 20/05/2016\n8. Letter of recommendation from the Caldicott Guardian or equivalent of the applicant’s organisation. Confirmed 20/05/2016\n9. Favourable opinion from a Research Ethics Committee. Confirmed 20/05/2016\n10. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 14/03/2016"]

{"sheet":"A0188","index":137,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0188"]
["Reference","15/CAG/0123"]
["Other Refs"]
["Application Title","aTTom: adjuvant Tamoxifen Treatment offer more (Version 3.0)"]
["Application Summary","This application from University of Birmingham set out the purpose of is a clinical\ntrial to compare and study the long term effects of patients taking tamoxifen for five\nand ten years. Over a million women worldwide took tamoxifen after surgery for\noestrogen receptor (or ER) positive breast cancer. The aTTom trial was designed to\ndetermine if taking tamoxifen for 10years compared with the standard of 5years\nwould improve patients’ outcome. Patients with breast cancer were randomised to\nStop tamoxifen or Continue for a further 5 years. The trial commenced in 1991 and\nclosed to recruitment in 2005 having accrued 8863 women from 178 UK hospitals.\nThe last patients completed treatment in 2010. Patients taking part in aTTom are\nfollowed up by their hospital (or GP where possible) but many patients become lost\nto follow-up. For this reason information on patient death had also been collected\nfrom the Office of National Statistics. Capturing information on as many patients as\npossible would be important to ensure the integrity of the trial results."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Dr Sean Jennings"]
["Address","Research Support Group, Room 119"]
[null,"Aston Webb Building"]
[]
["Postcode","B15 2TT"]
["Telephone"]
["Email"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","8000 Female participants only 18 Years onwards."]
["Description of confidential patient information used","Date of death, Cause of death, Date of cancer diagnosis, Site of cancer. The following personal data is used for identification of the patient by the Office of HSCIC, Name, NHS Number, Date of Birth, National Insurance Number, Postcode. (Address if NHS number is not provided with combination of other identifiers)."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Birmingham"]
["Status","Supported"]
[]
["Outcome Date","2016-06-09"]
["Next Review Date","2024-06-09"]
["Notes","01 August 2023 - change in data processor from NHS Digital to NHS England regarding ONS mortality data\n\nThis application was considered at the precedent set CAG meeting held on 13 March 2015.\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed\n\n2. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed 20/04/2016"]

{"sheet":"A0189","index":138,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0189"]
["Reference","16/CAG/0077"]
["Other Refs"]
["Application Title","2016 Accident and Emergency Survey"]
["Application Summary","This application from the Picker Institute Europe set out the purpose of carrying out the 2016 Accident and Emergency Survey sponsored by the Care Quality Commission. This was specifically to enable the transfer of identifiable data from acute trusts, to an approved survey contractor for the purpose of mailing out questionnaires for the 2016 accident and emergency survey. It was expect from past experience that the vast majority trusts involved will opt to use an approved survey contractor, either: Picker Institute Europe, Quality Health, Patient Perspective, CAPITA Surveys & Research or the new approved contractor, Membership Engagement Services Ltd. (MES).\n\nThe 2016 A&E survey will be the sixth carried out to date. It was expected that 147 trusts will be eligible for the survey (dependent on the outcome of the development work and chosen sampling strategy). Trusts will be asked to conduct the survey with preparations expected to begin in July 2016 and fieldwork expected to start from November 2016. All trusts will draw a sample of patients according to set criteria, and follow standardised materials and procedures for all stages of the survey. An overview of the survey methodology was provided with this application."]
["Applicant Organisation Name","Picker Institute Europe"]
["Contact Name","Chris Graham"]
["Address","National Patient Survey Programme"]
[null,"Picker Institute Europe"]
[null,"Buxton Court, 3 West Way, Oxford"]
["Postcode","OX2 0JB"]
["Telephone"]
["Email","Caroline.Killpack@PickerEurope.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","People aged 16 and over who visited an A&E department in the specified sampling month (likely to be August or September 2016). "]
["Description of confidential patient information used"," standardised unique identifier code, to be constructed as survey identifier, trust code followed by a whole number \n Title (Mr, Mrs, Ms, etc.)\n First name\n Surname\n Address Fields\n Postcode"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Care Quality Commission"]
["Status","Supported"]
[]
["Outcome Date","2016-06-13"]
["Next Review Date","2017-06-13"]
["Notes","This application was considered at the sub-committee CAG meeting held on 17 May 2016.\n\n1. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 13/05/2016"]

{"sheet":"A0190","index":139,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0190"]
["Reference","16/CAG/0057"]
["Other Refs","(previously 16/CAG/0011), 15/NE/0397"]
["Application Title","Is it possible to develop a complex intervention to improve the outcome of fall-related injuries in people with dementia?"]
["Application Summary","This application from Newcastle University set out the purpose of this study to assess\nwhether it was possible to develop a new approach to improve recovery from fall related\ninjuries in people with dementia living at home.\n\nFall related injuries are a significant cause of morbidity and mortality in People With\nDementia (PWD). There is presently little evidence to guide the management of such\ninjuries, and yet there are potentially substantial benefits to be gained if the outcome of\nthese injuries could be improved. This 26 month study aims to provide the evidence\nneeded for the design of an appropriate healthcare intervention for such PWD and to\nassess the feasibility of its delivery in the clinical setting.\n\nThis will be achieved by carrying out a clinical trial. In this programme of research, the\napplicant plans to do the background work needed to make sure that they design a trial\nthat has a good chance of being successful.\n\nThey are to start by reviewing existing literature and exploring what currently happens to\nPWD with fall related injuries in Newcastle, Stockton and Norwich. They will ask “How\nmany people currently have this problem and what happens to them at the moment?” The\nresearchers will find out what currently happens to PWD who ask for help after a fall.\nThey will keep a logbook of every PWD who sees their GP, calls an ambulance or goes to\nhospital because they have hurt themselves in a fall. Records will be checked to find out if\nthey were kept in hospital, or if they were referred to a clinic. Some people in each\nlocation will be asked to keep a detailed diary of all the help they had from the NHS and\nsocial services. A sample group will be interviewed along with their carers to explore their\nviews on any help they received, whether they needed any extra help and any\nsuggestions for improving services. Staff will also be approached to explore their ideas for\nimproving services. A group of experts, PWD and their carers will then review these\nsuggestions and help the researchers to develop a new approach and advise them on\nhow they can tell whether it has been helpful. The new approach will then be piloted with\njust 15 people in each area to see whether it is possible to deliver it in practice and to\nmake sure it is acceptable to PWD and their carer’s. At the end of the study the\nresearchers will be able to recommend how best to deliver the intervention in the future\nand to advise on the conduct of a largescale study to assess the impact of the new\napproach.\n\nSupport was requested to discover how many PWD present to health services with a fall\nrelated injury in 3 UK sites (Newcastle, Stockton, and Norwich). The other components of\nthe research will be conducted with consent or advice."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Louise M Allan"]
["Address","Biomedical Research Building"]
[null,"Campus for Ageing and Vitality"]
[null,"Newcastle upon Tyne"]
["Postcode","NE4 5PL"]
["Telephone","(0)191 208 1336"]
["Email","louise.allan@newcastle.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from paramedics/Emergency Department  in related injuries in people with dementia living at home."]
["Description of confidential patient information used","Patient name, NHS number, Hospital number, Date of birth, Gender, Diagnosis, GP registration details"]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Newcastle University"]
["Status","Expired"]
[]
["Outcome Date","2016-07-16"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in November 2022 that ‘s251’ support can be expired, As no identifiable information is accessed by any individuals outside of the direct care team. \n\nIn terms of public benefit, the information has been used to develop an intervention to help people with dementia who have fallen. This intervention is currently being tested in a pilot randomised controlled trial with a view to proceeding to a randomised controlled trial in the future.\n\nThis application was considered at the CAG subcommittee meeting held on 03 June 2016.\n\n1. CAG receipt of a favourable opinion from a Research Ethics Committee. Received,\nletter dated 22 January 2016\n\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\nConfirmed (version 13 24/5/16)"]

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[]
[]
["Application Number","0191"]
["Reference","16/CAG/0054"]
["Other Refs","16/EM/0068"]
["Application Title","Twelve month follow up of patients who have been detained under Section 136 of the Mental Health Act, 1983"]
["Application Summary","Section 136 of the Mental Health Act 1983 (MHA, Department of Health, 2008) allows\nthe police to detain, in a place of safety, any person found in a public place believed to\nhave a mental health condition resulting in a risk to themselves or others. Once within\nthe place of safety, further assessment and care can be explored. A person can be\nadmitted to hospital (either of their own free will or under another section of the MHA) or\nbe discharged, with or without a referral to ongoing care.\n\nThis application from Derbyshire Healthcare NHS Foundation Trust set out the purpose\nof investigating the proportion of individuals (who had been detained under a section\n136 in South Derbyshire), re-presenting to the Emergency Department (ED) with a selfharm\nor mental health related presentation, within the 12 months of their detention; and\ninvestigating how this relates to the management and outcome of their section 136\nassessment. This will increase understanding around the level of risk and prognosis for\nthis population and will help to inform clinical care.\n\nA previous internal audit conducted by Derbyshire Healthcare NHS Foundation Trust\nhad investigated the quality of documentation and communication for patients detained\nunder a section 136 between 30 September 2012 and 1 October 2013. The present\nstudy will be a follow up to this piece of work. Records kept by Derbyshire Healthcare\nNHS Foundation Trust and Derby Hospitals NHS Foundation Trust, for patients\nidentified within the audit, will be analysed.\n\nA recommendation for class 1, 4, 5, and 6 support was requested to link records kept\nby Derbyshire Healthcare NHS Foundation Trust and Derby Hospitals NHS Foundation\nTrust in order to conduct a one-off patient record search for patients detained under a\nsection 136."]
["Applicant Organisation Name","Derbyshire Healthcare NHS Foundation Trust"]
["Contact Name","Dr Simon Taylor"]
["Address","Hartington Unit"]
[null,"Royal Hospital"]
[null,"Chesterfield"]
["Postcode","S44 5BL"]
["Telephone"]
["Email","simon.taylor@derbyshcft.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individuals detained on the section 136 of the MHA between 30th September 2012 to 1st October 2013"]
["Description of confidential patient information used","Name, postcode, NHS number, date of birth, & date of death."]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Derbyshire Healthcare NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-06-17"]
["Next Review Date","N/A"]
["Notes","All identifiers have been pseudonymised.\n\nThe research department at Derbyshire Healthcare NHS Foundation Trust holds clinical information collected as part of the study which has had all identifiers removed, and pseudonymised IDs only retained.\n\nThe Information Management teams at the University of Derby and Burton Healthcare Foundation Trust and Derbyshire Healthcare govern access to the patient record systems (which were the original source of data).\n\nThe Information Management team at Derbyshire Healthcare NHS Foundation Trust hold the key enabling linkage between pseudonymised (study dataset) and identifiable data (held within patient record systems).\n\nAn end user cannot search the patient record system using the pseudonyms. So, a member of the research team could not re-identify the patients in the study without assistance from Derbyshire Healthcare’s Information Management team.\nStrict governance processes are in place to restrict access to patient records and identifiable patient data to those within a person’s care team or with appropriate legal basis.\n\nThe study has helped to provide an understanding of the risk that people detained under section 136 of the MHA are under in terms of future self-harm and mental health crisis resulting in presentation to secondary care. \nKey reasons for presentation to the Emergency Department following detention under section 136 were identified which included self-harm, thoughts of suicide/attempted suicide and problems related to mental health. Self-injury was the most common reason from all first presentations. More than one in five individuals attended the emergency department on at least two occasions within 12 months of detention. Use of alcohol was identified in over 40% of first presentations following detention. \n\nThe findings have been shared with colleagues at Derbyshire Healthcare NHS Foundation Trust via a presentation. The findings have raised awareness of the increased vulnerability of individuals detained under section 136 of future self-harm, which will add to a growing body of evidence enabling safer clinical decisions and robust, person centred care and safety plans. \n\nThis application was considered at the CAG subcommittee meeting held on the 17 June\n2016.\n\n1. Confirmation that a study specific ID will be used and not the hospital number.\nConfirmed, letter dated 14/6/16.\n\n2. Provision of a patient and public engagement plan whereby the applicant will address\nthe best mechanism for notifying this historic cohort together with the content of the\npatient notification. Provided, letter dated 14/6/16.\n\n3. Confirmation that a report on progress against this plan will be provided in the first\nannual review submitted to the group. Confirmed, letter dated 14/6/16.\n\n4. Favourable opinion from a Research Ethics Committee. Letter dated 29/2/16.\n\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\n97%, confirmed 10/5/16."]

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[]
[]
["Application Number","0192"]
["Reference","16/CAG/0066"]
["Other Refs","16/SC/0264"]
["Application Title","Hospital Alerting Via Electronic Noticeboard (HAVEN)"]
["Application Summary","Late recognition of deteriorating patients in hospitals causes treatment delays that\nresult in increased mortality and morbidity. Despite widespread introduction of vital\nsign-based early warning scores, deterioration of patients can go unrecognised.\nConsequently, developing systems for early recognition of patients at risk of severe\nreversible deterioration has become a key goal for the NHS. This application from\nOxford University Hospitals NHS Foundation Trust set out the purpose of producing\na hospital-wide IT system that enables a continuous risk assessment in all hospital\npatients, and predicts those at risk of deterioration.\n\nThis IT system will use routinely stored electronic data from Oxford University\nHospitals NHS Foundation Trust and Portsmouth Hospitals NHS Trust (including\ndemographics, laboratory results and vital signs) to create this continuous risk\nassessment. At present, these different types of data are stored in different local\ndatabases, and are not integrated or displayed in a way that supports decision\nmaking or calculation of patient risk. The project will implement a system to gather\nthe relevant data so that it can be used to gauge risk.\n\nRisk prediction algorithms will then be developed and validated, using the records\nof patients who were admitted to hospital and then admitted to an intensive care\nunit (ICU) after two or more days in hospital.\n\nData, including patient identifiers, will be exported from the source databases on a\nperiodic basis. The export files will be transferred to the HAVEN Linkage Server\ndirectly over the Trust network or via encrypted drive. The applicants will set up\nautomated processes to extract, transform and load the data into the HAVEN\nLinkage Server and create a linked database containing patient identifiers along\nwith the complete dataset for each patient.\n\nIdentifiable data will not be available for analysis. Each patient will be given a Study\nID as part of the extraction process. A mapping file linking hospital identifiers with\nthe database identifier will be created which will be held on the same linkage server.\nWhen a pseudonymised copy of the data is required a scripted pseudonymisation\nprocess will be used to generate the data export.\n\nPseudonymised data will be received from Portsmouth Hospitals NHS Trust to link\nwith the data from Oxford University NHS Foundation Trust\n\nA recommendation for class 1, 4, and 6 support was requested to cover the\ndisclosure of confidential patient information from Oxford University NHS\nFoundation Trust to the research team.\n\nConfidential patient information requested\n\nAccess was requested to data from all patients admitted to Oxford University NHS\nFoundation Trust.\n\nFor linkage: name, postcode (unit level), NHS number, date of birth (converted to\nage for analysis), date of death (which will have an offset applied for analysis), &\nadmission episode ID.\n\nGender and ethnicity will be retained for analysis."]
["Applicant Organisation Name","Oxford University Hospitals NHS Foundation Trust (OUH)"]
["Contact Name","Rachel Henning, Research Coordinator"]
["Address","Kadoorie Centre, Level 3"]
[null,"John Radcliffe Hospital"]
[null,"Headley Way, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865 857 613"]
["Email","rachel.henning@ndcn.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from all patients admitted to Oxford University NHS Foundation Trust.\nFor linkage: name, postcode (unit level), NHS number, date of birth (converted to age for analysis), date of death (‘will have an offset applied’ for analysis), & admission episode ID.\nRetained for analysis: gender, & ethnicity.\n"]
["Description of confidential patient information used","Late recognition of deteriorating hospitalised patients causes treatment delays, resulting in increased mortality and morbidity. Analysis of the Intensive Care National Audit and Research Centre (ICNARC) database shows that in 2012, 40,290 patients deteriorated to the point they required ICU admission after having spent two or more days on general hospital wards (29.6% of all ICU admissions). Their mortality rate was 1.5 times that of patients admitted directly to ICU from the emergency department (30.3% versus 19.7%). 1,620 of these patients deteriorated on the ward so severely that they suffered a cardiac arrest prior to ICU admission. \n\nFrom 2005 to 2013, a number of national reports found that hospital inpatients in the early phases of deterioration frequently go unrecognised despite current observation systems. In 2012 the Department of Health paper “The Power of Information” envisaged the development of “clinical portals” to bring together relevant patient information to provide safer care. In 2013, NHS England’s “Safer Hospitals, Safer Wards” publication emphasised the need for the NHS to use digital data to create safer patient environments.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Oxford University Hospitals NHS Foundation Trust (OUH)"]
["Status","Supported"]
[]
["Outcome Date","2016-07-04"]
["Next Review Date","2024-07-04"]
["Notes","Amendment supported 25 May 2023 to extend the duration of ‘s251’ support until 31 March 2026\n\n08 December 2020 - Amendment supported\nThe amendment, to add Royal Berkshire NHS Foundation Trust and South Warwickshire NHS Foundation Trust as additional data processors, and to update CAG on study data extraction procedures to include national data opt out, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n \nConfirmed:\n• The NHS Digital 2018/19 DSPT review for Oxford University Hospitals NHS Foundation Trust (RTH) was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked 08 October 2020). Please note the updated specific condition of support below. The 2019/20 DSPT has not yet been reviewed.\n\nOxford University Hospitals NHS Foundation Trust (RTH) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n• The NHS Digital 2018/19 DSPT review for Royal Berkshire NHS Foundation Trust (RHW) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 08 October 2020). The 2019/20 DSPT has not yet been reviewed.\n\n• The NHS Digital 2019/20 DSPT review for South Warwickshire NHS Foundation Trust (RJC), is confirmed as standards met (by email to CAG inbox on 08 December 2020) \n\n2. Confirmation of a favourable opinion from a Research Ethics Committee \nConfirmed: 17 April 2020\n\n21 October 2020 - Amendment supported to add Lancashire Teaching Hospitals NHS Trust as an additional data processor.\n\nSpecific conditions of support\n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold:\n\nConfirmed:\nThe NHS Digital 2019/20 DSPT review for Lancashire Teaching Hospitals NHS Foundation Trust (RXN) was confirmed as ‘Standards Met’ (confirmed by NHS Digital email received 21 October 2020)\n\nThe NHS Digital 2018/19 DSPT review for Oxford University Hospitals NHS Foundation Trust (RTH) was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked 11 August 2020). Please note the updated specific condition of support below.\n\nOxford University Hospitals NHS Foundation Trust (RTH) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n24 October 2019: Amendment supported to extend the duration of support to 31 March 2023. \n\nThis application was considered at the Confidentiality Advisory Group sub-committee meeting 29 June 2016.\n1. Provision of updated patient notification materials, including the patient information\nsheet (clinical, 6.3), and confirmation that these will be available on the trust website.\nReceived, letter dated 17/06/16.\n2. Favourable opinion from a Research Ethics Committee. Received, letter dated\n20/06/16.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\nReceived, confirmation (version 13) dated 18/05/16."]

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[]
[]
["Application Number","0193"]
["Reference","16/CAG/0059"]
["Other Refs","16/WM/0210"]
["Application Title","Lifestyle Risk Factors and Colorectal Cancer Screening:\nFIT Pilot Analysis and Development of a Risk-Adjusted\nPrediction Model."]
["Application Summary","This application from a student at Warwick University set out the purpose to\ninvestigate a new approach to CRC screening by combining an assessment of\nindividual risk with the faecal immunochemical test (FIT) result to determine whether\ntest performance is improved. The aim of this study is to determine whether\nintegrating lifestyle risk factors with the FIT result improves test performance for\nCRC detected at colonoscopy in an average risk screening population. The second\npart to this study will be to determine the association between different lifestyle risk\nfactors with CRC detected at colonoscopy and with the FIT result adding a further\ndimension to the FIT pilot analysis.\n\nThe current screening test has a lower than optimum sensitivity (ability of the test to\nidentify those with disease) and therefore a more recently developed test, the faecal\nimmunochemical test or FIT, has been piloted in the UK (April to October 2014).\nThis test has been shown to have a greater cancer detection and uptake rate. The\ntest also provides a quantitative result of haemoglobin present in faeces, with a\nhigher result indicating a higher risk of CRC. Another method to determine an\nindividual’s risk of CRC is to examine different aspects of their lifestyle. Lifestyle risk\nfactors such as smoking, alcohol intake and diet have been shown to have a\nsignificant effect on the risk of CRC; a UK study suggests that over half of CRC\ncases are due to these factors.\n\nParticipants aged 60 to 74 identified from the FIT pilot study will be sent a lifestyle\nquestionnaire on a case-control basis (1632 controls and 544 cases) to complete at\nhome and to return using a pre-paid envelope. Controls will be selected at random\nand the study will use a ratio of 3:1 controls to cases to counteract a lower response\nrate. This gives 1632 controls and 544 cases. Participation will be entirely voluntary\nand implied consent will be taken for returned questionnaires. The clinical care\nteam/director will help to identify any individuals who may have died since the pilot\nstudy to ensure that these people are not contacted or sent a questionnaire. The\nFIT result from the pilot study and the questionnaire results from this study will be\ncombined in a CRC predictive model to determine whether sensitivity is improved.\n\nThe FIT pilot data will be used to identify cases and controls. The FIT pilot data has\nbeen collected for the FIT pilot study which took place April to October 2014. The\nHSCIC (Health and Social Care Information Centre) have de-identified the data and\nprovide it to the FIT study team for analysis. Testkit ID is recorded on both the FIT\npilot data and also on CSV (comma separated values) files at the Bowel Cancer\nScreening Hubs. The Testkit ID is an eight-digit number with a check number only\nrecognised within the Bowel Cancer Screening System. CSV files contain the\nnames and addresses needed to send out the lifestyle questionnaires to the\nselected cases and controls as well as date of birth, gender and NHS number.\nHowever, names, addresses and Testkit ID will be the only information selected and\naccessed by the clinical care team/director of the hub and the researcher since only\ncertain columns will be selected for output in an Excel spreadsheet. This data\n(names and addresses) will only be accessed on-site. The clinical care\nteam/Director of the hub will provide details of what is extracted without the\nresearcher being exposed to the full record (“Sitting in method”). Once all\nquestionnaires and reminders have been sent, names and addresses will no longer\nneed to be accessed so this will be time limited access up to 3 months to allow for\nall the documents to be sent out.\n\nWhen sending out questionnaires a unique identifier relating to the Testkit ID will be\nincluded on the return questionnaire so that the research team remains unaware of\nthe identity of a participant’s responses but are able to record who has returned a\nquestionnaire. The Testkit ID can be used as a key between the research team and\nthe clinical care team at the hub. Therefore, the data is considered linkedanonymised\nas the Testkit ID links the data back to participants details in the CSV\nfiles as well as the FIT pilot data. Once data linkage is complete, any\npseudonymisation (i.e. test kit ID) will be deleted. This will ensure that there is no\nway to link back the information at the hub.\n\nCLAHRC (Collaborations for Leadership in Applied Health Research and Care) PPI\nrepresentatives were asked to pilot the cover letter, participant information sheet\nand lifestyle questionnaire for this study and based on their feedback these\ndocuments were amended. The PPI representatives were also asked about the\nacceptability of the proposal from a participant perspective. The views from the PPI\nrepresentatives were very positive and they thought the proposal would be\nacceptable from a patient perspective.\n\nA recommendation for class 1, 2, 3, 4 and 6 support was requested for the process\nof extracting and anonymising the information, to obtain and use information about\npast or present geographical location, to select and contact patients to seek their\nconsent. To link patient identifiable information obtained from more than one\nsource. For auditing, monitoring and analysing patient care and treatment and to\nallow access to an authorised user for one or more of the above purposes"]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Jennifer Cooper"]
["Address","Warwick Medical School"]
[null,"Gibbet Hill Road, Coventry"]
[]
["Postcode","CV4 7AL"]
["Telephone",7835232142]
["Email","jennifer.cooper@warwick.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","those diagnosed with CRC or advanced adenoma duringthose who were not diagnosed with cancer or advanced adenoma\nGender: Male and female participants\nLower age limit: 60 Years\nUpper age limit: 74 Years"]
["Description of confidential patient information used","Access was requested to names and addresses to enable mail out."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Department of Health Sciences"]
["Status","Expired"]
[]
["Outcome Date","2016-07-04"]
["Next Review Date","N/A"]
["Notes","The activity for which the section 251 support was given did not occur.  In order to be able to send out the lifestyle questionnaire a new extract was needed so we could determine who to send the questionnaires out to but in terms of the timeframe of the PhD project it was not feasible to collect this information and complete the study. Therefore no questionnaires were sent out and no identifiable information was processed and so the activity is considered to have not commenced. \n\nThis application was considered by the Confidentiality Advisory Group sub-committee meeting 22 April 2016\n\n1. Please confirm that repeated questionnaires will not be sent as reminders. Confirmed\n1/06/2016\n2. Please confirm that objection will not be limited to those who return blank\n(uncompleted) questionnaires. Confirmed 1/06/2016\n3. Favourable opinion from a Research Ethics Committee. Confirmed 1/06/2016\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\nPlease see security review requirement section of the HRA website:\nhttp://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentialityadvisory-\ngroup-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with\nany queries. Confirmed 1/06/2016"]

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[]
[]
["Application Number","0194"]
["Reference","16/CAG/0048"]
["Other Refs","09/H1102/1+5"]
["Application Title","LATTE: Long-term Anastrozole vs Tamoxifen\nTreatment Effects"]
["Application Summary","This application from Queen Mary’s, University of London set out the purpose of adding\ndata from the HSCIC to that already collected in the LATTE database.\nThe LATTE database (Research Ethics Committee reference 09/H1102/1+5) collects\nfollow up information on participants in the ATAC study (under consent given for that\nstudy). ATAC was a randomised, double-blind trial comparing Arimidex alone with\nNolvadex alone with Arimidex and Nolvadex in combination as adjuvant treatment in\npost-menopausal women with breast cancer.\nThere were approximately 9,500 post-menopausal women with breast cancer who\nparticipated in this trial. Of these, around 5,000 are alive and have not withdrawn\nconsent.\nA recommendation for class 4, 5, and 6 support was requested to allow the disclosure of\nconfidential patient information relating to approximately 5,000 breast cancer patients\nwho took part in the ATAC trial from Queen Mary’s, University of London to the HSCIC\nand from the HSCIC to Queen Mary’s, University of London."]
["Applicant Organisation Name","Queen Mary, University of London"]
["Contact Name","Nadia Haidar, Biospecimen Data Manager "]
["Address","Centre for Evaluation and Methods"]
[null,"Wolfson Institute of Preventive Medicine"]
[null,"Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone","020 7882 2930"]
["Email","n.haidar@qmul.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from participants in the ATAC trial into breast cancer from the HSCIC to Queen Mary’s University of London."]
["Description of confidential patient information used","Data from Applicant to NHS Digital: Full name, Postcode, Date of Birth, NHS Number and LATTE Study ID Number. \nData from Applicant to NHS Digital – Date of death, cause of death, evidence for breast cancer recurrence, other cancers, cerebrovascular events, heart disease, fractures."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of London"]
["Status","Supported"]
[]
["Outcome Date","2016-07-19"]
["Next Review Date","2024-07-19"]
["Notes","Amendment supported 21 March 2024 to extend the duration of ‘s251’ support until 25 February 2029, in order to continue to undertake follow-up for a further five years via NHS England\n\n17 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources – Hospital Episode Statistics (HES), cancer registration and ONS mortality data\n\n15 March 2019 – Amendment supported to enable follow-up via administrative datasets held by NHS Digital only for a further five years. \n\nThis application was considered by the Confidentiality Advisory Group sub-committee meeting 19 July 2016\n1. Provision of a revised data flow diagram with complete information as to what data will\nbe flowing to and from what organisations. This should include information about the\nformat in which the information will flow and how it will be stored. Received 19/05/16\n2. Provision of new or revised patient notification materials containing information about\nthe components of the research for which CAG support has been sought and\ninformation as to how patients can opt-out should they wish to. Received 18/07/16\n3. It is unclear if the full set of identifiers requested is required solely for linkage. The\napplicant should confirm which identifiers are required by the HSCIC for linkage, and\njustify any additional identifiers. Received 19/05/16\n4. Confirmation that information on patient and public engagement, specifically in\nreference to this unconsented linkage with the HSCIC, will be provided in the first\nannual review submitted to CAG. Received 19/05/16\n5. Confirmation as to the classes of support required. Received 19/05/16\n6. Favourable opinion from a Research Ethics Committee. Letter dated 21 January\n2014\n7. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\nConfirmed version 13, 10/06/16"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","0195"]
["Reference","15/CAG/0204"]
["Other Refs","16/LO/0012"]
["Application Title","Maternity-baby data study"]
["Application Summary","This application from Clinical Effectiveness Unit, Royal College of Surgeons of England\nset out the purpose of this application as forming part of a broader programme of work on\nmaternal and child health and sets out the intent to link key characteristics from maternal\nadmission records to hospitalisation patterns for their children. This will be a retrospective\npopulation-based cohort study involving babies and their mothers, whose birth/delivery\nepisodes were captured in hospital data between April 2001 and March 2013. The\nresearch questions were specified to be:\n1. How are maternal hospitalisation patterns prior to delivery related to birth\noutcomes and childhood readmissions to NHS hospitals in England?\n2. How do previous birth outcomes, inter-pregnancy interval and healthcare use in\nmothers and all her offspring influences childhood outcomes and hospitalisation\npatterns?\nData will be extracted from Hospital Episode Statistics (HES) held by the Health and\nSocial Care Information Centre, and transferred to the applicant. A recommendation for\nclass 5 and 6 support was requested to achieve the specific activities specified in the\napplication."]
["Applicant Organisation Name","Royal College of Surgeons of England"]
["Contact Name","Katie Harron"]
["Address","35-43 Lincoln's Inn Fields"]
[null,"London"]
[]
["Postcode","WC2A 3PE"]
["Telephone",2079272876]
["Email","Katie.Harron@lshtm.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Hospital data from all mothers who have given birth, and all children born, in the NHS in England between 2001 – 2014 (approx. 650,000 births per year)\n\n• GP Registration (required for linking maternity and birth records), \n• Baby date of birth (required to calculate accurate length of stay and time to readmission)\n• Date of death (required for analysis of readmissions)\n• Gender, ethnicity, district level postcode"]
["Description of confidential patient information used","Baby date of birth and patient date of death, gender, ethnicity and district level postcode to be retained and accessed by analyst and data manager at the Clinical Effectiveness unit"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Clinical Effectiveness Unity, Royal College of Surgeons of England"]
["Status","Expired"]
[]
["Outcome Date","2016-07-14"]
["Next Review Date","N/A"]
["Notes","23 August 2021 - Support Expired\nApplicant confirmed support is no longer required via email\n\n•\tPlease may you confirm the reason that support is no longer required \nApplicant confirmed that all the data for this study, including all identifiers, have been securely destroyed and are no longer being processed. \n\n•\tPlease may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency. A number of publications have arisen from this application                                                                                                                                    \n1. Favourable opinion from a Research Ethics Committee. Confirmed\n2. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed\n\n26 November 2015\nThis application was considered by the Confidentiality Advisory Group sub-committee meeting 26 November 2015 "]

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[]
[]
["Application Number","0196"]
["Reference","16/CAG/0053"]
["Other Refs","16/LO/0222"]
["Application Title","Prolonged Effects of Assisted reproductive technologies on the health of women and their children: a Record Linkage study for England (PEARL)"]
["Application Summary","This application from University of Oxford set out the purpose of this project to create a\nlinked dataset between HFEA infertility data and health data from the Clinical Practice\nResearch Database (CPRD) mother-baby track and to use the linked dataset to assess\nthe effect of ART on the health of women and their children after successful fertility\ntreatment.\nIn general, most children born after the use of fertility treatment (such as IVF) are healthy.\nHowever, there is a small increase in the number of children who are born early, have a\nlow birthweight, and who have health or developmental problems. Less is known about\nthe health of children born after fertility treatment as they grow up, as long-term follow-up\nstudies are costly and time consuming. As a result, many studies are not big enough to\ndetect small differences between the groups – which are important because the effects of\nfertility treatment on health may be subtle. More evidence is also needed about the long\nterm wellbeing of women who have had fertility treatment.\nPEARL is a record-linkage study of women and children in England. The study aims to:\n1. Find out the effect of fertility problems and fertility treatment on the health and\ndevelopment of ART children to adolescence.\n2. Look at the impact of successful fertility treatment on the health and wellbeing of\nwomen who underwent treatment.\n3. Estimate the additional costs to the NHS (if any) of caring for women and their children\nafter successful fertility treatment.\n4. Explore how changes in the number of patients agreeing to allow information about\ntheir fertility treatment to be used in research affects the results of studies that use this\ninformation.\nPEARL will include about 270,000 mothers and their children, around 4000 of who will\nhave had fertility treatment.\nThe information to be used comes from over 20 years of existing health records: details of\nfertility treatments held by the Human Fertilisation and Embryology Authority; Health\nrecords from GP practices in England held by the Clinical Practice Research Datalink,\nand records of hospital care, from Hospital Episode Statistics already linked to CPRD\ndata and held by the HSCIC.\nA recommendation for class 1, 2, 4 and 6 support was requested to achieve the\nspecified purpose."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Claire Carson"]
["Address","University of Oxford"]
[null,"Richard Doll Building, Old Road Campus,"]
[null,"Headington, Oxford"]
["Postcode","OX3 7LF"]
["Telephone",1865289755]
["Email","claire.carson@npeu.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from HFEA in relation to Name/postcode/NHS number/date of birth/date of death and linked mother baby data already held by HSCIC"]
["Description of confidential patient information used","1. Personal identifiers for the CPRD mother-baby linked dataset are held by HSCIC, who will be doing all the matching and linkage. Identifiable personal data for the CPRD dataset will not flow outside the HSCIC.\n \n2. Personal identifiers for the HFEA registry are held by the HFEA, and these will be sent to the HSCIC to use in the matching and linkage. The HSCIC will therefore have access to identifiable personal information for the women included in the HFEA registry.\n\n3. The Patient Demographic Service (PDS) at the HSCIC includes identifiable personal information for all individuals registered within the NHS. HSCIC will match this to the HFEA data to add NHS number to the HFEA identifiers. Information from the PDS will not flow outside the HSCIC.\n\n4.  After matching of CPRD data and the HFEA data using identifiable personal information, the data will be\n               pseudonymised. All patient identifiable data will be stripped, and will not be sent to the CPRD or research       "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Supported"]
[]
["Outcome Date","2016-07-22"]
["Next Review Date","2024-07-22"]
["Notes","Amendment supported 18 December 2023 to extend the duration of support until 31st December 2024\n\n16 May 2022 - Amendment supported\nAmendment supported to extend the duration of support until 31st December 2023.\n\n09 October 2020 - Amendment supported to extend the duration of support until 31 May 2022.\n\nAmendment request (Approved 10/07/2019)\nThe amendment to change the data flow for ths study is supported. In the original dataflow NHS Digital used patients’ NHS numbers to match women in the HFEA registry to women in the CPRD mother-baby dataset. The applicants sought support to amend the data flow so that NHS Digital used NHS numbers to link all women in the HFEA dataset to all women in the CPRD primary care dataset.  \n\nAmendment request (Approved 19/10/2018)\nThe amendment described a number of changes as follows:\n1. Submission of a revised data flow chart and description of data flow,\n2. An extension to support to cover the collection of routine data up to 31/12/2017,\n3. Addition of a supplementary study outcome which aims to understand the risk of cardio-metabolic conditions in children born from fertility treatment,\n4. Administrative point – references to HSCIC have been updated to NHS Digital throughout documentation.\n\nAmendment request (Approved 09/02/2017)\nFollowing a recommendation from the primary care data holders (CPRD’s Independent Scientific Advisory Committee), a minor change to the data flow was proposed. The original data flow had fertility data, stripped of identifiers and given a unique study ID, being sent by HFEA to the study team at the University of Oxford. The new data flow would have the same data being sent by HFEA to CPRD, where it would be stripped of the study ID and given the CPRD’s ID. The CPRD would then send the fertility data to the study team at University of Oxford, where they would merge it with the primary care and HES data, using the CPRD ID number. The study team will now only receive pseudonymised data with the CPRD ID number.\n\nSpecific conditions of support 09/02/2017\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed v13 reviewed, Satisfactory grade published.\n2. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 1 February 2017.                                                                                                                     This application was considered by the Confidentiality Advisory Group sub-committee meeting 06 May 2016                                                                                                                       1. An opt out process is implemented for the trial phase. Provided 27/06/2016\n2. Confirmation whether objections from 2010 onwards are applied retrospectively.\nConfirmed 27/06/2016\n3. Provision of draft web content materials for the NPEU. Provided 27/06/2016\n4. Retention period for records. Confirmed 27/06/2016\n5. Favourable opinion from a Research Ethics Committee. Received 27/06/2016\nConfirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Please see security review requirement section of the HRA\nwebsite: http://www.hra.nhs.uk/resources/confidentiality-advisorygroup/\nconfidentiality-advisory-group-cag-application-advice/ and contact\nExeter.helpdesk@nhs.net with any queries. Confirmed 27/06/201"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","0197"]
["Reference","16/CAG/0101"]
["Other Refs","16/WM/0143"]
["Application Title","RESIST: Understanding the role of depression in heart disease"]
["Application Summary","This application from UCL set out the purpose of contacting patients with an invitation letter and participant information sheet in order to seek their consent.\n\nThe study aimed to explore the role of inflammation in the association between depression and cardiovascular disease (CVD). Effective treatment of depression often included the use of antidepressant medications. Recent studies suggested that the use of antidepressants could improve cardiac outcomes and that patients who did not respond to antidepressant medication may face increased cardiovascular risk. The explanation for this was unclear, however patients who did not respond to antidepressant treatment had also been shown to have higher levels of inflammation. The study would analyse the effect of anti-depressants, using both qualitative and quantitative methodology. Patients with depression were to be recruited via an existing study and therefore were already in contact with researchers. It was proposed to recruit healthy controls via the GP surgery, and this would involve unsolicited contact via post. Administrative staff at the GP surgery would search the GP database for patients meeting the inclusion/exclusion criteria and send their names and addresses to a third party – Docmail. This organisation would receive the invitation letter and PIS from the researcher, and mail them out to the patients using the names and addresses provided by the GP surgery. No identifiable information would be accessed by the researcher. The recipient of the PIS and invitation letter would then contact the researcher if they wished to take part, and would subsequently be consented into the study. Docmail would not retain any data beyond a 28 day period to contact the potential participants. The researchers wished to use this method to ensure that healthy controls were recruited from the same practice as the depressed patients, to ensure the demographic characteristics were the same for both groups, and did not feel they could recruit enough people in the timescale for the study if they used poster advertising rather than direct contact."]
["Applicant Organisation Name","UCL"]
["Contact Name","Professor Glyn Lewis (CI); Miss Samantha Lawes "]
["Address","Research Department of Epidemiology and Public Health"]
[null,"1-19 Torrington Place"]
[null,"London"]
["Postcode","WC1E 7HB"]
["Telephone","02076791682"]
["Email","samantha.lawes.13@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants (18 - 74 years old)"]
["Description of confidential patient information used","We plan to recruit 90 participants, 60 with depression and 30 healthy controls"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","UCL"]
["Status","Supported"]
[]
["Outcome Date","2016-07-29"]
["Next Review Date","2017-07-29"]
["Notes","This application was considered by the Confidentiality Advisory Group sub-committee meeting 15 July 2016.                                                                                                                        1. Favourable opinion from a Research Ethics Committee. Confirmed 5 April 2016\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed 29 July 2016"]

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[]
[]
["Application Number","0198"]
["Reference","16/CAG/0038"]
["Other Refs","16/EM/0108"]
["Application Title","Risk Stratification tools to identify patients with advanced COPD"]
["Application Summary","This application from University Hospitals of Leicester NHS Trust set out the purpose of\ninvestigating which measurements best assess the severity of Chronic Obstructive\nPulmonary Disorder (COPD), and how best to use these measurements to determine\nhow many patients have advanced disease.\nThe project will use health data about patients with COPD that is already recorded by GP\npractices in Leicester, Leicestershire, and Rutland (LLR) and which is being used to help\nlocal health organisations work out the health needs of the local population. This\ninformation cannot be used to identify an individual patient by the research team. The\nresearchers will use this information to find out how many patients with advanced COPD\nare living in LLR and how best to predict their future needs for healthcare."]
["Applicant Organisation Name","University Hospitals of Leicester NHS Trust"]
["Contact Name","Professor Michael Steiner"]
["Address","Respiratory Biomedical Research Unit"]
[null,"Glenfield Hospit"]
[null,"Groby Road, Leicester"]
["Postcode","LE3 9QP"]
["Telephone","01162583998"]
["Email","michael.steiner@uhl-tr.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort will consist of pseudonymised data related to 16,000 primary care COPD patients treated in Leicester, Leicestershire and Rutland."]
["Description of confidential patient information used","NA, confidential patient information is not required."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University Hospitals of Leicester NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2016-07-28"]
["Next Review Date","2018-07-28"]
["Notes","Amendment Request (Approved 09/01/2018)\nThis amendment seeks support to allow University Hospitals of Leicester to make an application to NHS Digital, for the required pseudonymised SUS data to be shared direct with Arden and GEM CSU on their behalf, to enable the proposed data linkage to be undertaken. Primary care data would continue to be supplied to Arden and GEM CSU by GPs in the same format and method as set out in the original proposal, so there would be no change to these data flows. There is no change to the study purpose, methodology or benefits. The current approval permits the research study team to receive pseudonymised level risk stratification output along with specific COPD related data fields and there is no change to this either. The research study team will still receive pseudonymised record level data, as per original application and approval. The applicants stated that the amendment would also require a change to the data controllership arrangements for the project from LLR (Leicester, Leicestershire, and Rutland) CCGs to University Hospitals of Leicester NHS Trust.\n\nThis application was considered by the Confidentiality Advisory Group sub-committee meeting 21 April 2016.                                                                                                                        1. CAG receipt of the revised LCCG health records leaflet, correcting the factual\ninaccuracies about CAG and to allow greater ease for patients to register objection.\nConfirmed 22/06/2016\n2. CAG receipt of a favourable opinion from a Research Ethics Committee for the\nrevised patient leaflet. Confirmed 22/06/2016\n3. CAG receipt of a favourable opinion from a Research Ethics Committee. Received,\nletter dated 03 March 2016\n4. Support is conditional on suitable security arrangements (as evidenced by Information\nGovernance Toolkit (IGT) submission) being in place. Confirmed 22/06/2016"]

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[]
[]
["Application Number","0199"]
["Reference","16/CAG/0091"]
["Other Refs","16/EM/0286"]
["Application Title","Investigation into predictors of diagnosis in PAH patients"]
["Application Summary","This application from Sheffield Teaching Hospitals NHS Foundation Trust (STHFT) set out the purpose of investigating Pulmonary Arterial Hypertension (PAH). PAH is a disease primarily of small arteries in the lung which results in a progressive rise in lung blood pressure and heart failure. There are several types of PAH including Idiopathic PAH and Associated PAH related to a range of disease processes, including cirrhosis, connective tissue disease, congenital heart disease, HIV infection and sickle-cell disease. Literature documents the difficulties with Pulmonary Arterial Hypertension (PAH) diagnosis which involves many different types of clinical tests, and the lengthy time it can take to diagnose the condition from the advent of a patient’s first symptoms. This study aims to build a data environment for analysis in order to describe the PAH patient population in England, understand the natural history of disease and look for opportunities for improving predictive analytical methods to flag patients for diagnosis earlier.   The study design is a non-interventional retrospective database analysis of a PAH patient cohort based on data from the Pulmonary Vascular Disease Unit at Sheffield Teaching Hospitals NHS Foundation Trust (STHFT) and Hospital Episodes and Statistics (HES) data from the Health and Social Care Information Centre (HSCIC). It attempts to identify any predictive signals or markers which would allow earlier diagnosis of Pulmonary Arterial Hypertension patients and thus enable earlier right heart catheterization intervention, by analysing patient’s usage pattern of hospital services ahead of a confirmed PAH diagnosis. In order to link the STHFT datasets to the Hospital Episode Statistics (HES) data, identifiable information is required to be passed from STHFT to the Health and Social Care Information Centre (HSCIC) in the form of the patient NHS number. The methodology and data flows are set out in the application.                                                                                                         "]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Professor David Kiely"]
["Address","Pulmonary Vascular Disease Unit"]
[null,"Royal Hallamshire Hospital"]
[null,"Glossop Road"]
["Postcode","S10 2JF"]
["Telephone"]
["Email","david.kiely@sth.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from Sheffield Teaching Hospitals NHS Foundation Trust in relation to 1,907 patients suffering from PAH; anonymised information pertaining to other individuals with PAH will be provided by the HSCIC."]
["Description of confidential patient information used","NHS number will be used to perform the linkage. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Sheffield Teaching Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-08-16"]
["Next Review Date","N/A"]
["Notes","Support expired 18 June 2021\n\n16 April 2021 - Amendment supported\nThe amendment, to add new school entrants annually to the HERD database for a time period of five years, to receive annual updates from DfE for a period of five years, to receive monthly primary care updates for a period of five years, and to include Humber Teaching NHS Foundation Trust as an additional data processor, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions:\n\n1. Support is extended for a period of five years only rather than the requested ten year period. An extension to the amendment or a re-submission of the application will be required at that time.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold:\n\nConfirmed: The NHS Digital 19/20 DSPT review for Bradford Teaching Hospitals NHS Foundation Trust (Org Code: RAE) was confirmed as ‘Standards Met’ (by email to the CAG inbox on 16 April 2021). \n\nAs there are 5 or more organisations, security assurance has not be checked by the Confidentiality Advice Team (CAT) for all data processors. Support is recommended on the basis that the applicant is responsible for seeking assurance that the appropriate security arrangements are in place. The applicant should ensure that 19/20 DSPTs for the following organisations have been reviewed as ‘standards met’ by NHS Digital;  \n• Bradford District Care Trust (Org Code: TAD)\n• Airedale NHS Trust (Org Code: RCF)\n• Apollo Medical Software Solutions Ltd. (Org Code: 8HH66) \n• Department for Education\n• City of Bradford Metropolitan District Council (Org Code: 209)\n• Humber Teaching NHS Foundation Trust (Org Code: RV9)\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 04 March 2021\n\nAmendment request 30/12/2016\nThe amendment request was for an increase in the cohort size. The figure stated on the original application and approval letter was based on the number of patients in the Sheffield databases who had received a final confirmed diagnosis of PAH.\nThis calculation had not taken into account the number of patients referred with a suspicion of severe pulmonary hypotension which may have been suspected PAH which turned out to have other causes. In order to evaluate the diagnostic pathway and meet a secondary objective of the research, this additional data was required. In addition to this, there had been an increase in patient numbers at the unit and the inclusion of these additional patients would make the analyses more robust.                                                                                                         Specific conditions of support 30/12/2016\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmation of a satisfactory published submission was noted (version 13, 74%)\n2. Confirmation of a favourable opinion from a Research Ethics Committee. Letter provided on 28 December 2016.                                                                                                              "]

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[]
[]
["Application Number","0200"]
["Reference","16/CAG/0095"]
["Other Refs","10/H0721/51"]
["Application Title","European Network of National Schizophrenia Networks Studying Gene-Environment Interactions (EU-GEI. Work package 5: GenexEnvironment in the Prodrome"]
["Application Summary","This application from Institute of Psychiatry, Psychology and Neuroscience (IoPPN) King's College London (KCL) specified that patients with psychotic disorders such as schizophrenia, usually experience early signs of psychosis for 1–5 years prior to the first episode of frank illness. This early state is known as at risk mental state (ARMS) or prodrome. Individuals with ARMS appear to be at extremely high risk of developing psychosis; about one-third will do so while two-thirds will not make a transition to psychosis and their at-risk symptoms will either stay the same or improve. It is unclear why only a subset of those who are highly vulnerable to psychosis go on to develop the illness. There is increasing evidence that aetiological models of schizophrenia need to incorporate the role of genetic, social, psychological and biological factors, and to clarify how they interact. In the European Network of National Schizophrenia Networks Studying Gene-Environment Interactions (EU-GEI), the genetic, psychological and physiological interactions in individuals at high risk of psychosis were examined. The aim being to deliver a tool that can be used to help identify genetic and environmental factors that, when they interact, predict who is more likely to develop schizophrenia.\n"]
["Applicant Organisation Name","Institute of Psychiatry, Psychology and Neuroscience (IoPPN) King's College London (KCL)"]
["Contact Name","Prof Philip K. McGuire"]
["Address","Institute of Psychiatry, Psychology and Neuroscience"]
[null,"King's College London"]
[null,"De Crespigny Park"]
["Postcode","SE5 8AF"]
["Telephone"]
["Email","philip.mcguire@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from NHS Trust databases, the Health and Social Care Information Centre (HSCIC), & the NHS Care Records Service in relation to 100 individuals who have previously taken part in the ‘Identifying genetic and environmental interactions in psychosis’ study."]
["Description of confidential patient information used","Name, address (including postcode at unit level), NHS number, date of birth, date of death, GP registration, & gender will be used to verify identity, prevent inappropriate contact, contact the participant, &/or enable contact with GP's regarding up-to-date contact details.\nDate of birth, ethnicity, & gender will be retained for analysis.\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","King's College London"]
["Status","Supported"]
[]
["Outcome Date","2016-08-16"]
["Next Review Date","2017-08-16"]
["Notes","This application was considered by the Confidentiality Advisory Group sub-committee meeting 04 August 2016.                                                                                                                        1. Favourable opinion from a Research Ethics Committee. Provided.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 07 July 2016 (94% version 14). Please note maintenance of a satisfactory IG Toolkit submission for the duration of the approval length will be required.\n3. Patient notification materials to be disseminated to the specified patient groups and any patient objections respected. An update on dissemination and any issues experienced to be provided at time of annual review.\n4. Confirmation at annual review of intended point the processing of confidential patient information without consent will cease."]

{"sheet":"A0201","index":150,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0201"]
["Reference","16/CAG/0047"]
["Other Refs","16/LO/0902"]
["Application Title","Psychological Impact of Primary Screening for HPV"]
["Application Summary","This application from University College London (UCL) set out the purpose of data-linkage to allow invitations to participate in research to be sent out. The NHS Cervical Screening Programme is piloting the use of human papillomavirus (HPV) testing as the primary test in cervical screening. Women attending for cervical screening will first have an HPV test and cytology will only be carried out on the residual samples of women who are HPV positive. This differs to current screening where cytology is carried out first, followed by HPV testing if necessary.\nThis project aims to evaluate the psychological impact of this programme and has been commissioned by Public Health England. Potential participants will be identified by NHS laboratories at six pilot sites across England. 3,340 women will be approached at baseline and will receive an information sheet, consent form and questionnaire pack by postal mail to their home address. For those who do not respond, a reminder pack containing the same information will be sent out 3 weeks later.\nA mailing company called CPH Docmail Ltd will complete all printing and postage. Support was sought for the initial transfer of address information from the NHS laboratories to CPH Docmail. Thereafter the participants will have consented to being approached for the follow-ups and was not considered further by the CAG.\nA recommendation for class 2, 3, and 6 support was requested to allow the disclosure of confidential patient information from the relevant sites to CFH Docmail."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Jo Waller"]
["Address","Health Behaviour Research Centre, Department of Epidemiology and Public Health"]
[null,"Gower Street"]
[]
["Postcode","WC1E 6BT"]
["Telephone",2076795958]
["Email","j.waller@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from 673 women "]
["Description of confidential patient information used","NHS laboratories; name, address, & postcode "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2016-08-24"]
["Next Review Date","N/A"]
["Notes","2018 - Support Expired\nThe CAG application form states that recruitment at each site would take 8 weeks.  Support was given in 2016.  \n\nThe AR from 2018 confirmed that all processing of CPI had been completed and consent was now the legal basis.   \n\nJune 2016 - Application Supported\nThis application was considered by the Confidentiality Advisory Group meeting 29 June 2016.                                                                                                                    1. Receipt of the text for the patient notifications. Received 21/06/16\n2. Favourable opinion from a Research Ethics Committee. Received, letter dated 17/05/16\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Partial confirmation 16 August 2016"]

{"sheet":"A0202","index":151,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0202"]
["Reference","16/CAG/0040"]
["Other Refs","16/LO/0464"]
["Application Title","Validating an extended scale on the HCR-20 V3"]
["Application Summary","The 'Health, Clinical, Risk 20' (HCR-20) is the most commonly used risk assessment tool for assessing violence in the UK. Effective risk assessments help to ensure that offenders are given the correct support and treatment necessary to reduce their risk of reoffending. Previous studies have largely investigated the ability of the HCR-20 to predict violence. However, little emphasis has been placed on the HCR 20’s potential ability to identify changes in risk. Understanding this would help secure hospitals and prisons to achieve one of their core aims, facilitating them to re-integrate offenders back into society by reducing their risk.\nThis application from East London NHS Foundation Trust set out the purpose of testing the validity of a new 7-point scale for the HCR-20 and of assessing whether it is better than the original, already validated 3-point scale at evaluating change in risk. The study will also test whether improvements on a HCR-20 score is linked to a reduction in violent behaviour.\nTo conduct the study, a researcher will visit 5 prisons and 5 secure units. In each site, the researcher will train the clinicians to complete the HCR-20 assessments and score them using the new 7-point scale. As part of routine clinical practice, the clinicians at the various sites will then complete the HCR-20 using both the original 3-point scale and the new, yet to be validated 7 point scale. The researcher will then visit the sites and document the HCR-20 scores, violent behaviour in the 6 months prior to the HCR-20 scoring and any evidence of a change in risk (granted leave, moved to a more/less secure unit).\nAfter 12 months, the researcher will re-visit the sites and collect the HCR-20 scores, document violent behaviour and document any changes in risk. This data will then be analysed by the research team to determine whether extending the scale from 3 points to 7 points is better for detecting change in risk.\nA recommendation for class 1, 5, and 6 support was requested to allow the disclosure of confidential patient information from 5 prisons and 5 secure units to the research team from East London NHS Foundation Trust."]
["Applicant Organisation Name","East London NHS Foundation Trust"]
["Contact Name","Dr Phil Minoudis"]
["Address","12 Kenworthy road"]
[null,"John Howard Centre"]
[null,"Millfields unit"]
["Postcode","E95TD"]
["Telephone",2085102645]
["Email","phil.minoudis@elft.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"Y","medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Aged 18 or over\nMale\nResidents of a forensic mental health unit or a prison\nHave had at least one HCR-20 assessment completed."]
["Description of confidential patient information used","The sensitive patient information used will be any violent behaviours that have been demonstrated by the patient over\nthe previous 6 months, in addition to any evidence of any progressive or restrictive moves (I.E. moved to a less/higher\nsecure unit, given enhanced/basic status on IEP scheme, granted leave/ had leave rescinded). HCR-20 scores will\nalso be used."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Oxleas NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2016-09-05"]
["Next Review Date","2018-09-05"]
["Notes","This application was considered by the Confidentiality Advisory Group meeting 21 April 2016.                                                                                                                    1. Specific assurance that absolutely no identifiable data will leave any of the sites in any form. Confirmed\n2. Provision of updated study poster including a contact detail for the research team or justification as to why this would not be reasonably practicable. Received\n3. Favourable opinion from a Research Ethics Committee. Provided 25/08/2016\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission.\nThe published version 13 indicates the submission is marked as ‘satisfactory with improvement plan’ with requirement 13-112 (Information Governance awareness and mandatory training procedures are in place and all staff are appropriately trained) indicated as currently Level 1. Please be advised that those involved in processing the relevant data under this support must be fully aware of their responsibilities under the terms of this support."]

{"sheet":"A0203","index":152,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0203"]
["Reference","16/CAG/0117"]
["Other Refs","15/EM/0378"]
["Application Title","An extension of the Arnold Lodge Admission Cohort Reconvictions and Intervening Treatment (ALACRITy) study: 1983-2013"]
["Application Summary","This resubmitted application from the University of Nottingham set out the purpose of continued monitoring of the outcomes of a vulnerable cohort in terms of mortality and rehospitalisation, add to understanding of the long-term outcomes of these patients. This application intended to supersede and replace the support already provided for under references PIAG 4-07 (t)/2002 and ECC 4-15 (b)/2009. The study will generate long-term follow-up data that will help to inform public debate, service planning and patient care. Other potential benefits of the study include making community services aware of the need to address the risk of suicide and physical ill health as well as reoffending, and quantifying statistical risks and timescales for reoffending in clinical populations. There is also a potential benefit in raising awareness in mental health services of potential adverse outcomes such as excess mortality, particularly by suicide\nA recommendation for class 1, 4 and 6 support was requested to enable the relevant activities specified in the application."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Ramani Moonsinghe, Professor of Peripoerative Medicine, Head of Research Department for Targeted Intervention"]
["Address","University College London "]
[null,"Charles Bell House, 43-47 Foley Street "]
[null,"London "]
["Postcode","W1W 7AT "]
["Telephone",7956620717]
["Email","Ramani.moonesinghe@nhs.net  "]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ONS Mortality data obtained from the Health and Social Care Information Centre (HSCIC) (i.e. date of death, cause of death, district of death, current district of registration) is required to calculate mortality ratios"]
["Description of confidential patient information used","Names and dates of birth are necessary identifiers to link to the other data sources described. Patients will be allocated a unique participant number and identifiable data will not be entered on to the dataset. Patients will not be identified in the dissemination and findings will be reported in a way which restricts identifiability.\nONS Mortality data (HSCIC): date of death, cause of death, current district of registration. To calculate time at risk for\nreconviction and survival curves for reconviction and mortality. Mortality data will also be used to calculate Standardised\nMortality Ratios.\nNHS records: dates of admissions to and discharge from hospital, type of hospital (e.g. high secure, low secure,open), type of accommodation, employment. To calculate outcomes such as time in hospital, time at risk in the community, physical health, psychosocial adjustment.\nThe Mental Health Casework Section (formerly the Home Office Mental Health Unit) data: these case files detail the progress of patients on restriction orders e.g. dates of hospital admission and discharge, type of hospital (e.g. high secure, low secure, open), changes in restricted status. A researcher will visit the Home Office to view the files and then record the outcome data in an anonymised form.\nPolice National Computer data: dates and types of convictions and court disposals, periods of remand in custody. A separate application has been approved by the National Offender Management Service for conviction data as we acknowledge that police and prison data is outside the remit of CAG and Section 251.\nPrison Service data/information will be obtained from multiple sources including clinical notes, court reports and PNC data and includes: dates and duration of periods of imprisonment and security category of establishment (e.g Category A, Open prison), details of any recalls from life or determinate sentence licenses as for Mental Health unit above. To calculate time at risk of reoffending out of custody, progress for life sentenced prisoners in terms of release\non license.(A separate application has been approved by the National Offender Management Service for this type of data).\nCurrent circumstances: current consultant, type of residence (e.g. own home), level of CPA, any current legal restraints (e.g. supervised community treatment order)."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Leicester"]
["Status","Supported"]
[]
["Outcome Date","2016-09-16"]
["Next Review Date","2024-09-16"]
["Notes","Amendment Application (Approved 28/11/2018)\nAmendment supported 28 November 2018 to enable a duration extension to 31 December 2019, with a subsequent 5-year retention period to 31 December 2024.\n\nAmendment Application (Approved 17/07/2018)\nThe amendment requested support for the following three changes:\n1. Change of main applicant – the current named applicant, Professor Birgit Völlom, is leaving her post and will be replaced by Dr Simon Gibbon,\n2. Extension to the duration of support – due to delays in the receipt of data from NHS Digital, the applicants are seeking an extension to support to 31/12/2018,\n3. For information – patient-facing information has been updated following the implementation of the General Data Protection Regulations at the request of by NHS Digital.\n\nThis application was considered by the Confidentiality Advisory Group meeting 08 September 2016.                                                                                                                                 1. This application now supersedes references PIAG 4-07 (t)/2002 and ECC 4-15 (b)/2009. These references are no longer active.\n2. Support applies only to the relevant healthcare generated data as specified in the application. For example, data to be obtained from the Ministry of Justice or employment records would fall outside the scope of this approval.\n3. Any dissent or patient objection to be respected under the terms of this support with no need for the patient to demonstrate harm or distress if making an objection.\n4. An annual review to be provided every 12 months from date of final approval; the first annual review should include details of the number of patient objections made, and to consider the length of the retention period for identifiable information.\n5. Favourable opinion from a Research Ethics Committee. Received dated 22 September 2015\n6. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Version 13 reviewed grade published as ‘satisfactory’."]

{"sheet":"A0204","index":153,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0204"]
["Reference","16/CAG/0087"]
["Other Refs"]
["Application Title","Epidemiology of Critical Care provision after Surgery (EpiCCS)"]
["Application Summary","This pilot study is to explore how clinicians determine the risk of death in clinical practice and whether these risk estimates are accurate. Data will be collected on all patients undergoing surgery requiring overnight stay in hospital in participating UK hospitals for one week. The researchers will measure complications in these patients. In a sub-group of patients, the quality of recovery after surgery (e.g. ability to self-care, mobility etc) will also be recorded on day 3. The researchers will learn about if and when patients die after surgery through linkage to national databases held by the Department of Health.\nThis application from University College London set out the purpose of describing the rates and reasons for patients being admitted to critical care after inpatient surgery in the UK. A secondary aim is to estimate whether postoperative critical care admission is associated with patient benefit (a reduction in postoperative complications).\nA recommendation for class 4 and 6 support was requested to support the processing of identifiable data for the purpose of data-linkage."]
["Applicant Organisation Name","University College Hospital"]
["Contact Name","Dr S. R. Moonesinghe"]
["Address","Anaesthetics Department Podium 3"]
[null,"Maple Link Corridor"]
[null,"235 Euston Road"]
["Postcode","NW1 2BU"]
["Telephone",7956620717]
["Email","rmoonesinghe@gmail.com"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All inpatients undergoing surgery"]
["Description of confidential patient information used","Patient name, Date of birth, NHS number, Sex, Postcode"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Supported"]
[]
["Outcome Date","2016-09-16"]
["Next Review Date","2023-09-16"]
["Notes","This application was considered by the Confidentiality Advisory Group meeting.                                                            1. Justification of each data item required for linkage.\nThe following response was received by email:\n‘We propose to link the prospective patient-level dataset to:\ni. Mortality database from the Health and Social Care Information Centre (HSCIC) and the Office for National Statistics (ONS)\nii. Hospital Episode Statistics (HES)\nThe HSCIC/ONS mortality data provides a validated date of death for patients. HES will provide information on patient co-morbidity and inpatient hospital treatments, and will be used to validate some aspects of the prospective data (eg, dates of admission, discharge) as well as in the analysis of treatment patterns and outcomes (eg, a HES-derived comorbidity index will be used to risk-adjust postoperative complication rates).\nThe following patient identifiers are required in order to identify individual patients and to subsequently request mortality data from the HSCIC/ONS and HES, and co-morbidity data, inpatient hospital treatments and operative procedure codes from HES.\n Date of birth\n NHS number\n Postcode\n Sex\nUsing these identifiers, a match rank value obtained from the HSCIC/ONS and HES linkage process is an indication of the level of confidence that an EpiCCS record has been correctly matched to a HSCIC/ONS death record and patient data in HES. Matching is performed by comparing patient identifiable fields, such as date of birth, sex, NHS number and/or postcode, which are present in both HES and HSCIC/ONS. The lowest rank (1) is considered the best quality match and the higher rank (8) the lowest quality match. This process is similar to that outlined in the HSCIC's ‘Guide to Linked Mortality Data from Hospital Episode Statistics and the Office for National Statistics’(http://www.hscic.gov.uk/media/11668/HES-ONS-Mortality-Data-Guide/pdf/mortality_guide.pdf).\nThe match ranks used will take the following schema:\n Match rank 1: Exact match of Date of birth, Sex, NHS number and Postcode; if no match is found then                                                                                                                            Match rank 2: Exact match of Date of birth, Sex, NHS number; if no match is found then\n Match rank 3: Partial match of Date of birth and exact match of Sex, NHS number and Postcode; if no match found then\n Match rank 4: Partial match of Date of birth, and exact match of Sex, NHS number; if no match found then\n Match rank 5: Exact match of Postcode and NHS number; if no match found then\n Match rank 6: Exact match of Date of birth, Sex and Postcode where NHS number does not contradict the match and Date of birth is not 1 January and the Postcode is not in the 'ignore' list (communal establishments such as hospitals, prisons, army barracks, etc).\n Match rank 7: Exact match of Date of birth, Sex and Postcode where NHS number does not contradict the match and Date of birth is not 1 January.\n Match rank 8: Exact match of Date of birth, Sex and Postcode where Date of birth is not 1 January.\nPatient name will be used in the IT system to support its relational data-structure, as well as for local hospital sites to identify patients at a trust level to ensure all patients have had their data captured. Patient name would also further be required in order for trusts to identify data corresponding to patients who choose to opt out of the study prior to entering the data onto the secure EpiCCS database webtool’\nMembers queried the phrase ‘patient name will be used in the IT system to support its relational data-structure’. Members assumed that this meant that the name of the patient was needed alongside the NHS number in order to identify patients at local hospital level, and were happy to give support on this basis.\nNo other queries or concerns were raised.\n2. Provision of a clarification and justification of the exit strategy proposed.\nONS will provide quarterly updates on patients within the database who have died. Thus, patient identifiable data will be retained within the database for 10 years and 3 months after the final patient has been recruited. This will enable the ONS mortality data at 10 years post-recruitment to be linked to the patient records contained within the database. Following linkage of these data, all patient identifiers will be destroyed.\nMembers were satisfied with this response and raised no further queries or concerns.\n3. Clarification as to whether the patients would, in every instance, be seen by the anaesthetist on discharge.\n‘Due to the observational nature of the study, large number of patients planned for enrolment (sample size calculation of 8,177 patients), and the fact that the study is not introducing any additional interventions, the study protocol does not require that patients would be seen in every instance by the anaesthetist on discharge. To further clarify, patients would not be seen by the anaesthetist unless it was required as part of their routine medical/surgical care’.\nMembers were satisfied with this response and raised no further queries or concerns.\n4. Provision of the outcomes of PPI, as set out above.\nRepresentatives from patient and user organisations have been involved from the very early stages of the study; this included a patient representative being one of only three applicants on the grant which was awarded to support this study. The study Steering Group includes patient representatives and representatives from a variety of organisations including clinicians, nurses and professional representatives who have personal experience of surgery and anaesthesia. The study project team have also engaged the Royal College of Anaesthetists' (RCoA) Lay Committee for their opinions of the study protocol and patient information material. The Lay Committee is well established and engaged in many aspects of the RCoA's work.\nAfter reviewing the study protocol, and supporting appendices, the patient representatives on both the Steering Group and the RCoA's Lay Committee have been supportive of our approach. They have also specifically reviewed the wording used in our Participant Information Sheets, and agree with the amount of information provided and manner in which the study is handling notification and opt out.\nWe enclose correspondence from Richard Shawyer, a patient representative sitting on the Steering Group, responding directly to the issues raised by the CAG. We also attach correspondence from Elspeth Evans, a lay member of the Lay Committee.\nSubject to the outcomes of the PPI and taking due note of the CAG deliberations, as set out above, provision of suitable patient notification materials together with a description of how these will be disseminated. Please find enclosed copies of our revised Participant Information Sheet. The information sheet has been designed according to the HRA style guide. It has undergone revision since our CAG application and following review by the Research Ethics Committee (REC), as outlined further below. In our revisions, we have made the following amendments:\ni. made it more explicit that study data will be retained for 10 years,\nii. rephrased sections to say that none of the patients' data would be identifiable under the section \"Why haven’t I been asked for permission to use my information?\",\niii. highlighted that exemption under Section 251 of the Health and Social Care Act 2001 has been sought with regards to not seeking consent for patient identifiable information to be recorded,\niv. emphasised that patients can opt out of the study by expressing dissent to their clinicians as the first option, with email opt out changed to being the alternative option.\nWe plan to distribute the information sheets in pre-operatively on the day of surgery. This approach has been discussed with our patient representatives within the study Steering Group and the RCoA Lay Committee, and it was felt by all patients consulted to be an acceptable approach. All patient notification material will also be available on our study website (http://www.niaa-hsrc.org.uk/SNAP-2-EpiCCS-Project-Outline). We will also be asking participating hospitals to prominently display posters (see enclosed appendix 7) alerting patients to the fact that the study is taking place around pre-operative areas in the hospital.\nMembers noted that changes had been requested to the information sheets by the Research Ethics Committee. Although members were not entirely convinced that the patient and public involvement issue was resolved by the involvement of just one or two lay members, it was agreed that the information sheets were fit for purpose.\n5. Favourable opinion from a Research Ethics Committee. Confirmed 22 August 2016\n6. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 27 April 2016."]

{"sheet":"A0205","index":154,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0205"]
["Reference","16/CAG/0104"]
["Other Refs","16/LO/1367"]
["Application Title","The Paediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology (PARDIE) study"]
["Application Summary","This application from Guy’s and St Thomas’s NHS Foundation Trust (GSTFT) set out the purpose of PARDIE. This study is a multi-centre prospective study to identify how common new cases of paediatric acute respiratory distress syndrome (PARDS) are. Organised in the US, there are over 200 Paediatric Intensive care Units (PICUs) participating internationally. Led in the UK by GSTFT, this study is an observational, cross-sectional review of new cases of PARDS in PICUs involving 5 continuous days of screening and patient enrolment, occurring every 2 months over 6 months (4 total study weeks). There is no intervention. Patients are followed up to 90 days post enrolment for outcomes such as mortality and length of ventilation.\nA recommendation for class 1 and 6 support was requested to achieve the aims set out in the application"]
["Applicant Organisation Name","Evelina London Children’s Hospital"]
["Contact Name","Dr Jon Lillie"]
["Address","Paediatric Intensive Care"]
[null,"Evelina London Children’s Hospital"]
[null,"Westminster Bridge Road, London\n"]
["Postcode","SE1 7EH"]
["Telephone"]
["Email","jonathan.lillie@gstt.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants"]
["Description of confidential patient information used","Aim for total number of UK patients studied is 228 patients (124 main study and 104 subsidiary studies)\nName, date of birth, gender, ethnicity, weight, height\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Evelina London Childrens Hospital Guy’s and St Thomas’s NHS Foundation Trust "]
["Status","Expired"]
[]
["Outcome Date","2016-09-16"]
["Next Review Date","N/A"]
["Notes","All identifiable information held without consent has now been anonymised.   Any data currently being analysed is completely anonymised.  \n\nKhemani RG et al. Pediatric Acute Respiratory Distress syndrome Incidence and Epidemiology (PARDIE) Investigators; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study. Lancet Respir Med. 2019 Feb;7(2):115-128. doi: 10.1016/S2213-2600(18)30344-8 was published, cited by 200 publications already and multiple other papers have come from this. It remains the largest study of paediatric ARDS internationally and it has aided the clinician, patient and family  in prognostication for paediatric ARDS. It demonstrated significant mortality in this group which has leant to guiding further studies into interventions and therapies.\n\nThis application was considered by the Confidentiality Advisory Group meeting on the 08 September 2016.                                                                                                               1. Suitable patient notification materials, providing a clear mechanism to enable patient objection, to be disseminated and made accessible to relevant patients; information should also be provided on the Guy’s and St Thomas’ website.\n2. Support cannot be applied where a participant lacks capacity; other provisions under the Mental Capacity Act would apply and should be followed.\n3. Engagement with appropriate patient group, prior to publication of the dataset.\n4. Favourable opinion from a Research Ethics Committee. Received.\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Version 13 ‘reviewed grade’ confirmed as satisfactory 13/09/2016"]

{"sheet":"A0206","index":155,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0206"]
["Reference","16/CAG/0081"]
["Other Refs","16/LO/1065"]
["Application Title","Using Patient Data in Amyloidosis to Understand Complex Diagnosis Pathways and Treatment Patterns"]
["Application Summary","Amyloidosis is a rare life-limiting disease that can progress rapidly. Due to the rarity of amyloidosis and range of manifestations of the disease (often presenting as vague symptoms), patients often experience delays in diagnosis or may even remain undiagnosed. Delay in detection of amyloidosis may have an adverse impact on modifying the progression of the disease, even for those patients who receive therapy. Before a confirmed diagnosis of amyloidosis is finally provided to a patient, patients have often been seen by multiple physicians and may have received multiple incorrect diagnoses.\nThis application from Royal Free Foundation Trust set out the purpose of building a research platform for patients with amyloidosis. Management of all UK patients with amyloidosis is via the National Amyloidosis Centre (NAC) based at the Royal Free Hospital, although other aspects of their medical care are also be provided locally to the patient in secondary care and tertiary care centres.\n1. HSCIC shares pseudonymised, non-sensitive standard monthly subscription extracts of HES Admitted Patient Care, A&E and Outpatient data with IMS Health (in line with the existing data license).\n2. The NAC generates a study ID for each patient managed at the NAC. The NAC will send this and the NHS number to the HSCIC.\n3. The HSCIC supplements the NAC NHS number list with pseudonymised patient IDs, which are aligned to the HES extract IMS receives in step 1. This supplemented list (comprised of pseudonymised patient IDs and study ID) is then returned to the NAC.\n4. Thereafter all research activities will be conducted on de-identified data at IMS. The HES linked data will not leave IMS Health.\nAlthough there is a consent system has been in place since 2006, with a provision to ask all current patients whether they agree for their data to be used for research, there are patients who have been lost to follow up or who are deceased, where it has not been possible to ask for consent. In addition patients present in the database prior to 2006 will not have been asked this specific question. Due to the limited size of the cohorts of interest, identification of clinically meaningful and significant precursors/prognostic factors relies heavily on maximising the full historic records available.\nAll patients that have refused consent for their data to be used for non-clinical purposes will be excluded from the NAC dataset. Only aggregated non-patient level output will be shared. Tables of less than 5 patients will be suppressed and no data will be published that could lead to identification of a patient (even after their death).\nA recommendation for class 1, 2, 4, 5, and 6 support was requested to cover the transfer of identifiable data to the HSCIC for those patients for whom there is not an alternative legal basis for this processing."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Julian Gillmore"]
["Address","University College London"]
[null,"Rowland Hill Street"]
[]
["Postcode","NW3 2PF"]
["Telephone"]
["Email","j.gillmore@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female participants"]
["Description of confidential patient information used","NHS number from NAC [if they are a legal organisation]  in relation to 4803 Amyloidosis patients  "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2016-09-09"]
["Next Review Date","N/A"]
["Notes","18 June 2021 - Support expired\n\n1. Please may you confirm the reason that support is no longer required. If the reason is that all data has been pseudonymised, please may you confirm that the original identifiers which were supported are no longer being processed/retained, and an overview of what data items you still retain. \nThe data we retain is the HES data we received from NHS digital which is pseudonymised, and the original identifiers are only held at Royal Free. We do not expect to request any further data from NHS digital in future (that would mean more processing of identifiable data). We therefore believe that section 251 support no longer needs to be maintained to continue the use of the pseudonymised data. \n\n2. Please may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency.\n\n• Yielded benefits: Based on the data provided for the previous agreement, IQVIA has developed a full set of analysis regarding the NAC patient pathway for Amyloidosis. As a result of these discussions, there is a considerably better understanding of the Amyloidosis patient pathway, including per subtype. For example, for ATTR-CM patients treated at the NAC:\no There is a substantial delay in diagnosis following onset of symptoms, with patients using hospital services (either as an inpatient, outpatient or Accident & Emergency visit) a mean of 19.9 times during the 3 years before diagnosis; diagnosis of the wild-type form of ATTR-CM was delayed more than 4 years after onset of cardiac symptoms in 42% of cases\no Hereditary cardiac amyloidosis patients with a certain genetic mutation (V122I) were more impaired functionally and had worse measures of cardiac disease at the time of diagnosis, and poorer survival compared to the other subgroups (such as patients carrying a different genetic mutation, and patients with wild-type form of the disease)\no Analysis of the diagnostic and treatment pathways for different amyloidosis subtypes has also been completed after HES data was provided, leading to improved knowledge and patient benefits.\n\n• All parties now have a better understanding of treatments that occur outside of the NAC and patient outcomes. A set of papers from the outputs of the analysis have been already published as mentioned above or will be developed into publication and published in research journals, with one manuscript, entitled Natural history, quality of life and outcomes in cardiac ATTR amyloidosis, already published in the journal Circulation. Through publication, the results have been shared across the scientific community, increasing the body of knowledge on Amyloidosis disease, and benefiting Amyloidosis patients with potential future treatment innovations. \n\n\nPurpose of the Amendment 09/12/2016\nThe purpose of the amendment was to fulfil a request from NHS Digital to apply for a separate extract of HES data rather than using IMS Health’s copy of the HES data.                                        This application was considered at the Confidentiality Advisory Group meeting 30 June 2016.                                                                                                                      1. Provision of an explanation as to how the patient notification materials will be made as accessible as possible.\nYou responded that you would use the patient notification materials (submitted) as a poster in the waiting room of the NAC, and that this approach had been agreed with the UKAAG patient advisory group.\nThe response was forwarded to the members of CAG who considered the application. The members approved the response.\n2. Provision of revised patient notification materials explaining that NHS number will be transferred to the HSCIC.\nThe revised patient notification materials were submitted.\nThe CAG commented that these could be difficult for some patients to read and understand, but that they met CAG requirements. It was noted that REC approval had been given.\n3. Favourable opinion from a Research Ethics Committee. Received, dated 20/06/16\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Received, e-mail dated 11/7/16."]

{"sheet":"A0207","index":156,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0207"]
["Reference","16/CAG/0035"]
["Other Refs","16/LO/1067"]
["Application Title","Extension of a cohort mortality study of workers with blood lead measurement to include the analysis of cancer incidence data"]
["Application Summary","This application from the Institute of Occupational Medicine set out the purpose of researching cancer incidence among former lead workers.\nThe research team has previously collected data on the relation between levels of lead in the blood & mortality (ECC 8-05(g)/2011). They now wish to extend the mortality analysis to include cancer incidence/registration data as this will provide a more informative analysis, especially for the less fatal types of cancer. This is part of an international collaboration.\nThe only exchange of identifiable data will be to receive cancer registration data from the National Health Service Central Registers via the HSCIC's secure data download system.\nPseudonmyised information will then be transferred to the International Agency for Research on Cancer (IARC) in Lyon, France.\nA recommendation for class 4 and 6 support was requested to cover access to confidential patient information from the National Health Service Central Registers."]
["Applicant Organisation Name","Institute of Occupational Medicine"]
["Contact Name","Prof. Damien M McElvenny"]
["Address","Institute of Occupational Medicine"]
[null,"Research Avenue North"]
[null,"Riccarton Edinburgh"]
["Postcode","EH14 4AP"]
["Telephone",1314498085]
["Email","damien.mcelvenny@iom-world.org"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from 9,500 former lead workers in relation to cancer incidence data."]
["Description of confidential patient information used","Name/ NHS number/date of birth/date of death/gender/occupation "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Institute of Occupational Medicine"]
["Status","Expired"]
[]
["Outcome Date","2016-09-19"]
["Next Review Date","N/A"]
["Notes","This application was considered by Confidentiality Advisory Group sub-committee meeting 11 April 2016.                                                                                                                         1. Receipt of the text for the patient notifications. Received 4 May 2016\n2. Receipt of the terms and conditions of the contract with IARC\nApplicant confirmed that they do not have a contract with IARC (letter received 4 May 2016) and also confirmed that a Data Sharing Agreement would be provided to IARC, based on that used by HSCIC to supply data to IOM (email received 16 June 2016)\n3. Favourable opinion from a Research Ethics Committee. Confirmed 23 March 2016\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 19 September 2016."]

{"sheet":"A0208","index":157,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0208"]
["Reference","CR11/2013"]
["Other Refs","CA/2521"]
["Application Title","Radioiodine Treated Thyrotoxicosis Study"]
["Application Summary","This application from the University of Birmingham set out the purpose of a project to assess the long term outcome of treatments for thyroid diseases, especially hyperthyroidism and thyroid cancer.\nA recommendation for class 1 and 6 support was requested to cover access to cancer and mortality data from the NHS Central Register, maintained by the Data Linkage Service (DLS) at NHS Digital. A cohort of 12,000 patients was flagged at the DLS."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Professor J A Franklyn"]
["Address","2nd Floor IBR"]
[null,"The Medical School"]
[null,"Edgbaston Birmingham"]
["Postcode","B15 2TH"]
["Telephone"]
["Email","j.a.franklyn@bham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A cohort of 12,000 patients"]
["Description of confidential patient information used"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Birmingham"]
["Status","Expired"]
[]
["Outcome Date","2016-09-19"]
["Next Review Date","NA"]
["Notes","All data related to this study were safely deleted in accord with UoB regulations in 2019. Processing of CPI complete, and expires on 02 June 2023.\n\n1. Confirmation of suitable security arrangements via IG Toolkit submission Version 13 published; reviewed grade confirmed as ‘satisfactory’\n2. Consent should be taken for prospective data collection\n3. For those with whom contact is lost, data collection can proceed providing that any dissent is respected\n4. The applicant should report back on their progress in obtaining consent within the submission of the next Annual Review (due on 9 September 2017"]

{"sheet":"A0209","index":158,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0209"]
["Reference","14/CAG/1009"]
["Other Refs",147538]
["Application Title","Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest"]
["Application Summary","This application from the University of Warwick set out the purpose of a trial to work out how safe and effective adrenaline is as a treatment for patients who suffer out of\nhospital cardiac arrest. Data in relation to 8,000 patients who have been treated for cardiac arrest was requested. All surviving patients would be invited to take part in the follow up and consent obtained to access data.\nA recommendation for class 1, 2, 4 and 6 support was requested to cover access to confidential patient information in order to identify patients to seek consent from and to access mortality, HES, ICNARC and NICOR data in relation to deceased patients."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Professor Gavin Perkins"]
["Address","Warwick Clinical Trials Unit"]
[null,"Gibbet Hill Road"]
[null,"Coventry"]
["Postcode","CV4 7AL"]
["Telephone"]
["Email","g.d.perkins@warwick.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female"]
["Description of confidential patient information used","Name, Address, Post Code, Date of Birth, NHS Number, gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Warwick"]
["Status","Supported"]
[]
["Outcome Date","2014-08-26"]
["Next Review Date","2020-08-26"]
["Notes","Amendment Request (Approved 13/11/2018)\nThe amendment seeks support to link the PARAMEDIC 2 cohort with the UK Transplant\nRegistry. The following items of confidential patient information will be disclosed from the study\ndataset held at the University of Warwick, to the NHS Blood and Transplant Registry to facilitate linkage:\n First name, surname,  DOB (or approx. age if DOB not available),  Sex,  NHS number,\n Address,  Postcode.\n\nThe following data from the NHS Blood and Transplant Registry:\nStandard National Organ Transplant dataset for all Paramedic 2 trial participants in the organ\ntransplant database:\n1. All organ transplants covering the period from date trial started recruitment 23.12.2014 to the recruitment end date 31.03.2018 (kidney, liver, pancreas (inc SPK), intestine, heart, lung, multi-organ),\n2. Donor characteristics – type (living, DBD, DCD), age group, sex, cause of death,\n3. Recipient characteristics – age group, sex, primary diagnosis,\n4. Transplant information – year, organ(s) transplanted, transplant number, cold ischaemia time, HLA mismatch (where appropriate) & urgency status of recipient (where appropriate),\n5. Graft and patient survival times and censoring indicators (as appropriate for each organ).\n\nFrom the other datasets (i.e. Standard National Liver Transplant dataset, Standard National\nPancreas Transplant dataset, Standard National Kidney Transplant dataset and Standard\nNational Cornea Transplant dataset):\n6. Follow up information - including complications, number of readmissions,\nimmunosuppression, liver function tests\n\nAmendment Request (Approved 15/06/2018)\nThis amendment sought support for linkage of the study cohort with the Patient Episode Database Wales (PEDW) held by NHS Wales Informatics Services (NWIS). This would enable the proposed trial follow-up procedures to be achieved for the cohort of Welsh patients included in the study. Support was requested to allow the flow of confidential patient information to NWIS to enable linkage with the PEDW dataset, to enable the return of patient-level hospital data required for analysis.\n\nThis application was considered by the Confidentiality Advisory Group Sub-committee Meeting.\n1. Confirmation of suitable security arrangements via IG Toolkit submission, please see security review requirement section here. Confirmed 10/07/2014.\n2. Confirmation of a favourable REC opinion. Received.\n3. Please confirm why it is necessary to retain full date of birth and date of death for analysis purposes. This is for two main reasons: (1) dates of birth and death are needed for calculation of other variables that are used in the analysis, such as age at randomisation, and time from randomisation to death; (2) it is preferable to calculate ages or time periods from dates within the analysis program, rather than calculating them outside the analysis program and inputting the result. This minimises errors of calculation and data entry.\n4. Ensure that patient right to object to the use of their data is clear within all communication. Confirmed."]

{"sheet":"A0210","index":159,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0210"]
["Reference","16/CAG/0092"]
["Other Refs","16/LO/1269"]
["Application Title","Improving the management of drug resistant tuberculosis in the UK."]
["Application Summary","This application from University College London (UCL) set out the following aims. The increase in antimicrobial resistance is a source of concern. In the UK, for example, 6.8% of the 8,500 tuberculosis patients seen in 2012 were resistant to the first-line drug isoniazid. It is of great importance to prevent the loss of current anti-tuberculosis drugs. This project aims to inform clinical knowledge and policies surrounding drug resistant patients, thus improving management and reducing transmission by a) determining the best treatments for patients with isoniazid resistant tuberculosis disease and b) exploring the relationship between treatment outcomes and the causes of drug resistance.\nA recommendation for class 1, 2 5 and 6 support was requested to achieve the purposes set out in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Helen Stagg"]
["Address","Research Department of Infection and Population Health, UCL"]
[null,"4th floor"]
[null,"Mortimer Market Centre, off Capper St"]
["Postcode","WC1E 6JB"]
["Telephone"]
["Email"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Ex-patients"]
["Description of confidential patient information used","Name, date of birth, hospital identifier, treating hospital, treating clinician and NHS number."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2016-09-22"]
["Next Review Date","N/A"]
["Notes","July 2018 - Support Expired\nIn July 2018, we received confirmation that the study had ended and that all data was now anonymised.\n\nAmendment Request 10/02/2017\nThe amendment requested support for the collection of more detailed microbiological information in relation to the already approved project. The applicants clarified that this did not include any additional confidential patient identifiable information and the risk of identifiability was not increased through the collection of the more detailed clinical dataset.\nThe request for more detailed microbiology information (which contained no additional identifiable information) was as follows:                                                                             Data on drug resistance are recorded in Public Health England’s surveillance systems; the applicant currently has access to these data. A patient’s bacteria are classed as ‘resistant’ or ‘sensitive’ (binary format) in these systems. In the original proposal, this was the level of detail that access was requested to for phenotypic drug resistance.\n Drug resistance can also be determined by sequencing the DNA of the bacteria (genotypic resistance). Many different mutations can cause resistance to a single drug. This sequencing to get data on genotypic resistance was approved in the original application. Both genotypic and phenotypic resistance results are critical for this project; one cannot substitute for the other in my analysis, as their correlation is complex and imperfect.\n A binary phenotypic resistance result does not represent the full picture. The laboratory would have generated continuous numeric results, meaning the applicants can class bacteria as ‘very resistant’, ‘medium resistance’, ‘weakly resistant’, etc. The original application only asked to access the binary format data from the laboratory, rather than the numeric results. The latter, however, have now been shown to be substantially more useful for the project and, in ethical terms, only represent more clinical detail versus what was requested before.\n Public Health England’s laboratory database is the first port of call to get the phenotypic data with continuous numeric results. If the relevant data, particularly for older samples, have not been retained then the phenotypic testing will be repeated at the same time as the bacterial cultures are accessed for sequencing, thus requiring minimal extra manipulation of the   cultures.                                                                                                                                                                                               \nThe need to collect phenotypic data per se was not documented in the original application because Public Health England’s surveillance team only gave data on isoniazid resistant patients (as per the scope of the study) and thus the applicants could easily infer the binary variable (all patients ‘resistant’, none ‘sensitive’). The study inclusion and exclusion criteria thus capture this point. However, the proposed active data collection process to collect phenotype as a continuous variable will only start with this amendment and goes beyond that inclusion/exclusion criteria, thus the revision has been made.\n"]

{"sheet":"A0211","index":160,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0211"]
["Reference","16/CAG/0115"]
["Other Refs","15/EM/03"]
["Application Title","Vitamin D Study"]
["Application Summary","This application from University of Sheffield set out the purpose of determining the most effective treatment for Vitamin D deficiency, specifically whether a very high single oral dose of Vitamin D could have adverse effects. This would be investigated via a clinical study in which postmenopausal, Vitamin D deficient women would be randomised to one of three different single oral doses of Vitamin D. Consent would be taken for the study.\nRecruitment via posters and screening emails to Trust and University staff has been lower than expected due to a low prevalence of Vitamin D deficiency in those who volunteered. The applicant is therefore requesting support in order to target recruitment to women who are known to have Vitamin D deficiency. The Sheffield Teaching Hospitals Clinical Research Systems Team would be asked to search the Sheffield Teaching Hospitals database for women over 55 with a recent low Vitamin D result. These women would have had a recent vitamin D measurement via their GP practice, which would be analysed in the STH laboratories. They would return a spreadsheet to the Research nurse via Trust email, containing the requested identifiable patient data. The research nurse would use this information to screen for eligibility and send an invitation letter to the GP practice, from where it would be forwarded to the potential participant. Any further contact would be initiated by the patient, and the data would be destroyed.\nA recommendation for class 3 and 6 support was requested to select and contact patients to seek their consent and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Northern General Hospital"]
["Contact Name","Mr Simon Bowles"]
["Address","Metabolic Bone Centre"]
[null,"Northern General Hospital"]
[null,"Herries Road"]
["Postcode","S5 7AU"]
["Telephone",1142714705]
["Email","sbowles1@sheffield.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women"]
["Description of confidential patient information used","Patient name, address, Date of Birth, GP practice and 25(OH)D result."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Northern General Hospital"]
["Status","Expired"]
[]
["Outcome Date","2016-09-23"]
["Next Review Date","N/A"]
["Notes","The application was to search a Trust database to access patient vitamin D (25(OH)D) levels from this database prior to consent in order to better target our recruitment strategy. A letter was sent to the GP who then send to patient if suitable.\n\nAll of this activity was undertaken and the ‘list’ destroyed. People becoming involved in the research as a result of this list/letter strategy would have consented to do so.\n\nMany potential participants would have been invited that wouldn’t necessarily have had access to the study through other routes.\n\nThis application was considered by the Confidentiality Advisory Group sub-committee meeting 09 September 2016.                                                                                                           1. Favourable opinion from a Research Ethics Committee. Confirmed 24 August 2016\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Version 13 published and reviewed as satisfactory."]

{"sheet":"A0212","index":161,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","0212"]
["Reference","17/CAG/0011"]
["Other Refs"]
["Application Title","Genetic Mechanisms in Polyposis of the Bowel"]
["Application Summary","This application from Cardiff University set out the purpose of medical research into colorectal cancer (CRC), which is one of the most common cancers worldwide, with over one million new cases diagnosed each year. There is a considerable heritable component which is important for correct diagnosis on the basis of a family pedigree or through molecular characterisation. This study will employ 'next generation' sequencing methodologies to identify mutations that may clarify the genetic mechanisms involved in polyposis of the bowel. The study involves both living and deceased patients - the application for support only relates to the deceased patient cohort, the living patients will be consented.                                                                                 The submission had been made to CAG for consideration of arrangements in relation to the deceased patient cohort. From original approval of the research project in 2012, the applicants were accessing the data of deceased patients with consent from the next of kin. The project had received the relevant ethical and R&D approvals on this basis. It was brought to light in January 2016; the Access to Health Records Act 1990 does not provide a legal basis for next of kin to consent to the review of medical information of deceased patients. Upon receipt of this confirmation, the applicants halted recruitment of deceased patients in order to make amendments to the procedures for accessing this information. A substantial amendment was submitted to the REC to establish legal basis to access the deceased patient’s information, which was approved. The application to CAG followed this REC approval."]
["Applicant Organisation Name","Cardiff University "]
["Contact Name","Laura Butlin, Research Coordinator"]
["Address","RF108, First Floor, Cancer and Genetics Building"]
[null,"School of Medicine, Cardiff University"]
[null,"Heath Park Way, Cardiff"]
["Postcode","CF14 4XN"]
["Telephone","02920 687 859"]
["Email","butlinla2@cardiff.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support relates only to the deceased patients with a clinical diagnosis of polyposis of the bowel (10 or more separate colorectal polyps) estimated to be a maximum of 20 deceased patients"]
["Description of confidential patient information used","Name – to identify clinical records, validation and linkage,\nDate of birth – to identify clinical records, validation and linkage                                                   Date of death – validation and linkage.\nThe above identifiers together with gender will be retained for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University "]
["Status","Supported"]
[]
["Outcome Date","2017-01-27"]
["Next Review Date","2025-01-27"]
["Notes","Amendment supported 16 December 2022  to continue to follow up the 5 deceased patients recruited under ‘s251’ support, until 31 August 2025, and to include their anonymous data into data repositories\n\n28 September 2021 -Amendment supported to extend the duration of support until 31st August 2022\n\n15 September 2020 - Amendment supported to change the Chief Investigator to Dr Hannah West.\n\n01 September 2020 - Amendment supported to extend the duration of the study until 31 August 2021.\n\n25 April 2019 - Amendment supported to extend the study duration from 31 August 2019 to 31 August 2020, in order to increase the likelihood of recruiting the required number of participants.\n\nSpecific Conditions of Support\n1. Support is only extended for the duration of the study, at which point, confidential patient information in relation to the deceased cohort should be destroyed. Should new information arise during the course of the study which would justify the onward retention of identifiable information, the applicants should return to the Committee with an amendment/new submission, as appropriate, for further consideration prior to the expiration of this application.\n2. Support to process confidential patient information without consent cannot be backdated and is only effective from the 27/01/2017.\n3. Support can only be extended to England and Wales                                 \nRecommendation\nIt was recommended that the applicants referred to the Welsh Language Act (1993) to ensure adherence to the specified requirements in relation to the provision of information in relation to patient or service users in Welsh centres.                                                                      "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A0213","index":162,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0213"]
["Reference","16/CAG/0146"]
["Other Refs"]
["Application Title","The Association Between HsTrop and Tachyarrhythmias: Type 1 or Type 2 MI? (STRIPE-MI)"]
["Application Summary","This application from University Hospital Southampton NHS Foundation Trust set out the purpose of improving the management of patients presenting with fast heart rhythms and troponin rise. These could be evidence of Type 1 myocardial infarctions (known as T1MI and defined as troponin rises related to an acute blockage of a heart artery) or Type 2 myocardial infarctions (known as T2M1 and defined as a troponin rise secondary to an increased oxygen demand or reduced oxygen supply). Improvements in testing of troponin levels had led to an increase in the diagnosis of T2MIs. The researcher had identified a dilemma for clinicians in the treatment of these conditions, which could mean unnecessarily invasive treatments being given to patients with T2MI who were being treated as T1MI patients.                                           The research team proposed to review case notes retrospectively to find out more about these conditions, assessing the proportion of patients presenting with fast heart rhythm who had T1MI versus T2MI and looking at the management of these cases to determine whether unnecessarily invasive treatments were being given.                                                            The review of case notes and all analyses would be undertaken by the patient’s usual care team; therefore the application to CAG did not concern this activity. The applicant would be requesting HES data to provide 90 day and 12 month status of patients recruited to the study, and this was the activity for which 251 support under the COPI Regulations was required."]
["Applicant Organisation Name","University Hospital Southampton NHS FT"]
["Contact Name","Professor Nick Curzen"]
["Address","D Level East Wing"]
[null,"Coxford Road"]
[null,"Southhampton"]
["Postcode","SO16 6YD"]
["Telephone",2381204972]
["Email","nick.curzen@uhs.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cardiovascular                                                                                                                Inclusion criteria:\nAdults aged ≥ 18 years\nAn assigned NHS number\nAdmitted to UHS between April 2014 to December 2015\nPrimary diagnosis of either arrhythmia (Atrial fibrillation, Atrial Flutter, Atrial tachycardia, SVT, or VT) or NSTEMI\nAt least 1 HsTrop level checked on admission."]
["Description of confidential patient information used","The study will use information on patient name, NHS number, date of birth, gender, co-morbidities, admission reason to hospital, data on whether the patient is alive over the follow up period (90 day and 12 months), and any further admissions to hospital over the follow up period. This information will be available via hospital records available on the patients and HES data. Neither patients nor their relatives will be contacted for the data required for the study."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-12-20"]
["Next Review Date","N/A"]
["Notes","Identifiers were removed and replaced with a numbering system.   The study is now complete with no further activity.\n\nThe data suggest that troponin-positive tachycardia is not a benign diagnosis and has a mortality rate similar to similar to Non-ST elevation myocardianl infarction.   Formal labelling as type 2 MI is rare in real-life practice.   More investigation into the detection and management of type 2 MI and troponin positive arrythmia patients is warranted. \n\nSpecific conditions of support\n1. Please consider improving transparency and public involvement around the study (please note that this is a recommendation only, and that support is not conditional on this point)"]

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[]
[]
["Application Number","0214"]
["Reference","16/CAG/0143"]
["Other Refs"]
["Application Title","Model fidelity of early intervention services for psychosis"]
["Application Summary","This application from a Phd student at McGill University in Canada, working in collaboration with early intervention teams in England set out the purpose of strengthening the existing evidence base for the effectiveness of early intervention (EI) in psychosis.                                     Research had shown that better long-term health and social care outcomes were associated with early care after the first episode of psychosis. However there were variations in outcomes, one cause of which could be how closely the actual intervention carried out with patients conformed to the intended programme (the ‘fidelity’ of the service model). This application concerned the development of a ‘survey-based fidelity instrument’ to measure this and thereby address a confounding variable in research on the effectiveness of EI services.                     The application described a 3-part study. Support from CAG was sought only for Part 1 – the development of the fidelity instrument – which would involve the researcher accessing patient data in EI teams to complete the instrument. It was confirmed that aggregated patient data (% of patients receiving a health service at the EI team) would be used, and that this data would not be used for any other part of the study.                                                                      Random samples of patient files would be obtained from each of the EI teams involved, comprising a percentage of patients seen by the team. Two Team managers/ Clinical leads from each team would also complete the instrument; reports would be compared for discrepancies and the instrument evaluated for reliability and validity. Data from this part of the study will be transferred to Canada. It was stated that this would involve aggregated data only.  The researcher had considered the alternative of funding a member of the direct care team to extract the information from the medical record, and was not able to fund this as part of the PhD - however an application to NIHR had been made, for this purpose. The NIHR application was concurrent with the CAG application, to ensure support for the activity if the funding bid was unsuccessful."]
["Applicant Organisation Name","McGill University"]
["Contact Name","Ms Miriam Kincaid"]
["Address","1020 Pine Ave. West"]
[null,"Montreal, Quebec"]
[null,"Canada"]
["Postcode","H3A 1A2"]
["Telephone","(+1) 613 889 0753"]
["Email","miriam.kinkaid@mail.mcgill.ca"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Employees of early intervention services for first-episode psychosis teams.\n(The medical records/files of patients with first-episode psychosis who\nattend the early intervention services will be accessed) Male & Females between 14-65yrs                                                       Data from EI services in relation to patient care and treatment.                                             Full medical records to be reviewed. No individual level patient data will be extracted/retained."]
["Description of confidential patient information used","Access was requested to patient’s medical records, to collect information on treatment by Early Intervention services."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-01-05"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in 2020 that support can be expired - All participant recruitment and data collection is complete for the study. The data collection aspects for the stage of the study covered by CAG approval ended on 5 October 2017. Remaining recruitment and data collection (involved staff only and did not require access to medical records without consent so not relevant to the CAG approval) was completed on  7 January 20\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 4 January 2017.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. It was agreed that as this was a multi-site study, the CAT would not ask for individual confirmation from each site. Support from CAG was given on the understanding that the researcher would comply with the IG toolkit in place at each site."]

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[]
[]
["Application Number","0215"]
["Reference","17/CAG/0015"]
["Other Refs"]
["Application Title","Antibiotic Reduction and Conservation in Hospitals (ARK-Hospital)"]
["Application Summary","This application from Oxford University Hospitals NHS Foundation Trust set out the purpose of a research project which will test whether a package of strategies can help doctors, nurses, pharmacists and patients stop antibiotics in hospital when they are no longer needed. The package includes internet-based training, standard systems to review patients, regular support from pharmacists/infection specialists, and materials for patients.\nThe applicants will test the package in one hospital to make sure that it is practical, which is classed as the feasibility study element. The implementation of the package will then extend to 1-3 more hospitals, testing how many people use it and improving the package as required during the internal pilot stage. Following these two stages, if specific criteria have been met, the package will then be implemented in 36 hospitals in total, which will be the main trial of the intervention.\nThe CAG were asked to consider a specific element of the proposal which was around the analysis of primary outcome measures, where the applicants will compare mortality and antibiotic use in patients admitted to general medicine before and after the introduction of the package, using data from electronic hospital records from admission to 90 days later. The project involved an additional qualitative element; however, this was fully consented and therefore outside the scope of the CAG considerations."]
["Applicant Organisation Name","Oxford University Hospitals NHS Foundation Trust"]
["Contact Name","Professor Timothy Peto"]
["Address","Level 8"]
[null,"John Radcliffe Hospital, Headley Way"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865221226"]
["Email","tim.peto@ndm.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The applicant’s estimated that the cohort will be in the region of 630,000 patients of whom approximately 30% would have been prescribed antibiotics. The cohort included all individuals being admitted to hospital as an adult within acute or general medical inpatients defined by specific admission codes (speciality code 300 for first consultant episode for an inpatient spell, or second consultant episode where the first consultant episode has speciality code 180, which relates to A&E admission). There will be 38 NHS Trusts included within the project."]
["Description of confidential patient information used","Date of death, Age, Gender, Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Expired"]
[]
["Outcome Date","2017-02-20"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed that ‘s251’ support could be expired as of August 2023, as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant does not have access to any means of re-identifying.\n\nIn terms of public benefit, the ARK tool kit was developed for widespread application across the NHS. The intervention was highly acceptable to clinicians and healthcare professionals including many consultants with huge collective experience. The trial found that introduction of the ARK tool kit reduced hospital antibiotic use in a sustained way. These findings pave the way for introduction of the ARK tools into clinical practice with the potential to reverse decades of rising antibiotic use in hospitals, leading to reductions in antimicrobial resistance over the longer term and benefits for patients in terms of continuing to preserve effective antibiotics for the future whilst ensuring that they get appropriate treatment today.\n\n\nAmendment supported 03 October 2022 \n\nTo extend the duration of ‘s25’1 support until 31 August 2023\n\nSpecific Conditions of Support\n\n1. Appropriate patient notifications and objection mechanism to be developed and reported back, together with an update on progress, at first annual review. The following points should be accounted for:\na. A generic poster should be produced for display in the participating hospitals to provide high level information about the project. This should sign-post interested readers to where more detailed and specific information can be found, i.e. participating Trusts websites,\nb. A study-specific op-out mechanism should be devised which will allow patients to register dissent for the data to be used in the project, should they die.\nc. Provide alternative communications methods, together with a study specific email account.\n2. Support is extended to the three project phases (feasibility, pilot and main trial); however, it was noted that any amendments to the study design which impacted on the CAG recommendations would need to be submitted for consideration before progressing to the main trial.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – South Central – Oxford C REC issued on 07/02/2017).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Oxford University Hospitals NHS Foundation Trust has a published reviewed score of satisfactory at 97% at Version 13, 2015/16)."]

{"sheet":"A0216","index":165,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0216"]
["Reference","16/CAG/0135"]
["Other Refs","16/CAG/0083"]
["Application Title","Use of MDCT aortic root assessment to determine valve"]
["Application Summary","This application from the St Georges University Hospitals Foundation Trust set out the purpose to improve the rates of Paravalvular leak (PVL) in Transcatheter aortic valve implantation (TAVI) by an improved sizing of the aortic annulus using Multi-slice Computed Tomography (MDCT).\nParavalvular leak (PVL) in Transcatheter Aortic Valve Implantation (TAVI) is frequent with moderate-to-severe PVL occurring in over 5% of cases. PVL is not well tolerated in patients with severe Aortic stenosis as the left ventricle is typically non-compliant from left ventricular hypertrophy. The researchers plan to perform detailed MDCT assessments of the aortic root and hypothesise that these detailed metrics will strongly predict PVL, and that they can be used to improve THV sizing and improve patient outcomes.                                              Patients will be identified from a local TAVI database. MDCT images for all patients over 18 years old who have undergone an MDCT study prior to TAVI at the hospital will be retrospectively examined along with baseline patient and procedural characteristics. It is estimated that around 100 patients will be involved in this study. Various aortic root and aortic valve measurements will be recorded. The researchers believe that the height and shape of the sinotubular junction as well as the intercommisural distance will strongly predict the development of PVL after TAVI. Patient identifiable data will only be used for data collection. Once collected, all data will be de-identified and assigned a unique study number, in particular, imaging data will be de-identified using a DICOM anonymiser tool which removes 34 pieces of potentially identifiable patient information. If the TAVI database is incomplete on patient characteristic information e.g. presence of hypertension, the researcher plans to access the medical records at St Georges Hospital.                                                                                                                             "]
["Applicant Organisation Name","St George's University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Stephen Brecker"]
["Address","Blackshaw Road"]
[null,"Tooting"]
[null,"London"]
["Postcode","SW17 0QT"]
["Telephone","02087253556"]
["Email","sbrecker@sgul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,"Y","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 patients who have undergone a MDCT study prior to TAVI"]
["Description of confidential patient information used","Name/ Hospital ID number/date of birth"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","St George's University Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-11-03"]
["Next Review Date"]
["Notes","Applicant confirmed in september 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the usage of the computer simulations developed in this project have been associated with improved clinical outcomes of TAVI in bicuspid aortic valve.\n\n\nSpecific conditions of support                                                                                             1. Patients should be able to opt out via email as well as by contacting researchers. Details of both methods should be given on the patient information sheets.\nAppropriately updated patient information sheets were provided on the 14 October 2016.\n2. Age should be retained in years and weeks, rather than the full date of birth.\nThis was confirmed by email sent 14 October 2016"]

{"sheet":"A0217","index":166,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","0217"]
["Reference","16/CAG/0132"]
["Other Refs"]
["Application Title","Mystical seizures and salience in temporal lobe epilepsy"]
["Application Summary","This application from Cambridge University Hospitals set out the purpose of investigating mystical or religious experiences in patients with temporal lobe epilepsy (TLE). The researcher aimed to understand the meanings people gave to these experiences and the influence of religious tradition or upbringing through interviews with patients, and through MRI and EEG to establish whether there was a universal neurological site or structure associated with these experiences. Four patient groups would be compared: three with various experiences of TLE, and one group of non-patients from religious backgrounds.                                                     The recruitment process would involve screening patient records for eligibility prior to sending invitation letters. Screening medical records was deemed necessary as the phenomenon of mystical experience in TLE was rare and under-reported, and recruitment by other methods would not enable the researchers to reach enough patients. A dedicated researcher employed for this purpose (Dr Tennant) would review records at the hospital site together with Dr Eriksson (a member of the clinical care team at the site). A record of the patient’s name, telephone number and cohort assignment would be kept on a laptop which would be taken off site and shared with Dr Coles (the Chief Investigator). Invitation letters would be sent from the patient’s clinical care team. The record would be pseudonymised if the patient subsequently consented to the study, or destroyed if they did not consent."]
["Applicant Organisation Name","Addenbrooke's Hospital, Cambridge University"]
["Contact Name","Professor Alasdair Coles"]
["Address","Clifford Albutt Building, Level 4"]
[null,"Cambridge Biomedical Campus"]
[null,"Cambridge"]
["Postcode","CB2 0AH"]
["Telephone",1223762016]
["Email","ajc1020@medschl.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Inclusion Criteria:                                                                                                              a) Adults aged 18 and older.\nb) Established diagnosis of an epileptic disorder with partial seizure, with associated psychic auras relating to mystical experience (Cohort A).                                                                                            For controls:                                                                                                                      a) Adults aged 18 and older.\nb) An established diagnosis of epilepsy with pre-ictal or ictal emotional auras (Cohort B), established diagnosis of an epileptic disorder with seizure focus similar to patients in Cohort A but lacking mystical experiences (Cohort C), or religious participants with no history of neurological disease (Cohort D).                                                                                    Exclusion Criteria:\na) Patients with post-ictal psychosis.\nb) Patients who do not have the capacity to consent to be involved in the study (as assessed by criteria laid out in the\nMHA code of practice, section 4 (MCA, 2005))\nc) Patients with a history of substance abuse.\nd) Patients with significant cognitive impairment.\ne) Patients who unable to understand and communicate in English such that impedes the participant giving their\ninformed consent."]
["Description of confidential patient information used","The name and history of epileptic auras of patients are required for recruitment of participants with mystical seizure experiences. These data will only be used to identify patients who may fit into one of the study's research cohorts; once patients agree to participate a full list of what data we will use for analysis will be presented to them for their informed consent. Should patients not wish to participate, their data will not be accessed from hospital records again.                                                               "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-10-11"]
["Next Review Date","N/A"]
["Notes","Information has been retained only for those patients who have given written consent for us to do so, under the protocol IRAS 202899 and 16/LO/1328\n\nAt conferences, we have disseminated advice to neurologists seeing people with epilepsy that poor compliance [and therefore risk of seizures leading to harm] may be due to the religious content of seizures.\n\nThe CAG agreed that the minimum criteria under the Regulations appeared to have been met and that there was a public interest in projects of this nature being conducted."]

{"sheet":"A0218","index":167,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","0218"]
["Reference","16/CAG/0126"]
["Other Refs","REC: 16/LO/1154, IRAS:186097"]
["Application Title","Intraoperative hypotension in elder patients"]
["Application Summary","This application from University College London set out the purpose of preventing avoidable harm to patients over 65 years as a result of low blood pressure during operations. The study would record how often low blood pressure occurs in older patients having surgery, how long it persists for and how anaesthetists treat the problem.\nPatients would be identified by local investigators who were NHS anaesthetic department staff, and therefore able to access operating theatre lists as part of their clinical role. All patients over 65 undergoing surgery would be identified from the list and included in the study, unless they had expressed dissent as a result of posters in the department explaining the study. Consent would not be sought in order to avoid excluding those who were severely ill and unable to consent, which would bias the results given that this group was most at risk from complications due to low blood pressure. Data would be recorded by the local investigator on a paper case report form and anonymised apart from the retention of the patient’s gender and hospital ID number. The hospital ID number would be kept with the form on site for 30 days and used to identify the patient after surgery, when surgery outcome data would be recorded. The hospital ID number would then be removed, but gender retained. The data set would be transferred from the paper case report form to a secure encrypted online portal (REDCap) which is managed by RAFT and hosted by NHS Scotland. Local sites would be asked to retain a link between the study number and the hospital number. Once collated, the anonymised data from each site would be transferred to UCL data safe haven for final analysis and data storage.\n"]
["Applicant Organisation Name","Royal Free London NHS Foundation Trust"]
["Contact Name","Dr Daniel Martin"]
["Address","Department of Anaesthesia"]
[null,"Royal Free Hospital"]
[null,"London"]
["Postcode","NW3 2QG"]
["Telephone"]
["Email","daniel.martin@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Low blood pressure during surgery (intraoperative hypotension)                                              Inclusion criteria:\n- Aged >65 years\n- Underwent general anaesthesia or regional anaesthesia either alone or in combination in an operating theatre.\n- Emergency and elective surgery"]
["Description of confidential patient information used","The information being collected about patients is routinely documented as part of normal care.\n- Patient identifiable information: gender and hospital number.\n- Patient information: age group, presence of cardiovascular disease, use of medicines for high blood pressure.\n- Surgical information: the urgency and severity of surgery, whether the surgery is for cancer and surgical speciality.\n- Anaesthesia information: the grade of most senior anaesthetist present, anaesthetic management, whether the\npatient had a regional anaesthetic block (e.g. epidural).\n- Blood pressure information: how it was monitored, values before and during surgery and how it was treated.\n- Outcome information: in hospital death, presence or absence of myocardial infarction, kidney injury or stroke."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2016-09-28"]
["Next Review Date","N/A"]
["Notes","REC Acknowledged Study Closure on 12/5/2017\n\nPurpose of the Amendment 09/12/2016\nThe purpose of the amendment is to update the study dates specified in the application to bring the protocol in line with actual data collection. The amendment seeks to extend the study period from an initial 2 week window (48 hour recruitment period still in place) to a 10 week period. This has been deemed a non-substantial amendment by REC/HRA so does not require an additional REC review.                                                                                                         Further to the letter of 23 September 2016, the CAT team clarified that support from CAG was given for access to the anaesthetic record and surgery outcome data only. The information transferred from hospital sites via the REDCap system did not come under CAG approval as the only identifier to be retained was gender, which was not considered to be identifiable data in this context."]

{"sheet":"A0219","index":168,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","0219"]
["Reference","16/CAG/0121"]
["Other Refs"]
["Application Title","Epidemiology of Cancer after solid organ transplantation"]
["Application Summary","This application from University Hospitals Birmingham set out the purpose of investigating mortality from cancer following organ transplantation, and comparing clinical outcomes between the transplant and the non-transplant population. There was an increasing prevalence of cancer post-transplantation; further evidence would guide and inform clinical management and counselling for patients.\nCancer data is not routinely collated by transplant centres. In order to answer the research questions, the applicant proposed to link information from various national data resources, via the HSCIC/NHS Digital. This would include the UK Transplant Registry (mandated to collect information from all UK transplant centres), HES and ONS data, the UK Renal Registry and the General Practice Extraction Service (GPES). Identifiable data with NHS number and study number would be sent by the UK Transplant Registry, UK Renal Registry and National Cancer Intelligence Network to HSCIC/NHS Digital. This would be linked with HES, ONS and GPES data and de-identified and pseudonymised data would be returned to the applicant, with a patient study number allocated for follow-up. Study data would be destroyed at the end of the study."]
["Applicant Organisation Name","University Hospitals Birmingham"]
["Contact Name","Dr Adnan Sharif"]
["Address","Department of Nephrology and Transplantation"]
[null,"Queen Elizabeth Hospital"]
[null,"Edgbaston, Birmingham"]
["Postcode","B15 2WB"]
["Telephone",1213715861]
["Email","adnan.sharif@uhb.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All solid organ transplant recipients in England since April 2001 will have data extracted and will be analysed in an anonymised fashion. It is important to include children as cancer-related mortality is also very common in children and the spectrum of cancers seen differ in children versus adults. Therefore, specific analysis looking at children would be beneficial for the paediatric solid organ transplant population."]
["Description of confidential patient information used","We will be seeking data on time to death (time between transplantation and death) as an important outcome for survival analyses. In addition, we will be seeking data on ethnicity as part of important demographic data collection.\nNo other confidential or sensitive patient information will be used.\nNHS numbers will NOT be received by study investigators but used only by HSCIC for data linkage purposes.\nSee: 03 May 2019 – Amendment in Notes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2016-10-06"]
["Next Review Date","2024-10-06"]
["Notes","29 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - General Practice Extraction Service (GPES), Hospital Episode Statistics, (HES) and civil registration - deaths\n\n\n03 May 2019 – Amendment supported to increase the items of confidential patient information disclosed to NHS Digital for linkage purposes to include date of birth, gender and postcode alongside NHS Number. The amendment also requested a change of processor for the study analysis to University of Birmingham, which involved the transfer of an anonymised dataset only. \n\nAmendment (Approved - 10/10/2017)\nThe applicant had requested data from 2001 to the present day, as this was the period from which HES data was available. However they now wished to include earlier data (from 1985) found on the UK Transplant Registry and the National Cancer Registry, despite the fact that it could not be linked with HES data. This would allow more long-term survival analyses and changes in survival rates over previous decades to be analysed.\nThe study had not yet commenced. The applicant would update the patient notifications accordingly.\n\nSpecific conditions of support                                                                                             1. Please confirm that the contact for further information and opt out will be visible and accessible on the BTS website. Confirmed 5 October 2016."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02120","index":169,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02120"]
["Reference","16/CAG/0120"]
["Other Refs"]
["Application Title","Transcranial direct current stimulation impact on therapy"]
["Application Summary","This application from the University of Manchester set out the purpose of identifying participants for a study to determine whether tDCS (Transcranial direct current stimulation) can enhance the beneficial effects of behavioural speech and language therapy for aphasia (word finding difficulty after brain damage – in this case due to stroke).\nTo help with recruitment, the researcher proposed to screen patient discharge records (no longer accessed by the clinical care team as the patient was discharged) to identify patients who met the inclusion criteria for Phase 2 of the study, and send them an invitation letter. The medical record would be accessed at the hospital site and no identifiable information retained by the researcher. Formal consent would then be obtained from those who contacted the researcher to express an interest."]
["Applicant Organisation Name","School of Psychological Sciences                                                                                  Neuroscience and Aphasia Research Unit (NASU)"]
["Contact Name","Miss Margaret Sandars"]
["Address","Zochonis Building (Floor 3)"]
[null,"Brunswick Street"]
[null,"University of Manchester"]
["Postcode","M13 9PL"]
["Telephone",1613060451]
["Email","margaret.sandarssmith@manchester.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Female participants between 40-85                                                                  Study 1 - Single, unilateral left hemisphere stroke resulting in aphasia\nStudy 2 - Single, unilateral left hemisphere stroke resulting in persistent (>\none year) aphasia\nStudy 3 - Progressive aphasia resulting from atrophy to anterior or posterior\nlanguage areas, diagnosed at least one year ago.                                                                All participants must be native English speakers and right handed (to reduce variability in language localisation).\nThey must have normal hearing and normal or corrected-to-normal vision.                       Participants in study 1 must have damage to anterior or posterior language areas, caused by a single, unilateral left hemisphere stroke within the last 6 weeks.\nIn the second study, participants must have damage to these areas caused by a single, unilateral left hemisphere stroke occurring at least a year ago.                                               In study 3, participants must have progressive aphasia with anomia resulting from atrophy to anterior or posterior language areas, diagnosed at least one year ago.                       Participants in all studies must have anomia, as evidenced by their failure to name a number of the (circa 430) original screening items (at least 80 for study 1, 240 for study 2 and 120 for study 3) and must succeed in naming at least 20 of the screening items to ensure that they can complete and benefit from the therapy provided in the studies."]
["Description of confidential patient information used","Patient records held in paper form within the speech and language therapy department at Salford Royal Hospital relating to patients discharged between 6 months and 5 years ago will be accessed by the researcher in order to identify individuals who had a single stroke and were discharged from the speech and language therapy service with ongoing aphasia and who are currently at least 1 year post-stroke. Information sought for each patient will comprise:\nmedical diagnosis, speech and language therapy notes, full name and full address."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","The University of Manchester"]
["Status","Expired"]
[]
["Outcome Date","2016-10-17"]
["Next Review Date","N/A"]
["Notes","The study did not commence, as the study team were not able to gain access to the patient files they needed, and hence recruited to the study via other avenues (predominantly community groups).\n\nSpecific conditions of support                                                                                          1. Please advise which method you will use to ensure you do not contact any patients who are deceased.\nThe following response was received via email on 12 October 2016:\n‘After the researcher has identified potential participants from the discharge records, she will ask the speech and language therapy department administrator to access the Patient Centre system to check whether or not these individuals are recorded as deceased.\nThere remains a small possibility that the researcher will inadvertently make contact with patients who have passed away. As previously stated, these situations will be handled with the upmost sensitivity and a note will be placed on their records to avoid any future communications being sent out by others. The administrator will also be advised so that the Patient Centre system can be updated.'"]

{"sheet":"A02121","index":170,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02121"]
["Reference","16/CAG/0113"]
["Other Refs"]
["Application Title","The access to and outcomes of elective joint replacement surgery for patients with long-term conditions: a study using PROMs and administrative data."]
["Application Summary","This application from London School of Hygiene and Tropical Medicine set out the purpose of improving care provided to patients with long term conditions (LTCs). The study would use PROMS, HES and ONS mortality data to investigate variations in access to, and outcomes of, hip and knee replacement surgery for patients with different LTCs. This would include the comparison of PROMs and HES data, to assess the reliability and validity of identifying LTCs, and comparison of post-surgery outcomes for patients with different LTCs.\nData from patients who have undergone hip and knee replacements, and also participated in the PROMs programme, will be linked by HSCIC and provided in pseudo-anonymised form to the research team. A unique pseudonymised HESID will be used by the HSCIC to link the datasets. The team will also receive identifiable data from ONS mortality records in order to look at serious complications in hip and knee replacements for patients with long term conditions. Patients participating in the PROMS programme gave explicit consent for their data to be their data to be collected, used for research and linked with other data – however this consent does not extend to the use of identifiable mortality data."]
["Applicant Organisation Name","Phd Student/ Research Fellow"]
["Contact Name","Ms Belene Podmore"]
["Address","15-17 Tavistock Place"]
[null,"London"]
[]
["Postcode","WC19SH"]
["Telephone",7881596310]
["Email","belene.podmore@lshtm.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study population will be patients who have undergone a hip or knee replacement surgery and who have participated in the PROMs programme from April 2009 (programme start date). Patients will be excluded if they do not have a linked HES episode for their PROMs procedure.                                               Qualitative (WP2)\nHealthcare professionals who have the responsibility for referring or selecting patients for hip or knee replacement surgery (e.g. GPs, orthopaedic surgeons) who work in the NIHR CLAHRC North Thames geography. A diverse sample will be selected according to professional experience, geography and type of provider (e.g. tertiary, teaching, district hospitals)."]
["Description of confidential patient information used","Access was requested to date of death, gender and ethnicity.                                                  The majority of the data requested from HSCIC is data from the Patient Reported Outcomes Measures dataset (PROMS) and Hospital Episode Statistics data(HES) but no indicators have been requested that are patient identifiable. The only sensitive patient information is date-of-death data from ONS Mortality data to look at severe complications for patients who have undergone a hip and knee replacement surgery."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Expired"]
[]
["Outcome Date","2016-10-06"]
["Next Review Date","N/A"]
["Notes","Legal entity holding the data: Royal College of Surgeons of England \n\nThe linkage between patient-reported outcome measures and the Hospital Episode Statistics was carried out by NHS Digital. NHS Digital provided an anonymised extract to the RCS. NHS Digital (or its successor organisation) has access to the patient identifiers for these data as part of their wider remit as the main national NHS data provider. \n\nThe linked anonymised HES-PROMS database is kept on the RCS secure data environment, meeting all standard required to hold national anonymised health data. \n\nThe data that we gained access to with support under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 (‘Section 251 support’) were used to support, either directly or indirectly, the production five peer-reviewed papers: \n1: Podmore B, Hutchings A, Skinner JA, MacGregor AJ, van der Meulen J. Impact of comorbidities on the safety and effectiveness of hip and knee arthroplasty surgery. Bone Joint J. 2021 Jan;103-B(1):56-64. doi: 10.1302/0301-620X. \n2: Podmore B, Hutchings A, Konan S, Robson J, van der Meulen J. Access to hip and knee replacement surgery in patients with chronic diseases according to patient-reported pain and functional status. BMC Health Serv Res. 2020 Jul 1;20(1):602. doi: 10.1186/s12913-020-05464-3. \n3: Podmore B, Hutchings A, Konan S, van der Meulen J. The agreement between chronic diseases reported by patients and derived from administrative data in patients undergoing joint arthroplasty. BMC Med Res Methodol. 2019 Apr 24;19(1):87. doi: 10.1186/s12874-019-0729-5. \n4: Podmore B, Hutchings A, Durand MA, Robson J, Konan S, van der Meulen J, Lynch R. Comorbidities and the referral pathway to access joint replacement surgery: an exploratory qualitative study. BMC Health Serv Res. 2018 Oct 3;18(1):754. doi: 10.1186/s12913-018-3565-0. \n5: Podmore B, Hutchings A, van der Meulen J, Aggarwal A, Konan S. Impact of comorbid conditions on outcomes of hip and knee replacement surgery: a systematic review and meta-analysis. BMJ Open. 2018 Jul 11;8(7):e021784. doi: 10.1136/bmjopen-2018-021784. PMID: 29997141; PMCID: PMC6082478. \n\nThese recent papers have attracted 106 citations (Google Scholar). \n\nAnalysis of these data was also a key component of a successful PhD project: Podmore, Bélène. The access to and outcomes of elective hip and knee replacement surgery for patients with comorbidities: a study using PROMs and administrative data. Diss. London School of Hygiene & Tropical Medicine, 2019, available here: https://researchonline.lshtm.ac.uk/id/eprint/4653866/\n\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 3 August 2016.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed via email from NHS Digital, 11 August 2016"]

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[]
[]
["Application Number","02122"]
["Reference","16/CAG/0096"]
["Other Refs"]
["Application Title","Therapeutic Assessment (TA) of Adolescents Presenting with Self Harm versus Standard Psychosocial Assessment and Risk Management. Randomised Controlled Trial Long-term Follow Up."]
["Application Summary","Self-harm (SH) in young people who come into contact with mental health services in England is currently assessed under an information gathering and risk management framework. The follow up non-attendance (DNA) rate in child psychiatry has been estimated to be up to 70% and therefore the SH assessment appears to be a lost therapeutic opportunity.\nThe TOTAL trial was conducted to identify if a novel Therapeutic Assessment (TA) method had the potential to improve treatment engagement and presentations to emergency services in adolescents who self-harmed compared to standard care services. A medium-term follow up of this trial demonstrated sustained improvement in treatment engagement in adolescents who received TA versus Assessment As Usual (AAU), following an emergency presentation with self-harm. However, no significant differences in the frequency of self-harm leading to Accident and Emergency presentations were observed between the two assessment procedures over the two year study period.\nThis application from King's College London set out the purpose of investigating whether these results still apply or if the improved engagement leads to changes in A&E presentations and mortality at 6 and 10 year time points post randomisation.\nParticipants' clinical and mortality records will be reviewed at 6 and 10 years after the initial randomisation. Records will be sourced from a) CAMHS and AMHS electronic patient records within South London and Maudsley Trust, and b) A&E records of the index patients using HES-ONS linked data. The procedures for each at 6 and 10 year time points will be as follows:\na) Data on the absolute number of appointments attended after initial assessment, the number of missed appointments, episodes of self-harm not leading to A&E presentation, and the proportion of the adolescents who continued to self-harm will be collected by a KCL research worker employed on the research study, who will have access to the trust's electronic patient journey system. This data shall be obtained using patients' NHS numbers from the original study. All relevant data will be inputted into a separate database which will be kept within SLaM's secure server until data collection is complete (maximum one month). Once completed, the database shall be transferred and kept securely under KCL's secure server for analysis.\nb) Data on the total number of A&E presentations for self-harm and other reasons, mortality rates and reasons for death will be obtained via the HES Data Access Request Service. HES-ONS linked data shall be requested once at the 6 year time point and again at the 10 year time point using NHS identifiers. This data shall be collected externally by the Health and Social Care Information Centre and anonymised using the linked study identifiers. Once completed, the database shall be transferred, combined with EPJS data, and kept securely under KCL's secure server for analysis."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Dennis Ougrin"]
["Address","Child and Adolescent Psychiatry Department"]
[null,"Institute of Psychiatry"]
[null,"PO85 De Crespigny Park"]
["Postcode","SE5 8AF"]
["Telephone","02078480957"]
["Email","dennis.ougrin@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Females between 18 and 28                                                                              Data will be collected from the same sample of patients (N= 69). The inclusion criteria for the RCT were as follows:\n• Age 12- 18 (inclusive)\n• Presentation with self-harm\n• Referral for a CAMHS assessment"]
["Description of confidential patient information used","1. Frequency of A&E presentations for self-harm and other reasons\n2. Mortality data"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","King's College London (Research Management)"]
["Status","Expired"]
[]
["Outcome Date","2016-12-29"]
["Next Review Date","N/A"]
["Notes","03 June 2021 - Support expired\nApplicant confirmed exiting support by email 3 June 2021.\n\nApplicants no longer retain any identifiable data, and have written up a paper which should be published in due course.\n\n07 August 2020 - Amendment to share the pseudonymised data set with University of Leeds (UoL) ReducIng Self-Harm in Adolescents: Individual Patient Data meta-analysis (RISA-IPD) research team is supported.\n\nSpecific Conditions of Support                                                                                             1. Confirmation that this study will be limited to the linkages at 6 and 10 years.\na. Confirmed in correspondence dated 26 July 2016.\n2. Provision of outcome of satisfactory PPI, as set out in the previous outcome letter dated 21 July 2016.\na. The applicants provided an overview in correspondence dated 26 July 2016 explaining how current patients involved with the Supported Discharge Service (SDS) had subsequently contributed to the application. Members were satisfied with the level of patient engagement described by the applicants.                                                                                               3. Provision of suitable patient notification materials together with a description of how these will be disseminated, as detailed in the previous outcome letter dated 21 July 2016.\na. The applicants provided a patient notification poster for review and provided evidence of communications with Service Directors within Adult Services in the South London area which provided details of the trial and requested that the poster was made visible within their service area. Members discussed the content of the poster and agreed that this was a sufficient tool to meet the dissemination criteria previously specified."]

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[]
[]
["Application Number","02124"]
["Reference","16/CAG/0094"]
["Other Refs"]
["Application Title","Reducing misdiagnosis and antibiotic prescribing practices in hospitals: a case series review and qualitative study of diagnosis, management and treatment of urinary tract infections in adults aged over 70 years."]
["Application Summary","This application from University Hospitals Birmingham NHS Foundation Trust set out the purpose of investigating urinary tract infection (UTI). UTI is the second most common clinical reason for antibiotic treatment in primary and secondary care. The NICE quality standard for the diagnosis of UTIs for adults over 65 years states that diagnosis and treatment should be based on a full clinical assessment. However, clinicians have highlighted that these guidelines are not always followed in hospitals and that, in particular, urinary dipsticks (reagent strip tests) are commonly employed inappropriately or in isolation, leading to high rates of false positive results. An estimated 40% of cases of UTI in over 65 year olds are misdiagnosed, leading to over-prescribing of antibiotics. This has detrimental consequences to the patient and contributes to the emergence of antibiotic resistance.                                                        There are three components to the research:\nPart A – a retrospective case series review of 500 patient records to extract all data from patient admissions to eventual diagnosis / discharge pertaining to the diagnosis of the UTI. Funding has been secured to recruit a research nurse to undertake this review. The nurse will be employed by the NHS / Sponsor organisation however they are not or were not part of the patient’s care team. Data extracted will be recorded anonymously on an electronic case report form (e-CRF). No identifiable data will be shared with the core research team at Loughborough University. No identifiable data will be taken off Trust premises.\nPart B and C of the overall activity relate to interviews with clinicians (doctors, nurse and healthcare assistants) and patients. Support was not requested for these components and these were excluded from consideration by the CAG."]
["Applicant Organisation Name","University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham"]
["Contact Name","Dr Beryl Oppenheim"]
["Address","Consultant Microbiologist"]
[null,"Birmingham"]
[]
["Postcode","B15 2TH"]
["Telephone","01213716523"]
["Email","beryl.oppenheim@uhb.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from Birmingham Community Healthcare NHS Foundation Trust & the ROYAL WOLVERHAMPTON NHS TRUST in relation to 500 70+ year old patients, admission to either hospital site from January 2015 to June 2015, who have been diagnosed with a urinary tract infection."]
["Description of confidential patient information used","Whilst no identifiable data will be extracted, the researcher will have access to name, postcode, NHS number, date of birth, date of death, & any other identifiers contained in the notes.\nFrom patient records, data will be extracted on:\nVariables relating to urinary tract infections: date of admission, reason for admission, hospital ward/department, routine observations on admission, urine dipstick tests performed, urine microbiology results, clinical signs and symptoms of urinary tract infection, catheterisation (if yes, details of catheterisation), antibiotics prescribed for UTI, significant co-morbidities (up to four), other medications, date of discharge. This information will be recorded for the complete duration of the patient's stay in hospital from admission to discharge.\nIndividual and socio-demographic variables for identifying risk factors for UTI: age, gender, ethnicity, first language, independent living accommodation, history of falls, area of deprivation (derived from partial postcode data).\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Birmingham Community Healthcare NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-10-14"]
["Next Review Date","N/A"]
["Notes","Support was requested for a research nurse who was not part of the direct care team to have incidental access to case notes.   No identifiers were collected.   The case note review was completed in June 2017.\n\nThe study highlighted conflicting and unclear diagnostic pathways for urinary tract infection (UTI) that likely contribute to over-diagnosis. Urine tests are implemented routinely, rather than being used to confirm signs and symptoms of a UTI. In this patient group of elderly adults, routine dipstick testing and a reliance on urine microbiology may be unhelpful in guiding diagnostic decision-making which requires good clinical assessments.\n\nSpecific conditions of support                                                                                             1) Appropriate and clear patient notification materials to be provided on the website. This must have a clear and readily accessible mechanism to enable patient objection to be respected. To utilise existing PPI involvement to also disseminate patient notification materials.                    2) The research nurse to convert the sector level postcode to an area deprivation index at the point of extraction. Sector level postcode data will not leave the NHS site. Age of death only will be recorded. The research nurse will code the ward at the point of extraction, and only the ward code will be captured on the eCRF.                                                                                     3) Support relates only to this pilot activity. Should the applicant wish to extend or develop the pilot aspect, this would require a new application or should seek to use an alternative legal basis"]

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[]
[]
["Application Number","02125"]
["Reference","16/CAG/0093"]
["Other Refs"]
["Application Title","British Paediatric Surveillance Unit (BPSU) study of deaths in children with epilepsy aged under 16 years in the UK and the Republic of Ireland."]
["Application Summary","This application from the Institute of Child Health at University College London set out the purpose of providing important information regarding the number of deaths in children under 16 years of age with epilepsy in the UK. There is very little information regarding the extent of the problem and a prospective pilot study is much needed, to determine the size of the problem of death in children affected by epilepsy, to compare the differences between sudden unexplained death in epilepsy (SUDEP) and other causes of epilepsy deaths, and to allow future studies in this field.                                                                                                                 Epilepsy is a common condition, affecting more than 500,000 people in the UK. This means that almost one in every 100 people has the condition. It mainly affects the brain and causes repeated 'fits' or seizures. Epilepsy can start at any age, but it most often begins during childhood. It is very rare for a child to die from a seizure. However, studies have shown that people with epilepsy, including children and young people, have a higher risk of death than people without epilepsy. Death in a child with epilepsy may be due to a number of causes, including sudden unexplained death in epilepsy (SUDEP). SUDEP is defined as death for no obvious reason in a person with epilepsy, and it is hard to predict.\nUsing the BPSU ‘orange card’ reporting system, all Consultant Paediatricians in the UK and Republic of Ireland will be asked on a monthly basis to report all cases of deaths they have seen in children with epilepsy aged 16 years and under that meet the surveillance case definition (see section A17-1 and A17-2). The BPSU will subsequently inform the research team of the details of all clinicians who report a case. The research team will request the reporting clinician to complete a brief questionnaire using routinely collected information from the child’s medical record. The questionnaire will seek clinical data relevant to the study objectives (see sections A10 and A11) and limited patient identifiable data will be required to inform the analysis and identify duplicate cases. Patient identifiable information collected for the purposes of case verification and prevention of duplication only will be destroyed once this process has been completed. Questionnaire paper records will be stored in such a manner that the front sheet containing patient identifiers will be stored separately from clinical data sheets, in two separate locked cabinets and linked only by unique BPSU study case code."]
["Applicant Organisation Name","Institute of Child Health"]
["Contact Name","Professor Alastair Sutcliffe"]
["Address","Population, Policy and Practice Unit"]
[null,"30 Guilford Street"]
[]
["Postcode","WC1N 1EH"]
["Telephone","0207902367"]
["Email","a.sutcliffe@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Female children between 1-16 with epilepsy who have died.                            Inclusion criteria:                                                                                                                 The child must have had seizures or been treated with antiepileptic medication within the last 5 years.                                                                                                                            The International League Against Epilepsy defines it as a condition where two unprovoked seizures occur more than 24 hours apart (Knowlton et al). Epilepsy may be diagnosed in two additional circumstances: one unprovoked seizure plus a 60% or higher likelihood of additional seizures in the next 10 years (e.g., a patient who experiences a single seizure a month after having a stroke has a 60% or higher risk), or the presence of an epilepsy syndrome (e.g. a 13-\nyear-old patient presenting with a first convulsive seizure who has an electroencephalogram consistent with juvenile myoclonic epilepsy)                                                             Exclusion criteria:\n- Children under 28 days of age and greater than 16 years of age (include up to to their 16th birthday).\n- Children without a diagnosis of epilepsy.\n- Children who have not had seizures or been treated with antiepileptic medication in the last 5 years."]
["Description of confidential patient information used","The following limited patient identifiable data will be obtained for the purposes of identifying duplicate reporting of cases:                                                                                                                                  Date of birth\nLocal hospital number\nNHS/CHI number\nEthnicity\nSex\nPartial post code (first 4 digits only)                                                                                                The date of birth will be used to accurately calculate the age of the child at presentation to the hospital, these\nidentifiers will be destroyed at the end of the data collection period once duplicate cases have been identified and once the age calculations have been made."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","UCL - Institute of Child Health"]
["Status","Expired"]
[]
["Outcome Date","2016-09-19"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that support for this project can be ended.\n\nSpecific conditions of support\n1. Participant Information Sheets to include information on how to opt out of this use of data. Updated participant information sheets were provided and approved by the Sub-Committee on 19 September 2016"]

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[]
[]
["Application Number","02128"]
["Reference","16/CAG/0088"]
["Other Refs"]
["Application Title","A feasibility randomised controlled trial of mechanical chest compression devices for in-hospital cardiac arrest."]
["Application Summary","In the UK, 35,000 patients have a cardiac arrest in hospital each year. Less than one in five of these patients survives to leave hospital. Chest compressions are an essential treatment for cardiac arrest patients, but are often difficult for a person to deliver to a high standard (manual chest compressions). A mechanical chest compression device can be used to deliver chest compressions (mechanical chest compressions) instead of a person. Small studies suggest using these devices may improve patient survival when used as part of treatment for cardiac arrest patients in hospital. This application from the University of Warwick set out the purpose of conducting a feasibility study over a period of two years. 330 patients that have a cardiac arrest will participate. After initial treatment has been started (including manual chest compressions), patients will either continue to receive manual chest compressions or they will receive mechanical chest compressions. The treatment will be decided randomly. All patients will receive all other necessary treatments.                                                                          CAG support is requested for the following activities:\n1) To continue to collect data, post-mortem, for those participants who die before consent or advice can be obtained from the patient or their consultee (as appropriate).\n2) To continue to collect data, post-discharge, for those participants who were discharged from hospital before consent or advice can be obtained from the patient or their consultee (as appropriate) where there is no response to communications regarding dissent to data use. The site research team will make up to three contact attempts. This group is estimated to form <0.5% of all study participants."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Dr Keith Couper"]
["Address","Clinical Trials Unit"]
[null,"Warwick Medical School"]
[null,"Coventry"]
["Postcode","CV4 7AL"]
["Telephone","+44 (0) 2476151179"]
["Email","k.couper@warwick.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from Heart of England NHS Foundation Trust & University Hospitals Coventry and Warwickshire in relation to 330 patients that have a cardiac arrest and are treated in the trust."]
["Description of confidential patient information used","The following patient information will be collected for data validation:                                        Name\n NHS number\n Hospital number\n GP details\n Date of birth\n Gender                                                                                                                      Access was also requested to cover the processing of data from Heart of England NHS Foundation Trust and University Hospitals Coventry and Warwickshire to the University of Warwick for analysis.\n Age (not date of birth)\n Date of death\n Gender                                                                                                                           Age is required to describe the patient population that participated in the study. Date of death is required to enable the researchers to calculate the period between key events during the patient's hospital stay.                                                                                                           The researchers will collect limited sensitive patient information about the patient's physical health. The researchers will only collect data that is directly relevant to the participant's cardiac arrest. In particular, the researchers will collect information on the participant's relevant past medical history, details of their hospital admission, details of the cardiac arrest event, details of hospital care following the cardiac arrest event and participant survival, and neurological recovery.  This information will be collected by the NHS staff at the research site. They will collect research data from the participant's medical records and other NHS sources (e.g. computer records). All identifiers (excluding date of death and age, where applicable) will be removed from the dataset before it is transferred to the University of Warwick for analysis. Other than this the University of Warwick will not receive any identifiable data, except where the specific consent or advice has been gained for this (as part of the broader study, for which CAG support is not sought).  In addition, access was requested to cover the transfer of data from Heart of England NHS Foundation Trust and University Hospitals Coventry and Warwickshire to GP surgeries, and from GP surgeries to Heart of England NHS Foundation Trust and University Hospitals Coventry and Warwickshire for those participants who fall into group 2), above. This would be to:\n Check survival (as an outcome measure and to ensure that the research team do not cause unnecessary distress to the participant’s relatives).\n Confirm contact details where these are uncertain (to enable the research team to contact the participant following discharge)."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Warwick"]
["Status","Expired"]
[]
["Outcome Date","2016-10-10"]
["Next Review Date","N/A"]
["Notes","Application expired with effect from 31/12/2018\n\nAmendment - Approved (03/08/2017)\nThe amendment request was for the addition of a site which would also process identifiable data, as above.\nThe site named was Blackpool Teaching Hospitals NHS Foundation Trust.\n\nAmendment - Approved (31/08/2017)\nThe amendment request was for the addition of a site which would also process identifiable data, as above.\nThe site named was South Warwickshire NHS Foundation Trust.\n\nSpecific conditions of support                                                                                              1. Justification for the processing and retention of date of death, if this cannot be replaced with fact of death or some other less identifiable information. The following response was received via letter dated 31 August 2016:\n‘We plan to undertake a time-to-death analysis (Kaplan-Meier survival). This is an essential analysis that is required to help answer our research questions. Date of death is required to undertake this analysis.\nThe retention of the date of death data-point for ten years following study completion is required for data validation purposes in accordance with Good Clinical Practice guidelines’.\nThe Sub-Committee considered this information. Members accepted that this analysis did require full date of death.\n2. Provision of information as to how enquiries from the family members of individuals who die before advice or consent (as appropriate) can be sought will be managed. A response to this was included in the+B21 letter sent 31 August 2016:  ‘As detailed in our application, we do not plan to actively inform the family members of deceased study participants. However, in the spirit of openness, we do plan to place information about the study in the public domain (e.g. hospital newsletters).\nIn the event that family members approach the research team at the hospital site regarding their family members possible study participation, they will be informed whether or not their relative did participate in the study and they will be provided with verbal information about the study. If required, a participant information leaflet will be provided.\nOur default position is that we will retain and use all data where the participant has died before consent or advice can be sought. This is to prevent bias in results. However, in the event that this approach is unacceptable to the participant’s family, we will seek advice (e.g. PPI representatives) as to the most appropriate course of action on a case-by-case basis. This will include consideration of removing data from the study analysis. We expect such events to be extremely rare, given our experiences in other studies.’  Members considered this response and agreed that there were ethical issues around communications with the family members of deceased patients. CAG members were happy to accept this response subject to favourable opinion from the REC, and reassurance that the information to be placed in the public domain included details of how to contact the research team.\n3. Detail of the process whereby notification and opt out will be managed for those participants who were discharged from hospital before consent or advice can be obtained from the patient or their consultee (as appropriate).\n4. Provision of patient notification and opt out materials for those participants who were discharged from hospital before consent or advice can be obtained from the patient or their consultee (as appropriate). The following response to both this point and to point 3 was given in the letter sent on 31 August 2016:\n‘We expect this to be a very rare event given:\nOur sample size of 330 participants,\nThe high expected study mortality (less than 15% are expected to be discharged alive from hospital),\nThe robust effort that site research staff will make to approach participants before they are discharged from hospital. (See final approval letter for futher information on specific conditions and exclusions. "]

{"sheet":"A02131","index":175,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02131"]
["Reference","16/CAG/0080"]
["Other Refs"]
["Application Title","The LBIH Biobank"]
["Application Summary","This application from the University of Liverpool set out the purpose to identify potential donors to the Liverpool Biobank Hub (LBIH). Currently the Liverpool Tissue Bank has ethical approval for the collection and storage of tissue (and blood) that has been removed at the time of a procedure and is in excess of that required for diagnostic purposes. The aim of the Tissue Bank is to create a resource of tissues (and other biological material) with relevant clinical information to be made available for the research community to address specific questions relating to a disease condition. All existing tissue/data held within the Tissue Bank has been collected only when patients have given their informed consent to do so. Samples are anonymised at the time of banking by Tissue bank staff and are given a unique code. When samples are released researchers are given the Tissue bank code only. Only Tissue bank staff can link the original patient data with the Tissue bank code. Access to the database is strictly confined to tissue bank staff.  Currently potential donors are identified by a member of the clinical care team usually at the time of outpatient clinic appointments or inpatient admissions. The identification is performed using patient medical records, multidisciplinary team meetings, admissions lists, outpatient lists and directly by the clinical team providing care. Potential donors are first approached while they are attending scheduled outpatient clinic appointments or inpatient admissions. The initial approach to the patient regarding the Tissue Bank are made by a member of the clinical care team directly involved in the patient's care. The patients are given a patient information leaflet and consent form describing the work of the Tissue Bank and what donation would involve for the patient. The consent is taken by a member of the clinical care team. This is the optimal method of approach.  However the LBIH would now like to extend the collection to other areas where the clinical team do not have the time/ personnel to make the initial identification and approach. In these cases Consultant surgeon's secretaries will compile clinic/ operating lists and circulate them to clinical staff. At this point, the lists will also be circulated to a dedicated technician in the Biobank (it is envisaged that a different technician will be assigned to each collaborating NHS Trust). The Biobank team will then approach the potential participants for consent. The clinic/ operating list will then be deleted by the technician. No information about patients that do not consent to the biobank will be retained."]
["Applicant Organisation Name","The University of Liverpool"]
["Contact Name","Mrs Rhiannon Clarke"]
["Address","Department of Molecular and Clinical Cancer Medicine"]
[null,"3rd Floor Apex Building, Institute of Translational Medicine"]
[null,"Liverpool"]
["Postcode","L7 8TX"]
["Telephone","01517064503"]
["Email","Rhiannon.Hughes@liverpool.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Potential donors will be first approached while they are attending scheduled outpatient clinic appointments or inpatient admissions by a member of the clinical care team directly involved in the patient's care. The patient will be given a patient information leaflet and consent form describing the Tissue Bank and what donation would involve. If the patient agrees to consent to donate tissue, a sample will be taken which is surplus to diagnostic requirements and\ntransferred to the Tissue Bank for processing and storage.                                                         Most research relates to the understanding, diagnosis of and treatment of cancer."]
["Description of confidential patient information used","Access was requested to identifiable data including name, hospital number, NHS number, and date of birth from operating lists to the biobank technician"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-01-05"]
["Next Review Date","N/A"]
["Notes","23 November 2020 – Support no longer required\n\nSpecific conditions of support                                                                                                               Please confirm that the request for retention of tissue will be sent out in letter addressed from the consultant clinician involved in the direct care of the patient. Confirmation received that technicians will approach potential patients on ward or clinic to take informed consent."]

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[]
[]
["Application Number","02132"]
["Reference","16/CAG/0063"]
["Other Refs"]
["Application Title","aTTom-Extended: Extended follow-up of patients enrolled in the Adjuvant Tamoxifen Treatment - Offer More? (aTTom) trial"]
["Application Summary","The aim of the aTTom: adjuvant Tamoxifen Treatment offer more? Trial (MREC (1) 97/34, ISRCTN17222211) was to determine if taking tamoxifen for 10 years compared with the standard of 5 years improved overall survival and disease free survival. The preliminary analysis of the primary outcome measure was performed in 2013 and presented at the American Society for Clinical Oncology (ASCO) (http://meetinglibrary.asco.org/content/112995132).\nThe result demonstrated that taking tamoxifen for 10 years is superior to 5 years in reducing breast cancer recurrence and, probably, mortality.\nHowever, as the reductions in breast cancer mortality only emerge after 10 years, even longer follow-up is needed to assess how large the benefits are and to monitor safety (incidence of new primary tumours, in particular endometrial cancer and non-cancer mortality.                             It is entirely possible that the incremental improvements will continue longer term. Therefore it is important that follow-up  continues  for these patients to ensure the full impact on overall survival is understood.  This application seeks to extend the aTTom study, and to continue the follow up of the participants enrolled into the aTTom clinical trial (MREC (01)97/34) obtaining mortality data from the Office of National Statistics. Additionally approval is sought to conduct a translational sub study to validate diagnostic tests using tissue blocks from the patients previous randomised into the aTTom clinical trial (Trans aTTom - Sub study of aTTom Extended)  \n"]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Dr Daniel Rea"]
["Address","Institute of Cancer and Genomic Sciences"]
[null,"CR-UK Clinical Trials Unit"]
[null,"Edgbaston, Birmingham"]
["Postcode","B15 2TT"]
["Telephone","0121 4145345"]
["Email","D.W.REA@bham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Breast Cancer Patients.  Approval  is sought to use this data without retrospectively seeking consent from the aTTom clinical trial participants.\n8863 participants were enrolled in the aTTom clinical trial. These participants will be followed up within aTTom- Extended. Approximately 4500-5000 participants will be involved in the translational sub study Trans aTTom.\n"]
["Description of confidential patient information used","The following data will be requested from the Office for National Statistics via HSCIC:\n- Date of death\n- Cause of death\n- Date of Cancer diagnosis\n- Site of Cancer\nThe following personal data is used for identification of the patient by HSCIC\n- Full name\n- Date of Birth\n- NHS Number\n- Hospital ID Number\n- Address\n\nAnalysis; date of birth, date of death and post code at sector level\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Birmingham"]
["Status","Supported"]
[]
["Outcome Date","2016-07-08"]
["Next Review Date","2024-07-08"]
["Notes","Specific conditions of support                                                                                              1. Revised patient notification and patient and public involvement plans Received 06/07/2016"]

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[]
[]
["Application Number","02133"]
["Reference","16/CAG/0061"]
["Other Refs"]
["Application Title","Childhood Disintegrative Disorder Surveillance Study"]
["Application Summary","This application from a Guys and St Thomas NHS Foundation trust set out the purpose to investigate the causes of Childhood Disintegrative Disorder (CDD). Childhood Disintegrative Disorder (CDD) is a rare condition where a previously normal child very rapidly, sometimes even over a few days, loses intellectual and developmental skills. Children then stop communicating and playing with other children, and cannot look after themselves, often resembling a severe form of Autism. Approaches to investigate and manage this condition vary between clinicians, leading to confused messages to parents and carers, adding to the distress already encountered from grieving the loss of a previously healthy child. In the study of such a rare condition, it is important to ensure that case ascertainment is maximised (in order to accurately calculate incidence), and reporting bias is minimised in order to ensure the results accurately reflect the true nature of the condition and its current management.                                       To begin to unravel such rare conditions, the researchers first require knowledge on the number of new cases of CDD per year, the true spectrum of children with such presentation, how they are investigated and cared for, and crucially, their outcome. This project intends to undertake a 13-month surveillance study to determine incidence of CDD in children aged 2 years to 9 years 11 months 30 days, and a 1-year and 2-year follow-up study of this cohort, utilising the infrastructure of two established and highly successful national surveillance units (British Paediatric Surveillance Unit and Child and Adolescent Psychiatry Surveillance System) to identify and acquire such information. The BPSU and CAPSS offices operate a system of sending out a reporting card to all Consultant Paediatricians (BPSU) and Consultant Child and Adolescent Psychiatrists (CAPSS) on a monthly basis. The clinician \"ticks\" a box if they have seen a child with that condition that month, and returns the card to the BPSU/CAPSS office who then send the contact details of the reporting clinician on to the study team. At no time does the BPSU/CAPSS office receive any patient identifiable data. The study team then contact the reporting clinician directly and request a questionnaire is completed (attached document). The questionnaire is designed such that the front page containing minimal identifiers can be detached from the remaining pages containing the clinical research data. For the 1-year and 2-year follow-up, further data collected will include: functional status; extent of recovery if any, or indeed deterioration (short-term outcome); and confirmation of whether alternative diagnosis was reached.                                                                                       The onset of CDD is characterised by typically dramatic loss of skills in a previously healthy child - each case is likely to have contact with many health professionals over the course of their investigation and initial management, including several Consultants. As such one individual case may be reported to the study team by several individuals, and accurate de-duplication of cases is likely to be necessary. Once de-duplication has taken place, each dataset will be entered onto the secure password-protected database and be allocated a unique study identifier/number; the NHS number will therefore not be recorded electronically alongside the data to be analysed. At this stage, ages will be calculated and documented; therefore date of birth will not be recorded electronically alongside the data for analysis. The data will then be analysed anonymously."]
["Applicant Organisation Name","Evelina London Children's Hospital"]
["Contact Name","Dr Michael Absoud"]
["Address","Children's Neurosciences"]
[null,"St Thomas' Hospital, London"]
[null,"London"]
["Postcode","SE1 7EH"]
["Telephone","02071884665"]
["Email","michael.absoud@gstt.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","2 years to 9 years 11 months and 30 days.\nCDD is a condition that presents in childhood, most often between ages 3-6 years; it is imperative to capture data at the onset of the disorder to accurately reflect the range of presentation of the disorder, current investigative and management approaches, and short-term outcome.                                                                                                                               All data will be gathered from the patient's clinician through a questionnaire (using minimal identifiable data), and so there is no contact with the patient or family throughout the course of the study.\nIt is not anticipated that the participants will be burdened or put at risk in any way; usual patient care will continue to be provided by the patient's clinician."]
["Description of confidential patient information used","NHS number and Hospital number for de-duplication of cases and data linkage. Gender, ethnicity and date of birth will be used for analysis of data by demographics."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor","Guy's & St Thomas' Foundation NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-10-25"]
["Next Review Date","N/A"]
["Notes","The CI has confirmed that the study is closed, findings are currently being written up and section 251 support is no longer required. \n\nSpecific conditions of support                                                                                             1. Please provide information of PPI group’s views on the issue of whether this study should be conducted through a consented model.\nThe letter dated 28 August 2016 provided anecdotal evidence of views provided though patient involvement.\n2. Please provide further justification why consent is not possible. The letter dated 28 August stated that in rare conditions such as this one, there was a need for complete ascertainment as even a few refusals could distort the evidence with regards to incidence and outcome. In addition to this it was explained that consent would be a difficult topic to raise with patients, given that CDD is a devastating diagnosis that can only be confirmed after a lengthy process of excluding other more treatable conditions. There was likely to be a significant risk of losing cases if consent were required.                                                                                           3. The public information leaflet must be revised to reflect that identifiable information is disclosed outside the care team.\nA revised information leaflet was submitted and approved by the Sub-Committee."]

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[]
[]
["Application Number","02134"]
["Reference","16/CAG/0060"]
["Other Refs","IRAS project ID: 201398, REC reference: 16/NE/0146"]
["Application Title","The Two Week Wait (2WW) study - an investigation of patient non-attendance at urgent referral appointments for suspected cancer"]
["Application Summary","This application from the Department of Health Sciences at the University of York set out the purpose to investigate the reasons for non-attendance at clinical appointments as part of the two week wait process of referrals for suspected cancer as well as to identify interventions to improve timely access to urgent care.  Since 2000, NHS patients with suspected cancer have been guaranteed to see a hospital specialist within two weeks of the GP requesting an urgent referral - a Two Week Wait (2WW) appointment. This policy intended to shorten time to diagnosis and treatment, and ultimately improve survival rates. However, a significant minority of patients are not seen within two weeks, largely due to patients not attending, cancelling or postponing the appointment. Despite audit data identifying the scope of the problem, reasons for patients not attending or cancelling are unknown and no current studies have been identified which are examining this issue.                                                                                            This study will be completed in five phases:                                                                                 Phase 1 - Categorisation of patients not seen within two weeks of referral drawing on Leeds NHS Hospital Trust data for approximately 6,000 patients in 2014 and 2015.                             Phase 2 - Analyse variation in factors between patients who postpone or cancel their appointment, and those who do attend, to identify predictors of non-attendance. This will use cross-sectional analyses within the same data set as Phase 1.                                                Phase 3 - Compare rates of cancer diagnosis (and cancer stage at diagnosis) in attending patients with those who postpone, cancel or do not attend to assess the significance of non-attendance. Health outcome data for patients referred in 2009 will be analysed 1,2,3,4,5 and 6 years later and 1 year later for patients referred in 2014. This data will be compared to similar data from attending patients.\nPhase 4 – Explore the views of patients and GPs as to why patients do not attend 2WW appointments and interventions to improve attendance.                                                                 Phase 5 – Gain consensus from GP and patient stakeholder groups on the top 3 proposed interventions to improve attendance rates.  The quantitative research in phases 1-3 requires access to non-identifiable, routinely collected patient data via the Leeds Hospital Trusts’ Patient Pathway Manager (PPM). The researcher will have access to a limited view of PPM which has been created by the PPM informatics team at the study hospital site using a previously agreed study template. Anonymised medical events and outcomes will be accessed. Consent will not be sought given that this is routinely collected and anonymised data as part of a patients care, and thus not patient identifiable. The quantitative researcher will be based at the study hospital site under the supervision of the PPM informatics team at all times whilst accessing the study data set. The quantitative researcher (Rebecca Sheridan) will then work alongside these teams to pull the relevant data to a separate research database to conduct analysis from.  Potential patient participants for Phases 4 and 5 will also be identified via the PPM system by the data teams at SJUH following a non-attendance without reason for a 2WW referral for suspected cancer. The research team are the only holders of all the information and expertise to purposively sample the potentially eligible patient participants who should then be approached by their GP to take part in the interview. In addition, data on whether the GP practice with whom the individual eligible patient is registered, has been collected by the research team. Potentially eligible patients for Phase 4 interviews will be identified via their routine hospital records shortly after the patient's non-attendance at their urgent 2WW appointment for suspected cancer. This will be carried out by NHS staff that have the relevant permissions to routinely access and manage this data. Confidential, minimal identifiable patient data regarding eligible patients will be transferred to the research team at the University of York on a weekly basis to capture patients who have not attended their appointment within the last 7 days. On receipt of this information, each potential patient will be checked against study eligibility criteria by the research team who will then notify participating GP practices of a newly identified eligible patient. Eligible patients will then be approached in the first instance by a personalised invitation letter and study recruitment pack from their GP. Due to the practical constraints to follow-up of non-responding eligible patients by their GP or GP practice, the GP invitation letter will inform the patient that a nominated, experienced researcher will contact the patient within 7-14 days to discuss the study in more detail (if a signed consent form has not already been received by the research team expressing the patient's wish to take part in the study or to not take part in the study). Eligible patients will also be made aware that, subject to their consent, the researchers would like to collect data on their cancer status toward the end of the study. Data linkage with the National Cancer Registration Service would be completed in collaboration with the informatics team at Leeds Hospital Trust to prevent unintended access to non-anonymised data. Eligible patient participants have the option to withhold consent for collection of their cancer outcome data on the consent form whilst still taking part in the study.\n"]
["Applicant Organisation Name","University of York"]
["Contact Name","Dr Peter Knapp"]
["Address","Seebohm Rowntree Building, Area 4"]
[null,"Heslington"]
[null,"York"]
["Postcode","YO10 5DD"]
["Telephone","01904321675"]
["Email","peter.knapp@york.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Suspected Cancer. Data from patients not attending a two week wait scheduled appointment within 7 days captured on the Leeds Hospital Trust Patient Pathway Management System."]
["Description of confidential patient information used","NHS number, name, date of birth, postcode at the unit level, contact telephone number, registered GP, GP practice and patient postal address."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of York"]
["Status","Supported"]
[]
["Outcome Date","2016-10-31"]
["Next Review Date","2018-10-31"]
["Notes","Amendment Request (Approved 15/03/18)\nThis amendment requested an extension in the duration of support up to 31 October 2018. The applicants had experienced issues with recruitment which had caused delays with the proposal.\nAmendment Request (Approved 12/12/16)\nThe amendment requested a change to the recruitment process in connection with the qualitative interviews outlined within phase four of the project. The existing support only allowed for the applicants to make contact with patients if the individual was registered to a GP practice which had consented to be involved in the study; however, the applicants confirmed that they had limited uptake from GP practices and as such potential patient participants were being missed.\nThe amendment requested approval to change the recruitment procedure in connection with the GP practice recruitment and it was noted that the patient recruitment procedure would remain the same. The amendment requested support to allow the applicants to be provided with the GP practice details (not the patient details) should a patient be identified as eligible in all respects aside from the their GP practice having consented to participate in the study. The GP practice would then be provided with a personalised and targeted invitation in the hope of improving the recruitment rates and enabling approach to eligible patients.                                                 Specific conditions of support                                                                                                1. The consent form should be separated into two sections one to confirm consent and the other to confirm that the patient would not like to be contacted again. Confirmed 11/07/2016\n2. The letter should be amended to provide clarity that not all boxes need to be initialled.\n3. The letter should be amended to not mention cancer explicitly. Confirmed 11/07/2016\n4. Confirmation that patient information about those who dissented would be excluded from the information passed back to the hospital and not provided to the researcher or justification as to why this was required. Confirmed 11/07/2016.                                                                       5. The applicant was asked to confirm whether linkage would be undertaken by the informatics team or the researchers. Confirmed 11/07/2016\n6. GPs should be asked to consider the best way to approach patients either with letter or by phone-call based on their personal knowledge. If this was not possible the applicant was asked to provide a strong justification why not. Confirmed 11/07/2016\n7. The applicant was asked to consider further public engagement on the first phases of the project and whether GPs could be consulted on the recruitment process. Confirmed 11/07/2016"]

{"sheet":"A02135","index":179,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02135"]
["Reference","16/CAG/0049"]
["Other Refs"]
["Application Title","National cohort study of late effects of Hodgkin lymphoma treatment"]
["Application Summary","This application from the Institute of Cancer Research set out the purpose of the proposed study was to investigate the range of long- term late-effects of treatment in young women with Hodgkin Lymphoma (HL), in order to provide better information for patients and for decisions on treatment and follow-up.  This study will collect and analyse treatment and follow-up data on women treated for HL across England and Wales at ages ≤35 years during 1956-2010.  This application was to expand an existing national cohort study, which has collected cohort data on 5,000 women with HL. The cohort would be doubled in size to include HL patients with a wider range of treatments and more-recent patients, in order to increase the power, especially for less-common and more-recent treatment types, and would extend the range of morbidity and mortality outcomes examined.  The existing cohort was the largest and most powerful worldwide on treatment-related effects in HL, and has already produced several key publications on this. By expanding the cohort the aim was to improve understanding of late-effects of different treatment alternatives, of longer follow-up periods (important because these patients are treated young, with good survival), expand greatly the range of long-term effects for which rigorous data are available, and draw implications for treatment choice and personalised follow-up and screening schedules.  The principal aim of this study was to improve understanding of the risks of the wide range of long -term fatal and nonfatal morbidities in women treated for HL at young ages in relation to their treatment, and to create a unique risk profile of incidence and severity of multiple long- term co morbidities, in order to enable clinicians and patients to understand patients’ personalised risk profile when deciding on and consenting for treatment, and when managing follow-up and screening for late-effects.  "]
["Applicant Organisation Name","Institute of Cancer Research"]
["Contact Name","Professor Anthony J Swedlow"]
["Address","15 Cotswold Road"]
[null,"Sutton"]
[null,"Surrey"]
["Postcode","SM2 5NG"]
["Telephone","02087224012"]
["Email","Anthony.swerdlow@icr.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort size 10,000 [5,000 from the original study and 5,000 to be added in this study)             To collect and analyse treatment and follow-up data on women treated for HL across England and Wales at ages ≤35 years during 1956-2010."]
["Description of confidential patient information used","Data from;\nCancer registries, case notes, electronic records and clinical databases at hospitals, and existing cohort data that ICR Hold.\nPatient's demographic details: name, NHS number, date of birth, address.\nDiagnosis, including cancer diagnosis and dates of diagnosis, treatments and dates of treatments.\nDate and cause of death.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","The Institute of Cancer Research"]
["Status","Expired"]
[]
["Outcome Date","2016-05-23"]
["Next Review Date","N/A"]
["Notes","This application was superseded on 29 December 2023 by 24/CAG/0021\n\n15 December 2021 – Amendment supported\nAmendment supported to change the controller of the application from the Institute of Cancer Research to the Royal Marsden Hospital NHS Foundation Trust.\n\nSpecific conditions of support                                                                                               1. The applicant must signpost patients to the patient information available on the website and make information available via other means e.g. via GPs or support groups. Progress should be reported at the annual review stage. Confirmed 27/04/2016\n2. Scope of support covers the new aspects of the study as outlined in the application including the future data processing of data from the original cohort of 5,000 along with the new cohort of 5,000. It does not extend to the collection of the data of the original 5,000. Applicant accepted 27/04/2016."]

{"sheet":"A02136","index":180,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02136"]
["Reference","16/CAG/0033"]
["Other Refs"]
["Application Title","The Fenland Study - Phase 2"]
["Application Summary","This application from the University of Cambridge set out the purpose to understand\nthe causes and contributing factors of type 2 diabetes to inform effective public\nhealth policies.  Phase one of the Fenland study took a snap shot of participant’s biological &\nphysical health as well as dietary habits. Phase 2 of the Fenland study would allow\nthe researchers to see any changes in these over time and see how lifestyle,\ngenetic and environmental factors interact. The specific aim of this study is to recall\nparticipants of the Fenland Study for a follow-up assessment.  In order to ensure the most up to date contact information for the Fenland Study participants’ information from the Personal Demographic Service provided by the Health and Social Care Information Centre (HSCIC) will be used to validate the current contact information. This will assist in ensuring that invites to take part in this study are sent to the correct address or that an invite is not sent at all in the event that a participant has deceased since last contact. It is feasible that some of the participants may be pregnant at the time of their Fenland Study visit. Given the inclusion of a DEXA scan within the study visit the applicant will therefore ensure that any pregnant or potentially pregnant participant does not undergo a DEXA scan. Participants may either choose to defer their study visit until after pregnancy or to simply omit the DEXA scan from their study visit.  All participants from phase 1 who agreed to be re-approached for future research\nare eligible for phase 2. Participants will undergo a thorough health check at one of\nthree testing facilities in Cambridgeshire. This includes collection of blood samples,\nan oral glucose tolerance test, height, weight, hip & waist measurements, blood\npressure reading, an ECG (electrocardiogram), body fat distribution using\nultrasound and Dual Energy X-ray Absorptiometry (DEXA), and a fitness test.\nParticipants will also fill in a questionnaire assessing dietary and activity behaviours,\nas well as health & lifestyle elements. Following the visit participants will wear\nphysical activity monitors to establish energy expenditure and activity in a free living\nenvironment for 7 days. The follow up phase is expected to last up to 5 years.  "]
["Applicant Organisation Name","MRC Epidemiology Unit, University of Cambridge\nWork Address School of Clinical Medicine"]
["Contact Name","Professor Nick Wareham"]
["Address","Box 285, Institute of Metabolic Science"]
[null,"Cambridge Biomedical Campus"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223330315"]
["Email","nick.wareham@mrc-epid.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Investigations into the interaction between genetic, lifestyle and environmental risk factors that\nmay contribute to the development of common metabolic diseases, such as diabetes and obesity. Male and Female participants between 35 and 75.  All of the Fenland Study participants who consented to further contact will be approached with an invite to participate in\nthe follow-up (corresponds to 99.9% of the cohort)"]
["Description of confidential patient information used","NHS number\nGP practice code\nSurname\nForename\nAddress\nPostcode\nDate of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge School of Clinical Medicine"]
["Status","Expired"]
[]
["Outcome Date","2016-04-13"]
["Next Review Date"]
["Notes","Applicant confirmed in June 2023 that ‘s251’ support can be expired, as confidential patient information provided to the MRC Epidemiology Unit at the University of Cambridge from NHS Digital (now NHS England) have now been deleted and data destruction notice provided to NHS England.\n\nIn terms of public benefit, ‘s251’ support has enabled the Fenland Study team to send out invitations to more participants thanks to having up to date contact details and has significantly increased the number of participants that have been able to take part. As a result of being able to contact more participants with help from the List Clean Service, the follow up rate in Phase 2 was higher and researchers now have more data (and thus greater statistical power) coupled with greater representativeness. \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 07/04/2016\n2. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed 22/03/2016."]

{"sheet":"A02137","index":181,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02137"]
["Reference","16/CAG/0032"]
["Other Refs"]
["Application Title","Analysis; NHS No, date of birth, date of death, post code, gender, occupation ethnicity, Marital status, Next of Kin, Skin Colour. [relevant for indication of cancer risk]."]
["Application Summary","This application from The Christie NHS Foundation Trust set out the purpose of this application to establish a database of patients who have undergone surgery for various types of skin cancer at The Christie NHS Foundation Trust (The Christie) from 2002 to March 2016. This includes primary melanomas, basal cell carcinomas (BCCs), squamous cell carcinomas (SCCs) and Merkel cell carcinomas.  This database will build on current databases at The Christie to be used for research. There is currently a Melanoma Database for Medical and Clinical Oncology at The Christie, this does not include surgical-related clinical fields. Therefore the proposed database would focus on collecting data from surgical patients only, from 2002 to 2016. The aim is to incorporate the 'CoNCuR database with the current melanoma database from 2016 onwards. This joint melanoma database will encompass medical and clinical oncology, translational medicine and surgical data for The Christie.  The proposed database will provide follow-up data and more complete data that will positively complement the existing database. It was anticipated that this would also support future research and data collection more efficiently and successfully for future patient benefit.                                                                               1. The assigned data manager, or scientific officer, to extract patient identifiable data from the electronic hospital systems, medical case notes and GP letters into the Christie Skin Cancer Surgery Research (CoNCuR) database.\n2. The assigned data manager, or scientific officer, to then separate the patient identifiable data within the database into separate tables which will be connected by a Unique Code.\n3. To permit the disclosure of data to the HSCIC for the purpose of linking with the HES database."]
["Applicant Organisation Name","The Christie NHS Foundation Trust"]
["Contact Name","Mr Deemesh Oudit"]
["Address","Wilmslow Road"]
[null,"Manchester"]
[]
["Postcode","M20 4BX"]
["Telephone","01614463375"]
["Email","oudit.deemesh@christie.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Population base:\nThe population base will include patients who have undergone surgery for various types of skin cancer at The Christie NHS Foundation Trust (The Christie) from 2002 to March 2016.                   This includes primary melanomas, basal cell carcinomas (BCCs), squamous cell carcinomas (SCCs) and Merkel cell carcinomas.                                                                                                            Selection criteria:\nThe selection criteria will be for collecting surgical related data from January 2002 to March 2016 on:\n- All new melanoma referrals classified as stage 1 to 3 and\n- Any patients that had surgery for melanoma at The Christie NHS Foundation Trust."]
["Description of confidential patient information used","The confidential patient data that will be stored is:\n- Patient initials\n- Patient address\n- NHS number\n- Hospital number\n- GP registration\n- Date of birth\n- Date of death\n- Gender\n- Postcode (full)\n- Ethnicity\n- Skin colour\n- Occupation\n- Marital status\n- Next of Kin."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2016-06-21"]
["Next Review Date","2017-06-21"]
["Notes","Specific conditions of support                                                                                              1. Confirm that use of NHS number will not be kept for analysis purposes and date of birth and date of death are to be reduced to month and year or provide justification why these fields are needed. Confirmation received these data (date of birth & death) will be reduce to month and year and NHS number to be removed.19/05/2016.                                                                   2. Update the patient literature and consent materials to make it clear to the retrospective members of the cohort that this was a research database, that it was intended to hold the data in perpetuity and that other researchers will be allowed access to it. Confirmation that the same materials are to be used for both cohorts. Members requested that the literature must be updated to make it clear to the retrospective cohort members that their data was being processed for this project. An update and draft materials must be provided at the first annual review.\n3. Clarify what will happen to the identifiably data when it is separated from other data and provide a clear exit strategy and time frame for this. Clarification provided 19/05/2016; consent will support the exit strategy, data will be anonymised into the CoNCuR database.  "]

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[]
[]
["Application Number","02138"]
["Reference","16/CAG/0027"]
["Other Refs"]
["Application Title","Estimating the burden of complications of gastrointestinal infections."]
["Application Summary","This application from a student at the Department of Primary Care Health Sciences at University of Oxford in fulfilment of a PHD set out the purpose to estimate the burden of gastrointestinal disease and risk factors associated with severity/complications amongst individuals diagnosed with Campylobacter, non-typhoidal salmonellas (NTS) or verocytotoxin producing Escherichia coli (VTEC).  In order to select the cohort (approximately 300,000 people), the applicant will choose all those with a confirmed laboratory report of Campylobacter, NTS and VTEC from 2009-2014 from Public Health England’s (PHE) laboratory reports. This cohort will then be linked to primary care data using the Clinical Practice Research Datalink (CPRD) and linked to secondary care data using the Hospital Episode Statistics (HES) data, to the Office of National Statistics (ONS) mortality file on deaths registration and linked to the English Index of Multiple Deprivation (IMD).  Linkages will allow the common complications seen in primary care, to be quantified, the severe and rare complications seen in secondary care (hospitals) and registered deaths, as well as to quantify the volume, type and healthcare costs associated with such complications. It will also allow the measurement of risks associated with treatment."]
["Applicant Organisation Name","Department of Primary Care Health Sciences"]
["Contact Name","Ms. Oluwaseun Esan"]
["Address","New Radcliffe House"]
[null,"Observatory Street"]
[null,"Oxford"]
["Postcode","OX2 6GG"]
["Telephone","+44(0)1865 289283"]
["Email","oluwaseun.esan@phc.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with a diagnosis of gastrointestinal infection as a result of infection with Campylobacter, Non-typhoidal Salmonella and Verocytotoxin producing Escherichia coli (VTEC).                                                                                                                            Cases: all patients including children under the age of 16 with a laboratory confirmed report of Campylobacter spp.,non-typhoidal Salmonella or verocytotoxin producing Escherichia coli between 1st January 2009 and 1st January 2014.\nControls: Individuals including children under the age of 16 registered at CPRD-registered general practices who do not have a confirmed laboratory report of Campylobacter or Salmonella or Escherichia coli infection between 1st January 2009 and 1st January 2014."]
["Description of confidential patient information used","Linkage of PHE data to CPRD, HES and ONS mortality is sought by using NHS number. Where NHS number is missing, Date of Birth, Name and Postcode will be used to link data. Date of death recorded in HES will be validated against date of death recorded in ONS deaths registration. Full postcode is also required for linkage to IMD-10 overall score and the individual domains. Data linkage will be carried out externally to members of the research team. Linked\ndata files made available to the research team will contain no patient identifiable data."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Expired"]
[]
["Outcome Date","2016-11-09"]
["Next Review Date","N/A"]
["Notes","All identifiers have been deleted.\n\nThis work provided the basis for the following peer-reviewed publication and the related systematic review below.\nEsan, O.B., Perera, R., McCarthy, N., Violato, M. and Fanshawe, T.R., 2020. Incidence, risk factors, and health service burden of sequelae of campylobacter and non-typhoidal salmonella infections in England, 2000–2015: A retrospective cohort study using linked electronic health records. Journal of Infection, 81(2), pp.221-230.\nEsan, O.B., Pearce, M., van Hecke, O., Roberts, N., Collins, D.R., Violato, M., McCarthy, N., Perera, R. and Fanshawe, T.R., 2017. Factors associated with sequelae of Campylobacter and non-typhoidal Salmonella infections: a systematic review. EBioMedicine, 15, pp.100-111.\n\nSpecific conditions of support                                                                                                    1. Reasonable and proportionate effort should be made to be transparent about the study including opportunity for individuals to opt out. Please provide evidence that this has been explored. This should include notification on the University website at a minimum.\nThe applicant responded in an email that the opportunity to opt out was advertised on the study webpage with a notice period of 2 months, providing a link to the webpage.\nThe Chair of the Sub-Committee reviewed the response and confirmed that the minimum requirement had been met."]

{"sheet":"A02139","index":183,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02139"]
["Reference","16/CAG/0026"]
["Other Refs"]
["Application Title","Does adding a facilitated behaviour change intervention improve outcomes among people with recently diagnosed type 2 diabetes receiving intensive treatment in General Practice? The ADDITION Plus 10 year follow up study."]
["Application Summary","This application from the University of Cambridge set out the purpose to understand\nthe effect of intensive treatment of multiple risk factors in the course of diabetes.  People with diabetes have an increased risk of developing cardiovascular disease (heart attack or stroke). However, there can be a delay between the onset of diabetes and a person experiencing symptoms, making it difficult to detect early.  If people with diabetes were found earlier in the disease trajectory and treated before symptoms developed, the risk of them suffering from an early death or cardiovascular disease would be reduced.                                                     This study aims to collect 10 year follow up information on cardiovascular events and risk factors, treatment and mortality for the cohort of 1,212 participants of the ADDITION study who enrolled in the UK. This will allow an assessment of the longterm effects of the differences in treatment during the first five years after diagnosis.\nThe researchers plan to contact all ADDITION participants in the UK with a self report\nquestionnaire to assess health behaviour and patient-reported outcomes.\nPrior to sending any questionnaires, the participant list will be cross-checked with available records to minimise the risk of sending questionnaires to participants who are deceased. Each centre will also search medical records already held to collect data on intermediate biochemical and clinical measures, medication and health service use. Where an event is identified, relevant clinical information (such as death certificates, post mortem reports, medical records, hospital discharge summaries, electrocardiographs and laboratory results) will be collated. Data will be\ncollected over a 9-12 month period. A research assistant with necessary NHS permissions will also collect primary end point data from medical records. Where possible, and with the practice's permission, this will be collected remotely through System 1 using the Diabetes Research Network’s clinical system access. For practices not on this system, staff will travel to site to collect this data. S251 support is not requested for this element as the participants consent to access medical records had been obtained.                                                     Section 251 support was requested to obtain up to date address details for all participants in order to inform them of the 10 year follow up (and if they wish, speak to the study team about the study), invite to fill in questionnaires and to update the study team of their current GP practice in order to complete the follow up.  Consent to participate in the study had been obtained in writing at the point of\nscreening, including consent to collect data through medical records and consent to\nuse information for future related projects. Participants were also consulted on the\nproposed 10 year follow up plans and feedback from participants who attended the\n5 year follow up was overwhelmingly supportive of this. An information sheet will be\nincluded in the questionnaire confirming the nature of the 10 year follow up and\nreiterating the participants right to withdraw. Participants will be informed that\nrefusal to take part in the study further will not influence their normal medical care\nand that their participation is completely voluntary. Participants can contact the\nteam via email or telephone on the telephone numbers provided in the cover letter\naccompanying the questionnaire.  The applicant submitted two separate applications in parallel as each relate to\ndifferent IRAS ID’s, REC approvals and different cohorts. Please see the linked\napplication 16/CAG/0024 - ADDITION – 10 year follow up, IRAS ID 160001.  S251 support was requested to allow the disclosure of name, NHS number, GP\npractice code, address and postcode, date of birth and date of death, cause of\ndeath, to the researchers in order to contact the cohort. ONS and HES data will be\nrequested from the HSCIC."]
["Applicant Organisation Name","University of Cambridge, MRC Epidemiology Unit"]
["Contact Name","Professor Simon Griffin"]
["Address","University of Cambridge School of Clinical Medicine"]
[null,"Box 285, Institute of Metabolic Science"]
[null,"Addenbrooke's Hospital, Hills Road, Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223330315"]
["Email","simon.griffin@mrc-epid.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","This study aims to collect 10 year follow up information on cardiovascular events and risk factors, treatment and mortality for the cohort of 1,212 participants of the ADDITION study who enrolled in the UK. (Male and Females between 50 - 79)"]
["Description of confidential patient information used","NHS number\nGP practice code\nSurname\nForename\nAddress\nPostcode\nDate of Birth\nDate of Death                                                                                                                       Cause of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Expired"]
[]
["Outcome Date","2016-04-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, being able to track and trace participants has meant that the study team has been able to collect more information from the respective GP practices (as stated in Purpose 1b above) which has greatly improved the power of the study, thus making it more useful for planning NHS resource allocation and best practice in the treatment of type 2 diabetes. \n\n\nAmendment Request (29/06/2018)\nThe amendment requested support to link the HES/ONS data (which the applicant is already receiving with support) to existing records gathered as part of the wider study. This will include the follow-up information provided direct from GP practices. This linkage will be facilitated by use of the study ID.\nThe applicants will also be requesting data from the HQIP MINAP (Myocardial Ischemia National Audit Project, facilitated by NICOR) and SSNAP (Sentinel Stroke National Audit Programme, currently facilitated via the Royal College of Physicians).\nThe purpose of undertaking the linkage is to see whether it would be possible to facilitate the ongoing follow-up of this historic trial cohort by administrative means (i.e. NHS Digital), rather than contacting GPs for further information when the 15 years follow-up comes round.\n\nSpecific conditions of support                                                                                                 1. Favourable opinion from a Research Ethics Committee. Confirmed 1/02/2016\n2. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed 9/02/2016."]

{"sheet":"A02140","index":184,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","02140"]
["Reference","16/CAG/0024"]
["Other Refs"]
["Application Title","ADDITION - 10 year follow up"]
["Application Summary","This application from the University of Cambridge set out the purpose to understand the effect of intensive treatment of multiple risk factors in the course of diabetes.  People with diabetes have an increased risk of developing cardiovascular disease (heart attack or stroke). However, there can be a delay between the onset of diabetes and a person experiencing symptoms, making it difficult to detect early.  If people with diabetes were found earlier in the disease trajectory and treated before symptoms developed, the risk of them suffering from an early death or cardiovascular disease would be reduced.  This study aims to collect 10 year follow up information on cardiovascular events and risk factors, treatment and mortality for the cohort of 1,212 participants of the ADDITION study who enrolled in the UK. This will allow an assessment of the longterm effects of the differences in treatment during the first five years after diagnosis.\nThe researchers plan to contact all ADDITION participants in the UK with a self report questionnaire to assess health behaviour and patient-reported outcomes.\nPrior to sending any questionnaires, the participant list will be cross-checked with available records to minimise the risk of sending questionnaires to participants who are deceased. Each centre will also search medical records already held to collect data on intermediate biochemical and clinical measures, medication and health service use. Where an event is identified, relevant clinical information (such as death certificates, post mortem reports, medical records, hospital discharge summaries, electrocardiographs and laboratory results) will be collated. Data will be\ncollected over a 9-12 month period. A research assistant with necessary NHS permissions will also collect primary end point data from medical records. Where possible, and with the practice's permission, this will be collected remotely through System 1 using the Diabetes Research Network’s clinical system access. For practices not on this system, staff will travel to site to collect this data. S251 support is not requested for this element as the participants consent to access medical records had been obtained.                                                            Section 251 support was requested to obtain up to date address details for all participants in order to inform them of the 10 year follow up (and if they wish, speak to the study team about the study), invite to fill in questionnaires and to update the study team of their current GP practice in order to complete the follow up.                                                                         Consent to participate in the study had been obtained in writing at the point of screening, including consent to collect data through medical records and consent to use information for future related projects. Participants were also consulted on the proposed 10 year follow up plans and feedback from participants who attended the 5 year follow up was overwhelmingly supportive of this. An information sheet will be included in the questionnaire confirming the nature of the 10 year follow up and reiterating the participants right to withdraw. Participants will be informed that refusal to take part in the study further will not influence their normal medical care and that their participation is completely voluntary. Participants can contact the team via email or telephone on the telephone numbers provided in the cover letter accompanying the questionnaire.  The applicant submitted two separate applications in parallel as each relate to\ndifferent IRAS ID’s, REC approvals and different cohorts. Please see the linked\napplication 16/CAG/0026 - ADDITION Plus – 10 year follow up, IRAS ID 173399.                 S251 support was requested to allow the disclosure of name, NHS number, GP practice code, address and postcode, date of birth and date of death, cause of death, to the researchers in order to contact the cohort. ONS and HES data will be requested from the HSCIC."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Simon Griffin"]
["Address","MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine"]
[null,"Box 285, Institute of Metabolic Science, Addenbrooke's Hospital, Hills Road"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223330315"]
["Email","simon.griffin@mrc-epid.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Everyone who was diagnosed with type 2 diabetes during the screening stage of the study will be included, with the exception of 2 participants who requested previously to formally withdraw and those that have already passed away. (Male and Females between 50-79)."]
["Description of confidential patient information used","NHS number\nGP practice code\nSurname\nForename\nAddress\nPostcode\nDate of Birth\nDate of Death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge School of Clinical Medicine"]
["Status","Supported"]
[]
["Outcome Date","2016-04-08"]
["Next Review Date","2024-04-08"]
["Notes","23 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - HES and Civil registration mortality data\n\nAmendment Request (Approved - 04/06/2018)\nThe amendment requested support to link the HES/ONS data (which the applicant is already receiving with support) to existing records gathered as part of the wider study. This will include the follow-up information provided direct from GP practices. This linkage will be facilitated by use of the study ID.\nThe applicants will also be requesting data from the HQIP MINAP (Myocardial Ischemia National Audit Project, facilitated by NICOR) and SSNAP (Sentinel Stroke National Audit Programme, currently facilitated via the Royal College of Physicians).\nThe purpose of undertaking the linkage is to see whether it would be possible to facilitate the ongoing follow-up of this historic trial cohort by administrative means (i.e. NHS Digital), rather than contacting GPs for further information when the 15 years follow-up comes round.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 9/02/2016\n2. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed 9/02/2016\nAs the above conditions have been accepted and/or met, this letter provides\nconfirmation of final approval. I will arrange for the register of approved applications\non the HRA website to be updated with this information."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02141","index":185,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02141"]
["Reference","16/CAG/0007"]
["Other Refs"]
["Application Title","Information flow in General Practice: investigating the processing of discharge summaries to improve patient safety."]
["Application Summary","This application from a PHD student at the University of Nottingham set out the purpose to understand the systems in place for processing discharge summaries in primary care and to estimate a rate of error for compliance with actions requested by secondary care. It also hopes to shed light on why these processes might not be safe 100% of the time.  Discharge summaries are a crucial document for patient safety in the care transition process from secondary to primary care. Care transitions have been shown to be a risky time for patients, with respect to medication errors, risk of readmission and missed opportunities for follow-up. This is particularly true for elderly patients, especially those with cognitive impairment or lack of social support. Despite much investment by secondary care in improving the discharge summary, the way in which GP surgeries handle discharge summaries has been very little studied.  There are three stages to this research. The researcher will access to 300 patient records at GP practices. Twenty interviews with healthcare staff (GPs) will be conducted as well as focus groups with 5-8 participants.  The coinvestigator (RS), who is also an NHS employed academic GP, will be working alone to collect data in GP surgeries. Quantitative data will be obtained by looking at a sample of 300 medical records of patients aged 75 and older who have been discharged from an emergency hospital admission episode. A purposeful sample of practices will be obtained via contacts of the lead and coinvestigator and via the NIHR CRN. Practices will be sent invite letters and have the opportunity to discuss the study with the coinvestigator prior to taking part. It is anticipated that practices will volunteer staff who are interested in the study and who have senior roles within the practice. Ten practices from the Nottingham, Coventry and Manchester areas with varying characteristics will be recruited. Volunteering practices will also have their administrative systems mapped and this will be discussed with key members of those practices in twenty one to one interviews. Qualitative data from field notes and interviews will be analysed alongside the quantitative data to form an epidemiological picture of how English general practice performs in relation to the safe handling of discharge summaries. A small number of volunteer service users, around 5, will be identified through the PPI lead or clinical contacts of the coinvestigator.  S251 support is requested to allow the disclosure of identifiable information in electronic medical records of patients selected for the study to the researcher. Although date of birth and date of death will be used to determine inclusion in the study all data relating to patients will be anonymized prior to leaving the practice, once anonymized, data will reference only age in years and sex. CAT have discussed the potential in this application of accessing free text information. The researchers have confirmed that free text will be accessed to provide the inclusion criteria date of birth and date of death. This will then be anonymised into age in years and sex with no identifiers leaving the practice. For this reason it was felt relevant to process via the precedent set route."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Tony Avery"]
["Address","Division of Primary Care"]
[null,"D1417, Medical School, Queen's Medical Centre,"]
[null,"Derby Road, Nottingham"]
["Postcode","NG7 2UH"]
["Telephone","01158230209"]
["Email","tony.avery@nottingham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patient records for quantitative data collection; Age – 75 years and older.\nDischarge summary – from an emergency hospital admission episode not longer than 15 months and not less than 3 months prior to data collection in the practice."]
["Description of confidential patient information used","The entire electronic medical records of patients selected for the study will be reviewed.        This will include consultation entries, results of investigations, correspondence with secondary\ncare and administration notes. This information will be viewed live at the practice site and any data taken away from the practice will have been fully anonymized before leaving the site."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Research and Graduate Services, Kings Meadow Campus, Lenton lane, Nottingham"]
["Status","Supported"]
[]
["Outcome Date","2016-02-15"]
["Next Review Date","2017-02-15"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 7/12/2015\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 22/12/2015."]

{"sheet":"A02142","index":186,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02142"]
["Reference","16/CAG/0021"]
["Other Refs"]
["Application Title","Effectiveness and Cost-effectiveness of 'Usual Care' versus 'Specialist Integrated Care': A Comparative Study of Hospital Discharge Arrangements for Homeless People in England."]
["Application Summary","This application from University College London set out the purpose of establishing the ways in which Specialist Integrated Homeless Health and Care (SIHHC) services are being developed and used to facilitate hospital discharge in England. The study also aims to examine the impact this is having on quality of care for homeless people admitted to hospital and whether this care can help prevent readmission to hospital shortly afterwards.  The first work package (WP1 –for which support is not requested) seeks to gain an informed understanding of the ways in which SIHHC services are being developed and implemented to facilitate hospital discharge in England and the impact this is having on quality of care and organisational outcomes such as the prevention of readmission to hospital. For this work package, local service providers will be asked to identify and nominate potential participants.  The second work package (WP2, for which support is requested for datasets 1, 3, 4, and 5) is a data linkage and health economic analysis work package that will work with twenty sites across England where homeless patients have been admitted to hospital. A cohort of homeless people who have used specialist discharge scheme will be compared to a cohort of homeless people who have not used such provision. The study will also compare patient’s hospitalisation history before and after engagement with specialist services. Analysis will also be undertaken to understand whether the outcomes are a factor of homelessness specifically or are tied to deprivation."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Michelle Cornes"]
["Address","Social Care Workforce Research Unit"]
[null,"Strand"]
[null,"London"]
["Postcode","WC2R 2LS"]
["Telephone","01931 713123"]
["Email","michelle.cornes@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Female patients between 18 and 65 who are homeless and have been discharged from hospital."]
["Description of confidential patient information used","1. Homeless healthcare users; from local service providers; identifying and demographic data (forename, surname, aliases, date of birth, sex, current or previous postcodes (district level), hospital of admission, date of hospital admission, nationality, ethnicity, NHS number)              "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-05-11"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed support expired 08 November 2021.\n\nApplicant has confirmed all identifiable data has been deleted and has provided a number of public benefits.\n\nImpact 1: This research was cited by the Government as part of the impetus leading to a £16 million fund for pilot projects to support people experiencing homelessness after being discharged from hospital. \n\nImpact 2: National policy guidance on improving transfers of care has been changed and is now more inclusive of the needs of patients who are homeless. \n\nImpact 3: National policy guidance on safeguarding has been strengthened. \n\nImpact 4: Increases in numbers of discharge coordinators and intermediate care services and beds leading to improved health and well-being of patients.\n\n05 September 2019: Amendment supported to extend the duration of support to 30 November 2019. \n\nAmendment Request (Approved - 09/10/2018)\nThe amendment request set out the following three changes to the project:\n1. To extend the duration of support to the end of March 2019,\n2. To revise the variables included within the analysis dataset, with the addition of four new variables and to exchange one item previously listed,\n3. To revise the primary and secondary outcomes for the study.\nAmendment Specific Conditions of Support\n1. Confirmation of suitable security arrangements via IG Toolkit submission. (Confirmed – UCL School of Life and Medical Sciences; published satisfactory reviewed grade at 66% on Version 14.1, 2017/18).\n2. Confirmation of a favourable opinion from a Research Ethics Committee. (Confirmed).\n\nAmendment Request (Approved - 20/10/2017)\nThe amendment requested revisions to the variable requested from the HES dataset. The following data items would be added to the variable list for use in analysis:\n1. ARRIVALDATE\n2. AEATTENDCAT\n3. AEATTENDDISP\n4. TREAT2_N\nThe removal of the following data items from the HES extracted data was requested as they had been found to be unnecessary to the study:\n5. CARERSI\n6. CATEGORY\n7. CENDUR\n8. CENSAGE\n9. CENSTAT\n10. CENWARD\n11. DET_CFL\n12. DETDUR\n13. DETNDATE\n14. DOMPROC\n15. LEGLSTATST\n16. MENTCAT\n17. PROVSPNO\n18. VIND\n19. WARDSTRT\n\nAmendment Specific Conditions of Support\n1. Confirmation of suitable security arrangements via IG Toolkit submission. (Confirmed – UCL School of Life and Medical Sciences-Data Safe Haven reviewed satisfactory grade at 66% satisfactory on Version 14, 2016/17).\n2. Confirmation of a favourable opinion from a Research Ethics Committee. (Not Application – REC Favourable Opinion in place – revision to variables only requires consideration via CAG).\n\nOriginal Specific conditions of support                                                                                                      1. No-one who is or has been asked for consent in relation to work package 2 data set 2 and fails to respond will be covered by support under the Regulations. Confirmed 10/5/16.\n2. Anyone who is approached for consent in relation to other aspects of the study will be informed of the intention to use that data set without consent, and be given the opportunity to object. Confirmed 10/5/16.\n3. Confirmation as to who will be acting as Data Controller and as Data Processor(s) must be provided. Received, letter dated 07 April 2016."]

{"sheet":"A02143","index":187,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02143"]
["Reference","16/CAG/0015"]
["Other Refs"]
["Application Title","Evaluating variation in special educational needs provision for children with Down syndrome and associations with emergency use of hospital care."]
["Application Summary","This application from University College London set out the purpose of this study to inform policy about the impact of supportive service provision outside a healthcare setting on health outcomes, such as emergency hospital admissions. The aim was to define a comprehensive cohort of children with Down’s syndrome in England and Wales, to define their health profile, and compare it with the general population. Using healthcare records, the researchers are to follow cohorts of children from birth, primary school entry and secondary school entry and determine whether local authority variation in the type and timing of education support and/or out of home care was associated with emergency use of hospital services.  "]
["Applicant Organisation Name","University College London"]
["Contact Name","Prof Ruth Gilbert"]
["Address","UCL Professor of Cinical Epidemiology & Deputy Director the Administrative Data Research Centre for England (ADRC-E)"]
[null,"UCL Farr Insitute of Heath Informatics Research London"]
[null,"222 Euston Road, London"]
["Postcode","NW1 2DA"]
["Telephone","02035495670"]
["Email","r.gilbert@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children born after 1/1/97 and part of the National Down Syndrome Cytogenetic Register or with relevant ICD10 diagnostic code for Down syndrome, in their hospital records.\nFor each case we will randomly select nine individuals born in the same week, in the same year in the same local authority."]
["Description of confidential patient information used","No sensitive or confidential data will be requested by the researchers."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","UCL Institute of Child Health"]
["Status","Expired"]
[]
["Outcome Date","2016-07-05"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, work is ongoing using the pseudonymised dataset held by UCL.  The majority of this work is expected to complete spring 2025, when public benefits will be realised.\n\n\n09 July 2019 - Amendment supported to extend the duration of support under the Regulations until 31 December 2021\n\nSpecific conditions of support                                                                                                          1. At the first annual review provide information about how the control group will be informed about the use of their data for this project? E.g. notices on the organisation/study web pages or other medium. Provide revised information which should include clear information about the study."]

{"sheet":"A02144","index":188,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02144"]
["Reference","16/CAG/0139"]
["Other Refs"]
["Application Title","Life threatening bronchopulmonary dysplasia in infants - A rare disease BPSU survey"]
["Application Summary","This application from Newcastle upon Tyne Hospitals NHS Foundation Trust set out the purpose of collecting data on outcomes and treatment of chronic lung disease in babies born more than 8 weeks early. This condition could be serious, resulting in weeks or months spent in hospital on breathing machines, or even death. As the condition only affected small numbers of babies, very little was known about it. The study was expected to result in improvements in the management of this condition.  The BPSU methodology – an established surveillance methodology supported in principle by CAG – would be used. From 1st January 2017 to 31st December 2017, all BPSU contributing consultant paediatricians would be asked to report each month whether they knew of any premature babies who met the study criteria. Once the clinician had informed BPSU that they had identified a case (no identifiable data would be sent at this stage), BPSU would send them 3 questionnaires over the 13-month period for the study. The clinician would then extract data from the medical record for the questionnaire. Some identifiers would be included both for linkage and for analysis. The questionnaire would consist of a front sheet containing identifiable data (as listed below) which would be stored separately and linked to the questionnaires by a unique study number. The Principal Investigator for the study would retain the link. Analysis would be carried out on pseudonymised data, which would be labelled with BPSU study number rather than NHS number."]
["Applicant Organisation Name","The Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Contact Name","Dr Sundeep Harigopal"]
["Address","Consultant Neonatologist"]
[null,"Queen Victoria Road, Leazes Wing"]
[null,"Royal Victoria Infirmary"]
["Postcode","NE14LP"]
["Telephone","0191 2829616"]
["Email","Sundeep.harigopal@nuth.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any infant born at <32 completed weeks of gestation, without associated significant (including cardiorespiratory) congenital abnormality, where at (or beyond) 38 weeks postmenstrual age the infant is receiving positive pressure support by any route (ventilation, nasal continuous positive airway pressure (nCPAP), biphasic positive airway pressure (BIPAP) or humidified high flow nasal cannula with a flow more than 2lpm), without intercurrent illness to explain this need."]
["Description of confidential patient information used","Date of birth, date of death, NHS/CHI number, gender, hospital number and ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","The Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-10-11"]
["Next Review Date","N/A"]
["Notes","Only anonymised data was extracted/received.  Access to source data is now complete.\n\nThe study is now published and has given better understanding of the disease, management and practice variation.\n\nSpecific conditions of support                                                                                                        1. Favourable opinion from a Research Ethics Committee.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. "]

{"sheet":"A02145","index":189,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02145"]
["Reference","16/CAG/0131"]
["Other Refs"]
["Application Title","Niemann-Pick Type C (NP-C) Patient Finder"]
["Application Summary","This application from University College London Hospitals set out the purpose to evaluate if using combinations of England, Hospital Episode Statistics (HES ICD-10 codes linked to specific symptoms seen in Niemann-Pick C (NP-C), can identify patients who may have this disease. Having identified a patient who could potentially have NP-C, the treating physician will be contacted with a letter from the Principal Investigator (PI). This will inform them about the study, tell them that the study has identified a patient who might have NP-C, provide the HES patient identifier and suggest how they might confirm the diagnosis if they wish to do so. England, Hospital Episode Statistics (HES) data applies an ICD-10 code to each clinical symptom and procedure a patient experiences while attending a hospital, as either an inpatient or outpatient."]
["Applicant Organisation Name","University College London Hospitals"]
["Contact Name","Dr Robin Lachmann"]
["Address","Charles Dent Metabolic Unit"]
[null,"Box 92, National Hospital for Neurology and Neurosurgery"]
[null,"Queen Square, London"]
["Postcode","WC1N 3BG"]
["Telephone","02034484778"]
["Email","robin.lachmann@uclh.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Females age 50 and under who have a combination of symptoms compatible to a high indication of Niemann-Pick C according to the Niemann-Pick C suspicion Index."]
["Description of confidential patient information used","LocalpatID, hospital trust and consultant code"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2016-12-22"]
["Next Review Date","N/A"]
["Notes","June 2022 - Support Expired\nThe study was supported but never started due to issues with NHSD linking the information.   \n\nThe study can be expired.\n\nSpecific conditions of support                                                                                              1. Clarification as to when support to process information under this support will cease e.g. is follow–up data required and will this be taking place under the consent obtained by the clinician?\n2. Support applies to the purposes linked to the algorithm that will yield approximately 200-300 identified subjects.\n3. When requesting the dataset from NHS Digital that includes LOPATID and other codes, LOPATID to be separated from the dataset that flows to the external company/data analysts and to be sent directly to the applicant. Linkage will be undertaken between the two datasets by study ID.                                                                                                                              4. To amend the information provided to clinicians to:\na. make the numbers clearer (e.g. that 2-300 patients will be identified)\nb. include how the data was obtained, with advice to the clinician on how to counsel the patient and obtain appropriate consent for the processing of data for this specific activity.\nc. Make clear whether follow-up data is required, as part of follow-up to the research project.\nd. Ensure that any data flowing and further data processing takes place with appropriate consent, as obtained via the consultant, and ensure there is appropriate material provided to clearly support this.\ne. Factually amend the information provided with regards to HES ID to clarify the precise identifier required under support (LOPATID).  "]

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[]
[]
["Application Number","02146"]
["Reference","16/CAG/0127"]
["Other Refs"]
["Application Title","Detecting and alleviating language impairments due to Traumatic Brain Injury"]
["Application Summary","This research application was submitted by the University of Manchester and detailed an activity that would be supporting PhD student research. The Academic supervisor would be acting as the Chief Investigator.  Impairments in language function, or aphasia, can have a debilitating effect on a life. Acquired impairments can arise through various conditions such as stroke, brain tumours, and traumatic brain injury (TBI). Language deficits can occur following TBI when there is obvious injury to the language centres of the brain, however, there is also some evidence to show that even when these areas remain intact, language problems can occur.                                                                                                                                       There are three arms to this project:                                                                                               1. To determine how prevalent language problems are following TBI, when there is no obvious injury to the language areas, using a series of neuropsychological language tests.\n2. To determine why these problems occur. Using a relatively new method of MRI scanning, called diffusion tensor imaging (DTI), which detects the diffusion of water in the brain to form maps of neural connections, the applicant aims to determine if the deficits occur due to injury to the underlying connections of the brain.\n3. To test if the applicant can improve these patients’ language function using a technique called transcranial direct current stimulation (tDCS). tDCS is a non-invasive neurostimulation technique which delivers a small current of electricity to the brain to increase neuronal activity. It is thought to promote regeneration and rewiring of the connections in the brain, and so it is possible it would promote regeneration of injured language neural circuits, improving language function. This will be administered during the performance of language production and comprehension tasks and will be compared to a sham condition, in which the equipment is still used but no current is applied.                      "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Dr Michelle Hall"]
["Address","NARU, SPS, Level 3,"]
[null,"Zochonis Building, Brunswick Street"]
[null,"Manchester"]
["Postcode","M13 9PL"]
["Telephone","07795326663"]
["Email","michelle.hall@postgrad.manchester.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Aged 16-65\nEnglish speaking\nRight hand dominance\nTraumatic brain injury"]
["Description of confidential patient information used","Name, Date of Birth, Diagnosis\n\nAmendment (17/10/2017) - Patient Address"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","The University of Manchester"]
["Status","Expired"]
[]
["Outcome Date","2017-02-09"]
["Next Review Date","N/A"]
["Notes","The study did not commence, as the study team were not able to gain access to the patient files they needed, and hence recruited to the study via other avenues (predominantly community groups).\n\nAmendment (Approved - 17/10/2017)\nThe amendment requested permission to access additional data items: patient’s address in addition to name, date of birth and diagnosis. Support was in place to identify and seek consent from patients at the hospital site, however in order to improve recruitment this further request was to access patients’ address in order to send invitation letters.\n\nSpecific conditions of support                                                                                                     1. Members advised that the applicant should implement a poster/leaflets to provide information to the proposed cohort and to allow a right of objection that clarifies what will happen in the event of dissent.\n2. The mechanism for dissent to make clear that dissent is being expressed only in relation to this specific study.\n3. Members agreed that the results from this study should be shared widely so that a public benefit is shown. For example, members advised that the outputs should be shared with other charitable organisations in addition to Headway.                                                                                   4. Provision of an annual review every 12 months for the duration of the study, and notification of closure of application when processing confidential patient information without consent ceases."]

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[]
[]
["Application Number","02147"]
["Reference","16/CAG/0124"]
["Other Refs"]
["Application Title","A study to investigate the association between selective uptake of cervical cancer screening and all cause mortality."]
["Application Summary","This research application from Queen Mary University London, set out the following purpose. It has long been thought that women who suffer health problems, difficult living conditions and risky lifestyles are less likely to participate in screening programmes. Reasons for this include physical barriers in attending, less perceived risk of developing disease among others. Selective uptake of screening by health participants has been blamed for difficulties in interpreting the effect of cervical screening on cancer incidence between participants and non-participants. Since the aim of cervical screening is to detect precancerous lesions and avoid progression to cancer, less cervical cancer is usually observed among screened women. This in turn results in fewer deaths among screened women.  The aim of this study is to quantify the selective uptake of cervical screening in England by examining mortality among women who participate in screening compared to those who do not participate."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Prof Peter Sasieni"]
["Address","Charterhouse Square"]
[null,"London"]
[]
["Postcode","EC1M 6BQ"]
["Telephone","02078823544"]
["Email","p.sasieni@qmul.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Inclusion:\nCases: a sample of deaths between 1992 and 2012 in England (from ONS) among females born between 1923 and 1972 and age 20-69 in 1992 from a pre-specified sample of ICD-10 causes of death.\nCohort: select one woman at random for each death ('cases') from the cervical screening call/recall (NHAIS) database to have the same year of birth as case women.                          Note that a “case” can also be in the cohort.                                                                           Exclusion Criteria:\nDeath between 1992 and 2012 in women born before 1923 or after 1972.\nWomen who have migrated before age 70 or the end of the follow-up."]
["Description of confidential patient information used","NHS number and date of birth for linkage purposes.\nThe researchers will receive the following data:\nMonth and year of death\nMonth and year of screening episode\nMonth and year of birth"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","QMUL Joint Research Management Office"]
["Status","Supported"]
[]
["Outcome Date","23/11/2016-Revised 02/12/2016"]
["Next Review Date","2022-11-23"]
["Notes","Specific conditions of support                                                                                                1. Take forward patient notification plans as detailed in the response to provisional outcome and notify the named charities that the research project is being undertaken. Provide an update at annual review on the impact of this engagement.  "]

{"sheet":"A02148","index":192,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02148"]
["Reference","16/CAG/0117"]
["Other Refs"]
["Application Title","An extension of the Arnold Lodge Admission Cohort Reconvictions and Intervening Treatment (ALACRITy)"]
["Application Summary","This resubmitted application from the University of Nottingham set out the purpose of continued monitoring of the outcomes of a vulnerable cohort in terms of mortality and rehospitalisation, add to understanding of the long-term outcomes of these patients. This application intended to supersede and replace the support already provided for under references PIAG 4-07 (t)/2002 and ECC 4-15 (b)/2009. The study will generate long-term follow-up data that will help to inform public debate, service planning and patient care. Other potential benefits of the study include making community services aware of the need to address the risk of suicide and physical ill health as well as reoffending, and quantifying statistical risks and timescales for reoffending in clinical populations. There is also a potential benefit in raising awareness in mental health services of potential adverse outcomes such as excess mortality, particularly by suicide."]
["Applicant Organisation Name","The University of Nottingham"]
["Contact Name","Professor Birgit Völlm"]
["Address","Room B18 Institute of Mental Health Building,"]
[null,"Triumph Road, Jubilee Campus"]
[null,"Nottingham"]
["Postcode","NG7 2TU"]
["Telephone","0115 823 1266"]
["Email","birgit.vollm@nottingham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and Females over 18 years suffering from mental disorder.                                                      All first admissions to Arnold Lodge MSU up to 30th June 2013."]
["Description of confidential patient information used","Name/ NHS Number/Hospital ID/ GP registration/ Date of birth/ Date of death/Postcode/Occupation/Ethnicity/Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Nottinghamshire Healthcare NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2016-09-16"]
["Next Review Date","2017-09-16"]
["Notes","Specific conditions of support                                                                                                1. This application now supersedes references PIAG 4-07 (t)/2002 and ECC 4-15 (b)/2009. These references are no longer active.                                                                                  2. Support applies only to the relevant healthcare generated data as specified in the application. For example, data to be obtained from the Ministry of Justice or employment records would fall outside the scope of this approval.                                                                                                 3. Any dissent or patient objection to be respected under the terms of this support with no need for the patient to demonstrate harm or distress if making an objection.                                           4. An annual review to be provided every 12 months from date of final approval; the first annual review should include details of the number of patient objections made, and to consider the length of the retention period for identifiable information."]

{"sheet":"A02149","index":193,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02149"]
["Reference","16/CAG/0114"]
["Other Refs"]
["Application Title","LUCI: Long-term follow-up of urinary tract infection (UTI) in childhood and implications: an electronic record-linked cohort study."]
["Application Summary","The research application from Cardiff University set out the purpose of a project that aims to determine outcomes following urine infections (UTI) in childhood and to determine whether there is a difference between UTI identified through routine practice and UTI identified through systematic urine sampling (where all ill children have their urine sampled). It is thought that childhood UTI can lead to scarring of the kidneys which in some cases leads to long-term complications such as high blood pressure, chronic kidney disease and kidney failure. The evidence is weak and has been questioned. It was indicated there is an urgent need to clarify the association between childhood UTI, kidney scarring and long-term complications as the correct approach to urine sampling and diagnosis of UTI in children hinges on this association.  UTI is difficult to diagnose in children and applicant asserts it is shown that as many as 80% of UTIs are missed in primary care. A urine sample is required to diagnose UTI but urine is infrequently sampled from ill children in routine primary care (in less than 2% of consultations). The applicant has previously conducted two large studies where urine was systematically sampled from all ill children less than five years old (the DUTY and EURICA studies). Only a sample of these children were followed-up for a short time.                                                         In the current study the applicant proposes to use routinely collected data to follow-up DUTY and EURICA children for 5 years to determine outcomes for UTI identified through systematic urine sampling (including further UTI, hospital admissions, kidney scarring, high blood pressure and kidney failure). They will also determine outcomes for children (<5 years) presenting with an acute illness, with and without UTI, identified through routine practice."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Kathryn O'Brien"]
["Address","Division of Population Medicine, School of Medicine"]
[null,"Neuadd Meirionnydd, Heath Park"]
[null,"Cardiff"]
["Postcode","CF14 4YS"]
["Telephone","02920687162"]
["Email","obrienka@cf.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","There are two parts to this study:                                                                                               1)  Part 1 - eligible participants will be children presenting with an acute illness in primary care aged less than five years old between January 1999 and April 2012 in Wales (routine sampling). 2. Part 2 – eligible participants will be children who participated in the DUTY or EURICA studies \n(included children presenting with an acute illness in primary care aged less than five years old between March 2008 - April 2012 in England and Wales (systematic sampling).\n"]
["Description of confidential patient information used","Name/ NHS number/ GP registration/ Date of birth/ Postcode/Gender/ Ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff University"]
["Status","Expired"]
[]
["Outcome Date","2016-11-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in August 2022 that ‘s251’ support is no longer required, as the dataset is now pseudonymised and all confidential patient information has been deleted. \n\nIn terms of public benefit, the study looks at longer term outcomes following childhood UTI and results will aid GPs, Paediatricians and parents, and will help to inform policies concerning urine sampling in children\n\n\nSpecific conditions of support                                                                                                     1. Support extends to the transfer of specified information to NHS Digital and SAIL as indicated in the application. Where the anonymised dataset is to be retained in SAIL, no other additional datasets, aside from those specified within the application, are to be processed and added to this dataset using Regulation 5 as a legal basis. Future datasets, if considered appropriate, could be included via submission of an amendment to the CAG in future.                                              2. Applicant to consider who would be the appropriate recipients of relevant information in situations where the child becomes competent.  "]

{"sheet":"A02150","index":194,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02150"]
["Reference","16/CAG/0098"]
["Other Refs"]
["Application Title","THE fullPIERS RISK PREDICTION MODEL FOR WOMEN WITH PRE-ECLAMPSIA: EXTERNAL VALIDATION, RECALIBRATION AND ADDED VALUE OF A NOVEL BIOMARKER (PLACENTAL GROWTH FACTOR)"]
["Application Summary","This research application from Oxford University Hospitals NHS Trust set out the purpose of seeking to assess the predictive ability of the fullPIERS model in order to identify the risks of developing complications for pregnant women with pre-eclampsia in high resourced settings so as to aid clinicians in managing such pregnancies.  The hypertensive disorders of pregnancy (HDP), with pre-eclampsia being the most dangerous, complicate about 10% of pregnancies and are major contributors to maternal and perinatal morbidity and mortality. This is due to the severe complications that can result from them such as stroke, kidney failure and eclampsia for the mother, and fetal growth restriction and stillbirth for the baby. The ability to predict these adverse outcomes will aid the appropriate management and treatment by the early identification of women with higher risks of complications arising from HDP and applying timely interventions. In order for the fullPIERS model to be introduced into clinical practice, it is necessary to assess its predictive ability in a similar population cohort other than the one in which it was developed in (external validation) and to improve the model where possible by adding new biomarkers as well as recalibrating the model if and when required for better predictive performance. In order to determine eligibility and collect relevant information for this study, patient case records, of women who were admitted with hypertensive disorders of pregnancy (HDP) up to ten years ago, obtained through routine clinical care, will be screened by the researcher. The published PIERS equation will be applied to the individual eligible patient records in the validation datasets, to calculate the predicted probability of adverse outcome within 48 hours of admission. Data will be collected, entered into an anonymised database and will be used to validate the fullPIERS model to identify women at greatest risk for developing adverse maternal outcomes."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr. Manu Vatish"]
["Address","Level 3 Women's Centre"]
[null,"John Radcliffe Hospital"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865221009"]
["Email","manu.vatish@obs-gyn.ox.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Hypertensive disorders of pregnancy in participants aged 18-45"]
["Description of confidential patient information used","The patient information to be used includes, ethnicity, the year and month of birth, date of death, dates and time of hospital admission, medical history, recorded symptoms (e.g. headache, nausea) and laboratory tests (e.g. haematological, urine chemistry) and adverse outcomes such as maternal death and severe morbidity."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Expired"]
[]
["Outcome Date","2016-12-02"]
["Next Review Date","N/A"]
["Notes","The research team only collected anonymised data. The data was analysed and amalgamated with data from other centres. This was published. Our data was acquired prior to the routine use of plgf plasma biomarkers and formed part of the “standard of care” cohort.\n\nThe data files containing the harvested data were subsequently destroyed.\n\nThis work was published in\nPregnancy Hypertension 2019 Jan;15:42-50. Temporal and external validation of the fullPIERS model for the prediction of adverse maternal outcomes in women with pre-eclampsia \n\nSpecific conditions of support (Updated)                                                                                 1. The expectation is that the applicants will improve patient involvement, and to report against this extended involvement at time of annual review."]

{"sheet":"A02151","index":195,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02151"]
["Reference","16/CAG/0072"]
["Other Refs"]
["Application Title","TargetCOPD: A randomised controlled trial of targeted case finding for COPD versus routine practice in primary care."]
["Application Summary","Chronic obstructive pulmonary disease (COPD) places an increasing burden on the NHS, largely due to repeated inpatient admissions as the disease progresses. Although diagnosed COPD is estimated at 1.3% of the population, it is widely accepted that 50-80% of patients with clinically significant disease are not diagnosed and therefore unable to access effective treatments. Within the UK and elsewhere, there is increasing pressure to find these patients, both from patient groups and strategic documents.\nTargetCOPD compared the benefits and cost-effectiveness of two alternative case-finding approaches for identifying undiagnosed COPD in general practice. Using a cluster randomised controlled trial (RCT) design in 54 West Midlands general practices, we assessed two approaches (targeted case finding vs usual care). Patients between 40 and 79 years who were current or ex-smokers were invited to participate. Using an individual patient RCT nested\nin the targeted arm, we also compared the effectiveness and cost-effectiveness of active case finding using a postal questionnaire, and opportunistic case finding at usual surgery consultations. Patients who reported positive respiratory symptoms were invited for further spirometric assessment to ascertain whether they had COPD or not.\nWe have compared which method is the most effective and cost-effective in identifying new patients. We now have ethical permission to carry out longer term follow-up to evaluate whether the different approaches are also effective in improving long-term health of patients. We seek permission from the CAG to temporarily view patient identifiable data in order to link patient records with hospital admissions and mortality data via the HSCIC."]
["Applicant Organisation Name","The University of Birmingham"]
["Contact Name","Dr. Rachel Jordan"]
["Address","Public Health and Epidemiology Building"]
[null,"Health and Population Sciences, Edgbaston"]
[null,"Birmingham"]
["Postcode","B15 2TT"]
["Telephone","01214146775"]
["Email","r.e.jordan@bham.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients that are registered with a GP in the West Midlands area\n- Aged between 40 and 79 years\n- Must have a history of ever smoking\n- Must not have a diagnosis of COPD\n- They must have the ability to give informed consent"]
["Description of confidential patient information used","NHS number, Sex, Date of Birth, Postcode from GP records.                                                        We will be obtaining information from the Health and Social Care Information Centre on the following outcomes, up to 2017 in the first instance and further follow-up when more funding becomes available:\n- Hospital use data, including A&E admission information, outpatient and inpatient data\n- Mortality data, including date and cause of death."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Birmingham"]
["Status","Expired"]
[]
["Outcome Date","2016-06-03"]
["Next Review Date","NA"]
["Notes","End of study declared January 2019. Processing of CPI is complete. Data controller confirmed support can be expired, as of 02 June 2023.\n\nAmendment Request 03/03/2017\nThis amendment concerned revisions to two documents which had previously been considered by the CAG and the corresponding REC. The two documents, which were a patient poster and website information, had previously been approved; however, NHS Digital had requested minor alterations to wording in the documents to improve clarity, before releasing the research data required.                                                                                                                                     Specific conditions of support                                                                                                         1. A letter of support from the Caldicott Guardian (or equivalent) at applicants organisation."]

{"sheet":"A02152","index":196,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02152"]
["Reference","16/CAG/0043"]
["Other Refs"]
["Application Title","British Association of Dermatologists Biologic Interventions Register."]
["Application Summary","This application from the University of Manchester set out the purpose of monitoring the long-term safety of biologic treatments in the U.K. and Republic of Ireland for patients with psoriasis. The study will consist of two cohorts comparing (i) patients with psoriasis newly treated with one of the biologic therapies, to (ii) patients with similar disease characteristics treated with non−biologic systemic therapies (including PUVA, methotrexate, ciclosporin and acitretin). Patients will have been exposed to a variety of conventional treatments each with its own risks before starting on the biologic therapies.  Based on recruitment rates of a similar register (the British Society for Rheumatology Biologics Register - BSRBR) it is anticipated that 2000−4000 patients for each biologic therapy will be recruited over a five year period. During the same time period, a cohort of comparison patients on standard therapy will also be recruited. Due to the NICE guidelines recommending that all patients with psoriasis should be registered with a national register, it is envisaged that patients in the biologic cohort will be recruited from all dermatology departments in the UK. The comparison cohort will also be recruited from all contributing centres to reduce the risk of selection bias. However for the size of the comparison cohort it is estimated that a total sample of 4000 patients followed for five years is required to allow the register to detect at least a 3− to 4−fold increase in the risk of non−melanoma skin cancer, a particular concern in these patients who have been exposed to phototherapy.  BADBIR has an existing link with NHS Health and Social Care Information Centre (HSCIC) to receive Death and Malignancy information (Ref: MR1102) and are now applying for access to the Hospital Episodes Statistics data for study participants. However HSCIC has questioned the validity of the consent on the grounds that the consent material did not provide an adequate legal basis for the request to access HES data. HES data will allow a better understanding of the outcomes for patients receiving biologic therapy and up to 4,000 patients treated with conventional therapy to enable the short, medium, and long term safety of biologic treatment as compared to traditional therapy for psoriasis to be ascertained. The applicant has provided copies of the correspondence with the HSCIC as well as the consent forms."]
["Applicant Organisation Name","The University of Manchester"]
["Contact Name","Ian Evans (Programme Manager)"]
["Address","BADBIR, The University of Manchester"]
[null,"1st Floor Bright Building, Pencroft Way"]
[null,"Manchester"]
["Postcode","M15 6GZ"]
["Telephone","0161 306 1896"]
["Email","ian.evans@manchester.ac.uk "]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Exposed biologic cohort\n1. Patients with a diagnosis of psoriasis commencing treatment with a biological agent for therapy of their skin disease.\n2. Willingness to give informed consent for long term follow−up and access to all medical records.                                                                                                                          Control cohort\n1. Patients initiating or switching conventional therapy with oral PUVA, ciclosporin, methotrexate, fumarates or acitretin.\n2. If not switching therapy patients must have severe psoriasis meeting the severity criteria for biological therapy as in the BAD guideline (rule of 10s)\n3. Willingness to give informed consent to participate in long term follow up and access to all medical records."]
["Description of confidential patient information used","• Name (Surname / Forename)\n• Address (including postcode)\n• Gender\n• Date of Birth\n• NHS Number"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Manchester"]
["Status","Supported"]
[]
["Outcome Date","2016-03-24"]
["Next Review Date","2025-09-25"]
["Notes","Amendment supported 27 November 2023 to change the Chief Investigator (CI) from Professor Chris Griffiths to Professor Richard Warren\n\n01 November 2023 - change in data processors from NHS Digital to NHS England, regarding data source Hospital episode Statistics (HES)\n\nSpecific conditions of support                                                                                                \n1. Support is limited to the cohort already recruited. If still recruiting new recruits must be consented in a way that satisfies the HSCIC.\n2. The Patient information leaflets should be updated in line with recommendations from the HSCIC to ensure it complies with principles of the Data Protection Act (DPA)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02153","index":197,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02153"]
["Reference","16/CAG/0013"]
["Other Refs"]
["Application Title","A comparison of risk scores in consecutive, unselected chest pain presentations with suspected acute coronary syndrome in the era of high sensitive Troponin."]
["Application Summary","This application from Aintree University Hospital sets out a purpose of conducting a cohort observation study and database analysis to determine which of the three established methods of risk stratifying patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the era of high sensitivity troponins performs more effectively. The study also aims to determine whether the results of a high sensitivity troponin and electrocardiogram (ECG) on admission could be used alone to direct care. The cohort would consist of patients who had presented with suspected cardiac chest pains at Aintree University Hospital between 3rd June 2011 and 4th November 2011. All consecutive patients who presented to the emergency department of Aintree University Hospital, Merseyside with suspected cardiac chest pain would be identified by the admission coding of 'chest pain' and prospectively recruited into the database.  Section 251 support is required for the step in which the identifiers of patients who have been admitted to other hospitals and their clinical data is returned to those undertaking this project. Information related to these admissions will allow the researchers to contact the relevant consultants involved in the direct care of patients."]
["Applicant Organisation Name","Aintree University Hospital"]
["Contact Name","Dr Aleem Khand, Consultant Cardiologist & Chief Investigator for the project "]
["Address","University Hospital Aintree"]
[null,"Lower Lane"]
[null,"Liverpool"]
["Postcode","L9 7AL"]
["Telephone","0151 529 2802"]
["Email","aleem.khand@aintree.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who presented to the accident and emergency department at Aintree University Hospital between 3rd June 2011 – 4th November 2011 with suspected cardiac chest pain are included.                                                                                                                            Exclusion criterias: The presence of a definitive nonischaemic cause for chest pain (with and thus no troponin checked), traumarelated chest pain, cardiac arrest on arrival to the ED. Patients without HS troponin T which indicates no suspicion of a cardiac cause of chest pain were also excluded."]
["Description of confidential patient information used","Gender, Cause of death, date of death, date of hospital admission, NHS Number"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Aintree University Hospital NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2016-01-25"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised with no means to re-identify.\n\nIn terms of public benefit, on the basis of this research applicants have completely rewritten chest pain guidelines in their region. A QIP assessment revealed applicants had safely increased accident and emergency by 100% from 28% to 56%. this has saved the region at least £600,000 per year. This has also reduced AE overcrowding. As part of the advanced access collaborative for reducing variation in accident and emergency discharges, applicants have expounded the results of this original research nationally. This has led to adoption of the chest pain pathway and also it has been a NICE exemplar chest pain pathway.\n\n\nSpecific conditions of support                                                                                                 1. Support covers, in particular, the specified data on patients known to be admitted to other hospitals so that clinical data on these cases can be provided to the researchers by these direct care teams.\n2. Support is in place for the transfer of HES (and ONS mortality data) by the HSCIC to the applicant. Support should be limited to a one-off extraction.\n3. Other hospitals must ensure that they comply with their responsibilities under the Data Protection Act 1998 particularly in terms of meeting the first principle of fair processing.\n4. All data shared with researchers outside the care team must be anonymised.\n5. The researchers should ensure that they are complying with the terms of REC approval.\n6. This application should not be seen to set a precedent for identifiable data collected for audit purposes being used subsequently for research."]

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[]
[]
["Application Number","02154"]
["Reference","16/CAG/0025"]
["Other Refs"]
["Application Title","Extension of the Partnerships in Care Research Database"]
["Application Summary","This application from Partnerships in Care detailed the creation of a research database to\nuse for research studies to inform treatment and the planning of services.\nThe collection of data for the Partnerships in Care (PiC) research database commenced\nin 2001 and involved patient file information from four of the organisation's medium\nsecure hospitals being abstracted to form the database. This comprised information from\n935 patients.\nSubsequently, information on an additional cohort of 859 patients from the four original\nand from two additional hospitals were added to the initial cohort so that the total number\non the database is now 1794. This makes it one of the largest databases of detained\npatients within the UK.  "]
["Applicant Organisation Name","Calverton Hill Hospital"]
["Contact Name","Professor Conor Duggan"]
["Address","Ramsgate Park"]
[null,"Calverton Road"]
[null,"Arnold, Nottingham"]
["Postcode","NG5 8PT"]
["Telephone","01159661560"]
["Email","conor.duggan@partnershipsincare.co.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The collection of data for the Partnerships in Care (PiC) research database commenced\nin 2001 and involved patient file information from four of the organisation's medium\nsecure hospitals being abstracted to form the database. This comprised information from\n935 patients.\nSubsequently, information on an additional cohort of 859 patients from the four original\nand from two additional hospitals were added to the initial cohort so that the total number\non the database is now 1794. This makes it one of the largest databases of detained\npatients within the UK."]
["Description of confidential patient information used","(a) Mortality - date and cause of death\n(b) Hospital Episode Statistics                                                                                               Name, NHS Number, Date of birth, Hospital Number."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","29/07/2016"]
["Next Review Date","N/A"]
["Notes","May 2022 - Support Expired\nExpire support as study was given an unfavorable opinion by the REC, though a letter of conditional support was issued prior to this.   \n\nSpecific conditions of support\n1. The governance committee should consist of at least two lay representatives (case\nmanagers).\n2. Any patient who wishes to opt-out from their data being used would contact the\norganisation at Borehamwood. On receipt of this request, the Head of Research and\nDevelopment will then liaise with the IT Dept. to have the data removed."]

{"sheet":"A02155","index":199,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02155"]
["Reference","16/CAG/0157"]
["Other Refs"]
["Application Title","Case-control study for Campylobacter in the under 5s"]
["Application Summary","This application from University of Liverpool set out the purpose of an epidemiological case – control study to investigate children’s’ lifestyles, behaviours and environmental factors which made children ill from Campylobacter. The study would review the differences between children that have been ill with Campylobacter (cases) and those that have not been ill with diarrhoea and vomiting (controls). The research team would also examine the type of Campylobacter that infected the children and also assess the differences in awareness of food safety practices relating to chicken in the home and the value of preventing illness by estimating the amount that people would be willing to pay to avoid Campylobacter related illness.                                    The cases within this study would be identified by Public Health England through faecal samples that tested positive for Campylobacter. Letters of invitation and information leaflets will be sent to the parent/guardian of children with laboratory – confirmed cases from Public Health England. The application had sought s251 support to enable Public Health England to write to the identified cohort.   "]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor Sarah J O'Brien"]
["Address","Institute of Infection and Global Health"]
[null,"The Farr Institute @ HeRC, Waterhouse Building (Block F)"]
[null,"1-5 Brownlow Street, Liverpool"]
["Postcode","L69 3GL"]
["Telephone","01517958301"]
["Email","s.j.obrien@liverpool.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Laboratory-confirmed cases of campylobacter infection.                                                         The cases must have a Campylobacter positive faecal sample. The cases and controls must be 60 months old or under. The subjects must have provided their consent either online or via the post."]
["Description of confidential patient information used","Name, Address (including full postcode), Date of Birth."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Research Support Office, University of Liverpool"]
["Status","Supported"]
[]
["Outcome Date","2015-12-02"]
["Next Review Date","2017-12-02"]
["Notes","Specific conditions of support                                                                                                      1. Confidential patient information should only be retained until the activity of selecting and contacting patient had been completed. The identifiers should not be retained for the duration of the study or the specified retention period for the overall study data. Confirmed 22/10/2015\n2. The CAG sub-committee recommended that the letter be updated in line with their suggestions as noted above and that the REC review the updated letter again. Confirmed 22/10/2015                                                                                                                      UPDATED specific conditions of support\n3. Revision of the patient leaflet for factual accuracy to reflect correct approver and scope of support. Copy to be provided to CAG in 10 working days (updated)\n4. Confirmation from the REC that an amendment is or is not required in relation to the leaflet amendment, and copy of the favourable amendment outcome from the REC within one month (updated)"]

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[]
[]
["Application Number","02156"]
["Reference","CAG 5-03 (PR3)/2013"]
["Other Refs"]
["Application Title","Mortality outcome in the London COPD cohort"]
["Application Summary","COPD is a chronic and debilitating disease and is the 4th leading cause of mortality worldwide. It continues to be an increasing global health problem. COPD affects approximately 10% of men and women aged over 40 years in the UK. It is one of the commonest causes of hospital admissions, a major cause of sick days and early retirement from work.\nCOPD is associated with episodes of acute deterioration, called exacerbations. Exacerbations are important events in the natural history of COPD and contribute the most to the morbidity and mortality in COPD. We have shown them associated with faster decline in lung function, increased airway and systemic inflammatory markers when stable, poorer quality of life and healthcare costs associated with this important disease. No study has yet examined whether\nincreased lung dysfunction or inflammation is associated with mortality.\nWe would like to assess:\n1) the relationship between markers of emphysema and bronchiestasis and eventual mortality.\n2) the relationship between changes in airway inflammation over time and mortality\nWe hope that by improving our understanding of these processes, we will be able to develop future, more effective treatments, for which there is a pressing need."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Jadwiga Wedzicha"]
["Address","Centre for Respiratory Medicine, UCL Medical School"]
[null,"Royal Free Campus"]
[null,"Rowland Hill Street, London"]
["Postcode","NW3 2PF"]
["Telephone","0207 794 0500 extn 35718"]
["Email","j.wedzicha@ucl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","This study builds upon research designed to study COPD exacerbations and their impact on health status and disease progression. The application is for permission to obtain date and cause of death of previous participants in our longitudinal cohort of COPD patients who are dead or lost to followup. (between 600-700 patients)\nThe aim is (a) to examine whether measures of emphysema/bronchiestasis collected in 2003/2004 predict mortality, and (b) to see whether longitudinal changes in airway inflammation, lung function decline and exacerbation frequency predict mortality."]
["Description of confidential patient information used","Name, Date of death, date of birth, gender, cause of death.                                                           The reason for requesting access to these data is to examine the relationship between various disease markers and mortality."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor","University College London"]
["Status","Expired"]
[]
["Outcome Date","2014-01-07"]
["Next Review Date","N/A"]
["Notes","Original access to source data is now complete.   Participants consented to take part from 2013.\n\nThe study outcomes were published in a paper:\n\nDonaldson GC, Wedzicha JA. Rise In Blood Neutrophils, And Falls In Eosinophils, Over Time Is Associated With Mortality In COPD: A Joint Model Analysis. InA103. COPD: DISEASE PROGRESSION AND PROGNOSIS 2017 May (pp. A2726-A2726). American Thoracic Society.\n\nSpecific conditions of support                                                                                                       1. Favourable opinion from REC Received 28/10/2013\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 8/10/2013"]

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[]
[]
["Application Number","02157"]
["Reference","15/CAG/0103"]
["Other Refs"]
["Application Title","Behçet’s syndrome in children and young people in the United Kingdom"]
["Application Summary","This application from Alder Hey Children’s NHS Foundation Trust set out the purpose of utilising the BPSU surveillance methodology and notifications to members of the British Society of Paediatric Dermatologists, to ascertain a dataset to assess the epidemiology of Behçet’s syndrome in children and young people in the United Kingdom. Clinicians participating within the BPSU reporting mechanism will be informing cases of incidence to the BPSU office. The BPSU office notify the lead investigator and the research team will send a questionnaire consisting of specified identifiers and associated clinical data to the clinicians to complete and return. The identifiers will be kept separately from the clinical data for case verification and to de-duplicate the dataset. Once the data has been collated, the research team will remove all identifiers from the dataset to enable further analysis."]
["Applicant Organisation Name","Alder Hey Children's NHS Foundation Trust"]
["Contact Name","Dr Clare Pain"]
["Address","Consultant Paediatric Rheumatologist"]
[null,"Eaton Road"]
[null,"Liverpool"]
["Postcode","L12 2AP"]
["Telephone","01512824521"]
["Email","clare.pain@alderhey.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children below 16 years of age with suspected Behçet’s syndrome (new and follow-up cases) whom they have seen in the past month with 2 or more symptoms listed below:\n1) Oral aphthous ulceration based on symptoms or signs\n2) Skin involvement defined as erythema nodosum, pustulosis, folliculitis or acneiform lesions \n3) Positive pathergy test (skin prick test)*\n4) Eye involvement (symptoms or signs) defined as uveitis (inflammation in the front or middle of the eye) and/or retinal vasculitis (inflammation of blood vessels in the back of the eye)\n5) Genital ulceration (symptoms or signs)\n6) Family history of Behçet’s syndrome in a biological parent or sibling.\n7) Vascular involvement (symptoms/signs or radiological): Arterial or venous thrombosis     (blood clot), thrombophlebitis (inflammation of a vein) and/or aneurysm (balloonlike bulge in the wall of a blood vessel)\n8) Neurological involvement suggestive of Behçet’s syndrome."]
["Description of confidential patient information used","NHS or CHI Number, date of birth, partial postcode, gender and ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Alder Hey Children's NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2015-05-15"]
["Next Review Date","N/A"]
["Notes","Amendment request 03/01/2017                                                                                          The amendment requested the inclusion of partial data of birth (month/year) sex and ethnicity to be recorded in the clinical database.  The SLSP has been amended to represent the change that an anonymised section of the questionnaire can be sent to 2 study investigators by post – as fitting with local guidance.\nThe amendment also requested to extend the study for a further year, until May 2017.              Specific conditions of support  03/01/2017\n1. Confirmation of suitable security arrangements via IG Toolkit submission. (Confirmed v13 reviewed grade score 83% satisfactory with improvement plan in place)\n2. Confirmation of a favourable opinion from a Research Ethics Committee. (Confirmed – letter dated 06/05/2016).\n\nThe applicant confirmed that support can be expired as of 20 January 2022.\n\nThe public benefit of the study was use of the data collected to examine how many children in the UK are affected with a rare disease, Behcet’s, who looks after them and how they are treated. It has informed clinical practice internationally, improving care and service provision for this group of children.\n"]

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[]
[]
["Application Number","02158"]
["Reference","CR20/2014"]
["Other Refs"]
["Application Title","CAERPHILLY ISCHAEMIC HEART DISEASE STUDY SPEEDWELL STUDY - LONGITUDINAL STUDY OF ISCHAEMIC HEART DISEASE EARLY LIFE ORIGINS OF INSULIN RESISTANCE\nMORTALITY AND CANCER IN CHRISTS HOSPITAL SCHOOL COHORT"]
["Application Summary","The overall aim of all the projects in the COHORTs resource is to enhance our understanding of life course influences on the aetiology of chronic disease and physiological traits by examining life style, genetic and other exposures at varous wide range of different outcomes.                           More specifically; Both CaPs and Speed were intially set up in the late 1970s to look at cardiometabolic and haemostatic risk factors as predictors of future heart disease and stroke.  However over the ensuring 30 years of follow-up the range of ourcomes and phenotypes have greatly expanded so that age-related phenotypes such as cognitive function, dementia, hearing, physical perfomance and quality of life have been added especially for CaPS which is part of large multistudy collaboration.  BCG and CHS are more recent studies that were established in late 1990s when epidemiologists became very interested in how early life factors such as birth weight, post-natal growth and childhood and adolescent development could be markers of early factors (such as genetics or endocrine influences) on future obesity, glucose metabolism, diabetes, cancer and coronary heart disease.  All these studies have obtained blood samples and have consent to examine for genetic variations (SNPs) in realtion to health measures and have contributed to consortia incorporating in some cases 10,000s or 100,000s of paricipants, therefore greatly enhancing our understanding of disease pathways and potentially opening up new therapeutic treatments."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Yoav Ben-Shlomo"]
["Address","Department of Social Medicine"]
[null,"Canynge Hall"]
[null,"39 Whatley Road, Bristol"]
["Postcode","BS8 2PS"]
["Telephone","0117 928 7206"]
["Email","y.ben-shlomo@bristol.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","CaPS 2959 subjects                                                                                                            Speed 2348 subjects                                                                                                           BCG 679 subjects                                                                                                              CHS 1410 subjects"]
["Description of confidential patient information used","Mortality data, including date and cause of death, cancers and GP registration was requested. Name and date of birth would be used to link to HSCIC data."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Bristol"]
["Status","Supported"]
[]
["Outcome Date","2015-05-20"]
["Next Review Date","2024-05-20"]
["Notes","22 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – cancer data and Civil Registration Mortality data (ONS)\n\nMarch 2019 – Amendment to transfer the pseudonymised dataset held for the Caerphilly Ischaemic Heart Disease Study from the University of Bristol to the Dementia Platform UK, held by Swansea University was supported. Once transferred, ongoing cancer and mortality information will then be released from NHS Digital direct to Swansea University.\n\nSpecific conditions of support                                                                                                  1. Follow the pseudonymised method as detailed within your application form as an appropriate mechanism to exit from using confidential patient information. An update is required at Annual Review Stage.\n2. Please ensure that information in relation to the processing is available on the University website and that if future contact is planned the information sent to patients includes details of data disclosed from the HSCIC."]

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[]
[]
["Application Number","02159"]
["Reference","CR38/2014"]
["Other Refs"]
["Application Title","ADDITION - Cambridge"]
["Application Summary","The study aims to evaluate the effectiveness and cost-effectiveness of a stepwise screening programme for type 2 diabetes and intensive multi-factorial treatment in people with screen detected diabetes in English general practice.  "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Nick J Wareham"]
["Address","MRC Epidemiology Unit"]
[null,"Box 285, Institute of Metabolic Science"]
[null,"Hills Road, Cambridge"]
["Postcode","CB2 OQQ"]
["Telephone","01223 330315"]
["Email","nick.wareham@mrc-epid.cam.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","In the screening phase of the study, 135,825 people aged 40-69 years were identified from 60 practices across the East of England, 35,297 were identified at high risk of undiagnosed diabetes, 33,539 were invited for an initial blood test, 24,654 attended for blood tests and 867 people were diagnosed with type 2 diabetes and agreed to take part in the treatment phase of the study."]
["Description of confidential patient information used","Date of death and cause of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Cambridge"]
["Status","Supported"]
[]
["Outcome Date","2015-04-09"]
["Next Review Date","2024-04-09"]
["Notes","Specific conditions of support                                                                                                      1. Favourable opinion from REC Received 14 October 2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 23 March 2015."]

{"sheet":"A02160","index":204,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","02160"]
["Reference","CAG 2-07(c)/2013"]
["Other Refs"]
["Application Title","The Pesticide Users’ Health Study: Nervous system, eye, respiratory and skin disease among certified pesticide users."]
["Application Summary","This application from the Health and Safety Laboratory (HSL) detailed a large cohort study of pesticide users comprising of more than 60,000 individuals with the aim to determine whether exposure to pesticides can be associated with an increased risk of neurological disease"]
["Applicant Organisation Name","Health and Safety Executive"]
["Contact Name","Gillian Nicholls, Chief Investigator"]
["Address","HSE Science and Research Centre"]
[null,"Buxton"]
[null,"Derbyshire"]
["Postcode","SK17 9JN"]
["Telephone","020 3028 1967"]
["Email","Gillian.Nicholls@hse.gov.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Generic Health Relevance in male and females over 16 years old."]
["Description of confidential patient information used","NHS Number, Date of birth, Postcode, Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Health and Safety Laboratory"]
["Status","Supported"]
[]
["Outcome Date","2015-01-22"]
["Next Review Date","2025-01-22"]
["Notes","20 July 2020 - Amendment Request\n1. The amendment to collect further HES data from NHS Digital until the latest data that data is available for is supported, subject to compliance with the standard conditions of support.\n\n2. The amendment to transfer the NHS number from NHS Digital to National Records of Scotland (NRS), and vice versa is conditionally supported, subject to compliance with the standard and specific conditions of approval.\n\n3. The amendment to request support to amend support from a one-off data collection to being able to make further ad-hoc collections from national data when new or updated analysis is required. is not supported.\n\nAmendment Request (Approved 11/01/2018)\nThe Health and Safety Laboratory (HSL) was previously an agency of the Health and Safety Executive (HSE, the legal entity and data controller for the application activity). HSL has now become an integral part of the HSE and is now referred to as HSE Buxton or HSE’s laboratory. As such, the HSL can no longer be considered a separate data processor. The amendment requested a change to the data processor for the application activity to the Health and Safety Executive, with HSE Buxton as the location of the data processing.\nThe applicants further explained that, as part of the integration and the wider IT Infrastructure changes that are required to facilitate the above, the information which is held for this project will need to change location. It was clarified that this would affect all study data, including information received from NHS Digital.\n\nAmendment request\nThe original request to HRA CAG from the applicant was for Hospital Episode Statistics (HES) for the years 1997/98 to 2011/12, and set out precisely which fields would be requested. Since then the HSCIC has recommended adding three new fields to the data request; Episode Status (EPISTAT), patient classification (CLASSPAT) and finished admission code (FAE). Therefore, the applicant requested an amendment to their s251 support to include these fields.                 Specific conditions of support\n1. Confirmation of a favourable research ethics committee opinion. Confirmed.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 22/10/2014.\n3. Fair processing information should be included on relevant websites as advised by the ICO representative."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02161","index":205,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02161"]
["Reference","15/CAG/0179"]
["Other Refs"]
["Application Title","West Midlands Regional Children's Tumour Registry"]
["Application Summary","This application was from Birmingham Children's Hospital NHS Trust. The West Midlands Regional Children’s Tumour Registry (WMRCTR) holds data on all patients diagnosed with a childhood malignancy (or benign central nervous system tumour) aged 0-15 year inclusive within the West Midlands region. Demographic, diagnostic, treatment, outcome and follow-up data are collected. An additional long term follow up database is maintained of patients who are alive 5 years from diagnosis. This is carried out by postal follow up with the patient’s GP.\nHistorically, this specialist registry used to operate under the overarching support provided to the UKACR via Regulation 2 of the Health Service (Control of Patient Information) Regulations 2002. Following organisational structure changes from April 2013, it was noted that correspondence had taken place with Public Health England and the applicant prior to application consideration and the view provided that an individual application should be made to provide a clearer legal basis.                                                                                                     The registry was stated to be vital in allowing in-depth epidemiological, pathological and aetiological studies to be carried out on a population basis. Since its formation the WMRCTR has been involved in establishing incidence rates and trends in childhood cancer for the West Midlands region, and has been subject to peer review both in publications and presentations at national and international meetings. Other potential benefits from the WMRCTR were stated to include the continual monitoring of the health of survivors of childhood cancer through clinic based and postal follow-up. 1 in 1000 adults is now a survivor of childhood cancer. The National Cancer Survivorship Initiative and the new \"Living with and Beyond Cancer\" programme aims to develop and commission risk stratified pathways of post treatment management and improved management of the consequences of treatment. Risk stratified management is already in place in the late effects service at BCH, and the data collected through the Registry’s LTFU database will assist with further understanding of the consequences of treatment."]
["Applicant Organisation Name","Birmingham Children's Hospital NHS Foundation Trust"]
["Contact Name","Miss Helen Curry"]
["Address","Steelhouse Lane"]
[null,"Birmingham"]
[null,"West Midlands"]
["Postcode","B4 6NH"]
["Telephone","01213338249"]
["Email","helen.curry@bch.nhs.uk"]
["Medical Purposes","□","preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from a number of sources outlined above  in relation to patients diagnosed with a childhood malignancy (or benign central nervous system tumour) aged 0-15 year inclusive within the West Midlands region."]
["Description of confidential patient information used","NHS Number, Date of Birth, Date of death, Postcode, Gender, Ethnicity, "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-10-24"]
["Next Review Date","N/A"]
["Notes","Conditional support was recommended for a six month period in 2016, pending resubmission of a revised application, addressing some outstanding issues.  Support was superseded under 17/CAG/0103.\n\nFurther actions\nConsiderations should be made as part of a full application to the Confidentiality Advisory Group. It is expected that this will be considered at an April 2017 meeting (dates to be confirmed), which would require submission in March 2017.                                           Specific conditions of support\n1. Support applies for a period of six months from date of final approval 24/10/2016\n2. Detailed responses to points raised should be submitted in the form of a new application prior to expiry of the six month period.\n3. Provide a detailed response to the consideration around the possibility of obtaining prospective consent from patients for the use of their data.\n4. Provide a detailed response to the question of whether a deceased person’s data could be converted to ‘pseudonymised’ data.\n5. It is reminded that support under the Regulations does not permit onward access to identifiable data without consent. A detailed update around how onward disclosures have been managed in the interim period is required.\n6. Improvements in patient and public involvement and engagement in the proposal are strongly recommended. A detailed report against actual or planned activities is required as part of the resubmission.\n7. Provide detailed information around a clear mechanism for receiving and implementing patient dissent, taking into account the increased national importance on this aspect.\n8. Consider whether the activities described within the application should be processed under Regulation 2."]

{"sheet":"A02162","index":206,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02162"]
["Reference","16/CAG/0156"]
["Other Refs"]
["Application Title","UK FOCSS"]
["Application Summary","The application set out the purpose of assessing and comparing the performance characteristics of two screening tests given to women at risk of ovarian cancer during a longitudinal, consented study. The study findings would contribute to the evidence base that the UK National Screening Committee would consider in making a decision about the provision of a national programme for ovarian cancer screening for women at high risk.                                     Ovarian cancer was the sixth most common cancer in women in the UK and the most lethal of gynaecological cancers. Up to 10% of cases could be attributed to an inherited genetic predisposition. Women at high risk of developing this disease could be identified by genetic testing for a pathogenic gene mutation known to increase risk, or evidence of family history of cancers associated with the syndrome (e.g. ovary, breast, womb, and bowel). The only proven way to reduce the risk of developing ovarian cancer was the removal of the ovaries and fallopian tubes. However many women were unwilling to have this surgery, particularly younger women who still wished to have children. There was a demand from clinicians and high risk women to provide some form of screening, despite the lack of clear evidence of benefit.                                              The primary objective of the study was to develop an optimised screening strategy for high risk women in terms of the most appropriate screening tests, screening interval and criteria for interpretation of results."]
["Applicant Organisation Name","Department of Women's Cancer, Institute for Women's Health, UCL"]
["Contact Name","Professor Usha Menon"]
["Address","Gynaecological Cancer Research Centre"]
[null,"First Floor, Maple House"]
[null,"149 Tottenham Court Road"]
["Postcode","W1T 7DN"]
["Telephone","02034472108"]
["Email","u.menon@ucl.ac.uk"]
["Medical Purposes","Y","preventative medicine"]
[null,"Y","medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women 35 and over with a minimum 10% lifetime risk of developing ovarian cancer.                   3,563 women underwent Phase 1 screening (May 2002 - January 2008) and 4,348 women had Phase 2 screening (June 2007 – May 2012). The cohort was being followed up to monitor health, cancers and deaths until the study close date (April 2018)."]
["Description of confidential patient information used","Name, NHS Number, date of birth, mortality data, and postcode"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","UCL Joint Research Office"]
["Status","Expired"]
[]
["Outcome Date","2017-01-30"]
["Next Review Date","N/A"]
["Notes","June 2022 - Support Expired\nThe study never opened.\n\nNHS Digital queried the validity of the UK FOCSS consent when we applied to renew our data processing agreement. They advised we would need Section 251 support. We applied to CAG for permission which was subsequently approved by the HRA. \n\nHowever in November 2017 the study investigators decided NOT to set up a new data processing agreement with NHS Digital. The study had ended. \n\nSpecific conditions of support\n1. Evidence of public engagement work which has been, or will be, carried out in order to gauge the views of patients, families and the general public on this use of data.                                           The response was reviewed by the Chair, who was satisfied that PPI was being undertaken and that feedback would be incorporated to improve the study design and notifications.                                                                                                                            2. Evidence that the patient notification materials have been reviewed by patients/the public as part of this process and description of how these will be disseminated.                                           The Chair reviewed and approved the response.                                                                         3. A phone number to be provided so that patients have an alternative method of opting out.  The Chair reviewed and approved the response.                                                                   4. Favourable opinion from a Research Ethics Committee.\nCopies of REC approval letters referring specifically to versions of the study protocol, patient information sheets and consent forms were provided.\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission.\nConfirmed published and reviewed as Satisfactory.\n6. You were advised that CAG advice applies only to England and Wales – applications should be made to the relevant bodies in Scotland and Northern Ireland.                                                                                    "]

{"sheet":"A2163","index":207,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","2163"]
["Reference","16/CAG/0149"]
["Other Refs"]
["Application Title","Measuring inequalities in the access to and utilisation of genetic and genomic services across the Collaboration for Leadership in Applied Health Research and Care North West Coast Region [CLAHRC NWC"]
["Application Summary","This application from University of Central Lancashire set out the purpose of examining what helped patients make use of genetic services and possible reasons for not using these services. Research evidence had shown that factors like ethnicity, gender and level of education could affect whether or not people attended genetic services. The study would also examine if factors such as availability of transport or living in the countryside affected whether people attended the services. The research would provide evidence to inform service development across the region, and findings could be generalizable to other regional genetics services working on a similar model of service delivery.                                                                             The applicant would analyse data retrospectively for all new patients referred to the genetics service between 01 April 2013 and 31 March 2016.\nOn-site access was requested by the applicant to a limited patient dataset which would be extracted by IT services. This dataset would contain: date of referral, gender, date of birth, patient category e.g. ‘adult,'paediatric, 'pre-natal' 'cancer, source of referral e.g. 'hospital' 'GP, postcode of referrer, patient ethnicity, patient postcode. The applicant would then convert date of birth to age and postcode to MOSA area before transferring the dataset to University servers."]
["Applicant Organisation Name","University of Central Lancashire"]
["Contact Name","Mrs Sikhanyisiwe Nhamburo"]
["Address","Brook Building Room 247"]
[null,"Preston"]
[]
["Postcode","PR1 2HE"]
["Telephone","07974212077"]
["Email","snhamburo1@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from LWHT to PhD supervisor Caroline Walker in relation to new patients referred to the genetics service between 01 April 2013 and 31 March 2016"]
["Description of confidential patient information used","Date of referral, gender, date of birth, patient category e.g. ‘adult,'paediatric, 'pre-natal' 'cancer, source of referral e.g. 'hospital' 'GP',  postcode of referrer, patient ethnicity, patient postcode  "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Central Lancashire"]
["Status","Supported"]
[]
["Outcome Date","2017-03-13"]
["Next Review Date","2018-03-13"]
["Notes","Specific conditions of support\n1. Please ensure that notification about the study is posted on the hospital website and the local genetics services web site with a clear process for patients to opt out should they wish to do so. Please note that you are not required to seek consent from patients individually – patient notification refers to a public notice which is available to patients, and which enables them to opt out of inclusion in the study if they so wish.\nEvidence that patient notification will be placed on a website is included, and the text of the notification was provided via email on 23 December 2016.\nThe Chair commented that the phrase ‘anonymised’ would be preferable to ‘fully anonymised’ which the applicant had used in the patient notification.\n2. Please confirm that data will not be extracted until at least 2 months after these notifications have been posted. Confirmed in a letter dated 18 December 2016\n3. Please provide confirmation that UCLAN requires your academic supervisor to sign an undertaking in relation to duty of confidentiality. Signed Confidentiality Policy and honorary contract with confidentiality clause provided on 22 December 2016.\n4. Favourable opinion from a Research Ethics Committee. Confirmed 29 November 2016\n5. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. IGTK for Liverpool Women’s NHS FT confirmed published and reviewed as satisfactory."]

{"sheet":"A2164","index":208,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","2164"]
["Reference","17/CAG/0033"]
["Other Refs"]
["Application Title","Prospective observational study of the long term hazards of anti-TNF therapy in rheumatoid arthritis."]
["Application Summary","This application from the University of Manchester set out the purpose of monitoring the long-term safety of new drugs prescribed for rheumatoid arthritis in the NHS clinical setting. The BSRBR-RA study (a national observational study led by the British Society for Rheumatology) was set up in 2001 for this purpose.\nEach patient has consented to flagging with the national registers, access to full medical records for the completion of study questionnaires and for their name to be registered on the study database. However, the level of information within the consent form is not sufficient to fully explain the extent that participant's data will be used to link their data with NHS Digital/HES/other national organisations such as MINAP.\nThe consent form was updated in October 2016 to include linkage with HES data via NHS Digital, therefore consent is prospectively valid. As the previous consent did not include this linkage (which was not available at the time) this application is for support to carry out this linkage for patients consented into the study prior to October 2016 (previous consent form included with application)                                                                                                        Section 251 support was requested for the disclosure of confidential patient information from BSRBR-RA to NHS Digital, for patients recruited prior to October 2016"]
["Applicant Organisation Name","The University of Manchester"]
["Contact Name","Professor Kimme Hyrich"]
["Address","Arthritis Research UK Centre for Epidemiology"]
[null,"2nd Floor Stopford Bldg"]
[null,"Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone","01612755044"]
["Email","kimme.hyrich@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from NHS Digital  in relation to patients with a diagnosis of RA, who are over 16 and about to receive biologic or biosimilar therapy."]
["Description of confidential patient information used","NHS number/CHI/ HCN, date of birth and study ID transferred to NHS Digital for linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Manchester"]
["Status","Supported"]
[]
["Outcome Date","2017-03-13"]
["Next Review Date","2025-03-13"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmation provided with application.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmation provided with application.\n3. Please note that approval from CAG applies only to England and Wales – applications should be made to the appropriate bodies in Scotland and Northern Ireland for the processing of data in these countries."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02165","index":209,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02165"]
["Reference","16/CAG0142"]
["Other Refs","16/CAG0112"]
["Application Title","Epidemiology of Coeliac Disease in Southern Derbyshire"]
["Application Summary","This is a large data base of patients with coeliac disease collected by one clinician in a defined geographical area over many years. It is probably unique in being so comprehensive and detailed. It will allow diagnostic trends through the years to be determined and the causes of death compared with the general population. It will also allow the epidemiology of coeliac disease to be determined in the Asian population of Southern Derbyshire. Results of the\nanalysis will guide those health care workers involved in managing this condition and patients themselves about the frequency of diagnosis and risks to health and the best ways of managing this large group of individuals.\nEpidemiological and mortality studies will be undertaken in coeliac disease which is a branch of gastroenterology.\n"]
["Applicant Organisation Name","Royal Derby Hospital"]
["Contact Name","Dr Geoffrey K T Holmes"]
["Address","Derby Teaching Hospitals NHS FT"]
[null,"Uttoxter Road"]
[null,"Derby"]
["Postcode","DE22 3NE"]
["Telephone","01332341005"]
["Email","geoffreyholmes@compuserve.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"Y","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data base consists of 2,650 patients with coeliac disease residing in Southern Derbyshire between 1958 and 2014 by one clinician.\n"]
["Description of confidential patient information used","Full name\nAddress\nNHS or CHI number\nHospital ID no.\nGP registration\nDate of birth\nYear of birth\nDate of death\nPostcode\nGender \nEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2016-10-11"]
["Next Review Date","2017-10-11"]
["Notes","Specific conditions of support\n1. Assurance that the database will be pseudonymised.\n2. Favourable opinion from a Research Ethics Committee.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries."]

{"sheet":"A02166","index":210,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02166"]
["Reference","15/CAG/0182"]
["Other Refs"]
["Application Title","Understanding the Nature and Frequency of Avoidable Significant Harm in Primary Care (Phase 2)"]
["Application Summary","This application from the University of Nottingham set out the purpose of a retrospective cohort study (over the course of 12 months) involving case note review of primary care patients to identify instances of significant harm that are judged to be avoidable. Significant harms will include any serious adverse health events occurring during the 12 month data collection period.\nIt will involve 16 general practices in England in the retrospective cohort study. The total population of patients covered will be around 100,000; 2,500 patients in total across all of the practices. This sample will receive detailed retrospective case note review to identify the extent to which failures in primary health care contribute to any of these significant health problems.\nThe findings will be published in a report to the Department of Health, and in professional academic journals. Information will also be made available to the public and organisations/charities concerned with patient safety (using presentations/focus groups, social media, and liaison with the media).                                                                                                The stated aims were:\n1. To estimate the incidence of avoidable significant harm in primary care in England.\n2. To quantify, describe and classify the different types of avoidable significant harm, and their severity.\n3. To identify factors that, if addressed, could help reduce the incidence of avoidable significant harm in primary care in England in the future."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Anthony J Avery"]
["Address","Room D1415, D Floor, Medical School"]
[null,"Queen's Medical Centre Campus"]
[null,"Derby Road, Nottingham"]
["Postcode","NG7 2UH"]
["Telephone","01158230209"]
["Email","tony.avery@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","16 general practices in England in the retrospective cohort study. The total population of patients covered will be around 100,000; 2,500 patients in total across all of the practices. This sample will receive detailed retrospective case note review to identify the extent to which failures in primary health care contribute to any of these significant health problems."]
["Description of confidential patient information used","Names, dates of birth and NHS number\nGender, age, participating practice name. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-04-11"]
["Next Review Date","N/A"]
["Notes","Application expired with effect from 31/03/2018\n\nAmendment Request (Approved 13/12/2017)\nThe final approval for the application, which was issued in February 2016, attached a condition to the support which stated that support to process confidential patient information was only in place until 31/12/2016, as by this time it was anticipated that pseudonymised data only will be processed. Amendments were subsequently submitted to extend the duration of support to provide cover up to 31 March 2017 and 31 December 2017 respectively, which were both supported. The current amendment requested a further extension to the duration of support to provide cover up to 31 March 2018, which is the projected study end date. It was recommended in the original outcome that should the applicants require an extension to the duration of the support, this request should be submitted four weeks in advance of the proposed end date.\nThe applicants explained that the amendment was required as the applicants had completed 79% of the required data collection. The extension to support under the Regulations would enable the project to be completed. The amendment was submitted in line with the previously advised timeframe ahead of the expiration of the existing support.\nThe amendment also advised of physical relocation of servers at Cardiff University for information purposes.\n\nAmendment Request 20/03/2017\nThe final approval for the application, which was issued in February 2016, attached a condition to the support which stated that support to process confidential patient information was only in place until 31/12/2016, as by this time it was anticipated that pseudonymised data only will be processed. An amendment was subsequently submitted to extend the duration of support to provide cover up to 31 March 2017. The current amendment requested a further extension to the duration of support to provide cover up to 31 December 2017, which is the projected study end date. It was recommended in the original outcome that should the applicants require an extension to the duration of the support, this request should be submitted four weeks in advance of the proposed end date.\nThe applicants explained that the amendment was required as, whilst GPs have been recruited, they are unable to devote as much time as expected to data collection and so will take longer than expected to provide data. The amendment was submitted in line with the previously advised timeframe ahead of the expiration of the existing support.   \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Received\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. This should cover all entities and bodies processing confidential patient information e.g. University of Nottingham and the University of Cardiff (who would be supplying the technical infrastructure) Confirmed\n3. Patient information leaflet to be updated so that content does not lead to concern or undermine public confidence in the practice. Confirmed\n4. Data to be retained in identifiable form for no longer than 7 years.\n5. At least 6 weeks should be provided to enable patient information to be shared and patients given opportunity to dissent, prior to any access to identifiable data.\n6. Improved patient participation e.g. through GP patient participation group, and this should be reported against at time of annual review.\n7. Any relevant dissent must be respected.\n8. Confirmation of the specific time period for which confidential patient information will be processed, and hence how long support will be required. Support is expected to be required until 31 December 2016. At this point of time, processing of identifiable patient information should have ceased and only pseudonymised data will be processed; should this not be the case, please submit an extension 4 weeks in advance."]

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[]
[]
["Application Number","02167"]
["Reference","17/CAG/0012"]
["Other Refs"]
["Application Title","Cancer survival trends in the United Kingdom"]
["Application Summary","This application from London School of Hygiene & Tropical Medicine set out the purpose of medical research which was to estimate survival up to five years after diagnosis for patients diagnosed with a first, primary, invasive cancer in Wales and to investigate the pattern of survival for each of the main types of cancer by age, sex and calendar period. These estimates will be incorporated into a set of survival estimates for all four UK nations combined, to be submitted by the Department of Health in London to the Organisation for Economic Co-operation and Development for its biennial publication Health at a Glance.\nThe research is directly commissioned by the Department of Health on behalf of the Secretary of State. The London School of Hygiene and Tropical Medicine has been under contract with DH for eight years to undertake work of this nature, which feeds directly into policy and enables the UK to have directly comparable cancer survival statistics for all four UK nations and combined every year. Through the work carried out by the Cancer Survival Group at the London School of Hygiene and Tropical Medicine, the regional socio-economic and international inequalities in survival in the UK were identified in 1999, and have been tracked since, have been the basis for each of the national cancer plans in England in 2000, 2007, 2011 and 2015. The applicants will use the data in the study to estimate the pattern of survival by age, sex and time since diagnosis."]
["Applicant Organisation Name","London School of Hygiene & Tropical Medicine"]
["Contact Name","Professor Michel P Coleman"]
["Address","Prof of Epidemiology and Vital Statistics"]
[null,"Keppel Street"]
[null,"London"]
["Postcode","WC1E 7HT"]
["Telephone","02079272551"]
["Email","michel.coleman@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort intended to cover is all adults (men/women) between the ages of 15 and 99 years who were diagnosed with cancer during 1971 and 2013 and followed up to 31/12/2014 for each cancer separately and each age group, who were registered by the Welsh Cancer Intelligence and Surveillance Unit (WCISU). The data request refers to invasive, malignant cancers, but also other types of cancer, including in-situ (malignant but not yet invasive) and benign tumours and the small number for which this characteristic is uncertain. These data will be deployed to estimate five-year survival using a sub-cohort of patients diagnosed between 1995 and 2013 (18 year period) for whom vital status (alive, dead, emigrated or lost to follow-up) is known as at 31 December 2014. It is estimated that approximately 150,000 patients from Wales will be included."]
["Description of confidential patient information used","NHS number – quality control at WCISU (not for analysis),\n Date of Birth – required for date at diagnosis and death,\n Date of Death – required for survival calculations,\n Postcode – at unit level for geographical analysis,\n Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Department of Health"]
["Status","Expired"]
[]
["Outcome Date","2017-03-09"]
["Next Review Date","N/A"]
["Notes","04 February 2022 - Support Expired\nAll of the data has been deleted.\n\nThe public benefits that arise from this work with the provision of survival estimates for the United Kingdom for most common cancers to the Organisation of Economic Co-operation and Development (OECD), of which the UK is a member country. The results were incorporated in OECD's regular publications in the Health at a Glance series of indicators of the effectiveness of health system in managing various diseases, including cancer. Survival is the most important indicator of the effectiveness of health systems in managing cancer.\n\nSince 2017, OECD has obtained cancer survival estimates not only for the UK, but also around 50 countries worldwide, in partnership with the CONCORD programme for the global surveillance of cancer survival, which we lead in the Cancer Survival Group at the London School of Hygiene and Tropical Medicine. The CONCORD programme has separate statutory approval from the Confidentiality Advisory Group (ECC 3-04(i)/2011; last update 2 October 2021), and ethical approvals from the National Health Service Research Ethics Service (11/LO/0331; 6 October 2021), and the Ethics Committee of the London School of Hygiene & Tropical Medicine (12171; 6 October 2021).\n\nSpecific Conditions of Support\n1. Explore proportionate and practical opportunities for patient notification in relation to this specific project and identify a system to manage patient objection and dissent. Update the websites referenced to ensure transparency in relation to the data sources which supply relevant datasets to the study. A report and evidence will be required at the time of first annual review of the progress made against this condition.\n2. Explore and improve patient and public engagement opportunities specifically around this project with an appropriate cohort, particularly with a Welsh focus, in line with the project. A report and evidence will be required at the time of first annual review of the progress made against this condition.\n3. Undertake discussions with SAIL around the opportunity for potential collaboration and provide an update on this at first annual review.                                                                            4. It was acknowledged that the security assurance for this application was heavily dependent upon that which is in place for the Welsh Cancer Intelligence and Surveillance Unit (Application: CAG 6-06(a)/2014). Correspondence between the applicants and WCISU ahead of annual review is strongly recommended. It is highlighted that if there are any issues with the WCISU CPiP assurance at the time of their next annual review, this may impact on the status of this application."]

{"sheet":"A02169","index":212,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02169"]
["Reference","17/CAG/0029"]
["Other Refs"]
["Application Title","Surveillance of invasive Listeria infections in infants under 90 days of age"]
["Application Summary","This application from St George’s University set out the purpose of medical research into Listeria infection in infants. Listeria is a rare bacterial infection that can cause severe disease in babies under 3 months old and in pregnant women. Pregnant women can pass the infection to their unborn babies. This can cause miscarriage, premature birth or severe disease (such as meningitis) in newborn babies, often leaving the baby with long-term disabilities or resulting in death.\nThrough the British Paediatric Surveillance Unit (BPSU), the applicants will ask paediatricians to inform them of all babies with listeria infections in the UK and Ireland over a two years period. Paediatricians will be requested to complete a questionnaire during the illness and one when the baby is 12 months old. Data on listeria infections routinely submitted to microbiology laboratories will also be collected. The study will be included on the BPSU’s established “orange card” system of surveillance of rare diseases.\nCurrent NICE guidelines, advising doctors on antibiotic treatment for babies younger than 3 months, recommend an antibiotic combination that will treat listeria infection; however, this does not happen everywhere and some babies with possible listeria infection do not get the right antibiotics. Conversely, a recent national study of meningitis reported that only babies younger than 1 month of age had listeria meningitis, which suggested a possibility that thousands of babies between 2 and 3 months of age may be receiving antibiotics that were not needed.                                                                                                                                This study will define how common listeria is in babies aged under 3 months in the UK and Ireland, its short and long-term health complications and inform about the appropriateness of the national antibiotic guidelines in order to better prevent and treat this infection. The study will also help define the ethnic groups and areas where listeria may be a more common problem, this information is instrumental to increase awareness in pregnancy and alert the obstetricians of the need to cover listeria when treating at risk pregnant women."]
["Applicant Organisation Name","Royal Bristol Children Hospital"]
["Contact Name","Dr Stefania Vergnano"]
["Address","Level 6, UH Bristol Education and Research Centre"]
[null,"Upper Maudlin Street"]
[null,"Bristol"]
["Postcode","BS2 8AE"]
["Telephone","07770788880"]
["Email","stefania.vergnano@UHbristol.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort is all babies under the days of 90 days (3 months) with a clinical diagnosis of invasive listeria infection or suspected listeria infection treated for at least five days with appropriate antibiotics. The applicants highlight the importance of capturing every case. It is anticipated that there will be approximately 100 cases identified."]
["Description of confidential patient information used","NHS number – to triangulate data with national reference laboratories,\n Sex – analysis to establish whether there is a prevalence for the disease in either sex,\n Date of birth – to ensure all cases are captured when accessing HES/ONS and analysis to enable calculation of age at infection,\n Date of death - to calculate precise age at time of death,\n Partial postcode – for analysis to establish whether there are areas at higher risk of disease and/or clustering,\n Ethnicity – for analysis to establish whether there is a higher prevalence amongst particular ethnic groups."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","St George's University of London"]
["Status","Expired"]
[]
["Outcome Date","2017-03-20"]
["Next Review Date","N/A"]
["Notes","01 September 2020 - Support expired\nStudy ended 1 September 2020.  Demographic data used for de-duplication will be stored separately from the main database and has now been destroyed.\n\nThe study did not find any case of listeria in babies outside the neonatal period this provide evidence to change the current antibiotic guidelines that recommend the adjunct of an antibiotic for listeria till the age of 3 months. This study could reduce exposure to antibiotics of about 20,000 infants per year reducing the risk of side effects and hospital stay.\n\nSpecific Conditions of Support\n1. Support extends to England and Wales only.\n2. Use of archived tissue samples and associated data was not considered as part of this application for support. Any future requirement to use these tissue samples and their associated data would need to be submitted as an amendment to this project.\n3. Patient Notification – the patient notification poster should be revised to clearly state that identifiable data will be processed during the project. Confirmation that this poster has been updated should be provided at first annual review.\n4. Data Flow Diagram – the diagram should be updated to correct the typographical error and highlight where infant ethnicity has been collated from. Confirmation can be provided at first annual review that this revision was made.\n5. Support is required for the project from NHS Digital to enable the data processing and linkage described in the application. An update on the status of the application to NHS Digital should be provided at first annual review.\n6. Favourable opinion from a Research Ethics Committee. (Confirmed – Yorkshire and the Humber – South Yorkshire REC, issued on 29/11/2016)\n7. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Version 13 2015/16 reports a reviewed satisfactory grade at 66%)."]

{"sheet":"A02170","index":213,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2170]
["Reference","17/CAG/0025"]
["Other Refs","IRAS project ID: 218152, REC reference: 17/LO/0231"]
["Application Title","Liver transplantation as treatment for patients with hepatocellular carcinoma; a study using existing electronic data."]
["Application Summary","This application from the LSHTM set out the purpose of improving the role that liver transplantation could play as a treatment for patients with Hepatocellular carcinoma (HCC), a cancer of the liver. Survival rates were poor and liver transplantation was increasingly used as a treatment, leading to a shortage of livers. This in turn had led to an increase in the use of liver donors after cardiac death as well as brainstem death donors.  The researcher aimed to explore the incidence and mortality of HCC, assess the validity of linked national databases as a data source for HCC research, identify the impact of sociodemographic and clinical factors on treatment selection and survival of patients, and identify the outcomes of liver transplantation for patients who received a cardiac death liver donor. \n\nThe applicant requested linkage with three national databases: the National Cancer Registration and Analysis (NCRAS) database, the Hospital Episode Statistics (HES) linked to ONS database and the UK Liver Transplant (UKLT) database in order to evaluate the outcome of transplantation in HCC patients. \n\n"]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Mr David Wallace"]
["Address","15-17 Tavistock Place"]
[null,"London "]
[]
["Postcode","WC1H 9SH"]
["Telephone",7892706302]
["Email","david.wallace@lhstm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort is patients with a diagnosis of hepatocellular carcinoma over the age of 16 and who are waiting for or have undergone elective liver transplantation. "]
["Description of confidential patient information used","NHS number, gender, date of birth and postcode would be  provided to NHS Digital who would perform linkage with HES/ONS datasets and manage linkage with NHSBT and NCRAS datasets (data sent from NHSD and returned to NHSD).                                                          Date of death would be returned to the applicant. \n \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Supported"]
[]
["Outcome Date","2017-03-20"]
["Next Review Date","2024-03-20"]
["Notes","13 February 2023 \nChange in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and ONS Mortality Data \n\nAmendment supported 13 February 2023 \nTo extend the duration of ‘s251’ support until September 2024\n\n20/08/2019: Amendment request supported re-run the previously supported data linkage between the National Cancer Registration Analysis Service (NCRAS, Public Health England) and the Hospital Episodes Statistics (HES, NHS Digital) datasets.\n\nAmendment request (Approved 21/12/2018)\nThe amendment seeks to extend the scope of data collected from the data sources named in the application as follows:\n UK Liver Transplant, NHS Blood and Transplant (NHSBT) – to include 2017 and 2018,\n National Cancer Registration and Analysis Service, Public Health England (NCRAS) – to include 2016 and 2017,\n Hospitals Episodes Database, NSH Digital (HES) – to include 2017 and 2018.\nThe amendment also seeks an extension to the duration of support under the Regulations to December 2021 to facilitate the additional analysis.\n\nSpecific conditions of support\n1. Patient Notifications – provide an update at first annual review around the progress with displaying study information on the NCRAS and NHSBT websites.\n2. Study Findings Dissemination and Publication – provide an overview at first annual review around the proposed dissemination of study findings and publication. \n3. Favourable opinion from a Research Ethics Committee. (Confirmed – Brighton and Sussex REC issued on 10 February 2017). \n4. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Version 13 2015-16 shows a reviewed satisfactory grade at 70%). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number",2171]
["Reference","16/CAG/0064"]
["Other Refs","IRAS: 199545, REC: 16/NE/0042"]
["Application Title","The UK Renal Registry: a research database"]
["Application Summary","The data are already being collected by the UK Renal Registry in Bristol for national audit and quality assurance purposes with HRA exemption under s251, granted by the Secretary of State for Health. NHS Blood and Transplant collects some additional data relating to kidney transplantation. This application, as well as seeking to add research as an additional purpose, is a request for data-linkage with NHS Blood & Transport data & other databases (see below).\n\nData is already being released to the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Registry, which maintains a Europe-wide register of renal registries.\n\nThe research will be as follows:\n1. Epidemiology, including the reporting of disease rates, treatment rates and outcomes and associations between these and practice patterns.\n2. Linkage, including to HES, Public Health England, and ONS (and their equivalents in Wales, Scotland and Northern Ireland) as well as other disease registries such as Clinical Practice Research Datalink, the Intensive Care National Audit and Research Centre, the National Chronic Kidney Disease Audit, the National Diabetes Audit, the Sentinel Stroke National Audit Programme, the National Joint Registry, the National Hip Fracture Registry, the National Institute for Cardiovascular Outcomes Research.\n3. Providing end-points to quality improvement initiatives, including before-and-after studies and stepped wedge cluster randomised trials in which an intervention is being rolled out, but the order in which that happens at a unit level is randomised.\n4. Providing end-points to other previously recruited cohort studies and trials, providing these already have the necessary permissions and consent.\n"]
["Applicant Organisation Name","North Bristol NHS Trust"]
["Contact Name","Dr Zoe Plummer, Senior Project Manager (Research and Operations), The Renal Association "]
["Address","The Renal Association"]
[null,"Brandon House, Building 20a"]
[null,"Southmead Road, Bristol"]
["Postcode","BS34 7RR"]
["Telephone","0117 414 8155\n"]
["Email","zoe.plummer@renalregistry.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Conducting research on an existing non-research database (reference: PIAG 1-07c/2004). This application is a request for data-linkage between UK Renal Registry, NHS Blood & Transport data & other databases.\n\n1. All patients known to renal units with chronic kidney disease (CKD) stages 4 and 5. These patients are identified from the laboratory data held in the electronic health record.\n2. All patients with end-stage kidney disease (ESKD) treated conservatively or with dialysis or kidney transplantation. These patients are identified from the treatment time-lines and activity blocks in the electronic health record.\nFrom Laboratory Information Management Systems:\n3. All patients in primary or secondary care with acute kidney injury (AKI)."]
["Description of confidential patient information used","The following information is already collected under reference PIAG 1-07(c)/2004: name, address, postcode, date of birth, NHS number, hospital number, date of death, and data from NHS Blood and Transplant relating to kidney transplantation (such as transplant waiting list status and kidney donor characteristics)."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","North Bristol NHS Trust"]
["Status","Supported"]
[]
["Outcome Date","2017-03-07"]
["Next Review Date","2025-03-07"]
["Notes","27 January 2023 - change in data processors from;\n•\tPublic Health England (PHE) to UK Health Security Agency (UKHSA), regarding data sources Healthcare Associated Infections (HCAIs) and Novel Coronavirus (2019-nCoV)\n•\tNHS Digital, to NHS England regarding data sources – Hospital Episode Statistics (HES), and civil registrations (Deaths)\n\n03 August 2021 - Amendment supported to allow the disclosure of confidential patient information from the UK Renal Registry (UKRR) to NHS Digital in order to link to data from National Institute for Cardiac Outcomes Research (NICOR), in order to establish a centrally held cardiorenal audit and research database\n\n18 September 2020 - Amendment supported to process data collected under support in place for the UK Renal Registry audit (16/CAG/0153) for research purposes, as well as data collected for the UK Renal Registry Research Database.\n\n22 January 2020 – Amendment supported to revise the process of reviewing and approving applications made by researchers to the UK Renal Registry Database to gain access to information in the database\n\n12/04/2019: Amendment supported to change the named chief investigator, update the data flow chart for the study to bring in line with the supported data flows for the underpinning audit application (16/CAG/0153) and wider minor updates to the study protocol to reflect more accurately the patient numbers included, the types of research being undertaken and the approval process for applications wishing to use the data. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02172","index":215,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2172]
["Reference","17/CAG/0010"]
["Other Refs","IRAS: 183094, REC: 17/SC/0001"]
["Application Title","NRCT Research Database V1.0"]
["Application Summary","This research application from University of Oxford provided the following information. The UK National Registry of Childhood Tumours (NRCT) database was built up over several decades by the Childhood Cancer Research Group of the University of Oxford, and combined the administrative function as the UK cancer registry for childhood tumours with use for research into associations and risk factors for childhood cancers. The Registry function was transferred to Public Health England (for England), ISD Scotland (for Scotland) and the equivalent bodies for Wales and Northern Ireland, in April 2013. The Childhood Cancer Research Group closed in March 2014.\n\nPreviously, this activity used to operate under Regulation 2 of the Health Service (Control of Patient Information) Regulations 2002 from 2002 – 2013 and reporting was undertaken under the overarching umbrella of the UKACR. However, since transfer of the relevant registries from April 2013, the legal basis needed to be clearly put in place for continued processing. Pre-application advice was provided in 2015. It was subsequently explained that the delay in submitting an application was due to CCRG staff illness at the time of database transfer (hence approvals not addressed at the time), limited resources subsequently available and prolonged negotiations with the Office for National Statistics over mortality data held in the dataset.\n\nIt was stated that a legacy copy of the NRCT database was transferred within the University to the Richard Doll Centenary Archive (RDCA) of the Nuffield Department of Population Health, and is currently held in the Cancer Epidemiology Unit. The application indicated the database had been approved in 2012 by NRES Committee South Central- Oxford B as a Research Database (ref 12/SC/0532). Specific updates had not been provided to the CAG or its predecessor body.\n\nThe cover letter confirmed that the database includes data collected in the 1960s onwards, under the regulatory requirements of the times. With the closure of the CCRG, the applicant has been unable to locate all documentation for all of the earlier approvals. The documentation stated that the ONS agreed (August 2015) that they will act on the basis that approvals were valid at the time for collection and use of data provided by them (mortality, birth records).\n\nA recommendation for class 2, 5 and 6 support, under Regulation 5, was requested to enable the existing data held in the NRCT database to be retained and established as a research database under a clear legal basis and utilised under the new custodianship of the database. The database was built up over several decades and is to be used to provide de-identified information to researchers for use in approved, by the Data Access Oversight Committee, studies."]
["Applicant Organisation Name","Cancer Epidemiology Unit (University of Oxford)"]
["Contact Name","Professor Jane Green"]
["Address","Cancer Epidemiology Unit"]
[null,"Richard Doll Building, Nuffield Department of Population Health"]
[null,"Roosevelt Drive"]
["Postcode","OX3 7LF"]
["Telephone","01865289659"]
["Email","jane.green@ceu.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Childen listed on the National Registry of Childhood Tumours (NRCT) database"]
["Description of confidential patient information used","The following was specified:\n\nIdentifiers requested to be held on the database: Initials, full name, address, NHS Number, date/year of birth, date of death, postcode (unit level), gender, ethnicity and occupation.\n\nIdentifiers required for validation/linkage: Name, NHS Number, date of birth, date of death, postcode (unit level), grid references and derived address point/codepoint references.\n\nIdentifiers required for analysis: Name, date of birth, date of death, postcode (unit level), grid references and derived address point/codepoint references, gender, ethnicity, occupation.\n\nIt was clarified for research analyses that de-identified analysis datasets are produced and researchers will not be provided with access to identifiable data."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Oxford"]
["Status","Supported"]
[]
["Outcome Date","2017-03-28"]
["Next Review Date","2023-03-28"]
["Notes","Specific Conditions of Support (Updated)\n1. Support extends only to relevant information generated within England and Wales.\n2. Support applies only to the continued holding and retention of data collected on those children diagnosed with cancer. Additional data cannot be added to the existing holding to supplement the dataset.\n3. The database should be separated into clinical data and identifiable data. The identifiers should be sent to PHE for central retention for use with future linkage.\n4. Any request for continued or additional data linkage would be subject to a separate application and review process.\n5. Proceed with the identified proposals to improve patient notifications and provide an update on progress at first annual review.\n6. Proceed with the identified plans to improve lay representation in the project and provide an update on progress at first annual review.\n7. All research applications seeking support under Regulation 5 of these Regulations must provide evidence of a favourable ethical opinion from a Research Ethics Committee. Received 04 February 2017\n8. Confirmation from the Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Cancer Epidemiological"]

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[]
[]
["Application Number","2173"]
["Reference","CAG 2-03(PR2)/2014"]
["Other Refs"]
["Application Title","Mental Disorder & Cancer care: a data linkage study in south London II"]
["Application Summary","To link cancer registry data held with data held by SLAM, HES and mortality data which were all linked via existing approvals. The resulting pseudonymised database would be used to investigate whether people who have had a mental disorder have delayed presentation of cancer, trajectories of their cancer treatments and other incidental conditions compared to those who do not have a mental disorder."]
["Applicant Organisation Name","Kings College London"]
["Contact Name","Professor Robert Stewart"]
["Address","Institute of Psychiatry, King's College London"]
[null,"PO Box 63, De Crespigny Park"]
[null,"Denmark Hill, LONDON"]
["Postcode","SE5 8AF"]
["Telephone",2032288563]
["Email","robert.stewart@kcl.ac.uk"]
["Medical Purposes","□","preventative medicine"]
[null,"□","medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,"□","the provision of care and treatment"]
[null,"□","the management of health and social care services"]
[null,"□","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","NHS number, date of birth, Postcode (most recent home postcode) and patient first and last name"]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"□","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Kings College London"]
["Status","Expired"]
[]
["Outcome Date","2014-09-12"]
["Next Review Date"]
["Notes","Applicant confirmed study can be expired from ‘s251’ support on 18 November 2022 as the data has been pseudonymised. If further linkages/refresh are planned, applicants intend to submit a new application accordingly.\nWith regards to public benefit, the applicants confirmed that this unique linkage between mental healthcare and cancer care data has allowed several studies to be carried out on cancer as experienced by people with mental disorders. Applicants therefore hope to put together a clearer picture of how mental health may impact on quality of care which they will endeavour to flag to policy makers.\n\nApplication considered at CAG meeting on 10/04/2014.\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Received 09/07/2014\n\n2. Support is for the specified linkage only and additional applications should be made for support for further linkages. Confirmed\n\n3. Confirmation of satisfactory security arrangements via confirmation of a satisfactory IG toolkit submission. Confirmed v11 -  91%.\n\nAmendment (7/4/2017):\nThe applicant proposed to obtain the HES and ONS mortality data from PHE, as PHE\nalready held the data linked to Cancer Registry data. There would then be no need to\ncarry out linkage via NHS Digital.\nIn conjunction with PHE, the applicant would follow a pseudonymisation at source\nmethodology; this would involve both parties (SLaM and PHE) pseudonymising their NHS\nnumbers at source and the linkage would then be conducted by PHE using the\npseudonymised NHS number, as opposed to patient identifiers. Potential identifiers\nrequired for analysis (e.g. date of birth and date of death) would be truncated to month and\nyear.\n\nConfidentiality Advisory Group advice\nThe amendment requested was forwarded to the Chair who was of the opinion that the\namendment was desirable in that it would reduce the identifiability of the data, and would\nuse a dataset which already existed within PHE.\n\nConfidentiality Advisory Group conclusion\nIn line with the considerations above, the Chair agreed that the minimum criteria under the\nRegulations appeared to have been met for this amendment, and therefore advised\nrecommending support to the Health Research Authority."]

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[]
[]
["Application Number",2174]
["Reference","17/CAG/0031"]
["Other Refs","IRAS project ID: 203050"]
["Application Title","ReMLap"]
["Application Summary","This application from The Dudley group NHSFT set out the purpose of examining recovery in patients, following emergency Laparotomy, using questionnaires to capture the patient’s experience of recovery.\n\nThis high risk operation was often carried out on elderly and very unwell patients; it was known that an average of 15% would die within 30 days of surgery. Less was known about recovery, particularly after discharge. This small pilot study aimed to investigate the feasibility of a larger trial, to discover how many patients made a full recovery to the quality of life they had before the illness preceding the emergency laparotomy, and to find out about the experiences of those who did not. This research would help to inform patients about the long-term prospects of recovery, and to inform treatment during recovery.\n\nSection 251 support was requested in order to screen records to identify and contact a cohort of patients who had undergone the operation.\n\nA recommendation for class 3 and 6 support was requested in order to select and contact patients to seek their consent and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Dudley Group NHS FT"]
["Contact Name","Dr Julian Sonksen"]
["Address","Anaesthetic Department"]
[null,"Russells Hall Hospital"]
[null,"Dudley"]
["Postcode","DY1 2HQ"]
["Telephone",1384244076]
["Email","Julian.Sonksen@dgh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from Dudley Group NHS Foundation Trust in relation to patients who have undergone an emergency laparotomy"]
["Description of confidential patient information used","Access was requested to operation details and age in order to check eligibility. For eligible patients the name, hospital number, ward location and names of operating surgeons, anaesthetists and the patient’s normal medical/surgical team would be retained for the purpose of approaching first the clinician, then the patient, in relation to participation in the study."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Mrs Margaret Marriott (Clinical Research Unit, Russells Hall Hospital)"]
["Status","Expired"]
[]
["Outcome Date","2017-04-13"]
["Next Review Date","N/A"]
["Notes","Support was requested for the purposes of screening potential participants, which is now completed.\n\nThe public benefit of the REmLap study included greater awareness of the patients perspective of recovery and quality of life after major emergency abdominal surgery and better understanding of the speed and degree of recovery. This could then be used to inform future studies looking to improve outcomes and quality of recovery and life.\n\nSpecific Conditions of Support\n1. A 48 hour window should be allowed to enable patients to lodge dissent post-surgery before screening commenced.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed 28/02/17)\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed)"]

{"sheet":"A02175","index":218,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2175]
["Reference","17/CAG/0034"]
["Other Refs","IRAS: 215695"]
["Application Title","The Nuclear Community Charity Fund Chromosomal Study"]
["Application Summary","This application from the London School of Hygiene and Tropical Medicine set out the purpose of recruiting veterans exposed to ionising radiation, in order to research potential genetic damage and the possibility of transmitted genetic alterations in their children.\nThe British Government undertook a series of nuclear tests at sites through the South Pacific and Australia during the 1950-60’s in which over 22,000 British troops took part. Approximately 3000 veterans of this programme remain alive today. The question of whether these service personnel were exposed to ionising radiation as a consequence of their participation and, whether their health and that of their children has been unduly affected was raised in the decades following this testing programme and continues to be debated to this day.\nThis project aimed to carry out chromosomal analysis of cells from nuclear test veterans and their children. A control group of veterans would be matched on age, service, rank, and would have served at the same time in tropical regions but would be verified as not being present at test sites. The applicant stated that the work would help to improve understanding in this area, and would inform health and social care providers in their provision of care to this community of veterans and their families."]
["Applicant Organisation Name","Brunel University London"]
["Contact Name","Dr Rhona M Anderson"]
["Address","Work Address Department of Life Sciences"]
[null,"Institute of Environment, Health And Societies"]
[null,"Kingston Lane, Uxbridge, London"]
["Postcode","UB8 3PH"]
["Telephone",1895267138]
["Email","Rhona.Anderson@brunel.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from PHE in relation to the UK nuclear test veterans cohort"]
["Description of confidential patient information used","Access was requested to NHS number, date of birth and GP contact details."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Professor Peter Hobson (Brunel University London)"]
["Status","Expired"]
[]
["Outcome Date","2017-04-13"]
["Next Review Date","N/A"]
["Notes","Section 251 approval was obtained from the Confidentiality Advisory Committee for the purpose of patient recruitment via GP practices. The file received from NHS Digital only included NHS number, date of birth and GP practice contact details for the purpose of sending a study invitation via the GP practice. No clinical information was linked to this file. All identifiable patient information held without consent (for those who didn’t respond) under this support was deleted from all files via a destruction certificate provided on 31 January 2023.\n\nA population of (potentially) radiation exposed individuals are veterans of the British nuclear testing programme whereby it is estimated that over 20,000 UK servicemen attended at least one test site through the 1950s and 60s. The question of genetic risk to future generations remains an ongoing concern for this aged population, therefore, the Genetic and Cytogenetic Family trio (GCFT) study was undertaken to, in part, address this. The GCFT study seeks to examine if there is any chromosomal evidence of historical radiation exposure in nuclear test veterans and, if there is any evidence of an increase in genetic alterations in their adult children. The activity carried out under Regulation 5 enabled the researchers to contact and invite potential participants to this GCFT study. The cohort subsequently recruited represent an important and unique family trio grouping. The number of studies examining this question of genetic risk in exposed or potentially exposed human populations are limited, meaning the GCFT study outputs represent an important contribution with relevance beyond the nuclear test veteran population studied here, including those exposed for medical reasons and for those exposed in accidents or warfare. \n"]

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[]
[]
["Application Number",2176]
["Reference","17/CAG/0020"]
["Other Refs","IRAS project ID: 202736, REC reference: 17/NE/0025"]
["Application Title","Clinical and Biological factors associated with relapse and length of survival following relapse in UK neuroblastomas"]
["Application Summary","This application from Newcastle University set out the purpose of medical research into Neuroblastoma, which is an embryonal childhood tumour derived from cells which go on to form the sympathetic nervous system. It is one of the most difficult childhood cancers to cure with around 40% five-year survival in high risk cases (50% of all cases). Despite advances in neuroblastoma therapy relapse still occurs in 50% of high risk cases and in most high risk cases cure is no longer possible. Knowledge of factors which influence subsequent response and length of survival following relapse in neuroblastoma are important to determine which, if any, treatment at relapse is appropriate in individual cases, and may significantly affect the results obtained when evaluating new therapies for neuroblastoma in Phase I and II clinical trials.\nRecent studies report an increased frequency of recurrent, genetic abnormalities at relapse including segmental chromosomal abnormalities (SCA) and gene mutations for which a targeted treatment exists. This study is a retrospective epidemiological and genetic study which aims to determine clinical and genetic factors associated with neuroblastoma relapse and length of survival following relapse.\nThe application contains three work packages; however, the CAG considerations only extend to two of these as the second relates to children whose parents have already consented for inclusion in this study. The applicants intend to contact all 21 Paediatric Oncology principal treatment centres (formerly known as Children's Cancer & Leukaemia Group (CCLG) centres) to identify relapsed/refractory cases in the UK and Ireland diagnosed in children and young people aged 0 – 40 years from the year 2000 onwards. Eligible cases will be those who relapsed from 1st January 2000 onwards. The applicants also wish to further analyse the DNA of three children for whom consent has not been obtained for additional genetic studies and these children have died; consent has been obtained for a further 27 who are therefore not included in CAG’s consideration.\nFor work package one the CAG was asked to consider a recommendation of support to allow the relevant data extraction at the identified sites to be undertaken by clinical data co-ordinators, who are not be part of the direct care team. The extracted data will be added to an existing database, which includes cases diagnosed from four centres, from the pilot study, comprising information on all cases of recurrent neuroblastoma and will be enhanced with additional clinical, biological and treatment information from notes. Eligible cases will be those who relapsed from 01/01/2000 onwards. In the case of the four centres who have already contributed to the previous pilot study data from 2010 onwards will be collected as well as refractory cases from 2000."]
["Applicant Organisation Name","Wolfson Childhood Cancer Research Centre, Northern Institute for Cancer Research, Newcastle University"]
["Contact Name","Professor Deborah Tweddle"]
["Address","Level 6, Herschel Building,"]
[null,"Brewery Lane,"]
[null,"Newcastle upon Tyne"]
["Postcode","NE1 7RU"]
["Telephone","0191 2084421"]
["Email","deborah.tweddle@ncl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort was defined as all cases of relapsed/refractory neuroblastoma in the UK and Ireland (CAG remit extending only to England and Wales) diagnosed in children and young people aged 0-40 years from the year 2000 onwards.\n\nRelapse was defined for the project as recurrence or progression (any new lesion, soft tissue or bone) following an initial response (including partial) to any neuroblastoma therapy. Refractory disease will be defined as persistent disease after at least 2 different induction chemotherapy regimens (< partial response to induction) or patients who came off the high risk trial for refractory disease because they did not respond adequately to 2 lines of induction chemotherapy. The applicants expected to identify approximately 400 relapsed cases within the specified timeframe."]
["Description of confidential patient information used","Access to the following items of identifiable patient information was requested for the purposes described:\n Name – identify records,\n NHS number – recorded on patient record and viewed by data extractors,\n Hospital ID – recorded on patient record and viewed by data extractors,\n Date of birth – required for analysis to calculate age at diagnosis,\n Date of death – required for survival analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-05-02"]
["Next Review Date","2024-05-02"]
["Notes","Amendment supported on 09 October 2023 to extend the duration of the study until 30 September 2024 and the end of participant identification and data extraction is to be extended to 31 December 2023.\n\n01 October 2020 - Annual Review\n\nSpecific conditions of support (updated):\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Newcastle Upon Tyne Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n12 August 2020 - Amendment supported to extend the duration of the study until 31 March 2023.\n\nAdditional DSPT condition:\nNewcastle Upon Tyne Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nThe end date for the sample had been identified as 31 December 2018.\n\nSpecific Conditions of Support (Final)\n1. CAG recommendation of support extends to England and Wales only – alternative arrangements will need to be made for Scotland and Northern Ireland.\n2. Support is extended to cover the data extraction at the Paediatric Oncology Centres by staff members who are outside of the direct care team.\n3. Support is extended to cover the analysis database which holds items of confidential patient information. The following caveats were attached to this support:\na. Date of birth should be truncated to month and year format,\nb. Date of death should be replaced by a survival time calculation within the database. If date of death is required within its complete format, an amendment should be submitted to the CAG for consideration of this extension to the support.\n4. Further work is required to extend patient notification and objection for the project, accounting for the below points. An update on progress made should be provided at the time of first annual review:\na. Notifications should be available in both print and web-based,\nb. Established charity links should be utilised to further extend the distribution of information about the project,\nc. The opt-out mechanism requires further extension so this does not rely on previous treating clinicians and can be managed through communications with the applicants.\n5. Patient and Public Involvement and Engagement with the project should be extended. It was recommended that collaboration be undertaken particularly in relation to patient notification literature. An update on progress made should be provided at the time of first annual review.\n6. Favourable opinion from a Research Ethics Committee. (Confirmed – 13 March 2017)\n7. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Version 13, 2015-16, shows a published reviewed grade of satisfactory at 87%)."]

{"sheet":"A02177","index":220,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2177]
["Reference","17/CAG/0018"]
["Other Refs","IRAS project ID: 196279, REC reference: 15/LO/0992"]
["Application Title","Implementation of a Telephone-Based Case Management Intervention for Patients at risk of High Emergency Department Utilisation in the English NHS"]
["Application Summary","This application was submitted on behalf of the Nuffield Trust, however submission was made by Health Navigator, a for-profit company. The overarching activity is a randomised controlled trial (RCT) that has the objective of evaluating a proactive Health Coaching protocol aimed at preventing emergency department admissions for patients at high risk of unplanned hospital care with high care consumption. The protocol consists of regular and individualised contacts with a trained Health Coach (often a registered nurse) and includes care coordination efforts as well as advice and training to the patient. During the study period, participants and the control patients will be followed-up using health care utilisation assessment. The intervention group will also be followed using patient recorded outcomes measures, Health Coaches recorded patient outcomes measures and patient activation measures. The overall goal of this study is to investigate whether frequent visitors to emergency departments can have reduced avoidable health care utilisation through the active health control intervention. The study will be conducted in participation with Clinical Commissioning Groups and Hospital trusts in the trial sites, and will be conducted over a period of 4 years"]
["Applicant Organisation Name","Nuffield Trust (sponsored by HealthNavigator)"]
["Contact Name","An Nguyen, Head of Analytics "]
["Address","2 Smith Square"]
[null,"The Foundry"]
[null,"London, England"]
["Postcode","W6 8AF"]
["Telephone","+44 7999 732622"]
["Email","an.nguyen@hn-company.co.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Health Coaching protocol aimed at preventing emergency department admissions for patients at high risk of unplanned hospital care with high care consumption. The protocol consists of regular and individualised contacts with a trained Health Coach (often a registered nurse) and includes care coordination efforts as well as advice and training to the patient. "]
["Description of confidential patient information used","Support was requested for the following two aspects:\n\n1. The electronic transfer of all potential participant NHS Numbers (and associated risk score) to Health Navigator for review by the Health Coaches.\nAutomated screening:\nHospital records on care consumption will be reviewed automatically by a script (software application with a predictive model) on a daily or weekly basis. The script will analyse and make a risk score with help of care utilisation such as number of A&E attendances, non-elective admissions, elective admissions and outpatient visits as well as variables such as diagnosis codes, age, gender and discharge location. The result of this step is a ‘gross list’ of potential suitable patients containing NHS Numbers. The script is entirely automatic which means that no person screens any hospital data. This gross list will then be sent through a secure SFTP file transfer to the Health Coaches.\n\n2. The Health Coaches to review, on-site at each participating Trust, medical records for eligibility prior to sending invitations to participate. This would also include the Health Coaches receiving name, address and telephone number in order to seek consent.\nManual screening of medical records:\nThe Health Coaches will screen the patients on the ‘gross’ patient list using medical records. The Health Coaches searches for potential reasons to exclude patients who will not benefit from a Proactive Health Coaching intervention. The result from their assessment will be a ‘net patient’ list."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","HealthNavigator"]
["Status","Supported"]
[]
["Outcome Date","2017-05-04"]
["Next Review Date","2024-05-04"]
["Notes"]

{"sheet":"A02178","index":221,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2178]
["Reference","17/CAG/0013"]
["Other Refs","IRAS project ID: 211731, REC reference: 16/NW/0852"]
["Application Title","Do Patients with Social Deprivation present late with Dementia?"]
["Application Summary","The research study set out the purpose of establishing whether there was a relationship between the area of Liverpool patients were from, and the stage of the illness at which the patient presented to services. There was anecdotal evidence from clinical practice that patients with dementia presented later in the course of the illness and that opportunities to treat these patients earlier were being missed. The findings could influence the allocation of resources, for example to increase awareness of dementia symptoms in these areas.\n\nThe research team would collect data from assessments of new patients who presented to Mossley Hill Hospital Old Age psychiatry services with dementia. The data analyst department would extract all EPEX numbers that corresponded with patients within the Trust who received a dementia diagnosis between January 2016 and December 2016, and the particular Trust locations at which their case notes were stored. This list would be provided to three researchers who would access the case notes at each of these locations. The data would be recorded in pseudonymised form on a Mersey Care PC before leaving each location."]
["Applicant Organisation Name","Merseycare NHS Trust"]
["Contact Name","Dr Richard Barnes"]
["Address","Mossley Hill Hospital"]
[null,"Park Avenue"]
[null,"Liverpool"]
["Postcode","L18 8BU"]
["Telephone"]
["Email","richard.barnes@merseycare.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The research team would collect data from assessments of new patients who presented to Mossley Hill Hospital Old Age psychiatry services with dementia."]
["Description of confidential patient information used","Access was requested to: age, ethnicity, gender (recorded in binary fashion), MMSE (mini mental state examination) on 1st presentation, duration of symptoms, diagnosis, postcode, smoking status, alcohol use, illicit drug use and other comorbid medical conditions."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor","Pauline Parker (Mersey care NHS Foundation Trust)"]
["Status","Expired"]
[]
["Outcome Date","2017-05-08"]
["Next Review Date","N/A"]
["Notes","The study never commenced.   The research project was to have been undertaken by a ST trainee psychiatrist. Unfortunately the trainee rotated away from placement at Mersey Care and was unable to commit to time from their new post."]

{"sheet":"A02179","index":222,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2179]
["Reference","17/CAG/0060"]
["Other Refs","IRAS: 204688, REC reference: 17/WM/0134"]
["Application Title","Evaluation of the Recommended Summary Plan for Emergency Care and Treatment (RESPECT)"]
["Application Summary","This application from the University of Warwick sets out the purpose of medical research into the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) Process. The ReSPECT process aims to respect patient preferences and respect clinical judgement through shared conversations between a person and their healthcare professionals. The ReSPECT process is new for the NHS and needs to be evaluated because it is designed for use with all patients in all healthcare settings. It is designed to replace the Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) system and address issues with that system by placing a decision about whether a patient should or should not be for cardiopulmonary resuscitation within an overall care and treatment plan for emergency situation. An evaluation with sites that adopt ReSPECT early will enable an assessment of whether the process is used successfully to address such concerns and to identify whether any changes to the process are needed.\nOne of its principal aims is to make sure people understand the care and treatment options that may be available to them and that may work in a medical emergency and allow them to make healthcare professionals aware of their preferences. Past experience (e.g. Liverpool Care Pathway) has highlighted the importance of testing any changes to the way things are done. This project plans to study how, when and why these emergency treatment plans are made and the effects they have on patient care. It will use a mixture of methods for collecting information to achieve this aim.\nThe project involves a number of work packages; however, only work packages WP1B and WP3 are within the CAG considerations. The research requires the research team to access the following information from the patients’ clinical records:\n Information recorded on the ReSPECT form,\n Clinical justification for a ReSPECT recommendation,\n General information about the patient (e.g. demographic information, severity of illness measures, laboratory results).\nThis information will be linked by hospital based research staff to hospital held information on:\n NHS Safety Thermometer data for each individual patient\n Overall outcome for each individual patient (length of hospital stay, survival to discharge, discharge location type).\nThe data extraction will be undertaken by research nurses within the six acute NHS hospital sites for WP1 and WP3 in England. A diverse range of university affiliated and district general hospitals will be selected. The hospitals will also serve a diverse population consisting of different ethnicities in rural and urban areas."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Professor Gavin Perkins"]
["Address","Warwick Clinical Trials Unit"]
[null,"Warwick Medical School, University of Warwick"]
[null,"Coventry"]
["Postcode","CV4 7AL"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohorts for each work package were described as follows:\nWork Package 1B – will involve the data extraction from approximately 20 patients per site involved in the project, which will be purposively sampled from the patient records used within WP3. In the first participating Trust, the applicants will initially select up to 20 records to pilot the evaluation tool in the context of the ReSPECT process. At this stage, if it is found that the tool needed to be refined, a further sample up to 20 records would be selected for analysis. Analysis of these records will inform further sampling at the next Trust with analysis and sampling continuing in an iterative process across all six participating Trusts until there are no new changes in the pattern of consistency, transparency, and ethical reasoning. It is anticipated that there will be a total sample size of approximately 140 records, including those used in the pilot, accessed within this part of the project.\nWork Package 3 – will involve all adult inpatients meeting the inclusion criteria on the specified date of data collection for the NHS Safety Thermometer audit data collection. The applicants anticipate that this will be approximately 500 patients per site, totalling at least 3000 patients."]
["Description of confidential patient information used","The following items of confidential patient identifiable data are requested for the following purposes:\n Name – data linkage and to facilitate opt-out,\n NHS Number – data linkage and to facilitate opt-out,\n Hospital ID – data linkage and to facilitate opt-out,\n Date of birth – data linkage and to facilitate opt-out and truncated to age for analysis,\n District-level Postcode – for deprivation scoring in analysis,\n Gender – for analysis,\n Ethnicity – for analysis,\n Wider clinical information – for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Mrs Jane Prewett (University of Warwick, Research & Impact Services)"]
["Status","Supported"]
[]
["Outcome Date","2017-06-09"]
["Next Review Date","2021-06-09"]
["Notes","12 November 2019 - Amendment supported to extend the duration of the study for 12 months until 31 October 2020, and to remove Manchester University Hospitals NHS Foundation Trust from the scope of Section 251 support. \n\nAmenment Request (Approved - 3/11/2017)\nThe amendment request was for two additional sites to be added, to enable recruitment targets to be reached in the time available. This would add additional data processors to the scope of the support requested."]

{"sheet":"A02180","index":223,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2180]
["Reference","17/CAG/0044"]
["Other Refs","IRAS: 210852, REC: 17/WM/0066"]
["Application Title","S-AVANT. Follow-up to the AVANT study up to 8 and 10 years (median follow-up) in patients with colon carcinoma."]
["Application Summary","This application from Bristol Oncology Centre set out the purpose of a medical research project which was a follow-up study of participants previously randomised in the AVANT study at 8 and 10 years median follow-up. No visits to the study site, and no assessments or clinical examinations are required as data will be obtained from the medical notes of those participants who were randomised into the previous AVANT study. It is an opportunity to evaluate overall survival and therapy after relapse and to perform analysis on survival, second cancers and treatment after relapse, if any of those patients involved in the trial. It is explained in the application that the previous trial did not show prolongation of disease free survival at three years and adverse events were consistent with the safety profile for the drug being trialled (Bevacizumab in combination with FOLFOX-4 or XELOX); however, more relapses and deaths due to disease progression were observed in both bevacizumab arms which necessitates a more prolonged follow-up to assess the overall survival and to evaluate long-term results and safety.\n\nTreating teams at the investigational sites will identify participants from the previous trial from the records. Living patients will be contacted by a member of the investigator’s healthcare team or a member of the clinical research team at the site and approached for consent for the use of their data. Data from deceased patients and those patients lost to follow-up will the collated with support under the Regulations if approved.\n\nA recommendation for class 2, 3, 5 and 6 support was requested to cover the activities described within the application."]
["Applicant Organisation Name","University Hospitals Bristol"]
["Contact Name","Dr Stephen Falk"]
["Address","Bristol Oncology Centre"]
[null,"University Hospitals Bristol"]
[null,"Marlborough Street, Bristol"]
["Postcode","BS1 3NU"]
["Telephone",1173422419]
["Email","Stephen.Falk@UHBristol.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort includes all patients who were previously consented into the AVANT study, who have not subsequently withdrawn their consent from the trial and/or who opposed additional data collection. There are approximately 252 patients within the UK."]
["Description of confidential patient information used","Access was requested to the following items of confidential patient identifiable information from the investigational sites in relation to participants in the previous AVANT trial for the purposes stated:\n Name – for verification against source data (initials only) – previously collected and held by sponsor,\n Date of birth – for verification against source data – previously collected and held by sponsor,\n Gender – for verification against source data,\n Date of last contact/follow-up (routine follow up visit or phone contact),\n First relapse\n Date and site of relapse if applicable,\n If relapsed, how the relapse was diagnosed,\n Date and type of first relapse,\n Treatment after relapse for metastatic disease,\n First treatment of metastatic disease (chemotherapy and local treatment),\n Date and type of other cancer, biomarkers and adverse events occurred after AVANT database lock (31 Aug 2012) and related to bevacizumab or capecitabine administered in the AVANT study,\n Surgery,\n Survival Status - alive or deceased including date and cause of death,\n The presence of one or more additional diseases occurring alongside the primary disease (co-morbidity). These will include cardiomyopathy and/or congestive heart failure; arterial hypertension; pulmonary embolism; stroke; kidney disorders and any other disease or disorders that are recorded during the follow up period."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Gercor"]
["Status","Supported"]
[]
["Outcome Date","2017-06-09"]
["Next Review Date","2018-06-09"]
["Notes","Conditions\nThe CAG agreed that the minimum criteria under the Regulations appeared to have been met and that there was a public interest in projects of this nature being conducted, and therefore advised recommending support to the Health Research Authority, subject to compliance with the specific and standard conditions of support as set out below.\n\n1. Date of birth should be truncated to month and year format within the analysis dataset.\n2. Support is extended to England and Wales only.\n3. Favourable opinion from a Research Ethics Committee. (Received 21 February 2017)\n4. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Due to the number of sites involved with the project, it was acknowledged that the IG Toolkit Assessment for each would not be checked. However, support is recommended on the basis that each site involved has achieved a minimum of Level 2 assurance within the assessment)."]

{"sheet":"A02181","index":224,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2181]
["Reference","17/CAG/0063"]
["Other Refs","IRAS project ID: 187602"]
["Application Title","REFLECT: Recovery Following Intensive Care Treatment"]
["Application Summary","This research application from Oxford University Hospitals NHS Trust set out the purpose of investigating ways to improve the care of patients on general wards who have been discharged from the intensive care unit (ICU), given the high death rate which had been observed in this cohort (1 in 2 died before leaving hospital).\nThe applicant would achieve this aim by interviewing patients, relatives of deceased patients, interviews with staff and retrospective case record review of both surviving and deceased patients.\n\nConsent would be sought for all aspects other than the review of the records of deceased patients, for which s251 support was sought.\nThe project would combine information from several sources with experts skilled at making plans work, with the aim of putting a plan in place at local hospitals with the aim of testing it in a larger trial, and ultimately saving lives. The applicant stated that over 2300 lives would be saved in the UK each year if this plan worked and stopped only a quarter of the unexpected deaths in patients discharged from ICU.\n\nClass 1, 5 and 6 support was requested for the process of extracting and anonymising the information, for auditing, monitoring and analysing patient care and treatment, to allow access to an authorised user for one or more of the above purposes"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Mrs Sarah Vollam"]
["Address","Kadoorie Centre, Level 3"]
[null,"John Radcliffe Hospital"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone"]
["Email","sarah.vollam@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from various sites in relation to patients discharged from the ICU to a ward. "]
["Description of confidential patient information used","Access was requested to NHS number, date of birth, gender, and postcode. The applicant would be provided with a list of eligible patients, which they would further screen to ensure the cohort met the eligibility criteria. The records of these patients would be reviewed in order to identify aspects of care for improvement."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Ms Heather House, CTRG Team, University of Oxford"]
["Status","Expired"]
[]
["Outcome Date","2017-06-09"]
["Next Review Date","N/A"]
["Notes","Access to patient information was to facilitate retrieval of medical records of deceased patients. This work is complete and no identifiable data is held.\n\nThis work has resulted in several peer-reviewed publications reporting the results of the work, multiple national presentation of our findings, and adoption of the results into national clinical documents for management of patients discharged from intensive care.\n"]

{"sheet":"A02182","index":225,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2182]
["Reference","17/CAG/0058"]
["Other Refs","IRAS: 219521, REC: 17/LO/0049"]
["Application Title","National Chronic Kidney Disease Audit"]
["Application Summary","The National Chronic Kidney Disease Audit (NCKDA) collected between 2014-2016 data from 1057 general practices in England and Wales on testing of patients at risk of chronic kidney disease, as well as the identification and management of patients with chronic kidney disease. This non-research application is covered under reference CAG 6-07(c)/2013.\nThis current application requested support to allow the data to be used in future research of long term outcomes of audit participants after the audit ends, as otherwise the data would need to be deleted. The application requested support to transfer existing stored data which is currently held by Informatica. Anonymised clinical data will be stored at the London School of Hygiene & Tropical Medicine. Identifiable data (e.g. NHS numbers) will be stored separately in the secure data haven at the University College London. Future data on the outcomes (e.g. hospitalisations, deaths, heart disease, acute kidney problems in the context of other illness, complete kidney failure with need of dialysis) of patients who provided data for the audit will be collected by linking the NHS numbers to clinical records held in other databases in the coming years, thus forming a large cohort study on outcomes and health needs of patients at risk of or with chronic kidney disease in primary care.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover activities described in the application."]
["Applicant Organisation Name","Univeristy College London"]
["Contact Name","Dr Spiros Denaxas"]
["Address","UCL Institute of Health Informatics"]
[null,"222 Euston Road"]
[null,"London"]
["Postcode","NW1 2DA"]
["Telephone"]
["Email","s.denaxas@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients from the National Chronic Kidney Disease Audit (NCKDA), which collected between 2014-2016 data from 1057 general practices in England and Wales on testing of patients at risk of chronic kidney disease, as well as the identification and management of patients with chronic kidney disease."]
["Description of confidential patient information used","The data set will include the following items of confidential patient information:\n NHS Number – to be stored at UCL separately from the clinical dataset, which will be held at LSHTM – to be used for data linkage,\n GP Practice Codes/CCG codes – to be stored at UCL and utilised to calculate deprivation scoring and undertake geographical analysis,\n Gender – retained to validate data linkage at LSHTM,\n Ethnicity – for analysis – to be stored at LSHTM."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-06-12"]
["Next Review Date","2024-06-12"]
["Notes","20 January 2023 - change in data processor from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits\n\n16 May 2022 - Amendment supported\nAmendment supported to extend the duration of ‘s251’ support for 5 years until 2027, and to allow the disclosure of confidential patient information from University College London to the UK Renal Registry (UKRR) for the purposes of linkage, and for the flow back.\n\nAmendment Request (Approved 02/08/2018)\nThis amendment was submitted to seek support to reduce the flow of confidential patient information from the UK Renal Registry (UKRR) to the National Institute for Cardiovascular Outcomes Research (NICOR), hosted by Barts Health NHS Trust. The existing data flow supported the transfer of the complete UKRR dataset to NICOR. The amendment proposed reducing the dataset disclosed to NHS Number and UKRR pseudo-identifier.\n\nSpecific Conditions of Support\n1. Patient and Public Involvement and Engagement –\na. Take forward the planned activities as provided in the detailed public and patient involvement and engagement plan,\nb. Provide a report at first annual review around actual activity undertaken, together with ongoing plans.\n2. Patient Notification and Dissent –\na. Improve and extend patient notifications and dissent options over the course of the project, accounting for the requirements of the Welsh Language Act,\nb. Revise the website to include the provision of a single-page high-level overview of the project, which includes links to the more detailed sections – provide a copy of the text for consideration at first annual review.\nc. Provide a report at first annual review around progress which has been made in this progression, together with details of further plans.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 03/03/2017)\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – UCL School of Life and Medical Sciences Data Safe Haven report a reviewed satisfactory grade of 71% on Version 13, 2015-16)"]

{"sheet":"A02183","index":226,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2183]
["Reference","17/CAG/0036"]
["Other Refs","IRAS: 219826, REC: 16/LO/2145"]
["Application Title","Real-World Primary Biliary Cholangitis (PBC) patient pathways in South East England"]
["Application Summary","This application from University of Surrey set out the purpose of a feasibility study into Primary biliary cholangitis (PBC) (ICD-19 K74.3), an important rare liver disease and which is described as a model autoimmune condition. Studying rare liver diseases is challenging and case-finding is limited due to the low prevalence of the disease. There is paucity of real-world data on PBC mainly due to lack of awareness around this disease as well as due to fragmentation of data on patients with this rare condition. Currently, the availability of this information is held in different hospitals, GP surgeries and clinical laboratories. The applicants hypothesise that triangulating information from primary care, clinical laboratories and secondary care will provide an accurate real-world picture of the burden of PBC in South East England and overcome the limitations recognised in the data collected by the UK-PBC consortium."]
["Applicant Organisation Name","Royal Surrey County Hospital"]
["Contact Name","Dr Marinos Pericleous"]
["Address","Royal Surrey County Hospital"]
[null,"Egerton Road"]
[]
["Postcode","GU2 7XX"]
["Telephone"]
["Email","pericleousmarinos@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," "]
["Description of confidential patient information used","Access was requested to the following items of confidential patient information for the purposes as specified:\n NHS Number – to identify patient and perform linkage,\n Hospital ID – to enable linkage between a particular patient and the treating hospital where records of their liver disease are kept,\n Date of birth – to calculate age at diagnosis, progression free survival and age at death,\n Date of death – to calculate survival statistics including progression free and overall survival,\n Postcode (Sector Level) – to identify geographical clustering,\n Gender – ascertain disease preponderance in either sex,\n Ethnicity – ascertain disease prevalence in ethnic groups."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Sarah Martin (Royal Surrey County Hospital)"]
["Status","Supported"]
[]
["Outcome Date","2017-06-20"]
["Next Review Date","2018-06-20"]
["Notes","Specific Conditions of Support\n1. Patient Involvement and Engagement – provide an update at first annual review around the activities which have been undertaken in relation to plans set out in point three above.\n2. Patient Notification and Objection – provide an update on any patient notifications which have been undertaken, provide confirmation of which websites the project is advertised on and a summary of any dissent received (in line with point four above). This update should be provided at first annual review.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 18/01/2017)\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Royal Surrey County Hospital has a reported grade of satisfactory at 70% (Version 13, 2015-16)."]

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[]
[]
["Application Number",2184]
["Reference","17/CAG/0097"]
["Other Refs","IRAS: 228577, REC: 99/5/07"]
["Application Title","SEARCH - A population based study of genetic predisposition to ovarian cancer"]
["Application Summary","This research study from the University of Cambridge set out the purpose of obtaining epidemiological information and lymphocyte DNA on a population-based series of ovarian cases, to use in genetic association studies, and to define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes such as BRCA1 and BRCA2.\n\nMost of the ovarian cancer patients recruited since the start of the study were recruited through the local cancer registry(formerly the Eastern Cancer Registration and Information Centre - ECRIC), who would write to the patient’s GP asking the GP to send out information on the study. Participants are asked to provide a blood sample from which DNA is extracted, to complete a questionnaire on lifestyle and family history of cancer, to allow access to their medical record and for the study team to retrieve pathology material.\n\nThe application is submitted under the Precedent Set category ‘Validity of consent’. The study is still ongoing and new participants are asked to give consent for access to data from NHS Digital, ONS, PHE ‘and other central UK NHS bodies’. However, existing participants have only given specific consent for access to their medical record.\n\nThe study team state that since the outset they have accessed details on the patient’s cancer diagnosis from data held by the local Cancer Registry concerning patients’ cancer diagnosis (such as tumour size, tumour grade, node status and treatment), as well as regular updates on vital status from routine death notification data.\n\nThe applicant is now seeking to obtain cancer data from PHE, who prompted the CAG application in their letter of 17 March 2017 which asked:\n‘Please advise if the existing participants will be re-consented. If re-consenting is not feasible, please provide the definitive reasons and what alternative legal gateway is being sought to ensure compliance with the law’."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Public Health and Primary Care, Department of Oncology"]
[null,"University of Cambridge, Worts Causeway"]
[null,"Cambridge"]
["Postcode","CB1 8RN"]
["Telephone",1223761926]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from PHE relating to cases of primary malignant ovarian carcinomas diagnosed between ages 18 - 70 years."]
["Description of confidential patient information used","The applicant wishes to provide PHE with the following:\nName\nNHS Number\nDate of birth\nCancer registry number\n\nIn order to obtain information concerning:\nTumour site\nTumour morphology, grade and receptor status\nTumour size\nNumber of positive nodes\nStage\nTreatment data\nVital status\nCause of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Carolyn Read (School of Clinical Medicine, University of Cambridge)"]
["Status","Supported"]
[]
["Outcome Date","2017-06-23"]
["Next Review Date","2024-06-23"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), (including National SARS-CoV2 testing data (Hospital Episode Statistics (HES) and Electronic Health Record (EHR) as part of NCRAS)\n\nAmendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n09 November 2020 - Amendment conditionally supported to allow:\n• The disclosure of confidential patient information from the study team at University of Cambridge to Public Health England (PHE), for additional linkage of the ovarian SEARCH database to National SARS-CoV2 testing data, \n\n• and additionally to allow the data flow back to the study team at University of Cambridge from PHE (as although pseudonymised with the cancer registration number, there are sensitive data items including Covid-19 status and date of death, and the research team at University of Cambridge will be able to re-identify these patients).\n\nSpecific conditions of support\n1. Applicants are required to provide to the CAG Sub-committee updated information to go on the website, which makes it clear what information is being linked, why, and how to raise objections, within one month from the date of this letter.\n\nConfirmed - 17 November 2020: \nApplicant has responded to condition of support in application regarding updated website text. CAG content with response. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support.\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 18 August 2020\n\n28 July 2020 - Annual Review:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Public Health England (X25) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed:\nV14 published and reviewed for University of Cambridge, School of Clinical Medicine\nV13 published and reviewed for PHE\n3. Progress on public engagement work should be fed back at annual review.\n4. Please be aware that support for this activity applies only to England and Wales. An application to the appropriate approval bodies in Scotland should be made to cover the collection or processing of data in Scotland."]

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[]
[]
["Application Number",2185]
["Reference","17/CAG/0087"]
["Other Refs","IRAS: 212350, REC: 17/LO/0318"]
["Application Title","Pilot Study for the Tight-K Study"]
["Application Summary","This research study from Barts Health NHS Trust set out the purpose of investigating the effectiveness of administering potassium to patients after heart surgery, in order to prevent hearth rhythm problems. Although this treatment was commonly used, there was no scientific evidence that it worked. The applicant stated that the treatment was expensive, unpleasant for patients, and could lead to (unspecified) additional risks.\n\nThe study was a pilot which the applicant intended to run with 160 patients in order to test the feasibility of a further randomised controlled trial with 1770 patients. The pilot would specifically test the recruitment procedure and whether it would be possible to recruit an adequate number of patients within the timescale allowed, as well as testing data collection and highlighting any safety issues.\n\nSupport was requested to enable the research team to access identifiable data in order to screen for eligible patients, who would be approached either at their pre-surgery appointments by the clinician and the researcher in order to seek consent, or by the researcher via telephone, email or post.\n\nA recommendation for Class 3 and Class 6 support was requested to select and contact patients to seek their consent, and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Dr Ben O’Brien"]
["Address","St Bartholomew's Hospital"]
[null,"West Smithfield"]
[null,"London"]
["Postcode","EC1A 7BE"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from hospital waiting lists and theatre lists initially, and then from the medical notes of potentially eligible patients, in relation to those patients who would be undergoing elective coronary artery bypass surgery."]
["Description of confidential patient information used","The full medical record would be accessed in order to check the following:\n- history of previous AF.\n- previous use of medication to manage cardiac rhythm.\n- preoperative high-degree AV block.\n- preoperative serum potassium level above 5.5 mEq/L.\nThe research team would also access the patient’s contact details including phone number, email and address, in order to contact them to seek consent for the trial."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Elizabeth Clough (Joint Research and Management Office, Barts Health NHS Trust)"]
["Status","Supported"]
[]
["Outcome Date","2017-06-26"]
["Next Review Date","2018-06-26"]
["Notes","Specific conditions of support\n1. Public involvement work should be carried out to gauge the views of patients and the public on this recruitment method, and reported back to the CAG at annual review and as part of future applications.\nThe applicant advised of their plans, as follows:\n‘To consult with patient forums at Barts Healthcare, the Hatter Insitute and other institutions about the recruitment process. We will then feed this back as part of the CAG as part of the annual report and this will be used to help design any application for the main trial.\nWe plan to ask a sample of patients for their views and experiences of taking part in the pilot trial. The feedback from patients will then be incorporated into the main trial design and this will include patient views on the screening and recruitment methods used.\nWe have also invited another service user to be part of the independent Trial Steering Committee and he has accepted. We will now have two service users on the committee.’\nMembers reviewed this information and agreed that the applicant had completed all necessary actions. They were satisfied with the proposals for public engagement, and progress could be reported back at annual review.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 13 March 2017\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed via email from NHS Digital, dated 18 April 2017."]

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[]
[]
["Application Number",2186]
["Reference","17/CAG/0028"]
["Other Refs","IRAS: 216130, REC: 17/WA/0047"]
["Application Title","Professional decision making around next generation clinical genetics"]
["Application Summary","This application from Cardiff University set out the purpose of examining professional decision making processes in relation to the developing field of genomic technology.\nThe applicant described how these new technologies, such as DNA microarrays and genomic sequencing, have begun to enter clinical practice in a range of conditions. These technologies produced large amounts of data, some of which was clinically relevant, some of which was not, but large amounts of which - for example so called VUSs, variants of unknown significance – were uncertain. It was this uncertainty - whether or not a specific stretch of DNA was clinically relevant - and the decision making processes that surrounded it, that this project would examine. The applicant specifically intended to answer the question: ‘What genomic findings ‘count’ as results that should be shared with the family?’\nThe application to CAG was necessary as in order to examine decision-making processes, the applicant would be party to discussions in which patients would become identifiable to them. As part of the study, the applicant would be attending and recording MDT meetings. The recordings would be uploaded as sound files to Cardiff University server, where they would be later transcribed\nA recommendation for Class 5 and 6 support was requested for auditing, monitoring and analysing patient care and treatment and to allow access to an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Professor Adam Hedgecoe"]
["Address","School of Social Science, Cardiff University"]
[null,"Glamorgan Building, Cardiff"]
[null,"Cardiff"]
["Postcode","CF10 3WT"]
["Telephone",2920870027]
["Email","hedgecoeam@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,"Y","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from MDT meetings in relation to case discussions of patients where VUSs (variants of unknown significance – from genetic testing) feature in the decision making process."]
["Description of confidential patient information used","Audio recordings and transcription of MDT meetings.\nIdentifiable items will include: names, dates of birth, residence locations, GP names.\nOther data items will include: genetic tests results, other test results, prognosis, diagnosis, treatment options.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Helen Falconer (Research and Innovation Services, Cardiff University)"]
["Status","Supported"]
[]
["Outcome Date","2017-06-28"]
["Next Review Date","2018-06-28"]
["Notes","Specific conditions of support\n1. Please provide updated patient notifications including the statement that the researcher would leave the room with the recording equipment when a patient who has registered an objection is being discussed.\nUpdated patient notifications were provided and reviewed by the CAG, who agreed that they were satisfactory – although the notice did not explain that the personal information gathered in the process of the research was very quickly removed. Members recommended that this information be added so that patients were aware that every effort was taken to safeguard their personal information – however this was a recommendation only and support was not conditional on this point.\n2. Please confirm that the researchers will not be party to or record case discussions concerning children.\nThe CAG had accepted that this would not be feasible, as explained in the response to the request for information at 2, above.\n3. Please confirm that any patient who has not responded to a request for consent to observe their clinical consultation, or who has refused consent, will not be amongst the cases included in the observations of MDT meetings.\nOur expectation is that the majority of interviews and observations of consultations will take place after our MDT observations have started. While it is not necessary, it is possible that some of the people we observe in clinic or interview will be patients whose cases in MDT we listened to. However, because we are deleting identifiers from our sound recordings as we go, we would not be able to go back to the recording of an MDT meeting and remove all discussion of a patient who does not consent to consultation observations/interviews since, by that stage, we won’t be able to identify them (because we will have removed all identifiers).\nObviously, this would be possible prospectively, i.e. in those cases where interviews/ consultations precede MDTs (for example those cases where we wish to observe the discussion of uncertainty prior to testing), but these will be a minority. There are two ways in which this could be organised.\n1) The patient orientated researchers [Michael Arribas Ayllon and Research Assistant 2] could inform Adam Hedgecoe and Kath Job (who will be observing the MDTs) the names of those had not given/refused consent, and we could then use that as the basis for decisions around leaving MDTs when those patients’ cases come up. This has the drawback of involving the communication of patients’ names from one group of researchers to another.\n2) Alternatively we could ask for non-consent to be flagged in a patient’s notes so that at any future MDTs we could be informed that the patient had opted out and leave the meeting. The drawback of this is that it depends upon the clinical team both to flag patients in the notes and to carry that information forward into the MDT, and we as researchers cannot guarantee that this will take place.\nI would appreciate some guidance from the CAG as to which of these options is preferred as a way of excluding patients from MDT data collection on a prospective basis.\nThis response was accepted by the CAG. The request for advice was considered by the Chair, who was of the opinion that despite the drawback Option 1 would be the best option. Option 2 would be more difficult to implement, involved additional work for the clinical care team, and carried an increased risk that someone would be missed.\n4. Favourable opinion from a Research Ethics Committee. Provided 31 March 2017.\n5. Security assurance arrangements\na. The expectation is for the assessment to reach 91% within one year from final approval to avoid jeopardising the state of future approval. It is understood that the report confirms that a report to the WIGB on the progress made against the outstanding actions against the CPIP assessment by the first week of June 2017.\nb. A detailed report at time of annual review showing compliance with all outstanding actions. If there is any possibility that at time of annual review that all aspects have not been achieved, or that an improvement plan exists, this must be flagged in advance with the Advice Team following the report to WIGB in June 2017.\nc. As Professor Adam Hedgecoe is named as the lead for the outstanding aspects, to consider that this role be present at time of next consideration."]

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[]
[]
["Application Number",2187]
["Reference","17/CAG/0092"]
["Other Refs","IRAS: 224655, REC: 17/SW/0077"]
["Application Title","Evaluation of Prosthetic Joint infection (PJI) After Total Knee Replacement (TKR): Is the Assessment of Plasma Viscosity (PV) as Reliable as the Erythrocyte Sedimentation Rate (ESR)?"]
["Application Summary","This research application from University of Exeter Medical School set out the purpose of determining how effective the blood test called Plasma Viscosity (PV) would be in the assessment of joint infection after Total Knee Replacement (TKR) compared to the currently used blood test- the Erythrocyte Sedimentation Rate (ESR).\nThe research was to be carried out in response to a proposal at the hospital to replace the currently used test (ESR) with the PV test. Infection after knee replacement occurred in 1-2% of patients and was difficult to diagnose; the current ESR test combined with another blood test (the CRP) did not provide 100% accuracy in diagnosis but was a useful assessment tool.\nThe applicant stated that research was needed into the PV test before it could be used with confidence, as existing research had only established PV levels in non-infected joints. The applicant wished to establish a reference range for what happened to PV after joint replacement, particularly in infected cases, to enable them to identify abnormalities in practice, and reliably identify an infection.\nThis would be done by retrospective review of medical notes for the 300 patients on the hospital database who had undergone re-do knee replacement. The blood tests would have been completed on these patients, pre-operatively and post-operatively and the results recorded on medical notes. The researchers (three medical students from the University of Exeter medical school) would use these existing results to try and identify how well the PV correlated with the ESR and CRP. These students would access the data onsite, and transfer it to a spreadsheet in anonymised form after which it would be forwarded to a statistician for analysis.\nA recommendation for Class 1 and 6 support was requested for the purpose of extracting and anonymising the data, and to allow access to an authorised user for this purpose"]
["Applicant Organisation Name","University of Exeter Medical School"]
["Contact Name","Mr Andrew Toms"]
["Address","RD+E Hospital"]
[null,"PEOC"]
[null,"Barrack Road, Exeter"]
["Postcode","EX2 5DW"]
["Telephone",1392403562]
["Email","andrewtoms@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from the database of patients, and further from the medical records in relation to patients who had undergone revision total knee replacement, had the ESR and PV blood test pre-operatively (and infected cases who had at least one post-operative assessment of these blood tests, no earlier than 6 months after surgery)."]
["Description of confidential patient information used","Data required in order to identify the patient:\nName\nHospital number\nData to be extracted from the medical record:\n-Blood test results- to see if the patient had an infected knee replacement before surgery\n-Details of other medical history that could account for abnormal blood test results as opposed to an infected knee replacement\n-Details of knee replacement surgery from the hospital notes- to see if there was any evidence of infection found that has not been expected or found before\n-Microbiology results to see if a micro-organism was found during the operation that supports the diagnosis of an infected knee replacement\nNo identifiable data would be retained – the patient would be identified by a study number."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Mr Christopher Gardner (RD+E Hospital NHSFT)"]
["Status","Expired"]
[]
["Outcome Date","2017-06-29"]
["Next Review Date","N/A"]
["Notes","End of Study (Submitted 9/11/2017)\n\nSpecific conditions of support\n1. Please implement a mechanism to test the views of patients on this activity, and report back to the CAG at annual review. Evidence of some patient engagement work was submitted.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 10 April 2017\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. V13 for Devon and Exeter NHS Foundation Trust confirmed published and reviewed as satisfactory.\nAs the above conditions have been accepted and/or met, this letter provides confirmation of final approval. I will arrange for the register of approved applications on the HRA website to be updated with this information."]

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[]
[]
["Application Number",2188]
["Reference","17/CAG/0098"]
["Other Refs","IRAS: 228578, REC: 00/5/030"]
["Application Title","SEARCH: A population based study of genetic predisposition to endometrial cancer"]
["Application Summary","This research study from the University of Cambridge set out the purpose of investigating the role of inherited genetic variation in endometrial cancer and clinical outcomes. The study began in 1996 as one of several projects investigating genetic predisposition to a variety of cancers. This study recruited 4,000 patients with endometrial cancer and 3,400 controls.\nStudy participants (recruited via the Cancer Registry or local cancer networks by letter sent from the GP or network) were asked to provide a blood sample from which DNA was extracted, to complete a questionnaire on lifestyle and family history of cancer, to allow access to their medical record and for the study team to retrieve pathology material.\nThe application is submitted under the Precedent Set category ‘Validity of consent’. The study is still ongoing and new participants are asked to give consent for access to data from NHS Digital, ONS, PHE ‘and other central UK NHS bodies’. However, existing participants have only given specific consent for access to their medical record.\nThe study team state that since the outset they have accessed details on the patient’s cancer diagnosis from data held by the local Cancer Registry concerning patients’ cancer diagnosis (such as tumour size, tumour grade, node status and treatment), as well as regular updates on vital status from routine death notification data.\nThe applicant is now seeking to obtain cancer data from PHE, who prompted the CAG application in their letter of 17 March 2017 which asked:\n‘Please advise if the existing participants will be re-consented. If re-consenting is not feasible, please provide the definitive reasons and what alternative legal gateway is being sought to ensure compliance with the law’.\nA recommendation for class 4 and 6 support was requested to link patient identifiable information from more than"]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Public Health and Primary Care, Department of Oncology"]
[null,"Strangeways Research Laboratory, Worts Causeway"]
[null,"Cambridge"]
["Postcode","CB1 8RN"]
["Telephone",1223761926]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to linked data from Public Health England (PHE) concerning patients with cases of primary malignant endometrial carcinomas diagnosed between ages 18 - 70 years."]
["Description of confidential patient information used","Full patient details are held under consent including names and addresses.\nThe applicant would provide PHE with the following:\nName\nNHS Number\nDate of birth\nCancer registry number\nIn order to obtain information concerning:\nTumour site\nTumour morphology, grade and receptor status\nTumour size\nNumber of positive nodes\nStage\nTreatment data\nVital status"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Mrs Carolyn Read (Research Governance Officer, School of Clinical Medicine, University of Cambridge)"]
["Status","Supported"]
[]
["Outcome Date","2017-06-30"]
["Next Review Date","2024-06-30"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), (including National SARS-CoV2 testing data (Hospital Episode Statistics (HES) and Electronic Health Record (EHR) as part of NCRAS)\n\nAmendment supported 12 January 2023\nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n09 November 2020 - Amendment conditionally supported, to allow:\n• The disclosure of confidential patient information from the study team at University of Cambridge to Public Health England (PHE), for additional linkage of the endometrial SEARCH database to National SARS-CoV2 testing data, \n\n• and additionally to allow the data flow back to the study team at University of Cambridge from PHE (as although pseudonymised with the cancer registration number, there are sensitive data items including Covid-19 status and date of death, and the research team at University of Cambridge will be able to re-identify these patients).\n\nSpecific conditions of support\n1. Applicants are required to provide to the CAG Sub-committee updated information to go on the website, which makes it clear what information is being linked, why, and how to raise objections, within one month from the date of this letter.\n\nConfirmed - 17 November 2020: \nApplicant has responded to condition of support in application regarding updated website text. CAG content with response. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support.\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 18 August 2020\n\n28 July 2020 - Annual Review:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Public Health England (X25) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed\n\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. \n\nConfirmed:\nV14 published and reviewed for University of Cambridge, School of Clinical Medicine\nV13 published and reviewed for PHE\n\n3. Progress on public engagement work should be fed back at annual review.\n\n4. Please be aware that support for this activity applies only to England and Wales. An application to the appropriate approval bodies in Scotland should be made to cover the collection or processing data where data in Scotland.\n\nAs the above conditions have been accepted and/or met, this letter provides confirmation of final approval. I will arrange for the register of approved applications on the HRA website to be updated with this information."]

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[]
[]
["Application Number",2189]
["Reference","16/CAG/0118"]
["Other Refs","IRAS: 10073, REC: 10/MRE09/2"]
["Application Title","A Study of the Natural History of Renal Disease in TSC2/PKD1 Contiguous Gene Deletion Syndrome."]
["Application Summary","This application from the University of Cardiff set out the following detail. Tuberous sclerosis (TSC) is a rare, genetic condition that causes benign growths to occur in various body organs, particularly the brain, skin, kidney and heart. Other features of tuberous sclerosis include kidney (renal) cysts, seizures and intellectual impairment. Two causative genes have been identified, TSC1 and TSC2. Adjacent to TSC2 on chromosome 16, lies the gene PKD1. This gene is responsible for 85% of Autosomal Dominant Polycystic Kidney Disease, a genetic condition that causes multiple renal cysts to occur, usually in adulthood. Renal cysts are a well-recognised feature of tuberous sclerosis. There is a small subgroup of patients with tuberous sclerosis who have a more severe form of renal cystic disease, often with early or congenital onset. A gene deletion involving both TSC2 and PKD1 was described in 1994, known as the TSC2/PKD1 contiguous gene deletion syndrome.\n\nThe applicant aimed to determine the natural history of renal disease by a follow up study of these patients. This would provide important prognostic information for patients at diagnosis and help guide their management.\nA recommendation for class 4 and 6 support was requested to cover the relevant activities specified in the application, in relation to deceased patients."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Iris Egner"]
["Address","Institute of Medical Genetics"]
[null,"Cardiff University"]
[null,"Heath Park, Cardiff"]
["Postcode","CF14 4XN"]
["Telephone"]
["Email","EgnerI@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support was requested solely in relation to deceased persons. Where the referring Physician identifies a potential patient that is deceased, the applicant will ask to be informed that an eligible but deceased patient has been identified.\n\nParticipants would consist of two groups:\n1) Patients with TSC2/PKD1 contiguous gene deletions\n2) Patients with exclusive TSC1 or 2 gene alterations, not involving PKD1 (control group)."]
["Description of confidential patient information used","Requesting name, date of birth, date of death and NHS number, in order to identify and access medical notes at the respective health boards where the patient was registered. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Helen Falconer (Research and Innovation Services, Cardiff University,)"]
["Status","Supported"]
[]
["Outcome Date","2017-04-12"]
["Next Review Date","2024-04-12"]
["Notes","Amendment supported 23 April 2024 to extend the duration of support until 31 December 2024\n\n02 November 2022 – amendment supported to extend the duration of support to 31 August 2023\n\n28 September 2021- Amendment supported to extend the duration of support until 31 August 2022\n\n13 April 2021 - Amendment supported\nThe amendment, to extend the duration of support until 31 August 2021, and to increase the total recruitment target to 300 people, is supported, subject to compliance with the standard conditions of support.\n\nAmendment (30/04/2019)\nAmendment to extend the duration of support to 31 August 2020 was fully supported. \n\nAmendment - Approved (15/6/2018)\nThe amendment request an extension of the study end date to 31 August 2019, due to delays in recruitment.\n\nAmendment - Approved (2/7/2017)\nThe amendment request an extension of the study end date to 31 August 2018, due to delays in recruitment.\nThe delay in obtaining CAG approval had caused a delay in recruitment and the applicant did not anticipate that they would be able to meet the recruitment target of 255 by 30 June 2017. They currently had 209 participants recruited, and were optimistic that they would be able to recruit 46 further participants by 31 August 2018, and to complete data processing within this period. Although living participants would be consented into the study, some referred cases within this period may relate to deceased participants.\n\nSpecific conditions of support\n1. Support applies solely to deceased patients; any further use of their data outside of this specific activity should be the subject of a further amendment.\n2. Month and year of death to be recorded instead of the exact day of death.\n3. Deletion of date of birth in relation to deceased patients once the study is closed and data collection has ceased.\n4. Confirm the sample time period. Response provided confirmed that recruitment will proceed until the target of 255 participant has been reached. The study end date is currently anticipated to be the 31st August 2018.\n5. Requests for information should follow local organisational policies to ensure safe and secure receipt and response in order to maintain confidentiality.\n6. When requesting information from relevant clinicians, to ensure the correct legal basis (e.g. consent or Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 ‘section 251 support’) is clearly specified to ensure those disclosing are clear on the correct legal basis in order to fulfil their local responsibilities.\n7. Favourable opinion from a Research Ethics Committee. Received.\n8. Confirmation from the team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Version 13 published as satisfactory."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02190","index":233,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[9,0,11,0],[8,1,8,4],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[13,1,13,4],[14,1,14,4],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[27,2,27,4],[28,2,28,4],[29,2,29,4],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[34,1,34,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2190]
["Reference","17/CAG/0101"]
["Other Refs","IRAS: 227484, REC: 16/LO/2160"]
["Application Title","Acute Day Units as Crisis Alternatives to Residential Care (AD-CARE) Work package 3"]
["Application Summary","This application from University College London set out the purpose of medical research into the impact of the availability of Acute Day Units (ADU’s) on the acute readmission rates for mental health patients. ADU’s offer intensive, short-term community responses to mental health crises and aim to reduce costly and unpopular admissions, either by avoiding them or facilitating early discharge.\nThe applicants are requesting information from the Mental Health Services Dataset (MHSDS) held by NHS Digital to assess admission rates to acute psychiatric units, as well as compulsory admissions within 2014/15 and 2015/16. The aim of the study is to assess whether acute readmission rates are reduced in areas/Trusts with a more enhanced care pathway (defined as having an ADU in the pathway). The study will also examine whether patients in areas with ADU’s in the care pathway have different outcomes to similar patients who have an acute episode but do not have access to an ADU.\nA recommendation for class 2, 4 and 6 support was requested to cover activities as described within the activity."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor David Osborn"]
["Address","University College London"]
[null,"UCL Division of Psychiatry"]
[null,"149 Tottenham Court Road, London"]
["Postcode","W1T 7NF"]
["Telephone"]
["Email","d.osborn@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort will be established from all service users with records within the MHSDS who have used any acute (urgent) mental health care services for the two year study period (2014-2016). This will be defined by the use of in-patient, Acute Day Unit (ADU) or Crisis Resolution Home Treatment (CRT) services. Access to and use of these services will be used to identify the start and end of episodes of acute care. Service users will be able to contribute more than one episode of acute care. The MHSDS contains information in relation to over 1 million service users."]
["Description of confidential patient information used","The following items of confidential patient identifiable information have been requested for the purposes defined:\n NHS number – data linkage by NHS Digital,\n MHDS ID – data linkage and analysis,\n Date of birth – data linkage and analysis (MM/YY format),\n Gender – for analysis,\n Ethnicity – for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Tabitha Kavoi (University College London)"]
["Status","Expired"]
[]
["Outcome Date","2017-07-06"]
["Next Review Date","N/A"]
["Notes","June 2022 - Support Expired\nAll data destroyed and confirmed with DARS on 30 April 2021.\n\nPublication: https://pubmed.ncbi.nlm.nih.gov/34275509/\n\nNIHR Report: https://www.journalslibrary.nihr.ac.uk/hsdr/hsdr09180/#/abstract\n\nApproval granted on 28/07/2017\n\nRequest for Further Information (for Approval)\n1. Provide a complete list of every data item which will be returned from NHS Digital. (Confirmed – full dataset provided 19/07/2017).\n2. Clarify the purpose of the additional data mapping which will be undertaken with information from the census. Consider whether these outcomes could be achieved through the request for a richer dataset from NHS Digital. (Confirmed – the applicants clarified that they required Lower Super Output Area (LSOA) only to access the Deprivation Index. It was clarified that there was no requirement for full postcode to be provided).\n3. Clarify whether any correspondence has previously been undertaken with NHS Digital around the requirement to establish a legal basis for the activity described within the application. (Confirmed – applicants confirmed NHS Digital required the establishment of a legal basis to cover disclosure of the required dataset).\n\nProvisional Approval granted on 6/7/2017"]

{"sheet":"A02191","index":234,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[12,1,12,4],[35,1,35,4],[34,1,34,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[9,0,11,0],[8,1,8,4],[9,1,9,4],[10,1,10,4],[11,1,11,4],[15,0,20,0],[13,1,13,4],[14,1,14,4],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[27,2,27,4],[28,2,28,4],[29,2,29,4],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4]]}
[]
[]
["Application Number",2191]
["Reference","17/CAG/0103"]
["Other Refs","REC: 16/LO/1283, IRAS: 204132"]
["Application Title","West Midland's Regional Children's Tumour Registry"]
["Application Summary","This application from Birmingham Children's Hospital NHS Foundation Trust set out the purpose of medical research through the ongoing development of a research database. The West Midlands Regional Children’s Tumour Registry (WMRCTR) holds data on all patients diagnosed with a childhood malignancy (or benign central nervous system tumour) aged 0-15 year inclusive within the West Midlands region. Demographic, diagnostic, treatment, outcome and follow-up data are collected. An additional long term follow up database is maintained of patients who are living five years from diagnosis. This is carried out by postal follow up with the patient’s GP.\nHistorically, this specialist registry used to operate under the overarching support provided to the UKACR via Regulation 2 of the Health Service (Control of Patient Information) Regulations 2002. Following organisational structure changes from April 2013, it was noted that correspondence had previously taken place with Public Health England prior to application consideration and the view provided that an individual application should be made.\nThe application was originally considered at the CAG meeting held on 17 September 2015 when a provisional outcome was issued. The issues identified within the provisional response were not resolved until 24 October 2016, at which stage conditional support was recommended for a six month period under application reference 15CAG0179, pending resubmission of a revised application, addressing some outstanding issues.\nA recommendation for support under Regulation 2 of the Health Service (Control of Patient Information) Regulations 2002 was requested to cover activities as described in the application."]
["Applicant Organisation Name","Birmingham Children's Hospital NHS Foundation Trust"]
["Contact Name","Dr Martin English"]
["Address","Oncology Department, Birmingham Children’s Hospital"]
[null,"Steelhouse Lane,"]
[null,"Birmingham"]
["Postcode","B4 6NH,"]
["Telephone","0121 333 8242"]
["Email","martinenglish@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort is all patients diagnosed with a childhood malignancy (or benign central nervous system tumour) aged 0-15 year inclusive within the West Midlands region. Patients for inclusion will be identified by the Registry Manager and Data Manager from a number of sources including MDT meetings, the local patient administration system, pathology and radiology systems and direct correspondence from clinicians. Notifications of eligible patients from the region who were not treated at Birmingham Children’s Hospital will be provided by the West Midlands NCRAS service.\n\nThe data sources identified in the project are HES (inpatient, outpatient, A&E and mental health datasets), primary care data, NCRAS, NCRAS West Midlands and British Childhood Cancer Survivor Study (held at the University of Birmingham under the leadership of Professor Mike Dawkins, who is a Director of this WMRCT Registry)."]
["Description of confidential patient information used","The following items of confidential patient identifiable information have been requested for the purposes defined:\n Name – held in the database used for standard clinical care,\n Address – held in the database used for standard clinical care,\n NHS Number – for data linkage,\n Hospital ID – held in the database used for standard clinical care,\n GP registration – held in the database used for standard clinical care and data linkage,\n Date of birth – data linkage and analysis,\n Date of death – data linkage and analysis,\n Postcode – data linkage and analysis,\n Gender – for analysis,\n Ethnicity – for analysis."]
["S251 Class(es)","Y","Specific Support (REGULATION 2)"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor","Birmingham Children's Hospital NHS Foundation Trust"]
["Status","Supported"]
[]
["Outcome Date","2017-07-06"]
["Next Review Date","2024-07-06"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS)\n\n28 July 2020 - Annual Review:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Birmingham Women and Children's Hospital NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n06 January 2020 – Amendment supported to revise the two-year follow-up questionnaire to improve the clarity and include additional questions about the cause of the microcephaly. \n\nSpecific Conditions of Support\n1. Support is recommended on the basis that confidential patient identifiable data can be retained in respect of deceased patients. Confirmation is required in the interim report at six months from this approval around whether the patient identifiers and clinical data are stored separately within the database.\n2. Patient Notifications and Opt-Out – an interim report around the below details is required six months from the date of this approval letter:\na. Local patient information materials around the registry should be updated to provide an alternative means of raising dissent than speaking to the treating clinician,\nb. Assurance should be provided around how this alternative dissenting mechanism would be managed to ensure any dissent is respected.\n3. Patient and Public Involvement and Engagement – a report is required at first annual review to account for the following points:\na. Provide a detailed overview of the actual activity which has been undertaken in this area,\nb. Specific progress is expected with the specialist patient engagement group within Oncology/Haematology at the Birmingham Children’s Hospital,\nc. Provide an updated plan around how this activity will be carried forward through the project.\n4. Favourable opinion from a Research Ethics Committee. (Confirmed – issued 28 September 2016).\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Birmingham Children's Hospital NHS Trust IG Toolkit score on Version 14, 2016/17, is 66% reviewed satisfactory with an improvement plan in place)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number",2192]
["Reference","17/CAG/0093"]
["Other Refs","IRAS: 221729, REC: 17/NW/0356"]
["Application Title","Hodgkin Lymphoma Survivorship Questionnaire Study"]
["Application Summary","This research study, to be undertaken under supervision as part of a PhD in Epidemiology in Cancer Research, set out the purpose of investigating less well-reported nonfatal but clinically significant co-morbidities which develop in female Hodgkin Lymphoma (HL) survivors treated in childhood and young adulthood.\nMore patients were now surviving the disease long-term, due to high dose and combination chemotherapy and radiotherapy treatments. These treatments were known to be highly toxic to patients, however, and a range of nonfatal comorbidities could develop. The applicant had identified a lack of research into these co-morbidities in young women, who were amongst the first to be treated with newer, high risk treatments. The researcher would analyse the risk of developing different late effects in relation to risk factors such as age at treatment, treatment type and lifestyle factors in this cohort. The research was expected to contribute to the development of risk profiles to help inform treatment decisions, follow up policy and lifestyle decisions in these survivors.\nParticipants would be consented into the study. Support was requested to allow the research team to receive the list of eligible patients in order to exclude duplicates, ensure no deceased patients were contacted and to compare the characteristics of responders and non-responders. The invitation letters would be sent by the clinician once screened in this way by the research team.\nA recommendation for class 3 and 6 support was requested, to select and contact patients to seek their consent, and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Institute of Cancer Research, University of London"]
["Contact Name","Dr Aislinn Macklin-Doherty"]
["Address","15 Cotswold Road"]
[null,"Sutton"]
[null,"Surrey"]
["Postcode","SM25NG"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from the treating clinician (in England and Wales) in relation to Female HL survivors still alive more than 2 years after their first HL treatment, who were treated before the age of 46 years( between 1970-2015) and were currently over the age of 16."]
["Description of confidential patient information used","Access was requested to name, date of birth, NHS number, postcode, date of diagnosis and vital status."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Dr Charmaine Griffiths (Institute of Cancer Research)"]
["Status","Expired"]
[]
["Outcome Date","2017-07-25"]
["Next Review Date","N/A"]
["Notes","All patient information whose identifiable data was held without consent for this study (in order to contact them to consent) within a Microsoft Access database have now been deleted including a study ID and all other identifiers. There is no way to re-identify these patients in this study. \n\nThis study was a unique study in its length of follow up of Hodgkin Lymphoma patients including women treated up to 50 years ago. No other questionnaire has gathered information for women treated over this period of time for those treated in both adulthood and childhood. There were ultimately 237 participants enrolled who were treated at The Royal Marsden Hospital.  \n\nResults about long-term risk of thyroid disorders have been recently published and shared with participants: \n\nhttps://pubmed.ncbi.nlm.nih.gov/34738860/ \n\nThis study has provided us with important insights about long-term risk of thyroid disorders following treatment for Hodgkin Lymphoma. We have received feedback from participants who have expressed their gratitude for this information which they were able to share and help inform their GPs and facilitated improved management of their conditions. It has also been shared with the national charity Lymphoma Action who are in the processing of disseminating this work through their engagement groups and may also result in a podcast to patients about the results. We therefore feel that by undertaking this study it is contributing to a better understanding within the clinical and scientific community of how best to diagnose and manage these types of long-term side effects when they arise. \nWe are in the process of comprehensively analysing other outcomes data provided by patients responses which will further improve understanding of long term risk of treatment-related side effects, including those which have to date been poorly researched in this population such as pregnancy outcomes and osteoporosis and fracture risk. \n\nSpecific Conditions of Support\n1. The results of public involvement work should be fed back at annual review.\n2. Favourable opinion from a Research Ethics Committee. Confirmed – Favourable Opinion issued 13 July 2017.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed – Version 14 confirmed as satisfactory by email 19 July 2017."]

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[]
[]
["Application Number",2193]
["Reference","17/CAG/0024"]
["Other Refs","IRAS: 215818, REC: 17/YH/0024, Superceeded by 18/CAG/0126"]
["Application Title","Analysing Emergency and Urgent Care System Demand in Yorkshire and Humber: A data-linkage study of pre-hospital, emergency department and out of hours service data"]
["Application Summary","Addressing the long term rise in demand in EUC services is a key focus for the NHS. In the ambulance service the large proportion of urgent type calls that make up the service demand, point to the potential for an alternative response to the traditional ambulance transport to the ED. However there is currently a lack of detailed analysis of the demographic profile and characteristics of ambulance calls which would assist in deciding which calls and patients may be suitable for this alternative response.\nThis application from University of Sheffield set out the following purpose. This study aims to collect and analyse routine NHS data from a number of providers of emergency and urgent care (EUC) in the Yorkshire and Humber region and link the data to provide a coherent picture of EUC demand for a period of 60 months (2011 - 2015). It will map in detail the use of EUC services in order to identify patterns of service use and outcome by different patient and demographic groups over time; to identify groups of patients who currently utilise EUC services in different ways and who may benefit from an alternative, more appropriate approach to care.\nIt will achieve this through creating a database of routine health data to describe a detailed profile of patient demand across pre-hospital, hospital EUC settings and Out of Hours (OOH) services in Yorkshire and Humber over time, specifically to examine:\n1. A detailed picture of the pathways of care users of pre-hospital ambulance and urgent care services, OOH services, ED and inpatient services utilise.\n2. A detailed case mix analysis of these users of pre-hospital ambulance and urgent care services, OOH services, ED and inpatient services in order to understand patterns of service use by different patient groups or conditions (e.g. COPD, diabetes, mental health) and presentation based (e.g. frail elderly) in order to identify which patient groups present the greatest challenges to these services.\n3. Identify explanatory factors affecting the use of these acute and emergency services including factors modifiable by services (such as availability of services e.g. Mental health pathways) and factors not modifiable by services such as population, geographical and health factors known to affect service use.\nA recommendation for class 4, 5 and 6 support was requested to cover access."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Suzanne Mason"]
["Address","CURE, ScHARR, University of Sheffield"]
[null,"30 Regent Street"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone",1142220694]
["Email","s.mason@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Participants will be anyone who uses the Yorkshire Ambulance Service (YAS)/ NHS111, access out of hours (OOH) services and/ or emergency departments (EDs) during the 60-month period of the study, between 2011 and 2015."]
["Description of confidential patient information used","Identifiers required for validation/linkage:\n- Name\n- NHS Number\n- Data of birth\n- Date of death\n- Address\n- Postcode (unit level)\n\nIdentifiers to be retained for analysis:\n- Postcode (sector level – for deprivation scoring)\n- Gender\n- Ethnicity\n\n1. From YAS (999 and NHS 111 call data) items will cover:\n- Caller name, address/postcode, date of birth, age, gender and NHS number)\n- All data associated with the patient episode of care, for example clinical /call characteristics (incident number, type of call, type of response), presenting complaint, incident details (location of incident, date/all times relating to the incident, mode of access, disposal/discharge, disposal status (alive/dead).\n\n2. From the OOH/ED/inpatient Patient Administration system items will cover:\n- Patient identifiable details (patient name, address/postcode, date of birth, gender and NHS Number)\n- All data associated with the patient episode of care, for example date/times relating to the incident, incident number, mode of access, presenting complaint, investigations, treatments, disposal/discharge, diagnoses and disposal status (alive /dead).\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Dr Erica Wallis (Sheffield Teaching Hospitals NHS Foundation Trust)"]
["Status","Expired"]
[]
["Outcome Date","2017-04-19"]
["Next Review Date","N/A"]
["Notes","25 October 2018 - Support expired\nExpired on 25/10/2018, superceded by 18/CAG/0126\n\nAmendment (Approved - 7/8/2017)\nThe amendment requested the following two revisions to the application:\n1. Extension to the duration of support – it was acknowledged that existing approval was in place to enable the applicants to collate data for 2011-2015; however, the applicants are requesting an extension to the duration of the application scope to collect additional data for all of 2016 and part of 2017.\n2. Inclusion of an additional data source – the applicants are requesting linkage with mental health records held by Sheffield Health and Social Care NHS Foundation Trust."]

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[]
[]
["Application Number",2194]
["Reference","17/CAG/0094"]
["Other Refs","IRAS: 219895, REC: 17/NW/0345"]
["Application Title","The assessment of risk and safety in mental health services"]
["Application Summary","This application from the University of Manchester sets out the purpose of medical research into which risk assessments are currently used within mental practice within the UK, with a focus on how they are used prior to suicide, particularly in service users who been rated as low/no risk of suicide. The applicants are requesting support under the Regulations to identify a sample of 50 patients within the National Confidential Inquiry into Suicide and Homicide (NCISH) suicide database (covered under application PIAG 4-08(d)/2003), who died by suicide in 2015, following recent interaction with mental health services, where they were assessed as being low/no risk of suicide. Contact will then be made with the treating clinician of the patient to undertake a semi-structured interview around any risk assessment procedures undertaken with the service user.\nSupport is requested to use the established NCISH database to identify a cohort of relevant patients to enable their treating clinicians to be identified and approached for consent to be involved in an interview around the risk assessment tools which were used in the care of the deceased patient. This additional research purpose of the existing database is not covered in the existing research approval. Support is required for this standalone project."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Dr Nav Kapur"]
["Address","Centre for Mental Health and Safety"]
[null,"Jean McFarlane Building, University of Manchester"]
[null,"Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone"]
["Email","nav.kapur@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A sample of up to 50 patients who have died by suicide in 2015 (January – December) will be included in the study. These patients lived within the UK, were aged over 18 and classified as low/no risk of suicide at the last contact with mental health services (within three months prior to death)."]
["Description of confidential patient information used","The following data items from the NCISH database will be gathered in relation to the cohort and used for the following purposes:\n Name – validation,\n Date of birth – validation/analysis,\n Date of death – validation/analysis,\n Place of death – validation,\n Gender – validation and analysis,\n Postcode – validation and analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Lynne Macrae, Faculty Research Practice Governance Coordinator, University of Manchester"]
["Status","Supported"]
[]
["Outcome Date","2017-08-18"]
["Next Review Date","2024-08-18"]
["Notes","Specific Conditions of Support (Final)\n1. A report should be provided within six months from this letter around the patient, public and clinician involvement and engagement plans, addressing the following points:\na. An overview of actual activity which has occurred together with the outcomes/findings of this work,\nb. Details of how any feedback had been acted on,\nc. Updated plans for ongoing involvement and engagement.\n2. Correct the document reference in the footer for the invitation to clinicians letter prior to use.\n3. Support extends to England and Wales only.\n4. Favourable opinion from a Research Ethics Committee. (Confirmed – issued on 28 June 2017)\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – National Confidentiality Inquiry into Suicide and Homicide shows a reported grade of 77% satisfactory on version 14, 2016-17)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02195","index":238,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2195]
["Reference","16/CAG/0147"]
["Other Refs","IRAS: 213096, REC: 16WA0296"]
["Application Title","Understanding the police response to vulnerability and risk"]
["Application Summary","This application from Public Health Wales set out the following detail. This project is funded by the Police and Crime Commissioner for South Wales (through the Police Innovation Fund) and Public Health Wales (PHW), and has been developed by the Policy Lead for Public Health and Policing in collaboration with The National Society for the Prevention of Cruelty to Children (NSPCC) Cymru.\n\nThe vision of the project is that the police and partners will have the right knowledge, skills and support to identify and respond appropriately and effectively to early indicators of harm and vulnerability, breaking the generational cycle of crime. Early intervention has been adopted as a key principle by the South Wales Police and Crime Commissioner, and the memorandum of understanding with PHW commits both organisations to make every effort to ensure that individuals are supported to follow a health benefiting and crime free life. This research underpins the priorities of both organisations and aligns with the Well-being of Future Generations (Wales) Act (2015) which focusses on improving the social, economic, environmental and cultural well-being of Wales and mandates public bodies to think more about the long-term, work better with people, their communities and each other, look to prevent problems, and take a more joined-up approach. Additionally, looking to address vulnerability and risk through early intervention approaches aligns the project with the first two PHW strategic objectives: ‘working in a different way to improve our health’ and ‘giving our children a great start in life’."]
["Applicant Organisation Name","Public Health Wales"]
["Contact Name","Dr Katharine Ford"]
["Address","No 2 Capital Quarter"]
[null,"Tyndall Street"]
[null,"Cardiff"]
["Postcode","CF10 4BZ"]
["Telephone"]
["Email","katharine.ford@wales.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","As part of the application the applicants are not seeking to access NHS patient data. For the Niche and associated statutory partners data mapping, access will be sought to data held by the police and all statutory partners who receive the Police Protection Notification (PPN) referrals. This is historically collected data which it would be impractical to seek consent for. This data is identifiable so that the data sets held by different agencies can be matched so the applicant can fully understand the outcome of the PPN for individuals and researchers can therefore understand the journey that individuals follow once vulnerability is identified. This data will identify opportunities for change and other approaches to the response to vulnerability by the police and local services and will be used to create anonymous case studies to demonstrate the system.\n\nThe statutory agencies that receive the PPNs and therefore whom the applicant would seek access to personal identifiable data include:\n- Bridgend Local Authority Social Services (Child and Adult Services)\n- Victim Support\n- Domestic Abuse services- Calan DVS and Atal Y Fro,"]
["Description of confidential patient information used","As indicated in the application, examples of data sources the applicant would seek to include in this scoping exercise are:\n- Police data: including data on anti-social behaviour, violence (South Wales Police, Business Intelligence).\n- Ambulance call out data (Welsh Ambulance Services Trust)\n- Emergency department assault data (A&E ABMUHB, C&VUHB and CTUHB data)\n- Welsh Pupil Level Annual Schools Census and Pupil Attainment dataset (PLASC): (Welsh Government School Statistic team)\n- Emergency Hospital Admissions Data for Violence (EHAV) (Patient Episode Database for Wales (PEDW))\n- Local authority schools data (Local authority)\n- Social service data (e.g. child and adult services) (e.g. UK Data Service, www.daffodilcymru.org.uk)"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Laura Rossiter (Public Health Wales)"]
["Status","Expired"]
[]
["Outcome Date","2017-01-27"]
["Next Review Date","N/A"]
["Notes","Study Expired, Section 251 Support no longer required (Closure Report Submitted 23/11/2017)\n\nSpecific Conditions of Support (Updated 20/01/2017)\n1. Support will only be given at this time in relation to the data held by the Local Authority Social Services. Should the applicant wish to extend this to information specifically held by the PPU (and not subsequently transferred to the Local Authority), further information should be provided to aid the understanding of how this data falls within the extended scope of the definition of ‘patient information’. This information can be submitted as part of the response to provisional opinion, or later as an amendment to the study, as per the applicant’s preference. Confirmation received from the applicant (07/12/2016) that the PPU was the Niche database and was outside the remit of CAG – no further action required.\n2. Support only extends so far and to the extent that the use of data held by the Local Authority falls outside the consent to data sharing already given by service users. To the extent that the disclosure would fall within the scope of such consent there would, be no need for support and the activity could take place on the basis of that consent.\n3. Favourable opinion from a Research Ethics Committee. Received dated 21/10/16.\n4. Security assurance arrangements:\na. The expectation is for the assessment to reach 91% within one year from final approval to avoid jeopardising the state of future approval. It is understood that the report confirms that a report to the WIGB on the progress made against the outstanding actions against the CPIP assessment will be required in the October 2017 meeting.\nb. There should be full compliance with regards to a mechanism to respect patient/service user objection. The CAG will look specifically at this aspect at time of annual review.\nc. A detailed report at time of annual review showing compliance with all outstanding actions. If there is any possibility that at time of annual review that all aspects have not been achieved, or that an improvement plan exists, this must be flagged in advance with the Advice Team following the report to WIGB in October 2017.\nd. As the Head of IG is named as the lead for the outstanding aspects, to consider that this role be present at time of next consideration."]

{"sheet":"A02196","index":239,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2196]
["Reference","17/CAG/0082"]
["Other Refs","IRAS: 223176, REC: 11/LO/1718"]
["Application Title","Do specialist cancer services for teenagers and young adults (TYA) add value?"]
["Application Summary","This application from UCL set out the purpose of investigating the effectiveness of services for Teenagers and Young Adults (TYA) with cancer. NICE guidance states that all young people should have access to specialist services but provision in England was variable and there was no clear definition of ‘specialist care’. The study began to recruit young people aged between 13 and 24 years in 2012, to complete the BRIGHTLIGHT survey at 5-7 months after diagnosis, and then at 12, 18, 24 and 36 months. The final wave at 36 months is still underway, due for completion in April 2018.\nWhile participants consented to receive surveys at the above intervals, the following activities take place with CAG support:\n1. Data linkage with NHS Digital (to obtain HES data) – approved in 2014 under the reference ECC 8-05(d)/2011 under the Precedent Set criteria ‘Validity of consent’.\n2. Amendment made under the reference ECC 8-05(d)/2011 - Quality Health to administer surveys on behalf of the research team\n3. Amendment made under ECC 8-05(d)/2011 – to allow the applicant to obtain demographic data from PHE concerning the total population (TYA with cancer) in order to compare demographic features of the consented cohort with this entire population.\nThe current application is prompted by PHE, who flagged that data held under consent has been held for longer than the terms of that consent: the consent form stipulated that contact details would be held for 3 years, the expected duration of the study. Due to delays in approvals and recruitment, the three year period has now been exceeded. The applicant wishes to retain the contact details for continued activity necessary to carry out the study, including sending a newsletter to the cohort to inform them of study progress and to use the postcode for data linkages with PHE and NHS Digital.\n\nThe applicant was under the impression that REC approval to retain contact details provided an adequate basis for doing so.\n\nAlthough this aspect is not directly connected to the data linkage with PHE, PHE stated that they cannot release any data as the legal basis for retention of the contact details is in question. They do not consider the consent given by participants to cover the continued retention of patient contact details beyond the time specified in the consent form, and the REC approval does not provide a legal basis for this. The applicant is therefore applying for Section 251 support for this activity.\n\nA recommendation for class 1, 4 and 6 was requested to obtain and use information about past or present geographical location, to link patient identifiable information obtained from more than one source, to allow access to an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","University College London Hospitals NHS Foundation Trust"]
["Contact Name","Dr Rachel Taylor"]
["Address","1st Floor Central"]
[null,"250 Euston Road"]
[null,"London"]
["Postcode","NW1 2PG"]
["Telephone"]
["Email","rtaylor13@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Teenagers and Young Adults (TYA) with cancer. \nRecruited young people aged between 13 and 24 years in 2012, to complete the BRIGHTLIGHT survey at 5-7 months after diagnosis, and then at 12, 18, 24 and 36 months. The final wave at 36 months is still underway, due for completion in April 2018."]
["Description of confidential patient information used","Data is already held under consent in relation to teenagers and young adults with cancer\n\nPostal address, email address and phone number – consent form stated that these details would be held for 3 years, which time period has now expired for some participants. \n\nContact details are retained in order to update participants on the study. The applicant has also mentioned using these details to contact patients about other studies and states that this is included on the consent form. \nPostcode is held in order to make the necessary data linkages \n\nFor information  only\nThe applicant also holds date of birth and NHS number for each participant to carry out linkages (the linkage has been approved under the previous application to CAG to access HES data). These details were provided under consent and no timeframe was specified in the consent form for the retention of these specific data items. The patient information provided stated that linkages would be made with participant’s medical records and the Cancer Registry. The applicant considers these data items to be covered under consent and PHE did not query this. \nOther identifiers are also held for analysis under the original support and consent for this aspect is not currently in question."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Gemma Jones, Clinical Trials Operations Manager, UCL"]
["Status","Supported"]
[]
["Outcome Date","2017-08-21"]
["Next Review Date","2024-08-21"]
["Notes","01 August 2023 - change in data processor from NHS Digital to NHS England regarding Hospital Episode Statistics (HES) data"]

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[]
[]
["Application Number",2197]
["Reference","17/CAG/0076"]
["Other Refs","IRAS: 221205, REC: 17/SC/0371"]
["Application Title","The Invasive Dentistry – Endocarditis Association (IDEA) Study: A Study of the link between invasive dental procedures and critical medical events including infective endocarditis, myocardial infarction, stroke, pulmonary embolus and spontaneous pre-term birth."]
["Application Summary","This research application from the University of Sheffield set out that there is a concern that bacteria entering the circulation during invasive dental procedures (IDP) could lead to critical medical conditions including infective endocarditis (IE), myocardial infarction (MI), stroke, pulmonary embolus (PE) and spontaneous pre-term-birth (SPTB). Most concern has centred on IE, a heart infection with 30% first-year mortality where oral bacteria are the causal organism in 35-45% of cases. Before 2008 it was standard care for people at risk of IE to receive antibiotics before IDP. The effectiveness of doing this has never been proven, and in 2008 NICE recommended this should stop. However, the UK is the only country where antibiotics are not recommended for those at high-risk of IE and a recent study found that UK IE incidence has risen since 2008. The purpose of this study is to determine if there is a link between IDP and IE."]
["Applicant Organisation Name","The University of Sheffield\nAcademic Unit of Oral & Maxillofacial Medicine & Surgery"]
["Contact Name","Professor Martin H. Thornhill"]
["Address","University of Sheffield, School of Clinical Dentistry"]
[null,"Claremont Crescent"]
[null,"Sheffield"]
["Postcode","S10 2TA"]
["Telephone"]
["Email","m.thornhill@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support was requested to enable national data on courses of dental treatment and hospital admissions for infective endocarditis (IE), myocardial infarction (MI), stroke, pulmonary embolus (PE) or spontaneous pre-term-birth (SPTB) to be linked by NHS Digital, prior to returning a pseudonymised dataset to the applicant to investigate if there is a temporal link or association between invasive dental procedures and any of these events."]
["Description of confidential patient information used","Hospital Episode Statistics data will be used to identify patients who develop IE, MI, stroke, PE or SPTB and, using identifiable information, link this to routinely collected dental data to identify those who had an IDP in the period preceding their medical event."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor","Chris Deery, Univeristy of Sheffield"]
["Status","Expired"]
[]
["Outcome Date","2017-09-27"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed January 2023 that ‘s251’ support is no longer required, as NHS Digital and NHSBSA have now destroyed the data extracts that they held containing patient identifying information they used to produce the anonymised versions for the study team.\n\nIn terms of public benefit, the data from the study has resulted in the publication of two papers in international peer reviewed clinical research journals.\n\nSpecific Conditions of Support (Final)\n1. Provision of a favourable ethical opinion from a HRA Research Ethics Committee. (Confirmed – 15 September 2017)\n2. Confirmation of a satisfactory (as reviewed by NHS Digital) Information Governance Toolkit submission for entities processing identifiable information under this support (NHS Digital – confirmed; NHS Business Services Authority – confirmed via email 27/09/2017)."]

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[]
[]
["Application Number",2198]
["Reference","17/CAG/0119"]
["Other Refs","IRAS: 224425"]
["Application Title","Steps Towards Increasing Bowel Cancer Screening Uptake"]
["Application Summary","This application from the University of Leeds, which would contribute to a PhD Psychology project, would pilot and test a new low-cost behaviour change intervention to increase uptake of screening in the North East of England.\nThe project aimed to use techniques which had been successful in improving rates of cervical cancer screening, in the area of bowel cancer screening. All participants would be sent the bowel screening cancer kit, but would be randomised to 4 conditions, comprising: the addition of a motivational-intervention sheet, a paper-based task to help plan the use of the screening kit, both of these interventions and a control group receiving treatment as usual (the standard invitation letter and screening kit alone). This had the potential to improve participation from the current low rate of 52% return, increasing rates of early detection for bowel cancer and therefore survival rates, reducing inequality in uptake, and potentially reducing cost to the NHS.\nNHS Digital would receive data from the Bowel Cancer Screening Hub on eligible patients, removing any Type 2 objections and returning the list to the Hub, from where the screening materials and randomised interventions would be sent. The Hub would return information on screening uptake and demographic characteristics for each condition to NHS Digital, who would return anonymised individual level data to the University of Leeds."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Anastasia Tsipa"]
["Address","School of Psychology"]
[null,"Lifton Place"]
[null,"Leeds"]
["Postcode","LS2 9JT"]
["Telephone"]
["Email","A.I.Tsipa11@leeds.ac.uk"]
["Medical Purposes","Y","preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from NE Bowel Cancer Screening Hub in relation to male and female participants aged between 60 and 74 who are eligible for bowel cancer screening and due to receive a screening invitation from the NE Bowel Cancer Screening Hub."]
["Description of confidential patient information used","NHS number, date of birth and postcode would be used for linkage.\nData returned to the University of Leeds would include age at time of screening invitation and area-level measure of socio-economic deprivation (calculated by NHS Digital) as well as intervention condition, previous screening uptake and gender."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Faculty Research Office, University of Leeds"]
["Status","Expired"]
[]
["Outcome Date","2017-10-10"]
["Next Review Date","N/A"]
["Notes","The data has been processed and destroyed.\n\nThe findings of our large cluster randomised controlled trial found promising evidence that a newly developed combined norm-based motivational intervention and an implementation intention intervention may help to improve uptake of bowel cancer screening, particularly in the youngest age group of invitees (under 62.5 years old). We are currently seeking funding to test the effectiveness of this intervention to help improve uptake of the Faecal Immunochemical Test (FIT) that recently replaced the Faecal Occult Blood Test. If successful, this research will yield an effective, brief and easy to deliver behaviour change intervention that could be ‘rolled out’ nationally, thereby leading to increased detection of early-stage bowel cancers and the associated lives saved.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed.\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed via email from NHS Digital"]

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[]
[]
["Application Number",2199]
["Reference","17/CAG/0164"]
["Other Refs","IRAS: 207271"]
["Application Title","A case-control study to investigate transmission routes for sporadic STEC infections in England"]
["Application Summary","This research application from the University of East Anglia set out the purpose of identifying the most common sources of Shiga-toxin E. coli (STEC) infections in order to reduce their incidence. STEC infections are a public health concern due to the low infectious dose required for infection and the severity of the infection and associated complications. There were no recent case-control studies; an updated study was required to reflect improved detection methods and surveillance and identify current sources of infection. Recent analysis of STEC infections from Public Health England identified that while the number of infections per year remained relatively steady, those that can be attributed to food sources were falling. There was a need to identify the other transmission pathways so that preventative measures could be introduced so that the overall numbers decreased.\nSTEC became a notifiable illness in 2009, enabling PHE to access information on potential causes/exposures on a vast majority of identified cases. As part of national surveillance, cases will already have been identified from having provided stool samples that demonstrate the presence of STEC bacteria, and have completed a questionnaire about foods consumed and activities undertaken in the week prior to infection. Controls would be identified via NHS Digital from a database of individuals in England registered with a GP, who could be matched with cases as listed above.\nSupport is requested to allow the disclosure of this information from NHS Digital to PHE to allow PHE to contact the identified control group and ask them to complete the questionnaire. The questionnaire will not contain identifiable data, therefore will be returned directly to the University of East Anglia from the participant.\nSupport is also requested for staff at PHE to identify cases from the database held by PHE, match them to controls and provide a pseudonymised dataset to UEA for the purpose of the study. PHE would retain the ‘key’ matching data to controls.\nA recommendation for Class 1, 2, 3 and 6 support was requested for the purpose of extracting and anonymising the information, to obtain and use information about present or past geographical location, to select and contact patients to seek their consent and to allow access to an authorised user for the above purposes."]
["Applicant Organisation Name","Norwich Medical School, University of East Anglia"]
["Contact Name","Dr Paul Hunter"]
["Address","Norwich Medical School"]
[null,"University of East Anglia"]
[null,"Norwich"]
["Postcode","NR4 7TJ"]
["Telephone"]
["Email","paul.hunter@uea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to:\n1. Data from PHE in relation to patients on the national surveillance database held by PHE, comprising identified cases with a STEC-positive fecal sample and a copy of their enhanced surveillance questionnaire available on the PHE database.\n2. Data from NHS Digital in relation to: randomly chosen patients (or parents where the patients were are children), fulfilling age frequency matching to cases, from a database by NHS Digital of individuals in England registered with a GP."]
["Description of confidential patient information used","3. Data transferred to PHE from NHS Digital would include the following details for the purpose of matching controls to identified cases and sending invitation letters and questionnaires:\n Name\n Date of birth\n Full address including postcode\nThe following details would be accessed from the surveillance database at PHE:\n Name\n Address\n Gender\n Ethnicity\n Status of STEC infection\n Lab sample number and results of lab analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Research Enterprise Services (REN), University of East Anglia"]
["Status","Expired"]
[]
["Outcome Date","10/10/2017"]
["Next Review Date","2020-10-10"]
["Notes","06 January 2022 - Support Expired:\nDuring the study, we accessed two sets of data without consent from participants. One was the case group, as we used information routinely collected as part of PHE’s enhanced surveillance on Shiga toxin E. coli. The dataset that is currently held by this research team has been pseudonymised, with the identifiers used different to that of the original data set held by PHE. \n\nThe second set of data used without consent was a list, randomly selected, of people registered with GPs and residing in England that we used to invite people to serve as the control group in our study. It was provided by NHS Digital, and as required by our data sharing agreement with them, that dataset was deleted at the end of the study.\n\nManuscript preparation is underway for the results from this study, which we aim to publish in a peer-reviewed scientific journal. Once results are finalised, we will be able to comment on any new or unexpected risk factors for acquiring Shiga toxin E. coli in England compared to previous case-control studies, which may influence further public health decisions or research into decreasing infection numbers from this illness. Given the unusual study method (of using established enhanced surveillance for case data while recruiting controls from the general public), we also plan to discuss drawbacks and benefits to this particular study design, which will inform future research studies so that they are as robust as possible. \n\nAmendment Request (Approved 20/12/2018)\nThe amendment request sought support for an extension to the study recruitment period for case and control patients through to 31 March 2020. Revisions had also been made to the patient-facing documentation, following patient and public engagement activities, which had been submitted for review.\n\nSpecific Conditions of Support (Revised 29/06/2018)\n1. Provide confirmation that study-specific information would be displayed on the Public Health England website about the study together with details of an opt-out mechanism, should an individual wish to object to their inclusion in the study.\n2. PPI group to be set up, to input their views specifically on the use of data as the study develops. This should be reported back at annual review.\n3. Favourable opinion from a Research Ethics Committee. Confirmed.\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed."]

{"sheet":"A02200","index":243,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2200]
["Reference","17/CAG/0144"]
["Other Refs","IRAS: 213940, REC: 17/NW/0373"]
["Application Title","PPH Butterfly"]
["Application Summary","This research application from the University of Liverpool set out the purpose of testing a device designed to halt post-partum haemorrhage (PPH), as an alternative to the current invasive manual methods of treatment.\nPPH is a major problem, killing 140,000 women worldwide each year. Although few women die in the UK, it can result in significant difficulties such as weakness through anaemia, delayed recovery and psychological trauma which can in turn affect bonding with the baby. This Phase 2 clinical trial aims to test a device designed to replace the standard manual method of stopping PPH. The device has already been tested in healthy volunteers; this phase would trial the device on women undergoing PPH.\nIn addition to testing the efficacy and safety of the device, the research would evaluate the cost of the new intervention relative to the cost of standard treatment and would collect information about the delivery and subsequent clinical pathways followed in order to do this. To compare the new intervention with standard treatment, the researcher wished to access medical records without consent in order to identify a matched historical cohort and extract clinical information for analysis. Each study participant would be matched with two ‘control’ women for parity, mode of birth, blood loss, and experience of PPH to the nearest time and date 2 years prior to the study event.\nTo find these women, the hospital information team would search the patient record system and pass the details of eligible women to the research team (via the Hospital Records Team who would identify the patient via the hospital number, then deliver the case notes to the Research office at the hospital). The research team would access the full medical record in order to extract data."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor Andrew Weeks"]
["Address","Sanyu Research Unit,"]
[null,"Dept of Women’s and Children’s Health"]
[null,"Liverpool Women’s Hospital, Crown Street, Liverpool"]
["Postcode","L8 7SS"]
["Telephone"]
["Email","aweeks@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from Liverpool Women’s Hospital in relation to the control group: women identified from hospital records and matched to individuals within the study group for parity, mode of birth, blood loss, and experience of a PPH to the nearest time and date 2 years before."]
["Description of confidential patient information used","The following data would be accessed during the identification of the control group:\nHospital ID\nDate and time of delivery of baby\nTime of PPH\nMortality and clinical data relating to mother and baby.\nThe applicant stated that baby’s date of birth and time of delivery would be used only to identify the control group, and would not be used in analysis. Data would be anonymised prior to transfer to Bangor University Group."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-10-17"]
["Next Review Date","N/A"]
["Notes","Data was provided to the study Chief Investigator by members of the Information Governance team at the Liverpool Women’s NHS Foundation Trust who were  given criteria to search for in clinical records in order to identify the historical controls. Once identified those records were given reference numbers to be used  in the study and all personal identifiers were removed and as such the participants could never be known by the research team\n\nBleeding after childbirth is a major public health problem. Worldwide, it causes the death of a woman every 6 minutes. In the UK, between 10 and 20% of women bleed excessively after childbirth, requiring medication and invasive treatments to stop it. All would benefit from a simple first aid treatment like the PPH Butterfly. Indeed, the device has interest from the World Health Organisation and a commercial partner has been identified to take the device forward. This clinical study of the PPH Butterfly has been an important step in developing this important piece of technology. Whilst further studies are required to conclusively prove its benefit for women, it is well on its way to achieving its mission of being a new first line therapy for PPH. Full details of the study are reported online in the European Journal of Obstetrics and Gynecology and Reproductive Biology\n\n22/08/2019 – Amendment supported to extend the duration of support in place to 31 March 2020. Support was also extended to enable a wider pool of NIHR funded research midwives based at Liverpool Women’s Hospital to undertake the data extraction process\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 11 August 2017\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Liverpool Women’s Hospital NHS Trust – v14 confirmed"]

{"sheet":"A02201","index":244,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2201]
["Reference","17/CAG/0021"]
["Other Refs","REC: 16/SC/0466, IRAS: 186982"]
["Application Title","Pregnancy after kidney donation in living donor transplantation: a retrospective case-control study."]
["Application Summary","This application from Guy's & St Thomas' Hospitals Foundation NHS Trust set out the purpose of a medical research study which aimed to assess the risk of pregnancy complications after living donor nephrectomy using the database of living kidney donors held by NHS Blood and Transplant.\nThis database is unique, in that entry is mandatory if living donor nephrectomy is undertaken in the UK. By working in collaboration with NHS Blood and Transplant, the applicants will link the donor database to a separate national database of hospital records; Hospital Episode Statistics (HES), which will allow us to determine the outcomes after pregnancy in living donors. Linkage will be undertaken by NHS Digital. These outcomes will be compared with those of women of the same age (and with similar risk factors) who have not donated a kidney. The applicants will then be able to determine whether living donor nephrectomy confers increased risks in subsequent pregnancies and will be able to advise both clinicians and women considering donation accordingly. If there is an increased risk for example, women could be advised to complete their family before considering donation."]
["Applicant Organisation Name","Guy's & St Thomas's Foundation NHS trust and Kings College London"]
["Contact Name","Professor Nizam Mamode"]
["Address","Renal Offices, 6th Floor Borough Wing"]
[null,"Guy's Hospital"]
[null,"Great Maze Pond, London"]
["Postcode","SE1 9RT"]
["Telephone"]
["Email","nizam.mamode@gstt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The applicants have identified that the sample will include all female kidney donors who have had a subsequent pregnancy from 2001 to 2015. The estimated sample for the cases group (donors) based on available data is approximately 500 cases. The control group will be matched to that of the case group and is dependent on the actual number of cases; however, it is the applicant’s intention to match controls to cases at a ratio of 10:1, with an estimated maximum number of patients at 10,000."]
["Description of confidential patient information used","The items of confidential patient information required are identified as:\n NHS number – to identify cases and enable linkage,\n Date of birth – to validate linkage and for analysis,\n Postcode – calculated to Lower Super Output Area (LSOA),\n Date of death – in relation to the mother – truncated to MM/YY format for analysis,\n Gender – for the infant,\n Ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Miss Kay Thomas, Guy's & St Thomas' Hospitals Foundation NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2017-10-17"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that the CI has retired and thus has not been able to contact anyone in the research team. The data controller has confirmed that support can be expired.\n\nConditions of Support\n1. Type 2 objections should be applied to data released by NHS Digital.\n2. Patient and Public Involvement – further work is to be undertaken to engage the relevant patient population about the study.\na. A report should be provided around the outcomes of the proposed focus group, within six months of the date of this letter. At this stage, if the responses given from the engagement activity were negative, the CAG would take this into account when considering whether support should continue, or whether further actions were necessary.\nb. An updated public and patient involvement and engagement plan should be provided at this stage also, to be reported back at first annual review.\n3. Patient Notifications and Dissent – further work is required in this area to be reported back at three months from the date of this letter as follows:\na. Develop a poster to be used as a patient notification tool as per the guidance detailed above,\nb. Revise the document which was submitted as the patient notification poster to include additional information and in a format more appropriate to a leaflet,\nc. Contact should be made with appropriate national charities to explore the potential of displaying information on their websites, as per detail provided above. A report against the progress made in this area should be provided.\n4. Favourable opinion from a Research Ethics Committee. (Confirmed – 07 September 2016).\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Version 14, 2016-17, published reviewed grade at satisfactory rating of 92%)."]

{"sheet":"A02202","index":245,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2202]
["Reference","16/CAG/0122"]
["Other Refs","IRAS: 194088"]
["Application Title","Long term follow up of asymptomatic carotid surgery trial (acst-1)"]
["Application Summary","This application from the University of Oxford set out the purpose of ascertaining whether the risks of dementia were reduced in patients with narrowing of the carotid artery (a blood vessel in the neck) who underwent carotid endarctectomy (an operation to reduce this narrowing), compared with those allocated to treatment as usual.\nIn order to do this the applicant proposed to follow up participants from a large, randomised controlled trial, which took place in the UK and Sweden between 1993 and 2008, comparing these two groups for risk of stroke (ACST-1). At the time this trial demonstrated a small reduction of the risk of stroke following endarctectomy in the 5 to 10 years after the operation. To study longer term effects, the applicant would link the UK participants from ACST-1 with data from HSCIC/NHS Digital. Name, NHS number and date of birth would be sent to NHS Digital in order to obtain HES data and ONS data on which participants were deceased. Date of death, gender, and date of birth would be returned and retained by the study team in order to link participants back to the original study record.\nAlthough consent was given for researchers to access medical notes for audit purposes, consent was not given for the purpose of this study."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Rebecca Llewellyn-Bennett"]
["Address","Heart Studies Group, Clinical Trials Service Unit"]
[null,"Nuffield Department of Public Health, Richard Doll Building"]
[null,"Roosevelt Drive, Oxford"]
["Postcode","OX3 7LF"]
["Telephone"]
["Email","alison.halliday@nds.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Follow up participants from a large, randomised controlled trial, which took place in the UK and Sweden between 1993 and 2008, comparing these two groups for risk of stroke (ACST-1)."]
["Description of confidential patient information used","Access was requested to name, NHS number and date of birth (sent to NHS Digital for linkage) and date of death, gender, and date of birth to be returned to the study team and used to link participants back to the original study record."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-10-26"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, it was found that allocation in the study to immediate or later CEA did not appear to reduce dementia risk despite a reduction of stroke risk at five and ten years. The frequency of dementia in the participants over 75 years of age, with a blockage in the carotid artery in the neck (with no symptoms), is high. Participants with prior diabetes or a brain infarct (loss of blood to an area of the brain) is also closely associated with dementia risk. Because stroke is closely associated with dementia risk it remains possible that the prevention of stroke in specific high-risk populations may be beneficial in preventing dementia. European guidelines will continue to consider whether particular groups of asymptomatic participants might benefit from carotid artery surgery but a large, long-term randomised study will be necessary to determine this. \n\n\nAmendment (Approved - 21/06/2017)\nThe application described the data required in order to answer the research question, however due to a recent restructuring of patient records resulting from a re-classification of dementia, this data was now located in the Minimum Mental Health Dataset. The application had not specified that access to this dataset would be required. They also wished to link to the National Dementia and Antipsychotic Prescribing Audit dataset.\nLinkage to the Mental Health Minimum dataset and the Dementia Prescribing audit would enrich this study significantly since dementia may actually be more commonly reported in these datasets than HES or death certificates. The amendment therefore requested access to this dataset.\n\nSpecific Conditions of Support\n1. The scope of the support at this stage is limited to provision of data to NHS Digital for linkage with HES/ONS data; further support should be sought for Phase 2 where contact will be made with patients that are still alive. Confirmed as accepted by applicant in letter dated 10 October 2016.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 18 October 2016.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed published as reviewed and satisfactory score obtained."]

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[]
[]
["Application Number","A02203"]
["Reference","17/CAG/0158"]
["Other Refs","REC: 17/WA/0263"]
["Application Title","Managing the risk of self-inflicted death to support a psychologically safe and rehabilitative criminal justice pathway"]
["Application Summary","This application from the University of Manchester sets out the purpose of medical research into suicide amongst prisoners. This study will conduct an independent case series examining all self-inflicted deaths in prisons in England and Wales between 2016 and 2019. The applicants will examine trends over time and explore what may have contributed to the rise in self-inflicted deaths in custody. They will also examine specific groups (such as remand, women, older prisoners) and the circumstances of suicide to make recommendations regarding the recognition, assessment and management of suicide risk and related issues of general mental health care and training needs of staff. Furthermore, although deaths by those in, or shortly after leaving police custody, and those on community supervision or licence annually account for smaller numbers than self-inflicted deaths in prison, the risk is pervasive throughout the Criminal Justice System. Therefore this study will conduct a scoping exercise to ascertain what procedures are in place, and what data are collected, when a suicide occurs in the wider Criminal Justice System. This will add to a comprehensive body of information about self-inflicted deaths across the criminal justice pathway in order to inform prevention policies going forward.\n\nThis information will be provided to the Healthcare Manager at the prison where the individual died in order for information to be collated from the individual’s medical record (within the scope of support). The questionnaire containing information from the medical record will be returned to the applicants."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Jenny Shaw"]
["Address","2.317 Jean McFarlane Building"]
[null,"Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9PL"]
["Telephone"]
["Email","jennifer.j.shaw@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All deaths in prisons in England and Wales classified as self-inflicted from 1st January 2016 to 30th April 2019. This is estimated to be around 300 individuals.\nThe identification of the cohort will be undertaken by the research team at HM Prison and Probation Service and is outside of the scope of this application."]
["Description of confidential patient information used","The applicants will be provided with the following information:\n Identification number,\n Prisoner name,\n Establishment,\n Date of death,\n Prison number."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-10-24"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed that ‘s251’ support could be expired as of April 2019, as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the results of this research were disseminated as part of the wider programme of work. The research team liaised with agencies who have a vested interest in the findings as well as with audiences comprising of clinicians, practitioners, and academics in order to inform future research and the development of policy and practice in the area.\n\n\nAmendment Request (Approved - 9/1/2018)\nThe amendment was submitted to the CAG for information purposes due to a change in the overall methodology for the study. These changes were outside of scope of the element of the application which was supported under the Regulations; however, it was acknowledged that the change in protocol had led to revisions in the data questionnaires which were previously considered by the CAG.\n\nThe applicants clarified that additional information would be received directly from HMPPS. Rather than sending an email detailing name, prison number, prison and date of death, the Death in Custody team at HMPPS had agreed to send the research team a Death in Custody (DIC) questionnaire that would provide additional information. The DIC questionnaire is currently in use and completed by prison staff following a death in custody. By receiving this, the applicants clarified that this would prevent duplication through staff being required to complete the project specific questionnaire.\n\nIt was explained that the DIC questionnaire included additional demographic information (e.g. nationality, ethnic origin, age, religion); details relating to offence and sentencing (e.g. status of prisoner, type of recall if applicable, offence, sentence length); details of death (e.g. date of death, ligature and ligature point if applicable); prisoner location (e.g. location of cell, shared cell, type of cell); ACCT information (e.g. history of self-harm/suicide attempt, on an open ACCT, previous on an ACCT); healthcare (e.g. history of drug/alcohol abuse, detoxification). It was recognised that this information was not disclosed with support under the Regulations.\n\nThe applicants had revised the content of the study-specific Governor questionnaire in line with the additional information which would be provided direct from HMPSS. Further revisions were made to the healthcare questionnaires following feedback from a member of the Independent Steering Committee.\n\nSpecific Conditions of Support (Final)\n1. Explore the potential of linking with the Coroners’ Service to enable the project to be raised with the families of deceased patients. A report should be provided at the time of first annual review around the work undertaken here. (The applicants confirmed acceptance to this condition and confirmed a report would be provided at first annual review).\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 20 September 2017).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University of Manchester – Offender Health Research Network shows a reviewed grade of 83% satisfactory on Version 14, 2016/17)."]

{"sheet":"A02204","index":247,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02204"]
["Reference","17/CAG/0166"]
["Other Refs","REC: 17/LO/0890, IRAS: 222427"]
["Application Title","Using Guthrie cards for a serosurveillance study of maternally-derived antibody against Group B Streptococcus (GBS)"]
["Application Summary","This application from St George’s University of London set out the purpose of medical research to collect comprehensive information about the amount of antibody that protects infants from Group B Streptococcus (GBS), a bacterium (germ) that can cause serious infections such as meningitis, blood poisoning and pneumonia in newborns. The study seeks to obtain antibodies from the dried blood spots taken from newborn screening cards from 150 infants with GBS that occurred during 2014. These will be compared with a matched cohort of 300 healthy controls. The applicants will identify the patient cohort from a previous surveillance activity that was undertaken with support provided by Public Health England under Regulation 3 of the Control of the Health Service (Control of Patient Information) Regulations 2002. The study will then use the antibody test developed at Public Health England to measure antibody concentrations to work out how much antibody is needed to protect babies from GBS.\nThe applicant proposes a case control study to compare antibody in babies with disease with those without disease for case identification, anonymisation and laboratory work. Each case will be matched with two controls for gestation, sex and ethnicity taken at the same date to make sure that the results are accurate."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Dr Mehring Le Doare"]
["Address","Centre for International Child Health"]
[null,"Imperial College London"]
[null,"Norfolk Place"]
["Postcode","W2 1PZ"]
["Telephone"]
["Email","k.mehring-le-doare@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort\n 150 infants aged 0-90 days of age born at any English hospital and identified through national surveillance database as laboratory-confirmed GBS disease between January and December 2014.\n 300 control patients matched by age, sex and ethnicity matched controls."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes as specified below:\n NHS number – required to identify the patient,\n Date of birth – required to calculate age at diagnosis in days/weeks; enable matching by sex and gestation,\n Gender – control matching,\n Ethnicity – control matching,\n Age – analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-10-27"]
["Next Review Date","N/A"]
["Notes","No identifiable information was collected. Data was anonymised by the supplying laboratory team and no linkage was provided to patient identifiable information. \n\nThe information from this study will help to accelerate the licensure of a Group B Streptococcus vaccine. \n\nSpecific Conditions of Support (Final)\n1. Public and Patient Involvement and Engagement – further work should be undertaken in this area to address the following points:\na. The Group B Strep Support Charity should be approached about the study to explore whether they can facilitate interaction with an appropriate patient/parent group to discuss the study,\nb. The charity should be invited to comment on patient notification materials as well as be approached around publication on their website,\nc. The charity should be invited to comment on the research findings prior to publication,\nd. An update on the above activity will be required at the time of first annual review. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Patient Notifications – further work should be undertaken in this area to address the following points:\na. Patient notification materials should be prepared to raise the profile of the study, accounting for points raised in the summary of discussion above,\nb. The Group B Strep Support Charity should be invited to display these on their website,\nc. An update on the above activity should be provided at the time of first annual review, together with copies of the notification materials that were prepared for information purposes.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – issued on 23 June 2017).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Public Health England. Version 14 IGT reviewed grade confirmed as satisfactory at 72%)."]

{"sheet":"A02205","index":248,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02205"]
["Reference","17/CAG/0133"]
["Other Refs","IRAS project ID: 224706, REC reference: 17/IEC08/0040"]
["Application Title","Data quality on shared information"]
["Application Summary","This research study from the University of Sheffield was to be completed as part of an MSc in Health Informatics. It set out the purpose of improving communications between agencies via the electronic health record (EHR) completed by the patient’s GP. The study would examine GP records for ‘highlighted’ information (information recorded on a summary or flagged as a problem – which is shared with other organisations). This would enable comparison between primary care practices in relation to data shared with secondary care services, quality of records and what GPs consider important and relevant to share. The information shared by primary care services would inform decisions taken by professionals and was therefore important to patient care. The study would enable an informed discussion to be had within the healthcare environment in relation to the quality of GP record keeping and information sharing and any inconsistencies between practices.\nAlthough patient identifiable data would be accessed during the process of the data collection, the aim was to examine the process and quality of record keeping rather than to gather data on patient diagnoses or outcomes. This is consistent with Precedent Set category 10 - Incidental disclosures of identifiable information made to an applicant who is observing practices and procedures within a health and social care setting."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Dr Pablo Millares-Martin"]
["Address","Whitehall Surgery"]
[null,"Wortley Bech Health Centre"]
[null,"Leeds"]
["Postcode","LS16 5RP"]
["Telephone"]
["Email","pablo.martin@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from participating clinics in relation to 1000 patient records of patients aged 18 to 70."]
["Description of confidential patient information used","The researcher would access ‘highlighted’ information on the patient electronic record: information which is shared with other agencies. This extract would be anonymised onsite however the researcher wished to retain a link to the practice from which the data originated."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-11-02"]
["Next Review Date","N/A"]
["Notes","Expired on 02/11/2018 in lieu of study closure.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 20 October 2017.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed via email from NHS Digital dated 25 July 2017."]

{"sheet":"A02206","index":249,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02206"]
["Reference","17/CAG/0182"]
["Other Refs","IRAS project ID: 193449"]
["Application Title","Safety and Feasibility Evaluation of Tourniquets for Total Knee Replacement Study"]
["Application Summary","This research study from the University of Warwick set out the purpose of assessing the feasibility of a randomised controlled trial to determine whether use of a tourniquet in Total Knee Replacement (TKR) surgery increases the risk of blood clot.\nA tourniquet is used to interrupt the blood supply and drainage from the leg, to facilitate surgery. However, once the tourniquet is removed any blood clots that have accumulated in the leg could then return to the heart where they may then travel to the brain. This risk had not previously been examined. In order to assess the feasibility of carrying out a future RCT, the applicant would carry out a randomised controlled trial and qualitative research with consented patients, and a retrospective multi-centre cohort study.\nSupport was requested for the retrospective multi-centre cohort study, which would use data collected from the National Joint Registry (NJR) between April 2003 to December 2003 concerning the use of tourniquets in TKR surgery in England and Wales. This data would be linked to Hospital Episode Statistics (HES dataset) on reported blood clots, socio-demographics, co-morbidities and length of hospital stay for the TKR."]
["Applicant Organisation Name","CSRI"]
["Contact Name","Mr Peter D H Wall"]
["Address","University Hospital"]
[null,"Coventry"]
[]
["Postcode","CV2 2DX"]
["Telephone"]
["Email","p.d.h.wall@warwick.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to the following data from NJR in relation to patients who had TKR surgery between April and December 2003:"]
["Description of confidential patient information used","NHS number, date of birth, gender, postcode, procedure code and local patient identifier – to be transferred to NHS Digital for linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Mrs Jane Prewett, University of Warwick"]
["Status","Expired"]
[]
["Outcome Date","2017-11-06"]
["Next Review Date","N/A"]
["Notes","The data has been processed and a report prepared and published. The data has now been deleted.\n\nThe publication is available in the public domain and is helping to guide patient care.\n\nhttps://bmjopen.bmj.com/content/11/6/e045353 \n\n\nAmendment Request (Approved - 11/01/2019)\nThe amendment request sought to extend the duration of support under the Regulations for an additional year, to November 2019.\n\nSpecific conditions of support\n1. Please provide confirmation that NHS number, date of birth and postcode are all required to carry out the linkage.\n2. Please confirm that notification to the GP of study results applies to the prospective consented cohort only.\n3. Favourable opinion from a Research Ethics Committee. Confirmed 27 January 2017.\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. NJR and NHS Digital, both confirmed published and reviewed via NHS Digital website."]

{"sheet":"A02207","index":250,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02207"]
["Reference","17/CAG/0180"]
["Other Refs","REC reference: 16/SC/0073"]
["Application Title","MR865 (Whitehall Study)"]
["Application Summary","This longitudinal study at the University of Oxford set out the purpose of examining how cause-specific mortality in old age is influenced by various factors including lifestyle, socio-economic circumstances, cardiovascular risk factors, employment grade and self-assessment of physical and mental health. Various measures including plasma or genetic markers would be completed at middle and old age, and others such as whether mortality differentials by employment grade persist into old age, would be taken in old age alone."]
["Applicant Organisation Name","Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU)"]
["Contact Name","Professor Robert Clarke"]
["Address","University Offices, The Chancellor, Masters and Scholars of the University of Oxford\n"]
[null,"Wellington Square"]
[null,"Oxford"]
["Postcode","OX1 2JD"]
["Telephone","01865 743743"]
["Email","robert.clarke@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from NHS Digital in relation to 19,000 men who were aged 40-69 years when originally surveyed in 1967 – 1970:"]
["Description of confidential patient information used","5-digit Whitehall study number to be provided to NHS Digital to enable linkage with patient cause-specific mortality and cancer registrations\nDate of birth retained by the applicant in order to validate data\nDate of death to be returned to the applicant from NHS Digital"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), University of Oxford"]
["Status","Supported"]
[]
["Outcome Date","2017-11-15"]
["Next Review Date","2024-11-15"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 1 February 2016\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission.\nV14, CTSU Nuffield Dept of Population Health, University of Oxford - confirmed published and reviewed\nV14, NHS Digital – confirmed published and reviewed"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02208","index":251,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02008"]
["Reference","17/CAG/0107"]
["Other Refs","IRAS project ID: 222521, REC reference: 17/LO/0166"]
["Application Title","WMUK Rory Morrison Registry"]
["Application Summary","This application from University College London Hospitals NHS Foundation Trust set out the purpose of the establishment of a research database focussing on Waldenstroms Macroglobulinaemia (WM), a rare blood cancer caused by genetic changes in the cells of the immune system (called B cells) which affects over 400 patients per year in the UK. The optimum way of treating this disease is under investigation, as new therapies become available, but a clear picture of the disease in the UK is lacking. The project intends to address this through the establishment of a robust database of patients which can be utilised in the improvement of patient outcomes. The database will be managed by Dendrite Ltd."]
["Applicant Organisation Name","UCLH"]
["Contact Name","Dr. Shirly D'Sa"]
["Address","Cancer Division, 3rd Floor West"]
[null,"250 Euston Road, "]
[null,"London"]
["Postcode","NW12PG"]
["Telephone"]
["Email","shirley.dsa@uclh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with a diagnosis Waldenstroms Macroglobulinaemia (WM) or an associated condition who are patients at clinical sites registered with Dendrite as registry centres. It was identified that there would approximately 420 patients added to the registry over the next two years."]
["Description of confidential patient information used","The following items of confidential patient identifiable data are required for the purposes stated:\n Full name – for establishment of record and validation,\n NHS number –validation and linkage,\n Hospital ID – validation,\n Date of birth – linkage and analysis,\n Date of death – linkage, survival calculation and analysis,\n Gender – analysis,\n Ethnicity – analysis,\n Postcode (district level) – validation and analysis,\n Local hospital name and address – validation and analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-11-22"]
["Next Review Date","2023-11-22"]
["Notes","09 December 2020 - Annual Review approved\n\nSpecific conditions of support (updated):\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. University College London Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n\nAmendment request (Approved 29/10/2018)\nThe amendment requested the inclusion of an additional five hospital Trusts as data sources for the registry. The additional sites were as follows:\n Torbay Hospital, Torbay and South Devon NHS Trust, Torbay TQ2 7AA,\n Christie NHS Foundation Trust, Manchester, M20 4BX,\n King’s College Hospital NHS Foundation Trust, London, SE5 9RS,\n Bart’s Hospital, Bart’s Health NHS Trust, London, E1 8PR,\n Northwick Park Hospital, London North West University Healthcare NHS Trust, Harrow, HA1 3UJ.\nThese additional sites would be disclosing the same items of confidential patient information and supplementary clinical details to Dendrite Ltd, who were acting as processor and managing the registry.\nSpecific conditions of support\n1. The CAG should be informed at the time of annual review of any supplementary data sources which had been added to the Registry. This condition only applied where these supplementary sources provided the same information via the data flows which were currently supported by the CAG.\n2. Confirmation of suitable security arrangements via IG Toolkit submission (Confirmed – Dendrite Ltd. has a published satisfactory reviewed grade on V14.1, 2017/18).\n3. Confirmation of a favourable opinion from a Research Ethics Committee (Confirmed – existing REC approval extends to addition of new sites)\n\nOriginal Specific Conditions of Support\n1. Support extends to England and Wales only.\n2. Progress a consented model – work should be undertaken to move towards a consented model within the centres that operate a specialist Waldenstroms Macroglobulinaemia (WM) clinic and tertiary centres with large haemoto-oncology practices. This applies to both retrospective and prospective patients. An update will be required at the time of first annual review to provide an overview of progress which has been made in this area.\n3. Identifiability of the analysis dataset – this should be reduced by applying truncating and camouflaging dates and postcode.\n4. Date of birth should be deleted from the database following the survival calculations that are undertaken following the notification of date of death.\n5. Public and Patient Involvement and Engagement – provide a report at first annual review around further activity which has been undertaken in this area, together with updated plans moving forward.\n6. Patient notifications and dissent – the website text should be redrafted with input from an appropriate patient group to make this more accessible to the wider public. The revised draft of the text should be provided at the time of first annual review for consideration by the CAG.\n7. Favourable opinion from a Research Ethics Committee. (Confirmed – 20 November 2017).\n8. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University College London Hospitals NHS Foundation Trust and Dendrite – Version 14 2016/17 reviewed satisfactory)"]

{"sheet":"A02209","index":252,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02009"]
["Reference","17/CAG/0162"]
["Other Refs","IRAS project ID: 200928, REC reference: 16/YH/0298"]
["Application Title","GP Reminders for Bowel Scope Screening non-Participants"]
["Application Summary","This research study application from UCL set out the purpose of testing whether the inclusion of a GP endorsement to the '12 months’ reminder letter' can improve uptake of Bowel Scope Screening (BSS) among previous non-participants\nBowel cancer is a major public health concern in England, accounting for one in every eight cancer incidences and one in every ten cancer deaths. Bowel Scope Screening (BSS), also known as Flexible Sigmoidoscopy (FS) screening, helps prevent bowel cancer by locating and removing small, benign growths called ‘polyps’ from the bowel wall before they can become cancerous. Uptake of BSS is currently less than half of the invited population, which means that the estimated life-saving benefits of BSS are not being realised. Any improvement in uptake would justify the initial spending to encourage people to undergo screening.\nPreviously collected evidence showed that repeat invitations increased uptake of screening programmes by 8%. In previous studies, the applicant had demonstrated that reminders prompting non-participants were not only feasible, but effective in BSS. The present study aims to extend the evaluation of these reminders by testing the impact of adding a general practice endorsement to the letter – something which has been shown to be effective for other types of screening.\nNHS Digital would identify non-responders to the initial BSS invitation and remove Type II objectors. They would then randomise these patients to two groups – one would receive the standard reminder (usually sent by London North West Healthcare NHS Trust bowel screening hub at NHS Digital, on behalf of PHE), and the other group would receive the GP-endorsed reminder.\nSupport was requested to allow NHS Digital to disclose identifiers to Docmail to enable them to send the reminders via an automated system."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Yasemin Hirst"]
["Address","Cancer Communication and Screening, "]
[null,"Room 207, 1-19 Torrington Place"]
[null,"University College London"]
["Postcode","WC1E 7HB"]
["Telephone"]
["Email","y.hirst@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who had not responded to the first Bowel Scope Screening invitation."]
["Description of confidential patient information used","Access was requested to the following data from NHS Digital in relation to patients who had not responded to the first Bowel Scope Screening invitation:\nName, NHS number, full address and postcode.\nName of GP for the intervention group.\nNo identifiers are required for analysis. UCL will receive data from NHS Digital concerning the number of patients from each group who acted upon the reminder invitations, and the gender of the patient (as a gender gap has been identified in uptake of bowel screening)."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-11-30"]
["Next Review Date","N/A"]
["Notes","Expire\n\nAll identifiable data has been destroyed, confirmed July 2022.  The study tested the potential impact of proving  endorsements to support people invited for Bowel scope screening. The programme has now ceased preventing any further direct impact. \n\n\nSpecific conditions of support\n1. The Sub-Committee recommended that further public involvement work be carried out during the study (please note that this is a recommendation only, and support is not conditional on this point).\nThe applicant responded to this point in the same letter of 3 November 2017:\n‘As Research Department of Behavioural Science and Health at UCL, we are committed to including patients and public views in our research. We normally find patient representatives through patient consumer groups. But we are currently in the process of developing our own patient and public involvement panel as most of our research involves healthy individuals. As part of the future the engagement activities, we will further explore public views on being enrolled in research without consent and also evaluate past and future research materials’.\nThis response was reviewed and deemed appropriate.\n2. Favourable opinion from a Research Ethics Committee. Confirmed\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. \nV14 confirmed published and reviewed for NHS Digital\nV14 confirmed published and reviewed for Docmail"]

{"sheet":"A02210","index":253,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02210"]
["Reference","17/CAG/0055"]
["Other Refs","IRAS project ID: 226195, REC reference: 17/SC/0581"]
["Application Title","CRIS Linkage with DWP Employment and Benefits Data"]
["Application Summary","This application from the South London and Maudsley NHS Foundation Trust (SLaM) set out the purpose of medical research through the establishment of a research database. The application seeks approval to link records from the South London and Maudsley NHS Foundation Trust (SLaM) with the Department for Work and Pensions (DWP) Customer Information System (CIS) and DWP benefits data, to enable the provision of an anonymised data resource for research purposes using the Clinical Records Interactive Search (CRIS) system. The applicants propose to link and fully anonymise mental health clinical data on a historical cohort of approximately 280,000 adults of working age from the SLaM Biomedical Research Centre (BRC) CRIS system with DWP data on benefits. The cohort will be all patients seen by SLaM services between 01/01/2007 and 31/12/2016."]
["Applicant Organisation Name","Maudsley NIHR Biomedical Research Centre"]
["Contact Name","Professor Matthew Hotopf"]
["Address","South London and Maudsley NHS Foundation Trust, Maudsley Hospital"]
[null,"Denmark Hill"]
[null,"London"]
["Postcode","SE5 8AZ"]
["Telephone"]
["Email","matthew.hotopf@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort will be all patients seen by SLaM services between 01/01/2007 and 31/12/2016. This historical cohort consists of approximately 280,000 adults of working age."]
["Description of confidential patient information used","The following items of confidential patient identifiable information have been requested for the purposes defined:\n Name – linkage,\n Date of birth – linkage and retained in MM/YY format for analysis,\n Unit level postcode – linkage and retained as deprivation score for analysis\n Gender – for linkage and analysis,\n Date of death – for analysis – query\n Ethnicity – for analysis.\nThe patient identifiable data will be extracted from the established CRIS database and linked with DWP National Benefits Database by staff at the DWP. This proposal covers a one-off data linkage and extraction.\nAdditionally, the DWP will provide fully anonymised aggregate data (non-linked) to determine age, sex and locality-standardised annual rate of benefit-specific receipt."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","South London and Maudsley NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2017-12-01"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed January 2023 that ‘s251’ support could be expired as the DWP destroyed the SLaM confidential patient information after linkage, and confirmation of this was received by SLaM in January 2022. \n\nIn terms of public benefit, work is currently underway to explore the interrelationships between employment status, benefit receipt and mental health and treatment outcomes of people accessing secondary mental healthcare services. \n\n03 August 2020 - Amendment: support provided to extend the timeframe of the linkage to between 01 January 2007 and 01 July 2019.\n\nSpecific Conditions of Support\n1. Support is extended to England and Wales only.\n2. Support is extended to the linkage activities described within the application only and the data should not be used for any additional purposes.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – issued 30 November 2017).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - SLaM have a published reviewed grade at satisfactory at 89% on version 13 (2015/16). DWP have a confirmed project-specific IG toolkit which has been reviewed as satisfactory on 08 December 2016 by the External IG Delivery Manager at NHS Digital)."]

{"sheet":"A02211","index":254,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02211"]
["Reference","17/CAG/0176"]
["Other Refs","IRAS project ID: 224135, REC reference: 17/NW/0610"]
["Application Title","A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneursyms: The UK Complex Aneurysm Study (UK-COMPASS)."]
["Application Summary","This application from the Royal Liverpool and Broadgreen University Hospitals NHS Trust set out the purpose of medical research to examine how the different treatments for abdominal aortic aneurysm compare in terms of clinical benefit and the utilisation of NHS resources. The applicants intend to analyse the outcomes of all patients undergoing juxtarenal aneurysm treatment in England without altering their treatment, during a two-year period with collection of follow-up data over a five year period. The applicants will examine routinely performed scans and utilise data that is routinely collected by the NHS. Available data will be analysed to compare the safety and effectiveness of different treatments and to see if a particular treatment is better suited for particular features so patients can be offered bespoke treatment strategies. The project does include a consented PROMS element which is out of scope for CAG consideration.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Royal Liverpool and Broadgreen University Hospitals NHS Trust"]
["Contact Name","Professor Srinivasa Rao Vallabhaneni"]
["Address","Link 8C, Royal Liverpool University Hospital"]
[null,"Prescot Street"]
[null,"Liverpool"]
["Postcode","L7 8XP"]
["Telephone"]
["Email","fempop@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged between 25 – 100 years undergoing elective juxtarenal abdominal aortic aneurysm repair in England; juxtarenal abdominal aortic aneurysm defined and stratified into 4 strata of anatomical complexity as specified in 'Anatomical and Physiological Stratification' or those with a juxtarenal abdominal aortic aneurysm 55mm or larger in size and placed on medical management 'operation-deferred'.\nPatients treated from November 2017 to October 2019 will be screened retrospectively for inclusion. It is expected that confidential patient information in relation to approximately 8000 patients would be screened over the two year recruitment period to identify approximately 2000 patients with complex aneurysm repair for inclusion in the analysis. Interim analysis will be undertaken at 12 months to verify our estimates of sample size and power."]
["Description of confidential patient information used","NHS Digital will retrieve data from HES and supply to the research team at the Royal Liverpool and Broadgreen Hospitals NHS Foundation Trust on a two monthly basis. This will include the following data items:\n NHS number – Validation and linkage,\n Date of birth – Validation and linkage,\n HES-ID – provided in a pseudonymised format to allow data linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-12-13"]
["Next Review Date","2024-12-13"]
["Notes","12 February 2024 - change in data processors from NHS Digital to NHS England, regarding data source Hospital Episode Statistics (HES)\n\nAmendment supported 03 October 2022 \nTo allow the disclosure of confidential patient information from participating Trusts to Liverpool University Hospitals NHS trust, regarding retrospectively identified operation deferred/ medically managed abdominal aortic aneurysm (AAA) patients from 01 November 2017, and those patients whose operations were delayed due to the COVID-19 pandemic, between 23 March 2020 and 31 December 2023, and for NHS Digital to provide linked outcome data regarding these individuals.\n\n24 January 2022 - Amendment supported:\nAmendment supported 24 January 2022 to allow the disclosure of confidential patient information from Liverpool University Hospitals NHS trust to external NHS Trusts, for the purposes of query resolution\n\n20 July 2020 - Amendment\nThis amendment requests support to update the data fields that will be collected in each dataset, most of which are clinical data points. The applicants also request support to collect date of death (truncated to month/years) from NHS Digital HES/ONS data, as well as collect NHS number and date of birth from NHS Digital in follow up collections. These identifiable data fields are already collected, but this amendment seeks to use them for follow up data as well as at initial data collection. The applicants confirmed that there are no new data flows.\n\nSpecific Conditions of Support\n1. Support extends to England and Wales only.\n2. Patient and Public Involvement and Engagement – further activity should be planned and undertaken to progress public and patient involvement and engagement as the study commenced. It was acknowledged that this should be extended to more than one PPI representative within the Trial Steering Group. A report would be required at the time of first annual review to describe the wider additional activity which had been undertaken in this area.\n3. Patient Notifications and Dissent – it is recommended that a supplementary patient information leaflet is drafted to be provided to those patients who contact the team to request further information about the study. It was recommended that the patient and public representative group are involved with the preparation and review of this document. Submission of the document would be required at the time of first annual review together with an overview of how it was prepared.\n4. Favourable opinion from a Research Ethics Committee. (Confirmed – 30/11/2017).\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Royal Liverpool and Broadgreen University Hospitals NHS Trust shows a reviewed grade of 84% satisfactory on Version 14 (2016/17). NHS Digital shows a reviewed reported grade of 92% satisfactory on Version 14 (2016/17)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02212"]
["Reference","17/CAG/0191"]
["Other Refs","IRAS project ID: 232396"]
["Application Title","DETERMINE-PD"]
["Application Summary","This application from Newcastle University set out the purpose of running a pilot study to discover the level of incidence of delirium in Parkinson’s, how well the methods used to collect the data have worked and whether they could be used in a larger study.\nDelirium has not been previously studied in Parkinson’s. Delirium has overlapping features with Parkinson’s, such as confusion, hallucinations and sleep disturbances. This makes it difficult to diagnose; thus delirium in Parkinson’s may be more common than previously thought. It can cause permanent damage to the brain, making people more likely to develop dementia in the future, or worse for those who already have dementia. It is important that delirium is recognised quickly as it is treatable and early identification can lead to better outcomes.\nThe pilot study would be run at hospitals in Newcastle upon Tyne. Patients with Parkinson’s would be invited to take part if they were admitted to hospital.\nSection 251 was required to enable recruitment to the study: in the first instance the research team would send out an introductory letter to all patients at the Trust who were currently treated for Parkinson’s. The letter would give a brief summary of the study and advise that if the patient was admitted to hospital they would be approached about the study – this would provide the opportunity to opt out of the approach. Secondly, researchers would be notified if any of the patients were admitted to hospital through an electronic alert; a system already in use by the hospitals (Recurring Admission Patient Alerts or RAPA)\nThey would then visit the patient in hospital in order to seek their consent for the study, providing no dissent had been expressed.\nA recommendation for class 3 and 6 support is requested to select and contact patients to seek their consent and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Louise Allan"]
["Address","Biomedical Research Building"]
[null,"Campus for Ageing and Vitality"]
[null,"Newcastle upon Tyne"]
["Postcode","NE4 5PL"]
["Telephone"]
["Email","louise.allan@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from Newcastle upon Tyne NHS Trust in relation to patients attending clinics for Parkinson’s"]
["Description of confidential patient information used"," Name and address for sending information to each patient,\n RAPA alert advising the researcher of the name and ward of a Parkinson’s patient admitted to hospital, enabling them to identify and visit the patient to seek consent."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-12-08"]
["Next Review Date","N/A"]
["Notes","June 2022 - Support Expired\nAR from 2018 confirms that all identifiable data has been deleted as of August 2018.  Email also on file.\n\nSpecific Conditions of Support\n1. Favourable opinion from a Research Ethics Committee. Confirmed – received 13 December 2017.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed - Newcastle upon Tyne Hospitals NHS Trust, v14 confirmed published and reviewed."]

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[]
[]
["Application Number","A022103"]
["Reference","17/CAG/0156"]
["Other Refs","IRAS project ID: 232110, REC reference: 17/WM/0343"]
["Application Title","Rectal Cancer Oncological Complete Response Database (OnCoRe)"]
["Application Summary","This application from the Christie NHS Foundation Trust set out the purpose of establishment of a research database which will store data on patients who have been diagnosed with rectal cancer and treated with pre-operative radiotherapy or chemo-radiotherapy. In 10-20% of patients, this treatment results in a complete disappearance of the rectal tumour (known as a complete response) and it is data for these patients that the database will focus.\nUpon establishment, newly diagnosed patients will be included in the registry on a fully consented basis. The applicants are seeking support to include a historic patient cohort of over 1,000 patients from three previously registered audits with the Christie NHS Foundation Trust within the database. The application to the CAG concerns this historic patient cohort only.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover the activities as described in the application."]
["Applicant Organisation Name","Christie NHS Foundation Trust"]
["Contact Name","Professor Andrew Renehan"]
["Address","The Christie NHS Foundation Trust"]
[null,"Wilmslow Road"]
[null,"Manchester"]
["Postcode","M20 4BX"]
["Telephone"]
["Email","andrew.renehan@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The patient cohort for consideration within the CAG application consists of 1126 patients which were previously included within three local audits which were undertaken by the Christie NHS Foundation Trust.\nInformation will be transferred from the existing audit datasets into the new database; however, the applicants have confirmed that NHS number only will be transferred in its true format to enable follow-up of the patients to be undertaken. Follow-up would be undertaken at a local level between the applying Trust and its immediate referral centres within Greater Manchester; parts of Merseyside; South Lancashire; and North Wales."]
["Description of confidential patient information used","The following data items are required:\n NHS/CHI Number – linkage and analysis,\n Month and year of birth – analysis,\n District Level postcode – analysis,\n Gender – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-12-14"]
["Next Review Date","2024-12-14"]
["Notes","24 October 2019 – amendment supported to include additional clinical data fields within the information collected for inclusion within the database. This did not extend the items of confidential patient information included. Revised data collection proformas were provided which separated the data collection for new patients and follow-up data for existing patients.\n\nSpecific Conditions of Support (Final)\n1. Patient and Public Involvement and Engagement – provide a report at the time of first annual review of the actual activity undertaken against the plan provided in response to point two above. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – Overall study recweived favourable opinion on 02 October 2017. Favourable Opinion for substantial amendment issued on 30 November 2017).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – The Christie NHS Foundation Trust shows a self-assessed grade of 85% on Version 14, 2016/17. Email confirmation received 12/09/2017 that this is satisfactory)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02214"]
["Reference","17/CAG/0177"]
["Other Refs","IRAS project ID: 232616, REC reference: 17/NE/0334"]
["Application Title","Exploring DNA methylation as an initiating event in childhood cancers"]
["Application Summary","This application from Newcastle University sets out the purpose of medical research to investigate whether DNA methylation is an early event in childhood cancer. Cancer is caused by a series of abnormal genetic and epigenetic events. To investigate if abnormal DNA methylation is an early event in childhood cancer development, the applicants will compare methylation patterns of childhood cancer patients and healthy controls in previously collected blood spots taken 5-8 days after birth (i.e. before diagnosis in the cancer patients).\nThe Great North Biobank houses blood spots collected from neonates 5-8 days after birth between the years 1984-1994 in the local region. The Northern Region Young Persons’ Malignant Disease Registry (NRYPMDR) is a specialist population-based registry of all childhood and young adult malignancies diagnosed since 1968 in the northern region of England.\nUsing the NRYPMDR, the applicants will identify cases and access the neonatal blood spot card corresponding to individual cases from the Great North Biobank. Upon accessing cases, age and sex matched control blood spot samples will be selected. Name, date of birth and NHS number data will be used to confirm that selected controls were not on the NRYPMDR. Once cases and controls have been selected, blood spot samples will be assigned an identification number so that data can be anonymised, removing name, NHS number and day of birth. Use of the blood spot samples is out of the CAG remit; however, the associated data processing is what required a recommendation of support.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Jill A McKay"]
["Address","Wolfson Childhood Cancer Research Centre"]
[null,"Level 6, Herschel Building"]
[null,"Newcastle upon Tyne"]
["Postcode","NE1 7RU"]
["Telephone"]
["Email","jill.mckay@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female and male patients up to the age of 25 years, with a new born blood spot taken between 1984 and 1994 will be included in the study. Cases will be selected based on cancer type and availability of neonatal blood spot in the biobank. Controls will be selected to match cases based on sex and closest date of birth.\n60 cases will be recruited in total (30 patients and 30 control cases)."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as specified:\n Name – to enable correct sample to be retrieved from the biobank and validating control samples,\n NHS number – sample collection and validating control samples,\n Date of birth – sample collection, control sample matching and validation,\n Sex – control sample matching."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-12-19"]
["Next Review Date","N/A"]
["Notes","27 May 2022 - Support Expired\nElectronic data from Northern Region Young Persons' Malignant Disease Registry were accessed by a researcher holding the relevant permissions to identify cases of childhood leukaemia born between 1984-94. Name, DOB and NHS number were extracted on a paper copy to link with paper records for blood spot cards held by the Great North Biobank. Leukemia cases were identified from the biobanks paper records, whereby controls were then selected from these paper records matched for DOB, and where possible sex. Names of controls were transferred to a paper record and cross referenced to confirm they were not listed in the Northern Region Young Persons' Malignant Disease Registry. Samples were extracted from the biobank and coded for anonymity, only retaining case/control status, year of birth and sex (where available) - meaning subsequent identification is not possible. Paper records were destroyed via NHS confidential waste disposal. Researchers holding the subsequently generated anonymised biological data no longer have access to either electronic registry data or biobank paper records, which are both held securely by NHS and/or Newcastle University.   \n\nData collected have been utilised to help understand the early biological events that may initiate childhood leukaemia. These data will continue to be utilised to help understand the environmental determinants of childhood leukaemia as exposure-related methylation patterns are elucidated over time. Understanding the exposures related to childhood leukaemia initiation may help identify routes to prevention in the future. Moreover, discovering early disease biomarkers may aid early diagnosis or highlight at-risk individuals for monitoring, which is more likely to lead to improved patient outcomes.  \nSome analysed data have recently been shared with collaborators at the International Agency for Research on Cancer, to contribute to a publication investigating the epigenetic precursors of childhood leukaemia.    \n\nSpecific Conditions of Support (Final)\n1. Patient and Public Involvement and Engagement – provide a report at the time of first annual review around the additional activity which has been undertaken in this area. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 06.11.2017).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – a project specific IGTK has been submitted under reference EE133852- DNA Methylation – this shows a reviewed satisfactory grade of 66% on Version 14 (2016-17)."]

{"sheet":"A02215","index":258,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02215"]
["Reference","17/CAG/0165"]
["Other Refs","IRAS project ID: 219069, REC reference: 17/SC/0511"]
["Application Title","Evaluation of the sensitivity and specificity of the Wessex Trauma Network trauma unit bypass tool in predicting major trauma, with suggestions for modifications to assist pre-hospital clinicians in appropriate triage and transport."]
["Application Summary","This application from University Hospitals Southampton set out the purpose of medical research to ascertain the sensitivity and specificity of the Wessex Trauma Unit Bypass (TUB) tool in predicting severe injuries in patients who have been subjected to trauma. The purpose of this study is to evaluate the accuracy of a tool used by ambulance staff to help them decide which hospital a patient should be taken to, having been injured in a traumatic accident. Once this has been ascertained, the data will be further analysed to understand what areas of the patient condition or type of incident are common in patients who were inaccurately identified as either having been more or less severely injured than was apparent at the scene of the incident. Once this section has been completed, the tool will be modified and tested to see if the accuracy can be improved.\nThe applicants will define the patient cohort for inclusion from information requested via the Trauma Audit Research Network (TARN) and the University Hospitals Southampton (UHS) Emergency Department patient record system, Symphony. Sub-groups of over and under triaged patients will be generated from the cross-reference of information. The applicants seek to access the medical records of a proportion of patients within these sub-groups to enable a wider dataset to be extracted.\nA recommendation for class 1, 2 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University Hospitals Southampton"]
["Contact Name","Ms Eleanor Freshwater"]
["Address","Tremona Road"]
[null,"Southampton"]
[null,"Hampshire"]
["Postcode","SO16 6YD"]
["Telephone"]
["Email","els.freshwater@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort covers approximately 1000 patients (adults and children) booked in to the Southampton Emergency Department patient record system with presenting complaint 'Major Trauma' AND Level 1 trauma call placed in the Emergency Department prior to arrival of patient (based on pre-hospital pre-alert information)."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes described below:\n Name – included on initial Emergency Department record,\n Date of birth – to calculate age at event which will be retained for analysis,\n Hospital number – to identify and create study identifier,\n Sex – for analysis,\n Location where the traumatic incident occurred – to see if a trauma unit was bypassed."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-12-20"]
["Next Review Date","2018-12-20"]
["Notes","Specific Conditions of Support (Final)\n1. Patient and Public Involvement and Engagement – provide a report at the time of first annual review around the public and patient involvement and engagement activity which has been undertaken as the study progresses. It was noted that if the responses given were negative, the CAG would take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 19/10/2017).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University Hospitals Southampton shows a reviewed published grade at 73% satisfactory on Version 14, 2016/17)."]

{"sheet":"A02216","index":259,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02216"]
["Reference","17/CAG/0171"]
["Other Refs","IRAS project ID: 210262, REC reference: 17/LO/0631"]
["Application Title","Testing a diagnostic aid for hip dysplasia in primary care"]
["Application Summary","This research application from Great Ormond Street Hospital for Children stated that developmental dysplasia of the hip (DDH) is a condition where the 'ball and socket' joint of the hip does not properly form in babies and young children. Dislocation occurs in 1-2/1000 infants per year but milder forms occur in 40-60/1000. Because early recognition of disease is associated with better outcomes, it is national policy to examine all infants for the presence of DDH at birth and at 6 weeks in primary care (6-week hip check). Despite a compulsory hip check at the age of 6 weeks in primary care, missed diagnoses and infants incorrectly labelled with DDH remain an important problem, potentially leading to adverse consequences for infants, their families and the NHS.\nThe application set out details of a pilot study that seeks to improve the diagnosis of DDH in primary care through use of a diagnostic aid. The study is intended to test an existing previously developed diagnostic aid for DDH and will develop a training video that goes along with this checklist, tailored for use in primary care. The aim is to identify whether it may reduce the number of infants diagnosed late with DDH and that it may assist in infants being wrongly labelled with DDH.\nA recommendation for class 1, 5 and 6 support was requested to cover access to confidential patient information as detailed in the application."]
["Applicant Organisation Name","Great Ormond Street Hospital for Children"]
["Contact Name","Professor Andreas Roposch"]
["Address","Great Ormond Street Hospital for Children"]
[null,"Department of Orthopaedic Surgery, Great Ormond Street"]
[null,"London"]
["Postcode","WC1N 3JH"]
["Telephone"]
["Email","a.roposch@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","In this pilot, the aim is to look at the performance of a diagnostic aid when used by GPs who carry out the 6-week hip check.\nThree to six months following the 6-week hip check, the researcher will visit all practices again in order to discern if the infants had hospital contact for their hips. For this the research team would view any corresponding clinic letter, referral letters and any test results.\nA researcher will collect any follow up data only from each GP practices’ database, using unique NHS patient numbers, and categorize the appropriateness of referrals by a practice."]
["Description of confidential patient information used","Data will be obtained based on the results of this hip check. In particular, this was specified to include: name (for patient identification purposes), NHS number and date of birth (to enable identification and following through to secondary care), gender, ethnicity (to analyse their influence in the primary and secondary outcomes) and follow up/ treatment details.\nData to be extracted from each GP database includes; if a patient was admitted for treatment of a hip, if a patient obtained treatment of a hip in outpatients and if a patient had at least one hospital appointment for the hip."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-12-20"]
["Next Review Date","N/A"]
["Notes","31 Decembe 2019 - Support Expired:\nNo identifiable data was collected, only anonymised data, e.g. number of infant referrals during recruitment period.\n\nThis small study containing 6 GP practices was used to inform our current randomised controlled trial where we are looking for 152 practices. We were able to refine the trial documents, look at the primary care resources we would need and redistribute our trial checklist in an advantageous format. The qualitative work during this period also contributed to two publications.\n\n21 October 2019 - Amendment supported to extend the duration of support in place under the Regulations to 30 November 2019.\n\nAmendment supported 19 February 2019 to extend the support duration to 31 July 2019.\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 20/12/2017).\n2. Confirmation from the IGT Team at NSH Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – UCL School of Life and Medical Sciences shows a reviewed grade of satisfactory at 66% on Version 14, 2016/17)."]

{"sheet":"A02217","index":260,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02217"]
["Reference","16/CAG/0145"]
["Other Refs","IRAS: 215169, REC: 16/SC/0599"]
["Application Title","An investigation of decision making around treatment escalation"]
["Application Summary","This application from University Hospital Southampton NHS Foundation Trust (UHSFT) set out the purpose of understanding the decision-making processes of clinicians during deterioration and death of patients. The aim of this work was to identify opportunities to improve patient care through the use of Treatment Escalation Plans (TEPs) and inform future TEP escalation work.\nThe study would build upon an audit of data on deaths in hospital, collected by the Trust. Data had already been collected on the relationships between admission demographics, characteristics of condition on admission, illness trajectories, escalations decisions/discussions, intensive care involvement, complex clinical/social factors, potentially avoidable and failed discharges, frequency of palliative care team involvement and record of ‘do not attempt cardiopulmonary resuscitation’ order decisions. The proposal from the University of Southampton was for 2 researchers to further interrogate the medical records of deceased patients in order to better understand decision making processes in relation to people who deteriorate and die while in hospital, to track the trajectories of these patients and the resources mobilised. These trajectories could create difficult decisions for clinical staff particularly where there were issues with loss of capacity or situations distressing for relatives such as resuscitation.\nStructured, procedure specific TEPs were a useful means of improving understanding and communication when these types of decisions needed to be made and acted upon. This study aimed to gather information to inform the implementation and evaluation of TEPs.\nThe 2 researchers would complete an in-depth survey of case notes for a stratified sample of cases included in the Trust audit between 2 January 2015 and 3 July 2015 – a total of 45 cases would be examined. Prior to the study their approach would be piloted on a sample of 4 case notes, and a proportion would be cross-checked to ensure consistency (by the same 2 researchers). Data extracted would be pseudonymised and entered onto a spreadsheet. Data extraction would take place at the hospital site. Data extracted would be stored on the University of Southampton’s server.\nData collection would take 20 days.\nA recommendation for class 1 and 6 support was requested for the process of extracting and anonymising the information and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust (UHSFT)"]
["Contact Name","Professor Alison Richardson"]
["Address","University of Southampton"]
[null,"Building 67, Highfield Campus"]
[null,"Faculty of Health Sciences"]
["Postcode","SO17 1BJ"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,"Y","the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study would build upon an audit of data on deaths in hospital, collected by the Trust. Data had already been collected on the relationships between admission demographics, characteristics of condition on admission, illness trajectories, escalations decisions/discussions, intensive care involvement, complex clinical/social factors, potentially avoidable and failed discharges, frequency of palliative care team involvement and record of ‘do not attempt cardiopulmonary resuscitation’ order decisions."]
["Description of confidential patient information used","Access was requested to hospital ID number and month and year of birth in order to access the case notes of the individual at the UFHST site, and to establish patient age. This would be retained until analysis was complete. Date of death, gender, age, admitting speciality, date of admission, co-morbidities, history of presenting admission and functional status on admission and cause of death would be retained for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Southampton"]
["Status","Expired"]
[]
["Outcome Date","2017-02-06"]
["Next Review Date","N/A"]
["Notes","Specific conditions of support\n1. The CAG recommended that more public involvement work was carried out to improve transparency around this research. This could take the form of disseminating information on a website or newsletter to ensure that relatives or carers of patients who had died were able to become aware of this research. (please note that this is a recommendation only, and that support is not conditional on this point)\n2. Favourable opinion from a Research Ethics Committee. Confirmed 15 December 2016.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. V14 confirmed published and reviewed grade 77%."]

{"sheet":"A02218","index":261,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02218"]
["Reference","16/CAG/0102"]
["Other Refs","IRAS project ID: 207891, REC reference: 11/EE/0120"]
["Application Title","Health literacy and its relationship with process and outcomes in people undergoing dialysis or with a kidney transplant"]
["Application Summary","The specific research activity is undertaken to support a doctorate in Primary Care and Population Sciences and was submitted by NHS Blood and Transplant. Access to Transplant and Transplant outcome measures (ATTOM) study is a UK-wide research study examining the process of kidney transplant allocation in the UK. The study recruited 6842 patients from 2011-2013 with kidney disease at the time of starting dialysis treatment, at the time of receiving a kidney transplant or while on the kidney transplant waiting list. At recruitment, patients gave consent to have their information shared with NHS Blood and Transplant, the UK Renal Registry and the Scottish Renal Registry.\nHealth literacy is a term describing individuals' ability to access, understand and use health related information to improve their health. Analyses of the ATTOM dataset have shown that low health literacy is more common in those with lower socioeconomic status. The results also suggest that low health literacy might reduce the chance of patients receiving a kidney transplant. Health literacy research in people with kidney disease from the USA has shown increased use of emergency care, more dialysis-related complications and increased mortality among those with poor health literacy.\nThe research objective is to investigate for any effects of poor health literacy on health outcomes in people with kidney disease in the UK, including dialysis-related complications, access to kidney transplantation, hospital admissions, healthcare expenditure and mortality. The aim is that examining these relationships will inform future work to try to help people with poorer health literacy and kidney disease to manage their health more effectively.\nA recommendation for class 1 and 6 support was requested to achieve the relevant activities specified in the application."]
["Applicant Organisation Name","University of Cambridge Department of Surgery"]
["Contact Name","Chris Watson"]
["Address","University of Cambridge and Cambridge University Hospitals NHS Trust"]
[null,"Box 202, Addenbrooke’s Hospital"]
[null,"Hills Road, Cambridge"]
["Postcode","CB2 2QQ"]
["Telephone",{"$f":"44-1223-216108","v":-217287}]
["Email","cjew2@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients that provided consent for their identifiable data to be shared with the UK Renal Registry, Scottish Renal Registry and NHS Blood and Transplant. The cohort size would be approximately 6482 patients."]
["Description of confidential patient information used","Access was requested to Hospital Episode Statistics data, Payment by Results data and Office of National Statistics mortality data. NHS number and date of birth would be transferred to NHS Digital to enable the relevant linkages of the ATTOM cohort to these datasets."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-04-10"]
["Next Review Date","N/A"]
["Notes","This S251 application related to linkage of Hospital Episodes Statistics data to a dataset from an NIHR-funded cohort study (ATTOM). Linkage was performed under a data-sharing agreement with NHS Digital (DARS[1]NIC-14342-Q8W0X). Data were held at NHS Blood and Transplant (NHSBT). Analysis was completed according to the data sharing agreement. Analysis is now complete, and all datasets relating to this linkage have been deleted from NHSBT servers as per the data-sharing agreement (we received confirmation that this had been completed on 30/9/22). Any data derived from the linked HES datasets is in anonymised form.\n\nThe CAG agreement allowed linkage of HES data to the ATTOM study dataset. This allowed the NIHR-funded study dataset to be used for further research into kidney transplantation, specifically by Dr Ailish Nimmo, whose doctorate used these data to investigate the utility of cardiac screening prior to kidney transplantation. As well as contributing to a doctorate thesis, research using these data resulted in the following publications: \n\nNimmo A, Forsyth J, Oniscu G, Robb M, Watson C, Fotheringham J, Roderick PJ, Ravanan R, Taylor DM. A propensity score matched analysis indicates screening for asymptomatic coronary artery disease does not predict cardiac events in kidney transplant recipients. Kidney International Nov 2020 \n\nNimmo A, Ravanan R, Taylor DM Do routine hospital data accurately record comorbidity in advanced kidney disease populations? A record linkage cohort study BMC Nephrology 22(1): 95. March 2021 \n\nNimmo A, Latimer N, Oniscu GC, Ravanan R, Taylor DM, Fotheringham J. Propensity Score and Instrumental Variable Techniques in Observational Transplantation Studies: An Overview and Worked Example Relating to Pre[1]Transplant Cardiac Screening. \nTransplant International. 2022;35.\n\nThe first publication is a significant contribution to knowledge in this area, and has prompted changes in the clinical practice of screening for heart disease in potential transplant recipients.\n\nSpecific conditions of support\n1. Patient notification materials, providing contact details and a mechanism to respect any patient objection, to be disseminated via the UK Renal Registry and/or National Kidney Federation. If these two routes are not feasible, to provide further options for consideration by the CAG.\nThe response received on 21 September confirmed that communication would take place via the UK Renal Registry's 'Patient View' interface (formerly 'Renal Patient View'). This was indicated to be a webpage which allows patients to review their own lab results. It covers 71/74 UK renal units (http://www.renal.org/about-us/what-we-do/joint-activities/rixg/renal-patientview/which-units-have-renal-patientview#sthash.BlPuBcp1.dpbs) and has more than 50,000 registered patients.\nThe response suggested displaying a notice for a set time period on the news section of the log-in page. It was subsequently confirmed that a notice was displayed on the Renal PatientView System.\n2. Favourable opinion from a Research Ethics Committee. Received. It was noted the REC reference listed the IRAS ID as 68259\n3. Confirmation from the External IG Delivery Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Version 13 ‘reviewed grade’ published as ‘satisfactory’"]

{"sheet":"A02219","index":262,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02219"]
["Reference","17/CAG/0151"]
["Other Refs","IRAS project ID: 125842, REC reference: 13/LO/1508"]
["Application Title","A randomised trial of expedited transfer to a cardiac arrest centre for non-ST elevation out-of-hospital cardiac arrest (ARREST)"]
["Application Summary","This application from St Thomas’ Hospital sets out the purpose of medical research through a London-based multi-centre randomised controlled trial comparing expedited transfer to a specialised Cardiac Arrest Centre (CAC) to the current standard of care, which is transfer to the geographically closest emergency department, for a patient having a cardiac arrest without ST elevation (an abnormal electrical activity in the heart that is seen on the patient’s ECG). A CAC is a specialised centre for treating patients with a heart attack and expedited transfer to a CAC is standard of care for patients having a cardiac arrest with ST elevation.\nThis research takes place in an emergency context. The acute nature of the cardiac arrest and the time critical component to randomisation requires immediate action. The applicants have therefore requested and been approved a consent waiver for this trial from the Research Ethics Committee (REC) under the auspices of emergency research section 32(9) of the Mental Capacity Act 2005.\nSupport is requested to allow a research paramedic in the Clinical Audit and Research Unit (CARU) team at the London Ambulance Service (LAS), who is outside of the direct care team, access to the Patient Record Form which has been gathered by the paramedics. The research paramedic will then approach the individual to seek their consent for continuation in the trial.\nThe applicants state that gathering data on this full patient group is crucial for the success of the trial; however, it is acknowledged that this is complex patient group. The applicants are seeking support under the Regulations for the use of data in the following cases:\n1. To allow the research paramedic access to confidential information on the patient record form to gather anonymised data in relation to patients who die before regaining capacity and/or before a personal or professional consultee can give consent.\n2. Data collected up to the time a patient is approached and declines consent, unless the patient specifically requested that this data is deleted.\n3. Data collected on patients that have been discharged from hospital before they or a consultee could be approached about consent.\n4. To allow mortality tracking of all patients within groups two and three detailed above, up to 12 months post-event, by a research nurse at St Thomas’ Hospital London.\nA recommendation for class 1, 3 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","St Thomas’ Hospital"]
["Contact Name","Professor Simon R Redwood"]
["Address","King's College London/St Thomas' Hospital, Rayne Institute"]
[null,"Lower Ground Floor, South Wing"]
[null,"St Thomas' Hospital, London"]
["Postcode","SE1 7EH"]
["Telephone"]
["Email","Simon.Redwood@gstt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with suspected out-of-hospital cardiac arrest, male or female aged 18 and over. There will be 860 participants in total, with 430 in each arm of the trial."]
["Description of confidential patient information used","The research paramedic will require access to the full medical record for all patients. Those who are approached for consent and provide it will no longer require support under the Regulations.\nThe only item of confidential patient information which will be extracted from the patient’s record with support under the Regulations will be NHS Number. This will be transferred in an encrypted fashion by the research paramedic to a specific research nurse at St Thomas’ Hospital. The research nurse will have access to the encryption code, to enable the NHS Number to be transferred back to true format to enable mortality status to be checked up to one year post-event, at which stage the patient’s NHS number would be destroyed. If the patient has subsequently died in the interim year, the research nurse will record date of death in a time range from randomisation to ensure that the date of death cannot be worked out: <48 hours, 48 hours to 7 days, 8 days to 14 days, 15 to 30 days and >30 days."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","St Thomas’ Hospital"]
["Status","Supported"]
[]
["Outcome Date","2018-01-04"]
["Next Review Date","2025-01-04"]
["Notes","Specific Conditions of Support\n1. Support extends to allow the research paramedic involved in the trial access the patient records enrolled into the study, to facilitate an approach to be made for formal consent.\n2. Support cannot be extended to any patient who is approached for formal consent to participate and either declines to provide consent or fails to respond to the request.\n3. An overview would be required at the time of first annual review around the number of patients who were enrolled in the trial, but were discharged from hospital prior to an approach for consent to be made. Details would also be required around how many patients opted out from the use of their data, post-discharge from hospital in this circumstance.\n4. Patient and Public Involvement and Engagement – provide a report at the time of first annual review around the actual activity which has been undertaken in this area, together with feedback and an updated plan for the following year of the project. If the responses given were negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n5. Favourable opinion from a Research Ethics Committee. (Received – Substantial Amendment 2 received a favourable opinion 18/12/17).\n6. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Guy’s and St Thomas’ NHS Foundation Trust IGT shows a self-assessed grade of 92% satisfactory on Version 14, 2016/17, London Ambulance Service shows a self-assessed grade of 83% satisfactory on Version 14, 2016/17, reviewed as satisfactory with an improvement plan in place)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02220","index":263,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[34,1,34,4],[33,1,33,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[8,1,8,4],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[2,1,2,4],[7,1,7,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02220"]
["Reference","17/CAG/0159"]
["Other Refs","IRAS project ID: 233618, REC reference: 17/EE/0313, 17/LO/1569"]
["Application Title","Predicting flow to high-acuity services from 111: Data analysis plan"]
["Application Summary","This research application from The Behavioural Insights Team (BIT), commissioned by NHS England, set out the purpose of reducing potentially avoidable Emergency Department (ED) attendances to free up high-acuity resources. The study would focus on callers to the 111 service to determine why some of those who were told not to attend ED went on to do so in spite of this advice.\nThe study would consist of two parts. The first would be a quantitative analysis of data from 111 call records provided by NHS Digital as data controller in pseudonymised form (demographic data on patients and call handlers and call outcomes and call handlers). This data would be analysed to determine the characteristics of patients and call handlers most likely to lead to ED attendance after the 111 call.\nFor the second part of the study, qualitative analysis would be carried out on 200 recorded calls, linked to the record of service use soon after the call. Qualitative factors would include: the speed with which advice is given, opportunities to clarify the advice, planning discussions, the emotional tenor of the patient.\nThe sample for this would be drawn from the quantitative sample already provided by NHS Digital; all patients would have been advised not to attend ED – half would have attended nonetheless (and were subsequently coded as ‘not needing treatment, advice or guidance) and half would be patients who did not attend ED. For this sample, the call recording would be requested from the 111 service provider as data controller.\nBIT would be blinded to the outcomes of these calls during the qualitative analysis (i.e. they wouldn’t know whether the call in question was one which led to an ED attendance). The researchers would develop coding strategies using a Grounded Theory Approach to thematically record the most salient features of these calls which were not already routinely quantified as part of the 111 process. Finally, they would compare the thematic coding of both groups in order to identify whether any of these qualitative factors could explain different outcomes in terms of where a patient seeks treatment.\nA recommendation for class 1, 4 and 6 support was requested, for the purpose of extracting and anonymising the information, to link patient identifiable data obtained from more than one source, and to allow access to an authorised user for the above purposes."]
["Applicant Organisation Name","Behavioural Insights Team Ltd"]
["Contact Name","Dr Michael Hallsworth"]
["Address","The Behavioural Insights Team"]
[null,"4 Matthew Parker Street"]
[null,"Westminster, London"]
["Postcode","SW1H 9NP"]
["Telephone"]
["Email","michael.hallsworth@bi.team"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to the disclosure of RAIDR data from NHS Data Services for Commissioners Regional Office (DSCRO) and from 111 services to NHS Digital, to allow a flow of linked pseudonymised data to the study team."]
["Description of confidential patient information used","Following this, call records and linked data on subsequent ED attendance for 200 of these patients would be requested from the relevant 111 service for qualitative analysis of the call."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-01-08"]
["Next Review Date","N/A"]
["Notes","12 November 2021 - Support Expired:\nCPI was destroyed on publication of the study article.  \n\nFor the public benefits, this work directly informed NHS practice, and we also published a peer-reviewed article based on our data analysis, which is available here: https://bmjopen.bmj.com/content/10/3/e032043.info\n\nSpecific Conditions of Support (Final)\n1. Confirmation of Data Protection Registration is required for VOCARE and London Ambulance Service. Confirmed\n2. Favourable opinion from a Research Ethics Committee. Confirmed.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission.\nVOCARE – confirmed\nLondon Ambulance Service – confirmed (Improvement Plan in place)."]

{"sheet":"A02221","index":264,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02221"]
["Reference","17/CAG/0199"]
["Other Refs","IRAS project ID: 223767, REC reference: 17/NW/0675"]
["Application Title","The use of artificial nutrition and hydration at the end of life in acute stroke - a feasibility study"]
["Application Summary","This application from the Lancashire Teaching Hospitals NHS Foundation Trust set out the purpose of medical research into the use of artificial nutrition and hydration (ANH) at end of life care for patients who have suffered an acute stroke. The applicants have stated that more information is needed about the decisions made about the use of artificial nutrition and hydration at the end of life for patients with acute stroke and whether this affects how many patients experience common symptoms, such as pain, breathlessness or chest secretions. This feasibility study aims to determine whether these questions can be answered from the medical records of patients who have died following a stroke, and how many patient records would provide enough information to potentially detect a meaningful difference between how often patients who did and did not receive artificial nutrition and hydration experienced symptoms.\nA recommendation for class 1, 4 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Lancashire Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Dr Helen S Jones"]
["Address","ST5 Palliative Medicine, Lancashire Teaching Hospitals NHS Trust"]
[null,"Sharoe Green Lane, Fulwood"]
[null,"Preston"]
["Postcode","PR2 9HT"]
["Telephone"]
["Email","helenstephaniejones@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over, admitted to Lancashire Teaching Hospitals NHS Foundation Trust having suffered an acute stroke (either acute intracerebral infarction (blood clot) or acute intracerebral haemorrhage (bleed), which subsequently died during their admission. 40 patients will be recruited retrospectively from the previous six months admission."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes stated:\n NHS number – to allow record retrieval,\n Date of birth – to allow record retrieval and calculation of age for analysis,\n Date of death – to allow required calculations to be undertaken for analysis,\n Gender – for analysis,\nWider clinical information will be extracted from the patient medical records for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Dr Kina Bennett, Royal Preston Hospital"]
["Status","Expired"]
[]
["Outcome Date","2018-01-10"]
["Next Review Date","N/A"]
["Notes","29 December 2021 – Support Expired:\nThe applicant confirmed that support was no longer required. Data collection for the study was not commenced. \n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 08.12.2017)\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Lancashire Teaching Hospitals NHS Trust shows a satisfactory reviewed grade of 81% on Version 14, 2016/17)."]

{"sheet":"A02222","index":265,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02222"]
["Reference","CR13/2014"]
["Other Refs","HSCIC reference: MR369"]
["Application Title","Haemostatic Factors of Coronary Heart Disease"]
["Application Summary","This application from the Royal Free & University College Medical School set out a long term prospective study aimed at improving the identification of men at high risk for heart attack.\nA recommendation for class support was requested to cover access to mortality data from the NHS Central Register, maintained by the Data Linkage and Extract Service (DLES) at the Health and Social Care Information Centre. A cohort of 3,052 patients was flagged at the HSCIC"]
["Applicant Organisation Name","Royal Free & University College Medical School"]
["Contact Name","Professor Stephen Humphries"]
["Address","Royal Free & University College Medical School"]
[null,"Centre for Cardiovascular Genetics, 3rd Floor, Rayne Building"]
[null,"5 University Street, London"]
["Postcode","WC1E 6JF"]
["Telephone"]
["Email","steve.humphries@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A cohort of 3,052 patients was flagged at the HSCIC."]
["Description of confidential patient information used","access to mortality data from the NHS Central Register"]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-03-13"]
["Next Review Date","N/A"]
["Notes","All data has been destroyed and a certificate of destruction has been provided.\n\nDuring the course of this study over 65 papers were published examining, in UK healthy middle-aged men (the NPHSII study), the relationship between both haemostatic markers and genetic markers and risk of heart disease. Since the untimely death in 2007 of the study PI, Prof George Miller, we were unable to obtain funding to continue follow-up,, so the last papers from the study were published in in 2012.\n\nSpecific conditions of support\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed\n2. Confirmation of favourable REC opinion in line with comments above. Confirmed.\n3. Please make reasonable efforts to inform patients of ongoing data collection in line with the requirements of the Data Protection Act."]

{"sheet":"A02223","index":266,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02223"]
["Reference","18/CAG/0007"]
["Other Refs","IRAS: 214219, REC: 17/EM/0209"]
["Application Title","Evaluating alternative protocols for identifying and managing patients with familial hypercholesterolaemia: cost-effectiveness analysis with qualitative study"]
["Application Summary","This application from the University of Nottingham sets out the purpose of medical research with a focus on Familial Hypercholesterolaemia, which is the most common autosomal dominant disorder with at least 1 in 500 individuals (0.2%) affected by the more common heterozygote form. This is a multi-centre mixed methods study which includes database analysis, cost-effectiveness analysis, and qualitative interviews. The setting is UK Primary (general practice) and Secondary Care.\nThe study involves the extraction of routine secondary care NHS data and data from other databases of FH patients to inform the development of economic models for alternative protocols of FH identification and management. The study will compare current practice for cascade testing using differing criteria/thresholds, methods of testing [genetic, low density lipoprotein (LDL)], direct or indirect contacting of relatives, how far to test family (1st, 2nd, 3rd degree relatives etc.) and how this could be extended beyond specific health regions.\nThe applicants are seeking support to allow confidential patient information to be released from the Simon-Broome Registry, held by University College London, to NHS Digital to facilitate linkage with HES data. The following information will be provided back to the applicants on a pseudonymised, patient-level dataset: HES admitted patient-care, HES A&E and HES outpatient information. The applicants will supplement this pseudonymised dataset with anonymised data extracts from the Clinical Practice Research Datalink (CPRD) and the National Institute of Cardiovascular Outcomes Research (NICOR), which are out of scope for consideration of the CAG.\nThere is separate qualitative study which will involve interviewing patients; however, this is operated on a consented basis and is out of scope of the application for CAG consideration.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Nadeem Qureshi"]
["Address","University of Nottingham"]
[null,"Research and Graduate Services"]
[null,"King's Meadow Campus"]
["Postcode","NG7 2NR"]
["Telephone"]
["Email","nadeem.qureshi@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients, aged 18 years and over, who are listed on the Simon-Broome Registry. The sample size for this Simon Broome Registry-HES linkage will be the 3382 participants with the clinical diagnosis of FH (1650 men, 1732 women)."]
["Description of confidential patient information used","The following items of confidential patient information will be released by UCL to NHS Digital and processed for the purposes detailed below:\n Name – linkage,\n NHS Number – linkage,\n GP Registration – linkage,\n Date of birth – linkage and converted to age for analysis,\n Postcode (District Level) – linkage,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-01-26"]
["Next Review Date","N/A"]
["Notes","18 November 2020 - Application expired\nApplication expired as change in controllership from solely University of Nottingham to joint controllership between University of Nottingham and University of York. New application established under reference 20/CAG/0148\n\n16 October 2020 – Amendment supported to extend the duration of support for 12 months, until 31 March 2021.\n\n16 December 2019 – Amendment supported for the disclosure of specific items of confidential patient information to be disclosed from the Simon-Broome Registry to NHS Digital for linkage with ONS mortality data\n\nAmendment request (Approved 11/01/2019)\nThe amendment was submitted to seek support to extend the patient cohort for inclusion into the study to 3,553 patients.\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 28 December 2017).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - UCL School of Life and Medical Sciences show a reviewed grade of 66% satisfactory on Version 14, 2016/17. NHS Digital show a reviewed grade of 92% satisfactory on Version 14, 2016/17)."]

{"sheet":"A02224","index":267,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02224"]
["Reference","17/CAG/0205"]
["Other Refs","IRAS: 72614, REC: 11/LO/1065"]
["Application Title","MAPPING Study"]
["Application Summary","This multi-site research study, sponsored by Barts Health NHS Trust and coordinated by Imperial Healthcare NHS Trust set out the overall purpose of evaluating three new imaging techniques which could be used to detect tumour in adjacent lymph glands in womb cancer without surgical intervention. This was important for optimal treatment planning, and would benefit future patients in that they would be able to avoid having nodes surgically removed for examination. The study would evaluate the diagnostic performance of the new tests.\nPatients had been recruited to the study and given consent – however, new scenarios had arisen which had not been described to patients:\n1. In some cases a ‘false positive’ had been identified, when an imaging scan showed a positive lymph node. After removing the node, it was found to be negative. However, further imaging then showed the lymph to have grown – in these cases, this might mean that the scan had not shown a ‘false positive’, but that the positive node had not been removed in surgery.\n2. The research team asked for access to the post-surgical surveillance scans in order to correctly ascertain whether the ‘false positive’ node was in fact removed during surgery. This information was critical in order to achieve the study aims.\n3. In some cases, patients did not undergo surgery or did not have any nodal tissue removed. In these cases the research team wished to access the post-surgical scans to enable them to ascertain whether the nodes shown on the scans were benign or malignant. Again, this was vital in order to evaluate the effectiveness of the scans.\nSupport was therefore requested for an additional nine-month follow up past the consented period in order to review and evaluate these scans.\nA recommendation for class 5 and 6 support was requested for auditing, monitoring and analysing patient care and treatment and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Imperial Healthcare NHS Trust"]
["Contact Name","Professor Andrea Rockall"]
["Address","Queen Mary University of London"]
[null,"Old Anatomy Building"]
[null,"Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone"]
["Email","a.rockall@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from scans in relation to patients who consented to the MAPPING study."]
["Description of confidential patient information used","Only study number will be used to identify the scans; however during review of the scans the patients may be identifiable to the study team."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Barts Health NHS Trust"]
["Status","Expired"]
[]
["Outcome Date","2018-01-26"]
["Next Review Date","N/A"]
["Notes","March 2019 - Support Expired\nStudy is completed, the data retrieved, which is was some information on follow up imaging, was incorporated into the study database which is pseudonymised. \n\nThis study provided evidence of the diagnostic accuracy of MRI, FDG-PET/CT and FEC-PET/CT in the detection of metastatic lymph nodes in women with operable cervix cancer.   The results of the study have been published and are available for clinicians in order to understand the strength/weaknesses of these techniques. \n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – Substantial Amendment 14 – 20 December 2017).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Not checked for individual sites for multi-site studies – support is recommended on the understanding that the applicant will ensure that suitable security assurances are in place at each site, in the form of an up-to-date IG Toolkit which has been reviewed as satisfactory by NHS Digital.\nPlease see information governance section of the HRA website: https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/guidance-confidentiality-advisory-group-applicants/ and contact Exeter.helpdesk@nhs.net with any queries."]

{"sheet":"A02225","index":268,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02225"]
["Reference","17/CAG/0081"]
["Other Refs","IRAS project ID: 213210, REC reference: 17/YH/0144"]
["Application Title","UK Women's Cohort Study - HES"]
["Application Summary","This application from University of Leeds set out the purpose of research through the establishment of a database. The UK Women’s Cohort Study was established in 1993 on a consented basis to explore links between diet, lifestyle and chronic disease, in particular cancer. Approval was granted at this from each local REC for the study to follow participants for cases of cancer and other diseases. Individual consent forms were not required by the REC’s, therefore those women who returned questionnaires with a completed back page were considered to have provided consent for participation. The back page of the questionnaire informed participants that the purpose of the study was to examine \"the occurrence of certain diseases such as cancer which are registered by the National Health Service\" and participants were asked to provide their NHS number and GP address in order for their medical records to be accessed. The applicants hold name, date of birth and NHS number against a participant ID number from this historic consented study.\nThis application proposes the establishment of a new database, which will be generated from the existing cohort held by the applicants as part of the UK Women’s Cohort Study. The new database will hold the existing dietary information collated as part of the UK Women’s Cohort Study and will be linked with HES and ODR data held by NHS Digital. The applicants propose the disclosure of confidential patient identifiable data from the established cohort to the University of Leeds Integrated Research Campus (IRC). The IRC will then send this information to NHS Digital in order for the dataset to be linked with HES and ODR data for the cohort. This will be returned by NHS Digital to the IRC, whereby the research team will access the information via a Virtual Research Environment.\nA recommendation for class 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Janet E. Cade"]
["Address","Nutrition Epidemiology Group"]
[null,"School of Food Science and Nutrition"]
[null,"University of Leeds"]
["Postcode","LS2 9JT"]
["Telephone"]
["Email","j.e.cade@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort is already established and will include all participants within the existing UK Women’s Cohort Study, which amounts to 35,372 women."]
["Description of confidential patient information used","Confidential patient identifiable information will be transferred from the University of Leeds Nutrition Epidemiology Group UK Women’s Cohort data holding to the IRC platform within the University of Leeds to enable the set-up of this new proposed database. Data will then be shared with NHS Digital for linkage and returned to the University of Leeds.\n\nThe following items of confidential patient information will be required to facilitate the data linkage to be undertaken by NHS Digital:\n NHS number,\n Date of birth,\n Participant ID."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-02-02"]
["Next Review Date","2025-02-02"]
["Notes","20 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), civil registration mortality data, and National Cancer registration and Analysis Service (NCRAS)\n\n11 October 2022 – amendment supported\nTo change the data processor from University of Leeds Integrated Research Campus (IRC) to University of Leeds - LASER\n\nAmendment Request (Approved 28/03/2018)\nThe amendment requested approval to link the existing UK Women's Cohort Study (UKWCS) with National Cancer Registry and Analysis Services (NCRAS) data, held by Public Health England and ONS mortality data, held by NHS Digital.\nThe linkage with the ONS would be undertaken on an ongoing annual basis. Date (in DD/MM/YYYY format) and cause of death would be returned as part of this data request.\nThe linkage with NCRAS would be undertaken once only and would include return of Cancer Registration (Patient table, Tumour table, and Treatment table), which includes cancer subtype, diagnosis dates (used for survival analysis), site of cancer, and treatment information.\n\n\nSpecific Conditions of Support (Final)\n1. Support was extended to England and Wales only.\n2. Support is extended to the ongoing retention of the original UK Women’s Cohort Study database.\n3. Support is only extended to the linkage of the UK Women’s Cohort Study participants to the HES dataset held by NHS Digital at this stage. There is currently no support for the linkage to ONS data held by NHS Digital or NCRAS data held by Public Health England.\n4. A report would be required at first annual review around the actual activity which had been undertaken to engage and involve public and the patients within the project. An updated plan of activity would also be required at this time detailing the proposed involvement and engagement activities moving forward.\n5. Favourable opinion from a Research Ethics Committee. (Confirmed – received 21/06/2017).\n6. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - University of Leeds Integrated Research Centre shows a reported published score of 88% satisfactory on Version 14, 2016/17)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02226","index":269,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02226"]
["Reference","17/CAG/0167"]
["Other Refs","IRAS project ID: 233509, REC reference: 17/SC/0524"]
["Application Title","Prevalence and Investigation of Laboratory Diagnosed Anaemia in Secondary Care"]
["Application Summary","This application from the University of Southampton sets out the purpose of medical research to evaluate current routine practice in the diagnosis and investigation of anaemia in secondary care.\nThe aim of the project is to use data from a large teaching hospital that will develop an understanding of how a laboratory diagnosis of anaemia, i.e. a haemoglobin concentration below the normal reference range set by the world health organisation (WHO), is investigated and the economic impact of these investigations.\nData Analysts at University Hospital Southampton will access the electronic laboratory records to acquire the dataset for the defined study period which is all cases between 01/01/2016 – 31/12/2016, which meet the inclusion criteria. The Data Analysts had legitimate access to this data as part of their standard roles and as such, did not require support under the Regulations for this task. The dataset will be matched with diagnostic codes using the digital hospital medical records. Support is requested to enable access to a sub-cohort of approximately 10% of the patient cohort records to enable the accuracy of diagnostic coding to be checked.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","University of Southampton"]
["Contact Name","Dr James Plumb"]
["Address","Shakelton Department of Anaesthesia"]
[null,"Southampton General Hospital"]
[null,"Tremona Road"]
["Postcode","SO16 6YD"]
["Telephone"]
["Email","j.plumb@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with a confirmed laboratory diagnosis of anaemia at University Hospitals Southampton will be included. This will encompass both male and female, aged between 16 and 110 years, who were seen between 01/01/2016 and 31/12/2016 at University Hospitals Southampton. The laboratory diagnosis is classified as a haemoglobin concentration below the normal limit set by the World Health Organisation.\nTotal UK sample size: 33000"]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes set out below:\n Hospital Number – validation and linkage between laboratory data and patient episode information,\n Gender – for analysis.\nThe applicants would use the hospital number in order to access the full patient record in order to undertake an audit check of the diagnostic codes which had been applied to records."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University Hospital Southampton NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2018-02-02"]
["Next Review Date","N/A"]
["Notes","5 November 2021 - Applicant confirmed support should be expired as the study never began.\n\nSpecific Conditions of Support (Final)\n1. Patient Notification and Dissent – the following point should be actioned ahead of the project commencing:\na. An additional means of contact should be added to the opt-out mechanism (postal or telephone).\n2. Patient and Public Involvement and Engagement – further work should be undertaken in this area to address the following points:\na. Additional patient and public involvement and engagement activity should be undertaken in order to seek the views of a wider patient demographic, including an appropriate patient cohort,\nb. Feedback will be required at the time of first annual review around the actual activity which has been undertaken in this area, together with feedback,\nc. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – opinion issued 20/10/2017).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University Hospital Southampton Information Governance Assessment Report overall score for v14 (2016/17) – 73%, reviewed by NHS Digital as satisfactory)."]

{"sheet":"A02227","index":270,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02227"]
["Reference","17/CAG/0206"]
["Other Refs","IRAS project ID: 235523, REC reference: 18/WS/0001"]
["Application Title","The relationship between body composition, tumour activity, functional activity and survival in patients with advanced cancer"]
["Application Summary","This research study from Glasgow University, undertaken as part of a PhD qualification, set out the purpose of examining the relationship between the systemic inflammatory response, tumour activity, body composition, functional activity and survival in patients with advanced cancer. This would enable a better understanding of the basis of the loss of muscle mass and functional activity in patients with advanced cancer. The study could ultimately improve clinician’s ability to produce accurate prognoses for patients with advanced cancer.\nThe data to be used was already held as part of a previous, multi-centre study of over 300 patients examining the relationship between biomarkers and prognosis in patients with advanced cancer (the IPAC study). All of the participants in this study were now deceased.\nThe dataset was held in de-identified form with ‘anonymisation codes’ held by the CI of the IPAC study (who would also be the CI for the current study). Identifiable data would be required by the researcher in order to access patient CT scans. The applicant proposed to travel to sites in England and Wales with the anonymisation code for each individual patient. Local leads would then provide the NHS number for the patient at that site. The applicant would access the scans onsite and remove all identifiers before saving them to an encrypted USB stick. This would be marked with their unique study code (or ‘anonymisation’ code) before being uploaded to the IPAC database. De-identified data would then be provided to the researcher to complete their analysis.\nA recommendation for class 1 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Glasgow"]
["Contact Name","Dr Barry Laird"]
["Address","University of Edinburgh, Institute of Genetics and Molecular Medicine"]
[null,"Edinburgh Cancer Research UK Centre"]
[null,"Western General Hospital, Cewe Road, Edinburgh"]
["Postcode","EH4 2XR"]
["Telephone"]
["Email","barry.laird@ed.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who had previously consented to their inclusion in the IPAC study"]
["Description of confidential patient information used","Data will be accessed at individual NHS sites in England and Wales in relation to this cohort. NHS number and any identifiers which may be viewable on the CT scan will be accessed; however, patient identifiers will be removed from the copy of the scan which will be used or analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Edinburgh"]
["Status","Supported"]
[]
["Outcome Date","2018-07-02"]
["Next Review Date","2019-07-02"]
["Notes","Specific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. Confirmed – 18 January 2018\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Not assessed as multiple sites included in the project – it was advised that all sites are required to have a reviewed IG Toolkit rating of satisfactory on Version 14, 2016/17, which had been confirmed by NHS Digital)."]

{"sheet":"A02228","index":271,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02228"]
["Reference","18/CAG/0003"]
["Other Refs","IRAS project ID: 31578, REC reference: 11/AL/0311"]
["Application Title","FAST- Febuxostat versus Allopurinol Streamlined Trial A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia"]
["Application Summary","This application from the University of Dundee sets out the purpose of medical research which aims to follow-up patients from a fully-consented CTIMP (Clinical Trial of an Investigational Medicinal Product) which was evaluating the most effective treatment for gout. Patient information will be sent from the study research team at the University of Dundee to NHS Digital in order for linkage with HES and ONS records, to collate hospital admission and death data.\nA recommendation for class 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Dundee"]
["Contact Name","Professor Thomas MacDonald"]
["Address","University of Dundee/NHS Tayside"]
[null,"MEMO/HRC, Level 7, Ninewells Hospital & Medical School"]
[null,"Dundee"]
["Postcode","DD19SY"]
["Telephone"]
["Email","t.m.macdonald@dundee.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All English patient participants recruited to the FAST CTIMP study. The sample size is 1834 patients"]
["Description of confidential patient information used","The following data items will be transferred from University of Glasgow to NHS Digital:\n Name – validation and linkage,\n NHS number – validation and linkage,\n Date of birth – validation and linkage,\n Postcode – validation and linkage,\n Date of death – retained in full format for analysis,\n Cause of death – provided in ICD10 format for analysis,\n FAST-ID – linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Dundee"]
["Status","Supported"]
[]
["Outcome Date","2018-02-09"]
["Next Review Date","2025-02-09"]
["Notes","27 January 2023 - change in data processor from NHS Digital to NHS England, regarding  data sources Hospital Episode Statistics (HES) & ONS Mortality data.\n\nSpecific Conditions of Support (Final)\n1. Patient Notification – the drafted text around patient follow-up through data linkage with wider NHS datasets should be included within the next newsletter circulation.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 03/08/2011).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – NHS Digital shows a reviewed reported grade of satisfactory on Version 14, 2016-17)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02229","index":272,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02229"]
["Reference","18/CAG/0002"]
["Other Refs","IRAS project ID: 230333, REC reference: 17/WA/0410"]
["Application Title","Trajectories of diabetes related health measures (from linked lab data) and subsequent health and educational outcomes"]
["Application Summary","This application from Cardiff University set out the purpose of medical research aiming to better understand the effects of diabetes on educational outcomes. It was acknowledged that education may also have an impact on an individual’s diabetes management. The applicants have an interest in how other factors influence the relationships between health and education, these include characteristics of the child (e.g. gender), their families (e.g. single parent families), and the health services they use (e.g. type of diabetes clinic). The project aims to use linked health and education records to quantify the associations between differences in levels of HbA1c (an indicator of longer-term blood glucose levels) and educational outcomes.\nThe application involves the disclosure of confidential patient information from both the National Diabetes Audit (Adults – England) and National Diabetes Audit (Adults – Wales) (held by NHS Digital) and the National Paediatrics Diabetes Audit (held by the Royal College of Paediatrics and Child Health) to NHS Wales Informatics Services (NWIS). Data will also be released from the Higher Education Statistics Agency (HESA) dataset to NWIS; however, this is out of the CAG’s remit as it is not confidential patient information. Corresponding clinical data will be released direct to the Secure Anonymised Information Linkage databank (SAIL), which will then be linked with psedonymised demographic data.\nThe applicants clarified that HESA are providing all of the additional education data – for students in England and Wales at University plus school education data for students from English schools. The school education data for pupils from Wales is already provided by Welsh Government routinely into SAIL where is it is available in psuedonymised format for linkage to the new datasets.\nThe legal basis for the collection of National Diabetes Audit (England) is by Directions, National Diabetes Audit (Wales) the legal basis is “section 251” (Reference: 17/CAG/0124) and for the National Paediatric Diabetes Audit the legal basis is “section 251” (Reference: ECC 2-03(c)/2012).\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Robert French"]
["Address","Secure Data Lab"]
[null,"SPARK building"]
[null,"Maindy Road, Cathays"]
["Postcode","CF24 4HQ "]
["Telephone",7434512080]
["Email","steadfast@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All birth cohorts between 1983 and 2013 within England and Wales, for whom diabetes audit data (NPDA and NDA) from 2003 to 2018 and education data from 2003 to 2018 will be requested. It is anticipated that there will be 17,195 patients included within the project."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes defined:\n NHS number – used to create anonymised linkage field,\n Date of birth – used to create anonymised linkage field, validation and translated for analysis (week of birth),\n Gender – validation and analysis,\n Postcode – validation and translated to LSOA for analysis.\nWider clinical information will be provided from the diabetes audits for inclusion in the analysis dataset.\n Patient Name - in order to facilitate linkage with wider data sources (as of 07/12/18 Amendment)"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Cardiff Univeristy"]
["Status","Supported"]
[]
["Outcome Date","2018-02-09"]
["Next Review Date","2025-02-09"]
["Notes","14 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources - National Diabetes Audit (Adults – England) and National Diabetes Audit (Adults – Wales)\n\nAmendment supported 14 August 2023 to include 2 additional purposes for this application – to quantify the associations between parents’ and childrens’ diagnosis of diabetes and how these affect child outcomes, and to model the associations between school exclusions and diabetes health outcomes.\n\n29 June 2021 - Amendment supported:\nAmendment supported to allow NHS Digital to create a linkage key, and for NHS Digital to share NDPA/NDA identifiers with ONS-DAP to create a ‘DAP’ linkage key.\n\nAmendment Request (Approved 07/12/2018)\nThe amendment requests the inclusion of an additional data item, Patient Name, from\nthe data released by the National Diabetes Audits, in order to facilitate linkage with the\nwider data sources in the study.\nAmendment supported to allow the disclosure of confidential patient information from NHS Digital to the Department for Education, and to allow confidential patient information to be disclosed for the National Diabetes Audit and National Paediatrics Diabetes Audit from NHS Digital to NWIS.\n\nSpecific Conditions of Support (Final)\n1. Support extends to the release of confidential patient information from the National Diabetes Audit (Adult – England) and National Diabetes Audit (Adult – Wales) (held by NHS Digital) and the National Paediatrics Diabetes Audit (held by the Royal College of Paediatrics and Child Health) to NHS Wales Informatics Services (NWIS).\n2. Patient Notification and Dissent:\na. Project-specific patient notification materials should be displayed for a two-month period ahead of any release of data from the National Diabetes Audit and the National Paediatric Diabetes Audit datasets, to facilitate patient objections.\nb. The section titled ‘Opting out of the Study’ should be updated to include confirmation of the cut-off date for the receipt of objections.\n3. Patient and Public Involvement and Engagement – further work should be undertaken in this area to address the following points:\na. Children who are now adults with diabetes, who will be included in the project should be approached about the study, in order to seek their views on the proposed activity,\nb. Further work should also be undertaken to seek the views of patients and the public around the acceptability of using confidential patient information as described in the application in order to establish the anonymous dataset to be used in analysis,\nc. A report should be provided at the time of first annual review around the actual activity which has been undertaken in this area, together with any feedback or outputs,\nd. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n4. Favourable opinion from a Research Ethics Committee (Confirmed – 05/12/2017).\n5. Security Assurance Arrangements – NWIS have provided a CPIP (Caldicott: Principles into Practice) report showing a 94% satisfactory assessment rate.\nAs the above conditions have been accepted or met, this letter provides confirmation of final approval. I will arrange for the register of approved applications on the HRA website to be updated with this information."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02230","index":273,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02230"]
["Reference","18/CAG/0010"]
["Other Refs","IRAS project ID: 40999, REC reference: 10/H0401/36"]
["Application Title","Prevention of Fall Injury Trial"]
["Application Summary","This application from the University of Warwick set out the purpose of medical research to undertake follow-up of patients recruited to the PreFIT (Prevention of Fall Injury Trial) trial, which was commissioned in 2010. The purpose of the trial was to estimate the cost and value of population-based screening, the effects of different types of interventions, the ability of clinicians to deliver these types of interventions at scale and the willingness of older people to engage with the interventions. The intention was to provide an evidence-base to inform decisions about investment into interventions to prevent trip and fall injuries. Public Health England, NHS England and the NIHR are awaiting the outcomes from the trial.\nThe trial was fully consented and recruited 9,821 aged between 70 and 101 years of age. The primary outcome for the trial was fracture, ascertained through HES data and participant self-report. All participants provided consent to for follow up and access to their medical records; however, explicit consent was not taken for ONS mortality data. The applicants had previously received HES data from NHS Digital; however, upon submission of a renewal of this data linkage, which included an amendment to extend the linkage to ONS mortality data, the IGARD Group was unable to approve the request for data linkage. It was cited that the original consent which was taken covered three year duration only and had not explicitly stated that linkage with ONS mortality information would be undertaken.\nA recommendation for class 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Professor Sarah Lamb"]
["Address","Warwick Clinical Trials Unit"]
[null,"University of Warwick"]
[null,"Gibbet Hill Road, Coventry"]
["Postcode","CV4 7AL"]
["Telephone"]
["Email","sarah.lamb@ndorms.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who provided informed consent to participate in the PreFIT trial."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as described:\n NHS Number – linkage,\n Date of birth – linkage,\n Postcode – linkage,\n Date of death – analysis,\n Cause of death – analysis.\nSupport is requested to allow the disclosure of confidential patient information from the University of Warwick to NHS Digital, to enable linkage with HES and ONS mortality datasets, which will be returned to the applicants for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Research and Innovation Services, Cardiff University"]
["Status","Expired"]
[]
["Outcome Date","2018-02-15"]
["Next Review Date","N/A"]
["Notes","08 December 2021 - Support expired:\nApplicant confirmed on 8 December 2021 that CAG support is no longer required because there is no longer any processing of any confidential patient information items which were collected with ‘s251’ as the legal basis under common law. The applicant retains items of confidential patient information with consent as the legal basis, and these will also shortly be deleted. NHS Digital do not require ‘s251’ to be in place to retain the data provided by them. \n\nSpecific Conditions of Support\n1. Support is extended to the linkage with HES and ONS data for the sub-cohort of 2,322 patients who were not sent supplementary consenting information in relation to the follow-up study only.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University of Warwick shows a reviewed grade of 97% satisfactory on Version 14, 2016/17)."]

{"sheet":"A02231","index":274,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02231"]
["Reference","17/CAG/0189"]
["Other Refs","IRAS project ID: 217555, REC reference: 17/NE/0310"]
["Application Title","Surveillance of Incidence of first time diagnosis of Early Onset Depression in children aged 3-13 years the United Kingdom and Republic of Ireland (EOD-UK & ROI)"]
["Application Summary","This epidemiological study from Northumberland Tyne and Wear NHS Trust set out the purpose of determining the incidence of first diagnosis of Early Onset Depression (EOD) in children between the ages of 3 years, and before the 13th birthday in the UK and Republic of Ireland, as reported by consultants in child and adolescent psychiatry using the Child Adolescent Psychiatry Surveillance System (CAPSS) methodology. In addition, the results of the study would provide detailed descriptions of the presentation and clinical features of children with EOD and the current management strategies in place, referral pathways and duration between symptom onset and diagnosis. The condition of EOD had not previously been investigated, and was considered to be rare, however it led to a fourfold increase of suicide attempts compared to later onset depression, and it was therefore important to recognise and treat the condition.\nThe CAPSS methodology is based on the British Paediatric Surveillance Unit (BPSU) methodology and has been approved in principle by the CAG:\nA recommendation for class 1 and 6 support was requested to cover the process of accessing and anonymising the information and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Northumberland Tyne and Wear NHS Trust"]
["Contact Name","Dr Aditya Sharma"]
["Address","Academic Psychiatry, Wolfson Research Centre"]
[null,"Campus for Ageing and Vitality"]
[null,"Newcastle upon Tyne"]
["Postcode","NE4 5PL"]
["Telephone"]
["Email","aditya.sharma@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from all clinicians registered with CAPSS in relation to children exhibiting early onset depression between the ages of 3 and 13"]
["Description of confidential patient information used","NHS number, date of birth, gender, partial postcode and ethnicity to allow the removal of duplicate reports,\nPartial postcode and gender retained for analysis to allow investigation of geographical and demographic influences."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Northumberland Tyne and Wear NHS Foundation Trust"]
["Status","Expired"]
[]
["Outcome Date","2018-02-15"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, dissemination of research data will have a patient and public benefit in future. This is the first study in the British Isles looking into the surveillance epidemiology of this condition. Applicants have been able to review how these children are being managed, the complexity of presentations, and consideration can now be given on how specific treatment guidelines could be developed.\n\n\nSpecific Conditions of Support (Final)\n1. Please note that support from CAG only extends to England and Wales\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 03 October 2017).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Not requested for each site; support is based on the assumption that the applicant will ensure that satisfactory security assurances are in place for each site).\nPlease see information governance section of the HRA CAG website, and contact exeter.helpdesk@nhs.net for further advice."]

{"sheet":"A02232","index":275,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02232"]
["Reference","18/CAG/0005"]
["Other Refs","IRAS: 234583"]
["Application Title","Using Guthrie cards for a serosurveillance study of maternally-derived antibody against pertussis"]
["Application Summary","This application from Public Health England sets out the purpose of medical research which aims to identify the amount of antibody which is required to be administered to pregnant women to protect infants from pertussis (whooping cough) in order to inform the maternal vaccination programme. The applicants will use dried blood spots from newborn baby dried bloodspot screening cards for the study. The study will be undertaken comparing antibody from DBS from 150 infants with pertussis that occurred during 2012 with DBS from 300 healthy controls. The project will be facilitated by using the PHE national surveillance activity that identified babies with pertussis disease and requesting laboratories storing the cards to take up to two of the dried blood spots that remain on the card for analysis. The laboratories will also be asked to provide two other cards taken at the same time to act as the healthy controls. The antibody test which was developed at Public Health England will be used to measure antibody concentrations to work out how much antibody is needed to protect babies from pertussis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Public Health England"]
["Contact Name","Dr Kirsty Le Doare"]
["Address","St George's University of London"]
[null,"Cranmer Terrace"]
[null,"London"]
["Postcode","SW17 0RE"]
["Telephone"]
["Email","k.mehring-le-doare@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," 150 infants under the age of three months identified by national active surveillance between 1st September 2011 and 1st September 2012, infected with pertussis.\n 300 healthy controls – gestational age and sex matched."]
["Description of confidential patient information used","Data in relation to the patient cohort will be taken from the PHE national surveillance records, which were gathered during a 2012 outbreak. The information by laboratory staff to identify a control cohort blood spot for inclusion in the study:\n NHS number – used to match records to sample\n Date of birth – used to match records to sample and identify matched control cohort,\n Gestational Age at birth – identify matched control and analysis,\n Sex – used to match records to sample and identify matched control cohort,\n Ethnicity – used to match records to sample and identify matched control cohort."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-02-27"]
["Next Review Date","N/A"]
["Notes","02 December 2021 - Support expired\nApplicant confirmed that the study was completed, and that support can be expired as the original identifiers are no longer being processed/retained.   \n\nRegarding public interest, the work shows the importance of standardised collection and storage of dried blood spots if they are to be used in immunological research. The public benefits were explained in the final report which was enclosed.\n\nSpecific Conditions of Support (Final)\n1. Patient and Public Involvement and Engagement – further work should be undertaken in this area to address the following points:\na. Undertake further activity with a wider audience to include parents, both mothers and fathers, who have an appropriate interest in the research,\nb. Specific engagement about the proposed study, rather than general discussion around the use of Guthrie cards for research purposes, should be undertaken,\nc. A report would be required at the time of first annual review around the activity which has been undertaken, together with nay feedback,\nd. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Patient notifications and dissent – further work is required in this area to address the following points:\na. Work should be undertaken to find a more appropriate channel for patient notifications for this study. If a specific support group for pertussis cannot be located, explore more generic support networks for new parents to find a suitable alternative,\nb. A report should be provided at the time of first annual review around the activity which has been undertaken in this area, together with the confirmation of any wider communications that have been published around the project.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – North East – York REC (17/YH/0323) – favourable opinion issued 12/10/2017).\n4. Confirmation from the IGT Team NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Public Health England shows a reviewed reported grade of 72% satisfactory on version 14, 2016/17)."]

{"sheet":"A02233","index":276,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02233"]
["Reference","17/CAG/0198"]
["Other Refs","IRAS project ID: 214795, REC reference: 16/NE/0401"]
["Application Title","Long term outcomes of functional neurological symptoms in children"]
["Application Summary","This application from the Newcastle upon Tyne Hospitals NHS Foundation Trust set out the purpose of the establishment of a research database into neurological symptoms in children. The applicants state that children and young people with functional symptoms will be identified from a database operating in the Newcastle paediatric neurology department since 1997. The identified patients’ Newcastle hospital medical records will be examined to see to what extent their problems have persisted into adulthood and to try to identify factors associated with successful (symptom free) long term outcomes. The applicants will also perform a record-linkage study to identify involvement of the local NHS Trust that provides psychological and mental health services, to see whether involvement of these services has been associated with better long term outcomes.\nThis is a single purpose study and the assembled dataset will be destroyed after use. The topic of study is functional neurological symptoms - problems with abnormal movement, sensation, inability to move etc. with no conventional medical cause resulting from psychological factors. The project’s aim is to identify long term outcomes after children present with functional neurological symptoms: whether their problems persist into adulthood.\nA recommendation for class 4, 5 and 6 support was requested to cover activities as defined in the application."]
["Applicant Organisation Name","Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Contact Name","Dr Rob Forsyth"]
["Address","Sir James Spence Institute"]
[null,"Royal Victoria Infirmary"]
[null,"Newcastle upon Tyne"]
["Postcode","NE1 4LP"]
["Telephone"]
["Email","rob.forsyth@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort will be established from an existing database containing 11,000 records and it was anticipated there will be approximately 120 individuals who would meet the inclusion criteria for the project."]
["Description of confidential patient information used","Access was requested to the following items of data for the project:\n NHS Number – data linkage,\n Hospital ID no – data linkage,\n Name – data linkage,\n Last known address – data linkage,\n Date of birth – data linkage,\n Date of death – data linkage,\n Postcode (clarified this is required at unit level) – data linkage,\n Gender – data linkage,\n Health service district– data linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-02-28"]
["Next Review Date","N/A"]
["Notes","01 December 2021 - Support expired\nApplicant confirmed on 1 December 2021 that the application was for a one-time sharing of data between hospital records systems (to identify patients of one NHS Trust known to another). All data extracts external to the hospital clinical records systems have now been deleted. The public interest was the understanding of long term outcomes of functional neurological disorders (FND) late after presentation in children’s services, in case remediable factors could be identified associated with long term persistence of FND that could allow for adjustment of care to improve late outcomes. In the event we found that the long term outcomes of FND presenting in children is generally very positive.\n\nSpecific Conditions of Support\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 11 January 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Contact should be made with the Exeter Helpdesk (exeter.helpdesk@nhs.net) to follow this up. (Confirmed – NTW Trust shows a 76% satisfactory rating on Version 14, 2016/17)."]

{"sheet":"A02234","index":277,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02234"]
["Reference","18/CAG/0021"]
["Other Refs","IRAS: 215981, REC: 17/SC/0574"]
["Application Title","The incidence of hydroxychloroquine retinopathy in England a prospective case-finding study."]
["Application Summary","This application from the Oxford Eye Hospital sets out the purpose of medical research which aims to undertake the first population-based study to determine the incidence of hydroxychloroquine retinopathy in the UK. This research is important in order to help quantify the public health burden from hydroxychloroquine retinopathy, and inform the decision making process screening provision. In the USA, screening is recommended: when signs of retinal damage are detected, hydroxychloroquine is stopped before permanent visual loss occurs. This study will directly inform any recommendation for hydroxychloroquine retinopathy screening within the National Health Service.\nThe information will be collected over a two year period.\nA recommendation for class Class 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Oxford University Hospitals NHS Trust"]
["Contact Name","Miss Srilakshmi Sharma"]
["Address","Oxford Eye Hospital"]
[null,"John Radcliffe Hospital"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone"]
["Email","Srilakshmi.Sharma@ouh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Adult patients (over 18 years of age)\n Male or female\n Diagnosed with hydroxychloroquine retinopathy 240 patients anticipated"]
["Description of confidential patient information used","Data required from reporting clinicians:\n Local hospital number – validation - retained to allow one year follow-up questionnaire to be sent and to enable local clinicians to identify patients\n Month and year of birth –validation – retained to allow one year follow-up questionnaire to be sent and to enable local clinicians to identify patients and analysis\n Gender –analysis\n Ethnicity – analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-03-01"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and identifiers only retained by direct care team.\n\nIn terms of public benefit, the data from this study will inform the review of the national Hydroxychloroquine Retinopathy Monitoring recommendations due in 2024 which impacts 70,000-80,000 individuals in the UK. This study forms the only mechanism to monitor the yield of cases detected as a consequence of this national policy recommendation.\n\n\nSpecific conditions of support\n1. Support extends to England and Wales only.\n2. Patient and public involvement and engagement should be continued with the Macular Society in order to disseminate study findings\n3. Patient Dissent, information sent to clinicians should include a reminder to exclude any patient who has dissented from the use of their data\n4. Favourable opinion from REC (Confirmed – 15 January 2018)\n5. Confirmation of suitable security arrangements via IG Toolkit submission. (Confirmed - Oxford University Hospital NHS Foundation Trust which incorporates Oxford Eye Hospital show a reviewed grade of 99% on Version 14, 2016/17)."]

{"sheet":"A02235","index":278,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02235"]
["Reference","17/CAG/0187"]
["Other Refs","IRAS: 225531"]
["Application Title","The Street Triage Project V1"]
["Application Summary","This research study from the University of Sheffield set out the purpose of exploring the experience of service users who have undergone ‘Street Triage’, and their understanding of its role, purpose and delivery. The research would include observations of practice in multi-disciplinary teams, and aimed to inform future practice in England and Wales.\nStreet Triage is a health and social care crisis intervention service, based on joint working between various agencies including the police, and designed to improve patient experiences during mental health crises.\nThe research aims to build an evidence base for the effectiveness of the intervention and will seek the views of NHS patients as well as staff employed by NHS Trusts who are involved with the scheme and Police Officers who work in collaboration with NHS staff on the scheme. The research is deemed important as this new model of care may be incorporated as part of the NHS 5-year Forward plan; joint working between the police and health and social care professionals is likely to become mandated by amendments to the Mental Health Act 1983 in the future.\nSupport was requested for two aspects of the study: recruitment, via a third party who would send out surveys to patients, and observations of staff working as part of Street Triage Schemes– the researcher would accompany staff on call-outs, and although they would not observe any interactions between patients and staff, there could be incidental disclosure of patient details during the period before and after the interaction.\nA recommendation for class 3 and 6 support was requested to select and contact patients to seek their consent, and to allow an authorised user access for the above purpose."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Miss Rivka Smith"]
["Address","School of Law,\nBartolome House,"]
[null,"Winter Street,"]
[null,"Sheffield,"]
["Postcode","S3 7ND"]
["Telephone"]
["Email","rivka.smith@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to \n1. Data from Sheffield triage Scheme in relation to patients who were subject to Sheffield Street Triage scheme over an 18-month period between 1st September 2016 and 1st March 2017 (estimated 1000)"]
["Description of confidential patient information used","Access was requested to \n1. Data from Sheffield triage Scheme in relation to patients who were subject to Sheffield Street Triage scheme over an 18-month period between 1st September 2016 and 1st March 2017 (estimated 1000)\nName\nDate of birth\nPostcode\n2. Incidental disclosures of patient details during observations undertaken by the researcher; no information relating to individual patients is to be recorded."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-03-02"]
["Next Review Date","2019-03-02"]
["Notes","Specific Conditions of Support\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 20/12/2017)\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via satisfactory review of Information Governance Toolkit (IGT) submission. Confirmed for: UK Mail Ltd (specifically Imail which is a sub-division of UK Mail), Sheffield Health & Social Care NHS Trust and Derbyshire Healthcare NHS Trust. Additional site confirmed as holding a satisfactorily review IGT submission: Rotherham, Doncaster and South Humber NHS Foundation Trust – confirmed 14/08/2018)"]

{"sheet":"A02236","index":279,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02236"]
["Reference","17/CAG/0114"]
["Other Refs","IRAS project ID: 223746, REC reference: 17/NW/0234"]
["Application Title","Understanding homicide against family carers: Expanding the focus from individual- to contextual-relational factors-A Phase II Analysis"]
["Application Summary","This application from Mersey Care NHS Trust set out the purpose of undertaking qualitative research to gain a wider understanding of circumstances and processes under which homicide against a caregiver by an individual with a mental health diagnosis occurs. The applicants have devised a multi-level framework which will be utilised to analyse the clinical records of six patients currently detained in secure services with a conviction of murder or manslaughter against a family carer. The purpose of the study is to identify risk and protective factors in these cases to inform prevention or reduction of violence by patients with a mental health diagnosis against caregivers and to inform future research directions. The overarching aim is to inform the development of carer safety guide for use in routine clinical practice.\nA recommendation for class 2, 4 and 6 support was requested to cover activity as described in the application."]
["Applicant Organisation Name","Mersey Care NHS Trust"]
["Contact Name","Mr Andy Brown"]
["Address","Autism Spectrum Disorder Assessment and Liaison Team (FPASDALT)"]
[null,"Mersey Care NHS Trust"]
[null,"Rainhill Road, Rainhill"]
["Postcode","WA9 5DB"]
["Telephone"]
["Email","Andrew.Brown@merseycare.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort will involve the records of six patients within the Mersey Care Trust region detained in High Secure Services with a conviction of murder or manslaughter between 2002 and 2015, of their Mother, Father, sibling or current or ex -spouse/partner, where the victim was over 16. Patients will have a range of diagnoses from psychosis, depression."]
["Description of confidential patient information used","The applicants will have access to the full clinical record of the patients involved in the study; however, identifiable data will not be extracted as this is not required for analysis.\n\nThe applicants will, if possible, collate the following items to support analysis:\n Age at time of event,\n Sex,\n Ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-03-02"]
["Next Review Date","2019-03-02"]
["Notes","Specific Conditions of Support (Final)\n1. Patient and Public Involvement and Engagement – provide ongoing reports, at annual review stage, of the activity which has been undertaken with the patient and public group which is associated with the project. If the response received from patient and public engagement and involvement is negative, the CAG will take this into account when considering whether continued support can be recommended.\n2. Patient Notifications – provide an update at the time of first annual review around the progress which has been with the Research Facilitation Forum in providing generic notices within sites around the Trust being research active.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 13 June 2017)\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Mersey Care NHS Foundation Trust, Version 14, 2016/17 – email received 02/03/2018)."]

{"sheet":"A02237","index":280,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02237"]
["Reference","18/CAG/0012"]
["Other Refs","IRAS project ID: 224902, REC reference: 17/SW/0268"]
["Application Title","Exploring collaborative working in adult intellectual (learning) disability services"]
["Application Summary","This application from the University of Plymouth sets out the purpose of medical research focusing on how the multi-disciplinary teams involved in the provision of specialised care and support to adults with intellectual learning difficulties (I(L)D) work collaboratively in the provision of this care.\nIn order to understand how I(L)D services are set up to support collaborative working, the applicant undertake an observation of three different adult I(L)D community teams for one week each. This will provide an understanding of how the services are set up to support collaboration, together with an understanding of what collaboration between professionals in these services looks like. Alongside, interviews will be held with three professionals with a range of roles from each team to understand how professionals themselves understand collaboration in these services. The applicant will also record and examine interactions between professionals in multidisciplinary already occurring meetings. These meetings are one area for which there is an expectation that collaboration occurs, for example to enable care planning for service users.\nThe focus of the project is on the medical professionals delivering care to patients, not the patients; however, it is acknowledged by the applicant that in shadowing the care professionals and examining the multi-disciplinary meetings, patient confidence may be in directly breached.\nA recommendation for class 1 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Plymouth"]
["Contact Name","Miss Madeleine Tremblett"]
["Address","Psychology Office"]
[null,"University of Plymouth"]
[null,"Drakes Circus"]
["Postcode","PL4 8AA"]
["Telephone"]
["Email","madeleine.tremblett@plymouth.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The applicant will be observing health care professionals who provide care and support to adults living with an intellectual learning difficulty within England."]
["Description of confidential patient information used","The applicant is not seeking access to any confidential patient information; however, it has been identified that this may be disclosed incidentally during the course of the observations with staff."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-03-02"]
["Next Review Date","N/A"]
["Notes","31 December 2019 - Support Expired:\nSupport is no longer required as all data that was collected for the study (audio recordings) were anonymised (all identifiers deleted from the recordings) immediately after data collection whilst on NHS sites. Therefore I have had no access to any identifiable data since 2019. The anonymised data that is held is held on secure servers at the University of Plymouth and will be deleted after 10 years in line with Plymouth University's retention policy. The data held is transcriptions of meetings (where patients were discussed, but all identifiable markers are removed) and audio recordings of the same meetings (10.5 hours) with anything identifiable removed and voices changed. \n\nClinical guidance refers to collaboration as the chosen form of teamwork for multidisciplinary teams (MDT). Professionals in intellectual (learning) disability (I(L)D) services are advised by NHS England to collaborate in MDTs to address the multiple and complex needs of clients. In the past 20 years the need for has been re-emphasised in I(L)D services due to a number of serious service issues. Mencap’s Death by Indifference report (2007) demonstrated widespread neglect in care for people with I(L)D, resulting in a number of avoidable deaths, reiterating the need for change to collaborative community care. However, there is little guidance on what collaboration looks like for professionals to draw on and improve care for the public with I(L)D needs. \n\nThis body of work has begun to unpick how teams collaborate, to enable professionals to build and reflect on their practice, drawing on evidence of what actually happens in I(L)D team meetings. For example, findings show that potential risk issues were found to be raised as concerns by healthcare professionals. If healthcare professionals raised the concern as their own opinion, early in a discussion, team members gave space in the meeting to hear the issue and provided advice. Findings show that trouble and difficult conversations between team members are carefully managed with the use of laughter. Finally, when allocating tasks team members draw on their professional identity to delicately negotiate who is best to do different tasks for clients. \n\nThe public benefit of this work is two-fold. First, the teams that took part in the research have had training sessions delivered to help them to reflect on their team work and collaborative practice. Reflective practice is key to clinical development and for providing continual professional development, which the clients that they work with benefit from. Second, the work has been published as a thesis that anyone will be able to access to support teams who work with people with I(L)D, an executive summary has been shared with the NHS trusts that took part in the research to disseminate learning to all their I(L)D teams to learn from, and the findings are being developed as academic articles to further disseminate the work to the wider public. \n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 30/11/2017).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Devon Partnership Trust shows a self-assessed grade of 77% satisfactory on Version 14, 2016/17 – email confirmation received 23/01/18 from NHS Digital as satisfactory)."]

{"sheet":"A02238","index":281,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02238"]
["Reference","17/CAG/0173"]
["Other Refs","IRAS project ID: 232954, REC reference: 17/NE/0342"]
["Application Title","An evaluation of the impact of the MedEye System in one U.K. Hospital Trust"]
["Application Summary","This application from Newcastle University sets out the purpose of medical research into the use of MedEye, a bedside tool used to prevent medication administration errors. The system scans medication at the bedside and verifies whether the correct medication is being administered. The combination of MedEye technology with an electronic health record (EHR) and prescribing system holds a great deal of promise to reduce medication errors at the administration stage for hospitalised patients. However, without evidence on safety, effectiveness and efficiency, it is difficult for health care organisations to prioritize this technology among many other potential safety interventions.\nThe study contains a number of elements; however, the CAG consideration is only in relation to the first aim of the project, which is to evaluate what effect the MedEye system has on the incidence of serious medication administration errors. Two research observers will undertake observation of medication administration in the wards 2-4 weeks prior to the roll out of MedEye and then 4-8 weeks afterwards. The observers will be clinically experienced healthcare professionals who hold an honorary contract with the Trust. They will be blinded to the clinician’s prescribing instructions. Support is requested to allow the researcher observers to access the medical records of the patients whose medication administrations were observed to check the accuracy of drugs administered against those prescribed.\nA recommendation for class 1, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Sarah Slight"]
["Address","School of Pharmacy"]
[null,"Sir James Spence Institute Building"]
[null,"Newcastle University"]
["Postcode","NE1 4LP"]
["Telephone"]
["Email","sarah.slight@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged over 18 years admitted to adult wards during the study period will be eligible to be indirectly involved in the study. 16 wards will be included in the study which will be half surgical and half medical.\nEach single tablet administration which is observed is classed as one observation. It is intended that 16,000 medication administrations will be observed in total. Intravenously administered and solution based medications are excluded from the project."]
["Description of confidential patient information used","The following items of confidential patient information will be accessed and utilised for the purposes described:\n Patient name – validation,\n NHS ID Number – validation,\n Date of Birth – accessed to enable patient age to be recorded – analysis.\nFurther clinical details in relation to the patient’s prescription will also be required."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-03-05"]
["Next Review Date","N/A"]
["Notes","23 March 2020 - Support Expired:\nCPI was anonymised prior to analysis.\n\nMedEye is a bedside tool used to prevent medication administration errors. The system scans medication at the bedside and verifies whether the correct medication is being administered. The combination of MedEye technology with an electronic health record (EHR) and prescribing system holds a great deal of promise to reduce medication errors at the administration stage for hospitalised patients. However, without evidence on safety, effectiveness and efficiency, it is difficult for health care organisations to prioritize this technology among many other potential safety interventions.\n\nOur feasibility study provided some evidence that MedEye could improve patient safety, but further data is needed to confirm this. Unfortunately data collection was hindered due to the pandemic. Further refinements to the system were also identified and can be utilised to improve the system. \n\n18 October 2019: Amendment supported to reduce the number of patients to be included in the study to 2,000. Support was also extended to the inclusion of nursing students, employed via the Trust bank, to undertake the study bedside observations. \n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Newcastle upon Tyne Hospitals NHS Foundation Trust shows a reviewed grade of 92% satisfactory on Version 14, 2016-17)."]

{"sheet":"A02239","index":282,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02239"]
["Reference","17/CAG/0188"]
["Other Refs","IRAS project ID: 232363, REC reference: 17/NE/0362"]
["Application Title","Improving the Diagnosis and Management of neurodegenerative dementia of the Lewy body type in the NHS (DIAMOND-Lewy). Work package 1 Review (WP1R) - Reviewing the impact of the assessment toolkit on diagnosis of Lewy body dementia."]
["Application Summary","This research application from the University of Cambridge aimed to review the impact of the assessment toolkit on diagnosis of Lewy body dementia.\nSection 251 support was sought for one aspect of an over-arching programme, funded by The National Institute for Health Research (NIHR), which focused on Lewy Body dementia (LBD) which includes two related disorders: Dementia with Lewy bodies (DLB) and Parkinson’s Disease Dementia (PDD). The signs and symptoms of LBD were often difficult to detect and currently only about one in three cases were diagnosed; As a result many patients with LBD received sub optimal management.\nThe programme had two main aims:\n(i) To improve the recognition and prompt diagnosis of LBD through the introduction of a simple assessment tool.\n(ii) To improve patient management and outcomes through the development and introduction of an evidence based toolkit for clinicians.\nWork completed to date comprised the establishment of the proportion of cases of LBD diagnosed prior to use of the assessment tool, and development of the assessment tool including a pilot of the tool in NHS settings. To evaluate the impact of the assessment tool the researcher wished to re-examine the current diagnosis pathways of LBD.\nThis would necessitate access to medical records by the research team, as there was no diagnostic code for LBD. The applicant would request a list of all patients seen by participating memory/dementia assessment services and movement disorder services over an over an 18-month period, in order to screen their clinical notes and extract the required information.\nA recommendation for class 1 and 6 support was requested for the purpose of extracting and anonymising the information and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor John O'Brien"]
["Address","Department of Psychiatry, University of Cambridge"]
[null,"School of Clinical Medicine, Box 189, Level E4"]
[null,"Cambridge Biomedical Campus, Cambridge"]
["Postcode","CB2 0SP"]
["Telephone"]
["Email","john.obrien@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The data items would be used to identify which service the patient was seen in, and to remove duplicate referrals.\nChecking for duplicate referrals would occur at NHS Trust sites. The data would be de-identified (date of birth reduced to age, data of death to age at death) prior to transfer to Newcastle University for analysis."]
["Description of confidential patient information used","Access was requested to:\nData from clinical teams and support staff (IT and administrative staff) to the research team:\nName\nDate of birth\nNHS/Hospital number\nData extracted from clinical notes:\nDate of birth\nDate of death\nGender\nDiagnosis\nDate of diagnosis\nCognitive score at diagnosis\nLast 4 digits of NHS number"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-03-13"]
["Next Review Date","N/A"]
["Notes","10 December 2021 - Support expired:\nThe original identifiers are no longer kept, each case has data consisting of study number, age, sex, diagnosis, whether dead.\n\nThe benefits of this research were that we were able to show that the introduction of an assessment toolkit for diagnosis of dementia with Lewy bodies (DLB) was associated with a significant (35%) increase in diagnostic rates for DLB.\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – Overall study 28 November 2017, Substantial Amendment, 21 February 2018).\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – satisfactory on Version 14, 2016/17\nNorthumberland, Tyne and Wear NHS Foundation Trust –sponsor (NTW),\nNewcastle upon Tyne Hospitals NHS Foundation Trust (NUTH),\nNorthumbria HealthCare NHS Foundation Trust (NHCT),\nCambridgeshire and Peterborough NHS Foundation Trust (CPFT),\nNorfolk and Norwich University Hospitals NHS Foundation Trust (NNUH)."]

{"sheet":"A02240","index":283,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02240"]
["Reference","17/CAG/0032"]
["Other Refs","IRAS project ID: 212072, REC reference: 17/SC/0073"]
["Application Title","Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study"]
["Application Summary","This application from NDORMS, University of Oxford set out the purpose of improving knowledge of the risks and benefits of osteoporosis treatment in patients with kidney disease.\nKidney disease is associated with a significantly increased risk of broken bones with substantial implications for patients, NHS and society. Drugs used to reduce the risk of bone fracture in osteoporosis were sometimes used for patients with kidney disease, however the mechanisms leading to bone brittleness were different in kidney disease patients, and these drugs could worsen kidney function. Further evidence was required to inform treatment for these patients.\nThe applicants propose to compare users of the most common treatment for osteoporosis (bisphosphonates) to non-users with similar characteristics, linking information from the Clinical Practice Research Datalink (CPRD) to the UK Renal Registry (UKRR) via NHS Digital.\nIdentifiable UK Renal Registry data would be provided direct to NHS Digital for data linkage using HES (Hospital Episode Statistics) IDs which would be provided by CPRD, using existing procedures approved by the Independent Scientific Advisory Committee (ISAC) at MHRA, for CPRD/HES linked data. This process is in line with previously used and ongoing similar procedures for the linkage of CPRD to external data sources including HES or the National Joint Registry.\nA recommendation for class 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","NDORMS, University of Oxford"]
["Contact Name","Dr Daniel Prieto-Alhambra"]
["Address","NDORMS, University of Oxford"]
[null,"Botnar Research Centre, Windmill Road"]
[null,"Oxford"]
["Postcode","OX3 7LD"]
["Telephone"]
["Email","daniel.prietoalhambra@ndorms.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from the UK Renal Registry in relation to patients with an eGFR<45 (based on serum creatininee) aged 40 years or older at the age of biochemistry testing."]
["Description of confidential patient information used","Applicant would receive:\n1. CPRD (patient socio-demographics, clinical measurements as recorded by general practitioners, laboratory results, clinical events, and primary care prescriptions); and\n2. UKRR relevant biochemistry measurements, renal outcomes, and acute kidney injury (where applicable)."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-03-15"]
["Next Review Date","2019-03-15"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 9 March 2017.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – BHDG, University of Oxford – reviewed satisfactory grade at 82% on Version 13, 2015-16)."]

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[]
[]
["Application Number","A02241"]
["Reference","15/CAG/0208"]
["Other Refs","IRAS project ID: 172593, REC reference: 15/EM/0471"]
["Application Title","PEPS Data Linkage Study"]
["Application Summary","This application from University of Nottingham sets out the purpose of the study to clarify safety and service use among participants in the PEPS trial by examining data obtained from the Health and Social Care Information Centre (HSCIC). The number and type of hospital admission, emergency department attendance and deaths which will be looked at to find out whether participants who were allocated to receive PEPS therapy experienced more of these events than participants who were allocated to receive usual treatment only.\nSupport is requested to allow the disclosure of NHS number and date of birth from the sites who participated in the original PEPS trial to the HSCIC for linkage purposes.\nThese participating sites will submit participant identifiable information (NHS number and date of birth) to the Health and Social Care Information Centre (HSCIC) for data linkage purposes.\nHSCIC will search for the data for the relevant participants and provide this data to the University of Nottingham for analysis. Data received from HSCIC will have the NHS number removed and will be identified by the trial ID number and date of birth only.\nHSCIC data will be linked with the existing PEPS trial dataset so that the data on hospital admissions, emergency department attendances and deaths received from HSCIC can be analysed by treatment group (i.e. by whether participants were allocated to receive PEPS therapy or usual treatment).\nA recommendation for class 1, 4 and 6 support was requested."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Mary McMurran"]
["Address","University of Nottingham, Institute of Mental Health"]
[null,"Triumph Road"]
[null,"Nottingham"]
["Postcode","NG7 2TU"]
["Telephone"]
["Email","mary.mcmurran@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Sites who participated in the original PEPS trial, participants who were allocated to receive PEPS therapy and participants who were allocated to receive usual treatment only."]
["Description of confidential patient information used","Access was requested to NHS number for linkage purposes and date of birth and date of death are to be used for analysis purposes. Date of birth is to be removed once validation of linkage has been done, date of death is to be retained for a period of 7 years."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2016-05-27"]
["Next Review Date","2017-05-27"]
["Notes","Specific conditions of support\n1. Patient opt out must be respected\n2. Provide a timeline of the actions it is intend to take (or provide some other method of reassurance) in order to provide an effective opt out process\n3. Favourable opinion from a Research Ethics Committee.\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed 17/05/2016"]

{"sheet":"A02242","index":285,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02242"]
["Reference","18/CAG/0050"]
["Other Refs","Previously 15/CAG/0195, IRAS project ID: 180646, REC reference: 15/LO/1861"]
["Application Title","The DESiGN Trial Detection of small for gestational age fetus (SGA) – a cluster randomised controlled trial to evaluate the effect of the Growth Assessment Protocol (GAP) programme"]
["Application Summary","This application from King's College London and Guy's & St Thomas' NHS Foundation Trust set out the purpose to transfer the data controllership arrangements for the application activity currently supported under 15/CAG/0195, from University College London’s Comprehensive Clinical Trials Unit. The change was brought about due to a change in trial sponsorship.\nThe application activity previously supported under reference 15/CAG/0195 set out the purpose of medical research into the Growth Assessment Programme (GAP), which aimed to improve the identification of small babies by considering maternal characteristics such as size and ethnicity when assessing growth.\nHospitals are randomised, rather than individual women who will receive the care allocated to their hospital avoiding contamination of the intervention. All maternity units in the trial will introduce the GAP programme eventually, but one group will use GAP immediately, while the other group will delay implementation of GAP. The time before the introduction of GAP in the delayed arm means the applicant can compare maternity units using GAP with those continuing with usual care.\nA recommendation for class 1, 3 and 6 support was requested to enable the activity specified in the application."]
["Applicant Organisation Name","King's College London and Guy's & St Thomas' NHS Foundation Trust"]
["Contact Name","Dr Dharmintra Pasupathy"]
["Address","Division of Women's Health, Women's Health Academic Centre KHP"]
[null,"10th Floor North Wing, St. Thomas' Hospital"]
[null,"Westminster Bridge Road, London"]
["Postcode","SE1 7EH"]
["Telephone"]
["Email","dharmintra.pasupathy@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","To collect this data the research team will need to review notes of all women delivering children within the 13 hospital sites (which are classed as the participants) to extract the anonymised data required for analysis."]
["Description of confidential patient information used","Data on few secondary outcomes, such as clinical detection of SGA and compliance assessment, are not routinely available in the hospital systems. "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-03-21"]
["Next Review Date","N/A"]
["Notes","16 April 2021 - Support Expired:\nAll of the data was pseudonymised at the time of its removal from the NHS Trusts. It is currently stored on secure servers using only a study ID (pseudonym). The original identifiers linked to the study IDs are retained only at the NHS Trusts from where the records came. The research team do not hold any original identifiers. \n\nIn terms of public benefits. These are yet to be realised however the anticipated benefits are as follows:\n1. Publications of research findings (first results publication has now been submitted to an academic journal). \n2. It is anticipated that the results of the research, once published, will inform national policies and guidelines regarding the diagnosis of SGA and prevention of stillbirth. \n3. If the national policy is to continue roll-out of the studied intervention, then it is anticipated that the research findings will assist NHS Trusts in improving the quality of its use, thereby potentially improving the effectiveness of the intervention. \n\n24 July 2020 – Amendment supported to extend the duration of the study until 30 November 2020.\n\nAmendment request (Approved 18/01/2019)\nThe amendment sought support to extend the duration of support under the Regulations to 30 November 2019.\n\nSpecific Conditions of Support (Final)\n1. All pre-existing conditions of support related to 15/CAG/0195 remain applicable.\n2. The pre-existing annual review cycle remains applicable, with the next annual review to be received 4 weeks before 09/05/2018, and then on an annual basis to this schedule.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Guy’s and St Thomas’ NHS Foundation Trust shows a reviewed satisfactory grade on Version 14, 2016/17).\n4. Favourable Opinion from a NHS Research Ethics Committee. (Confirmed – Favourable Opinion 12 January 2018 – support had been ongoing for the project since 20 November 2015)."]

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[]
[]
["Application Number","02243"]
["Reference","16/CAG/0136"]
["Other Refs","IRAS project ID: 209035, REC reference: 16/LO/1684"]
["Application Title","Personalised Risk assessment in Febrile illness to Optimise Real-life Management across the European Union (PERFORM)"]
["Application Summary","This application, submitted by Imperial College Healthcare Trust, sets out the purpose of the establishment of a research database to assess the management and outcome of febrile children who seek medical treatment in hospital whilst providing data for comparative health evaluation and cost effectiveness modelling. The management and outcome of children who seek medical treatment in hospital MOFICHE component of the study will collect routine clinical data on patients presenting to emergency departments and the data will be used for a prevalence study of bacterial illness amongst febrile children in order to study the determinants of diversity between countries in hospital admission, antibiotic prescription and investigations related to clinical signs and symptoms in 50,000 febrile children, of which the UK is to recruit 15,000 children aged 0-18 years. It involves the creation of a large multicentre database holding routinely collected electronic patient information.\nA recommendation for class 1, 5 and 6 support was requested to cover the activities specified in the application."]
["Applicant Organisation Name","Imperial College Healthcare Trust"]
["Contact Name","Professor Michael Levin"]
["Address","Professor of Paediatrics and International Child Health, Dept of Paediatrics"]
[null,"Wright Flemming Institute"]
[null,"Imperial College London"]
["Postcode","W2 1PG"]
["Telephone"]
["Email","m.levin@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to patient data via hospital databases to allow for the bulk extraction of emergency department presentation data. Support was requested to enable members of the research team to access patient data from UK hospital databases. It is at this initial stage that researchers will have access to confidential patient information. It was confirmed that the extracted dataset will not contain any identifiable information."]
["Description of confidential patient information used","Date of birth was specified to be the confidential patient data item to be extracted."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-01-11"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in 2020 that support can be expired as recruitment to the PERFORM study ended, including those aspects which were covered by CAG support.\n\nAmendment Request (Approved - 23 March 2018)\nThe patient-facing materials which supported the elements of the study which have support under the Regulations had been revised by the applicants. Copies were submitted for consideration by the CAG.\n\nSpecific Conditions of Support\n1. Provide confirmation that the opt-out procedure will be facilitated via the submission of the completed opt-out form to members of the care team. Confirmed\n2. Provide a report on the additional patient and public involvement work which has been undertaken in connection with the project. This should be provided alongside the standard annual review documentation.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 12/01/2017, Substantial Amendment 1, to cover for Patient Notification Materials)\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Version 13 2015/16, reported at a satisfactory reviewed grade 66%)."]

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[]
[]
["Application Number","A02244"]
["Reference","17/CAG/0204"]
["Other Refs","IRAS project ID: 235847, REC reference: 18/SC/0003"]
["Application Title","CRIS Linkage wtih the Office for National Statistics Census Data"]
["Application Summary","This application from Office for National Statistics and the South London and Maudsley NHS Foundation Trust (SLaM) sets out the purpose of medical research through the establishment of a research database linking mental health records from the South London and Maudsley NHS Foundation Trust (SLaM) with UK Census data and mortality data, held by the Office for National Statistics (ONS), to enable provision of an anonymised data resource for research purposes.\nA cohort of people with relevant clinical diagnoses and clinical information will be linked to their data from the UK census from 2001 and 2011. SLaM is a large mental health trust covering a geographic catchment of four London boroughs (Lambeth, Southwark, Lewisham, and Croydon) and a population of around 1.2 million residents. SLaM also provides a range of national specialist services accessed across England. The ONS census runs every ten years and surveys all residents in England and Wales. The census asks after individual-level and household-level circumstances and includes questions around employment/ occupation and worklessness, education, tenure/ type of property, access to household vehicles and heating, number of persons resident in the household, carers, self-rated health and disability, migration, citizenship and ethnicity, language, and religion.\nThe resulting anonymised database will be used as a research tool to further explore the wider inequalities of patients with a mental health diagnosis. A control cohort will also be established within the database of people who are not known to SLaM services but who were resident within one of the four boroughs covered by SLaM at the time of the census which the applicant has confirmed is out of scope.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","Office for National Statistics and the South London and Maudsley NHS Foundation Trust (SLaM)"]
["Contact Name","Dr Jayati Das-Munshi"]
["Address","Institute of Psychiatry, Psychology & Neuroscience (IoPPN)"]
[null,"King’s College London"]
[null,"Dept of Health Service & Population Research, PO 33"]
["Postcode","SE5 8AF"]
["Telephone"]
["Email","jayati.das-munshi@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The patient cohort is all patients registered in the SLaM CRIS database, which covers approximately 350,000 individuals."]
["Description of confidential patient information used","Confidential patient information as detailed below will be provided by SLaM for the purposes outlined. This will be linked to wider sensitive data from the census dataset for analysis.\n Name – linkage,\n Date of birth – linkage and calculation of age for analysis dataset,\n Gender – linkage and analysis,\n Postcode – linkage and translated to borough/LSOA/MOSA for analysis\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-03-23"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in April 2024 that ‘s251’ support could be expired, as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant does not have access to any means of re-identifying.\n\nIn terms of public benefit, the linked data has informed discussions around lower levels of census uptake in people with mental disorders. Applicants have used this research to raise this issue at public meetings, and have developed weights to account for this non-response so that future work using this linked data takes into account/is not affected by this type of bias. The research has helped to further inform the field, and improve understanding of how to maximise linked data to tackle social and economic inequities impacting people with severe mental disorders. In addition, the data has contributed to teaching and education, and to public understanding of data linkage. \n\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 19 February 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – ONS – 70% satisfactory on Version 14, 2016/17 and South London and Maudsley – 91% satisfactory on Version 14, 2016/17)."]

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[]
[]
["Application Number","A02245"]
["Reference","17/CAG/0172"]
["Other Refs","IRAS project ID: 231574"]
["Application Title","Expanded Access of Blincyto® in Patients with Acute Lymphoblastic Leukaemia: A Retrospective Observational Study"]
["Application Summary","This application from OXON Epidemiology aims to characterise the population receiving the drug Blincyto in Europe, under an early access program, and to investigate outcomes and utilisation. The drug is approved in the US by the FDA, and conditionally approved by the EMA (European Medicines Agency) for the treatment of adults (and more recently children) with relapsed and/or refractory (R/R) Philadelphia chromosome-negative (Ph-) B-precursor Acute Lymphblastic Leukaemia (ALL).\nDue to the high level of unmet clinical need in these patients, Amgen has been providing Blincyto via an early access program for a number of ALL subgroups who met pre-specified disease criteria in countries where such programs are permitted. The pool of eligible patients in the 6 countries is estimated to be approximately 400-500 B-precursor ALL patients.\nThe applicant is requesting Section 251 support for two aspects of the study:\n1. To access the data of deceased adult patients,\n2. To allow research staff, who are not considered part of the direct care team, to identify and approach living patients for consent to access their medical records.\nA recommendation for class 1, 3 and 6 are more appropriate – for the purpose of extracting and anonymising the information, for auditing, monitoring and analysing patient care and treatment and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","OXON Epidemiology"]
["Contact Name","Professor Adele Fielding"]
["Address","University College London Hospital, 250 Euston Rd,"]
[null,"Bloomsbury"]
[null,"London"]
["Postcode","NW1 2PG"]
["Telephone"]
["Email","a.fielding@ucl.ac.uk'"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The population receiving the drug Blincyto, under an early access program.\nThe applicant is requesting Section 251 support for two aspects of the study:\n1. To access the data of deceased adult patients,\n2. To allow research staff, who are not considered part of the direct care team, to identify and approach living patients for consent to access their medical records."]
["Description of confidential patient information used","Access was requested to:\n1. Identifiers from patient’s clinician to research staff, in order to contact the patient and seek consent.\n2. Data from medical notes in relation to deceased patients identified by their treating clinician as taking Blincyto:\nThe full medical record will be accessed on-site; however the only identifiable data extracted will be date of death.\nDate of birth will be truncated to month and year."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-03-28"]
["Next Review Date","2019-03-28"]
["Notes","Specific Conditions of Support (Final)\n1. Please consider notifying living patients of the access to their data for the purpose of contacting them to seek consent, placing information in the public domain to enable them to opt out if they so wish. Please note that this is a suggestion and support is not conditional on this point.\n2. Please be aware that the CAG recommendation applies to England and Wales only. Approvals should be sought from the relevant bodies for any data processing that will take place in Northern Ireland and Scotland.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 16 February 2018)\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission.\nUCLH – v14 confirmed published and reviewed\nLeeds Teaching Hospitals NHS Trust – v14 confirmed published and reviewed\nBarts Health NHS Trust – v14 confirmed published and reviewed"]

{"sheet":"A02246","index":289,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02246"]
["Reference","18/CAG/0043"]
["Other Refs","IRAS project ID: 228447, REC reference:18/LO/0272, CAG18/0043"]
["Application Title","Predictive biomarkers for more effective targeted therapy of colorectal cancer patients with anti-EGFR antibodies"]
["Application Summary","This application from the Royal Surrey County NHS Foundation Trust sets out the purpose of medical research with a focus on investigating the expression pattern and prognostic significance of HER family and other heterologous receptors in paired primary colorectal cancers and their corresponding metastatic lesions and patient response to treatment. The study is using archival tumour blocks from colorectal cancer patients. These will be accessed via the Royal Surrey County Hospital pathology Department and the patient details will be anonymised at the time performing the antibody staining in the laboratory. The data for subsequent analysis for the association between expression of biomarker and overall survival and will be anonymised using patient number, or date of birth; no label will identify the patient name.\nSupport is requested to allow the disclosure of confidential patient information from Royal Surrey County NHS Foundation Trust to Kingston University for analysis. The applicants will be accessing 150 colorectal tumour tissue samples from 2007, most of the patients will be deceased.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Royal Surrey County NHS Foundation Trust"]
["Contact Name","Dr Sharadah Essapen"]
["Address","Royal Surrey County NHS Foundation Trust,"]
[null,"St Luke's Cancer Centre,"]
[null,"Egerton Road, Guildford"]
["Postcode","GU2 7XX"]
["Telephone"]
["Email","s.essapen@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","150 patients will be identified from medical notes and coding system who were diagnosed with colorectal cancer attending Royal Surrey hospital for chemotherapy since 2007."]
["Description of confidential patient information used","The following items of data will be used for the purposes as set out below:\n• Name – for requesting tissue blocks\n• Hospital ID – for requesting tissue blocks\n• date of birth – to calculate survival analysis\n• date of death – to calculate survival analysis\n• Gender - analysis\nThe applicants will use confidential patient information to extract relevant tumour samples and to create a pseudonymised dataset to support analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-04-06"]
["Next Review Date","2019-04-06"]
["Notes","Specific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 23rd March 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Royal Surrey County Hospital overall score 69% on version 14 2016/17"]

{"sheet":"A02247","index":290,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02247"]
["Reference","17/CAG/0001"]
["Other Refs","IRAS project ID: 196230, REC reference: 16/LO/0275"]
["Application Title","Infective endocarditis after valve replacement: outcomes after surgical and transcatheter valve implantation and the impact of the NICE 2008 guidelines on prosthetic valve endocarditis"]
["Application Summary","This application from Guy’s and St Thomas’ NHS Foundation Trust set out the purpose of this research proposal into Infective Endocarditis (IE), which is a life-threatening condition caused by infection within the heart, most commonly on a heart valve. Infective Endocarditis is much more common in people who have undergone a heart valve replacement. Since 2007 a new keyhole method of heart valve replacement – transcatheter valve implantation (TVI) – has been available, which avoids the need for open heart surgery. TVI is mainly used for patients who are too frail to undergo open heart surgery.\nThe applicants want to understand how many patients develop Infective Endocarditis, which patients are affected, together with survival rates. The applicants also plan to compare the risk of Infective Endocarditis after TVI with the risk of Infective Endocarditis after conventional open heart surgery. The applicants will also look at whether the number of heart valve replacement patients who develop Infective Endocarditis has changed over time. Specifically, they will study the numbers of patients with Infective Endocarditis before and after 2008, when UK guidelines from NICE advised stopping antibiotic prescriptions for prevention of Infective Endocarditis.\n\nThe study design is a retrospective cohort analysis. Patients who had undergone TVI will be identified from datasets held by the National Institute for Cardiovascular Outcomes Research (NICOR) - the UK TAVI registry (for transcatheter aortic valve intervention), the National Congenital Heart Disease Audit (for transcatheter pulmonary valve intervention), and the Adult Cardiac Surgery Audit (for surgical valve replacement). These NICOR datasets will then be linked to Hospital Episode Statistics to identify patients who have subsequently developed Infective Endocarditis. Linkage will be conducted by NHS Digital. To obtain information about the diagnosis and management of prosthetic valve Infective Endocarditis, the research team will contact the consultant who performed the TVI procedure and request further specific information from the patient's record.\nA recommendation for class 1, 5 and 6 support was requested to cover activities detailed within the application."]
["Applicant Organisation Name","Guy’s and St Thomas’ NHS Foundation Trust"]
["Contact Name","Dr Bernard Prendergast"]
["Address","Guy's and St Thomas' NHS Foundation Trust,"]
[null,"St Thomas' Hospital, "]
[null,"Westminster Bridge Rd, London"]
["Postcode","SE1 7EH"]
["Telephone"]
["Email","Bernard.Prendergast@gstt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The patient cohorts were described as follows:\n Patients undergoing aortic or pulmonary transcatheter valve implantation (TVI) in England between 2007 and 2015. This cohort will be linked to the Hospital Episode Statistics (Admitted Patient Care) to identify patients developing Infective Endocarditis (IE) following TVI (TVI-IE).\n Patients undergoing surgical valve replacement (SVR) in England between 2000 and 2015. This cohort will be linked to the Hospital Episode Statistics (Admitted Patient Care) to identify patients developing Infective Endocarditis (IE) following SVR (SVR-IE).\n Patients with prosthetic valve endocarditis (affecting any surgically implanted mechanical or biological prosthesis, but not those with isolated valve repair) before (Pre NICE-PVE) and after (Post NICE-PVE) March 2008. These cohorts will be identified from linkage of the NICOR National Audit of Adult Cardiac Surgery to Hospital Episode Statistics (Admitted Patient Care).\nThe applicants anticipated that there would be approximately 70-140 patients within the TVI-IE cohort."]
["Description of confidential patient information used","Access was requested to the following items of confidential patient information for the stated purposes:\n NHS Number - Required for downstream identification of patient to their operating consultant cardiologist,\n Date of birth - Required to calculate age at time of procedure and age at diagnosis of Infective Endocarditis,\n Date of death - Required to calculate survival post-procedure."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Guy’s and St Thomas’ NHS Foundation Trust "]
["Status","Expired"]
[]
["Outcome Date","2017-02-10"]
["Next Review Date","N/A"]
["Notes","12 May 2020 - Support expired\nCertificates of data destruction were sent to NHS Digital on this date.\n\nThe main manuscript reporting study findings is completed and currently under review at a cardiovascular journal. \n\nSpecific Conditions of Support\nFavourable opinion from a Research Ethics Committee. (Confirmed – Substantial Amendment 1 dated 12/12/2016, London Bromley REC)\nConfirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Guy's & St. Thomas' NHS Foundation Trust – Version 13 (2015-16) published score of 74% a reviewed satisfactory grade)."]

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[]
[]
["Application Number","A02248"]
["Reference","16/CAG/0138"]
["Other Refs","IRAS project ID: 178569, REC reference: 15/WM/0275"]
["Application Title","Genetic analysis of ovarian granulosa cell tumours"]
["Application Summary","This application from University Hospitals of Leicester set out the purpose of improving the diagnosis, and prediction of recurrence of, granulosa cell tumours (GCTs) in clinical settings. For GCTs, the initial survival rate was high (a 90% 5 year survival rate) as the cancer was usually identified early. However up to 50% of these patients would have a later recurrence of the cancer and life expectancy for these patients was low (20% survival rate). The recurrence could be between 5 and 40 years later, so was difficult to predict.\nResearch carried out in New Zealand had identified genetic markers unique to these tumours, enabling prognostic tests to be carried out. The researcher wished to further explore these genetic markers and to ascertain whether accurate predictions could be made, using tissue samples from patients diagnosed with GCTs before 2005, and linking them with current survival data for each of these patients.\nA consultant pathologist would identify the tissue samples by searching history databases and cancer centres, using the terms ‘ovarian tumour’ and ‘granulosa cell tumour’. After screening the search results to ensure the patients were suitable for the study, the pathologist would obtain the patients’ pathology slides and tumour samples (consent would not be required for use of this tissue under the Human Tissue Act, as it was obtained before 2006). A list of these patients would then be sent to the Cancer Registry, to obtain survival data and date of death. The pathologist would link this information with the tissue samples before stripping out the identifiers and allocating a study number to link the samples with the data. The pseudonymised samples would then be sent to the research team for analysis. The team would have access to the sample, together with age and survival data for each sample.\nA recommendation for class 5 and 6 support was requested for auditing, monitoring and analysing patient care and treatment and to allow access to an authorised user for the above purpose"]
["Applicant Organisation Name","University Hospitals of Leicester"]
["Contact Name","Dr Esther Moss"]
["Address","University Hospitals of Leicester"]
[null,"Leicester General Hospital"]
[null,"Gwendolen Road, Leicester"]
["Postcode","LE5 4PW"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to confidential patient information from UK Cancer Registry by the consultant pathologist at Leicester University Hospital. This would also involve the flow of confidential data from the pathologist to the UK Cancer Registry, for linkage.\nA consultant pathologist would identify the tissue samples by searching history databases and cancer centres, using the terms ‘ovarian tumour’ and ‘granulosa cell tumour’. After screening the search results to ensure the patients were suitable for the study."]
["Description of confidential patient information used","A list of these patients would  be sent to the Cancer Registry, to obtain survival data and date of death. The pathologist would link this information with the tissue samples before stripping out the identifiers and allocating a study number to link the samples with the data. The pseudonymised samples would then be sent to the research team for analysis. The team would have access to the sample, together with age and survival data for each sample."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-04-19"]
["Next Review Date","N/A"]
["Notes","This application reference expired with effect from 01/08/2019.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Provided 28 December 2017\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed via published review on 19 April 2017."]

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[]
[]
["Application Number","02249"]
["Reference","18/CAG/0059"]
["Other Refs","IRAS project ID: 231248, REC reference: 18/LO/0107"]
["Application Title","Evaluating the effect of Community Mental Health services on the lives of people with mental health problems in England over a time of economic insecurity"]
["Application Summary","This application from the Administrative Data Research Centre at the University of Southampton sets out the purpose of medical research with an aim to explore if administrative data sources can provide reliable long-term data to study the real world experiences of people with mental health problems in England. The study aims to establish a cohort of patients who received community mental health services in England in 2006 via the Mental Health Minimum Dataset (MHMDS) and the Clinical Practice Research Datalink (CPRD).\nThe study aims to investigate the effect of long-periods of adverse economic conditions on the mental health of the population. This will be undertaken by linking previously collected data from various administrative sources about an established patient population. The study cohort will be established from those patients in England receiving mental health care as recorded in the MHMDS and CPRD extracts for the 2006/7 financial year. This cohort will then be followed up across a ten year period (to 2016/17 financial year extract) in order to establish a long-term picture of the mental health care services these individuals accessed, together with detail around their socio-economic status (provided by DWP data), wide patient characteristics (provided via CPRD) and mortality data. The aims to evaluate the impact the period of financial insecurity, caused by the 2008 financial crisis, has had on the lives of mental health service users."]
["Applicant Organisation Name","Administrative Data Research Centre at the University of Southampton"]
["Contact Name","Dr Peter W Smith"]
["Address","University of Southampton"]
[null,"Social Statistics Research Institute, Building 39, Room 2009,"]
[null,"Highfield campus, University of Southampton, Southampton"]
["Postcode","SO17 1BJ"]
["Telephone"]
["Email","p.w.smith@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Participants who received community mental health services according to MHMDS and CPRD in the 2006/7 extract between the ages of 18 – 64, living in England.\n 3 sub-groups of patients will be created:\n1. Patients captured solely on the CPRD – receiving only primary care services,\n2. Patients recorded within both the CPRD and MHMDS – receiving both primary and secondary care,\n3. Patients captured solely within MHMDS – receiving community mental health services from a secondary care provider; however, it remains unclear whether these individuals are also receiving primary care mental health services.\n The sample size is unknown but it is estimated that the MHMDS will hold approximately 200,000 eligible records and CPRD 100,000; however, the crossover between the two is not known."]
["Description of confidential patient information used","The data sources are:\n Mental Health Minimum Dataset (NHS Digital),\n Clinical Practice Research Datalink (NHS Digital),\n Department for Work and Pensions Administrative Dataset,\n ONS Mortality Data (NHS Digital).\nThe following data sources will be included in the study; however, are out of scope for the CAG consideration as they will provide aggregated data only:\n CQC Community Mental Health Service User Survey – aggregated data only\n NHS England – bed occupancy – aggregated data only\n DH Financial Mapping Data for Mental Health – aggregated 2006-12 data only\nThe following items of confidential patient information are required for the purposes as described:\n Name – linkage,\n NHS number - linkage,\n Date of birth – linkage – age kept for analysis (query at death or time of care interaction),\n Date of death – analysis – in year/quarter format only,\n Cause of death – analysis,\n Postcode – linkage – kept as deprivation index for analysis\n Address – linkage,\n Government regional office – linkage and analysis,\n Sex - analysis,\n Ethnicity – analysis.\nWider clinical and demographic information will be provided by NHS Digital which will be supplemented by economic/benefits data from DWP for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of Southampton"]
["Status","Expired"]
[]
["Outcome Date","17/04/2018"]
["Next Review Date","N/A"]
["Notes","The study never started as part of the funding fell through (ADRC-E funding from ESRC was lost)\n\nSpecific Conditions of Support (Final)\n1. Patient Notification Materials – further work should be undertaken with the Service User Advisory Group to review the patient information materials which support the project to ensure the text is accessible to a wide patient audience. A report should be provided at the time of first annual review around the activity which has been undertaken in this area, together with copies of the revised information materials.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 05/02/2018)\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – NHS Digital, Version 14, 2016/17)."]

{"sheet":"A02250","index":293,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02250"]
["Reference","17/CAG/0155"]
["Other Refs","IRAS project ID: 213647"]
["Application Title","Investigation of Aneurysm Repair Decision Aid (ARDA) for Management of Abdominal Aortic Aneurysms: Safety Validation and Impact Assessment."]
["Application Summary","This application from the Royal Liverpool and Broadgreen University Hospitals NHS Trust set out the purpose of developing a binary clinical decision tool to help patients and surgeons decide on the best treatment strategy for abdominal aortic aneurysm (AAA), based on the Aneurysm Repair Decision Aid (ARDA), which the study also sought to validate.\nAAA is a ballooning of the main artery supplying the body; if this grows and ruptures, 80% of patients will die. However, there are risks associated with repair of the artery. ARDA, a custom-designed computer programme, provides information on the expected AAA growth rate and risk of rupture, the chance a patient will need AAA repair, the chance of the patient surviving the repair and the length of time of survival (5 or 10 years). The development of a binary clinical decision tool based on this programme could potentially maximise patient survival and facilitate cost-effective use of resources.\nIn order to validate ARDA and develop the clinical decision tool, support was required for access to retrospective data from the National Vascular Registry (NVR). The data would be transferred to NHS Digital who would link it with ONS mortality data before transferring a de-identified dataset to the research team at Royal Liverpool and Broadgreen University Hospitals for analysis.\nA recommendation for class 1, 4 and 6 support was requested for the purpose of extracting and anonymising the information, to link patient identifiable information obtained from more than one source, and to allow an authorised user access for the above purposes."]
["Applicant Organisation Name","Royal Liverpool and Broadgreen University Hospitals NHS Trust"]
["Contact Name","Professor S.R. Vallabhaneni"]
["Address","Link 8C, Royal Liverpool University Hospital"]
[null,"Prescot Street"]
[null,"Liverpool"]
["Postcode","L7 8XP"]
["Telephone"]
["Email","fempop@liv.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data in relation to all patients included on NVR having undergone an elective AAA repair between 01/01/2012 and 31/12/2015, who are over 18 and have not undergone previous aortic surgery"]
["Description of confidential patient information used","The following data items will be transferred from the National Vascular Registry to NHS Digital:\nNHS number – to validate and link with mortality data\nDate of birth – to validate. This will then be truncated for analysis to MM/YY format"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-10-25"]
["Next Review Date","2020-10-25"]
["Notes","Amendment Request (Approved 20/04/2018)\nThe amendment requested support to change the flow of data within the project. The proposed flow of data is as follows:\n The National Vascular Registry (NVR) would send the specified identifiers and study ID only to NHS Digital, which would be utilised by NHS Digital to link the cohort to ONS Mortality data.\n The linked dataset would be returned to the Royal Liverpool University Hospital by Study ID only.\n In addition, NVR would also create a pseudonymised dataset, including wider clinical information, using the same study ID and transfer this direct to the Royal Liverpool University Hospital.\n Royal Liverpool University Hospital would link both datasets via the study ID.\n\nSpecific conditions of support\n1. The dissent process should take place via the NVR rather than the researcher, and patient notifications should be updated accordingly.\nThe applicant confirmed that the NVR had agreed to administer the dissent process and had updated patient notification accordingly.\nThe response was reviewed and approved by the Chair.\n2. Public involvement on the research group should be strengthened. The Sub-Committee recommended two patient representative be regularly engaged in order to be able to update the patient group they represent.\nThe applicant responded: ‘We have now involved two additional patients to our Public Patient Involvement group (total of three representative) for this project and we are planning to conduct regular meeting with them to provide them with an update of the project progress and results’.\nThe response was reviewed and deemed appropriate by the Chair.\n3. Favourable opinion from a Research Ethics Committee. Confirmed 26 July 2017.\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Royal Liverpool and Broadgreen University Hospitals NHS Trust: v14 Confirmed published and reviewed via NHS Digital website."]

{"sheet":"A02251","index":294,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02251"]
["Reference","18/CAG/0038"]
["Other Refs","IRAS project ID: 235803, REC reference: 18/NW/0012"]
["Application Title","A randomised controlled trial to evaluate invitation to community-based low dose computed tomography (LDCT) screening for lung cancer versus usual care in a targeted population at risk."]
["Application Summary","This application from the Leeds Teaching Hospitals NHS Trust set out the purpose of medical research which aims to test targeted Low Dose Computed Tomography (LDCT) scans screening in community settings concentrating on deprived areas of Leeds. The intention is to randomise 55-80 year old smokers or ex-smokers to intervention or usual care groups prior to approach. The intervention group will be invited to assessment for a Lung Health Check (including LDCT screening for high-risk people) framed as a pilot health service.\nThe applicants intend to compare outcomes between the invited group and a usual care group, which won’t be invited to take part or know that they are in a research study. By comparing outcomes with a control population, the true benefits (of reducing number of late stage cancers, and therefore lives saved) and possible harms (of over-diagnosis) of introducing screening in the UK will be assessed."]
["Applicant Organisation Name","The University of Leeds"]
["Contact Name","Dr Matthew Callister"]
["Address","Consultant Respiratory Physician"]
[null,"St James University Hospital"]
[null,"Beckett Street, Leeds"]
["Postcode","LS9 7TF"]
["Telephone"]
["Email","matthew.callister@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Smokers or ex-smokers, aged between 55-80 years old, who are judged to be at increased risk of lung cancer as estimated by three criteria within the Leeds CCG area. There a wider range of clinical inclusion/exclusion criteria which would need to be satisfied before a patient would be invited to participate.\nThe cohort will consist of 62,980 people randomised, of which the following is anticipated:\n 31,490 people allocated to the intervention arm to receive an invitation to a Lung Health Check LDCT screening (including LDCT screening for people at high risk of lung cancer)\n 31,490 people allocated to the control arm who will not be approached but are necessary to follow study outcomes\n 6,892 people attending for lung health check and undergoing LDCT screening"]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set out:\n Name – to invite participants, deleted after invitation process,\n Patient Address including postcode – for invitation process and retained for ensure validity of randomisation (audit to be undertaken 6 months from randomisation then deleted),\n Postcode – converted to index of multiple deprivation and retained for analysis,\n NHS number– validation of sample, identification and linkage and long-term follow-up,\n Date of birth – linkage and analysis and retained for long-term follow-up,\n Date of Death – analysis – full format,\n Cause of Death – received in ONS coded format,\n Postcode – analysis (Deprivation score) and intervention arm (facilitate invitation) and retained for all to facilitate long-term follow-up,\n Gender – analysis and retained for analysis,\n GP Registration (practice) – required for invitation process and retained for analysis,\n Named GP – required for invitation process and then deleted,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-04-20"]
["Next Review Date","2024-04-20"]
["Notes","Amendment supported 25 May 2023 to remove NHS England (previously NHS Digital) as a data processor for the application, and to amend the data flows required to link YLST to OYL, to allow;\n\n1.\tReed Wellbeing Ltd (processor for One You Leeds) would disclose confidential patient information (name, address, date of birth, gender and a OYL unique ID) about the OYL cohort to the YLST Data Scientist at Leeds teaching Hospital NHS Trust.\n\n2.\tThe YLST Data Scientist will download the supplied confidential patient information to Leeds teaching Hospital NHS Trust secure network, and use name, address and gender to identify the NHS Number. \n\n3.\tThe YLST Data Scientist would disclose confidential patient information (NHS Number and OYL unique ID) from Leeds teaching Hospital NHS Trust to the University of Leeds, where linkage with the YLST cohort would take place in the Leeds Institute for Data Analytics Virtual Research Environment (LIDA VRE). \n\n4.\tUniversity of Leeds would disclose confidential patient information (OYL unique ID for matched participants) back to Reed Wellbeing Ltd (processor for One You Leeds), in order for them to link back to the required clinical fields, and provide the required information back to University of Leeds (also via the OYL unique ID). \n\n\n24 April 2023 - change in data processor from NHS Digital to NHS England, regarding Personal Demographics Service (PDS)\n\nAmendment supported 17 November 2022 \nTo amend the data flows required to link YLST to OYL, to allow;\n\n•\tthe disclosure of confidential patient information (name, address, date of birth, gender and a OYL unique ID) about the OYL cohort from Reed Wellbeing Ltd to NHS Digital,\n\n•\tNHS Digital to use confidential patient information to link to the Personal Demographics Service (PDS), to identify the NHS Number,\n\n•\tthe disclosure of confidential patient information (NHS Number and OYL unique ID) from NHS Digital to the University of Leeds, for the purposes of linkage with the YLST cohort,\n\n•\tand for the disclosure of confidential patient information (OYL unique ID for matched participants) from University of Leeds to Reed Momenta, in order for them to link back to the required clinical fields, and provide the required information back to University of Leeds (also via the OYL unique ID),\n\n\nAmendment supported 20 October 2022 , to allow;\n•\tIdentification of newly-eligible participants for screening,\n•\tPathway navigation for repeat non-responders,\n•\tRecontacting people disengaging from screening programme using patient navigation, \n•\tAnd to confirm an administrative change - the data processor name at University of Leeds has changed from ‘University of Leeds- IRC’ to ‘University of Leeds-LASER’,\n\n04 January 2022 - Amendment supported to:-\n• update the purposes of the study to include sharing anonymous aggregate data for lung cancer risk distribution with the “4 in the lung run” 4ILTR team at University of Nottingham,\n• extract smoking codes at an additional earlier timepoint,\n• allow Reed Wellbeing (on behalf of One You Leeds (OYL)) and YLST Database in Leeds Institute for Data Analytics to disclose confidential patient information to NHS Digital in order for NHS Digital (as a trusted third party) to link the cohort together and provide information back to Reed Wellbeing, to allow assessment of the rates at which study participants have accessed smoking cessation services from (OYL) during the study period, \n• clarify that analysis will be undertaken by a researcher from Queen Marys University of London rather than York Trials unit remotely through the Virtual Research Environment hosted by Leeds Institute for Data Analytics,\n• clarify ‘s251’ support is in place to disclose confidential patient information from the YLST Database in Leeds Institute for Data Analytics to NHS Digital in order to link with ONS Mortality data and NCRAS data (now retained at NHS Digital), and provide the applicant with date of death and other outcome data\n\n01 July 2020 - amendment supported to increase the sample size from 62,980 to 90,000, and to extract additional data to enable the analysis of the impact of frailty/comorbidity\n\n20/08/2019: Amendment request supported to enable patient frality score extracted from patient records to be retained for analysis. The storage arrangements for the study back-up data were also updated – these will be retained on a fully encrypted hard-drive at Leeds Teaching Hospitals NHS Foundation Trust. \n\nAmendment (Approved 20/07/2018)\nThe amendment outlined the following three revisions to the study:\n1. Change to individuals accessing and extracting confidential patient information from GP practice databases - The applicants are seeking to extend support to enable a wider group of individuals to undertake the data access and extraction processes at GP practices, in order to identify patients who were eligible for invitation to the trial. Specific roles had been identified within the research team, which were the Project Manager, Data Manager, Lead Nurse and Contributing Consultants and the West Yorkshire Research and Development team who are able to assist with this data extraction.\n2. Inclusion of an additional exclusion criteria - The applicants are proposing an extension to the trial exclusion criteria to include those patients who were resident in a nursing home.\n3. Change to Data Transfer Methodology - It was explained that data transferred from GP practices to the Leeds Institute for Data Analytics (LIDA) within the University of Leeds and Leeds Teaching Hospitals NHS Trust will now be transferred via the Biscom transfer system, rather than the previously described N3 connection.\n\nSpecific Conditions of Support (Final)\n1. Support is recommended for the initial six year period for which the study is currently funded. Any extension to this duration would need to be submitted as an amendment as such time as additional funding is secured.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – overall proposal received favourable ethical opinion on 22 January 2018. Substantial amendment received favourable opinion 28 March 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed)\n Leeds Teaching Hospitals, organisation code RR8, complies with the Information Governance Toolkit (v.14 2016-2017). Reviewed grade Satisfactory with a score of 78%.\n University of Leeds – IRC, organisation code 8E218-IRC, complies with the Information Governance Toolkit (v14. 2016-2017). Reviewed grade Satisfactory with a score of 88%.\n CFH Docmail LTD, organisation code 8HN70, complies with the Information Governance Toolkit (v14. 2016-2017). Reviewed grade Satisfactory with a score of 100%.\n\n03 September 2021 - amendment supported to extract, store and analyse the electronic frailty index (eFI) v2 codes in the same way as the eFI codes, and to re-contact by telephone some high risk patients who previously did not undergo an LDCT scan to see if they now wish to proceed with ongoing screening."]

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[]
[]
["Application Number","A02252"]
["Reference","18/CAG/0057"]
["Other Refs","(Previously 17/CAG/0045)"]
["Application Title","Hospice-led innovations for end of life care"]
["Application Summary","This application from NHS England and Hospice UK set out the purpose of evaluating the effectiveness of innovations in end of life care. This revised application was resubmitted to replace the activity which was previously supported under application 17/CAG/0045. It was acknowledged that there was a change to data controller and processor arrangements for the project.\nResearch had shown that 80% of patients preferred to die at home, and only 5% in hospital, however the reality was that end of life care was more likely to take place in a hospital setting, which was costly as well as unwelcome for patients. Care models had been introduced at 24 hospices, aimed at reducing hospital-based end-of-life care. These models of care would be evaluated using both quantitative and qualitative methodology; the end result would be a report and set of recommendations for NHS England and end of life care commissioners, and advice for hospices on how to implement the most effective new models.\nThis application specifically related to the use of identifiable information to link patient datasets for quantitative analysis, in order to examine whether rates of hospital-based end-of-life care decreased where the new care models were used.\nThe Hospices involved would transfer identifiable information to NHS Digital, who would link these to the HES and ONS databases. NHS Digital would release a pseudonymised file to McKinsey and Company for analysis.\nA recommendation for class 1, 3, 5 and 6 was requested for the process of extracting and anonymising the information, to link patient identifiable information obtained from more than one source, for auditing, monitoring and analysing patient care and treatment and to allow access to an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","NHS England and Hospice UK"]
["Contact Name","Mr Giles Colclough"]
["Address","McKinsey and Company"]
[null,"1 Jermyn Street"]
[null,"London"]
["Postcode","SW1Y 4UH"]
["Telephone"]
["Email","Giles_Colclough@mckinsey.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The Hospices involved would transfer identifiable information to NHS Digital, who would link these to the HES and ONS databases. NHS Digital would release a pseudonymised file to McKinsey and Company for analysis."]
["Description of confidential patient information used","Access was requested to NHS number, date of birth, gender, postcode."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-04-20"]
["Next Review Date","2019-04-20"]
["Notes","Specific Conditions of Support (Final)\n1. All pre-existing conditions of support related to 17/CAG/0045 remain applicable.\n2. The pre-existing annual review cycle remains applicable, with the next annual review to be received 4 weeks before 29/03/2019, and then on an annual basis to this schedule.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – NHS Digital sole processor of confidential patient information)."]

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[]
[]
["Application Number","A02253"]
["Reference","18/CAG/0049"]
["Other Refs","IRAS project ID: 225268, REC reference: 17/LO/1723"]
["Application Title","Using primary care to increase uptake of the Bowel Scope Screening Programme in Yorkshire: evaluating paper and telephone based interventions"]
["Application Summary","This application from University College London sets out the purpose of medical research which aims to investigate whether GP practice based interventions can help increase the uptake of bowel scope screening in Hull and other parts of Yorkshire. Over a six month period, individuals due to receive their NHS Bowel Scope Screening invitation (identified through GPs) will be randomly be assigned to one of three groups with attendance monitored and compared between groups:\n1. Usual care: no contact from GPs.\n2. Primer and self-referral letter: A letter advising of the future delivery of a BSS invitation will be sent by the individual’s GP, along with a locally tailored leaflet explaining the test. If the practice receives notice that an individual did not attend their appointment, a letter highlighting the self-referral process will be sent.\n3. Primer and patient navigation: As above, a letter and leaflet will be sent ahead of the NHS BSS invitation. If the practice receives notice that an individual did not attend their appointment, a call to the individual will be made. This call will aim to identify and address personal barriers to uptake and, if appropriate, help arrange a new appointment. If no telephone contact is possible, a self-referral letter will be sent.\nSupport under the Regulations is required to facilitate groups two and three as the additional patient contacts which are detailed in these two options will involve sharing confidential patient information outside the direct care team without consent."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Lesley McGregor"]
["Address","University College London"]
[null,"1-19 Torrington Place"]
[null,"London"]
["Postcode","WC1E 7HB"]
["Telephone"]
["Email","l.mcgregor@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort\n1. Patients aged between 55 years and 21 days and 55 years and 48 days at the time they are enrolled in the study, who are registered with a GP practice participating in the trial.\n2. Patients will be excluded from inclusion in the study if they:\na. Have had their large bowel removed.\nb. Have a stoma bag to collect their stool.\nc. Are currently being treated for inflammatory bowel disease (i.e. ulcerative colitis, Crohn’s disease, etc.).\nd. Are awaiting heart surgery or who have had heart surgery in the last three months.\ne. Have been diagnosed with cancer (any type) in the last 12 months.\nf. Are registered on their GPs clinical system as a type II objector/opt out."]
["Description of confidential patient information used","The following items of confidential patient information are requested from the patient’s GP record:\n Full name – to enable intervention materials to be sent,\n Full Address – to enable intervention materials to be sent,\n NHS Number – to facilitate linkage via NHS Digital,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-05-01"]
["Next Review Date","2020-05-01"]
["Notes","10 August 2020 - Amendment supported to extend the duration of support until 01 January 2020.\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – project received a favourable opinion on 05/12/2017. Substantial Amendment received a favourable on 24/04/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – MailaDoc Ltd. Version 14.1, 2017/18 confirmed satisfactory by email direct from NHS Digital on 18/04/2018)."]

{"sheet":"A02254","index":297,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02254"]
["Reference","18/CAG/0031"]
["Other Refs","IRAS project ID: 229763, REC reference: 17/SW/0289"]
["Application Title","Unexplained visual loss following silicone oil removal in patients presenting with retinal detachment in the United Kingdom: results of a prospective surveillance study"]
["Application Summary","This application from County Durham and Darlington NHS Foundation Trust sets out the purpose of medical research with a focus on unexpected loss of vision following removal of silicone oil used to treat retinal detachment. This is a prospective study utilizing the BOSU methodology. The research will be carried out at the City Hospitals Sunderland NHS Foundation Trust.\nA recommendation for class 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","County Durham and Darlington NHS Foundation Trust"]
["Contact Name","Ms Haifa Madi,"]
["Address","County Durham and Darlington NHS Foundation Trust"]
[null,"Sunderland Eye Infirmary"]
[null,"Queen Alexandra Road"]
["Postcode","SR2 9HP"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients, aged 18 years and over, the following confidential patient information will be released by BOSU to the applicant:"]
["Description of confidential patient information used"," Local hospital number – to allow reporting clinicians to be able to identify patient,\n Month and year of birth –validation,\n Gender – analysis of demographic factors."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-05-03"]
["Next Review Date","N/A"]
["Notes","All information required for this study will be routinely available from the hospital notes. The study will collect no identifiable data, but a minimum amount of non- identifiable data will be collected to examine demographic factors and allow the investigators to identify duplicate reports though probability matching.  Support was required for incidental access to identifiers.  \n\nThe natural history, incidence and risk factors for this rare and serious complication is uncertain with many cases ending up with impaired vision. Analysis of the data from this country wide observational data on this phenomenon would enable its natural history to be more clearly defined making counselling patients less challenging.\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 19 December 2017).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – City Hospitals Sunderland NHS Foundation Trust, Version 14.1, 2018/18, satisfactory grade confirmed by NHS Digital email 19/04/2018)."]

{"sheet":"A02255","index":298,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02255"]
["Reference","17/CAG/0016"]
["Other Refs","IRAS project ID: 214998, REC reference: 16/LO/2260"]
["Application Title","Patient Reported Outcome Measures for Neurological Conditions"]
["Application Summary","This application from Aneurin Bevan University Health Board set out the purpose of validating and assessing a Patient Reported Outcome Measure (PROMIS Plus questionnaire) for a range of neurological conditions across Wales. The questionnaire would ask for patients’ views on their own health and their quality of life. It would be validated in those diagnosed with the following neurological conditions: Multiple Sclerosis, Acquired Brain Injury and Parkinson’s Disease, with the aim of creating a PROM which could be used for all neurological conditions. At present there were PROMs tailored to each individual neurological condition, and one generic PROM which measured health-related quality of life but did not capture the impact of common impairments and limitations in function shared by people with neurological conditions.\nThe use of one PROM for a range of neurological conditions would standardise the data collected for different conditions identifying inequalities in health and social care provision across Wales and support the evaluation of service development.\nQuestionnaires would be sent to patients from specialist clinics across Wales.\nLead clinicians at neurological clinics would screen their clinic lists for eligible patients and provide this to researchers to enable them to send questionnaires.\nA recommendation for class 3 and 6 support was requested for the purpose of selecting and contacting patients to seek their consent, and to allow access to an authorised user for that purpose."]
["Applicant Organisation Name","Aneurin Bevan University Health Board"]
["Contact Name","Dr J Hewitt"]
["Address","Aneurin Bevan University Health Board,"]
[null,"Ysbyty Ystrad Fawr"]
[null,"Ystrad Fawr Way, Ystrad Mynach, Hengoed"]
["Postcode","CF82 7EP"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Access was requested to patient’s age, health status (ie are they pregnant), and rough geographical location to enable researchers to establish eligibility.\nDate of birth is listed as an identifier used for comparison with the national dataset.\nName and full address including postcode was requested in order to send out questionnaires."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-05-24"]
["Next Review Date","N/A"]
["Notes","Specific conditions of support\n1. Please feedback the results of the PPI work to the CAG, when complete, and advise whether any changes will be made to the study as a result of this work.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 15 March 2017.\n3. Security assurance arrangements\na. The expectation is for the assessment to reach 91% within one year from final approval to avoid jeopardising the state of future approval. It is understood that the report confirms that a report to the WIGB on the progress made against the outstanding actions against the CPIP assessment by the first week of June 2017.\nb. There should be full compliance with regards to a mechanism to respect patient objection. The CAG will look specifically at this aspect at time of annual review.\nc. A detailed report at time of annual review showing compliance with all outstanding actions. If there is any possibility that at time of annual review that all aspects have not been achieved, or that an improvement plan exists, this must be flagged in advance with the Advice Team following the report to WIGB in June 2017.\nd. As the Associate Director/Programme Director Value-Based Health Care - Employed by Aneurin Bevan University Health Board is named as the lead for the outstanding aspects, to consider that this role be present at time of next consideration."]

{"sheet":"A02256","index":299,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02256"]
["Reference","18/CAG/0041"]
["Other Refs","IRAS project ID: 237861, REC reference: 97/141"]
["Application Title","Liverpool Lung Project"]
["Application Summary","This application from the University of Liverpool set out the purpose of medical research\nwith a focus on improving the early detection of lung cancer at an earlier and more\ncurable stage. The Liverpool Lung Project (LLP) has been active since 1997 with\nparticipants providing informed consent to their involvement. This observational study\ninvestigates differences between lung cancers to identify opportunities for improving\ndiagnosis or treatment. The LLP is primarily funded by the Roy Castle Lung Cancer\nFoundation and is one of the largest prospective lung cancer case-control and population\ncohort studies in Europe, recruiting mainly in Liverpool, but more recently also in\nBlackpool. 13000 participants have been recruited into the study: approximately 8000\nhealthy volunteers and the remainder patients recruited via collaborating NHS GP\npractices and hospital sites. Recruitment remains active for the project, to ensure that the\nstudy population reflects current medical practice and remains relevant. The LLP protocol\nwas updated in 2015 and extends to June 2021.\nAt recruitment, following informed consent, lifestyle and clinical history data is collected\nby questionnaire and blood samples are taken. Additional tissue samples were taken with\nparticipant permissions. Clinical and outcome data is also collected (from hospital records\nand NHS Digital) as part of the follow-up procedures for participants.\nA recommendation for class 1, 3, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor John K Field"]
["Address","University of Liverpool, William Henry Duncan Building"]
[null,"6 West Derby Street"]
[null,"Liverpool"]
["Postcode","L7 8TX"]
["Telephone"]
["Email","J.K.Field@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All participants recruited to the Liverpool Lung Project between 1997 and 2017."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes defined:\n Name – validation\n NHS Number – linkage,\n Date of Birth - linkage,\n Date and cause of death – provided by NHS Digital for analysis,\n Gender – validation ,\n Sub sector postcode – linkage and analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-05-10"]
["Next Review Date","2024-05-10"]
["Notes","22 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – HES, ONS mortality information and cancer registration information\n\nSpecific Conditions of Support\n1. Support extends to the release of confidential patient information and subsequent data processing undertaken by NHS Digital in relation to the cohort of participants recruited from the opening of the study in 1997 to the implementation of revised consenting materials, brought into use from 23 April 2003. Linked data would be returned to the applicants for analysis.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – in place since October 1997).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – NHS Digital acting as data processor)."]

{"sheet":"A02257","index":300,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02257"]
["Reference","17/CAG/0054"]
["Other Refs","IRAS project ID: 219200, REC reference: 17/YH/0095"]
["Application Title","Life and Bladder Cancer: The Yorkshire Cancer Research Bladder Cancer Patient Reported Outcomes Survey"]
["Application Summary","This research application from University of Sheffield set out the purpose of developing a PROMS (Patient Reported Outcome Measure) questionnaire that would reflect the experience of patients in patients with bladder cancer, before and after treatment. The information would be used together with clinical data to understand outcomes within the population, to identify gaps in care and barriers to care improvement, and to shape clinical care delivery\nSurveys would be sent to eligible patients by Quality Health on behalf of the applicant.\nA recommendation for class 4 and 6 support was requested to link patient identifiable information obtained from more than one source and to allow access to an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor James Catto"]
["Address","University of Sheffield Medical School"]
[null,"Beech Hill Road"]
[null,"Sheffield"]
["Postcode","S10 2RX"]
["Telephone"]
["Email","j.catto@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from participating NHS Trusts in relation to patients alive within 10 years of having a current or previous diagnosis of bladder cancer, who had been treated by one of the participating NHS Trusts."]
["Description of confidential patient information used","Name, address, NHS number date of birth and postcode was required for a time-limited period to administer the survey mail-out.\nEthnicity, gender, year of birth and deprivation score would be retained for analysis.\nStudy ID number would be retained for linkage"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-05-05"]
["Next Review Date","N/A"]
["Notes","25 June 2021 - Support expired\nApplicant confirmed on 25 June 2021 that support no longer required. \n\nReason CAG support is no longer required:-\nData collection has been completed. The questionnaires have all been sent out by the survey provider, Quality Health Ltd and the responses collated.\nThe patient identifiable data held by Quality Health Ltd to send the questionnaires has been destroyed. The certificate of data destruction has been provided.\nThe study team holds a dataset of pseudonymised questionnaire responses, disease and treatment information.\nThe results are being analysed and the first research paper has been published:\nQuality of Life After Bladder Cancer: A Cross-sectional Survey of Patient-reported Outcomes (10.1016/j.eururo.2021.01.032)\n\nPublic health benefits from the cross sectional study\nData from the cross sectional study reflects the experience of patients with bladder cancer. The information will be used together with clinical data to understand outcomes within the population, to identify gaps in care and barriers to care improvement, and to shape clinical care delivery\n\n\nAmendment supported 14 February 2019 to extend the support duration to 30 April 2020.\n\nSpecific conditions of support\n1. Please note that if no response is received from the patient, or consent is refused, in both cases no further information can be accessed in relation to this individual patient. Agreement confirmed by the applicant in the letter sent 2 May 2017.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 30 March 2017.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Review result published and confirmed satisfactory via NHS Digital website."]

{"sheet":"A02258","index":301,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02258"]
["Reference","18/CAG/0008"]
["Other Refs","IRAS project ID: 233478, REC reference: 18/SC/0007"]
["Application Title","Sight-threatening chemical injury study in association with the British Ophthalmological Surveillance Unit"]
["Application Summary","This application from the Buckinghamshire Healthcare NHS Trust set out the purpose of medical research involving a survey of visual compromise resulting from chemical injury, using prospective case ascertainment through the British Ophthalmological Surveillance Unit (BOSU) monthly reporting card scheme. This is an active surveillance system involving all UK consultant ophthalmologists.\nThe primary aim of this study is to ascertain the incidence of sight-threatening ocular chemical injury in the UK. This is to include demographic details of patients and details of causative chemical and mechanism of injury. The secondary aims of this study are to assess the best corrected visual acuity at presentation and 6 months, and the surgical interventions required.\nThis is an epidemiological study using only information available from the patient case notes. Ophthalmologists will indicate that they have seen a new case through the BOSU. The BOSU collects no patient identifying information but will notify the study team of all new cases, who will contact the reporting ophthalmologist directly for completion of a questionnaire.\nA recommendation for class 2, 5 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","Buckinghamshire Healthcare NHS Trust"]
["Contact Name","Dr Nicola Cronbach"]
["Address","Buckinghamshire Healthcare NHS Trust,"]
[null,"Mandeville Wing, Stoke Mandeville Hospital"]
[null,"Mandeville Road, Aylesbury"]
["Postcode","HP21 8AL"]
["Telephone"]
["Email","nrjcronbach@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients (aged up to 150 years) within England and Wales, with a diagnosis of sight-threatening chemical injuries. It is estimated that there will be approximately 100 reported incidences within the 12 month study period."]
["Description of confidential patient information used","The following items of confidential patient information will be provided by the treating clinicians at individual Trusts to the applicants for the purposes as set out below:\n Hospital Number – sample validation to remove duplicate entries,\n Date of birth – MM/YY format only for sample validation to remove duplicates and analysis – calculated to age at incident,\n Postcode – district level – geographical analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-05-15"]
["Next Review Date"]
["Notes","Applicant confirmed May 2023 that ‘s251’ support can be expired, as all information is held in such a manner that individuals are no longer identifiable, and there are no means for the information to be reidentified by any party.\n\nWith regards to public benefit, the ‘s251’ support provided has helped Increased knowledge of the epidemiological patterns of severe ocular chemical injury and management options across the UK\n\nSpecific Conditions of Support (Final)\n1. Support extends information generated in England and Wales only.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 22 March 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission or future replacement. (Confirmation received from NHS Digital (Received 02/05/2018).\n4. Maintenance of satisfactory security arrangements for the duration of the support."]

{"sheet":"A02259","index":302,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02259"]
["Reference","18/CAG/0006"]
["Other Refs","IRAS project ID: 191072, REC reference: 17/EM/0464"]
["Application Title","A Prospective Study of Acute Severe Poisonings In Children"]
["Application Summary","This application from Derby Hospitals NHS Foundation Trust sets out the purpose of medical research which will determine the incidence and identify the circumstances surrounding severe accidental poisoning in children under 15 years in the UK and Republic of Ireland resulting in death, or signs and symptoms of poisoning defined as needing significant monitoring or support. This is a prospective, national, surveillance cohort study, conducted in secondary care in collaboration with the British Paediatric Surveillance Unit (BPSU). Paediatricians within UK and Republic of Ireland will report cases of severe poisoning through the BPSU ‘orange card’ system over a period of 13 months as part of this study. The BPSU methodology is supported in principle by the CAG.\nAccidental poisoning is an avoidable problem and remains an important public health issue. It is well recognised that blanket approaches to public health campaigns are often ineffective. By identifying specific trends in severe poisonings, in particular including specific substances that frequently cause significant harm, it is hoped that these can be subsequently be targeted.\nA recommendation for class 1, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Derby Hospitals NHS Foundation Trust"]
["Contact Name","Dr Elizabeth Starkey"]
["Address","Derbyshire Children’s Hospital"]
[null,"Royal Derby Hospital"]
[null,"Uttoxeter Road, Derby"]
["Postcode","DE22 3DE"]
["Telephone"]
["Email","elizabeth.starkey@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children in England and Wales aged 15 years and under with a diagnosis of acute unintentional or accidental poisoning over a 13 month period (proposed start March/April 2018).\nIt is estimated that the sample will be approximately 125 children."]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed by treating clinicians at individuals Trusts, for the purposes as set out below:\n NHS Number – sample validation and removal of duplicate entries,\n Hospital Number – sample validation and removal of duplicate entries,\n Date of birth – sample validation and removal of duplicate entries and analysis\n Date of death – analysis,\n Gender – analysis,\n Ethnicity – analysis.\nAll identifiers, with the exception of gender and ethnicity, will be destroyed at the end of the data collection period, when the sample has been validated and duplicate entries removed. Date of birth and death will be used to calculate age at incidence and death, before being destroyed."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-10-15"]
["Next Review Date","N/A"]
["Notes","19 January 2022 - Support Expired:\nAll identifiable data has been deleted and the data is now pseudonymised.  \n\nWe have currently still have gender, ethnicity, age in years and months as this was part of our data analysis.\n\nSignificant poisoning can cause serious symptoms requiring various treatments, but rarely results in death.   Adult  medications including opiates, sedatives and psychiatric treatments are currently not subject to child resistant packaging law, and can cause significant harm to children suggesting  further legislation is necessary on all medications to prevent harm and even death in children. Furthermore, a large proportion of  episodes involved illicit drug use, suggesting that further public health medicine and drug safety campaigns are required  to educate both young people and  their families around the risks and dangers of  illicit drug use.\n\nSpecific Conditions of Support (Final)\n1. Support extends to England and Wales only.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 30 January 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Derby Hospitals NHS Foundation Trust, V14.1, 2017/18, satisfactory – by email 14 May 2018)."]

{"sheet":"A02260","index":303,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02260"]
["Reference","18/CAG/0060"]
["Other Refs","This application is a consolidation of PIAG 3-09(e)/2003 and PIAG 1-05(d)/2008, IRAS project ID: 223031 REC reference: 02/0/090"]
["Application Title","European Prospective Investigation into Cancer and Nutrition, Oxford cohort (formerly \"the Royal College of General Practitioners/Imperial Cancer Research Fund Diet, Hormones and Health Study\")Known as EPIC- Oxford"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research. EPIC-Oxford is an open-ended prospective study of men and women aged 20 and above at recruitment, between 1993 and 1999 in the UK. The cohort was recruited through GPs and postal questionnaires and provided a blood sample Follow-up included postal questionnaires, diet diaries and linkage to NHS records for death, cancer registration and hospital admissions. The study is designed to examine effects of diet on long-term health, with specific focus on vegetarians. EPIC-Oxford is the only large prospective study in the world with dietary data and blood samples for a large number of vegetarians with linkage for the whole cohort to cancer diagnoses, hospitalisations and causes of death.\nThe application was submitted to consolidate and replace two historically supported projects: PIAG 3-09(e)/2003 and PIAG 1-05(d)/2008.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover the activities involving the processing of confidential patient information, as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Timothy Key"]
["Address","University of Oxford, Cancer Epidemiology Unit"]
[null,"Richard Doll Building,"]
[null,"Roosevelt Drive, Oxford"]
["Postcode","OX3 7LF"]
["Telephone"]
["Email","tim.key@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort was recruited into the EPIC-Oxford study between 1993 and 1999, which included adult vegetarians and comparable non vegetarians who were living in the UK at the time of recruitment. 65,411 patients were recruited to the project."]
["Description of confidential patient information used","The following items of confidential patient information will be required to facilitate linkage with wider NHS datasets:\n Study ID – for linkage,\n Name – for linkage,\n NHS number – for linkage,\n Hospital Number – to link with tissue samples,\n Date of birth – for linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-05-15"]
["Next Review Date","N/A"]
["Notes","January 2022 - Support expired\nApplicant confirmed in January 2022 that ‘s251’ support is no longer required because NHS Digital have chosen to accept the consent model for EPIC-Oxford for processing the Hospital Admissions data. The identifiers are already processed to obtain Cancer registration and Mortality data and IGARD have advised that these identifiers may also be used to process and supply linked Hospital Admissions Data to The University of Oxford. The approval followed consultation with the EPIC-Oxford Participant panel whose unanimous “reasonable expectation” was that their consent covered the linkage and supply of Hospital Admissions Data\n\nIn terms of public benefit, the applicants provided examples of novel and reliable findings on the impacts of diet on health. Recent publications on diet in relation to risks of both cardiovascular disease and fractures showed that vegetarians have a lower risk of heart disease than meat-eaters, but also that they have a higher risk of stroke, principally haemorrhagic stroke; this was the first reliable report on stroke risk in vegetarians and the findings are important for public benefit, allowing organisations including the NHS to provide the public with reliable and up-to-date information on the impact of vegetarian diets on risk for cardiovascular disease.\n\nSpecific Conditions of Support (Final)\n1. Application activity previously supported under the references PIAG 3-09(e)/2003 and PIAG 1-05(d)/2008 are now expired and have been transferred to application reference 18/CAG/0060.\n2. All pre-existing conditions of support related to PIAG 3-09(e)/2003 and PIAG 1-05(d)/2008 remain applicable\n3. The pre-existing annual review cycle remains applicable, with the next annual review to be received 4 weeks before 06/10/2018, and then on an annual basis to this schedule.\n4. Support extends to the linkage with HES data held by NHS Digital and PEDW data held by NHS Wales Informatics Service\n5. Support does not extend to linkage with ONS mortality information, held by NHS Digital or cancer registration information, held by Public Health England as an alternative legal basis of consent was in place to support this linkage.\n6. Support extends to England and Wales only. Alternative arrangements are required for the processing of data within Scotland and Northern Ireland.\n7. Patient and Public Involvement and Engagement – additional work should be undertaken to establish a patient panel from the participating patient cohort. A report should be provided at next annual review around the progress made, together with an overview of any feedback provided by patients. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n8. Patient Notifications and Dissent – confirmation should be provided at next annual review that the following points have been addressed:\na. Alternative contact means, i.e. telephone number, email address, should be added to the website to make contact with the research team more accessible,\nb. The objection mechanism should be promoted in the next newsletter, to ensure all participants are informed of the right to dissent.\n9. Favourable opinion from a Research Ethics Committee. (Confirmed – favourable opinion under reference 02/9/090. Updated REC reference to be applied).\n10. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – NHS Digital and University of Oxford Cancer Epidemiology Unit, Version 14.1, 2017/18, satisfactory)."]

{"sheet":"A02261","index":304,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02261"]
["Reference","17/CAG/0096"]
["Other Refs"]
["Application Title","SEARCH: A population based study of pre-disposition to breast cancer"]
["Application Summary","This research study from the University of Cambridge set out the purpose of investigating the role of inherited genetic variation in breast cancer risk and clinical outcomes. The study began in 1996 and has 15,000 women with breast cancer and 3,400 controls as consented participants. Study participants (recruited via the Cancer Registry or local cancer networks by letter sent from the GP or network) are asked to provide a blood sample from which DNA is extracted, to complete a questionnaire on lifestyle and family history of cancer, to allow access to their medical record and for the study team to retrieve pathology material.\nThe application is submitted under the Precedent Set category ‘Validity of consent’. The study is still ongoing and new participants are asked to give consent for access to data from NHS Digital, ONS, PHE ‘and other central UK NHS bodies’. However, existing participants have only given specific consent for access to their medical record.\nThe study team state that since the outset they have accessed details on the patient’s cancer diagnosis from data held by the local Cancer Registry concerning patients’ cancer diagnosis (such as tumour size, tumour grade, node status and treatment), as well as regular updates on vital status from routine death notification data.\nThe applicant is now seeking to obtain cancer data from PHE, who prompted the CAG application in their letter of 17 March 2017 which asked:\n‘Please advise if the existing participants will be re-consented. If re-consenting is not feasible, please provide the definitive reasons and what alternative legal gateway is being sought to ensure compliance with the law’.\nA recommendation for class Class 4 and 6 support was requested to link patient identifiable information from more than one source, and to allow access to an authorised user for this purpose."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Oncology, Strangeways Research Laboratory"]
[null,"Worts Causeway"]
[null,"Cambridge"]
["Postcode","CB1 8RN"]
["Telephone"]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to enable data to be provided to PHE in order to link with data relating to patients with primary malignant breast carcinomas diagnosed between ages 18 and 70 years."]
["Description of confidential patient information used","Full patient details are held under consent including names and addresses.\nThe applicant wishes to provide PHE with the following:\nName\nNHS Number\nDate of birth\nCancer registry number\n\nIn order to obtain information concerning:\nTumour site\nTumour morphology, grade and receptor status\nTumour size\nNumber of positive nodes\nStage\nTreatment data\nVital status\nCause of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-06-21"]
["Next Review Date","2024-06-21"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), (including National SARS-CoV2 testing data (Hospital Episode Statistics (HES) and Electronic Health Record (EHR) as part of NCRAS)\n\nAmendment supported 12 January 2023\nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n09 November 2020 - Amendment conditionally supported, to allow:\n• The disclosure of confidential patient information from the study team at University of Cambridge to Public Health England (PHE), for additional linkage of the breast SEARCH database to National SARS-CoV2 testing data, \n\n• and additionally to allow the data flow back to the study team at University of Cambridge from PHE (as although pseudonymised with the cancer registration number, there are sensitive data items including Covid-19 status and date of death, and the research team at University of Cambridge will be able to re-identify these patients).\n\nSpecific conditions of support\n1. Applicants are required to provide to the CAG Sub-committee updated information to go on the website, which makes it clear what information is being linked, why, and how to raise objections, within one month from the date of this letter.\n\nConfirmed - 17 November 2020: \nApplicant has responded to condition of support in application regarding updated website text. CAG content with response. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331)  was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support.\n\n3.\tConfirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 27 July 2020\n\n28 July 2020 - Annual Review:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Public Health England (X25) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed:\nV14 published and reviewed for University of Cambridge, School of Clinical Medicine\nV13 published and reviewed for PHE\n3. Progress on public engagement work should be fed back at annual review.\n4. Please be aware that support for this activity applies only to England and Wales. An application to the appropriate approval bodies in Scotland should be made to cover the collection or processing data where data in Scotland."]

{"sheet":"A02262","index":305,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02262"]
["Reference","17/CAG/0186"]
["Other Refs","IRAS project ID: 228894, REC reference: 17/LO/1596"]
["Application Title","REACH Pregnancy Circles: An individual-level randomised controlled trial of group antenatal care"]
["Application Summary","This research study from the University of East London set out the purpose of completing a randomised controlled trial (RCT) of a model of group antenatal care called Pregnancy Circles offered to women living in deprived and ethnically mixed parts of London, Essex and Bedfordshire. The trial aims to test the effectiveness of the group-based care. This RCT follows a pilot trial which tested feasibility of, and best methods for, the trial.\nA Pregnancy Circle involves about 12 pregnant women, who live close to each other and are due to give birth around the same time, having their antenatal care together in a community setting. The groups are facilitated by 2 midwives who combine clinical care with antenatal education and peer support. Care is organized in this way for the groups of women throughout their pregnancy and replaces standard antenatal care. There is good evidence from other settings that group antenatal care has a positive impact on women’s experiences of antenatal services and may lead to better health outcomes. This study would test the effectiveness of this model of care by primarily looking at any increases in rates of vaginal birth for these groups.\nSection 251 support was sought to enable researchers to assist clinical care staff with recruitment. The research team would identify suitable participants from referral records, and provide information by post before consent was requested at direct care appointments.\nA recommendation for class 3 and 6 was requested to select and contact participants to seek their consent, and to allow access to an authorised user for the above purpose"]
["Applicant Organisation Name","University of East London"]
["Contact Name","Angela Harden, Professor of Health Sciences (Chief Investigator)"]
["Address","University of London"]
[null,"Northampton Square"]
[null,"London"]
["Postcode","EC1V 0HB"]
["Telephone","+44 (0) 20 7040 5034"]
["Email","angela.harden@city.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from the referral record of participating maternity services, in relation to women who are currently pregnant and registered for antenatal care with one of the included maternity services, who also live within the working area covered by the Pregnancy Circle trained midwives, have an estimated delivery date that fits with a proposed pregnancy circle, and are over 16:"]
["Description of confidential patient information used"," Name\n Address\n NHS Number\n Estimated date of delivery"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-05-18"]
["Next Review Date","2024-05-18"]
["Notes","Specific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 27 April 2018)\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmation is not required for each individual site, however support is recommended on the understanding that the applicant will ensure that the appropriate security assurances are in place at each site. Please see the information governance toolkit section of the CAG website for further information)."]

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[]
[]
["Application Number","A02263"]
["Reference","18/CAG/0025"]
["Other Refs","IRAS project ID: 233062"]
["Application Title","Improving Prediction of Outcome in Out of Hospital Cardiac Arrest Patients - The King's Out of Hospital Cardiac Arrest Registry (KOCAR)"]
["Application Summary","This application from King’s College Hospital NHS Foundation Trust (KCH) sets out the purpose of medical research with a focus on the outcome of patients that suffer out of hospital cardiac arrest (OOHCA). The data will be used to validate a risk stratification tool to support clinical decision making upon admission. Information on patients suffering from OOHCA and subsequently brought to KCH will be collected from the London Ambulance Service (LAS). Information will be requested from NHS Digital on the mortality status of those patients. Those patients that are still living will be contacted by telephone for a follow up interview to identify the outcome of the OOHCA.\nA recommendation for class 1, 2, 3, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","King's College Hospital"]
["Contact Name","Professor Philip MacCarthy"]
["Address","Professor of Interventional Cardiology"]
[null,"King's College Hospital"]
[null,"London"]
["Postcode","SE5 9RS"]
["Telephone"]
["Email","philip.maccarthy@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients over the age of 18yrs admitted to KCH via London Ambulance Service having suffered an Out of Hospital Cardiac Arrest between 1st May 2012 and 31st December 2017.\nSample size: 400 patients approximately 150 survivors for telephone interview."]
["Description of confidential patient information used"," Data released by LAS: Computer Aided Dispatch Number (CAD), date of reaching admitting hospital – linkage. Data obtained under a data sharing agreement,\n Data identified from patient records at KCH: Unique KCH hospital number, NHS number, Occupation, GP and post-code – to facilitate linkage with ONS mortality information at NHS Digital and patient contact."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-05-18"]
["Next Review Date","2019-05-18"]
["Notes","Amendment request (Approved 26/11/2018)\nThe amendment seeks support for a change to the data flows in the study. The request seeks to change the method of data extraction from London Ambulance Service to Kings College Hospital. The amendment proposed that the main applicant would to attend the London Ambulance Service site to extract the data directly from records prior to disclosure to Kings College Hospital. In the proposed arrangement, the applicant would have access to wider confidential patient information within London Ambulance Service records than was currently supported. It was confirmed that the same information would be extracted from the patient records.\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 23 April 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – NHS Digital confirmed a satisfactory reviewed grade for King’s College Hospital NHS Foundation Trust V14.1, 2017/18 and NHS Digital V14.1, 2017/18)."]

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[]
[]
["Application Number","02264"]
["Reference","18/CAG/0028"]
["Other Refs","IRAS project ID: 210181, REC reference: 16/NW/0654"]
["Application Title","Mixed methods evaluation of the Getting it Right First Time programme: improvements to NHS orthopaedic care in England"]
["Application Summary","This application from University College London set out the purpose of medical research which aims to evaluate the planned changes to orthopaedics, as part of the ‘Getting it Right First Time’ Project (GIRFT), to identify lessons to inform future efforts to improve the organisation and delivery of services. The applicants will study documents relating to the changes and interview a wide range of stakeholders (hospital staff, commissioners, and national project team) about how the changes were implemented and what impact they have had. The applicants will analyse performance and cost data before, during and after the changes to assess whether the GIRFT programme has a) reduced variations in both the cost of care and the way it is delivered and b) improved patient outcome measures. We will also conduct focus groups with patients and members of the public to explore their perceptions of the planned improvements to care.\nThe Getting it Right First Time project (GIRFT) aims to deliver improvements in quality and reductions in the cost of NHS orthopaedic care across England. It involves three core strategies: (1) feedback of performance data to hospitals; (2) tailored written feedback to underperforming hospitals; and (3) changes to the way hospitals are paid, to encourage improvement. The GIRFT approach will in due course be rolled out across nine other NHS surgical specialities.\nThe application describes a number of activities; however, only studies two and three require CAG consideration. These sub-studies will undertake analysis on dataset of linked information which will be created from the National Joint Registry together with HES and PROMS data provided by NHS Digital. The applicants will only receive a pseudonymised data set for analysis; however, support under the Regulations is required to facilitate the linkage between the datasets.\nThe applicants state that evaluation will enable them to understand better what works, at what cost, but also to study how changes of this kind are implemented and sustained. Feedback will be provided to change leaders and decision-makers, locally and nationally, as well as identifying lessons to inform future efforts to improve care. Lay versions of the study reports will be produced for patients and the public, as well as management briefings for NHS policy makers, managers and clinical leaders."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Helen Barratt"]
["Address","North Thames"]
[null,"University College London\n"]
[null,"Department of Applied Health Research, 1-19 Torrington Place"]
["Postcode","WC1E 7HB"]
["Telephone"]
["Email","h.barratt@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," The patient cohort will include all elective primary joint replacement procedures carried out in NHS Trusts in England for the period April 2009 to March 2018.\n It is estimated that there will be approximately 1 million patients within this cohort.\nConfidential patient information will be transferred from the National Joint Registry to NHS Digital to facilitate data linkage."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as described:\n NHS number – linkage and analysis,\n Date of birth – linkage,\n Sex – linkage,\n Postcode – linkage and analysis (Deprivation scoring),\n Study ID – linkage and analysis,\n Ethnicity – from NHS Digital for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-05-30"]
["Next Review Date","N/A"]
["Notes","24 March 2021 - Application Expired\nApplicant confirmed by email on 24 March 2021 that they wished to exit support. The applicants hold only a pseudonymised dataset and do not retain any identifiable information. \n\nSpecific Conditions of Support (Final)\n1. Work should be undertaken to review the content of the patient notification materials in order to simplify the content in order to make this accessible to a wider audience. A report back on work undertaken should be provided at first annual review, together with a copy of the revised text for consideration.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – ethical opinion has been in place for the overall study since 26/08/2016).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - University College London, School of Life and Medical Sciences show a satisfactory reviewed grade on Version 14.1, 2017/18 and NHS Digital)."]

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[]
[]
["Application Number","A02265"]
["Reference","18/CAG/0004"]
["Other Refs","IRAS project ID: 234991, REC reference: 17/EM/0445"]
["Application Title","Transient patella dislocation and mode of early mobilisation"]
["Application Summary","This application from the Heart of England NHS Foundation Trust sets out the purpose of medical research which aims to find out if there is an increase in the likelihood of knee cap dislocation among people that were bottom shufflers and/or straight to walkers compared to those that crawled. Walking also changes the dynamics operating between the knee cap and the trochlea. A secondary aim will be to find out if there is any relationship between age of onset of independent walking and knee cap dislocation in later life.\nSupport is requested to allow the main applicant access to computerised medical records of MRI scans on the radiology reporting system in order to identify an eligible patient cohort to be invited to participate in the study. Confidential patient information will used to facilitate the invitation and consent process.\nA recommendation for class 1, 3 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","Heart of England NHS Foundation Trust"]
["Contact Name","Dr Bamikole Ogunwale"]
["Address","Department of Radiology, Birmingham Heartlands Hospital"]
[null,"Bordesley Green East"]
[null,"Birmingham"]
["Postcode","B9 5SS"]
["Telephone"]
["Email","bamikole.ogunwale@heartofengland.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Patient – aged between 10 and 35 years, with record of a knee cap dislocation within the last three years.\n Control – aged between 18 and 35 years, who have undergone an MRI scan of the knee in the last three years but without evidence of malfunction between the patella and femur articulation (patellofemoral dysfunction) or rupture of the anterior cruciate ligament of the knee, which can be related to patellofemoral dysfunction.\n 200 patients in total will be invited (100 per cohort).\nEligible patients will be identified using a key word/phrase search of the radiology reporting systems."]
["Description of confidential patient information used","The following items of confidential patient information will be recorded for eligible patients for the purposes outlined:\n Name – to send out invitation/questionnaires,\n Full address and postcode – to send out invitation/questionnaires,\n Date of birth – sample validation and analysis,\n Sex – recorded for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-05-31"]
["Next Review Date","2019-05-31"]
["Notes","Specific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – 02 January 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Heart of England NHS Foundation Trust, Version 14.1, 2017/18, reviewed satisfactory – email confirmation received 30/05/2018)."]

{"sheet":"A02266","index":309,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02266"]
["Reference","18/CAG/0044"]
["Other Refs","IRAS project ID: 178835, REC reference: 18/SS/0016"]
["Application Title","Long Term follow up of the ASCO Trial into Electronic Records (LATER)"]
["Application Summary","This application from Imperial College London sets out the purpose of medical research with a focus on people with higher blood pressure and higher cholesterol in mid-life have a higher risk of dementia and other illnesses in later life. However, there is little support from randomised trials or genetic studies that lowering midlife blood pressure, or prescribing statins prevent dementia, or have a legacy effect in the reduction in the risk of heart attack or stroke. Therefore more data is needed in order to support public health interventions to prevent dementia. Dementia is an insidious condition, and probably develops over many years. Very long term trials may not be feasible, would be extremely expensive, and would take many years before they could have an impact on public health. In order to lengthen the follow up period of existing trials, it is proposed to follow up UK participants in the ASCOT trial, which ran from 1998 to 2002, by using information in the electronic health records of the UK national health systems and to measure the development of dementia over the very long term.\nSupport is requested to allow the linkage of a data set already held by NHS Digital to be extended to include HES, mental health, dementia audits.\nA recommendation for class 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Peter Sever, Chief Investigator"]
["Address","ICTEM building floor 3"]
[null,"room 333, Imperial College London, Hammersmith Hospital Campus, Du Cane Road"]
[null,"London "]
["Postcode","W12 ONN"]
["Telephone","0207 594 1100"]
["Email","p.sever@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort would comprise of participants in the historic ACOT trial – approximately 7,303 patients."]
["Description of confidential patient information used","NHS Digital currently holds confidential patient information in relation to all ASCOT trial participants. Support is requested to link the study cohort with ONS mortality information, hospital episode statistic datasets, mental health datasets, and dementia national audits. Linked data will be released in a pseudonymised format to the applicants, using participant trial ID’s to enable linkage with the wider data currently held by the applicants."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-06-04"]
["Next Review Date","2024-06-04"]
["Notes","Specific Conditions of Support (Final)\n1. Support extends to England and Wales only.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 19th February 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Imperial College London School of Public Health, Medical Trials and Research, V14.1, 2017/18 confirmed as satisfactory via NHS Digital email 04/06/18 and NHS Digital)."]

{"sheet":"A02267","index":310,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02267"]
["Reference","18/CAG/0054"]
["Other Refs","IRAS project ID: 232691, REC reference: 17/LO/2004, Subreference for 2018 Amendment:18/CAG/0154"]
["Application Title","Lung cancer screening study using low dose CT to support the development of blood tests for early cancer detection"]
["Application Summary","This study from University College London sets out the purpose of medical research to investigate the feasibility of introducing low dose computed tomography (LDCT) screening to a group of adults at high risk of lung cancer. Potential participants will be identified from their GP records by a member of the UCLH study team, attending individual practices, as current or ex-smokers between the ages of 55 and 80 years. Potential participants will be sent an invitation letter. A sub-group of patients will also be sent a separate paper questionnaire on screening uptake. Potential participants’ information, including age, sex, ethnicity, smoking status, and index of multiple deprivation score and rank, will be collected and linked to LHC attendance data. By analysing those who attend and those who do not, the applicants hope to understand what factors might influence whether or not a participant attends a LHC. Uptake is one of the primary objectives for this study and it is essential to understanding the population impact of a future UK LDCT screening programme. The application has been made to the CAG in order to allow the research team access to GP record systems in order to identify and invite potential participants to the study.\nA recommendation for class 1, 3, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Samuel Janes"]
["Address","University College London"]
[null,"Rayne Institute, University College London"]
[null,"5 University Street, London"]
["Postcode","WC1E 6JF"]
["Telephone"]
["Email","s.janes@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1. Individuals aged 55 to 80 years within the North Central and North East London area, who meet either of the following criteria:\na. Have a history of at least 30 pack years of smoking (or at least 20 years duration), and if former smokers, have quit in the past 15 years\nb. 6-year lung cancer risk of ≥1.3%.\nA maximum of 100,000 patients from 600 GP practices will be invited to recruit 25,000 participants. If the enrolment figure is not achieved, the applicants state that there are further 25-50,000 patients in the geographical region who will be eligible.\nIn addition, all individuals eligible for invitation to the initial Lung Health Check appointment will be included in the uptake study (pseudonymised data on demographic characteristics and smoking status, and the screening uptake and behaviour questionnaire)."]
["Description of confidential patient information used","The following items of confidential patient information will be extracted from GP records for the purposes as described:\n Full Name and Title – to facilitate invitation,\n Date of Birth – translated to age for analysis,\n Full Address – to facilitate invitation,\n NHS Number – for linkage (undertake with consent),\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-06-05"]
["Next Review Date","2024-06-05"]
["Notes","02 August 2021 - Amendment supported to enable incidental access to confidential patient information stored within the SUMMIT Clinical Record Management System (SCRMS) by GRAIL Bio UK Ltd software engineers for the purposes of database maintenance by including GRAIL Bio UK Ltd as a data processor\n\n10 March 2021 - Amendment supported\nThe amendment, to enable access to confidential patient information stored within the SUMMIT trial database by one additional named contractor for the purposes of database maintenance is supported, is supported, subject to compliance with the standard conditions of support.\n\n13 October 2020 – Amendment supported\nThe amendment, to remove Group B, comprised of patients who are not at a high risk of developing smoking related cancers, to reduce the age range of eligible patients to 55-77 years of age, and reduce the target accrual to 25,000, is supported, subject to compliance with the standard conditions of support.\n\n17 August 2020 - Amendment supported to enable access to confidential patient information stored within the SUMMIT trial database by three additional named contractors for the purposes of database maintenance.\n\n13 July 2020 - Amendment supported to extend the recruitment window from 15 months to 2 years until 8 March 2021, to additionally retain the postcode, and to update patient facing documentation to account for the previous amendment which extended geographical recruitment to London and the surrounding area. \n\nApplicant should make an effort to minimise the postcode when possible.\n\n05 December 2019 – Amendment supported to extend the geographical cohort eligible for invitation to the study include London and surrounding areas, include two reminder letters for patients invited to participate and a ‘Did not attend’ letter for those patients who booked an appointment but failed to attend. \n\n14 October 2019: Amendment supported to enable access to confidential patient information within the trial database by two named contractors, working on site at University College London under honorary contracts, to enable maintenance of the trial database to be undertaken. \n\nAmendment Request (Approved 08/11/2018) - Subreference 18/CAG/0154\nThe amendment submitted sought approval for a number of significant changes to the project, as summarised below:\n Inclusion of an additional new patient cohort in the study – this will comprise of aged-matched individuals not at high-risk of lung cancer (Group B). It is proposed that 25,000 patients will be recruited to this group. Recruitment of patients in this group will follow the same pathway as the main patient group – potentially eligible patients will be identified from GP records and invited to participate in the study. \n The study title would also be amended to reflect this change from ‘Lung cancer screening study using low dose CT to support the development of blood tests for early cancer detection’ to ‘Cancer screening study with or without low dose lung CT to validate a multi-cancer early detection test’. \n The age range for eligibility has been amended from 55-80 years to 50-77 years. \n Support was originally recommended to allow access to 100,000 patient records in order to recruit the 25,000 patients at high-risk of lung cancer. The amendment requested that this was extended to 800,000 patient records to ensure the 50,000 recruitment target (25k per cohort) could be achieved. \n Support was requested to extend the duration which information on patients who do not respond to the formal consent request (non-responders) in retained from 15 months to 10 years for analysis purposes.\nSpecific conditions of support (Final)\n1. Provide feedback of the views of patients and the public around the proposed increase in sample size (up to 800,000 patients) and ongoing follow-up for 10 years of non-responding patients. This feedback can be provided from activity previously undertaken in this area if these specific points were explored, or via a newly planned activity. An overview of the activity carried out and questions posed together with the demographics of the group approached should be provided within three months of the date of this outcome letter for consideration. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Further work should be undertaken to extend the communications strategy for the study to ensure this is promoted as widely as possible to maximise the potential for patients within the lower risk cohort to see the information. Provide details of the wider plans proposed in this area, together with any supplementary materials for review, within three months of this outcome letter for consideration.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 30 July 2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – by email from NHS Digital dated 05 June 2018 in respect of Version 14.1, 2017/18 for the following:\n CFH Docmail Ltd,\n University College London,\n University College London Hospital NHS Foundation Trust,\n Amazon Web Services,\n Participating GP practices (600 practices) - Not requested for each site; support is based on the assumption that the applicant will ensure that satisfactory security assurances are in place for each site.\n\nOriginal Specific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 27 February 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – by email from NHS Digital dated 05 June 2018 in respect of Version 14.1, 2017/18 for the following:\n CFH Docmail Ltd,\n University College London,\n University College London Hospital NHS Foundation Trust,\n Amazon Web Services."]

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[]
[]
["Application Number","A02268"]
["Reference","18/CAG/0015"]
["Other Refs","IRAS project ID: 239236, REC reference: 18/EE/0029"]
["Application Title","Improving diagnosis and management in dementia with Lewy bodies using the CPFT Research Database (CRATE)"]
["Application Summary","This application has been submitted by the University of Cambridge on behalf on the Cambridgeshire and Peterborough NHS Foundation Trust sets out the purpose of medical research which aims to improve the diagnosis and management of care for patients with dementia with Lewy Bodies. Using the Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) Research Database (CRATE) the Lewy-CRATE project will identify a cohort of ~1,000 dementia with Lewy bodies (DLB) cases and several thousand non-DLB disease dementia controls to allow a detailed examination of their characteristics and outcomes.\nOnce the patient cohort has been identified, linkage will be undertaken with HES and ONS datasets held by NHS Digital. The linked dataset will be returned to the Cambridgeshire and Peterborough NHS Foundation Trust at which stage this will be pseudonymised. Researchers at the University of Cambridge will access the pseudonymised dataset in order to examine the patterns of early predictors, presentations and symptoms associated with DLB to facilitate early diagnosis. This will inform the development and testing of a natural language processing App to aid diagnostic decision making for clinicians in real time. The applicants assert that by linking with both local and national databases, more detail will be gathered about the full course of the disease from the early stages onwards, identify risk factors for disease development, and look at what might be changed to prevent worse outcomes.\nThe project is in partnership with a similar study which is being undertaken by King’s College London and the South London and Maudsley NHS Foundation Trust – it was noted that the grant which was secured to fund the project was a joint collaboration between all organisations; however, there will be no linkage/disclosure of confidential patient information between the two project arms. The KCL/SLaM project has sought its own relevant approvals. The CAG consideration here relates only to the University of Cambridge and Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) element."]
["Applicant Organisation Name","University of Cambridge (on behalf on the Cambridgeshire and Peterborough NHS Foundation Trust)"]
["Contact Name","Professor John O'Brien"]
["Address","Department of Psychiatry, University of Cambridge"]
[null,"School of Clinical Medicine, Box 189, Level E4"]
[null,"Cambridge Biomedical Campus, Cambridge"]
["Postcode","CB2 0SP"]
["Telephone"]
["Email","john.obrien@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Patients (male and female) aged 50 years and over,\n Diagnosis of dementia, dementia with Lewy bodies, cognitive impairment, or Parkinson’s Disease from 2005 onwards within the Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) CRATE research database,\n It is estimated that approximately 500 patients with dementia with Lewy bodies (DLB) would be identified and 12,500 patients within the non-DLB disease dementia controls.\nThe patient cohort will be established via the CPFT CRATE database – confidential patient information will be shared with NHS Digital in order to link with HES and ONS mortality data."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set out:\n NHS number –linkage,\n Date of birth – linkage and analysis (01/MM/YY format),\n Postcode – linkage and analysis (LSOA format),\n Date of death – analysis (MM/YY format),\n Sex – linkage and analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-06-13"]
["Next Review Date","2024-06-13"]
["Notes","07 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources - ONS mortality data and Hospital Episode Statistics (HES).\n\n13 December 2021 - Amendment supported\nAmendment supported to extend the duration of support until 31 March 2024.\n\n19 June 2020 - Amendment supported to update the cohort size to a total of ~22,000 from original study estimate of ~13,000\n\nSpecific conditions of support\n1. Patient and Public Involvement and Engagement – a report would be required at the time of first annual review to address the following points:\na. Provide an overview of the additional activity which has been undertaken in this area with the local dementia carers group and the study-appointed patient and public representatives,\nb. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 30 May 2018)\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Cambridgeshire and Peterborough NHS Foundation Trust, V14.1, 2017/18 confirmed as satisfactory in direct email from NHS Digital dated 13 June 2018)."]

{"sheet":"A02269","index":312,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02269"]
["Reference","18/CAG/0056"]
["Other Refs","IRAS project ID: 216615, REC reference: 18/LO/0490"]
["Application Title","Retinoblastoma gene mutations and risk of secondary primary tumours"]
["Application Summary","This application from Barts Health NHS Trust set out the purpose of medical research to investigate the relation between types of retinoblastoma, a cancer of the eye occurring in children, mutation and the rates of occurrence of second primary tumours. The study will link retrospective patient data held by Barts Hospital, Great Ormond Street Hospital and the Royal London Hospital with National Registry of Childhood Tumours – now part of the Richard Doll Archive, and within the Public Health England Cancer Registration system. Once linked, the database will be pseudonymised prior to analysis taking place."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Dr Zerrin Onadim, Head of Retinoblastoma Genetic Screening Unit"]
["Address","Retinoblastoma Office, Pathology & Pharmacy Building"]
[null,"Royal London Hospital, 80 Newark Street"]
[null,"Whitechapel, London"]
["Postcode","E1 2ES"]
["Telephone","020 3246 0265"]
["Email","z.onadim@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A retrospective patient cohort will be identified from records held at Barts Hospital, Great Ormond Street Hospital and the Royal London Hospital. Patients would be aged up to 15 years at the time of diagnosis. It is estimated that there will be around 600 patients included within the study."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set out below:\n Name – linkage,\n Hospital ID – linkage,\n NHS number – linkage,\n Date of birth – linkage and in a pseudonymised format for analysis,\n Date of death – pseudonymised for analysis,\n Gender – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-06-15"]
["Next Review Date","2024-06-15"]
["Notes","06 June 2023 - change in data processor from Public Health England to NHS Digital to NHS England, regarding data sources National Cancer Registration and Analysis Service (NCRAS) and Hospital Episode Statistics (HES).\n\nSpecific Conditions of Support (Final)\n1. Provide an interim report within three months of the date of this letter around the findings of the patient and public engagement survey. This should provide an overview of the number of responses received together with any feedback provided. If the responses given were negative, the CAG will take this into account when considering whether support can continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – issued 19/03/2018)\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Bart’s Health NHS Trust, Version 14.1, 2017/187, confirmed reviewed grade of satisfactory by NHS Digital email 13/06/2018)."]

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[]
[]
["Application Number","A02270"]
["Reference","18/CAG/0040"]
["Other Refs","IRAS project ID: 229566, REC reference: 18/SC/0086"]
["Application Title","The eLIXIR project/ eLIXIR: Early Lifecourse data Cross-Linkage in Research: a Multidisciplinary partnership - linked data for research into maternal and child health"]
["Application Summary","This application from the South London and Maudsley NHS Foundation Trust set out the purpose of medical research which aims establish a unique life course approach to mental and physical health disorders by combining maternal, infant and child clinical data into a single database. Approval is sought to link data from three Trusts: South London and Maudsley NHS Foundation Trust (SLAM), Guys and St Thomas NHS Foundation Trust (GSTT) and King’s College Hospital NHS Foundation Trust (KCH) to create a data platform with linked mental healthcare and hospital records for pregnant women, infants and children.\nThe initial stage proposed in this application will involve a bringing together maternity data from Guys and St Thomas NHS Foundation Trust and King’s College Hospital NHS Foundation Trust, neonatal/paediatric data from Guys and St Thomas NHS Foundation Trust and King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust mental healthcare data."]
["Applicant Organisation Name","Maudsley NIHR Biomedical Research Centre"]
["Contact Name","Professor Robert J Stewart"]
["Address","South London and Maudsley NHS Foundation Trust"]
[null,"Maudsley Hospital"]
[null,"Denmark Hill, London"]
["Postcode","SE5 8AF"]
["Telephone"]
["Email","robert.stewart@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," The population base is pregnant women, aged 16 upwards, and children receiving care from KCH and GSTT and people receiving mental health care from SLAM.\n This covers a catchment of around 600,000 residents predominantly residing in Lambeth and Southwark."]
["Description of confidential patient information used","The following data items are required from the three Trusts in order to facilitate linkage and creation of the eLIXIR specific cohort. It is stated that the SLAM Clinical Data Linkage Service requires this data items as a minimum to ensure data linkage can be achieved:\n Name,\n NHS number,\n Hospital Number – this will be replaced with study-ID in database,\n Date of birth,\n Postcode,\n Full Address.\nThe following will be required as part of the research database for analysis:\n Sector-level postcode – translated into Lower Super Output Area or deprivation scoring for analysis,\n Sex,\n Ethnicity,\n Month and year of death.\nResearchers would only receive access to a de-identified dataset for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-06-15"]
["Next Review Date","2024-06-15"]
["Notes","03 October 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES) and the National Immunisation Management System (NIMS) database\n\n04 January 2023 – amendment supported to allow disclosure of confidential patient information from the eLIXIR database at South London and Maudsley NHS Foundation Trust to UK Government Human Fertilisation and Embryology Authority for data linkage and to the National Immunisation Management System (NIMS) databases at NHS Digital, and the return of linked datasets to South London and Maudsley NHS Foundation Trust\n\n15 July 2020 – Amendment supported to link eLIXIR data, held by SLaM CRIS, with NHS Digital HES data.\n\n03 February 2020 – Amendment supported to allow the applicants to conduct an additional linkage between eLIXIR and Lambeth DataNet, in order to include Primary Care data to the existing linkage capability between maternity, neonatal and mental health services. \n\nSpecific Conditions of Support (Final)\n1. Support is extended to the linkage of the South London and Maudsley NHS Foundation Trust CRIS dataset together with BadgerNet maternity and neonatal data sources from Guys and St Thomas NHS Foundation Trust and King’s College Hospital NHS Foundation Trust only. Linkages with wider data sources would need to be submitted as an amendment for consideration.\n2. A report is required at the time of first annual review to provide feedback on the following points:\na. The applicants are asked to consider how potentially diminishing returns may impact on the quality of the database and what steps may be taken to mitigate against this,\nb. Clarification is required of the intended exit strategy for the project, should additional funding beyond the initial three year project not be received. Confirmation should be provided around how the destruction of confidential patient information would be handled in this circumstance,\nc. Provide an update around how the Oversight Committee is ensuring that all data releases conform to the ICO Code of Practice for Anonymisation,\nd. Provide an update at the on the outcomes of the additional patient and public involvement and engagement activity which was scheduled. It was noted that if the outcomes were negative that the CGA would take this into consideration when considering whether support can continue or if further action is required,\ne. Planning should begin around a communication strategy for the children within the cohort, who become adults – feedback should be provided around progress made in this area for consideration by the CAG.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 22/03/2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – South London and Maudsley NHS Foundation Trust shows a reviewed grade of 91% satisfactory on Version 14.1, 2017/18 by NHS Digital 14/06/2018)."]

{"sheet":"A02271","index":314,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02271"]
["Reference","18/CAG/0070"]
["Other Refs","IRAS project ID: 236515, REC reference: 18/SC/0204"]
["Application Title","Renal Replacement Anticoagulant Management"]
["Application Summary","This application from the Intensive Care National Audit & Research Centre (ICNARC) set out the purpose of medical research which aims to study the effects of two anticoagulants, heparin and citrate, on patients who are undergoing continuous renal replacement therapy (CRRT). CRRT is often used in intensive care units when a patient is suffering from an acute kidney injury which prevents their kidneys working properly. CRRT is a machine which takes over the kidney functions until the patient’s own kidneys recover. Traditionally heparin is added to the patient’s blood as it enters the CRRT machine to prevent it from clotting. Recently, citrate anticoagulation is being used as it may be more controllable and cheaper. Both heparin and citrate anticoagulation therapies are associated with different risks for the patients and it is currently unknown whether either form of anticoagulation is more effective.\nDetailed electronic health records are available for all patients admitted to UK ICUs. The applicants will use these records to identify adult patients treated in 184 non-specialist adult ICUs in England that needed at least one day of CRRT between 01/04/2009 and 31/03/2017. By surveying these ICUs to see which have swapped to citrate anticoagulation and when this changeover occurred, the applicants will examine the effects of changing from heparin to citrate on patients’ well-being.\nConfidential patient information will be released by ICNARC and the UK Renal Registry to NHS Digital to facilitate linkage with HES and ONS datasets. Linked records will be returned to the applicants in a pseudonymised format by study ID for analysis.\nThe applicants will look at patients' survival, degree of sickness and how fast they recover. Analysis will also be undertaken to measure the cost of the two types of anticoagulation so we can assess the cost/benefit trade-off for both types of anticoagulation.\nThe ICNARC Case Mix Programme operates with support under the Regulations under reference: PIAG 2-10(f)/2005."]
["Applicant Organisation Name","Intensive Care National Audit & Research Centre (ICNARC)"]
["Contact Name","Dr Peter Watkinson"]
["Address","Division of Anaesthetics, Critical Care & Theatres"]
[null,"Kadoorie Centre for Critical Care Research and Education, Level 3,"]
[null,"John Radcliffe Hospital, Oxford"]
["Postcode","OX3 9DU"]
["Telephone"]
["Email","peter.watkinson@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 16 and over, admitted to an adult or general ICU in England and Wales, which participates in the ICNARC case mix programme, between 01/04/2009 and 31/03/2017. Patients would have been in receipt of CRRT for at least one calendar day during the ICU stay. It is estimated that 85,000 patients would be included within the project."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes described:\n NHS number – linkage,\n Date of birth – linkage and analysis,\n Date of death – linkage and analysis,\n Postcode – linkage and converted to LSOA for analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-06-21"]
["Next Review Date","N/A"]
["Notes","22 November 2021 - Support expired\nThe applicant confirmed that suppor was no longer required.\n\n29 August 2019: Amendment supported to extend the duration of support under the Regulations to 31 December 2019. \n\n26/03/2019: Amendment supported to extract confidential patient information and clinical information in relation to patients identified as having undergone continuous renal replacement therapy at Oxford University Hospitals NHS Foundation Trust.\n\nAmendment Request (Supported 08/11/2018)\nThe amendment seeks support to extend data linkage to the Patient Episode Database for Wales (PEDW) via NHS Wales Informatics Service (NWIS) in order to obtain healthcare usage data for Welsh patients. NWIS had confirmed that the linkage would be facilitated on NHS Number alone.\nSpecific conditions of support\n1. Confirmation of suitable security arrangements (Confirmed – Caldicott Principles Into Practice (CPiP) Assessment for NWIS received 25/10/2018)\n2. Confirmation of a favourable opinion from a Research Ethics Committee (Confirmed – Non-\nSubstantial amendment confirmed 24/08/2018).\n\nSpecific Conditions of Support (Final)\n1. Patient information materials should be revised to explain that the linkage to be undertaken is intended in the future.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 17/04/2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – ICNARC, Version 14.1, 2017/18, confirmed reviewed grade of satisfactory via website update, NHS Digital undertaking wider processing)."]

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[]
[]
["Application Number","A02272"]
["Reference","17/CAG/0048"]
["Other Refs","IRAS project ID: 217010, REC reference:17/LO/0281"]
["Application Title","Long-term follow-up of the East London Sickle Cell Disease Neonatal Cohort"]
["Application Summary","This application from the Royal London Hospital sets out a purpose to follow-up patients previously entered into the Sickle Cell Disease database which was established in East London in 1983. This cohort, referred to as the East London Newborn cohort, is a unique cohort of patients diagnosed with universal newborn screening in the London Boroughs of Hackney since 1983. The cohort is under continuous clinical follow up at The Royal London Hospital, although a minority have transferred care to other clinics or become lost to follow-up. The first report on the cohort was published in 2007. After a further decade of follow-up, an analysis of outcomes and risk factors will provide important data to inform health service planning and treatment decisions for Sickle Cell Disease in the UK and elsewhere. The current study will require collecting and validating clinical, laboratory and radiological data on all cohort patients, and undertaking a number of statistical analyses on the dataset. Data on patients under current follow-up at Royal London Hospital is maintained on a secure clinical database at site. Information on patients in other clinics will need to be sought from their GP or specialist. Attempts will be made to trace those lost to follow-up. In order to avoid bias and to enable an accurate assessment of overall outcomes, the applicants wish to use data from all patients within the cohort, if they have been lost to follow-up.\nThe request for support is designed to cover a further 10 year follow up on patients from the East London newborn cohort. This will include clinicians updating in respect of patients who are still under the care of the Royal London Hospital (out of scope of the support request), requesting information from clinicians for those patients who have moved to other hospitals for their treatment (support to cover the processing of the information) and attempts to locate patients who are lost to follow-up through contacting GP surgeries.\n"]
["Applicant Organisation Name","Royal London Hospital "]
["Contact Name","Dr Paul Telfer"]
["Address","Barts Health NHS Trust"]
[null,"Department of Haematology, Royal London Hospital"]
[null,"4th Floor Pathology and Pharmacy Building, Newark Street"]
["Postcode","E1 2ES"]
["Telephone"]
["Email","Paul.Telfer@bartshealth.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort is all patients added to the East London newborn cohort with sickle cell disease, found during the universal newborn screening, from its establishment in 1983. The established cohort is 396 patients; however, there will be additional patients who were added from 2007 (date of last analysis) onwards, who will also be followed up."]
["Description of confidential patient information used","Access was requested to the following items of confidential patient identifiable information for the purposes advised:\n Name – identification/verification,\n NHS Number – identification/verification,\n Hospital ID No- identification/verification,,\n GP Registration – identification/verification,\n Date of birth – identification/verification and analysis (applicant advised that this can be converted to MM/YY format if CAG require),\n Date of death – identification/verification and analysis (applicant advised that this can be converted to MM/YY format if CAG require),\n Postcode – analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-09-07"]
["Next Review Date","2024-09-07"]
["Notes","Amendment supported 12 January 2023\nTo expand the cohort to include the entire population of patients with sickle cell disease followed in the clinical services at Barts Health NHS Trust and registered on the Sickle Cell Disease Clinical database for more than 6 months, confirm that the duration of follow up for each patient will be from registration in the service up until 30 June 2025, and to amend the data flow to remove any input from external organisations, (as follow up will now be undertaken only at Barts Health NHS Trust)\n\n11 November 2019: Amendent supported to extend the duration of support to 30 October 2020, enable follow-up of the patient cohort for an additional year to 31 December 2018 and to extend the inclusion criteria to include all children diagnosed with sickle cell disease by universal screening and referred to the Hackney Children’s Hospital (up to 1998) or Royal London Hospital (after 1998) as their first treatment centre. The supported amendment also described changes in the research objectives and wider clinical variables which would be collected for anlaysis, which did not alter the scope of section 251 support. \n\nSpecific Conditions of Support (Final)\n1. Reduction of Identifiers – the date of birth and death should be truncated to month and year format, and postcode should translated to lower-layer super output area within the research dataset.\n2. Patient and Public Involvement and Engagement – at the time of annual review, provide an overview of actual activity which has been undertaken against those activities which were planned and a revised plan for activity in this area moving forward.\n3. Patient Notifications – provide an update at the time of annual review around the progress which has been made with the study newsletter and the wider extension of this network-wide.\n4. Favourable opinion from a Research Ethics Committee. (Received – 08 March 2017)\n5. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Version 14, 2016-17, reviewed satisfactory grade at 77%)."]

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[]
[]
["Application Number","A02273"]
["Reference","CR17/2014"]
["Other Refs"]
["Application Title","EPIDEMIOLOGICAL STUDY OF BRCA1 AND BRCA2\nMUTATION CARRIERS"]
["Application Summary","This application from the University of Cambridge requested support in order to access mortality and cancer data from the Data Access Request Service (DARS) at the Health and Social Care Information Centre (HSCIC).\nThe study aims to follow-up a cohort of BRCA1 and BRCA2 mutation carriers with associated epidemiological, clinical, pathological and genetic data to study cancer epidemiology in mutation carriers was flagged at the HSCIC for mortality and cancer updates.\nThe applicant confirmed that the retrospective cohort had previously consented to accessing their medical records and any stored samples from previous operations being used for this research. The applicant also confirmed that confidential patient information would not be held once analysis had been completed.\nSpecifically the study seeks to:\n1. Obtain prospective estimates of cancer incidence, including second cancers, in carriers.\n2. Evaluate lifestyle/hormonal factors which might modify risks.\n3. Evaluate evidence for variation in cancer risks by mutation type.\n4. Identify genetic variants which modify the cancer risks in carriers.\n5. Evaluate the associations between mammographic density (MD) and breast cancer (BC) risk in carriers.\n6. Evaluate the pathological and clinical characteristics of breast and ovarian tumours in carriers.\n7. Evaluate the efficacy of prophylactic oophorectomy and mastectomy (and potentially other interventions)."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Antonis Antoniou, Chief investigator "]
["Address","Centre for Cancer Genetic Epidemiology Department of Public Health and Primary Care and Department of Oncology\n"]
[null,"University of Cambridge, Strangeways Research Laboratory"]
[null,"2 Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone","01223 748630"]
["Email","aca20@medschl.cam.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The applicant confirmed that for the prospective cohort, the participants would be required to complete a questionnaire, provide a blood sample at baseline and consent would be sought for follow-up stages. The Confidentiality Advice Team (CAT) advised that the applicant must make efforts to inform the retrospective cohort regarding of the processing of their data and align patient notification with guidance from the Information Commissioners’ Office (ICO) https://ico.org.uk/. The CAT also advised that s251 support would be approved for the retrospective cohort only. With regard to recruitment of the prospective cohort, the consent model must make clear that the subjects’ identifiers will be used to link to the Health and Social Care Information Centre in order that long term follow up data on subjects can be obtained. The consent wording should be submitted to the Health and Social Care Information Centre (HSCIC) for consultation and approval."]
["Description of confidential patient information used","Confidential patient information was requested to permit access to NHS number, name, date of birth and address including postcode."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-03-31"]
["Next Review Date","2024-06-13"]
["Notes","Amendment supported 24 July 2023 to confirm that Professor Doug Easton is being replaced as Chief Investigator by Professor Antonis Antoniou.\n\n22 June 2023 - change in data processor from NHS Digital to NHS England, regarding mortality and cancer data\n\nSpecific conditions of support\n1. Support was approved for the retrospective cohort only\n2. Support only applies to data generated in England and Wales.\n3. Prospective cohort consent model must be submitted to the Health and Social Care Information Centre (HSCIC) for consultation and approval.\n4. Provide fair processing/patient notification materials. Provided on the 31 March 2017. The document was reviewed and approved by the CAG.\n5. Follow the anonymised method as detailed within your application form as an appropriate mechanism to exit from using confidential patient information.\n6. A current REC Favourable opinion letter. Confirmed January 2015.\n7. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 23rd March 2015.\n8. Provide confirmation of how you are intending to proceed with IGT/REC approval to the Confidentiality Advice Team by 1st May 2015. Confirmed as per specific conditions 6 and 7.\n"]

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[]
[]
["Application Number","02274"]
["Reference","18/CAG/0029"]
["Other Refs","IRAS project ID: 120058, REC reference: 13/LO/0980"]
["Application Title","The effect of remote ischaemic preconditioning and glyceryl trinitrate on peri-operative myocardial injury in cardiac bypass surgery patients (ERIC-GTN study)- a four arm randomised controlled trial"]
["Application Summary","This application from University College London sets out the purpose of medical research with a focus on Remote Ischaemic Preconditioning (RIPC) a phenomenon known to protect the heart against ischaemia reperfusion injury. This is an established randomised control trial with four arms comparing the infusion of GTN or a placebo saline infusion during coronary artery bypass surgery.\nInformation has emerged indicating an increased mortality rate in one arm of the study one year post follow up. The initial trial protocol does not allow follow up of patients after discharge, so the patients consented into the study did not provide informed consent for this access to additional data.\nThe study is ongoing but new information on the outcomes of the study would be in the public interest and requires further analysis.\nA recommendation for classes 1 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Derek Yellon"]
["Address","67 Chenies Mews"]
[null,"University College London"]
[null,"London"]
["Postcode","WC1E 6HX"]
["Telephone"]
["Email","d.yellon@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients enrolled into the ERIC study up to one year post consent and surgery. 260 patients.\nData from trial case report forms and medical records will be reviewed to identify cause of death and the trial arm the patient was randomised to."]
["Description of confidential patient information used","The following items of confidential patient information will be released to the non-clinical research team:\n Hospital ID - linkage\n Date of Birth – linkage and converted to age for analysis\n Date of Death MM/YY – analysis\n Gender - analysis\n Ethnicity - analysis\n Lifestyle analysis – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-06-29"]
["Next Review Date","N/A"]
["Notes","2019 - Support expired\nAt the end of the study, no identifiers were retained.\n\nThe public benefits of this work mostly focus on the advancement of knowledge in this area of research. One of the research team successfully received his MD(Res) and results were disseminated across our colleagues to better inform patient care.\n\nSpecific Conditions of Support (Final)\n1. Patient Notification and Dissent – information should be included on the Hatter Institute website to inform patients and the public around the additional follow-up which is not included in the study. Study results should also be disseminated via this forum.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 30 April 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - University College London Hospitals NHS Foundation Trust show a reviewed grade of 80% satisfactory on Version 14.1, 2017/18 Bart’s Health – show a reviewed grade of 77% satisfactory on Version 14.1, 2017/8)."]

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[]
[]
["Application Number","02274"]
["Reference","18/CAG/0080"]
["Other Refs","IRAS project ID: 241144, REC reference: 18/WA/0159"]
["Application Title","Development and Validation of Barts Heart Centre Surgical Infection Risk (B-SIR) Tool to Predict Surgical Site Infection After Cardiac Surgery"]
["Application Summary","This application from Barts Health NHS Trust set out the purpose of medical research which aims to develop an assessment tool that will help identify patients at risk of developing surgical site infections after cardiac surgery. The study also aims to compare the new tool with the other risk assessment tools. Surgical site infections are serious complications following surgery which can lengthen a patient’s stay in hospital and increase the risk of morbidity and mortality.\nThe applicants will be undertaking a retrospective case note review of patients who underwent a coronary artery bypass graft (CABG) and/or valvular surgery at the Barts Heart Centre between January 2016 and December 2017, who meet the study inclusion criteria. Wider clinical information will be collated from locally held records of data which were prospectively collected for submission to the following audits/surveillance activities: Intensive Care National Audit and Research Centre (ICNARC), National Institute of cardiovascular Outcomes Research (NICOR) and Public Health England (PHE) SSI Surveillance."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Mrs Rosalie Magboo"]
["Address","Barts Heart Centre - Intensive Care Unit"]
[null,"St. Bartholomews, West Smithfield"]
[null,"London"]
["Postcode","EC1A 7BE"]
["Telephone"]
["Email","Rosalie.RenaMagboo@bartshealth.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients underwent a coronary artery bypass graft (CABG) and/or valvular surgery at the Barts Heart Centre between January 2016 – December 2017. This will be established from a search of the locally held SSI Surveillance register at Bart’s Heart Centre. It is estimated that 2,000 patient records will be included."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes of linkage between the three datasets:\n Medical Record Number/Hospital Number,\n Date of birth,\n Date of surgery."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-06"]
["Next Review Date","N/A"]
["Notes","14 February 2022 - Support Expired:\nApplicant confirmed 14 February 2022 that support can be expired as there is no longer any confidential patient information processed. \n\nIn terms of public benefit, applicants were able to develop and validate the Barts Surgical Infection Risk Tool, which is currently being used clinically to assess risks of patients in developing surgical site infection after cardiac surgery.\n\nSpecific Conditions of Support (Final)\n1. The study should be promoted on the Trust website – confirmation that this has been actioned, together with a copy of the text, should be provided within three months of this date of this letter.\n2. Work should be undertaken with the Cardiac Surgery Patient Group to devise a strategy to share the research findings with patients – an update around this work should be provided at the time of first annual review.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 04 July 2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Barts Health NHS Trust shows a reviewed satisfactory grade on V14.1, 2017/18)."]

{"sheet":"A02276","index":319,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02276"]
["Reference","18/CAG/0087"]
["Other Refs","IRAS project ID: 219628, REC reference: 18/EM/0084"]
["Application Title","A critical evaluation of community based integrated care policy"]
["Application Summary","This application from the University of Essex set out the purpose of medical research which aims to determine how national policy discourses underpinning community based integrated care have been enacted as programme resources designed to create behaviour change in health professionals and service users. Secondly, the study will aim to evaluate to what extent these programme resources have been successful at meeting both policy maker’s aims and creating changes to wider structures. The aim of the research is to conduct a critical evaluation of community based integrated care policy by first of all determining the way in which the local implementers (CCG, County Council, Lead Provider) have re-contextualised and enacted national policy discourses in the form of discursive and material programme resources. The applicant will be undertaking interviews with patients and various members of staff delivering care, as well as undertaking observations of the multidisciplinary teams who deliver community-based care.\nThe project has a number of elements which are out of scope for the CAG review. The two elements which the CAG is being asked to consider are the day-to-day office observations and the recordings of multi-disciplinary meetings. The research aims and outcomes do not require confidential patient information; however, it is acknowledged that the applicant may be incidentally exposed to information of this type when observing health care professionals delivering their work.\nThe applicant will undertake 140 hours of participant observation within the multidisciplinary team offices. This will be split across the four integrated care teams and will involve 35 hours of observation in each office. The main applicant will hot desk in the office, in order to blend into the office environment. No confidential patient information would be recorded by the Chief Investigator, as part of her field notes.\nNon-participant observation of eight complex case review multidisciplinary team meeting (two meetings per integrated care team), which include members of external agencies, such as GPs, social workers, and mental health professionals will be carried out. The meeting would be video-recorded without the main applicant being present. The reason for this approach is to capture highly valid data that can be subject to detailed sociolinguistic analysis that accounts for body language, as well as verbal communication. The main applicant would be there at the beginning and end of the meeting to set the video recorder up. The Chair of the meeting will briefed on how to pause and restart the recording if sensitive information was being discussed that they did not want to be recorded. These observations will take place in the Multidisciplinary Team offices where the meetings are held. The main applicant will transcribe the video recording on site, so no confidential patient information would be transferred offsite. The applicant would not transcribe any confidential patient information from the recordings."]
["Applicant Organisation Name","University of Essex"]
["Contact Name","Ms. Hannah Kendrick"]
["Address","School of Health and Social Care"]
[null,"University of Essex, Colchester Campus"]
[null,"Wivenhoe Park"]
["Postcode","CO4 3SQ"]
["Telephone"]
["Email","hk16201@essex.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The applicant will be observing:\n Health Professionals contained with multidisciplinary teams, internal to the community based integrated care provider (nurses, physios, OTs).\n Professionals belonging to external partners who are involved in multidisciplinary team meetings (GPs, social workers, mental health professionals)"]
["Description of confidential patient information used","The applicant is not seeking access to any confidential patient information; however, it has been identified that this may be disclosed incidentally during the course of the observations with staff."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-09"]
["Next Review Date","N/A"]
["Notes","19 January 2022 - Support Expired\nAll identifiable data (sound files, identifying codes) have been destroyed securely. Anonymised transcripts and field notes are stored on my personal laptop in an encrypted folder. This will be kept for a maximum of 10 years. I will be the only person to have access to this data, but it may be shared with other academics for the purpose of publications. \n\nThe public benefit that arose from this work is that it provided the lead provider with detailed findings and data on how their service change was working in practice and what impact it was having on staff and patients. This was fed back to the provider for them to act on this feedback and to improve services that patients and the public access. The integrated care service evaluated in this study was funded by public money and so provided analysis of how tax-payer money is being used in the development of health services.\n\nSpecific Conditions of Support (Final)\n1. The planned patient and public engagement activity should proceed, which should include discussion around the communications strategy and patient dissenting mechanism for the study. Feedback on the outcomes of this activity should be provided within six months of final support coming into effect. If the responses given are negative, the CAG would take this into when considering whether support can continue, or if further action is required.\n2. Patient Notifications and Dissent – a communications strategy should be developed for the study, including a meaningful dissenting mechanism. An overview of how and where information would be displayed, together with copies of any documentation, would be required as part of the six month interim report.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 26 March 2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Anglican Community Enterprise (Social Enterprise) – satisfactory reviewed grade on V14.1, 2017/18 by NHS Digital email on 03/07/2018)."]

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[]
[]
["Application Number","A02277"]
["Reference","18/CAG/0082"]
["Other Refs","IRAS project ID: 239199, REC reference: 18/LO/0649"]
["Application Title","Breast Cancer (BC) Predict - Providing breast cancer risk as part of the national breast cancer screening programme: building an evidence base on benefits and harms to inform a decision to implement"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research which aimed to automate the breast cancer risk estimation process to assess feasibility of rolling this out more widely as part of the NHS Breast Screening Programme.\nThe National Institute for Health and Care Excellence (NICE) states that women at high-risk of breast cancer should have more frequent breast mammography (x-ray) screening and be offered risk-reducing treatment with the medicines tamoxifen, raloxifene or anastrozole. However, women at increased risk of breast cancer in the NHS Breast Screening Programme (NHSBSP) cannot be offered prevention drugs or extra screening as the screening programme does not currently estimate or inform women of their risk.\nA proportion of women attending breast screening will be invited to join the study. Those opting to participate will join via online consent, following which they will complete the online breast cancer risk estimation tool. Women may also opt to have a mammogram, though this is not compulsory. Those who have a mammogram will have breast density assessed from the mammogram and this will be combined with the information they provide in the online questionnaire to estimate their breast cancer risk. Risk information will be sent to participants via letter after confirmation of a normal mammogram result (approximately 6-weeks after consent).\nThere are three elements to the study which required support under the Regulations which include Phase 1 of the proof of principle – in which women attending on the day for a mammogram will be invited to participate in order to test the systems. Phase 2 of the proof of principle will be initiated once the initial phase has tested that the study processes work and will test whether these work optimally and confirm that there is no requirement for a control group. Following this, the main study will be initiated across the three areas.\nWomen will be recruited from three NHS Breast screening programmes: Greater Manchester (Withington Community Hospital, Oldham lntegrated Care Centre and the Trafford mobile screening van only), East Cheshire (Macclesfield District General Hospital and Stockport mobile breast screening van locations) and East Lancashire (Burnley General Hospital and East Lancashire mobile breast screening van locations). Recruitment is over a 16-month period and sites will each be open to recruitment to BC-Predict for a period of 8 months."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Gareth Evans"]
["Address","University of Manchester"]
[null,"Department of Medical Genetics (6th Floor)"]
[null,"St Mary's Hospital, Oxford Road, Machester"]
["Postcode","M13 9PL"]
["Telephone"]
["Email","Gareth.Evans@mft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The following inclusion criteria have been established for the various study phases:\n\nProof of Principle Study - Phase 1 inclusion criteria\n Attending for breast screening at relevant site.\n Mammogram to be performed at relevant site on day of consent to the study.\n Able to complete the BC-Predict risk assessment questionnaire at their screening visit.\n Willing to receive their breast cancer risk information.\n Born biologically female.\n Approximately 20 participants across three sites.\n\nProof of Principle Study - Phase 2 inclusion criteria\n Invited for breast screening at active site.\n Able to complete the BC-Predict risk assessment questionnaire\n Willing to receive breast cancer risk information.\n Born biologically female.\n Approximately 180-360 participants across three sites.\n\nMain study inclusion criteria\n Born biologically female\n Invited for first breast screening with the Greater Manchester, East Cheshire, or East Lancashire breast screening programmes or invited for a mammogram at East Cheshire or East Lancashire and aged between 57 and 63 years.\n 8,000 who join the study, but 18,700 who are invited.\n Main study controls - approximately 18,700 but these women will not be recruited to the study.\n\nSupport is requested for three elements of the application activity. In Phase 1 of the proof of principle study, support under the Regulations is requested to enable the research assistant access to confidential patient information from the NHS Breast Screening Service (NBSS) system in order to invite patient to the study. Support is requested to allow the applicants remote access to confidential patient information held within the NBSS database at the three NHS Trusts in order to extract information in relation to relevant patients in order to invite them to participate in the study, together with the control cohorts."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set out below:\n Name – to allow invitation and risk letters,\n NHS Number – validation and linkage,\n Date of birth – sample validation,\n Date of death – sample validation and analysis,\n Full Address and postcode – send invitation and risk letters,\n GP Name and address – to enable outcomes to be shared,\n Breast Screening number – to enable outcomes to be shared."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-13"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in March 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised.  \n\nSpecific Conditions of Support\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 09 July 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Manchester University NHS Foundation Trust, V14.1, 2017/18, confirmed satisfactory by NHS Digital email on 14 June 2018)."]

{"sheet":"A02278","index":321,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02278"]
["Reference","18/CAG/0071"]
["Other Refs","IRAS project ID: 216324, REC reference: 18/YH/0058"]
["Application Title","Avoiding Cardiac Toxicity in lung cancer patients treated with curative-intent radiotherapy to improve survival"]
["Application Summary","This application from Leeds Teaching Hospitals NHS Foundation Trust set out the purpose of medical research which aims to understand the link between the dose of radiotherapy treatment given treat patients with lung cancer and potential damage caused to surrounding organs, including the heart, which is caused by the radiation therapy. The proposed trial will use retrospectively collected radiotherapy data from the Leeds Teaching Hospitals NHS Foundation Trust and the Christie NHS Trust, in Manchester, to investigate this.\n\nThe overall project comprises of seven work packages, of which this application concerns work packages one and two. The hypothesis of this study is that by sparing radiation sensitive cardiac sub-structures, survival in lung cancer patients after radiotherapy can be improved by at least 10% at one year. The applicants explain that the two work packages included in this application are not designed to answer this question, but will contribute to a body of evidence linking radiation heart dose and survival of lung cancer patients.\n\nPatients will be identified from electronic radiotherapy records held at each institution by members of the clinical care team. Confidential patient information will be disclosed to Public Health England in order to linkage with the National Cancer Registration and Analysis (NCRAS) dataset."]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Foundation"]
["Contact Name","Dr Kevin Franks"]
["Address","St James's University Hospital"]
[null,"Bexley Wing, Beckett Street "]
[null,"Leeds"]
["Postcode","LS9 7TF"]
["Telephone","0113 206 7854"]
["Email","kevin.franks@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who received curative intent radiotherapy in the Leeds Teaching Hospitals NHS Foundation Trust and the Christie NHS Trust for lung cancer, between 01/01/2010 and 30/12/2016. There is a proposed sample of 2,050 patients."]
["Description of confidential patient information used","The following items of confidential patient information will be used for the purposes described:\n NHS Number – linkage,\n Date of birth – linkage and analysis (used to calculate age at diagnosis),\n Sex – linkage,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-07-13"]
["Next Review Date","2024-07-13"]
["Notes","21 November 2023 - change in data processors from NHS Digital (previously Public Health England) to NHS England, regarding data source National Cancer Registration and Analysis Service (NCRAS).\n\n19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS)\n\n01 March 2021 – Amendment supported\nAmendment supported to extend the end date of support to 20 November 2021.\n\nSpecific Conditions of Support (Final)\n1. An interim report on the findings from the planned patient and public involvement and engagement activities should be provided by the end of September 2018 for consideration. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary. (Condition Met 25/10/2018)\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 16 March 2018).\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Public Health England (X25) satisfactory reviewed grade on Version 14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02279"]
["Reference","18/CAG/0090"]
["Other Refs","IRAS project ID: 237697, REC reference: 18/WA/0157"]
["Application Title","What changes in Medium Secure Care? A long term follow up study of outcomes, care, supervision and patients' experiences."]
["Application Summary","This application from Abertawe Bro Morgannwg Health Board set out the purpose of medical research which aims to identify how Medium Secure Services in Wales have changed over the last twenty years in relation to thresholds for clinical decision making, care pathways, patient experiences, and outcomes. The aim is to help inform future practice and improve patient experiences and outcomes.\nArchived healthcare records of individuals admitted to and discharged from medium security in Wales in the last twenty years will be examined in terms of collecting data linked to care pathways, clinical decision making, and clinical profiles of patients. From this data, individuals discharged to less secure or community placements, who have available follow up records, will be followed up to collect forensic, clinical and social outcome data. The research also include a second element in which a subset of discharged individuals still in contact with mental health services, and their carers will be invited to participate in a semi-structured interview regarding their experiences and perspectives of secure mental health care, and their quality of life subsequent to medium secure care. This activity will be consented and is out of scope for CAG consideration."]
["Applicant Organisation Name","Abertawe Bro Morgannwg Health Board"]
["Contact Name","Dr Ruth Bagshaw"]
["Address","Abertawe Bro Morgannwg University Health Board"]
[null,"Caswell Clinic,"]
[null,"Glanrhyd Hospital, Tondu Road, Bridgend"]
["Postcode","CF31 4LN"]
["Telephone"]
["Email","Ruth.Bagshaw@wales.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort\n All adult patients were admitted and discharged from a Welsh Medium Secure Unit over the last 20 years.\n It is estimated that there would be 300 patients included within the study.\n Deceased patients would be included if their death had occurred within the last 10 years."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set out:\n Name – linkage and sample verification,\n NHS number – linkage,\n Date of birth – linkage,\n Date of death – sample validation,\n Local Health Board identifier – linkage,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-13"]
["Next Review Date","N/A"]
["Notes","23 July 2021 - Support expired\nApplicant confirmed on 23 July 2021 that support no longer required. \n\n1. Please may you confirm the reason that support is no longer required \nAll documents containing patient identifiable information destroyed.\n\n2. Please may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency.\nDocument provided detailing the research results of the study, which include;\n• Greater awareness of those at risk of readmission and recall based on risk \n• Validating measures to more appropriately move patients across the forensic pathway based on risk and recovery; helping reduce bias and promote public protection.\n\n20 January 2020 – Amendment supported  to revise the data flows, so that anonymised data is extracted to computers at Cardiff Metropolitan University rather than Abertawe Bro Morgannwg, so that the data can be analysed using SPSS software\n\nSpecific Conditions of Support (Final)\n1. Provide confirmation at the time of first annual review that the study information was displayed on the Health and Care Research Wales website.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 12 July 2018).\n3. Security assurance arrangements (Confirmed – NWIS SLSGA received 01 June 2018)."]

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[]
[]
["Application Number","02280"]
["Reference","18/CAG/0084"]
["Other Refs","IRAS project ID: 227587, REC reference: 18/SC/0201"]
["Application Title","Household transmission of Cryptosporidium in NW England and Wales, 2018-19: Risk factors and likely mechanisms for secondary spread."]
["Application Summary","This application from the University of Liverpool set out the purpose of medical research which aims to estimate the secondary spread of Cryptosporidium, which is a major contributor to human diarrhoeal illness and infection with this parasite causing over 4,000 cases of diagnosed illness in England and Wales each year, that happens in the home and identify asymptomatic infection, which might have a role in transmitting disease. In addition, risk factors and characteristics associated with secondary spread will be described, including any differences in transmission between species.\nThe study will identify 400 cases from NW England and Wales over the course of 2018-19, and invite them and their household to take part. Each case will complete a questionnaire and each household member will provide a stool sample. Data will be analysed to show factors associated with spread and stool samples will be genetically characterised to accurately describe patterns of transmission.\nCryptosporidium is laboratory reportable when confirmed, and cases can only be identified via surveillance. In order to identify patients/households to be invited to participate in the study, surveillance databases will be trawled by staff based at Public Health England and Public Health Wales. Staff will not have access to any wider information that they would do as part of their standard role; however, as the data will be used for a wider purpose (research), support under the Regulations is required to support this change in purpose.\nFor invited potential participants who do not raise an objection to the use of their data within the two weeks from invitation, confidential patient information will be passed from PHE/PHW to research nurses based at the NIHR Clinical Research Network North West Coast, in order to facilitate the invitation/recruitment process. The applying research team will not have access to any confidential patient information until consent has been provided by the patient.\nA recommendation for class 2, 3 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Dr Rob Christley"]
["Address","Inst. Vet Science,"]
[null,"University of Liverpool"]
[null,"Leahurst Campus"]
["Postcode","CH64 7TE"]
["Telephone"]
["Email","robc@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort\n The study population is residents of North West England and Wales, 2018-19.\n Any laboratory confirmed case of Cryptosporidium isolated from one of the laboratories in NW England or Wales is eligible for initial inclusion as an index case.\n Study data will be collected for one year.\n The applicants are aiming to collect 400 index cases and their households with an approximate overall sample size of 1,000."]
["Description of confidential patient information used","The following items of confidential patient information are required to facilitate the invitation process:\n Name,\n Full address and postcode,\n Date of birth – required to enable correspondence to be appropriately addressed to patient or parent/guardian,\n Telephone number – to facilitate the recruitment contact."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-20"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in 2020 that support can be expired -The requirement for support from CAG is no longer needed as applicants are closed to recruitment. All electronic data have been pseudonymised and this also only includes consenting participants. All original information initially pertaining to anyone selected prior to consent has been deleted/discarded. \n\nIn terms of public benefit, the analytical study work demonstrated that additional cases of Cryptosporidium occur in over a quarter of homes with a case. This is likely to affect up to a third of people in the home and cause considerable burden of illness. This was especially common where the index is a young child, with mums and other siblings most at risk of secondary infection. The work supports recognition of this pathogen as burdensome and of considerable significance in immunocompetent individuals, and further work proposed includes designing methods which can identify true secondary transmission with increased accuracy. \n\nSpecific Conditions of Support (Final)\n1. The invitation letter for the project should be revised to include detail of who a patient can contact in the event that they have received the study invitation prior to receiving confirmation of their Cryptosporidium diagnosis. The revised document should be provided within three months of receipt of this letter.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 20 July 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission for organisations processing data in England and NHS Wales Informatics Service CPIP Assurance for organisations processing in Wales (Confirmed – SLSGA from NWIS dated 31/05/2018, NHS England, V14.1, 2017/18 IG Toolkit reviewed satisfactory grade confirmed via website, Royal Liverpool and Broadgreen University Hospitals NHS Trust, V14.1, 2017/18 IG Toolkit reviewed satisfactory grade confirmed via email dated 06 July 2018)."]

{"sheet":"A02281","index":324,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02281"]
["Reference","18/CAG/0113"]
["Other Refs","IRAS project ID: 237585, REC reference: 18/LO/0972"]
["Application Title","British Paediatric Surveillance Study of Food Protein Induced Enterocolitis Syndrome (FPIES) presenting to Paediatricians in the UK and Republic of Ireland"]
["Application Summary","This application from University Hospitals of Leicester NHS Trust set out the purpose of medical research using the established British Paediatric Surveillance Unit (BPSU) methodology to investigate Food Protein Induced Enterocolitis Syndrome (FPIES), a delayed type of food allergy in infants, which leads to repeated vomiting and other gut symptoms several hours after a trigger food (or baby formula) is eaten. It can lead to rapid dehydration and shock.\nThe study will operate via the approved BPSU methodology: the BPSU ‘orange card’ reporting system, which is approved in principle by the CAG. All UK and Ireland paediatricians participate the compulsory reporting system over a 13 month period, where they are asked to return a card to BPSU stating whether or not they have observed a case of the disease under observation (in this case FPIES). BPSU then provides details of clinicians who have reported a case of the disease to the research team, who send a questionnaire for the clinician to fill in.\nThe applicants are also seeking to supplement reporting by the BPSU orange card methodology by contacting regional children’s allergy centres to encourage reporting at centres where several new cases of FPIES may be seen each month. These centres will act as sentinel sites and will be contacted at 3, 6 and at 13 months at the end of prospective surveillance to ensure completeness of reporting. Sentinel sites will be self-selecting. The applicants intend to recruit these sites by emailing the Paediatric Allergy Group membership of the British Society of Allergy and Clinical Immunology at the start of the BPSU study asking for expressions of interest to act as sentinel sites. In addition sentinel sites will also be sites where co-investigators work."]
["Applicant Organisation Name","University Hospitals of Leicester NHS Trust"]
["Contact Name","Dr Gary Hylton Stiefel"]
["Address","University Hospitals of Leicester NHS Trust"]
[null,"Respiratory Office, Ward 28, Level 4 Windsor Building"]
[null,"Leicester Royal Infirmary, Infirmary Square"]
["Postcode","LE1 5WW"]
["Telephone"]
["Email","gary.ghs.stiefel@uhl-tr.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," All children aged up to two years at the time of initial Food Protein Induced Enterocolitis Syndrome (FPIES) reaction, where there was a history of vomiting within four hours of eating where removal of this food resulted in resolution of symptoms.\n It is estimated that 300 patients would be identified over the 13 month reporting period."]
["Description of confidential patient information used"," NHS Number – sample validation/remove duplicates,\n Date of birth – sample validation/remove duplicates and to calculate age at presentation for analysis,\n Postcode (District Level) – sample validation/remove duplicates and to calculate distance travelled to secure diagnosis/deprivation scoring for analysis,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-20"]
["Next Review Date","N/A"]
["Notes","18 January 2022 - Support Expired:\nThe study has been completed and the work has been published. Please find enclosed the paper. All patient identifiable information on the questionnaires has been removed. The databases for analysis of the data has no patient identifiable information except a study number. We only have a master spreadsheet (and earlier versions saved) which has a study number and the patient identifiable information including NHS number, date of birth , sex and first 4 digits of post code. This is password protected and only accessible by researchers in the children’s hospital.\n\nPublic benefits:\n1. The research has been published in the Journal Archives of disease in childhood and article attached. This will raise awareness about FPIES to paediatricians around the country in a bet to improve diagnosis and management.\n2. The finding of the research has been presented in National meeting including BSACI annual conference (2020, 2021), Allergy UK charity Masterclasses (2021 x 2) as well as regional allergy meetings in Northwest and Wessex. It has been presented at the BPAIIG meeting to clinicians. Therefore clinicians in primary care, secondary care and tertiary care have been reached out to.\n3. The results have been shared with the charities Allergy UK and FPIES UK. We intend on doing further work with the charities to help patients with FPIES.\n4. We have worked with the BDA to help inform the and guide dietary management of FPIES amongst dietitians.\n\nAll of these activities have been aimed at improving awareness of FPIES and thus hopefully helping recognition and diagnosis of this rare condition. This would enable appropriate management and dietary management to be instigated.\n\n\n27/03/2019: amendment supported to allow the return of completed BPSU questionnaires, containing specified items of confidential patient information, by electronic transmission. Minor changes to patient-facing documents accepted.\nSpecific Conditions of Support (Final)\n1. Support extends to England and Wales only.\n2. Favourable opinion from a Research Ethics Committee (Confirmed 20/06/2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University Hospitals of Leicester NHS Trust shows a reviewed satisfactory grade on Version 14.1, 2017/18)."]

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[]
[]
["Application Number","A02282"]
["Reference","18/CAG/0066"]
["Other Refs","IRAS project ID: 203822, REC reference: 18/YH/0135"]
["Application Title","United Kingdom Childhood Cancer Study"]
["Application Summary","This application from the University of York set out the purpose of medical research to undertake follow-up of patients who were previously enrolled in the UK Childhood Cancer Study (UKCCS), which recruited childhood cancer patients and matched controls between 1991 and 1996. The UKCCS was established with the primary aim of investigating the potential causes of cancer diagnosed before 15 years of age, in England, Scotland and Wales.\nThe UKCCS has a case-control design: each child diagnosed with cancer (n=4430) during the study period (1991-1996) was matched on sex, date of birth (month and year), and area of residence (Family Health Service Authority in England & Wales, and Health Board in Scotland) to two children of the same age who did not have cancer.\nThe proposed study aims to continue the longitudinal follow-up of the established cohorts via linkage with hospital episode statistics, cancer registrations and mortality information, to be undertaken by both NHS Digital and NWIS.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","University of York"]
["Contact Name","Professor Eve Roman"]
["Address","Epidemiology and Cancer Statistics Group"]
[null,"Department of Health Sciences"]
[null,"University of York"]
["Postcode","YO10 5DD"]
["Telephone"]
["Email","eve.roman@york.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","English and Welsh patients previously enrolled within the UK Childhood Cancer Study (UKCCS). The cohort comprised of 4,430 cases of childhood cancer and 9,758 matched controls. It is estimated that 3934 cases and 8641 controls were resident in England and Wales."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as described:\n NHS number (Old-Style only) – linkage,\n Date of birth – linkage/validation and analysis,\n Gender – linkage/validation and analysis.\n Date of death – analysis,\n Cause of death – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-07-24"]
["Next Review Date","2024-07-24"]
["Notes","Specific Conditions of Support (Final)\n1. Support extends to England and Wales only.\n2. Support is extended to the complete cohort of patients and controls recruited to the UKCCS within England and Wales.\n3. Patient and Public Involvement and Engagement activity – work in this area should proceed as per the overview provided within the application.\na. An overview the activity undertaken together with any feedback from patients should be provided at the time of annual review,\nb. The patient notification materials and communications strategy should be discussed as part of this work to see if further improvements can be made and revised documentation provided for consideration,\nc. The dissemination of research findings should be discussed in order to improve the mechanism to share results,\nd. If the responses given were negative, the CAG would take this into account when considering whether support should continue, or whether further actions are necessary.\n4. Favourable opinion from a Research Ethics Committee (Confirmed – 27 April 2018).\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University of York, Department of Health Sciences Version 14.1, 2017/18, confirmed satisfactory by NHS Digital email on 13/06/18 and NHS Digital).\n6. Confirmation from the Head of Information Governance at NHS Wales Informatics Services of suitable security arrangements in respect of Welsh data processing via Caldicott Principles into Practice Assurance Report (Confirmed – 23 July 2018)."]

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[]
[]
["Application Number","02283"]
["Reference","18/CAG/0085"]
["Other Refs","IRAS project ID: 243673, REC reference: 18/NW/0399"]
["Application Title","Investigating the use of ‘frailty’ on death certificates and admission information- a retrospective case note analysis"]
["Application Summary","This application from Sheffield Hallam University set out the purpose of medical research which is a preliminary study to investigate the use of the term 'frailty' and whether the use in case records is consistent with the use on death certificates. Frailty is a significant factor in the morbidity and mortality of older people. Frailty has been defined as \"…a distinctive health state related to the ageing process in which multiple body systems gradually lose their in-built reserves\" (BGS, 2014a) and is a recognised syndrome in the UK. Increasing numbers of older people are admitted to hospital with acute problems and are either admitted with frailty or become frail after admission. Frailty affects clinical outcomes and may be a cause of death but is not an inevitable consequence of ageing. This leads to questions of how frailty might be detected and prevented in an inpatient population.\nThe project will involve a retrospective case note review of patient records at Sheffield Teaching Hospitals NHS Foundation Trust. The Bereavement Services Manager will identify the patient cohort for inclusion from the hospital database of recorded deaths – this initial identification is out of scope for the CAG application, as the individual has legitimate access to this information. Patient names and hospital numbers will be used to request patient records in order to capture wider clinical information. Support is sought under the Regulations to support the disclosure of this information to the applicant and legitimise access to the patient cohort medical records in order to extract the pseudonymised dataset required for analysis."]
["Applicant Organisation Name","Sheffield Hallam University"]
["Contact Name","Dr Margaret M. Dunham"]
["Address","Sheffield Hallam University, College House,"]
[null,"Collegiate Campus, Collegiate Crescent"]
[null,"Sheffield, South Yorkshire"]
["Postcode","S10 2BP"]
["Telephone"]
["Email","m.dunham@shu.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who died within Sheffield Teaching Hospitals NHS Foundation Trust during the six month period between the beginning of January 2017 and the end of June 2017, who had the term frail/frailty or associated synonyms recorded on their death certificate. The sample size is estimated to include 301 patients."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes identified:\n Name – validation and identification of cohort,\n Hospital number– validation and identification of cohort,\n Date of birth – to note age at event for analysis,\n Date of death – sample validation (ensure death occurred within study inclusion period),\n Postcode (District Level) – analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-07-30"]
["Next Review Date","N/A"]
["Notes","14 January 2022 - Support expired\nNo identifying data related to any of the deceased’s records has been retained. Time and lack of funding prevented this from progressing to a larger study, a sample of 20 patients notes were viewed electronically on site at the hospital and no patient identifiers (DOB, DOD or location) were retained.\n\nThe aim of the research project was to investigate the practices of identifying, assessing and managing frailty in the older patient population through the prevalence and use of the term ‘frailty' on death certificates and associated admission/case notes. The study findings were presented at the RCN International Research conference 2019, other national UK research meetings in 2019 and also presented locally at the Sheffield Teaching Hospital’s annual research meeting. The findings of this study were shared to inform good practice in geriatric assessment and raise the concern of accuracy and consistency in recording cause of death. \n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 11 June 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Sheffield Teaching Hospitals NHS Foundation Trust shows a satisfactory reviewed grade on V14.1, 2017/18)."]

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[]
[]
["Application Number","02284"]
["Reference","18/CAG/0094"]
["Other Refs","IARS: 201429, REC: 16/YH/0406"]
["Application Title","The ACUTE (Ambulance CPAP: Use, Treatment Effect and Economics) feasibility study: A pilot randomised controlled trial of prehospital CPAP for acute respiratory failure"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research which aims to assess whether it is possible and worthwhile to undertake a full-scale study comparing continuous positive airways pressure (CPAP) delivered by paramedics to standard oxygen treatment for acute respiratory failure, and if so, how this trial should be carried out. The trial will also determine whether there are sufficient patients presenting with acute respiratory failure to make a large scale trial investigating the effectiveness of CPAP feasible. Evidence will also be collected to demonstrate that it is possible to randomise patients, collect data and follow up patients with acute respiratory failure in any future definitive trial.\nThe trial will be carried out within the West Midlands Ambulance Service. Paramedics will identify adults with acute respiratory failure when attending 999 emergency calls. The aim is to include 120 participants in the study – half will be randomly assigned to a group that will receive CPAP, while the other half will be treated with standard oxygen therapy. All the patients will then undergo normal hospital treatment and be followed up for a month to see if they survive. Patients will be recruited to the trial under emergency research procedures, whereby verbal consent will be sought from those patients with capacity to provide this. Patients who are assessed as without capacity to consent will be included within the trial without a verbal approach for consent. After arrival in hospital, research paramedics will approach patients, in order to seek informed consent for their continued involvement in the study. If the patient does not regain capacity, advice will be sought from a personal or nominated consultee around the patient’s ongoing participation in the trial.\nThe trial has already begun recruitment; however, it was found that some patients were not well enough to be approached for consent about the study and subsequently died before this approach could be made. The rationale for the submission to the CAG is that the applicants are seeking support to access confidential patient information for patients who were enrolled in the trial, but died in hospital prior to an approach being made around consent into the trial. The trial steering committee agreed that data in relation to this cohort of patients was important for the safety analysis of the study findings.\nNo confidential patient information will be recorded in relation to these patients; however, the research paramedics will require access patient’s medical records in order to extract relevant clinical information for analysis."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Gordon Fuller"]
["Address","Regent Court"]
[null,"2 Regent Street"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone"]
["Email","g.fuller@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort to be included in the trial is as follows:\n Adults aged over 18 years with acute respiratory distress, identified by paramedics responding to 999 calls.\n The sub-cohort of patients of relevance to the CAG application is those who were enrolled in the trial, but died in hospital, prior to being approached for informed consent for their participation"]
["Description of confidential patient information used","The research paramedic will have access to the full hospital record of the patient in order to extract the data relevant for analysis. The following items of confidential patient information are requested for the purposes of the identified:\n Name – to identify enrolled patients in hospital records systems,\n Date of death – recorded in days since admission – analysis\n Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-08-28"]
["Next Review Date","N/A"]
["Notes","18 January 2022 - Support Expired:\nAll original patient identifiers have been deleted/erased/removed. The remining data items are age, sex, date of illness, and clinical data such as vital signs. No personal, hospital, or ambulance service identifers remain.\n\nThe ACUTE study has been published in scientific journals and presented at research conferences. The findings of the study will inform future ambulance service management of patients iwth acute respiratory failure.\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – Favourable Ethical Opinion for Substantial Amendment 4, 20 August 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – V14.1, 2017/18 reviewed satisfactory grade by NHS Digital email on 09 August 2018 for the following organisations:\n University Hospital of North Midlands NHS Trust – RJE,\n Burton Hospitals NHS Foundation Trust – RJF,\n The Royal Wolverhampton NHS Trust - RL4,\n Heart Of England NHS Foundation Trust - RR1,\n East Cheshire NHS Trust – RJN,\n University Hospital Birmingham NHS Foundation Trust – RRK,\n Sandwell and West Birmingham Hospitals NHS Trust – RXK,\n University Hospitals Coventry And Warwickshire NHS Trust – RKB,\n George Eliot Hospitals NHS Trust – RLT.\n Derby Teaching Hospitals NHS Foundation Trust – RTG (Confirmed at initial review)."]

{"sheet":"A02285","index":328,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02285"]
["Reference","18/CAG/0014"]
["Other Refs","IRAS project ID: 225649, REC reference: 17/SC/0204"]
["Application Title","Mechanisms of Change in Psychological Therapy"]
["Application Summary","This application from Royal Holloway University of London sets out the purpose of medical research to examine the relationship between cognitive change and symptom change during psychological therapy for people with symptoms of depressive and anxiety disorders. It is expected that the study will find that a change in a client’s attitudes and beliefs will be associated with symptom change during psychological therapy, and that changes in cognition will occur before changes in symptoms. Data will be collected from clients receiving individual psychological therapy in City & Hackney Improving Access to Psychological Therapies (IAPT) service and the 'Let's Talk' IAPT service, Barnet, Enfield and Haringey Mental Health NHS Trust. Data from 200 participants will be required to examine the relationship between cognitive change and symptom change.\nThe project had originally been designed in such a manner that the IAPT therapists (direct care team) would identify potential participants; however, issues with recruitment were encountered which led to eligible patients not being invited to participate. The revised process proposes the main applicant review’s patient medical records to identify potential participants and provide details to the team administrators, to enable participant information materials to be passed to the patients when they attend for their appointment or posted to them with their assessment letter."]
["Applicant Organisation Name","Royal Holloway University of London"]
["Contact Name","Iona Symington"]
["Address","Department of Psychology, Royal Holloway University of London"]
[null,"Egham,"]
[null,"Surrey"]
["Postcode","TW20 0EX"]
["Telephone"]
["Email","Iona.Symington.2016@live.rhul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Male/Female patients over 18 years of age,\n Clients who are receiving individual psychological therapy from City and Hackney IAPT service and the 'Let's Talk' IAPT service, Barnet, Enfield and Haringey Mental Health NHS Trust and Whittington Hospital NHS Trust ,\n There will be 120 patients recruited to the study (33 have already been successfully recruited, 87 further participants are required). It is estimated that access to 380-400 patient records will be required in order to achieve this recruitment target."]
["Description of confidential patient information used","The applicant will need access to the full patient record in order to determine which patients are eligible for inclusion in the study. The following data items are required for the purposes as set out below:\n Patient Name – to allow invitation to participate to be provided,\n Therapist’s Name – to allow invitation to participate to be provided,\n Date of Appointment – to allow invitation to participate to be provided,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-08-28"]
["Next Review Date","N/A"]
["Notes","Confidential information was only used to identify potential candidates for participation in the study and was never recorded, only conveyed verbally to treating clinicians to alert them that their client was eligible for the study and to gain consent.\n\nThis procedure permitted recruitment to the study with minimal disruption to the clinician-client relationship and with minimal time required.\n\nSpecific Conditions of Support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – initial approval issued 20/04/2017, Change in Methodology 22/11/2017 and Change of Chief Investigator 01/06/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Barnet, Enfield and Haringey Mental Health NHS Trust and Homerton University Hospital NHS Foundation Trust, V14.1, 2017/18 by email 16 August 2018. Additional Site: Whittington Hospital NHS Trust – confirmed by email on 13 September 2018)."]

{"sheet":"A02286","index":329,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02286"]
["Reference","18/CAG/0102"]
["Other Refs","IRAS project ID: 232756, REC reference: 18/LO/0614"]
["Application Title","HES and NICOR data linkage for cardiac failure population analysis"]
["Application Summary","This application from Kings College London set out the purpose of medical research which aims to understand population-based, patient-level analysis of heart failure in England over a five-year period using a data set created by linking HES and NICOR (National Institute for Cardiovascular Research Outcomes) databases. Analyses will look into the re-occurrence of hospitalisation after the initial diagnosis of heart failure, the influence of population factors on risk of re-hospitalisation and the resultant cost implications.\nNHS Digital will be undertaking linkage between the NICOR (National Institute for Cardiovascular Outcomes Research) and HES databases and will provide a pseudonymised dataset to the applicant for analysis. The NICOR audit programme operates via support under the Regulations (application reference: 17/CAG/0071 (previously ECC1-06(d)/2011)."]
["Applicant Organisation Name","Kings College London"]
["Contact Name","Emily Kwong, Clinical Engineer"]
["Address","KiTEC-King’s Technology Evaluation Centre"]
[null,"School of Biomedical Engineering & Imaging Sciences, King’s College London"]
[null,"5th Floor, Becket House, 1 Lambeth Palace Road, London"]
["Postcode","SE1 7EU"]
["Telephone","020 7848 9526"]
["Email","emily.kwong@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," All patients aged over 18 years old with heart failure in England between 2011 and 2016.\n Estimated sample size: 81,393."]
["Description of confidential patient information used"," NHS Number – Linkage,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-08-29"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as the activity did not commence. \n\n30 May 2022 - Amendment supported:\nAmendment supported to extend the duration of ‘s251’ support until 10 May 2023.\n\n20 July 2020 - Amendment: The applicants sought support to clarify the data flows to be used in the study, confirming that there were no changes to the actual flows.\n\n06 January 2020 – Amendment supported to clarify the specific items of confidential patient information required to conduct the data linkage between HES and NICOR, to confirm the study cohort as patients diagnosed with heart failure between 2013/14 and 2017/18 and extend the duration of the study until 31 October 2020\n\nSpecific conditions of support (Final)\n1. Further patient and public involvement and engagement activity should be undertaken as the project progresses. It is recommended that this include consultation with a patient representative group. Feedback around the actual activity undertaken together with an overview of the findings is required at the time of first annual review. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. The patient notification text should be revised to make the language more accessible to lay reader. Feedback should be sought as part of the wider patient and public involvement and engagement activity. A copy of the revised text should be provided at the time of first annual review, together with an overview of the work which had been undertaken in its revision.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 19 April 2018).\nPage 5 of 8\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – NHS Digital undertaking data processing)."]

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[]
[]
["Application Number","A02287"]
["Reference","18/CAG/0091"]
["Other Refs","(Previously 17/CAG/0178), IRAS project ID: 239924, REC reference: 18/YH/0200"]
["Application Title","Connected Bradford Linked Education and Healthcare Research Database"]
["Application Summary","This application from the Bradford Teaching Hospitals NHS Foundation Trust set out the purpose of medical research which will establish a research database aiming to understand the relationship between child health issues and educational attainment levels within the Bradford and Airedale locality.\nThe sample to be included within the database will be all individuals within the Bradford and Airedale locality who were born between 01 January 1988 and 01 September 2014. It is proposed that routinely collected data from the following sources will be linked to create the research database:\n1. Primary Care data from all 88 GP practices across the Bradford and Airedale region,\n2. Secondary care inpatient, outpatient and emergency care data from Bradford Teaching Hospitals NHS Foundation Trust and Airedale NHS Foundation Trust,\n3. Community Care data from Bradford District Care Trust,\n4. School Education data from Bradford Council and North Yorkshire County Council who receive this information direct from the schools.\nData source four detailed above is out of remit for the CAG, as they do not fall within the definition of confidential patient information as defined in s251(11) of the NHS Act 2006.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Bradford Institute for Health Research - Bradford NHS Foundation Trust"]
["Contact Name","John Wright"]
["Address","Bradford Institute for Health Research - Bradford NHS Foundation Trust"]
[null,"Duckworth Lane"]
[null,"Bradford"]
["Postcode","BD9 6RJ"]
["Telephone"]
["Email","John.wright@bthft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients within the Bradford and Airedale region, born between 01 January 1988 and 01 September 2014. The sample size is estimated to be 220,000 patients."]
["Description of confidential patient information used","Confidential patient information will be provided by all healthcare providers participating in the study, in order to facilitate linkage across datasets. The following items of confidential patient information are requested the purposes described:\n Name – linkage\n NHS number - linkage,\n Date of birth – linkage,\n Address (First Line) – linkage,\n Postcode – linkage and analysis,\n Sex – linkage and analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-09-03"]
["Next Review Date","2024-09-03"]
["Notes","13 December 2021 - Amendment supported\nAmendment supported to allow the disclosure of confidential patient information from The Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) and Apollo, to University College London (UCL), as an additional data processor to support geospatial data linkage.\n\n16 April 2021 - Amendment supported\nThe amendment, to add new school entrants annually to the HERD database for a time period of five years, to receive annual updates from DfE for a period of five years, to receive monthly primary care updates for a period of five years, and to include Humber Teaching NHS Foundation Trust as an additional data processor, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions:\n1. Support is extended for a period of five years only rather than the requested ten year period. An extension to the amendment or a re-submission of the application will be required at that time.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold :\nConfirmed: The NHS Digital 19/20 DSPT review for Bradford Teaching Hospitals NHS Foundation Trust (Org Code: RAE) was confirmed as ‘Standards Met’ (by email to the CAG inbox on 16 April 2021). \n\nAs there are 5 or more organisations, security assurance has not be checked by the Confidentiality Advice Team (CAT) for all data processors. \nSupport is recommended on the basis that the applicant is responsible for seeking assurance that the appropriate security arrangements are in place. The applicant should ensure that 19/20 DSPTs for the following organisations have been reviewed as ‘standards met’ by NHS Digital;  \n• Bradford District Care Trust (Org Code: TAD)\n• Airedale NHS Trust (Org Code: RCF)\n• Apollo Medical Software Solutions Ltd. (Org Code: 8HH66) \n• Department for Education\n• City of Bradford Metropolitan District Council (Org Code: 209)\n• Humber Teaching NHS Foundation Trust (Org Code: RV9)\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 04 March 2021\n\n28 August 2020 - Specific conditions of support updated:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. All staff at City of Bradford Metropolitan District Council that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\n30 July 2020 - Amendment supported to extend the duration of support until 31 December 2021 and to update patient communication materials associated. \n\n16 December 2019 – Amendment supported to extend the patient cohort to include all patients with a date of birth up to 01/09/2016 and to extend the duration of support until  31/12/2020. The data flows and sources were also amendment in order to facilitate linkage to educational data held by the Department for Education.\n\nSpecific conditions of support (Final)\n1. All patient-facing materials should be reviewed to ensure that all references to linkage with the Department for Education’s National Pupil Database have been removed.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 03 August 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – published satisfactory reviewed grade on V14.1, 2017/18 for the following organisations:\n Bradford Teaching Hospitals NHS Foundation Trust (Org Code: RAE),\n Bradford District Care Trust (Org Code: TAD),\n Airedale NHS Trust (Org Code: RCF),\n City of Bradford Metropolitan District Council (Org Code: 209),\n Apollo Medical Software Solutions Ltd. (Org Code: 8HH66)."]

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[]
[]
["Application Number","A02288"]
["Reference","18/CAG/0052"]
["Other Refs","IRAS project ID: 223838, REC reference: 18/SW/0051"]
["Application Title","BPSU survey of severe Chronic Fatigue Syndrome/Myalgic Encephalopathy"]
["Application Summary","This application from the University of Bristol sets out the purpose of medical research focusing on children with Chronic Fatigue Syndrome or Myalgic Encephalitis (CFS/ME), who had persistent disabling fatigue for at least 3 months. The fatigue and symptoms are made worse by activity (post exertional malaise) and are not relived by rest. Children with CFS/ME have other symptoms including muscle aches, headaches, and poor concentration. Children with severe chronic fatigue syndrome or ME are only able to leave their house occasionally (if at all). They have severe fatigue and often severe pain and many require help with daily activities such as eating and washing. Currently, it is unknown how often children develop severe CFS/ME or what treatment they receive.\nThe proposed study will follow the agreed BPSU methodology, in order to receive reporting via the orange card system of every child with severe CFS/ME. A follow up one year later will be conducted to understand the progression of the illness.\nA recommendation for class 1, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Bristol and Royal United Hospitals Bath NHS Foundation Trust"]
["Contact Name","Esther Crawley"]
["Address","Centre for Child & Adolescent Health"]
[null,"Bristol Medical School"]
[null,"Oakfield House, Oakfield Grove, University of Bristol"]
["Postcode","BS8 2BN"]
["Telephone"]
["Email","Esther.Crawley@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from reporting clinicians in relation to identification of cases of Chronic Fatigue Syndrome in Children will be collated over a one year reporting period. It is estimated that around 33 cases will be identified in this duration."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes specified:\n NHS number – linkage,\n DOB month and year only – linkage and analysis,\n Gender – linkage and analysis,\n Ethnicity – analysis,\n Partial postcode – linkage."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-09-04"]
["Next Review Date"]
["Notes","Applicant confirmed in October 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised. \n\nIn terms of public benefit, the figures of incidence/prevalence will directly benefit the public because no prior prevalence for Severe ME/CFS was known, and provision of treatment for these patients is difficult.  This finding will inform decision-making towards service provision for this severely affected group of patients.  Service provision can include domiciliary visits and is hence expensive and an accurate sense of case numbers is of high value.\n\nPublication of further data is still ongoing and this will cover assessment, investigation and referral of the children and young people and their management. Accurately capturing and publishing this data is of high public value as it will permit the planning and resourcing of service provision in the future, which is important for this vulnerable and marginalised patient group.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. (Confirmed – issued 20/03/2018)\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University of Bristol, Bristol Medical School, Sever Paediatric CFS/ME Surveillance Study, shows a reviewed satisfactory grade of Version 14.1, 2017/18)."]

{"sheet":"A02289","index":332,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02289"]
["Reference","18/CAG/0111"]
["Other Refs","IRAS project ID: 233974, REC reference: 18/LO/1163"]
["Application Title","Detection Dementia from Retinal Morphology: a Big Data Machine Learning based Retrospective Case-Control Study"]
["Application Summary","This application from Moorfields Eye Hospital NHS Foundation Trust set out the purpose of medical research which aims to investigate if there is a link between changes in appearance of the retina, the light detecting structure at the back of the eye, and the onset of Alzheimer’s disease.\nMoorfields Eye Hospital holds a large database of ‘optical coherence tomography’ images (OCT images) of patients’ retinas. This application seeks to link this database with diagnostic information held by NHS Digital to enable the images of eyes of patients who developed dementia to those who have not. The primary research aim will be to identify on these scans of the patient’s retinas, the morphological features associated with a diagnosis of dementia. The secondary research aim will focus on how retinal morphology evolves with time.\nThe applicants will share confidential patient information, with a unique study ID, from records held at Moorfields Eye Hospital with NHS Digital to facilitate linkage with HES. Pseudonymised OCT images will be shared with the UCL Institute of Ophthamology. NHS Digital will also release pseudonymised HES information to UCL, to enable linkage with the OCT images for analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Moorfields Eye Hospital NHS Foundation Trust"]
["Contact Name","Mr Pearse Keane"]
["Address","Moorfields Eye Hospital"]
[null,"162 City Road"]
[null,"London"]
["Postcode","EC1V2PD"]
["Telephone"]
["Email","p.keane@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," All patients aged 40 years old and older who have had an OCT scan in the Moorfields Trust from 01/01/2008 to 01/06/2018.\n It is confirmed that there will be 257,450 patients included within the sample."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes set out:\n Study ID – for further linkage,\n NHS Number – linkage,\n Date of Birth – linkage,\n Sex – linkage and analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-09-13"]
["Next Review Date","2022-09-13"]
["Notes","Specific conditions of support (Final)\n1. Revise the text of the patient notification material in line with comments made by the CAG around the use of confidential patient information within the project. Revised documentation should be provided within two months of the date of this outcome letter.\n\n2. Feedback should be provided at the time of first annual review around the wider patient and public involvement and engagement activity which has been undertaken. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\nCAG confirmed condition met as part of 2021 Annual review\n\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 01 August 2018).\n\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – NHS Digital facilitating linkage)."]

{"sheet":"A02290","index":333,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02290"]
["Reference","18/CAG/0105"]
["Other Refs","IRAS project ID: 243183, REC reference: 18/WM/0211"]
["Application Title","The Incidence, Management and Early Outcome of Congenital Ichthyosis"]
["Application Summary","This application from the Birmingham Women’s And Children’s NHS Foundation Trust set out the purpose of medical research using the established British Paediatric Surveillance Unit (BPSU) methodology to investigate incidence of Ichthyosis, which is a group of incurable genetic conditions with abnormally thick, scaly skin. The most severe type of ARCI is harlequin ichthyosis (HI) where thick scales (plaques) encase the baby, causing problems with breathing, feeding, movement, eye closure and temperature control. Historically such babies died at birth or in the first month of life (neonatal period) but they can survive with modern treatments. Less extreme ARCI types present with a collodion membrane (CM), where the skin is tight but less rigid. Many of these improve with time, some even resolving completely within weeks.\nBabies with HI and CM are very rare. Staff in maternity units recognise them but need help from skin specialists to care for them. There is no proven correct treatment so practice varies; some babies remain in the neonatal intensive care unit for weeks whilst others are nursed within a more normal setting. Babies with CM may suffer from unnecessary medical interventions. Some health professionals express the view that babies with HI should be left to die, unaware that the condition is now treatable.\nThe BPSU methodology has received support in principle from the CAG.\nThrough the established BPSU orange card reporting system, paediatricians and neonatologists will report all new cases of harlequin ichthyosis and collodion membrane in their service in the UK and Ireland over a 25 month reporting period. Babies who die soon after birth may not be seen by a paediatrician so the applicants intend to liaise with other bodies to identify perinatal deaths. For each reported case, the reporting clinician will be asked to complete a research questionnaire. For babies still alive at 30 days, a follow-up questionnaire will be sent to be completed at 6 and 12 months.\nThe project extends to the UK and the Republic of Ireland; however, the CAG support would extend to England and Wales only. The applicant has been advised to seek alternative arrangements for data processing in the wider countries involved in data collection.\nThis application differs from standard BPSU projects as it has built in sample verification checks via linkage with a wider non-research programme which operates with support under the Regulations, as follows:\n NCARDRS – Public Health England’s National Congenital Anomaly and Rare Disease Registration Service (CAG 10-02(d)/2015), to identify stillborn babies that fall within the study cohort.\nIt is also stated that the main applicant’s will also undertake monthly verification checks by contacting reporting clinician’s to assess whether the reported cases meet certain diagnostic criteria. This activity does not require support under the Regulations as data would only be disclosed to the treating clinician.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Birmingham Women’s And Children’s NHS Foundation Trust"]
["Contact Name","Professor Celia Moss"]
["Address","Birmingham Women's and Children's NHS FT"]
[null,"Birmingham Children's Hospital, Steelhouse Lane"]
[null,"Birmingham"]
["Postcode","B4 6NH"]
["Telephone","07774858176"]
["Email","celia.moss@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," All babies born with harlequin ichthyosis (ICD10 Q80.4) or collodion membrane (ICD10 Q80.2) whose diagnosis evolves into Autosomal Recessive Congenital Ichthyosis (ARCI) across the two year reporting period.\n It is anticipated that there will be 64 cases reported across this period."]
["Description of confidential patient information used","The following items of confidential patient information will be supplied by the individual treating clinicians:\n NHS Number – validation,\n Hospital Number – validation and follow-up,\n Date of birth – validation,\n Date of death – analysis,\n Postcode (Sector Level) – analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-09-14"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and identifiers deleted.\n\nIn terms of public benefit, novel and useful findings arising from the unconsented use of identifiable patient data in this study were the birth incidence of collodion and harlequin ichthyosis, the good clinical condition and good prognosis of collodion baby, and the substantial proportion that resolve spontaneously.\n\n\n08 January 2021 - Annual Review Approved\n\nSpecific conditions of support (updated)\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Birmingham Women’s and Children’s NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Pending).\nConfirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed–Birmingham Women’s And Children’s NHS Foundation Trust shows a published satisfactory reviewed grade on V14.1, 2017/18)."]

{"sheet":"A02291","index":334,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02291"]
["Reference","18/CAG/0100"]
["Other Refs","IRAS project ID: 240684, REC reference: 18/SC/0243"]
["Application Title","HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which is a Clinical trial of an Investigational Medicine Product (CTIMP Study) which is assessing a new cholesterol lowering treatment, which if shown to be effective, could have a major impact on the number of people dying of vascular disease or suffering strokes or heart attacks in the UK. The application has been submitted to the CAG under the Precedent Set criteria one – participant identification studies, to enable a large sample of potentially eligible patients to be identified and invited to participate in the study. The UK sample size is estimated at 12,000 patients, which will be randomised on a 50/50 basis to receive the experimental drug versus placebo. The CAG is only required to consider participant identification and recruitment element of the study – after which, patients will provide informed consent for their involvement in the study.\nAcute Hospital Trusts and NHS Digital will undertake a search to identify potentially patients based on the inclusion criteria. This information will be shared with the Clinical Trial Service Unit at the University of Oxford to enable the establishment of a pre-screening database. List screening will be undertaken via NHS Digital prior to invitation letters being issued to potentially eligible patients.\nA recommendation for class 3 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Louise Bowman"]
["Address","Clinical Trial Service Unit, Richard Doll Building"]
[null,"Old Road Campus, Roosevelt Drive"]
[null,"Headington, Oxford"]
["Postcode","OX7 3LF"]
["Telephone"]
["Email","louise.bowman@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," All patients aged 55 years and over, with a history or evidence of cardiovascular disease through at least one of the following: myocardial infarction, ischaemic stroke or peripheral arterial disease (evident by lower extremity artery revascularisation or aortic aneurysm repair.\n It is estimated that 400,000 patients will be invited across England, Wales and Scotland in order to recruit the required patient cohort of 12,000 patients.\n Alternative arrangements are being made via the Public Benefit and Privacy Panel for the recruitment of Scottish patients."]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed by Acute Hospital Trusts and NHS Digital in relation to potentially eligible patients to the Clinical Trial Service Unit at the University of Oxford, for the purposes as set out below:\n Full name and title – to facilitate invitation,\n Full latest address and postcode – to facilitate invitation,\n Date of birth – to ensure eligibility and sample validation,\n NHS number – to facilitate invitation and sample validation,\n Hospital number – to facilitate invitation and sample validation,\n GP Registration – to facilitate invitation,\n Sex – sample validation,\n ICD-10 or other diagnostic or procedure codes – to ensure eligibility\n Fact of death – sample validation"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","13/09/2018"]
["Next Review Date","2024-09-13"]
["Notes","Amendment supported 01 February 2024 to remove Paragon Customer Communications as a data processor.\n\n15 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Civil Registration – Deaths, GP registration, demographic data, and NHS entry/exit information.\n\n04 May 2022 - Amendment supported\nAmendment supported to reduce the eligibility criteria to men aged 40 years and over and to reduce the point-of-care total cholesterol threshold required at screening to enter the run-in, and to revise the relevant patient facing materials accordingly.\n\n10 August 2021 - Amement supported to amend the wording of the notification materials regarding a second invitation letter to patients who do not respond to the first contact attempt\n\n28 September 2020 - Amendment supported to allow the sending of a second invitation letter to patients who did not respond to the first contact attempt. \n\n25/03/2019: Amendment supported to add Paragon Customer Communications Ltd an additional processor, to facilitate the patient invitation process.\nSpecific conditions of support (Final)\n1. Support extends to England and Wales only – alternative arrangements should be made via the Public Benefit and Privacy Panel for the recruitment process within Scotland.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 31 May 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University of Oxford – Medical Sciences Division – Nuffield Department of Population Health – Clinical Trial Service Unit, Version 14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02292","index":335,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02292"]
["Reference","18/CAG/0124"]
["Other Refs","IRAS project ID: 231039, REC reference: 18/WA/0222"]
["Application Title","Automated Cancer Diagnosis and Prognosis Using Digital Images"]
["Application Summary","This application from the University of Leeds set out the medical purpose of medical research which aims to validate a machine learning algorithm (a computer-based processing system) which has been developed to identify a range of cancers without human input. The algorithm extracts morphological features from images which is uses to achieve a diagnosis.\nThe aim of the project is collect a large database of images which will be used to refine and validate the developed algorithm so it can be used to diagnose a wider range of cancers of the breast, skin, digestive system, liver, female reproductive tract, lung, urinary tract and hormonal system. This will involve scanning 12,000 cases of both malignant and benign diagnoses from records held at the Leeds Teaching Hospitals NHS Trust. The scanned images will be linked with clinical and demographic patient information. The resulting database will be anonymised prior to release to the University of Leeds for analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Nicolas Orsi"]
["Address","Women's Health Research Group, Leeds Institute of Cancer & Pathology"]
[null," Wellcome Trust, Brenner Building"]
[null,"St James's University Hospital, Beckett Street, Leeds"]
["Postcode","LS9 7TF"]
["Telephone"]
["Email","n.m.orsi@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Patients aged between 18 and 115 years, who were diagnosed with cancer on biopsy or resection specimens at Leeds Teaching Hospitals NHS Trust, where there is archival tissue that has been sectioned and H&E stained.\n Both malignant and benign cases will be included.\n Patients will be excluded if samples are still in use for current diagnosis or prior case review.\n 12,000 patients will be included in the sample."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes specified:\n NHS Number – linkage and validation,\n Date of birth – to calculate age for analysis,\n Date of death – to calculate survival time,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-09-24"]
["Next Review Date","2024-09-24"]
["Notes","08 April 2022 - Amendment supported\nAmendment supported to allow access and collection of confidential patient information from; The Mid Yorkshire Hospitals NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Hull University Teaching Hospitals, Airedale NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, Harrogate and District NHS Foundation Trust and York and Scarborough Teaching Hospitals, to increase the number of total cases from 12,000 to 80,000, and to add Panakeia Technologies Limited as an additional collaborator and funder to the study.\n\n10 February 2022 - Further condition applied for next annual review due 24th September 2022:\n1. Further evidence of additional Patient and public involvement is required at the next annual review with feedback surrounding how the study results can be disseminated to patients and the public. It would be useful for the applicant to record key details, such as numbers involved and their characteristics. Condition met 11 September 2023\n\nSpecific conditions of support\n1. Further activity should be undertaken with the Leeds Patient and Public Involvement Group to seek views around how the study results can be disseminated to patients and the public. Feedback is required at the time of the first annual review around the activity which has been undertaken in this area together with an overview of the feedback which was provided.\nCondition met as part of annual review February 2022.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 30 August 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission \n(Confirmed – Leeds Teaching Hospitals NHS Trust shows a reviewed satisfactory grade on Version 14.1, 2017/18)."]

{"sheet":"A02293","index":336,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02293"]
["Reference","17/CAG/0051"]
["Other Refs","IRAS project ID: 212148, REC reference: 17/LO/0556"]
["Application Title","Head or Heart Database"]
["Application Summary","This application from University College London defined a research application which aimed to demonstrate the research potential of unconsented linkage between “dormant” (historical) trial data and administrative records for understanding long-term intervention effects. Through doing this, the applicants aim to evaluate the long-term safety and effects of giving nutritional supplementation in infancy on cognitive development. Data linkage is requested with HES (facilitated by NHS Digital) and the National Public Database (facilitated by the Fisher Family Trust), with initial referral to the NHS Patient Demographics service to complete the historic trial datasets with NHS numbers and addresses during school years to allow linkage with HES/NPD.\nThe cohort will be established from a unique series of eleven infant feeding trials with over 4,000 participants recruited between 1982 and 2001. The studies, which measured cognitive function at various points of follow up, struggled with low-response rates in later years, with retention as low as 12% by the age of 15 years., using conventional follow-up methods, it remains unclear whether the expected cognitive benefits sustain into adolescence and adulthood. Importantly, follow-up studies have also suggested that such interventions carry risks. As an example, in preterm infants nutrient-enriched diets that promote early growth were found to be associated with worse plasma lipid profiles and higher blood pressure in adolescence. The applicants explained that only a long-term follow-up of trial participants could address the unexamined balance between cognitive benefits and suggested potential metabolic harms.\nThe applicants advise that the historical trials did not seek consent for linkage with administrative data. Due to the limited quality and availability of administrative records, linkage to administrative data was not an option that was available to the investigators at the time of recruitment to those trials (between 1982 and 2001).\nA recommendation for class 2, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Ruth E. Gilbert"]
["Address","UCL Professor of Cinical Epidemiology & Deputy Director the Administrative Data Research"]
[null,"Centre for England (ADRC-E), University College London"]
[null,"30 Guilford Street, London"]
["Postcode","WC1N 1EH"]
["Telephone"]
["Email","r.gilbert@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The historic trials have a combined cohort of over 4,000 patients which will form the sample for study in this project."]
["Description of confidential patient information used","The following items of confidential patient information were requested:\n Name – linkage,\n NHS Number – linkage (only small number available),\n Date of birth – linkage and analysis,\n Date of death – analysis only\n Unit level postcode – linkage and deprivation score calculation,\n Gender – analysis,\n Ethnicity – analysis,\n Historical address details – linkage only."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-10-12"]
["Next Review Date","N/A"]
["Notes","The applicant confirmed in July 2022 that ‘s251’ support is no longer required as all confidential patient information is now pseudonymised. \n\nAmendment Request (Approved 12/10/2018)\n\n\nAn amendment was submitted for consideration alongside the response to the provisionally supported outcome, due to a required change to the data processor undertaking linkage with educational data. The amendment described the following two changes:\n1. Inclusion of the Fisher Family Trust (FFT) as a processor for linkage with education data,\n2. Change to the data flows proposed for the project, to remove the requirement for confidential patient information to flow between NHS Digital and the educational data processor (now proposed as FFT).\n\nSpecific conditions of support (Final)\n1. Provide confirmation at the time of first annual review that the pseudonymisation linkage file and analysis datasets are being held in separate locations.\n2. Patient and Public Involvement and Engagement –\na. Undertake additional patient and public involvement and engagement as the project progresses,\nb. Seek input around how the patient notifications and dissenting mechanism can be improved,\nc. Provide a report on actual and planned activity at first annual review.\n3. Patent Notifications and Dissent –\na. Improve and broaden the patient notification and dissent mechanisms as the project progresses,\nb. Provide a report, together with any notification materials developed, at first annual review on actual and planned activity at first annual.\n4. Favourable opinion from a Research Ethics Committee. (Confirmed – London City & East REC issued favourable opinion on 22 April 2017. Substantial amendment confirmed 23 March 2018).\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - UCL School of Life and Medical Sciences-Data Safe Haven, Version 14.1, 2017-18 published satisfactory reviewed grade, The Fisher Family Trust, confirmed standards met on the DSPT – equivalent to satisfactory rating on IGTK – by email 13/09/2018)."]

{"sheet":"A02294","index":337,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number",2294]
["Reference","18/CAG/0126"]
["Other Refs","IRAS project ID: 215818, REC reference: 18/YH/0234, previously under CAG reference 17/CAG/0024"]
["Application Title","Connected Health Cities: Data linkage of urgent care data"]
["Application Summary","This application from University of Sheffield was provided as part of an amendment submission to the previously supported 17/CAG/0024. The initial project was conditionally supported on 19 April 2017 on the basis of a specific-project only, which collected routine NHS data from a number of providers of emergency and urgent care (EUC) in the Yorkshire and Humber region and linked the data to provide a coherent picture of EUC demand for an initial period of 60 months (2011 - 2015). A subsequent amendment was supported on 07 August 2017 which extended the data collection duration to include records up to the end of 2017. The scope of support was also extended at this time to include data from mental health records held by Sheffield Health and Social Care NHS Foundation Trust.\nAmendment – Change to Project Classification\nThe revised application submission requested a change to the project classification, from a specific-project only to a research database. The database would comprise of the information which had been collated with support under the Regulations for the specific project under reference 17/CAG/0024."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Dr Rosie Gough, Project Manager "]
["Address"," Centre for Urgent and Emergency Care Research (CURE)"]
[null,"School of Health and Related Research (ScHARR)"]
[null,"30 Regent Street, Sheffield"]
["Postcode"]
["Telephone",7543041493]
["Email"," r.e.gough@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The specific identifiers are listed below. In particular, data on individual patient episodes will be collected from participating services. Participants will be anyone who uses the Yorkshire Ambulance Service (YAS)/ NHS111, access out of hours (OOH) services and/ or emergency departments (EDs) during the 60-month period of the study, between 2011 and 2015."]
["Description of confidential patient information used","Identifiers required for validation/linkage:\n Name,\n NHS Number,\n Data of birth,\n Date of death,\n Address,\n Postcode (unit level) for deprivation scoring.\nIdentifiers to be retained for analysis:\n Gender,\n Ethnicity.\n\nRoutine data obtained from YAS/ NHS111, OOH services and acute trusts (with 24-hour consultant led EDs) within Yorkshire and Humber, who are served by YAS, will be collected. A 60-month period of data collection will take place, to include the most recent service data available. Data will be collected from routine electronic data sources i.e Ambulance Service Computer Aided Dispatch (CAD) Data and OOH/ED/inpatient Patient Administration Systems.\n\n1. From YAS (999 and NHS 111 call data) items will cover:\n caller name, address/postcode, date of birth, age, gender and NHS number)\n All data associated with the patient episode of care, for example clinical /call characteristics (incident number, type of call, type of response), presenting complaint, incident details (location of incident, date/all times relating to the incident, mode of access, disposal/discharge, disposal status (alive/dead).\n\n2. From the OOH/ED/inpatient Patient Administration system items will cover:\n Patient identifiable details (patient name, address/postcode, date of birth, gender and NHS Number)\n All data associated with the patient episode of care, for example date/times relating to the incident, incident number, mode of access, presenting complaint, investigations, treatments, disposal/discharge, diagnoses and disposal status (alive /dead).\n\nA proportion of YAS (999 and NHS 111) calls and OOH attendances during the study period will be transported/ referred to participating EDs. A process of data linkage of those pre-hospital emergency and acute care episodes conveyed to the ED will take place, in order to understand and detail the full pathway of care undergone by these patients. In these instances, YAS CAD data and OOH data will be linked with the ED data of participating EDs.\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-10-25"]
["Next Review Date","2024-04-19"]
["Notes","Amendment supported 25 May 2023 to extend the duration of support until 30 December 2025\n\nAmendment supported 20 December 2022 to extend the duration of support until 25 June 2023\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January 2022 to extend the duration of support until 31 December 2022.\n\n19 October 2020 – Amendment supported\nThe amendment, to extend the duration of support until 31 December 2021 and to allow confidential patient information, relating to patients with Functional Neurological Disorder, to be disclosed from Sheffield Teaching Hospitals NHS Foundation Trust to the CUREd database research team, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support (Final)\n1. All pre-existing conditions of support related to 17/CAG/0024 remain applicable.\n2. The pre-existing annual review cycle remains applicable, with the next annual review to be received four weeks before 19/04/2019, and then on an annual basis to this schedule.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 26 June 2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University of Sheffield – School of Health and Related Research, V14.1, 2017/18 – reviewed satisfactory grade)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02295","index":338,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2295]
["Reference","18/CAG/0189"]
["Other Refs","Replacement of CR6/2013, NHS Digital ref: MR515"]
["Application Title","Helicobacter pylori Screening Study: a randomised stomach cancer prevention trial"]
["Application Summary","This application from Queen Mary, University of London set out the purpose of a randomised controlled trial to determine whether screening and treatment of the infection in middle age can reverse the increased risk of stomach cancer in patients infected with Helicobacter pylori.\nA recommendation for class support was requested to cover access to cancer data from the NHS Central Register at the Health and Social Care Information Centre. A cohort of 62,454 patients was flagged.\nThis application received provisional support in 2015, however the specific conditions of support remained outstanding at that time therefore support to avoid a breach of the common law duty of confidentiality was not in effect."]
["Applicant Organisation Name","Queen Mary, University of London"]
["Contact Name","Professor Joan Morris, chief Investigator        "]
["Address","Population Health Research Institute, \nSt George’s. University of London\n"]
[null,"Cranmer Terrace"]
[null,"London "]
["Postcode","SW17 0RE"]
["Telephone",7870100124]
["Email","jmorris@sgul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used"]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-10-26"]
["Next Review Date","2024-10-26"]
["Notes","12 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Cancer registrations and civil registrations – Deaths\n\n07 December 2021 - Amendment supported\nAmendment supported to transfer data controllership of the study from Queen Mary University of London to St George’s University of London, and to revise the data flows so that NHS Digital will disclose confidential patient information from the Mortality and Cancer Notifications dataset to St George’s University of London, instead of Queen Mary University of London.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Provided.\n2. Continued efforts are to be made to inform the cohort about the continued processing of confidential patient information without consent, and for any objections to be respected. A clear report focusing specifically on the communications taken, content, and status of any patient objections, to be provided at time of next annual review, which is due no later than 12 months from date of this letter and on an annual basis to avoid jeopardising the future status of this activity.\n3. Confirmation of suitable security arrangements via satisfactory IG Toolkit (or replacement) submission. Confirmed. The applicant must note that satisfactorily reviewed (by NHS Digital) security assurances, for the duration of support and at each annual review stage must be evidenced at time of submissions."]

{"sheet":"A02296","index":339,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number",2296]
["Reference","18/CAG/0153"]
["Other Refs","IRAS project ID: 238743, REC reference: 18/WA/0291"]
["Application Title","The POOL study: Establishing the safety of waterbirth for mothers and babies: A cohort study with nested qualitative component."]
["Application Summary","This application from Cardiff University set out the purpose of medical research which aims to evaluate whether the use of birthing pools during labour and water births leads to an increased risk in poor maternal and infant outcomes. Data will be collected on all births in around 30 maternity units between January 2015 and November 2020 to find out how many women used birthing pools during labour, the number of water births and whether the women or infants come to any extra harm as a result of water birth. Routinely collected data will be used. For infants needing specialist care, data will be retrieved from the National Neonatal Research Database (NNRD). The NNRD operates with support under the Regulations via application reference ECC 8-05(f)/2010. There is a supplementary qualitative element to the study which involves online discussion boards and site case study observations which does not require consideration by the CAG.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Julia Sanders"]
["Address","School of Healthcare Sciences, College of Biomedical and Life Sciences, Cardiff University,"]
[null,"Room 1.7, Ty Dewi Sant, Heath Park"]
[null,"Cardiff"]
["Postcode","CF14 4XN"]
["Telephone"]
["Email","SandersJ3@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All women giving birth at a participating NHS site in England or Wales between January 2015 and November 2020. It is anticipated that this will include 600,000 maternity records."]
["Description of confidential patient information used","The following items of confidential patient information will be released by EuroKing to the National Neonatal Research Database, based at the Chelsea and Westminster Hospital NHS Foundation Trust, for the purposes of sample validation and linkage:\n Study-specific Linking Field,\n Surname,\n Infant’s NHS Number,\n Infant Date of Birth,\n Postcode,\n Maternity Unit of Birth,\n Ethnicity – for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-11-02"]
["Next Review Date","2024-11-02"]
["Notes","24 September 2021 - Amendment, to extend the duration of support until March 2023, is supported, subject to compliance with the standard conditions of support.\n\n09 August 2021 - Amendment supported to expand the opt-out option in one site to ensure people are able to opt-out if they wish.\n\nSpecific conditions of support (Final)\n1. Revise the patient leaflet to remove the word ‘retrospectively’ from the dissenting paragraph. This should be actioned prior to the study start; however, confirmation should be provided at the time of first annual review that this was undertaken.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 09 October 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Chelsea and Westminster NHS Foundation Trust and EuroKing Maternity Software Solutions (Healthcare Software Solutions YGMAJ) have confirmed satisfactory reviewed grade on Version 14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02297","index":340,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2297]
["Reference","17/CAG/0145"]
["Other Refs","IRAS project ID: 195002, REC reference: 17/NW/0278"]
["Application Title","Outcomes of Drug Coated Balloon Angioplasty, A UK Real Life Experience from 2009 to 2015"]
["Application Summary","This research application from Norfolk and Norwich University Hospital NHS Foundation Trust set out the purpose of investigating long terms outcomes of Drug Coated Balloon Angioplasty Treatment, a novel therapy as opposed to standard Drug Eluting Stent insertion. This could provide an important source of information for health professionals and patients to guide future clinical practice and research.\nIt is currently standard practice for drug eluting stents to be used, which lead to challenging long-term complications. Early studies with the alternative method of Angioplasty with Drug Coated had shown encouraging results in terms of overcoming these complications and leaving less of a permanent impact. This study would investigate outcomes of this method for all types of coronary artery disease from 01/01/209 to 31/12/2015 at this NHS centre, with an estimated cohort size of over 1000 patients.\nData from the Trust database would be linked with NICOR (National Institute for Cardiovascular Outcomes Research) data to enable recording of any follow-up events for at least 12 months following the procedure.\nIdentifiers would be disclosed to NICOR for this purpose – the data returned from NICOR would be pseudonymised."]
["Applicant Organisation Name","Norfolk and Norwich University Hospital NHS Foundation Trust"]
["Contact Name","Simon Eccleshall, Chief Investigator"]
["Address","Norfolk and Norwich University Hospital NHS Foundation Trust, "]
[null,"Department of Cardiology, Colney Lane"]
[null,"Norwich"]
["Postcode","NR4 7UY"]
["Telephone","01603 287607 "]
["Email","simon.eccleshall@nnuh.nhs.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data from Norfolk and Norwich University Hospital NHS Foundation Trust in relation to patients who have received Drug Coated Balloon Angioplasty."]
["Description of confidential patient information used","NHS Number, gender and date of birth would be disclosed to NICOR to obtain follow-up data.\nNHS Number, gender and date of birth would also be disclosed to the direct care team at other hospitals, should a patient have had a repeat procedure at a different site."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-09-07"]
["Next Review Date","2024-09-07"]
["Notes","Amendment supported 17 January 2024 to change the Chief Investigator from Dr Upul Wickramarachchi to Dr Simon Eccleshall\n\n03 January 2024 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil Registration – deaths\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits.\n\n16 March 2022 - Amendment supported\nAmendment suppored to extend the duration of support to 23 December 2031, and to clarify that health outcomes of patients will be received from NHS Digital and NICOR until this time.\n\n16 December 2019 – Amendment supported to allow the disclosure of confidential patient information to NHS Digital to facilitate linkage with HES and ONS. Support was also given for the extension of the eligible study cohort to the 15 November 2019, to include an additional 6,000 patients and to extend the duration of support to 30 April 2021\n\nAmendment Request (Approved 29/10/2018)\nThe amendment seeks to extend the patient cohort included in the study – the proposal will now follow-up patients who were fitted with drug eluting stents, in order to compare the outcomes with the initial patient cohort, who were treated with drug-coated balloon. There is estimated to be 3,000 patients in the drug eluting stent cohort to be followed up. The same data flows and data items will be followed as currently supported in the project. It was explained that data in relation to the initial patient cohort was still pending from NICOR – the applicant advised that they were seeking support to follow-up the comparison cohort simultaneously to expedite the linkage process to enable analysis to commence.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 4 May 2017.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 1 September 2017"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number",2298]
["Reference","16/CAG/0134"]
["Other Refs","IRAS project ID: 208811, REC reference: 16/EE/0374"]
["Application Title","Follow-up of the Hertfordshire Cohort Study through Hospital Episode Statistics"]
["Application Summary","This application from the University of Southampton set out the purpose of on ongoing, originally consented activity as specified in the application form. Evidence was provided through an extract of DAAG minutes that NHS Digital had expressed the view that consent was no longer considered to be valid on the grounds the consent referred only to GP data, and an application to the CAG had been advised by the data controller of HES.\nA recommendation for class 4, 5 and 6 support was requested to enable continued holding and processing of information already collected."]
["Applicant Organisation Name","University of Southampton"]
["Contact Name","Professor Elaine Dennison, Professor of Musculoskeletal Epidemiology"]
["Address","MRC Lifecourse Epidemiology Centre (University of Southampton), "]
[null,"Southampton General Hospital"]
[null,"Southampton"]
["Postcode","SO16 6YD"]
["Telephone","02380 777624"]
["Email","emd@mrc.soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 37,000 people born between 1911 and 1939 in Hertfordshire, whose births and early years were documented by Health Visitors. A subset of 2997 men and women who were born between 1931-9 who attended baseline clinics during 1998-2004 to characterise their health and genotype."]
["Description of confidential patient information used","The application form specified access to NHS Number and date of birth within HES as these were used to assign internal serial numbers and enable linkage to cohort data. Further detail within the form confirmed that the data have already been extracted, comprising PseudoHESID, NHS number, postcode, sex, date of birth, date of admission, method of admission, source of admission, date of discharge, destination on discharge, main specialty, primary diagnosis, other diagnoses, primary procedure and other procedures."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-04-11"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in April 2024 that ‘s251’ support could be expired, as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant does not have access to any means of re-identifying.\n\nIn terms of public benefit, there have been a number of scientific papers, either already published or in press, that consider the associations between lifestyle and health in midlife with subsequent health outcomes.\n\n\n19 April 2023 - change in data processor from NHS Digital to NHS England, regarding data source Hospital Episode Statistics (HES).\n\n10 August 2020 - Amendment seeking support to undertake a further data linkage to HES data, held by NHS Digital, for the period 01 April 2010 to 31 March 2019 and for updates at yearly intervals, is conditionally supported, \n\nAdditional condition of support: The applicant is required to submit a further amendment request for support for any further annual data collection updates from HES after 5 years from 2019. \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Received dated 24 October 2016\n2. Confirmation from the relevant team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Published as satisfactory MRC Lifecourse Epidemiology Unit version 14"]

{"sheet":"A02299","index":342,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2299]
["Reference","CR28/2014"]
["Other Refs","21/71/61 - MR278"]
["Application Title","Study of a Birth Cohort from Hertfordshire"]
["Application Summary","This application from MRC Epidemiology Resource Centre, Southampton General Hospital, requested support in order to access mortality data from the Data Access Request Service (DARS) at the Health and Social Care Information Centre (HSCIC).\nThe Hertfordshire Birth Cohort (MR278) comprises 35000 people born between 1911 and 1939 who were overseen in early childhood by health visitors in the county. Records are being used to explore the relationship between health in infancy and eventual cause of death and also to investigate lifecourse influences on ageing as well as mortality among these men and women. A cohort of 35000 patients was flagged at the DARS."]
["Applicant Organisation Name","MRC Epidemiology Resource Centre, Southampton General Hospital"]
["Contact Name","Professor Elaine Dennison, Professor of Musculoskeletal Epidemiology"]
["Address","MRC Lifecourse Epidemiology Centre"]
[null,"Southampton"]
[]
["Postcode","SO16 6YD"]
["Telephone",2380777624]
["Email","emd@mrc.soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The Hertfordshire Birth Cohort (MR278) comprises 35000 people born between 1911 and 1939 who were overseen in early childhood by health visitors in the county."]
["Description of confidential patient information used","Data from the Central Register which are currently retained by the applicant, old and new\nNHS number, name at birth, date of birth, gender.\nMortality data which includes date of birth, date of death, place of birth and place of death,\nname at birth and death, gender, address, occupation and cause of death."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-08-17"]
["Next Review Date","2024-08-17"]
["Notes","18 August 2023 - change in data processor from NHS Digital to NHS England regarding demographics and mortality data\n\nSpecific conditions of support\n1. Favourable opinion from REC. Confirmed 15th July 2015.\n2. Confirmation of suitable security arrangements via IG Toolkit submission.\nConfirmed 20th April 2015.\n3. Provide confirmation of how you are intending to proceed with IGT/REC approval\nto the Confidentiality Advice Team by 1st May 2015. Confirmed as per specific\ncondition 1 and 2."]

{"sheet":"A02300","index":343,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02300"]
["Reference","18/CAG/0178"]
["Other Refs","IRAS project ID: 247047"]
["Application Title","DEveloping a Complex Intervention for DEteriorating Patients using Theoretical Modelling (DECIDE study)"]
["Application Summary","This application from City, University of London set out the purpose of medical research\nwhich aims to develop an intervention to change the behaviour of nurses when reacting to\na patient’s ‘Early Warning Score’ (EWS). EWS is a tool which is used in hospital to assist\nnurses in recognising deteriorating patients. These tools provide a record of clinical\nobservations, including blood pressure, heart rate, breathing rate, temperature and\noxygen levels, which also generating an early warning score every time observations are\nperformed. The higher the score, the risk is greater that deterioration will continue. The\ntools also instruct staff on what action to take – for example, if a patient has a medium or\nhigh EWS, nurses should contact a doctor for assistance. There is however evidence that\nthese instructions are not always followed, leaving unwell patients at risk.\nThe proposed study involves staff only and has been submitted to the CAG as an\nelement of the project will involve researchers observing nurses undertaking clinical\nobservations on hospital wards. The behaviours which are observed on the wards will be\ncompared to the ideal behaviours set out in the published guidance. The research team\ndo not require access to confidential patient information for the purposes of the study;\nhowever, it is recognised that in observing staff undertaking their daily tasks, it is likely\nthat the researcher will be incidentally exposed to confidential patient information."]
["Applicant Organisation Name","City, University of London"]
["Contact Name","Mr Duncan J Smith"]
["Address","7a Cliff Road"]
[null,"Brighton"]
[]
["Postcode","BN2 5RD"]
["Telephone"]
["Email","duncan.smith.1@city.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Staff observations will be undertaken at two hospital wards providing general care for\nacutely unwell medical and/or surgical patients. Across 6-8 months period, 180 hours of\nstaff observation will be undertaken across the two wards.\n"]
["Description of confidential patient information used","The applicant is not seeking support to access any confidential patient information during\nthe observation of nursing on the hospitals wards; however, it has identified that this may\nincidentally be disclosed. It cannot be foreseen what items of confidential patient\ninformation would be disclosed. Some clinical details may be of interest to the study;\nhowever, it is confirmed that these would relate to the clinical observations that form part\nof the EWS and would not fall within the definition of confidential patient information."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-11-07"]
["Next Review Date","N/A"]
["Notes","20 January 2022 - Support Expired\nData was collected without any identifiers, hence no need to pseudonymise.\n\nResults from the work for which CAG approval was required have been disseminated in 2 peer reviewed publications. Findings have shaped the content of a behaviour change intervention to improve responses to deteriorating patients (by nursing staff) in the acute hospital setting. The intervention will be piloted in subsequent research.\n\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed 30/10/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed – University College\nLondon Hospitals NHS Foundation Trust – has a published satisfactory\nreviewed grade on V14.1, 2017/18)."]

{"sheet":"A02301","index":344,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number",2301]
["Reference","18/CAG/0145"]
["Other Refs","IRAS project ID: 237300, REC reference: 18/EM/0258"]
["Application Title","Synergy between PCI with TAXUS and Cardiac Surgery: SYNTAX Extended Survival (SYNTAXES)"]
["Application Summary","This application which has been submitted by University Hospital Southampton NHS Foundation Trust on behalf of the Erasmus Medical Center (based in Netherlands), set out the purpose of medical research which aims to undertaken a ten year follow-up of patients who participated in the SYNTAX trial. The SYNTAX trial was the first large-scale randomised controlled trial which investigated Coronary Artery Bypass Grafting (CABG) versus Percutaneous Coronary Intervention (PCI) with drug-eluting stents in patients with coronary artery disease. The study follow-up completed at five years follow-up; however, questions remain outstanding around which of the two treatments provided better outcomes for patients within the trial. This application proposes undertaking a non-interventional 10 year follow-up of patients who were enrolled in the trial via NHS administrative datasets.\n\nThe follow-up will be coordinated by University Hospital Southampton NHS Foundation Trust on behalf of all sites within England and Scotland. Confidential patient information in relation to the study participants will be disclosed from the seven English sites to the named applicant at University Hospital Southampton NHS Foundation Trust, who will coordinate the follow-up process via NHS Digital. Alternative arrangements will need to be made by the applicant in relation to the Scottish site."]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust"]
["Contact Name","Prof Nicholas Curzen"]
["Address","E level North Wing"]
[null,"University Hospital Southampton"]
[null,"Tremona Road"]
["Postcode","SO166YD"]
["Telephone"]
["Email","nick.curzen@uhs.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All 245 patients who participated in the SYNTAX trial, in England."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes stated:\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage\n Hospital ID – sample validation,\n Date of birth – sample validation and linkage,\n Date of death – analysis,\n Gender – analysis,\n Study ID – sample validation and linkage."]
["S251 Class(es)",null,"Specific Support"]
[null," Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-11-08"]
["Next Review Date","N/A"]
["Notes","August 2020 - Support Expired\nExpired as of August 2020, as this is when the data was destroyed.\n\nThe public benefit gained from these data will be to inform the decision making and counselling for patients with a choice between surgery or stenting for complex coronary disease.\nThe findings were published in The Lancet in September 2019 and continue to inform current practice.\n\nSpecific conditions of support (Final)\n1. Support extends to the English sites only.\n2. Involvement and engagement activity should be undertaken with an appropriate group\nof patients and members of the public to test the acceptability of using confidential\npatient information without consent for the application purpose. An overview of the\nactivity undertaken and the feedback provided would be required at the time of first\nannual review. If the responses given were negative, the CAG would take this into\naccount when considering whether support can continue, or whether further action is\nrequired.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 06/11/2018).\n4. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements\nvia Information Governance Toolkit (IGT) submission (Confirmed - University\nHospital Southampton NHS Foundation Trust and NHS Digital show a published\nsatisfactory reviewed grade on V14.1, 2017/18)."]

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[]
[]
["Application Number","A02302"]
["Reference","18/CAG/0119"]
["Other Refs","IRAS project ID: 233983, REC reference: 18/LO/1043"]
["Application Title","Comprehensive Patient Records (CPR) for Cancer Outcomes: A feasibility studyWorkstream 5: Patient Reported Outcome Measures (PROMs)"]
["Application Summary","This application from the University of Leeds set out the purpose of medical research which, through the overarching research programme, aims to investigate the long-term effects of cancer and cancer treatment. The specific work stream which is presented in this application (Work Stream 5) relates to the collection of PROMs (Patient Reported Outcome Measures) data from patients around their opinions on their health, treatment, quality of life and other issues. This information will be linked with the wider clinical information collected throughout the study to create a comprehensive patient record, showing the long-term effects of cancer of quality of life, health and wellbeing.\nThe recruitment process is directed by the direct care team of patients; however, the applicants have identified two points within the process were wider staff at Leeds Teaching Hospitals NHS Trust, who would not be considered part of the direct care team, would potentially have access to confidential patient information and are seeking support under the Regulations to legitimise this data access. Patients invited to participate in the study will provide consent to wider activities, including linkage of the PROMs information with their wider clinical care record, which is out of scope for the CAG. The study will include a cancer patient cohort and a matched control cohort for comparison."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Geoff Hall"]
["Address","University of Leeds"]
[null,"Leeds Cancer Centre"]
[null,"St James's University Hospital"]
["Postcode","LS9 7TF"]
["Telephone"]
["Email","geoff.hall2@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Cancer Patients – 2,000 Breast, ovarian and colorectal cancer survivors aged over 18, at around five years post-diagnosis.\n Control Patients – 4,000 patients referred to dermatology for suspected cancer, but no cancer diagnosis was made.\n Controls will be matched on age, gender and GP practice."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes described:\n Name – invitation,\n NHS number – invitation and sample validation,\n Full address and postcode – invitation."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-11-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised\n\nIn terms of public benefit, the applicants anticipate that findings will provide detailed data on cancer survivors’ health and quality of life outcomes which can be used for improvements in service provision, improved information for patients and clinical teams, optimising post-treatment support, and informing future research. \n\n\n25 May 2022 - Amendment supported\nAmendment supported to extend the duration of ‘s251’ support until November 2022.\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 10/09/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Leeds Teaching Hospitals NHS Trust – Version 14.1, 2017/18 – reviewed grade satisfactory)."]

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[]
[]
["Application Number","A02303"]
["Reference","18/CAG/0159"]
["Other Refs","IRAS project ID: 235275, REC reference: 18/LO/1514"]
["Application Title","Housing, family and environmental risk factors for hospital admissions in children"]
["Application Summary","This application from University College London set out the purpose of medical research which aims to investigate the impact of environment and socio-economic factors on hospital admissions in children. The project will use an established birth cohort of infants born in England between 2005 and 2014. This will be linked by the Office of National Statistics (ONS) to 2011 Census Data and small area level data on air pollution and building characteristics in order to create a dataset to facilitate analysis.\nThe birth cohort was established with support under the Regulations via application PIAG 2-10(g)/2005, which was subsequently amended under application reference CAG 9-08(b)/2014. The amended application linked the birth cohort data with HES data at NHS Digital to collate information on mothers and babies admitted/readmitted to hospitals in the first year of birth. An amendment was subsequently supported in May 2016 which linked the dataset with ONS mortality data to collate additional information around deaths in infants aged over one year and maternal deaths within one year of delivery of the child. City, University of London is the controller for the birth cohort information which is retained by ONS.\nThe application has been submitted for consideration by the CAG to seek support to use the data held within the established dataset for the wider research purposes described within the application. Support is also sought for the processing of confidential patient information which will be undertaken by ONS to link this dataset with Census, air pollution and building characteristic information. These supplementary datasets do not fall within the legal definition of confidential patient information, as set out at section 251(11) of the NS Act 2006, and processing of this information would not fall within the remit of the CAG to support. The dataset with which the birth cohort will be linked are as follows:\n 2011 Census information (for births between March 2010 and March 2012 – one year before/after Census) – data collected will include information on overcrowding, house type and tenure, type of heating, mother and fathers length of stay in the UK and knowledge of English,\n Department for Environment, Food and Rural Affairs information on full postcode level data on annual levels of eight specified pollutants modelled using atmospheric transport models,\n Information around distance to A roads and motorways using maternal postcode at delivery,\n Ministry of Housing, Communities and Local Government information around Energy Performance Certificates (EPC) for building characteristics."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Pia Hardelid"]
["Address","UCL Great Ormond Street Institute of Child Health\n30 Guilford Street\nLondon\nWC1N1E"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N1EH"]
["Telephone"]
["Email","p.hardelid@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children born alive in England to English resident mothers between 01 January 2005 and 31 December 2014. There are 7 million children recorded in the existing sample. A sub-cohort of patients within this will be established for linkage with the 2011 Census which will include all births between March 2010 and March 2012."]
["Description of confidential patient information used","The following items of confidential patient information held within the established birth cohort dataset will be used for the purposes described:\n Name (Mother) – linkage to 2011 Census information,\n NHS Number (Infant) – linkage to fully identifiable ONS birth registration data as part of linkage to Census,\n NHS Number (Mother) – within the birth cohort data set,\n Date of birth (Mother and Infant) – linkage,\n Date of death (Infant) – analysis,\n Date of death (Mother) – within the birth cohort data set,\n Postcode (birth) – linkage and analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-11-09"]
["Next Review Date","2024-11-09"]
["Notes","\nAmendment supported 12 July 2023 to allow the applicant to use full dates of birth and full dates of death of children in the cohort, in order to derive certain variables required for analysis\n\nAmendment supported 25 May 2023 to allow the applicant to use postcodes from birth registration data for validation of the PDS postcodes, and to use postcodes from birth registration for linkage to air pollution and housing data should the PDS postcodes not be reliable, and to clarify that linkage of the mother baby cohort to daily air pollution data will be for the years 2010-2014, rather than 2010-2012\n\n30 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES) and ONS mortality data\n\nAmendment supported 31 March 2023 to extend the duration of ’s251’ support until 31 December 2025\n\nAmendment supported 31 March 2023 to clarify that injury admissions are an outcome with regards to this study, and to inform CAG that the application will be funded by MRC (until March 2024) followed by HDR-UK\n\nAmendment supported 16 January \nTo extend the duration of ’s251’ support until 31 December 2024\n\n12 January 2021 - Amendment supported\nThe amendment, to revise the data flow so that ONS provide patient identifiers to NHS Digital for linkage to the Patient Demographic Service (PDS), the sending of the linked dataset to ONS Secure Research Service for linkage to UCL provided postcode level data on environmental exposures, is fully supported, subject to compliance with the standard conditions of support.\n\n24 November 2020 - Amendment supported \nTo link full postcode of patients already held within their dataset to lower super output areas (LSOA), before ONS SRS restricting researcher access to full postcode.\n\n08 July 2020 - Amendment supported \nTo allow linkage of data for the birth cohort to longitudinal environmental exposure via linkage to maternal and child postcode histories in the Personal Demographic Service (PDS), which are held by NHS Digital.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee (Confirmed 05 October 2018).\n2. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Office for National Statistics has a published satisfactory reviewed grade on V14.1, 2017/18)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02304"]
["Reference","17/CAG/0129"]
["Other Refs","IRAS project ID: 218569, REC reference: 17/LO/1267"]
["Application Title","Critically ill children and young people: do national Differences in access to Emergency Paediatric Intensive Care and care during Transport affect clinical outcomes and patient experience? The DEPICT study"]
["Application Summary","This NIHR funded study set out the purpose of looking at how differences in access to paediatric intensive care (due to distance from the intensive care unit), and care provided during transport to intensive care, affect clinical outcomes and patient experience. The primary outcome would be 30 day mortality rate. Patient experience would be investigated via questionnaires (for which support was not required as they would take place under consent).\nThere are currently fewer than 30 paediatric intensive care units (PICUs) in the UK. This means that a critically ill child taken to their nearest hospital will need to be transferred to a PICU. Such transports are usually done by PICU retrieval teams (PICRTs), mobile teams who take specialist expertise to the child and safely transport them to a PICU. There are national variations in how PICRTs are organised and deliver clinical care.\nThe study would combine data from PICANet (an international audit of paediatric intensive care which collects data on all children admitted to paediatric intensive care units (PICUs) in the UK and Ireland) and the CMP (an audit of patient outcomes from adult, general critical care units (intensive care and combined intensive care/high dependency units managed by ICNARC) covering England, Wales and Northern Ireland. Various outcome measures would be extracted, including: how long it takes a PICRT to reach the patient, how long it takes the child to reach the PICU, the seniority of clinicians performing the transport, medical procedures performed by the PICRT and any critical incidents during transport, and investigate whether any of these factors influence how likely a child is to survive. This would provide a basis to complete cost/benefit analysis and to study if and how alternative models of service delivery could improve clinical outcomes.\n\nIdentifiers would be sent from PICANet and ICNARC to NHS Digital, who would look for any records from the CMP database that were also in the PICANet database. The resulting dataset would be linked with ONS/HES data and transferred in pseudonymised form back to PICANet.\nCMP would also receive the pseudonymised list of those patients in both CMP and PICANet database, marked with the unique CMP identifier and the DEPICT study number before removing the CMP identifier and transferring this dataset to PICANet in Leicester, where the data would be analysed.\nA recommendation for class 4 and 6 support was requested to link patient identifiable information obtained from more than one source and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","NIHR"]
["Contact Name","Dr Padmanabhan Ramnarayan"]
["Address","Children's Acute Transport Service"]
[null,"26-27 Boswell Street"]
[null,"London"]
["Postcode","WC1N 3JZ"]
["Telephone"]
["Email","P.Ramnarayan@gosh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from PICANet and ICNARC in relation to critically ill children and young people under the age of 16 requiring emergency transport to a paediatric intensive care unit in England and Wales between 2014 and 2016 (IRAS form refers to participants identified from clinical notes – this is for the consented questionnaire aspect of the study):"]
["Description of confidential patient information used","NHS number, date of birth, name, postcode and unique local identifier and study number from PICANet, University of Leeds to NHS Digital.\nNHS number, date of birth, postcode from ICNARC to NHS Digital (name is not available in the ICNARC dataset)."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-09-26"]
["Next Review Date","N/A"]
["Notes","Expire support,\nConfirmed by email 22 September 2021\n\n•\tPlease may you confirm the reason that support is no longer required \n•\tIf the reason is that all data has been pseudonymised, please may you confirm that the original identifiers which were supported are no longer being processed/retained, and an overview of what data items you still retain. \n\nData has been pseudonymised and study team are not able to re-identify\n\n•\tPlease may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency.\n\nSpecifically related to the linkage support by CAG applicants have published two papers and we have one more planned and a final report being considered by the funder:\n\n\nAmendment Request (Approved 13/11/2018)\nThe amendment request seeks support to undertake the same follow-up as currently supported in England, for Welsh patients via NHS Wales Informatics Service (NWIS). Identifiers would be sent from ICNARC (Intensive Care National Audit and Research Centre) and PICANet (Paediatric Intensive Care Audit Network for the UK – based at the University of Leeds) to allow follow-up via the Patient Episodes\nDatabase Wales. This had been cited as a requirement in the initial application; however, the data flows required to support this have only now been finalised.\nIt was confirmed that NHS Number alone would be disclosed from PICANet and ICNARC to NHS Wales Informatics Service to facilitate linkage. The same data flows as currently supported for the English patients would then follow, with applicants only receiving pseudonymised linked by study ID for analysis.\nSpecific conditions of support\n1. Data linkage via NHS Wales Informatics Service would be undertaken on NHS Number alone – the protocol document should be updated to reflect this agreed process.\n2. Confirmation of suitable security arrangements (Confirmed – Caldicott Principles into Practice (CPiP) Assessment for NWIS received 25/10/2018).\n3. Confirmation of a favourable opinion from a Research Ethics Committee (Confirmed – 07/11/2018).\n\nOriginal Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 19 September 2017.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 22 August 2017."]

{"sheet":"A02305","index":348,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02305"]
["Reference","18/CAG/0171"]
["Other Refs","IRAS project ID: 192792, REC reference: 18/LO/1760"]
["Application Title","Epidemiological studies of the Porton Down veterans: a ten-year update of mortality and cancer incidence"]
["Application Summary","This application from King’s College London, University of Oxford and University of Lancaster set out the purpose of medical research which aimed to undertake a 10 year update of mortality and cancer incidence of the patient cohort included in the 2002-07 Porton Down Veterans study. The previous study investigated whether military veterans who were exposed to chemical agents as part of the ‘human volunteer programme’ at the UK government's research establishment at Porton Down, had unusual rates of cancer incidence or mortality compared to veterans who did not attend Porton Down, and the general population.\nThe original study was considered by the Patient Information Advisory Group (PIAG) in December 2002 and support was recommended for the project (at that time, under Section 60 of the Health and Social Care Act 2001). Within this study, the University of Oxford assembled a cohort of patients who were flagged in the NHS Central Register which comprised of c20,000 Porton Down veterans who took part in the ‘human volunteer programme’ between 1941 and 1989. The patient records were linked to routine data held by the Office for National Statistics to compare their pattern of deaths and cancer registrations up to 2004, with that of a comparison cohort of c20,000 non-Porton Down military veterans. The study established that, although there was a small (6%) excess of all-cause mortality, this could not be attributed to any specific exposure at Porton Down and might have been related to unmeasured factors such as smoking. There was no excess of cancers.\nThis study will update mortality and cancer registration data by at least 10 years. This new data will enable the analyses carried out previously to be repeated, but with increased statistical power so a more full examination of the impact of rare exposures and outcomes at a level of detail not possible in the original study. The remit of the CAG extends to data linkage to be undertaken via NHS Digital. The application references linkages via NHS Scotland and the North Ireland Statistics and Research Agency; however, an alternate legal basis would need to be established in relation these patient groups."]
["Applicant Organisation Name","King’s College London, University of Oxford and University of Lancaster "]
["Contact Name","Professor Nicola T Fear"]
["Address","King's Centre for Military Health Research"]
[null,"Weston Education Centre"]
[null,"10 Cutcombe Road, LONDON"]
["Postcode","SE5 9RJ"]
["Telephone"]
["Email","nicola.t.fear@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The proposed study involves the same patient cohort which was established during the original 2002-07 study. This included a cohort of Porton Down veterans’ who attended the facility as part of the 'human volunteer programme' between 1941 and 1989, comprising of 18,276 individuals. A control comparison cohort was also included which comprised of individuals with a military service number adjacent to a Porton Down veteran, but did not attend the facility themselves, comprising 17,600 individuals."]
["Description of confidential patient information used","The following items of confidential patient information have been identified by the applicant as being required for the study purposes:\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage (where available),\n Date of birth – sample validation, linkage and analysis,\n Date of death – sample validation and linkage,\n Address – (text of address at discharge from military service) – linkage,\n Postcode (District Level) – sample validation and linkage,\n Gender – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-11-16"]
["Next Review Date","2024-11-16"]
["Notes","12 April 2022 - Amendment supported, to extend the duration of ‘s251’ support until 1 November 2022.\n\n16 December 2019 – Amendment supported to remove University of Oxford as a controller within the scope of the application\n\nSpecific conditions of support (Final)\n1. Patient and public involvement and engagement activity should be progressed as per the plans which were detailed in the initial application. An overview of the actual activity undertaken should be provided at the time of first annual review, together with any feedback which was provided, for consideration. If the responses given were negative, the CAG will take this into account when considering whether support can continue, or whether further action is required.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 26 October 2018).\n3. Confirmation from the IGT Team at the NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – King’s College London – King’s Centre for Military Health Research and NHS Digital have published satisfactory reviewed grades on V14.1, 2017/18)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02306","index":349,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02306"]
["Reference","18/CAG/0112"]
["Other Refs","IRAS project ID: 245343, REC reference: 18/SC/0363"]
["Application Title","Understanding the mental health needs of mothers involved in family court cases: A research study exploring linkage between family court and mental health data"]
["Application Summary","This application from South London and Maudsley NHS Foundation Trust and King's College London Institute of Psychiatry set out the purpose of medical research through the establishment of a research database which intends to generate evidence about the health needs of mothers who are involved in care proceedings (including recurrent care proceedings). Care proceedings are family court cases where the local authority applies to the court to have a child removed from parental supervision because they believe a child is risk of significant harm.\nThe application proposes to link information from Children and Family Court Advisory and Support Service (Cafcass) around care proceedings to patient records held in the Clinical Research Interactive Search (CRIS) database, which holds information on mental health service users at the South London and Maudsley (SLaM) NHS Foundation Trust. Health data for women who link to mental health records within the CRIS database will be compared against the records of women who do not.\nThe three objectives which have been cited for the research database are as follows:\n1. Evaluate linkage success between Cafcass and mental health service data held by CRIS,\n2. Describe the frequency, type and timing of mental health service use among mothers involved in care proceedings,\n3. Evaluate risk factors (such as live birth interval) for involvement in care proceedings for women using mental health services."]
["Applicant Organisation Name","South London and Maudsley NHS Foundation Trust and King's College London Institute of Psychiatry"]
["Contact Name","Professor Ruth Gilbert"]
["Address","GOS UCL Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone"]
["Email","r.gilbert@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort One: Women involved in care proceedings who were resident in one of the Local Authorities between 01/04/2007 and 31/03/2017 as identified from the Children and Family Court Advisory and Support Service (Cafcass) dataset. This consists of 3,396 mothers who will be included within the cohort regardless of whether successful linkage is achieved with mental health records within the South London and Maudsley NHS Trust CRIS database. This cohort will be used to answer the questions set out in objectives one and two.\n Cohort Two: The CRIS database will provide information in relation to women accessing mental health treatments within the four Local Authority Areas which SLAM Covers (Lambeth, Southwark, Lewisham and Croydon) and information in relation to women accessing supplementary addiction services for an additional three local authorities (Wandsworth, Greenwich and Bexley). Women will be aged 16 – 55 years accessing mental health services from 01/04/2007 – 31/03/2017. The sample size for this cohort has not yet been established; however, the applicants have estimated, based on previously published information, that the CRIS cohort will include 399,630 women aged 20-59 years, so it is expected that the target cohort will contain similar numbers, based on a slightly different age range. This cohort would be used to answer the questions posed in objective three."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes required:\n Name – linkage,\n Date of birth – linkage,\n Postcode – linkage and analysis,\n Gender – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-11-20"]
["Next Review Date","N/A"]
["Notes","26 November 2020 - Support expired\nApplicant confirmed via email that they were exiting support.\nApplicant has confirmed they no longer hold any identifiable information as it has been truncated and deleted. \n\nSpecific conditions of support (Final)\n1. The project summary on the SLaM-CRIS website should be revised to clearly state that confidential patient information would be processed in the creation of the analysis dataset to be used in the study and provide clear objection methods. A copy of the revised text should be provided for review within three months of the date of this outcome letter and prior to any detail being posted on the study websites.\n2. Support is extended to processing of confidential patient information by South London and Maudsley NHS Trust to facilitate linkage with the information disclosed by the Children and Family Court Advisory and Support Service only.\n3. Support only extends to the creation of the dataset for cohort one, required to address objectives one and two, at this time. Feedback is required on the findings of these elements of the study before support would be considered in relation to objective three of the overall project.\n(Condition met: 22 May 2020 - support extended to include work on objective 3 of the research)\n4. Feedback would be required at the time of first annual review around the outcomes of the planned patient and public involvement and engagement activity. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n5. Favourable opinion from a Research Ethics Committee (Confirmed – 05 September 2018).\n6. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – South London and Maudsley show a satisfactory reviewed grade on V14.1, 2017/18)."]

{"sheet":"A02307","index":350,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02307"]
["Reference","18/CAG/0151"]
["Other Refs","IRAS project ID: 241544, REC reference: 18/IEC08/0020"]
["Application Title","Prevalence of hip femoroacetabular impingement (FAI) syndrome in the general population"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research which aims to use existing data which was collected under the Somerset and Avon Health Survey (SASH), which was conducted between 1993-5 and 2002-3, to understand how common hip impingement syndrome (Femoroacetabular Impingement – FAI) is in the general population. The purpose of the original Somerset and Avon Health Survey was to determine population requirements for elective surgery, including hip replacement.\nHip impingement syndrome was first described in 2003 and is a condition of the hips which causes pain in young adults. The symptoms are hip pain or clicking, catching or stiffness, restricted range of hip movement, lack of hip osteoarthritis and presence of certain types of hip shapes seen on x-ray.\nData and x-rays collected under the previously consented Somerset and Avon Health Survey will be used for this additional research purpose. As the condition was first described after this initial research was carried out, the existing consent which was in place would no longer be considered valid for these additional research purposes. Guidance was sought from the Confidentiality Advice Team as part of the review undertaken by the NHS Research Ethics Committee around this point. The application has been submitted to the CAG to seek support under the Regulations to use this existing historical data for the additional research purposes which were not described within the initial study. No additional linkage is proposed in the study."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Dr Rita Patel"]
["Address","NIHR CLAHRC West"]
[null,"9th Floor, Whitefriars Lewins Mead"]
[]
["Postcode","BS1 2NT"]
["Telephone"]
["Email","Rita.Patel@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","22,978 patients who had originally provided consent to participate in the Somerset and Avon Health Survey."]
["Description of confidential patient information used","Access the following items of confidential patient information will be required, to facilitate the creation of the pseudonymised dataset required for analysis purposes in the newly proposed research study:\n Name/Initials – to be deleted from analysis dataset,\n GP Registration – will be replaced with a number variable in the analysis dataset,\n Date of birth – will be used to calculate age at the time of examination for analysis,\n Date of death – will be used to calculate age at death for analysis,\n Postcode – will be replaced with broad geographical areas for analysis,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-11-20"]
["Next Review Date","2019-11-20"]
["Notes","March 2019 – amendment supported to extend the duration of support to 30 September 2019 and to extend the access to pseudonymised analysis data and x-rays to wider study collaborators.\nSpecific conditions of support (Final)\n1. The website text should be revised to make this more accessible to a wider public audience. This should be reviewed by a patient group prior to resubmission. This should be provided for review within three months of the date of this outcome letter.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 18 June 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements (Confirmed – University of Bristol SSCM - The Hip Study (EE133799-SSCM-THS), has submitted a Data Security and Protection Toolkit. NHS Digital email confirmed standard met – V14.1 2017/18 IG Toolkit equivalent on 15/11/2018)."]

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[]
[]
["Application Number","02308"]
["Reference","17/CAG/0052"]
["Other Refs","IRAS project ID: 202042, REC reference: 17/SC/0152"]
["Application Title","NETS2HD-Six year outcomes for children with Hirschsprung's Disease"]
["Application Summary","This NIHR-funded research study from Oxford University set out the purpose of investigating outcomes for a cohort who were diagnosed with Hirschsprung's Disease as infants between 01/10/10 and 31/03/2012, and underwent various types of procedure for an operation called a ‘pull through procedure’. The study would investigate the relationship between choice of procedure, and clinician and parent reported health and wellbeing outcomes for this cohort, now reaching school age.\nAnonymised details of this cohort were retained as part of a previous study – the British Association of Paediatric Surgeons Congenital Anomalies Surveillance System (BAPS-CAPSS).\nTwo activities were described in the summary of the application on IRAS:\n1. The collection of follow-up data for the BAPS-CAPSS study by research nurses onsite. This data would not be linked with reported outcomes for the current study.\n2. The research study NETS2HD would link data from the BAPS-CAPSS study to the outcome data reported by clinicians and by parents via questionnaire. Support was requested to allow the researcher Dr Benjamin Allin, and research nurses, to contact parents of this cohort in order to seek consent for the NETS2HD study. Parents would at this time be informed that their child had been included in the BAPS-CAPSS study, data for which was collected under s251 support.\nSupport was requested to allow the disclosure of confidential patient information from patient medical records to research nurses and Dr Benjamin Allin. Support was only requested for the second activity; however in discussion CAG members agreed that support was also required for the first activity."]
["Applicant Organisation Name","Oxford University"]
["Contact Name","Dr Benjamin Allin"]
["Address","National Perinatal Epidemiology Unit"]
[null,"Old Road Campus"]
[null,"Headington, Oxford"]
["Postcode","OX3 7LF"]
["Telephone"]
["Email","benjaminallin@doctors.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from patient medical records in relation to all children diagnosed with Hirschsprung’s Disease in the UK and Ireland between the 1st of October 2010, and the 31st of March 2012, who were less than six months of age at diagnosis, and whose clinical information was previously included in the BAPS-CASS Hirschsprung’s Disease study."]
["Description of confidential patient information used","NHS number, name, date of definitive operation or stoma formation if definitive procedure has not been performed, and parent’s names and telephone numbers would be accessed."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-05-18"]
["Next Review Date","N/A"]
["Notes","31 January 2019 - Support expired\nThe applicant confirmed that the study had ended on 31 January 2019, at which point there was no further processing confidential patient information with support under the Regulations. \n\nThe study has now finalised data collection, and no data is held without consent. No further support is required.\n\nThrough processing of data in the described manner, it has been possible to collect parent reported outcomes data as well as clinician reported outcomes data. This has provided new insights into the management of children born with Hirschsprung’s disease which can help improve the care of future generations. Collecting such data would not have been possible without section 251 approval. The study has now finished and no further processing is required.\n\nSpecific conditions of support\n1. Patient notifications: a telephone number should be provided for participants to contact in order object to the use of their data, as well as an email address.\nA revised poster was provided on 5 May 2017, including a telephone number as well as an email address.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 5 May 2017.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed via website – v14 published, reviewed as satisfactory."]

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[]
[]
["Application Number","02309"]
["Reference","18/CAG/0152"]
["Other Refs","IRAS project ID: 249637, REC reference: 18/WA/0268"]
["Application Title","Evaluation of patient access to medical test result services in general practice."]
["Application Summary","This application from the University of Bristol set out the purpose of medical research which aims to gain a better understanding of the services currently offered to provide electronic medical test results of GP practice patients in England. The study involves a number of components involving patients and practice staff, on a consented basis in order to gain understanding in this area and to seek the views of patients and clinicians in relation to different text results services.\nThe CAG was being asked to consider one element of the overarching research programme relating to GP practice cases studies (section 3.4.3 of the research protocol). This element of the project involved the research team undertaking observations of GP practice staff. The aim was to observe how the test result services function, identify staff and staff roles, clarify electronic test result dissemination routes and collect documentation such as standard operating procedures. All GP practice staff who deal with medical test result services will be observed, which may include reception and back-office staff. There will be six GP practices involved in this element of the study, which will be observed at two time points: baseline in May 2019 and at the end of the fieldwork (January 2020). The researcher undertaking the GP practice observations is not considered part of the direct care team and may be incidentally exposed to confidential patient information during the course of the observation, though this information itself does not form the focus of the observation. It was noted that support could not be provided to healthcare professionals/staff, but that support was requested only for the incidental disclosure of relevant patient information.\nA recommendation for class 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Dr Gemma Lasseter"]
["Address","NIHR Health Protection Research Unit (HPRU) in Evaluation of Interventions"]
[null,"Bristol Medical School, Population Health Sciences, University of Bristol,"]
[null,"(OF22) Oakfield House, Oakfield Grove, Bristol"]
["Postcode","BS8 2BN"]
["Telephone"]
["Email","gemma.lasseter@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All GP staff involved in the handling of medical test results will be observed, which may include reception and back-office staff. Patients registered with six GP practices which are participating in the observational element of the study, who have undergone a medical test for which results are received during the observation period, could potentially have their confidential patient information incidentally disclosed to the researcher during the course of the observation."]
["Description of confidential patient information used","The applicant is not seeking support to access any confidential patient information during the GP practice staff observations; however, it has identified that this may incidentally be disclosed. It cannot be foreseen what items of confidential patient information would be disclosed."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-11-28"]
["Next Review Date","N/A"]
["Notes","Specific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 03 August 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Six Participating GP practices which have not yet been identified. Not requested for each site; support is based on the assumption that the applicant will ensure that satisfactory security assurances are in place for each site).\n\nThe applicant confirmed in August 2022 that ‘s251’ support is no longer required because support was provided in relation to observational work conducted in participating general practice and Dictaphone recordings, and no confidential patient information was collected or is retained as a result of the observational and qualitative interview work, as outlined in the original application. \n\nWith regards to public benefit, the research found lots of variation between GP practices in terms of the types of electronic test results services being offered, although both patients and staff talked about the possible benefits of these services, more guidance is needed to make sure these benefits can be measured and fairly shared across different types of GP practices, staff groups and patients.  These findings will be useful for policy makers, and GP practices thinking about offering electronic services to patients and will help them offer access in the most effective and equitable ways possible for practices and their patients. \n"]

{"sheet":"A02310","index":353,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02310"]
["Reference","17/CAG/0078"]
["Other Refs","IRAS project ID: 205549, REC reference: 17/SW/0107,  Replacement of ECC 4-03(e)/2012. Overall audit appication covered under 17/CAG/0071, previously ECC 1-06(d)/2011."]
["Application Title","Barts Health-NICOR - Extended Use of Data V1.1 2017"]
["Application Summary","This research database application from Bart’s Health NHS Trust set out details of the\ntransfer of the established Patient Outcomes Registry, currently held by University\nCollege London to Bart’s Health NHS Trust.\nThe research database was established under the historic reference ECC 4-03(e)/2012\nwith the aim to develop further the research potential of audit data to understand better\nthe causes of coronary heart disease, timing and evolution of risk, and the interplay\nbetween biological, interventional and environmental factors.\nThe overall audit application, covered under reference 17CAG0071 (historically ECC 1-06\n(d)/2011) has also transferred to Bart’s Health NHS Trust. A letter of support had been\nreceived from the Healthcare Quality Improvement Partnership (HQIP), who\ncommissioned these audits, and are specified to be the data controllers for the purposes\nof the application. This application was received from Bart’s Health NHS Trust. The\npurpose of the application was to transfer the data processing arrangements from\nUniversity College London, to Bart’s Health NHS Trust. It was confirmed that existing UCL\nstaff would undertake a TUPE transfer to Bart’s Health NHS Trust and HQIP would remain\nthe data controller for the purposes of this application."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","James Chal, NICOR Chief Operating Officer"]
["Address","Barts Health NHS Trust"]
[null,"2nd Floor, 1 St Martin’s le Grand"]
[null,"London"]
["Postcode","EC1A 4NP"]
["Telephone"]
["Email","j.chal@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Not applicable, this application was a change of data processor"]
["Description of confidential patient information used","Transfer of the established Patient Outcomes Registry, currently held by University\nCollege London to Bart’s Health NHS Trust.\n\nSee notes section for amended data flows as of 30/11/2018."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-06-29"]
["Next Review Date","N/A"]
["Notes","Expired\n\nApplication superseded by new application 22/CAG/0118. Changes to controller as of 24th June 2022\n\n\n29 November 2019: Amendment supported to enable confidenital patient informaiton (NHS Number, date of birth, postcode, and sex) to be disclosed to NHS Digital to faciltate linkage with the HES and ONS datasets and NHS Wales Informatics to facilitate linkage with the Patient Episodes Database for Wales was supported. Linked data will be made available in the database for use for research purposes. \nAmendment Request (Approved 30/11/2018)\nThis amendment has been submitted to seek support as part of the existing application for the supplementary data flows required for the purposes of the VICORI (Virtual Cardio-oncology research initiative) project. The full title of the VICORI research is ‘Cardio-oncology: A high resolution national electronic health record investigation of the interplay between cancer and heart disease’.\nThis amendment is to the data flows for National Cardiac Audit Programme (NCAP) to include sharing of wholly pseudonymised NICOR (National Institute for Cardiovascular Outcomes Research) data previously linked by NHS Digital to ONS (Office for National Statistics life status data) and HES (Hospital Episode Statistics) with the National Cancer Registration and Analysis Services (NCRAS) already linked to HES and ONS data at Public Health England for the (Virtual Cardio-Oncology Research Initiative (VICORI) Research Project.\nThe NICOR audit data is already linked with HES and ONS data as part of these existing approvals; however, the current data sharing agreement with NHS Digital prohibits onward sharing of this information with third parties. An application has been made to NHS Digital for approval for onward sharing of these linked data. As part of this application, NHS Digital has requested that the CAG application be updated to reflect the data flows for this specific project.\n\nThis amendment request seeks support for the following data flows:\n1. Enable linkage and onward sharing of pseudonymised HES and ONS data already linked to NICOR (HQIP) audit data to PHE. The NICOR audits include:\na. MINAP (Heart attacks)\nb. Percutaneous Coronary Intervention (Angioplasty)\nc. Adult Cardiac Surgery\nd. Cardiac Rhythm Management (Arrhythmia)\ne. Congenital Heart Disease\nf. Heart Failure\ng. Linked HES\nh. Linked ONS\n2. To link the above to pseudonymised National Cancer Registration and Analysis Service (NCRAS) data already linked to HES and ONS data at Public Health England (PHE) Office for Data Release (ODR) - according to the memorandum of understanding between NHS Digital and PHE. The NCRAS data includes:\na. Site specific cancer\nb. Audits\nc. Existing links:\n Systemic Anti-Cancer Therapy Dataset,  the National Radiotherapy Dataset,  Linked HES,  Linked ONS\n\nSpecific Conditions of Support\n1. All pre-existing conditions of support related to ECC 4-03 (e)/2012 remain applicable.\n2. Support does not extend to cover data linkages with additional data sources outside\nthose which had previously been approved under application ECC 4-03(e)/2012. A\nrequest for these additional data linkages was required to be submitted as a\napplication amendment under this revised reference.\n3. The pre-existing annual review cycle remains applicable, with the next annual review\nto be received 4 weeks before 28/06/2018, and then on an annual basis to this\nschedule.\n4. Support extends to England and Wales only.\n5. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission. (Confirmed – Version 14, 2016-17\nshows a reviewed grade of 77% satisfactory, including an updated reference to\nNICOR).\n6. Favourable Opinion from a NHS Research Ethics Committee. (Confirmed –\nFavourable Opinion 09 June 2017)."]

{"sheet":"A02311","index":354,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02311"]
["Reference","18/CAG/0175"]
["Other Refs","IRAS project ID: 246818, REC reference: 18/SC/0387"]
["Application Title","Do Invasive Dental Procedures Cause Prosthetic Joint Infections (PJI)? - The PJI Study"]
["Application Summary","This study from the University of Sheffield set out the purpose of medical research which aims to understand whether there is a link between invasive dental procedures and prosthetic joint infections. NHS Digital will identify a patient cohort consisting of those who have been admitted with a late prosthetic joint infection via the HES database. This will be linked to dental records by the NHS Business Service Authority. The applicants will receive a pseudonymised dataset form both processors which will be linked by unique study ID for analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Martin H. Thornhill"]
["Address","University of Sheffield, Academic Unit of Oral & Maxillofacial Medicine, Surgery & Pathology"]
[null,"School of Clinical Dentistry, Claremont Crescent"]
[null,"Sheffield"]
["Postcode","S10 2TA"]
["Telephone"]
["Email","m.thornhill@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals identified on the NHS Digital Hospital Episode Statistics database who we admitted to hospital between 01/04/2010 and 31/03/2017 with a primary or secondary discharge diagnosis consistent with a late prosthetic joint infection (LPJI). It is estimated that there will 87,000 patients included in the cohort."]
["Description of confidential patient information used","The following items of confidential patient information will be released by NHS Digital to NHS Business Service Authority to facilitate linkage:\n Name,\n NHS Number,\n Date of birth,\n Postcode (Unit level),\n Address,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-12-04"]
["Next Review Date","N/A"]
["Notes","Application Expired\n\nApplicant confirmed in August 2022 that ‘s251’ support no longer required, as NHS Business Services Authority confirmed that they no longer retain any confidential patient information that was processed under ‘s251’ support.\n\nWith regards to public benefit, the data has demonstrated that there is no significant association between invasive dental procedures and prosthetic joint infections, thus there is no need for patients with prosthetic joints to receive antibiotic prophylaxis.\n\nSpecific conditions of support (Final)\n1. Information around the study should be displayed on the University of Sheffield website. Confirmation is required within three months of this outcome that this has been enacted, together with a copy of the text for consideration.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 29 August 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – NHS Business Services Authority and NHS Digital have a published satisfactory reviewed grade on V14.1, 2017/18)."]

{"sheet":"A02312","index":355,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02312"]
["Reference","18/CAG/0156"]
["Other Refs","IRAS project ID: 250338, REC reference: 18/ES/0118"]
["Application Title","The Distribution of Highly Sensitive Troponin in the Critically Unwell and Associated Mortality - The DIGNITY Study"]
["Application Summary","This application from University Hospital Southampton NHS Foundation Trust set out the purpose of medical research which aims to examine the consequences of high sensitivity troponin elevation in patients admitted to any of the three adult critical care areas (general, cardiac or neurosciences) within the Trust. The project will assess whether high sensitivity troponin elevation has a role as a biomarker for predicting patient’s outcome.\nThe troponin test is a very effective way of rapidly excluding a heart attack if the test is negative. However there are a number of causes of a raised high sensitivity other than a heart attack, particularly critical illness states. This can leave clinicians uncertain of the cause of a positive result and could result in patients being wrongly treated for a heart attack. This is especially relevant in critical care because patients are often unable to tell clinicians whether they have chest pain. In the absence of features of a heart attack an abnormal result suggests that the heart is inflamed or unwell causing the release of high sensitivity troponin.\nPatients will be recruited on a consecutive basis over the course of six months in order to collate information for the study analysis. The clinical course and changes in high sensitivity troponin will be followed during the intensive care admission to see whether changes in the result reflect the patient’s clinical progress. Additional high sensitivity troponin tests will be added onto blood tests (if not already requested) on day one and two, and then every other day after that for the duration of the patient’s intensive care admission. Long term mortality status checking will be carried out via linkage with the ONS mortality information held by NHS Digital.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust "]
["Contact Name","Dr Jonathan Hinton, Cardiology Registrar"]
["Address","Coronary Research Group, Level D East Wing, University Hospital Southampton"]
[null,"Tremona Road"]
[null,"Southampton"]
["Postcode","SO166YD"]
["Telephone",2381208535]
["Email","j.hinon1@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult patients (aged 18 years and over) admitted to one of the three adult intensive care areas (general, cardiac or neuroscience) that have biochemistry blood samples taken as part of their routine care. Recruitment will run over a six month period and consecutive patients will be enrolled in the study. It is anticipated that 1500 – 1750 patients would be recruited."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes set out. Access to the full patient record would be required in order to extract the relevant clinical information required for analysis:\n NHS Number – sample validation,\n Hospital Number – sample validation and linkage to records,\n Date of birth – analysis,\n Date of death – analysis,\n Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-12-04"]
["Next Review Date","2024-12-04"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee (Pending).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University Hospital Southampton NHS Foundation Trust has a published satisfactory reviewed grade on Version 14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02313","index":356,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02313"]
["Reference","18/CAG/0177"]
["Other Refs","IRAS project ID: 235911, REC reference: 17/WM/0432"]
["Application Title","Evaluation of the medium to long term impact of commercial open-group behavioural weight loss programmes on body weight and diabetes risk in adults with overweight and obesity."]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research which aimed to undertake five and 10 year follow-up of participants within the WRAP (Weight Loss Referrals for Adults in Primary Care) trial. The WRAP trial involved the referral of patients to commercial open-group behavioural weight loss programmes, such as Weight Watchers, to help them lose weight and reduce risk factors for diseases including diabetes, cardiovascular disease and some cancers. The WRAP trial is one of only two trials of this type of programme that has measured weight at a two-year follow-up and has also measured diabetes-related outcomes. It is also larger and has a considerably higher retention rate that the other trial at two years (68% versus 26%). Modelling of the long term impact of these programmes on illnesses and related treatment costs suggests that these programmes are likely to be cost-effective in the long term for adults who are overweight or obese. However, no trials of this type of intervention have measured outcomes beyond two years and uncertainty over the long-term impact of these programmes on body weight, diabetes, and other obesity-related conditions, limits the strength of evidence. It is explained that by undertaking five and 10 year follow-up to evaluate the trial objectives in order to provide valuable information weight regain and diabetes incidence in the medium-term and will enable more realistic estimation of long-term impacts on disease incidence and associated resource use.\nThe purpose of the application to CAG is to undertake tracing via NHS Digital in order to update contact information for participants in the original trial to ensure that invitations to participate in the follow-up study are correctly directed, or not sent to patients who have died in the intervening period. NHS Digital had confirmed that the consent which was previously taken is sufficient to legitimise the follow-up via records; however, it does not extend to cover the validation of contact details."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Amy Ahern, Chief Investigator"]
["Address","MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine"]
[null,"Box 285 Institute of Metabolic Science"]
[null,"Cambridge Biomedical Campus, Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","+44 (0)1223 330315"]
["Email","amy.ahern@epid.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Participants who took part in the original WRAP study and consented for further follow up will be invited to attend the 5-year and 10-year follow up visits. 1040 participants had consented to further follow-up from the original 1267 baseline cohort."]
["Description of confidential patient information used","The following items of confidential patient information are required in order to validate the patient cohort, update the contact details and facilitate the invitation process for the follow-up study:\n Name – sample validation and tracing via NHS PDS,\n GP Registration – sample validation,\n Date of birth – sample validation and tracing via NHS PDS,\n Date of death – sample validation,\n Full address and postcode – sample validation, tracing via NHS PDS and invitation process."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-12-10"]
["Next Review Date","2024-12-10"]
["Notes","Specific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 08 December\n2017).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed – NHS Digital has a\npublished satisfactory reviewed grade on V14.1 2017/18)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02314","index":357,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02314"]
["Reference","17/CAG/0160"]
["Other Refs","IRAS project ID: 205376"]
["Application Title","The HOME Study: A study comparing two different ways of looking after older people in hospitals to see if we can improve how quickly they go home."]
["Application Summary","This NIHR-funded study from the University of Oxford set out the purpose of testing a\npsychiatric approach to the identification and management of psychological problems, to\nsee if it enables faster discharge for older people on acute general hospital wards.\nDementia, confusion, depression and anxiety often contribute to a longer hospital stay,\nbut are missed in wards which focus mainly on physical symptoms. Patients would be\nrandomly allocated to receive the usual care or usual care plus the new approach, which\nwould involve seeing a doctor or nurse who specialises in psychological problems in the\nmedically ill.\nSupport was requested in order to identify participants and subsequently seek their\nconsent. The applicant proposed to screen patient notes as soon as possible following\nadmission to hospital, and to approach eligible patients for consent. Researchers would\nbe embedded within the clinical care team during the recruitment period.\nData concerning those who did not give consent to participate would be retained in order\nto assess the generalisability of the study findings. The applicant confirmed in response\nto queries that this would be pseudonymised to age and gender, and destroyed at the\nsame time as personal data for trial participants, however further clarification may be\nrequired in relation to when the pseudonymisation will take place.\nThe study would take place in England and Scotland – CAG support was requested\nfor England only.\nSupport was requested to allow members of the wider research team (including research\nnurses, practitioners, assistants or doctors) access to patient medical records in order to\nscreen for eligibility for inclusion in the study.\nData would also be retained on those patients who do not consent to the study –\ndate of birth, gender and reason for non-participation.\nA recommendation for class 3 and 6 support is requested to select and contact\npatients to seek their consent, and to allow access to an authorised user for the\nabove purpose."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Prof Michael Sharpe"]
["Address","University of Oxford, University Department of Psychiatry"]
[null,"Warneford Hospital"]
[null,"Oxford"]
["Postcode","OX3 7JX"]
["Telephone"]
["Email","michael.sharpe@psych.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from patients meeting the following criteria:\n Male/Female inpatients on an acute ward at one of the three participating English\nsites,\n Have been admitted to hospitals non-electively,\n Be aged 65 or older,\n Be expected (by their clinical team) to remain an inpatient for at least 2 days from the\ntime of the baseline assessment,\n Be able to give informed consent or, if unable to give informed consent, a consultee or\nlegal representative advises that study participation is appropriate.\n3,244 patients will be recruited to the study; however, it is likely that a greater number of\nmedical records will need to be screened to identify eligible patients."]
["Description of confidential patient information used","Access to the full medical record will be required to screen for eligibility against the above\ncriteria.\nDate of birth will be used to confirm age and eligibility and retained to assess the\ngeneralisability of the research."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-10-25"]
["Next Review Date","N/A"]
["Notes","08 October 2020 - Support expired.\n\nSpecific conditions of support\n1. Support is not in place for the retention of date of birth of participants who did not consent – this must be reduced to age.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 6 October 2016.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. \nV14 Royal Devon and Exeter NHS Foundation Trust confirmed published and reviewed.\nV14 Oxford University Hospitals NHS Foundation Trust confirmed published and reviewed.\nV14 Cambridge University Hospitals NHS Foundation Trust confirmed published and reviewed."]

{"sheet":"A02315","index":358,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02315"]
["Reference","14/CAG/1041"]
["Other Refs","IRAS Project ID: 160671, REC number: 14/NW/1491"]
["Application Title","Missed Diagnostic Opportunities"]
["Application Summary","This application from the University of Manchester set out the purpose of reviewing General Practice patient records to study Missed Diagnostic Opportunities (MDO) to estimate the MDO rate in UK general practice. Patient safety and in particular the occurrence of medical errors, has received considerable global attention since the publication of the landmark report ‘To Err is Human’ in 1999. Within the range of possible errors, medication related errors and diagnostic errors have been identified as the most common types of error in the primary care (e.g. general practice) setting. Despite their potential for, and actual significant impact, diagnostic errors (now termed missed diagnostic opportunities (MDOs)) have received relatively limited attention by academic researchers. Data on the numbers, types and causes of such MDOs encountered in general practice are limited and there are no large-scale studies in the UK that provide an\naccurate measure of MDO and harm rates in UK general practice. From what is known\nglobally, it seems that MDOs are more common in general practice than in hospitals and\nthere is a wide range of estimates of the actual rate of harm. Recent work in the United\nStates combining data from three large studies puts the MDO rate at 5% of all patient -\ndoctor encounters, but similar data from the UK is lacking.\nClass 1, 5 and 6 support is being requested to allow access to an authorised user for the\nprocess of extracting and anonymising the information and to audit, monitor and analyse\npatient care and treatment."]
["Applicant Organisation Name"]
["Contact Name","Professor Stephen Campbell"]
["Address","The University of Manchester"]
[null,"7th Floor Williamson Building"]
[null,"Oxford Rd, Manchester"]
["Postcode","M139PL"]
["Telephone"]
["Email","stephen.campbell@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","General Practice patient records."]
["Description of confidential patient information used","Access was requested to General Practice patient records."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-03-09"]
["Next Review Date","N/A"]
["Notes","Only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nNo one had undertaken a study of diagnostic error in general practice in the UK before. By gaining section 251 approval we were able to undertake this novel and important piece of empirical research to inform practice. We produced a seminal piece of research that was cited as one of the top safety articles in 2021. We showed the error rate and where errors are most likely to occur which provides insight into the nature of errors and what causes them. In understanding these issues, we can design interventions to better support individuals (patients and clinicians as well as address any system issues (e.g. around test results). Without Section 251, this research would have been impossible. \n\nIncidence, origins and avoidable harm of missed opportunities in diagnosis: longitudinal patient record review in 21 English general practices - PMC (nih.gov)\n\nSpecific conditions of support\n1. Favourable opinion from REC Received 17th December 2014\n2. Confirmation of suitable security arrangements via IG Toolkit submission.\nConfirmed 9th March 2015"]

{"sheet":"A02316","index":359,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02316"]
["Reference","15/CAG/0131"]
["Other Refs","IRAS project ID: 173789, REC reference:15/NW/0233"]
["Application Title","Integrate"]
["Application Summary","This application from the University of Liverpool set out the purpose of a prospective study to develop an enhanced surveillance and management system. The study will identify and clinically investigate individuals with the symptoms of gastrointestinal illness, from oral notification of symptoms to laboratory investigation of samples. The integrated real-time, surveillance/diagnosis/investigation system was centred on the patient to detect community outbreaks sooner, enable Health Protection professionals and Environmental Health Officers to intervene quickly and to lessen short and long-term harm. To develop the integrate system, part one of the research was to conduct a retrospective study to identify high risk or high incidence through the analysis of public health surveillance data collected through a number of sources, including but not limited to NHS 111 and Public Health England. Part two of the study included contacting patients to seek consent to participate within the laboratory based studies.\nA recommendation for class 2, 4 and 6 support was requested to cover access to an authorised user to obtain and use information about the past or present geographical location and also to link patient identifiable information obtained from one or more source."]
["Applicant Organisation Name"]
["Contact Name","Professor Sarah J O’Brien"]
["Address","University of Liverpool"]
[null,"1-5 Brownlow Street,"]
[null,"Liverpool"]
["Postcode","L69 3GL"]
["Telephone"]
["Email","S.J.Obrien@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"Y","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study will identify and clinically investigate individuals with the symptoms of gastrointestinal illness, from oral notification of symptoms to laboratory investigation of samples."]
["Description of confidential patient information used","Access was requested to name, NHS number, date of birth and postcode."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-07-21"]
["Next Review Date","N/A"]
["Notes","Identifiers have been destroyed.   The sponsor representative of the data controller confirmed that the CI had left their employ, and that support could be ended as a result.\n\nSpecific conditions of support\n1. Amend ‘time work’ to ‘time off work’ within the patient information leaflet.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 19th March 2015 and amendment confirmed 15th June 2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 25th March 2015."]

{"sheet":"A02317","index":360,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02317"]
["Reference","15/CAG/0140"]
["Other Refs","IRAS project ID: 177759, REC reference: 15/EE/0207"]
["Application Title","Preceding paraneoplastic encephalitis in ovarian cancer"]
["Application Summary","This application for the University of Birmingham set out the purpose of an epidemiological case-control study to review the incidence of Paraneoplastic Encephalitis before the diagnosis of ovarian cancer. The study is to also examine the characteristics of the patient cohort and to identify the risk factors of developing an episode of Paraneoplastic Encephalitis in ovarian cancer. The study cohort will include all newly diagnosed cases with ovarian cancer during 1st January 2014 to 31st December 2014 from Birmingham Women’s NHS Foundation Trust, Sandwell and West Birmingham Hospitals NHS Trust and Birmingham and Solihull Mental Health NHS Foundation Trust. Confidential patient information will be extracted and linked on site with NCIN Public Health England data and once data linkage has been completed, the applicant will pseudonymised the data. The control group will be matched by age and socioeconomic status and selected from the same group of cases who were diagnosed with ovarian cancer within the same time period, but did not develop Paraneoplastic encephalitis.\nA recommendation for class 4 and 6 support was requested to cover access to an authorised user for the purpose of linking confidential patient information from Birmingham Women’s NHS Foundation Trust, Sandwell and West Birmingham Hospitals NHS Trust and Birmingham and Solihull Mental Health NHS Foundation Trust and also NCIN Public Health England."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Miss Kit Yi Wong"]
["Address","School of Clinical and Experimental Medicine"]
[null,"College of Medical and Dental Sciences, University of Birmingham"]
[null,"Edgbaston, Birmingham"]
["Postcode","B15 2TT"]
["Telephone"]
["Email","KYW485@student.bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Linking confidential patient information from Birmingham Women’s NHS Foundation Trust, Sandwell and West Birmingham Hospitals NHS Trust and Birmingham and Solihull Mental Health NHS Foundation Trust and also NCIN Public Health England."]
["Description of confidential patient information used","Access was requested to NHS number, date of birth, date of death and ethnicity. The applicant would require access to hospital medical records in order to review pathology reports, radiology reports and clinical summaries concerning the clinical symptomatology in each episode. The applicant confirmed that the identifiers will be removed once the data has been pseudonymised."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-09-08"]
["Next Review Date","NA"]
["Notes","Data controller confirmed June 2023 that study did not start therefore support can be expired.\n\nSpecific conditions of support\n1. Provide assurance that the applicant will be supervised by the clinical supervisor at all times when accessing and processing confidential patient information. Confirmed 21/07/2015\n2. Favourable opinion from a Research Ethics Committee. Confirmed 11/05/2015\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed 29/08/2015"]

{"sheet":"A02318","index":361,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02318"]
["Reference","15/CAG/0156"]
["Other Refs","IRAS project ID: 177351, REC reference: 15/EM/0159"]
["Application Title","A randomised controlled trial to test the effectiveness of GP-based text-message reminders to facilitate uptake of colorectal cancer screening in London"]
["Application Summary","This application from University College London (UCL) set out the purpose to\ninvestigate the effectiveness of a primary care-based text message reminder to\npromote CRC screening uptake in London. In England, the NHS Bowel Cancer\nScreening Programme (BCSP) aims to screen 60% of the eligible population every\ntwo years. Increasing evidence demonstrates that General Practitioner (GP)\nendorsement promotes CRC screening uptake and there is a growing interest in the\nuse of text message reminders to increase participation in cancer screening. The\nBowel Cancer Screening Programme does not routinely collect patient mobile\ntelephone numbers, and so the mobile numbers stored on the Primary Care\nPractices clinical system will be used. This study will be conducted in 180 primary\ncare practices in London and is expected to run for two months.\nEligible patients (i.e. patients who are being invited to participate in the bowel\ncancer screening programme for the duration of the study, registered with a\nparticipating GP practice) will be identified by a member of the direct care team at\nthe London Bowel Cancer Screening Hub. They will then be randomly allocated to\nreceive usual care (i.e. control) or usual care plus a primary care-based text\nmessage reminder to return their kit (if they have not done so already) seven weeks\nafter the kit was dispatched. The text message will act as a prompt to return the\ntests kits if they have not already done so.\nThe study will use a Patient Care Messaging (PCM) system (provided by an\nMHealth company i.e. iPlato), which provides a secure cloud based server which\nwill connect data between the London Bowel Cancer Screening Hub and the GP\npractices through the N3 server. iPlato will automatically match screening eligible\nindividuals to their GP records and randomise them to the control or intervention\ngroup (using CCG specific randomisation lists) within the server. In addition, the\nhub will include the kit return date for each participant matched with their GP\npractices data in order to make sure that people who have returned their kit will not\nreceive a text reminder.\nAt the end of the study the hub will send a fully anonymised dataset to the\nresearchers at UCL for analysis."]
["Applicant Organisation Name","University College London (UCL)"]
["Contact Name","Dr Christian von Wagner"]
["Address","Senior Lecturer in Behavioural Research in Early Diagnosis of Cancer"]
[null,"1-19 Torrington Place, University College London"]
[null,"Department of Epidemiology and Public Health"]
["Postcode","WC1E 6BT"]
["Telephone"]
["Email","c.wagner@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support is requested to allow the disclosure of confidential patient information from\nGP records and the London Bowel Cancer Screening hub to iPlato to enable them\nto link episode level data on screening participation with mobile phone records held\nby the GP."]
["Description of confidential patient information used","A recommendation for class 4 & 6 support was requested to cover access to NHS\nnumber, GP practice code, date of birth, consent status and mobile phone number."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-08-12"]
["Next Review Date","N/A"]
["Notes","June 2022 - Support Expired\nThe data were deleted in 2016 and only completely anonymised data remain.\n\nSpecific conditions of support\n1. Confirmation that the data being reviewed by researchers was fully anonymised.\nConfirmed 04/08/2015\n2. Confirmation should be provided that GP’s will be informed of all information going to\niPlato and be provided with information on registering patient objections. Confirmed\n04/08/2015\n3. Clarification to be provided on how iPlato will know if two participants live at the same\naddress if they have no access to addresses. Confirmed 04/08/2015\n4. Efforts should be made to engage with patients in relation to the study prior to the\nstart. Confirmed 04/08/2015\n5. Clarification regarding the requirement for deprivation scores. Confirmed 04/08/2015\n6. Favourable opinion from a Research Ethics Committee. Confirmed 04/08/2015\n7. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. Confirmed 04/08/2015"]

{"sheet":"A02319","index":362,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02319"]
["Reference","15/CAG/0157"]
["Other Refs","IRAS project ID: 149490, REC reference: 14/SC/1294"]
["Application Title","Case-control study for Campylobacter in the under 5s"]
["Application Summary","This application from University of Liverpool set out the purpose of an epidemiological case – control study to investigate children’s’ lifestyles, behaviours and environmental factors which made children ill from Campylobacter. The study would review the differences between children that have been ill with Campylobacter (cases) and those that have not been ill with diarrhoea and vomiting (controls). The research team would also examine the type of Campylobacter that infected the children and also assess the differences in awareness of food safety practices relating to chicken in the home and the value of preventing illness by estimating the amount that people would be willing to pay to avoid Campylobacter related illness.\nThe cases within this study would be identified by Public Health England through faecal samples that tested positive for Campylobacter. Letters of invitation and information leaflets will be sent to the parent/guardian of children with laboratory – confirmed cases from Public Health England. The application had sought s251 support to enable Public Health England to write to the identified cohort. This part of the application had been previously been approved at the April 2015 meeting.\nThe applicant had also previously sought s251 support for the purpose of obtaining contact details from the Health and Social Care Information Centre (HSCIC) in order for the research team to write to healthy individuals to ask them to participate within the study. The applicant had confirmed that confidential patient information for all children under the age of 5 would need to be extracted from all English NHAIS systems. This part of the application was not approved at the April 2015 meeting.\nThe application for s251 support was first reviewed through the precedent set process and was deferred to the April 2015 meeting by the chair. The applicant resubmitted the application to the July meeting to provide additional information as specified within the letter dated 18th May 2015.\nA recommendation for class 2, 3 and 6 support was requested to allow access to an authorised user for the purpose of obtaining and using information about past or present geographical location and also to select and contact patients to seek consent."]
["Applicant Organisation Name"]
["Contact Name","Professor Sarah J O'Brien"]
["Address","University of Liverpool, Institute of Infection and Global Health"]
[null,"The Farr Institute @ HeRC, Waterhouse Building (Block F)"]
[null,"1-5 Brownlow Street, Liverpool"]
["Postcode","L69 3GL"]
["Telephone"]
["Email","S.J.Obrien@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A recommendation for class 2, 3 and 6 support was requested to allow access to an authorised user for the purpose of obtaining and using information about past or present geographical location and also to select and contact healthy control cohort patients to seek consent."]
["Description of confidential patient information used","Access was requested for the Health and Social Care Information Centre (HSCIC) to access name, address and age in years and months for the healthy control cohort."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-12-02"]
["Next Review Date","N/A"]
["Notes","Identifiers have been destroyed.   The sponsor representative of the data controller confirmed that the CI had left their employ, and that support could be ended as a result.\n\nSpecific conditions of support\n1. Confidential patient information should only be retained until the activity of selecting and contacting patient had been completed. The identifiers should not be retained for the duration of the study or the specified retention period for the overall study data. Confirmed 22/10/2015\n2. The CAG sub-committee recommended that the letter be updated in line with their suggestions as noted above and that the REC review the updated letter again. Confirmed 22/10/2015\n3. Favourable opinion from a Research Ethics Committee. Confirmed\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed by the HSCIC on 25th March 2015\nUPDATED specific conditions of support\n5. Revision of the patient leaflet for factual accuracy to reflect correct approver and scope of support. Copy to be provided to CAG in 10 working days (updated)\n6. Confirmation from the REC that an amendment is or is not required in relation to the leaflet amendment, and copy of the favourable amendment outcome from the REC within one month (updated)"]

{"sheet":"A02320","index":363,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02320"]
["Reference","15/CAG/0184"]
["Other Refs","IRAS project ID: 159209, REC reference: 15/YH/0426"]
["Application Title","Young people with Attention Deficit Hyperactivity Disorder (ADHD) in transition from children’s services to adult services (CATCh-uS): a mixed methods project using national surveillance, qualitative and mapping studies."]
["Application Summary","This application from University of Exeter Medical School set out the purpose of\nutilising the BPSU surveillance methodology and Child and Adolescent Psychiatry\nSurveillance Service (CAPSS) to focus on young people with Attention Deficit\nHyperactivity Disorder (ADHD) when they are too old to stay with children’s\nservices. Existing work suggests that Young People with ADHD are particularly\nlikely not to transfer to adult mental health services but there has yet to be an in\ndepth study of this issue in the UK.\nThis project has two main streams of research. A six months surveillance study of\nYoung People with ADHD on medication that are within six months of the age\nboundary for discharge from their children’s service with a nine month follow-up to\nfind out where these Young People were transferred to. The surveillance element of\nthe study will run in parallel through the Child and Adolescent Psychiatry\nSurveillance Service (CAPSS) and the British Paediatric Surveillance Unit (BPSU).\nEach month these units will mail a tick box response card to all consultant\npaediatricians and child psychiatrists in the UK and ROI. Consultants will report\nwhether, within the last month, they have seen a young person who needs ongoing\nmedication for ADHD and is within six months of the age boundary for their service.\nReporting clinicians will be sent a baseline questionnaire to confirm the eligibility of\nthe case, collect details about current treatment and comorbidity and collect minimal\nidentifier details to allow linkage to follow up reports. Additionally, researchers will\nask for contact details of the adult service to whom they referred, ask them to\nevaluate the different aspects of an optimal transition and whether they are willing\nto be interviewed. After nine months, a follow-up questionnaire will be sent to each\nreporting clinician for each reported case to establish if the young person was\nsuccessfully referred to adult services.\nThe other elements of the study do not require s251 support as they do not involve\nthe use of clinical data without consent. Five Trusts will act as recruitment centres.\nPractitioners from these recruitment sites will scan their patient database for eligible\nyoung people. The research nurses enrolling participants will only be informed\nabout and approach individuals who have indicated via a discussion with their\nclinician that they would be happy to have a conversation with a research nurse\nabout the study. The research team will then conduct interviews with Young People\nand health care professionals to explore their views and experiences of the\ntransition between children’s and adult services. Finally the study will map services\navailable for young adults with ADHD.\nA recommendation for class 5 and 6 support was requested to cover access for\nauditing, monitoring and analysing patient care and treatment and to allow access\nto an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","University of Exeter Medical School"]
["Contact Name","Professor Tamsin Ford"]
["Address","University of Exeter Medical School"]
[null,"Rennes Drive"]
[null,"Exeter"]
["Postcode","EX4 4RN"]
["Telephone"]
["Email","t.j.ford:exeter.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Young People with ADHD on medication that are within six months of the age boundary for discharge from their children’s service with a nine month follow-up to find out where these Young People were transferred to."]
["Description of confidential patient information used","Access was requested to NHS number, Hospital number, first four digits of the\npostcode, gender, age in years, ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-11-03"]
["Next Review Date","2016-11-03"]
["Notes","Specific conditions of support\n1. Confirmation was required that information about the study would be provided to\npatients and the public on a public facing website. Confirmed\n2. Favourable opinion from a Research Ethics Committee. Confirmed\n3. Confirmation from the IGT Team at the Health and Social Care Information\nCentre of suitable security arrangements via Information Governance Toolkit\n(IGT) submission. only NHS Devon Partnership Trust will be processing\nidentifiable information - Confirmed 15/10/2015"]

{"sheet":"A02321","index":364,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02321"]
["Reference","15/CAG/0192"]
["Other Refs","IRAS project ID: 144367/851360/839, REC reference: 15/NW/0061"]
["Application Title","Outcomes of adolescents transitioning from children's ADHD services"]
["Application Summary","This application from Central Manchester University Hospitals NHS Foundation Trust set out the purpose of a follow up for a group of adolescents (100) discharged from ADHD services at the age of 18 years. It is hypothesised that there will be a relationship between discharge from child ADHD services and an increasing incidence of young people presenting in crisis situations having disengaged from adult ADHD services.\nIt aims to identify the following:\n Is there an association between discharge from child ADHD services and increased incidence of young people presenting in crisis situations and within the criminal justice system, substance misuse services and social care services?\n Outputs will inform the next study, which will add to the growing body of knowledge which is aiming to improve CAMHS to Adult Mental Health Service (AMHS) transitional services.\nA recommendation for class 1 and 6 support was requested to cover the activity specified in the application"]
["Applicant Organisation Name","Central Manchester University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Louise Theodosiou"]
["Address","North Manchester CAMHS"]
[null,"The Bridge, Madison Place"]
[null,"Central Park"]
["Postcode","M140 5DP"]
["Telephone"]
["Email","louise.theodosiou@cmft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ADHD nurses at the 5 sites (Salford, Emerge, North, South and Central Manchester as per the protocol) will identify the potential participants. Following the opt-out consent process, the Chief Investigator will collect follow-up data for participants whom have not exercised the opt-out option.\nThe cohort will be aged 18-21 and are adolescents who were discharged from the five ADHD services (Salford, Emerge, North, South and Central Manchester) at the age of 18yrs between the two year period from 01/04/12 to 01/04/14.The ADHD nurses from each site will write to 50 participants from each site to obtain a sample of 20 from each site after the opt-out option. The applicant will obtain follow-up date from / access the records of these 100 patients from the following data bases: CAMHS(CORC) Adult psychiatry and liaison service (AMIGOS AND ICIS), Adult ADHD service, criminal justice system, substance misuse service and social care\ndatabase. This access is indicated to be provided via organisational approval and outside of CAG scope to provide support)"]
["Description of confidential patient information used","Support is requested to enable disclosure of NHS Number and name to the Chief Investigator to enable the linkages. Gender and occupation would be retained for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-02-05"]
["Next Review Date","N/A"]
["Notes","The dataset containing the identifiable data collected i.e. NHS number and name, was deleted at the end of the study, as it was no longer required.\n\nSpecific conditions of support\n1. Clarification that the identifiers requested are sufficient to achieve the linkage purposes. The response confirmed that NHS number and name would be sufficient.\n2. Where access to data sources (e.g. criminal justice system) is indicated to be provided via organisational approval, access to these will not be undertaken under this approval, namely Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002\n3. Provision of a favourable opinion letter from a Research Ethics Committee – provided 05/02/2015\n4. A satisfactory score of 75% for Central Manchester University Hospitals NHS Foundation Trust was noted.\n5. An update participant invitation letter was provided in response to this outcome. The applicant should contact the REC to identify whether this change requires REC review or amendment."]

{"sheet":"A02322","index":365,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02322"]
["Reference","15/CAG/0195"]
["Other Refs","IRAS Project ID: 180646/848125/4/52, REC number: 15/LO/1861"]
["Application Title","The DESiGN Trial Detection of small for gestational age fetus (SGA) – a cluster randomised controlled trial to evaluate the effect of the Growth Assessment Protocol (GAP) programme"]
["Application Summary","The Growth Assessment Programme (GAP) aims to improve the identification of small\nbabies by considering maternal characteristics such as size and ethnicity when assessing\ngrowth. Evidence from only observational studies suggest that GAP is better at identifying\nbabies at risk. However, a key concern is that adjustment for maternal ethnicity, some very\nsmall or very large babies might be missed or wrongly identified. Correct identification of\nsmall babies is fundamental as appropriate management and follow up reduces their risk\nof a stillbirth. Therefore, a well- designed clinical trial is needed to assess if GAP is better\nin identifying small babies.\nHospitals are randomised, rather than individual women who will receive the care\nallocated to their hospital avoiding contamination of the intervention. All maternity units in\nthe trial will introduce the GAP programme eventually, but one group will use GAP\nimmediately, while the other group will delay implementation of GAP. The time before the\nintroduction of GAP in the delayed arm means the applicant can compare maternity units\nusing GAP with those continuing with usual care.\nThe primary objective of the study is:\n to determine whether implementation of the GAP programme will result in an improved\nantenatal detection of small infants\n to investigate the effect of the intervention on short-term maternal and neonatal\noutcomes\n to estimate the impact of GAP on clinical service provision and health economics.\n to assess fidelity and quality of implementation, acceptability and identify contextual\nfactors associated with variation in outcomes of GAP\nInterviews will be undertaken on a consented basis.\nA recommendation for class 1, 3 and 6 support was requested to enable the activity\nspecified in the application."]
["Applicant Organisation Name","King’s College London"]
["Contact Name","Dr Dharmintra Pasupathy"]
["Address","Division of Women's Health, Women's Health Academic Centre KHP"]
[null,"10th Floor North Wing, St. Thomas' Hospital"]
[null,"Westminster Bridge Road, London"]
["Postcode","SE1 7EH"]
["Telephone"]
["Email","Dharmintra.Pasupathy@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients on maternity wards (hospitals are randomised)."]
["Description of confidential patient information used","Data on few secondary outcomes, such as clinical detection of SGA and compliance\nassessment, are not routinely available in the hospital systems. To collect this data the\nresearch team will need to review notes of participants. In order to reduce the number of\nnotes to review they will restrict the review to participants that had an SGA infant and they\nwill need to use participant identifiers to select the notes to review"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-05-09"]
["Next Review Date","N/A"]
["Notes","This application was superseded by 18/CAG/0050\n\nNo specific conditions of support."]

{"sheet":"A02323","index":366,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02323"]
["Reference","15/CAG/0205"]
["Other Refs","IRAS project ID:184451"]
["Application Title","Use of a frailty index in end of life care"]
["Application Summary","This application from Newcastle University sets out the purpose of the researcher aiming\nto help GPs identify and assess the severity of frailty amongst their patients; researchers\nhave put together a simple tool in one of the GP computer systems. An electronic frailty\nindex (eFI) is calculated, by using information from patients’ electronic health records.\nThe research in this proposal will look at whether and how the eFI would be useful to help\nGPs to identify their frail, older patients who may be approaching the end of life.\nThe researchers have already looked at how the eFI changes in the last few months of\nlife. They now plan to go on to see if the eFI could signal the point at which palliative care\nshould be considered. First, they will examine a selection of patient notes, to see if they\ncan detect any links between the frailty score, GP treatments and current\nrecommendations for palliative care. Second, they will interview GPs to find out if they\nwould find a frailty score easy to understand, and useful in practice. The researchers will\nuse the findings of the research to begin to influence what GPs do on a day to day basis,\nand also to develop future research.\nA recommendation for class 1 and 6 support was requested."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Professor Barbara Hanratty"]
["Address","Institute of Health & Society and Newcastle University Institute for Ageing"]
[null,"Newcastle University, Campus for Ageing and Vitality"]
[null,"Newcastle upon Tyne"]
["Postcode","NE4 5PL"]
["Telephone"]
["Email","barbara.hanratty@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Deceased patients"]
["Description of confidential patient information used","Access was requested to the electronic health records of deceased patients."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2016-03-14"]
["Next Review Date","N/A"]
["Notes","Supported expired as of 31 December 2017. Application activity under support was not started.\n\nSpecific conditions of support\n1. Confirmation that information about the study will be made available via the\norganisation’s web sites. Confirmed 3/02/2016\n2. Favourable opinion from a Research Ethics Committee. Confirmed 3/02/2016\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of\nsuitable security arrangements via Information Governance Toolkit (IGT) submission.\nAdvice from the HSCIC; the applicant should include statements from each of the\norganisations they are working with, that they are happy that the research is covered\nunder their IG Framework. (referencing in this section the advice sought from CAG\nand HSCIC). Confirmed 3/02/2016"]

{"sheet":"A02324","index":367,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02324"]
["Reference","16/CAG/0016"]
["Other Refs","IRAS project ID: 192649, REC reference: 16/LO/0155"]
["Application Title","The Survey of the Mental Health of Children and Young People 2016"]
["Application Summary","This application from NatCen Social Research set out the purpose of this study, which is the latest in a series of national social surveys focusing on the mental health of children and young people in the general population of England and Scotland. It has been commissioned by the Health and Social Care Information Centre with funding from the Department of Health and aims to estimate the prevalence of mental health conditions in children and young people aged 2-19.\nThe survey involves collecting information about health and wellbeing from:\n- parents/carers of children and young people aged 2-19,\n- young people aged 11 and over,\n- teachers of children and young people aged 5-16.\nAll selected participants will be sent an advanced letter about the research. Following this letter, an interviewer will call at the address and leave a leaflet explaining more about the research. For those who consent to take part, information will be collected from parents, carers and young people in their own homes using a computer assisted personal interview (CAPI) administered by a trained social survey interviewer. Information will be collected from teachers using an online questionnaire.\nThe interview with parents, carers and young people will focus on many different aspects of health - both physical and mental - as well as subjective wellbeing, use of services, risk and protective factors (such as neighbourhood context and social support, among many other things) and standard sociodemographic factors (e.g. age, sex and employment status of parents). Interviewers are trained social survey interviewers, many of whom will have previously worked on surveys involving children and or covering sensitive issues.\nThe survey findings will support the planning, commissioning and improvement of services across mental health, care and education from 2018 onwards. The up to date information will allow resources to be better targeted and more responsive to the mental health and well-being needs of children and young people.\nA recommendation for class 3 and 6 support was requested to cover access to Name, address, including postcode, age and sex."]
["Applicant Organisation Name","NatCen Social Research"]
["Contact Name","Helen Henderson"]
["Address","NatCen Social Research"]
[null,"35 Northampton Square"]
[null,"London"]
["Postcode","EC1V 0AX"]
["Telephone"]
["Email","Helen.Henderson@natcen.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The survey involves collecting information about health and wellbeing from:\n- parents/carers of children and young people aged 2-19,\n- young people aged 11 and over,\n- teachers of children and young people aged 5-16."]
["Description of confidential patient information used","Access was requested to name, address, including postcode, age and sex to be extracted from the HSCIC MIDAS system and passed from HSCIC to NatCen and ONS."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2016-06-30"]
["Next Review Date","2018-06-30"]
["Notes","Amendment request (Approved 14/09/2017)\nThe amendment request was for an extension to the end date of the study. Fieldwork had been due to take place September 2016-June 2017 – however, due to delays in the receipt of the sample this would now take place January 2017-September 2017. This would in turn delay the date for destruction of the following data: names and addresses of those who do not take part and of those who do take part but do not consent to data linkage or being contacted for follow up research. This would not be possible until the end of November 2017. Data reconciliation and data processing would take longer than anticipated due to previous survey delays and as such, the applicant proposed destroying names and addresses of those who take part but do not consent to data linkage or being contacted for follow up research by the end of January 2018.\nEarlier survey delays had also had a knock-on effect on completion of the project – the proposed final end date of archiving data would now be December 2018.\n\nSpecific conditions of support\n1. Change the timeframe from receipt of letter to interview to 10 days Confirmed 25/04/2016\n2. Clarify the ‘how to withdraw process’ should patients change their minds about the use of their data at a later point Confirmed 25/04/2016\n3. Amend the reference to the Health Research Agency to the Health Research Authority Confirmed 25/04/2016\n4. Favourable opinion from a Research Ethics Committee. Received 25/04/2016\n5. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries. Confirmed 18/03/2016"]

{"sheet":"A02325","index":368,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02325"]
["Reference","16/CAG/0125"]
["Other Refs","IRAS project ID: 190257, REC reference: 15/WM/0464"]
["Application Title","Does Learning to Perform Surgery on Cadavers Lead to Better Surgeons and Safer Patients?"]
["Application Summary","This research application from University of Warwick set out the purpose of a study that aims to measure the learning of junior surgeons-in-training as they perform their first few operations. The study will investigate whether doing a new training course using cadavers enhances this 'learning curve'.\nDue to changes in working regulations, today’s trainee surgeons will have had far fewer hours of experience in the operating theatre by the time they become consultants than in the past. There has been a change in the training culture in the modern NHS. One way of overcoming this problem is by using simulated surgery. One of the most promising simulation opportunities for learning surgery is found in using donated, deceased human bodies (‘cadavers’).\nA recent change in the law has allowed human cadavers to be used for training surgeons in the UK for the first time in history. It is not yet known whether this type of training will help young surgeons to learn operations more quickly and to a higher standard. Research is needed in order for the NHS and medical schools to spend public money providing simulation training facilities across the UK.\nA recommendation for class 1 and 6 support was requested to cover access to Hospital ID for the purpose of this medical educational research study that will involve Surgeons-in-training who are in their 3rd-5th year of training in the West Midlands area as participants."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Dr Hannah James"]
["Address","Room 10124, CSRI"]
[null,"Clinical Sciences Building, University Hospital Coventry & Warwickshire"]
[null,"Clifford Bridge Road, Coventry"]
["Postcode","CV2 2DX"]
["Telephone"]
["Email","hsmith2202@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The data that will be analysed will relate to those who have had an operation (dynamic hip screw fixation or hemiarthroplasty for fractured neck of femur, or open fixation of an ankle fracture) performed by the participating surgeons between September 2014 and August 2015."]
["Description of confidential patient information used","Access was requested to Hospital ID."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-02-27"]
["Next Review Date","N/A"]
["Notes","The only identifiers that were held related to ‘Hospital Number’ These have been deleted.  \n\nSurgical training is threatened by reduced working hours and a health service that is struggling. There is a need to maximise training efficiency to ensure the calibre of the future consultant surgical workforce is maintained to provide the best level of care for patients. One solution is using simulation as an adjunct to the traditional master-apprentice training model. Junior surgeons-in-training can be rapidly upskilled in the simulation laboratory, moving the early part of the learning curve away from patients. Cadaveric simulation is a type of surgical training that utilises deceased human bodies to teach operations. It is a particularly promising training technology as it provides a very realistic learning experience. We do not know if this type of training improves patient outcomes, or even if it is feasible to measure patient-level outcomes following a cadaveric simulation training intervention for junior surgeons.  \n \nA multicentre randomised controlled trial compared the performance of cadaveric vs standard-trained junior surgeons-in-training. The results showed that there were some improvements in implant position as measured from post-operative x-rays, across three common trauma operations for hip and ankle fractures, following cadaveric simulation training.  \n \nThis pragmatic trial was a piece of early feasibility work to inform future larger trials. These early results suggest that it is possible to measure patient-level benefit following a surgical training intervention. It also suggests that there could be measurable benefit in patient clinical outcome and cost savings for the health service if junior surgeons-in-training routinely received cadaveric simulation, which requires future large studies to investigate. \n\nSpecific conditions of support\n1. Provision of a favourable ethical opinion. Received\n2. Confirmation of satisfactory security arrangements via Information Governance Toolkit satisfactory review. Reviewed score published as satisfactory."]

{"sheet":"A02326","index":369,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02326"]
["Reference","16/CAG/0133"]
["Other Refs","IRAS project ID: 210327, REC reference: 16/WS/0189"]
["Application Title","Incidence of infectious disease in BME groups using Onomap"]
["Application Summary","This application from Public Health Wales set out the purpose of a proof of concept study. It confirmed that communicable diseases disproportionally affect certain\nethnic groups. Minority ethnic groups often have higher rates of infectious diseases\ndue to their links with countries where the prevalence of infectious disease is high.\nHowever, local transmission of infectious diseases may also cluster in ethnic\ngroups, reflecting social mixing. Understanding racial/ethnic variation in the\nincidence of infections in Wales is important to assist in the setting of priorities for\ncommunicable disease surveillance and control, for targeting interventions and the\nintroduction of new services for vulnerable population groups. However, to do this\nrequires information on the rates of infectious disease in specific ethnic groups.\n'Onomap' is a name-based ethnicity classification software package, developed at\nUniversity College London. The package comprises of over 1 million surnames and\n500,000 forenames derived from public registries from over 185 ethnic groups. The\nsoftware is used to classify a person into their most likely ethnic group based on\ntheir name.\nA recommendation for class 1, 4 and 6 support was requested."]
["Applicant Organisation Name","Public Health Wales"]
["Contact Name","Dr Daniel Thomas"]
["Address","Head of Surveillance - Health Protection division, Public Health Wales"]
[null,"Number 2, Capital Quarter, Tyndal Street"]
[null,"Cardiff"]
["Postcode","CF10 4BQ"]
["Telephone"]
["Email","daniel.thomas@wales.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data held on the Information Bureau of Infectious Diseases and Microbiology\nDatastore), both owned by Public Health Wales."]
["Description of confidential patient information used"," full name, (Onomap requires a full name (i.e. forename and surname) in\norder to assign ethnicity to an individual.)\n gender,\n date of birth/age,\n NHS number,\n postcode (or super output area). States postcode required to identify super\noutput area (SOA) of residence.\n disease or causative agent diagnosed/tested for and date of\ntesting/diagnosis (only people tested for/diagnosed between 1st January\n2014 and 31st December 2015, inclusive, will be extracted from these\ndatabases).\n Extraction of two years' data (1st January 2014 - 31st December 2015,\ninclusive) from the Information Bureau of Infectious Diseases (IBID) on\ncases of selected notifiable disease or causative agents.\n The applicant will also collect information from the microbiology datastore\non all those who underwent testing for a selected notifiable infectious\ndisease in Wales, irrespective of outcome, between 1st January 2014 and\n31st December 2015. The latter will be analysed to answer the secondary\nresearch objectives."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-04-05"]
["Next Review Date"]
["Notes","Applicant confirmed by email in July 2023 that ‘s251’ support could be expired, as of April 2017. It was established that the data controller did not consider this activity to be a breach of confidentiality, and ‘s251’ support was incorrectly applied for as not required originally. Confidential patient information was processed under the establishment order.\n\nSpecific conditions of support\n1. Support covers only the proof of concept study in relation to investigating hepatitis\ninfection. Any future study would require a new application.\n2. Favourable opinion from a Research Ethics Committee (received dated 20 October\n2016).\n3. Confirmation from NHS Wales Information Services that the CPiP assessment is\nsatisfactory, or steps will be taken to ensure it reaches a satisfactory level. Report\nreceived 28 March 2017.\n4. Security assurance level to reach 91% within one year from date of final approval. A\nreport confirming this to be provided at time of annual review. Liaison with NHS\nWales must be undertaken in advance to ensure the deadlines are met.\n5. There should be full compliance with regards to a mechanism to respect patient\nobjection.\n6. Age instead of date of birth to be processed."]

{"sheet":"A02327","index":370,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02327"]
["Reference","17/CAG/0009"]
["Other Refs","IRAS project ID: 203880, REC reference: 17/NW/0289"]
["Application Title","Risk factors for influenza-related complications in children"]
["Application Summary","This application from the University of Oxford set out the purpose of a study that\naims to find out which children are more likely to develop further complications if\nthey get flu or a flu-like illness. During the 2009/10 swine flu pandemic the public\nwere advised to avoid their GP and seek advice from the National Pandemic Flu\nService (NPFS). The NPFS kept records of which parents and children sought\nadvice regarding flu or flu-like illness. The NPFS did not collect information\nregarding which children went on to develop further complications or required\nhospitalisation.\nWhile the University of Oxford is not intending to receive identifiable information,\nthe study would involve two different organisations processing identifiable\ninformation held or received to achieve this purpose. Support was therefore\nrequested to provide a legal basis, in order to mitigate against a breach of\nconfidentiality, to enable the processing of the relevant information by the two legal\nentities for this purpose.\nA recommendation for class 1 and 6 support was requested to cover the following.\nThe NPFS will identify records of children who were assessed during the 2009/10\nswine flu pandemic. Information from the NPFS records will then be linked to\ninformation from children’s GP surgery records by NHS Digital."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Kay Wang"]
["Address","Nuffield Department of Primary Care Health Sciences"]
[null,"University of Oxford, Radcliffe Primary Care"]
[null,"Woodstock Road, Oxford"]
["Postcode","OX2 6GG"]
["Telephone"]
["Email","kay.wang@phc.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort is anticipated to be approximately 20,000 children aged 0-18 years old\nwho had flu or a flu-like illness during the 2009/10 swine flu pandemic for which\nthey or their parents sought advice from the National Pandemic Flu Service\n(NPFS)."]
["Description of confidential patient information used","The NPFS will extract the name, address, postcode, date of birth and\ngender, and transfer to NHS Digital. NHS Digital will use this information to trace\ntheir NHS numbers and link the NPFS service to their GP record.\n\nThe identifiers will be removed once the two datasets are linked and the research\nteam at the University of Oxford will not receive or access any confidential patient\ninformation."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-06-06"]
["Next Review Date","N/A"]
["Notes","The activity did not commence because of numerous complications with governance requirements required for the data linkage as detailed in email to REC on 28th August 2018.  Lack of certainty about timelines for establishing the linkage made it impossible to ensure that sufficient staff time would be available to conduct the analyses.\n\nSpecific conditions of support\n1. Written confirmation of the appropriate data controller (Public Health England) and\ndata processor relationships (NHS Digital) within the context of the Data Protection\nAct 1998. confirmed.\n2. Favourable opinion from a Research Ethics Committee. Received.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission. Received for NHS Digital and\nPublic Health England."]

{"sheet":"A02328","index":371,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02328"]
["Reference","16/CAG/0142"]
["Other Refs","IRAS project ID: 197678"]
["Application Title","Epidemiology of coeliac disease in Southern Derbyshire"]
["Application Summary","This application from Derby Teaching Hospitals NHS Foundation Trust set out the purpose of calculating mortality in coeliac disease, particularly with regard to malignancy. The clinician accessing the data would be using a database which he personally developed over many years. He stated that he was responsible for compiling a register of all patients with coeliac disease living in the Southern Derbyshire area from 1958 when coeliac disease was first diagnosed in adults in Derby, and had kept this up to date. There are now 2650 patients listed.\nThe data base would allow diagnostic trends through the years to be determined and the causes of death compared with the general population. It would also allow the epidemiology of coeliac disease to be determined in the Asian population of Southern Derbyshire. Results of the analysis would guide those health care workers involved in managing this condition and patients themselves about the frequency of diagnosis and risks to health and the best ways of managing this large group of individuals.\nFor this particular study the applicant wished to obtain mortality data from the HSCIC/NHS Digital, and for this he required support from CAG. He would provide identifiable data relating to deceased patients to ONS, in order to obtain the patient’s death certificate. The cause of death would be correlated with patient data held on the database. The applicant stated that only he would access the data, and that he would anonymise the data before publication of results.\nClass 1, 2, and 6 support was requested for the process of extracting and anonymising the information, to obtain or use information about past and present geographical location and to allow access to an authorised user for one or more of the above purposes."]
["Applicant Organisation Name","Derby Teaching Hospitals NHS FT"]
["Contact Name","Dr Holmes"]
["Address","Royal Derby Hospital"]
[null,"Uttoxter Road"]
[null,"Derby"]
["Postcode","DE22 3NE"]
["Telephone"]
["Email","geoffreyholmes@compuserve.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with coeliac disease living in the Southern Derbyshire area from 1958 onwards. 2650 patients listed."]
["Description of confidential patient information used","Access was requested to name, NHS number, Hospital ID number, date of birth, date of death and postcode in order for NHS Digital to link the data.\nName, date of birth, date of death, postcode, gender and ethnicity would be retained for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","11/10/2016"]
["Next Review Date","2017-10-11"]
["Notes","Specific conditions of support\n1. Assurance that the database will be pseudonymised.\n2. Favourable opinion from a Research Ethics Committee.\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Please see security review requirement section of the HRA website: http://www.hra.nhs.uk/resources/confidentiality-advisory-group/confidentiality-advisory-group-cag-application-advice/ and contact Exeter.helpdesk@nhs.net with any queries."]

{"sheet":"A02329","index":372,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02329"]
["Reference","17/CAG/0040"]
["Other Refs","IRAS project ID: 199067, REC reference: 16/NW/0503"]
["Application Title","Incidence Study of Birdshot Retinochoroidopathy in the UK V1"]
["Application Summary","This application from Moorfields Eye Hospital set out the purpose of establishing the incidence of Birdshort chorioretinopathy (BRC) which was a relatively new diagnosis. This was the first incidence study, and would set a baseline rate for comparison with future studies.\nBCR was an autoimmune inflammatory disease which caused slowly progressive visual dysfunction. It could be difficult to diagnose as early symptoms were not severe. Treatment often involved systemic immunosuppression, which carried a risk of significant side effects. The disease and treatment carried a high morbidity rate as well as psychological effects. The study would investigate risk factors using demographic and geographical data, and results of laboratory investigations.\nThe study would use the BOSU (British Opthalmological Surveillance Unit) reporting system, which has been developed in conjunction with the CAG and is approved in principle.\nOpthalmologists would be asked to report any cases of BCR diagnosed within the last month to the research team, who would then send a questionnaire to the clinician for each case they had reported. The clinician would return the questionnaire, containing pseudonymised data including demographic data and clinical data, to the research team for analysis. This questionnaire would be sent out again a year later.\nA recommendation for class 2 and class 5 support was requested to obtain and use information about past or present geographical location and for auditing, monitoring and analysing patient care and treatment"]
["Applicant Organisation Name","Moorfields Eye Hospital"]
["Contact Name","Mr Mark Westcott"]
["Address","Barts Health Care"]
[null,"Barts Hospital, West Smithfields"]
[null,"London"]
["Postcode","EC1A 7BE"]
["Telephone"]
["Email","Mark.Westcott@moorfields.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Opthalmologists would be asked to report any cases of BCR diagnosed within the last month to the research team."]
["Description of confidential patient information used","Access was requested to month and year of birth, sex, ethnicity and 1st half of postcode of the patient (returned from the clinician to the applicant on the questionnaire). The applicant would calculate the age of the patient and enter this onto their database in months, rather than month and year of birth, to reduce identifiability of the dataset.\nThe other details would be retained.\nPatients would be assigned a hospital ID number which would be kept to facilitate linkage for follow-up of patients after 1 year, when their clinician would be asked to return a second questionnaire."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-03-23"]
["Next Review Date","2018-03-23"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Favourable opinion letter provided by applicant.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmation provided via Exeter helpdesk, email forwarded from NHS Digital on 13 March 2017.\n3. Please note that approval only applies to England and Wales and the appropriate applications should be made for data processing in Scotland and Northern Ireland."]

{"sheet":"A02330","index":373,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02330"]
["Reference","17/CAG/0069"]
["Other Refs","IRAS project ID: 224432"]
["Application Title","Early identification of necrotising enterocolitis (NEC) in preterm infants"]
["Application Summary","This research study from Sheffield Teaching Hospitals NHS Trust set out the purpose of furthering knowledge of necrotising enterocolitis (NEC) in premature babies, to be achieved by a retrospective review of medical notes.\nNecrotising enterocolitis is one of the most common infections within premature babies worldwide. Causes of the infection are still not clear, and despite extensive research into preventative methods, the rates of infection, often resulting in long term complications and death, are still high. Long term implications could include further health complications that require longer hospital stays.\nThe research aimed to identify whether early clinical observations could indicate the severity and outcome of the disease, enabling earlier and more effective intervention. It was anticipated that it may be possible to create an additional diagnosis tool for systemic symptoms allowing the identification of NEC in infants earlier.\nMedical records would be accessed on site, and anonymised data extracted.\nClass 1 and 6 support was requested for the process of extracting and anonymising the information and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Trust"]
["Contact Name","Miss Megan Greasley"]
["Address","School of Health and Related Research (ScHARR)"]
[null,"30 Regent Street"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone"]
["Email","mgreasley1@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from Sheffield Teaching Hospitals NHS Trust in relation to preterm infants that were diagnosed with NEC at the Sheffield Teaching Hospitals Neonatal Unit between 1st January 2014 and 31st January 2017."]
["Description of confidential patient information used","The full medical record would be accessed by the researcher.\nData fields to be recorded were listed at Q14 on the IRAS form. No identifiers would be retained for analysis other than gender."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-06-06"]
["Next Review Date","2018-06-06"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 18 May 2017.\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. V14 published on website, confirmed reviewed as satisfactory."]

{"sheet":"A02331","index":374,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02331"]
["Reference","17/CAG/0075"]
["Other Refs","IRAS project ID: 211962, REC reference: 17/NW/0095"]
["Application Title","Incidence of JLSE in CYP and their access to care in the UK and ROI"]
["Application Summary","This research application from the University of Liverppol set out the purpose of determining the incidence of Juvenile-onset Systemic Lupus Erythematosus (JSLE) or ‘childhood lupus’ – a rare disease where the immune system attacks the body.\nThis disease was difficult to diagnose and its effects could vary from mild to severe. The study aimed to increase knowledge of the number of cases, how long it took to diagnose, the impact of new diagnostic criteria, the severity of the disease effects, and treatments used within the first year.\nThe study would use the BPSU ‘orange card’ reporting system, a compulsory reporting system which enabled study of rare conditions. Paediatricians in the UK would be obliged to report to the BPSU whether or not they had come across a case of the condition listed (in this case JSLE). The clinician details would be passed from the BPSU to the research team, who would send a questionnaire to the clinician, requesting minimally identifiable, clinical information on the patient.\nFor this particular study the researcher would also identify other clinicians who might see patients with JSLE, through the British Society for Paediatric Dermatology (BSPD), the British Association for Paediatric Nephrologists (BAPN), the British Isles Lupus Assessment Group (BILAG) and the Barbara Ansell National Network for Adolescent Rheumatology (BANNAR) group. These clinicians would be asked to report all new cases meeting the surveillance case definition directly to the study team, who would proceed to send the questionnaire as above.\nA recommendation for class 1, 2, 4 and 6 support was requested for the process of extracting and anonymising the information, to obtain and use information about past or present geographical location, to link patient identifiable information obtained from more than one source and to allow access to an authorised user for one or more of the above purposes"]
["Applicant Organisation Name","University of Liverppol"]
["Contact Name","Dr Hanna Lythgoe"]
["Address","University of Liverpool, 1st Floor, Institute In The Park"]
[null,"Alder Hey Children's Hospital"]
[null,"Eaton Road, Liverpool"]
["Postcode","L12 2AP"]
["Telephone"]
["Email","hannalythgoe@doctors.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from clinicians in relation to children identified by clinicians as having Juvenile-onset Systemic Lupus Erythematosus (JSLE) or ‘childhood lupus’."]
["Description of confidential patient information used","Partial date of birth (month/year), date of death, NHS number and partial postcode (first part only).\n\nAmendment 15/11/2017\nApplication chanmged so researchers can store NHS numbers and full date of birth in order to follow up participants. This data would be stored separately to the dataset for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-08-04"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2022 that support can be expired as the data is anonymised. \n\nIn terms of public benefit, findings of the study include the incidence of lupus, challenges in classification of lupus, the ongoing high steroid burden and disease damage one year after diagnosis. The data is important to developing future studies in lupus to improve outcomes in JSLE such as through the Treat to Target Lupus programme of research\n\n17 December 2020 - Amendment supported\nAmendment supported to allow the applicants to cross-check the NHS numbers of patients who were recruited to a consented cohort study (UK JSLE Cohort Study and repository) in order to count the number of patients included in the consented study who would also have been eligible for the non-consented study.\n\nAmendment request (Approved 15/11/2017)\nThe applicant had stated during the application process that they would not need to process full date of birth. Although date of birth would be reduced to month and year of birth before being stored for analysis, the applicant later realised that they would require complete date of birth to act as a back-up for the NHS number (in case of transcription error etc.) to allow them to remove case duplications. They would also need to store NHS numbers and full date of birth in order to follow up participants. This data would be stored separately to the dataset for analysis.\n\nSpecific conditions of support\n1. Please note that CAG approval applies to England and Wales only. Please confirm that approvals will be sought from the relevant bodies for any processing of data outside England and Wales, as the application refers to the UK and Ireland.\nThe applicant responded in a letter dated 17 May 2017:\n‘Approval for the study in Scotland has been approved through the Public Benefit and Privacy Panel through the BPSU. In Northern Ireland we will follow the well-established BPSU methodology under their guidance and support.’\nMembers reviewed this response and raised no concerns.\n2. The approach to patient notification for patients not referred by a consultant paediatrician should be described, including the route to be taken by these patients in order to opt out, and the procedure for ensuring that opt outs would be respected.\n‘The process of patients opting out would be the same in both systems. In addition to the general publicity of the study (detailed below) adult clinicians likely to see a case and not on the BPSU system will be sent the public information leaflets with each monthly email sent by the study team in order that they can be displayed and made available if needed. Patients wishing to opt out can do so by informing their local team. We are not asking them to directly inform patients about the opt out process, this is the same process approved for the BPSU. It is the responsibility of the treating clinician to ensure that any patient, who has advised their doctor (paediatrician/adult clinician) that they do not wish their information to be used in research/audit, is not notified to the study team.\nThe study will be publicised through a variety of methods likely to be seen by patients with lupus and/or their families including through LUPUS UK and the BPSU website to ensure that the general public are able to access details of the study. This will include details of how to contact the study team if further information is required and inform them that they must inform their doctor if they do not wish their medical records to be used for audit or research. The study team have no direct contact at all with patients and have no means to contact them at all’\nThe Sub-Committee reviewed this response and considered the approach to patient notifications and opt out to be satisfactory.\n3. Favourable opinion from a Research Ethics Committee. Confirmed.\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission.\nIt was noted that the IG Toolkit for Alder Hey Children’s NHS Foundation Trust had been reviewed as ‘Satisfactory with Improvement Plan’ by NHS Digital.\nThe Improvement Plan was provided to the Sub-Committee for review. It was noted that data flows were not clearly mapped and a request had been made for a flow mapping exercise to be undertaken in order to meet the following criteria:\n‘All transfers of hardcopy and digital person identifiable and sensitive information have been identified, mapped and risk assessed; technical and organisational measures adequately secure these transfers’. This would enable NHS Digital to assess the legal basis for all data flows.\nThe applicant undertook to complete this action by December 2017, and further training of staff would be complete by March 2018.\nThe Sub-Committee was happy with the applicant’s response and agreed to recommend support, subject to confirmation at annual review that all outstanding actions for the Improvement Plan had been complied with.\nAs the above conditions have been accepted and/or met, this letter provides confirmation of final approval. I will arrange for the register of approved applications on the HRA website to be updated with this information."]

{"sheet":"A02332","index":375,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02332"]
["Reference","17/CAG/0083"]
["Other Refs","previously 17/CAG/0022, IRAS project ID: 215262,REC reference: 17/SC/0042"]
["Application Title","Is the Current Threshold for Diagnosis of \"Abnormality\", including non-ST Elevation Myocardial Infarction, using Raised Highly Sensitive Troponin Appropriate for a Hospital Population? The CHARIOT Study"]
["Application Summary","This application from University Hospitals Southampton specified the following. The\ncurrent upper limit of normal for high sensitive troponin (Hs Trop) is derived from a healthy\npopulation aged 18-40. Any measurements above the upper limit of normal indicate the\npossibility of a heart attack when taken in the correct context. However, it is already\nknown that troponin levels can be high in certain individuals as a result of other causes.\nFactors that can influence a patient’s troponin include age, gender, infection, heart failure,\nhigh blood pressure, diabetes mellitus and inflammatory conditions. When the standard\nlevels used from a healthy population are applied to patients presenting to hospital,\npatients can be incorrectly diagnosed and treated as having a heart attack inappropriately.\nThis issue has been exacerbated by the new highly sensitive troponin blood tests being\nused in modern clinical practice\nThe CHARIOT Study aims to check the Hs Trop levels on patients who have already had\nblood tests undertaken as part of their routine clinical care. The study will not require any\nadditional blood samples to be collected. A total of 20,000 consecutive patients will be\nrecruited to the study with this number specified as required to give an accurate\nrepresentation of the levels of Hs Trop in the population of patients who are admitted and\ncared for in the hospital.\nThe aim of this study is to define the upper limit of normal for a high sensitive troponin\nlevel for a hospital population.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover the relevant\nactivities specified in the application."]
["Applicant Organisation Name","University Hospitals Southampton"]
["Contact Name","Dr Jonathan Hinton"]
["Address","University Hospitals Southampton"]
[null,"Coronary Research Group, Level D East Wing, University Hospitals Southampton"]
[null,"Tremona Road, Southampton"]
["Postcode","SO16 6YD"]
["Telephone",2381208535]
["Email","Jonathan.hinton@uhd.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort relates to all patients attending UHS and requiring biochemistry testing as part\nof their routine care; this includes all clinical presentations in the adult population."]
["Description of confidential patient information used","Access was requested to enable access to information related to the potential cohort. In\nparticular, this would involve access to NHS Number, Hospital Number (will be used to\naccess the electronic hospital records of patients recruited to the study), date of birth (to\nconfirm that the hospital number corresponds to the correct patient) and gender."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-05-19"]
["Next Review Date","2025-05-19"]
["Notes","15 July 2020 – Amendment supported to allow the disclosure of confidential patient information from University Hospital Southampton to NHS Digital in order to facilitate a further two and a half year mortality status follow-up via linkage with HES and ONS data.\n\n28 March 2019 - Amendment supported to allow the disclosure of specified items of confidential patient information from University Hospital Southampton to NHS Digital in order to facilitate one year mortality status follows-up via linkage with HES and ONS data.\n\nSpecific conditions of support\n1. Favourable opinion from a research ethics committee. Received.\n2. Confirmation from NHS Digital that the IG Toolkit submission has been reviewed\nand is considered satisfactory. Email received 19 May 2017 confirming version\n14 satisfactory from NHS Digital in relation to University Hospitals\nSouthampton NHS Foundation Trust.\n3. Explicit right of objection to be included in information made available to the\nrelevant population. Provided."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02333"]
["Reference","17/CAG/0105"]
["Other Refs","IRAS project ID: 222896, REC reference: 17/YH/0078"]
["Application Title","Cardiovascular markers of ischaemic stroke risk: a registry of stroke patients, their associated risk factors and cardiovascular investigations"]
["Application Summary","This application from Leeds Teaching Hospitals NHS Trust set out the purpose of medical research investigating the diagnostic yield of cardiac monitoring in the identification of atrial fibrillation in stroke patients. The project aims to review all patients admitted to Leeds Teaching Hospitals Trust with a diagnosis of ischaemic stroke between 2014 and 2015. The applicants will record the co-existing medical conditions of the patient cohort together with the cardiac investigations that were performed to create a detailed stroke database. With this data, the aim is to determine the diagnostic yield of cardiac monitoring in the diagnosis of atrial arrhythmia, look for any cardiac markers which may predict recurrent events and determine whether current risk scores such as CHA2DS2VASc could be used to identify those patients in sinus rhythm who go on to develop an ischaemic stroke.\nA recommendation for class 4, 5 and 6 support was requested to cover activities as described within the application."]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Trust"]
["Contact Name","Dr Muzahir H Tayebjee"]
["Address","Department of Cardiology"]
[null,"Great George Street"]
[null,"Leeds General Infirmary"]
["Postcode","LS1 3EX"]
["Telephone"]
["Email","muzahir.tayebjee@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The patient cohort for inclusion is all patients who were admitted to Leeds Teaching Hospitals NHS Trust with a diagnosis of ischaemic stroke between 01/01/2014 and 31/12/2015. This cohort encompasses 1,812 admissions (including 126 recurrent episodes)."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes identified:\n NHS number – data linkage,\n Study ID – data linkage,\n Sex – analysis,\n Patient age – at stroke event – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-09-21"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that section 251 support for this project can be ended.\n\nSpecific Conditions of Support\n1. Patient and Public Involvement and Engagement – provide a report back at first annual review around the additional activity which has taken place with the patient group as the study has progressed.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – 22 August 2017).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Leeds Teaching Hospitals NHS Trust shows a reviewed reported grade of 78% satisfactory on Version 14, 2016-17. The Phoenix Partnership shows a reviewed reported grade of 100% satisfactory on Version 14, 2016-17)."]

{"sheet":"A02334","index":377,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02334"]
["Reference","17/CAG/0106"]
["Other Refs","IRAS project ID: 218404, REC reference: 16/LO/2714"]
["Application Title","NICE Fit"]
["Application Summary","This application from Croydon University Hospital set out the purpose of determining whether the Faecal Immunochemical Test (FIT) could be used as an effective triaging tool to identify patients at risk of bowel cancer, avoiding the need for unnecessary endoscopic examination. This would ultimately reduce cost to the NHS and avoid risk and discomfort for patients.\nThere is currently no way to predict if a patient’s symptoms are due to bowel cancer, which means that patients presenting to their GP with bowel symptoms that warrant investigation are automatically referred for colonoscopy, which must be carried out within 2 weeks. Only 10-15% of these turn out to have underlying bowel cancer or significant pathology such as precancerous polyps. NICE guidelines stipulate a two week referral time for investigation of symptoms associated with a high probability of bowel cancer, and to improve pick up rates for bowel cancer widened the criteria for investigation in 2015 – resulting in a large number of unnecessary examinations. The FIT test is a one-off stool test that can be done by patients at home and has shown promise in predicting cancer in both the screening and symptomatic patient settings. It has been identified as a priority by NHS England as a technology that can improve early cancer diagnosis and save costs.\nThe FIT team would work with the cancer services team at Croydon Health Services NHS Trust to extract information on patients first referred by their GP, then triaged to undergo colonoscopy within 2 weeks. The team would obtain a list of eligible patients including addresses and basic demographics, send them the study information and testing kit by post and follow up with one phone call to discuss the study.\nA recommendation for class 3 and 6 support was requested in order to select and contact patients to seek their consent, and to allow access to an authorised user for this purpose."]
["Applicant Organisation Name"]
["Contact Name","Mr Muti Abulafi"]
["Address","Croydon University Hospital"]
[null,"530 London Road"]
[null,"Croydon"]
["Postcode","CR7 7YE"]
["Telephone"]
["Email","muti.abulafi@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from the Patient Tracking List (usually held by individual Trust cancer service offices) in relation to patients referred with suspected bowel cancer under the 2 week rule, who are triaged to undergo colonoscopy"]
["Description of confidential patient information used","Name\nHospital ID Number\nPostcode\nTelephone number\nDate of colonoscopy"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-06-26"]
["Next Review Date","2018-06-26"]
["Notes","Specific conditions of support\n1. Patient notification approach to be identified and progress to be reported back at annual review.\n2. Further public engagement work to be carried out and reported back at annual review.\n3. Favourable opinion from a Research Ethics Committee. Confirmed 8 June 2017.\n4. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. v14 confirmed published and reviewed"]

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[]
[]
["Application Number","02335"]
["Reference","17/CAG/0116"]
["Other Refs","IRAS project ID: 215639"]
["Application Title","The incidence, presentation, treatment, and motor outcomes of essential infantile esotropia in the UK"]
["Application Summary","This application from Cardiff and Vale University Health Board set out the purpose of\ninvestigating essential infantile esotropia or congenital esotropia, a large angle\naccommodative squint which develops within first six months of life. Reported incidence\nfrom population studies in the USA did not correspond with clinical experience in\nophthalmology departments in the UK, where the condition appeared to be rare and\ndeclining in incidence.\nThe study aimed to determine the number of incident cases of the condition, the\npresentation, treatment choice and early motor outcomes of cases in the UK. This would\nprovide better understanding of the epidemiology of the disease and guide future surgical\ndecisions.\nThe BOSU reporting card system, a methodology approved in principle by the CAG,\nwould be used: this is a compulsory reporting system for ophthalmologists who are\nobliged to report an incidence of any of the rare conditions currently under surveillance. In\nthis case when a case of congenital esotropia was encountered, the clinician would\nrecord this on a monthly reporting card which would be returned to BOSU. BOSU would\nthen notify the research team, who would send a questionnaire to every clinician for each\nreported case of this condition. Clinical data in relation to the patient would be entered on\nthe questionnaire and returned to the research team by the treating clinician. A follow-up\nquestionnaire is sent after a year.\nA recommendation for class 1 and 6 support was requested for the purpose of\nextracting and anonymising the information and to allow access to an authorised\nuser for the above purpose."]
["Applicant Organisation Name","Cardiff and Vale University Health Board"]
["Contact Name","Mr Patrick Watts"]
["Address","Cardiff and Vale University Health Board"]
[null,"B6, University Hospital Wales"]
[null,"Cardiff"]
["Postcode","CF14 4XW"]
["Telephone"]
["Email","patrick.watts@wales.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from treating ophthalmologists in relation to patients with non-accommodative, stable angle of esotropia, greater than 20 prism dioptres with an onset before 6 months of age in a neurologically normal child:"]
["Description of confidential patient information used","Hospital number, date of birth, ethnicity, gender and postcode."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-09-19"]
["Next Review Date","N/A"]
["Notes","Data analysis is complete and all patient identifiable material has been anonymised  \n\nThe study showed the incidence of essential infantile esotropia in the UK, and the practice pattern of management of essential infantile esotropia in the UK, the presenting features and outcome of treatment which have been presented at scientific meetings. A paper is in the process of being written.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed.\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission. See ‘Security Assurances’,\nbelow.\n3. Please note that the CAG recommendation applies to England and Wales only.\nApplications would need to be made to the appropriate bodies in Scotland and\nNorthern Ireland to cover any data processing in these locations."]

{"sheet":"A02336","index":379,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02336"]
["Reference","17/CAG/0117"]
["Other Refs","IRAS project ID: 208361, REC reference: 17/YH/0218"]
["Application Title","Prevalence and characteristics of fractures in preterm infants presenting to Accident and Emergency: A retrospective study."]
["Application Summary","This study from the University of Sheffield set out the purpose of determining if pre-term birth was a major cause for childhood fractures. The research team would look at whether there were any differences in clinical (including imaging) features of fractures presenting in accidental and inflicted injury in preterm children up to the age of 2. This would increase knowledge in this area, and was envisaged to be of particular use to doctors when deciding if a fracture with no other obvious explanation in a pre-term child was caused by accidental or inflicted injury.\nThe applicants proposed to collect information from records of physical examinations, blood tests and x-ray features of fractures in preterm children. Medical records of ‘term’ children would also be studied to compare the presentation of accidental and inflicted fractures to see if there were any differences.\nThe initial list of eligible patients would be obtained from the coding office at the hospital. Data would be collected on-site and anonymised, however it would be necessary to share data between sites in order to identify children who had been treated at both sites. This process would be managed by Dr Amakah Offiah. Each of the two other named members of the research team would work at one of the sites to identify participants, and would send NHS number, name and date of birth to Dr Offiah to enable her to identify the duplicates. Following this, a study number for these participants would be provided to both researchers.\nThe full medical record would be accessed onsite by the researchers in order to extract anonymised information for analysis.\nA recommendation for class 1 and 6 was requested for the purpose of extracting and anonymising the data and to allow access to an authorised user for the above purpose."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Ms Liting Tong"]
["Address","Room 15 Apt 3 The Bathfield"]
[null,"2 Powell Street"]
[null,"Sheffield"]
["Postcode","S37NX"]
["Telephone"]
["Email","ltong1@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from clinical notes at Sheffield Children’s Hospital Accident and Emergency Department and Jessop Hospital in relation to children (both term and preterm) below the age of 2, who have had either accidental or inflicted fractures and are otherwise healthy (selected from lists of children born at these sites between 2005 and 2015)."]
["Description of confidential patient information used","NHS number, name and date of birth would be accessed by one named researcher for participants from both sites in order to remove duplicate between sites and to check that the child was within the correct age range.\nClinical notes would be accessed on-site to extract the data in anonymised form."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-10-27"]
["Next Review Date","2018-10-27"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed.\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmation must be provided that v14 of the IG Toolkit is in place and has been reviewed as satisfactory. Nottinghamshire Healthcare NHS Trust, Mental Health Services Community and Palliative Care - Confirmed published and reviewed as satisfactory via email from NHS Digital.\nLetter re-issued 27 October 2017 with corrected version of Protocol in table of documents.\nThis supersedes the previous version of the final outcome letter dated 25 September 2017"]

{"sheet":"A02337","index":380,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02337"]
["Reference","17/CAG/0126"]
["Other Refs","IRAS project ID: 225416, REC reference: 17/ES/0088"]
["Application Title","Surveillance of Severe Microcephaly in the UK and Ireland (SSM-UKI)"]
["Application Summary","This application from University College London Great Ormond Street Institute of Child Health sets out the purpose of medical research into Microcephaly, which describes a baby with a ‘small head’, who has experienced poor head growth before or after birth. This rare condition may be associated with abnormal brain structure or development, and with disability, although some babies will develop normally. Many different causes of microcephaly have been described, including genetic disorders, exposure during pregnancy to environmental toxins, certain drugs, infection or malnutrition.\nThe study involves undertaking surveillance throughout the UK and Ireland through the British Paediatric Surveillance Unit (BPSU), a surveillance system for paediatric rare diseases. Questionnaires will be completed by clinicians (mainly paediatricians) participating in the BPSU system, who will retrieve information from routine hospital case notes. Over 13 months, we will collect reports of any newly diagnosed babies aged under one year and then collect follow-up information when these children are one and two years of age to find out about their subsequent health and development outcomes. The applicants also intend to validate the information received via the BPSU reporting with the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS), held by NHS Digital for English patients and Welsh Congenital Anomaly register (CARIS), held by Public Health Wales for Welsh patients. Linkage is also proposed with the Newborn Hearing Screening Programme (NHSP), held by Public Health England to determine whether any infants are identified through screening for a hearing impairment.\nThe applicants are requesting retention of patient identifiers until the children are 11 years of age to enable future linkage with educational outcome data. The request to retain the data forms part of this application; however, the future data linkage does not.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University College London Great Ormond Street Institute of Child Health"]
["Contact Name","Dr Rachel L Knowles"]
["Address","Population Policy and Practice Programme"]
[null,"UCL Great Ormond St Institute of Child Health"]
[null,"30 Guilford St, London"]
["Postcode","WC1N 1EH"]
["Telephone"]
["Email","rachel.knowles@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children in England and Wales aged under three years who are diagnosed with severe microcephaly during their first year of life during the 13 month surveillance period. An approximate sample size of 400 patients is required for the analysis."]
["Description of confidential patient information used"," NHS number – validation and retained for future linkage,\n Date of birth – validation, analysis and retained for future linkage,\n Date of death – validation and analysis,\n Sex – validation and analysis,\n Postcode (unit level) – validation, analysis and retained for future linkage,\n Ethnicity – for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2017-09-08"]
["Next Review Date","2024-09-08"]
["Notes","06 January 2020 – Amendment supported to revise the two-year follow-up questionnaire to improve the clarity and include additional questions about the cause of the microcephaly. \n\nSpecific Conditions of Support\n1. Support extends to England and Wales only.\n2. Support extends to the retention of confidential patient information as described in the application until patients reach 11 years of age in order to facilitate data linkage with the Department for Education. The additional future data linkage via the Department for Education is not included within this recommendation of support.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 31 July 2017)\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - University College London reviewed reported grade of 66% satisfactory on version 14, 2016/17)."]

{"sheet":"A02338","index":381,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02338"]
["Reference","17/CAG/0161"]
["Other Refs","IRAS project ID: 212510"]
["Application Title","Epidemiological surveillance of Fetal Alcohol Syndrome in the United Kingdom and the Republic of Ireland in children under 16 years of age"]
["Application Summary","This research application from Leeds Teaching Hospitals NHS Trust aimed to determine the incidence in the UK and Ireland of Fetal Alcohol Syndrome (FAS), a specific condition with a clear case definition. (The study would not look at other paediatric disorders caused by alcohol exposure during pregnancy).\nFetal Alcohol Syndrome (sometimes known as FAS) is a rare condition which occurs when the developing baby is exposed to alcohol in the womb. Alcohol can cross the placenta into an unborn baby's blood stream, affecting the development of the brain, leading to challenges in learning and development. Alcohol can also affect the development of other parts of the unborn baby’s body, particularly the face.\nExpected benefits from the collection of accurate incidence data included an increase in clinician awareness of FAS which could aid accurate and timely diagnosis, improved education and greater awareness of FAS among health care professionals leading to more confident counselling of pregnant women regarding alcohol use. This would improve the care offered to affected children and enable prevention of the disorder in future siblings. The incidence data would also allow for the necessary resources to be allocated for the development of specialised services to diagnose and manage the disorder.\nThe study would use the BPSU methodology, an established methodology already approved in principle by the CAG. A reporting card system is used: every month an electronic reporting card with a list of conditions currently under surveillance is sent to consultants and other specialists, who return the card notifying the BPSU of any cases they have seen, or stating that they have not seen any cases for this condition. BPSU pass the details of clinicians who have reported cases of the relevant condition to the researcher, who will send the clinician a questionnaire for each reported case, requesting pseudonymised, clinical data to be returned for analysis.\nData on births would be obtained from the ONS and relevant agencies in Scotland and Wales to inform estimates of birth prevalence (this would be anonymous data).\nClass 1, 2, 4 and 6 support was requested for the process of extracting and anonymising the information, to obtain and use information about past or present geographical location, to link patient identifiable information obtained from more than one source and to allow access to an authorised user for the above purposes."]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Trust"]
["Contact Name","Dr Kathryn Johnson"]
["Address","Leeds teachings Hospital NHS Trust"]
[null,"Leeds Neonatal Service, Leeds General Infirmary D floor. Martin Wing"]
[null,"Great George St. Leeds."]
["Postcode","LS1 3EX"]
["Telephone"]
["Email","kathrynjohnson1@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from paediatric clinicians in relation to all children up to the age of 16th birthday presenting with clinical signs of fetal alcohol syndrome as outlined in the case definition."]
["Description of confidential patient information used","Date of birth, sex, ethnic group, first half of postcode (district), NHS number (or equivalent), hospital number are collected.\nSector level postcode, ethnicity, and gender are retained for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-11-27"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that support for this project can be ended.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. Confirmed"]

{"sheet":"A02339","index":382,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02339"]
["Reference","17/CAG/0169"]
["Other Refs","IRAS project ID: 230702, REC reference: 17/LO/1361"]
["Application Title","Investigating an organ donation intervention in primary care: A single-practice feasibility study."]
["Application Summary","This application from University of Bedfordshire, part-funded by NHS Blood and Transplant, aimed to test the feasibility of using U.K. primary care settings to increase registration to the NHS Organ Donor Register (NHS ODR) by asking patients if they would like to join during consultations. This could potentially address the problem of low registration to the NHS ODR (currently only 35%).\nPrevious research has shown that this works effectively in the USA; however as it involves additional staff time and workload it is necessary to test the feasibility of the intervention in a UK setting. The intervention consists of three elements: training staff in organ donation information, the display of leaflets and posters in the waiting room and asking patients during consultations if they wish to join the register (also called prompted-choice). A single GP practice in Luton, U.K. has agreed to run the intervention for a three-month period.\nSupport was requested to allow the CI access to the patient database for the GP practice in order to set up a prompt on the system which would remind staff to ask the patient about organ donation and to fill in a short questionnaire which would later be extracted by the CI. The questionnaire would not contain any identifiers. Setting up this prompt was not expected to reveal identifiable patient information; however there was a possibility that there would be some incidental disclosure. There was also a potential disclosure when extracting information from the database – although the aim would be for the system to calculate age from date of birth, there was again a possibility of incidental disclosure.\nA recommendation for class 1 and 6 support was requested for the process of extracting and anonymising the information and to allow access to an authorised user for this purpose."]
["Applicant Organisation Name","University of Bedfordshire"]
["Contact Name","Miss Catrin P Jones"]
["Address","Institute for Health Research"]
[null,"University of Bedfordshire"]
[null,"Hitchin Road, Luton"]
["Postcode","LU2 8LE"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to data from Medici Medical Practice in relation to all patients registered at the practice."]
["Description of confidential patient information used","Support under s251 is requested because of the possibility of incidental disclosure primarily as the researcher will be setting up prompts in the patient database for staff to use in consultation.\nThere was also potential for incidental disclosure of age, gender and ethnicity of patients who registered onto the tissue bank, and brief incidental disclosure of date of birth before this was converted to age (the researcher aimed to set up the database to complete this action but could not yet ascertain whether this would be effective)."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2017-12-08"]
["Next Review Date","N/A"]
["Notes","Specific conditions of support\n1. Support is in place until 26 October (one year from the date of this letter). Any extension to the time period must be submitted as an amendment for CAG support.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 3 November 2017.\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. V14 for Dr AK Sahdev’s Practice confirmed published and reviewed on 6 December 2017"]

{"sheet":"A02340","index":383,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02340"]
["Reference","CAG 2-05(b)/2013"]
["Other Refs","IRAS Project ID: 101138/422284/4/657, REC number: 12/NW/0303"]
["Application Title","Pandemic Influenza Triage in the Emergency Department"]
["Application Summary","This application from the University of Sheffield detailed a prospective observational cohort\nstudy of patients attending emergency departments with suspected pandemic influenza so as\nto evaluate existing triage methods, identify clinical predictors of adverse outcomes and\ndevelop new triage methods. A recommendation for class 1, 4, 5 and 6 support was\nrequested to cover access to a standardised assessment form completed by emergency department staff for all patients presenting to a hospital registered with the study with\nsuspected pandemic influenza. CLRN research nurses would then track patients until 30 days\nafter initial emergency department attendance through a hospital record review. Cross checks\nfor completeness of the dataset would be undertaken by comparing NHS numbers with the\nIntensive Care National Audit and Research Centre (ICNARC) database and missing mortality\ndata would be requested from the Office of National Statistics (ONS)."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Steve Goodacre"]
["Address","University of Sheffield"]
[null,"Regent Court, 30 Regent Street"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone"]
["Email","s.goodacre@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients presenting to a hospital registered with the study with suspected pandemic influenza"]
["Description of confidential patient information used","Access was requested to NHS number, hospital number, date of birth, date of death and\ngender."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2013-08-29"]
["Next Review Date","N/A"]
["Notes","The source data that contains the identifiers was stored on a virtual machine hosted by the University of Sheffield. After an exhaustive check of all data files, output files, scripts, analysis datasets etc. any file that contained any identifiable data was identified and deleted from the virtual machine. It is no longer possible from the data held to identify any patient.\n\nFull details of the publications and impact arising from the PRIEST study are available at https://www.sheffield.ac.uk/scharr/research/centres/cure/priest  \n\nA living systematic review of prediction models for COVID-19 (https://www.bmj.com/content/369/bmj.m1328.long) identified the PRIEST score as the only one of the eight models identified with adequate performance and low risk of bias that had been developed for emergency department triage.\n\nThe PRIEST score has been recommended for prognostication in suspected COVID-19 by the American College of Emergency Physicians.\n\nThe PRIEST score can be found on MDCALC, where it can be calculated and used by clinicians to support decision-making.\n\nThe PRIEST score was used by Yorkshire Ambulance Service senior clinical support cells to help assess need for hospital conveyance in patients with suspected COVID-19.\n\nThe finding that repeated contact with NHS-111 telephone services may be associated with unrecognised risk of deterioration was fed back to Yorkshire Ambulance Service to inform updates to NHS-111 triage pathways.\n\n\n17 July 2020 – Amendment supported to clarify that NHS Digital and Yorkshire Ambulance Service NHS Trust will act as data processors, to provide a revised protocol, updated to amend the aims of the study, to confirm additional data items and to clarify the process staff will follow when working from home.\n\nSpecific conditions of support\n1. A response to the below conditions needs to be provided within three months of the issuing of this letter: a. Confirmation that further amendments, or a new application, will be submitted if the database is to be used for any purposes in addition to those described in the application.\n \nb. An effective mechanism to pseudonymise the free text is created and fed back to the CAG. If an effective mechanism cannot not be created, then the free text data will need to be anonymised after use. Confirmation that any identifiable information extracted from the free text will be destroyed. \n\nc. A patient notification strategy is devised and fed back to the CAG. This needs to contain an explanation on why the amount of information collected is required. \n\t\nd. Further patient and public involvement is carried out. Members suggested that a questionnaire is created and disseminated via engagement with appropriate patient groups and charities. \n\ne. A list of participating Trusts, recruited to date, is provided. The addition of any further Trusts must be submitted via an amendment \n\nf. Should any further changes be made to the protocol, other than the addition of new participating Trusts, then a new application is submitted. \n\t\nConditions confirmed as met 06 November 2020\n\n2. Confirmation of suitable security arrangements via IG Toolkit submission. \nConfirmed – University of Sheffield – School of Health and Related Research (by NHS Digital email dated 06 August 2019), Yorkshire Ambulance Service NHS Trust (by check of the NHS Digital DSPT tracker on 25 June 2020) and NHS Digital (by NHS Digital email dated 10 June 2019) have confirmed ‘Standards Met’ grade on DSPT submission 2018/19. \n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 29 June 2020 \n\n\n\nAmendment Request (Approved 19/12/2013)\nAn amendment request was received on 18 November 2013, seeking access to cause of\ndeath in addition to the other identifiers listed above. The request was considered at an office level by the Confidentiality Advice Team as there was no increase to the identifiability of the dataset, and a recommendation of support was provided.\n\nSpecific conditions of support\n1. Favourable opinion from REC Received 22/08/2013\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed\n22/08/2013\n3. If a pandemic situation occurs, please confirm details of the research team and inform\nCAG so that final support can be confirmed (following Vice-Chair’s advice). This can\nbe done urgently within five working days. The Vice-Chair will take the decision since\nthe Chair is part of the applicant’s organisation.\n\n19 March 2020 – amendment conditionally supported to make revisions to the application prior to its activation to study patients with COVID-19, including changing the study title from PAINTED to PRIEST and include the University of Sheffield as data controller\n\n1.\tThe Adolescent Information Leaflet needs to be revised as follows;\n\na.\tIn the middle column, the word \"directly\" is to be inserted before \"identified.”\n\nb.\tIn the section “What do you want from me?” is to be revised to add \"an indirect identifier\" after NHS Number.\n\nc.\tIt also needs to be explained that the NHS Number will be used for linkage to other datasets or National registers.\n\n2.\tThe Child Information Leaflet needs to be revised so that the use of “pseudonymised” in the first column is changed to “anonymised.”\n\n3.\tThe poster for children needs to explain that the NHS Number will be used for data linkage. \n\n4.\tOn the Adult Information Leaflet, the last bullet point in the box titled “What will we do with your information?” needs to be amended from “anonymised” to “pseudonymised.”\n\n5.\tThe poster for adults needs to state that the NHS Number will be used for data linkage. \n\n6.\tConfirmation of suitable security arrangements via IG Toolkit submission. Confirmed – University of Sheffield – School of Health and Related Research has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 06 August 2019. \n\n7.\tConfirmation of a favourable opinion from a Research Ethics Committee. Confirmed 11 March 2020.\n\nConditions met – 20 March 2020"]

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[]
[]
["Application Number","A02341"]
["Reference","CAG 2-07(b)/2014"]
["Other Refs","IRAS Project ID: 136073/596627/4/584"]
["Application Title","The prevalence of patterned cutaneous injuries in child maltreatment"]
["Application Summary","This application from Cardiff University set out the purpose of determining the prevalence of patterned cutaneous injuries and the common types of implements used as weapons in child maltreatment. The study aimed to support efforts in creating a greater knowledge base on the mechanism of injury and the implements that cause them; the applicant specified that a detailed understanding on the types of injuries caused by implements will help clinicians in their investigations."]
["Applicant Organisation Name","Cardiff University "]
["Contact Name","Professor Alison Kemp"]
["Address","Institute of Primary Care and Public Health"]
[null,"Cardiff University School of Medicine"]
[null,"Neuadd Meirionnydd, Heath Park"]
["Postcode","CF14 4YS"]
["Telephone"]
["Email","KempAM@cf.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A recommendation for class 1, 4 and 6 support was requested to cover access to a patient image database and paediatric records within the child health department at Cardiff and Vale University Health Board in relation to patients treated over 10 years. Images would be linked to records using hospital number, the total potential population was 3000-4000."]
["Description of confidential patient information used"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-02-20"]
["Next Review Date","2016-02-20"]
["Notes","Specific conditions of support\n1. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 20 February 2015\n2. Confirmation of a favourable opinion from a research ethics committee. Confirmed\n3. Please ensure that images are anonymised prior to removing from hospital sites."]

{"sheet":"A02342","index":385,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02342"]
["Reference","CAG 2-07(a)/2013"]
["Other Refs","IRAS Project ID: 30293/79289/1/286, REC number: 09/H1013/80"]
["Application Title","Developing effective strategies to reduce unscheduled care in\nchronic disease: Validation of a “red flag” system that identifies patients who are at risk of becoming frequent users of unscheduled care"]
["Application Summary","This application from the University of Surrey aimed to understand the need for urgent or unscheduled healthcare and assess whether the need may be reduced if more comprehensive routine care was developed. The application detailed carrying out data linkage only in order to test the validity of a “red-flag” system which was developed as part of a wider research programme. A recommendation for class 1, 4 and 5 support was requested to allow a researcher access to data on GP practice sites in order to extract pseudonymised data to link to SUS data."]
["Applicant Organisation Name","University of Surrey"]
["Contact Name","Dr Tom Chan"]
["Address","Department of Health Care Management and Policy"]
[null,"University of Surrey, Austin Pearce Building"]
[null,"Guildford, Surrey"]
["Postcode","GU2 7XH"]
["Telephone"]
["Email","t.chan@surrey.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to demographic data in all adult patients’ records within participating GP practices."]
["Description of confidential patient information used","The processing of demographic data including NHS number, name and date of birth was required in order to pseudonymise patient information at GP practice sites."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2013-11-01"]
["Next Review Date","2015-11-01"]
["Notes","Specific conditions of support\n1. Favourable opinion from REC Received 27/11/2012\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 04/10/2013, IG improvement plans in place.\n3. Patient representatives should be included within the project advisory group; it is recommended that at least 2 patient members are included. Confirmed 09/07/2013 that 2 patient representatives would join the project steering board with effect from its August 2013 meeting.\n4. The patient information poster should be updated to include details of how a patient can opt out of inclusion into the study via the research team and local GP practice. Received 09/07/2013.\n5. Access to SUS or equivalent dataset in identifiable format is not included within this recommendation as it is understood that this will be fully pseudonymised prior to disclosure to a researcher. Confirmed 09/05/2013."]

{"sheet":"A02343","index":386,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02343"]
["Reference","CAG 2-07(b)/2013"]
["Other Refs","IRAS Project ID: 121553/433036/4/753"]
["Application Title","The assessment of institutional violence and aggression: an evaluation of the predictive accuracy of five risk assessment tools"]
["Application Summary","This application from Ashworth High Secure Hospital detailed a study to follow up 111\npatients who were engaged in a baseline study carried out between 2000-2002, in order to\ndetermine the validity of a risk assessment tool developed within the baseline study."]
["Applicant Organisation Name","Ashworth High Secure Hospital"]
["Contact Name","Professor Jane Ireland"]
["Address","University of Central Lancashire, Ashworth Research Centre"]
[null,"Ashworth Hospital, Parkbourn"]
[null,"Maghull, Merseyside"]
["Postcode","L31 1HW"]
["Telephone"]
["Email","jlireland1@uclan.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Access was requested to records in relation to admissions over the 10 year period since\nthe baseline study took place. Records would be accessed using the Patient\nAdministration and Clinical Information System (PACIS). Support was requested in relation\nto those patients who had left the Ashworth Hospital. Where patients were still in treatment\nat Ashworth, they would be approached for consent where it was considered to be\nappropriate by the responsible clinician."]
["Description of confidential patient information used"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2013-06-28"]
["Next Review Date","N/A"]
["Notes","June 2022 - Support Expired\nThe study was published in 2016 and no identifiers were retained. \n\nThe paper was published in an open access journal and so the benefit is arguably to academics, which would be see as public. It was also submitted to the REF exercise.\n\nThis was an academic paper though and not all has a reach to the general public. In this case the reach is to academics and driving the developing of future research.\n\nSpecific conditions of support\n1. Favourable opinion from REC Received 17 April 2013\n2. Confirmation of suitable security arrangements via IG Toolkit submission.\nConfirmed 20 June 2013"]

{"sheet":"A02344","index":387,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02344"]
["Reference","CAG 5-03 (PR2)/2013)"]
["Other Refs"]
["Application Title","United Kingdom Immune Thrombocytopenia Registry"]
["Application Summary","This application from Barts Health NHS Trust set out the purpose of studying the natural history of immune thrombocytopenia (ITP), a rare disease characterised by platelet drop and bleeding, estimating prevalence and incidence of comorbid illnesses in the ITP cohort, and describing current treatment pattern and measuring treatment effectiveness. A database was already in place collecting demographic, clinical and treatment data using a fully consent based model.\nA recommendation for class support was requested to cover access to Hospital Episode Statistics (HES) and mortality data from the Health and Social Care Information Centre as the consent form did not make reference to this. The additional HES data would be used in order to validate data already collected by the study and enhance the overall data capture."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Umesh Doobaree"]
["Address","Royal London Hospital"]
[null,"Whitechapel Road"]
[null,"Whitechapel, London"]
["Postcode","E1 1BB"]
["Telephone"]
["Email","umesh.doobaree@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A database [of ITP cohort] was already in place collecting demographic, clinical and treatment data using a fully consent based model."]
["Description of confidential patient information used","Support was requested to cover access to Hospital Episode Statistics (HES) and mortality data from the Health and Social Care Information Centre."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2013-07-16"]
["Next Review Date","2016-07-16"]
["Notes","Specific conditions of support\n1. Confirmation of a favourable opinion from a research ethics committee. Received.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Confirmed 16 July 2013."]

{"sheet":"A02345","index":388,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02345"]
["Reference","CAG 6-03(PR4)/2013"]
["Other Refs","IRAS Project ID: 123048/458303/4/488, REC ID: 13/LO/0931"]
["Application Title","Comparing psoriasis treatments and care pathways using routine data"]
["Application Summary","This application from the University of Surrey set out the purpose of a study to describe the\neffect of formulation, combination, and sequence of primary and secondary care therapy for\npsoriasis on health service utilisation and costs using data routinely collected as part of clinical\nservices in primary and secondary healthcare service. A recommendation for class 1, 4 and 5 support was requested to cover access to data of 23,000 adult patients, across three CCG\nareas, with a GP diagnosis of psoriasis."]
["Applicant Organisation Name","University of Surrey"]
["Contact Name","Professor Simon de Lusignan"]
["Address","Department of Health Care Management and Policy"]
[null,"University of Surrey, Austin Pearce Building"]
[null,"Guildford, Surrey"]
["Postcode","GU2 7XH"]
["Telephone"]
["Email","t.chan@surrey.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support was requested to cover access to data of 23,000 adult patients, across three CCG\nareas, with a GP diagnosis of psoriasis."]
["Description of confidential patient information used","Access was requested to name, NHS number, date of birth, postcode and gender."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2013-11-11"]
["Next Review Date","2014-11-11"]
["Notes","Conditions of support\n1. Favourable opinion from a Research Ethics Committee. Received 2 August 2013.\n2. Confirmation of suitable security arrangements via IG Toolkit submission. Approved 4\nOctober 2013, with an improvement plan in place.\n3. Confirmation that free text data will not include any identifiable data. Confirmed 11\nNovember 2013 that free text data would now not be extracted."]

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[]
[]
["Application Number","02346"]
["Reference","CAG 7-06(b)/2013"]
["Other Refs","IRAS Project ID: 116641/490676/4/864, REC number: 13/LO/1363"]
["Application Title","Decision making for children with high risk brain tumours"]
["Application Summary","This application from University College London set out the purpose of a project to explore\ndecision making amongst clinicians, parents and children regarding care and treatment for\nchildren with high risk brain tumours. The study aimed to allow the production of guidance to\nbe used by health care professionals, parents and children. A recommendation for class 1, 3\nand 6 support was requested in order for a researcher to attend a multidisciplinary neurooncology meeting held weekly at the study site and identify eligible participants. The\nresearcher would record name, gender, age diagnosis, planned investigations and their\nresults. The researcher would then be present for the first clinical consultation with the family\nin order to seek consent."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Myra Bluebond-Langner"]
["Address","Institute of Child Health"]
[null,"University College London"]
[null,"30 Guilford Street, London"]
["Postcode","WC1N 1EH"]
["Telephone"]
["Email","bluebond@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support was requested in order for a researcher to attend a multidisciplinary neurooncology\nmeeting held weekly at the study site and identify eligible participants (children with high risk brain tumours). The researcher would then be present for the first clinical consultation with the family in order to seek consent."]
["Description of confidential patient information used","Access was requested to name and date of birth."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2013-12-18"]
["Next Review Date","N/A"]
["Notes","The data controller has confirmed that support for this project can be ended.\n\nSpecific Conditions for Support\n1. Confirmation of a favourable opinion from a Research Ethics Committee. Received\n15/11/2013\n2. Confirmation of suitable security arrangements via IG Toolkit submission Confirmed\n02/09/2013\n3. In line with the comments above, efforts should be made to raise awareness of the study\nprior to attendance at the first clinical consultation to ensure that objections can be\nregistered. If this is in place, then support is not required for this stage of the process. It\nwas confirmed that consultants or other appropriate clinicians would inform parents\nof the researcher’s presence and provide an opportunity for objections to be raised\nprior to introduction to the researcher."]

{"sheet":"A02347","index":390,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02347"]
["Reference","18/CAG/0180"]
["Other Refs","IRAS project ID: 246796, REC reference: 18/NS/0106"]
["Application Title","LAUNCHES QI: Linking AUdit and National datasets in Congenital HEart Services for Quality Improvement"]
["Application Summary","This application from University College London set out the purpose of medical research\nwhich aims to improve services for congenital heart disease and provide a template for\nother lifelong conditions by linking five national datasets to provide better information on\nservices. The following datasets will be linked: National Congenital Heart Disease Audit\n(NCHDA), paediatric intensive care audit, (PICAnet), adult intensive care audit (ICNARC\nCase Mix Program), Office of National Statistics mortality information (ONS) and Hospital\nEpisode Statistics (HES) data. This will provide information on how to link national data\nsets and whether it is feasible to do this routinely, and create a research database to\nexamine the care given to CHD patients from multiple perspectives. The project will\ndescribe patient care trajectories; identify metrics for driving quality improvement (QI),\ninforming commissioning and policy; explore variation across services to identify priorities\nfor quality improvement.\nThe audit datasets which will be linked within the application are as follows:\n National Congenital Heart Disease Audit – forms part of the NICOR (National\nInstitute for Cardiovascular Research Outcomes) audit programme commissioned by\nHQIP. Barts Health NHS Trust are processors for the NICOR programme. This audit\noperates with support under the Regulations covered by application reference\n17/CAG/0071 (previously ECC 1-06(d)/2011),\n Paediatric Intensive Care Audit – commissioned by HQIP. University of Leicester is\nthe data processor. This audit operates with support under reference PIAG 4-\n07(c)/2002.\n Adult Intensive Care Audit – This audit operates with support under reference PIAG\n2-10(f)/2005.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Christina Pagel"]
["Address","Clinical Operational Research Unit, Department of Mathematics"]
[null,"University College London"]
[null,"4 Taviton Street, London"]
["Postcode","WC1HOBT"]
["Telephone"]
["Email","c.pagel@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients included within the national congenital heart disease audit. This comprises of all\npatients who have undergone at least one procedure related to congenital heart disease\nsince 2000 up to March 2018. The sample includes 122,267 patients."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes\ndescribed:\n Study ID – linkage,\n Name - sample validation and linkage,\n NHS Number – sample validation and linkage,\n Hospital ID Number – sample validation and linkage,\n Date of birth – sample validation and linkage,\n Postcode – sample validation and linkage, translated to IMD score for analysis,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-11-30"]
["Next Review Date","2024-11-30"]
["Notes","17 December 2021 - Amendment supported\nAmendment supported to extend the duration of support to 08 October 2023.\n\n16 June 2021 - Amendment supported\nSupport provided to extend the period of support until 20 April 2022.\n\n17 November 2020 - Annual review approved\n\nSpecific conditions of support (updated)\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Barts Health NHS should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n29 November 2019: Amendment supported to clairfy the format in which identifers, date of birth (MM/YY format) and age (to four decimal places), would be processed for analysis purposes. \n08 March 2019 - Amendment supported to allow the study team to request the hospital name and the place of death, recorded as a category, from the data sources, to be retained for analysis purposes.\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 26/10/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed: Barts Health NHS\nTrust (covering NICOR), University of Leeds (SEED – covering PICAnet),\nICNARC (covering Case Mix Program) and NHS Digital – published satisfactory\nreviewed grade on v14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02348","index":391,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02348"]
["Reference","18/CAG/0182"]
["Other Refs","IRAS project ID: 249166, REC reference: 18/SS/0127"]
["Application Title","UK Prospective Diabetes Study (UKPDS) Legacy Study: long term follow-up of participants into electronic health records"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which\naims to undertaken longitudinal follow-up participants within in the UK Prospective Diabetes\nStudy (UKPDS). This original study ran from 1977 and 1997 and was extremely successful\nand demonstrated that important complications of type 2 diabetes can be prevented by better\nblood glucose and blood pressure control than that usually achieved, using existing\ntreatments.\nThe researchers now wish to use this established resource to study the effect of blood\npressure lowering and improved glucose control on reducing the risk of developing dementia\nlater in life. Further analysis will also be undertaken to assess the effect of blood pressure\nlowering and improved glucose control on reducing the long-term risk of death, other\nimportant diseases e.g. heart attacks, strokes and kidney disease) and healthcare use.\nConfidential patient information will be disclosed to NHS Digital in order to facilitate linkage\nwith HES, ONS mortality information, the mental health minimum dataset (MHMD) and the\ndementia audit to be used in analysis. This will be linked to the existing UKPDS data held by\nUniversity of Oxford for analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Rury R. Holman"]
["Address","University of Oxford, Diabetes Trials Unit, OCDEM"]
[null,"Churchill Hospital, Old Road"]
[null,"Headington, Oxford"]
["Postcode","OX3 7LE"]
["Telephone"]
["Email","rury.holman@dtu.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients previously enrolled in the UK Prospective Diabetes Study. There are 5,102\npatients in the cohort. There are 4028 English patients within the sample."]
["Description of confidential patient information used","Confidential patient information will be disclosed from the University of Oxford to NHS Digital\nto facilitate linkage. The following data items are cited as necessary for the purposes\nspecified:\n UKPDS Study ID – linkage,\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage,\n Date of birth – sample validation, linkage and analysis,\n Date of death – sample validation, linkage and analysis (MM/YY format),\n Postcode – sample validation and linkage,\n Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-12-20"]
["Next Review Date","2024-12-20"]
["Notes","Amendment supported 07 March 2024 to extend the duration of ‘s251’ support until October 2028, and for the disclosure of confidential patient information from the University of Oxford to the Belfast Health and Social care Trust to support linkage to Northern Irish outcome data (the actual NI linkage is outside of scope of ‘s251’ support)\n\n13 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources -  HES, ONS mortality information, the mental health minimum dataset (MHMD) and the dementia audit.\n\nSpecific conditions of support (Provisional)\n1. Support extends to England and Wales only.\n2. Favourable opinion from a Research Ethics Committee (Confirmed).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed – NHS Digital has a\npublished satisfactory reviewed grade on V14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02349","index":392,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02349"]
["Reference","18/CAG/0024"]
["Other Refs","IRAS project ID: 228733, REC reference: 18/EE/0036"]
["Application Title","Pregnancy Outcome Prediction Study: Transgenerational and Adult Review"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research\nto follow-up the families who had previously participated in the fully-consented POPS (the\nPregnancy Outcome Prediction Study). The historic study recruited 4,212 women who\ndelivered their first baby in Cambridge between 2008 and 2012. During their pregnancies,\nwomen attended for research scans, donated their blood and placentas for research, and\nallowed researchers access to the medical data surrounding their delivery. Over the last\ntwo years, the applicants have published the results of this study that have influenced\nhealth policy and pregnancy care.\nThe applicants currently hold for every mother who participated in POPS a very highly\ndetailed record of the pregnancy and the baby's growth in the womb. The extensive\ninformation which is currently held in relation to POPS pregnancies provides a unique\nopportunity to understand how health in the womb influences later health outcomes.\nThe POPS pregnancy records will be linked with the HES dataset at NHS DIgital to find\nout more about the current health status of the POPS mothers and children, and their\nrisks of experiencing disease. This will enable exploration of how pregnancy data can be\nused to predict the risk of adverse health outcomes (for example high blood pressure,\nobesity, diabetes or learning difficulties) in both mothers and children later in life. This is a\nprospective study which will perform annual data linkage for both the mother and child\nuntil the child turns 18.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application form."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Gordon C S Smith"]
["Address","University of Cambridge"]
[null,"Box 223 The Rosie Hospital"]
[null,"Robinson Way, Cambridge"]
["Postcode","CB2 2SW"]
["Telephone"]
["Email","gcss2@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study will utilise the historical POPS cohort of 4212 mothers who gave birth to their\nfirst child in the Rosie Hospital between 2008 and 2012. The POPStar cohort comprises\nboth mothers and their children, 8,424 individuals in total in the cohort, who did not\nwithdraw from the study. The sample size is expected to decrease slightly after the study\nexclusion criteria had been applied."]
["Description of confidential patient information used","The following items of confidential patient information will be required for both the mother\nand child for the purposes as set out below:\n Name – linkage and validation\n NHS number – linkage (NHS Digital only) and validation,\n Date of birth – linkage and validation,\n POPS ID – linkage and validation,\n POPStar ID – for linkage with historic data."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2018-12-21"]
["Next Review Date","2024-12-21"]
["Notes","Amendment - 12 December 2019 - Amendment supported to revise the data flows involved in the application in order for NHS Digital to apply the National Data Opt-Out to the patient list prior to the application of a study specific opt-out.\n\nAmendment - 14 June 2019 – amendment supported to enable the disclosure of specified items of confidential patient information (Name, date of birth, POPS ID and POPStar ID) to the Office for National Statistics to faciltate linkage with the National Pupil Database. \n\nAmendment Request (Approved 21/12/2018)\nThe amendment request was submitted which sought to remove data linkage with the\nDepartment for Education from the study scope.\n\nSpecific conditions of support (Final)\n1. Support is extended to the linkage with the HES database within NHS Digital only.\nAny requirements to link the cohort with the wider datasets held by NHS Digital should\nbe submitted as an amendment to the application.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission. (Confirmed: NHS Digital – has a\npublished satisfactory reviewed grade on Version 14.1, 2017/1)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02350","index":393,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2350]
["Reference","18/CAG/0181"]
["Other Refs","IRAS project ID: 247503, REC reference: 18/NW/0748"]
["Application Title","Cost effectiveness modelling for adaptive liver surveillance in uveal melanoma patients screened with Magnetic Resonance Image or Ultrasound using the Liverpool Uveal Melanoma Prognosticator Online (LUMPO)."]
["Application Summary","This application from the University of Liverpool set out the purpose of medical research\nwhich aims to assess the cost-effectiveness and sensitivity of a mathematical model\n(LUMPO) that estimates prognosis and screening intervals for patients with uveal\nmelanoma, a cancer of the eye. A retrospective analysis will be undertaken of the\npredictions made by LUMPO compared with the actual screening and outcome data for\nthe same individuals, to enable a determination of the effectiveness and sensitivity of\nLUMPO to improve quality of life by reducing the number of unnecessary scans to be\nmade.\nIt is explained that despite being associated with a high metastatic risk, there is no\nconsensus in the ophthalmology or oncology community on the frequency of liver\nsurveillance for the detection of metastatic disease in patients with uveal melanoma.\nCurrently, prediction for patients with uveal melanoma is undertaken using a\nmathematical model called LUMPO, by inputting clinical and histological features of the\ntumour together with genetic information. It is explained that it is now important to\ndetermine the effectiveness of this system to determine surveillance screening intervals in\npatients at high risk of developing metastatic disease.\nPatients will be identified from the Ocular Oncology Biobank, established by Royal\nLiverpool and Broadgreen University Hospital NHS Trust. Patients have provided their\nconsent to the use of their tissue samples and data in the biobank; however, this consent\nextends to the use of anonymised data only. This application requires the release of\nHospital Numbers to the student investigator, working under an honorary contract, to\nenable access to hospital records in order to view ultrasounds and MRI reports.\nPseudonymised data will be extracted from records and returned to the biobank. A\npseudonymised dataset will be provided for the research analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor SE Coupland"]
["Address","Institute of Translational Medicine, LOORG"]
[null,"3rd Floor, William Henry Duncan Building"]
[null,"6 West Derby Stree"]
["Postcode","L7 8TX"]
["Telephone"]
["Email","S.E.Coupland@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients between 18 – 100 years who were diagnosed with uveal melanoma and\nunderwent MRI or ultrasound screening, between August 2008 and August 2018, and are\nregistered in the Ocular Oncology Biobank, established by Royal Liverpool and\nBroadgreen University Hospital NHS Trust. It is estimated that 500 patients would be\nincluded in the study."]
["Description of confidential patient information used","Hospital Number will be disclosed from the Ocular Oncology Biobank to facilitate access\nwith wider hospital records. The student investigator will access patient records via\nhospital systems in order to view MRI and ultrasound scans."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-12-21"]
["Next Review Date","N/A"]
["Notes","06 May 2021 - Support expired\nApplicant confirmed by email on 6 May 2021 that all confidential patient information has been pseudonymised before being deleted. \n\nSpecific conditions of support\n1. Date of death should be coarsened to MM/YY format within the analysis dataset.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 21 November\n2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed – Royal Liverpool\nand Broadgreen University Hospital NHS Trust has a published reviewed grade\non V14.1, 2017/18)."]

{"sheet":"A02351","index":394,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02351"]
["Reference","18/CAG/0118"]
["Other Refs","IRAS project ID: 236982, REC reference: 18/EM/0227"]
["Application Title","HPV primary testing in cervical cancer screening: using behavioural science to understand anxiety and attendance"]
["Application Summary","This application from University College London set out the purpose of medical research\nwhich aims to understand attendance and anxiety around cervical screening and Human\nPapillomavirous (HPV) testing. HPV is a common sexually transmitted infection which\ncauses nearly all cervical cancers, of which there are around 3,000 new cases each year\nin the UK. It is noted that the NHS Cervical Screening Programme will be introducing\nprimary HPV testing of all cervical screening before deciding whether to look for abnormal\ncells, which will be rolled out across England in 2019. This will mean that women\nattending cervical screening will be informed of their HPV test result together with\nnotification of any abnormal cells changes, following their screening test.\nThe applicants explain that knowledge about HPV and its links to cervical cancer is poor\namong women in the UK. One group of patients who may potentially struggle the most\nwith the test results are those who test positive for HPV, but are not found to have\nabnormal cell changes requiring further investigation. It is acknowledged that this specific\nsituation may be difficult to understand and for the screening programme to communicate\nwithin standard letters.\nThis study comprises of two main areas as follows:\n1. A survey will be used to assess women testing HPV positive with normal cytology\nwhich will be circulated shortly after their screening result, with prospective 12 month\nfollow-up. Within this element of the study, two cohorts will be established through the\nuse of two invitation letters – half will receive a standard cover letter and the second\ncohort will receive a cover letter with behavioural science applied throughout the\nwording and format. The CAG is being asked to consider this element of the project\nas researchers will access confidential patient information on site at the participating\nTrusts in order to identify the eligible patients. 1,475 women will be approached and\nwill receive an invitation letter, information sheet and questionnaire to their home\naddress. For those who do not respond, a reminder pack containing the same\ninformation will be sent three weeks later. CFH Docmail, a mailing company, will\nundertake all printing and postage of invitation materials.\n2. Interviews will be conducted with up to 40 women testing HPV positive with normal\ncytology. The patient sample will be derived from those who participated in the\nquestionnaire and indicated that they would be interested in participating in an\ninterview. This element is out of scope for the CAG application as participants will\nhave consented to the contact about the interviews.\nA recommendation for class 2, 3 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Jo Waller"]
["Address","UCL, Department of Behavioural Science and Health"]
[null,"1-19 Torrington Place"]
[null,"London"]
["Postcode","WC1E 6BT"]
["Telephone"]
["Email","j.waller@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women aged between 24 and 65, who undertake a cervical screening test at Manchester\nUniversity Hospitals NHS Foundation Trust and London North West Healthcare NHS\nTrust and received a HPV positive result with normal cytology would be invited to\nparticipate in the study. The recruitment process will be carried out over a period of 2 – 5\nmonths and 1,475 women will be invited to participate in the trial."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set\nout:\n Name - to facilitate invitation,\n Address and postcode – to facilitate invitation,\n Study ID – for linkage purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-07"]
["Next Review Date","N/A"]
["Notes","16 February 2022 - Support Expired\nSupport is no longer required because all recruitment and data processing has been completed. The original identifiers used to mail participants were securely destroyed shortly following processing, and the only data we now hold has been pseudonymised and cannot be linked to individual participants. This retained pseudonymised data includes age, clinical test result, index of multiple deprivation score, and clinical site (NHS Trust). \n\nPublic benefits include the findings of this study directly feeding into, and informing, the wording used in national cervical screening test result letters and information materials (e.g. leaflets sent alongside result letters). These letters and materials were developed jointly with NHS Cervical Screening Implementation Committees and Public Health England. \n\n\nSpecific conditions of support\n1. Feedback would be required at the time of first annual review in relation to the\nadditional patient and public involvement and engagement activity which has been\nundertaken as the project progressed. If the responses given are negative, the CAG\nwill take this into account when considering whether support should continue, or\nwhether further actions are necessary\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 19 December\n2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed –\n CFH Docmail Ltd. has a published reviewed grade of satisfactory on Version\n14.1, 2017/18.\n London North West University Healthcare NHS Trust has a published reviewed\ngrade of satisfactory on Version 14.1, 2017/18\n Manchester University NHS Foundation Trust (Org Code: R0A) does not have a\npublished V14.1 2017/18 Toolkit."]

{"sheet":"A02352","index":395,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02352"]
["Reference","18/CAG/0176"]
["Other Refs","IRAS project ID: 248818, REC reference: 18/WA/0337"]
["Application Title","Take home naloxone Intervention Multicentre Emergency setting feasibility trial (TIME)"]
["Application Summary","This application from Swansea University set out the purpose of medical research which\naims to investigate the impact of the distribution of Take Home Naloxone kits on the\nreduction of deaths from opioid overdose. Naloxone is a medicine that reverses opioid\ndrug overdoses and is routinely used by paramedics and doctors in emergency settings.\nThere are schemes in the UK and in other countries where naloxone is included in 'kits'\nwhich are given to drug users, along with brief training in how to use them. These ‘Take\nHome Naloxone’ (THN) kits contain a dose of naloxone, a means of administering this\ndose, and written/graphic instructions. Despite the increasing popularity of THN kits, very\nlittle is known about the relative harms and benefits of this intervention, especially on a\npopulation level.\nThe proposed study will investigate whether it is possible for paramedics and emergency\ndepartment doctors and nurses to give out THN kits to drug users and if data could be\ncollected in a future trial to determine whether this method of distributing THN reduces\ndeaths from overdose. The study will be carried out in four areas of the UK – in two\nareas, THN kits will be given to patients who are at risk of overdose via the emergency\ndepartment and the ambulance service. Information will be collected about deaths,\noverdoses, and related emergency ambulance calls and emergency department\nattendances and admissions. This information will be compared with figures from the\nfurther two areas where THN is not distributed in this way.\nConsent will not be taken from patients within the study – the application has been\nsubmitted to the CAG in order to seek support under the Regulations to legitimise access\nto confidential patient information by members of the research team in order to facilitate\nfollow-up via NHS administrative datasets held by NHS Digital (for English sites) and\nSecure Anonymised Information Linkage (SAIL) databank and NHS Wales Informatics\nService (NWIS) (for Welsh sites).\nThe study also involves and qualitative interview element which will be operated on a\nconsented basis and is out of scope of the application to the CAG.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","Swansea University"]
["Contact Name","Helena Emery - Research Officer"]
["Address","Floor 2, ILS2"]
[null,"Swansea University Medical School"]
[null,"Singleton Park, Swansea"]
["Postcode","SA2 8PP"]
["Telephone","01792 (60) 2011"]
["Email","helena.emery@swansea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," For the intervention, the patient cohort will include adult (18 years of age or over)\npatients attended for overdose or acute intoxication, as well as those attended for\nopioid use related problems such as needle site injuries/infections or falls/other injury\nrelated to opioid intoxication.\n For comparison group, the patient cohort will include adult (18 years of age or over)\nopioid users at high risk of fatal opioid overdose who make up a wider peer group and\nmay overlap with those eligible to receive the intervention.\n Approximately 1,520 patients will be included, 760 across the intervention sites and\n760 at the control sites. The study is scheduled to run from 01/09/2018 to 01/09/2019."]
["Description of confidential patient information used","The following items of confidential patient information will be extracted from patient\nmedical records held in the emergency department and ambulance service databases for\nthe purposes stated:\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage,\n Hospital ID No – sample validation and linkage,\n Date of Birth – sample validation, linkage and analysis,\n Postcode (District Level) – sample validation and linkage,\n Sex – sample validation, linkage and analysis,\n Date of death – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-07"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, summaries of data received have been included in the final study report, which is currently undergoing review. \n\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 16 October\n2018).\n2. Security assurance arrangements:\na. The expectation is for the CPiP assessment to reach 91% within one year\nfrom final approval to avoid jeopardising the state of future approval. It is\nunderstood that the report confirms that updates would be provided to WIGB, via\nNWIS of updates to the project to ensure assurance standards are achieved.\nb. Hull Royal Infirmary (Hull and East Yorkshire NHS) and Northern General Hospital\nSheffield (Hull and East Yorkshire NHS) (RWA) – satisfactory reviewed grade on\nV14.1, 2017/18 of NHS IG Toolkit – confirmed by email from NHS Digital,\n27/12/2018,\nc. Yorkshire Ambulance Service (RX8) – satisfactory reviewed grade on V14.1,\n2017/18 of NHS IG Toolkit – confirmed by email from NHS Digital, 28/12/2018."]

{"sheet":"A02353","index":396,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02353"]
["Reference","18/CAG/0013"]
["Other Refs","IRAS project ID: 230351, REC reference: 18/EM/0014"]
["Application Title","Evaluating the real-world implementation of the Family Nurse Partnership in England: a data linkage study"]
["Application Summary","This application from University College London set out the purpose of medical research\nto evaluate how the real-world implementation of the Family Nurse Partnership varies\nacross England. The research will complement results from the trial, by providing a more\ndetailed assessment of whether there are part icular settings in which the Family Nurse\nPartnership works well. To do this, we will use electronic records that are routinely\ncollected as part of health, education, and social care services to compare outcomes for\nthe Family Nurse Partnership participants with similar families who did not take part in the\nFamily Nurse Partnership.\nThe applicants will look at outcomes for children (e.g. emergency hospital admissions for\npossible neglect or abuse, development at school-age, referrals to social services) and\nmothers (e.g. continuing education after birth, subsequent pregnancies, hospital\nadmissions due to violence or injuries). Exploring whether the Family Nurse Partnership\nworks better for some families (e.g. the youngest teenagers) than others will help improve\ntargeting of resources and highlight groups in need of alternative support. Findings from\nthe study will help policy-makers decide whether the Family Nurse Partnership should be\noffered to families in their local setting. Evidence generated by this study will support\ncommissioners in providing improved services for mothers and children who could benefit\nmost, and lead to increased efficiency through more effective targeting of resources.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Katie Harron"]
["Address","University College London"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1 N 1EH"]
["Telephone"]
["Email","k.harron@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"," Mothers (aged 13-24 years) and their children born between April 2010 and March\n2017.\n There will be two cohorts – those within the Family Nurse Partnership and a control\ncohort which was not.\n It is estimated that the total sample size will be around 1 million patients, of which\napproximately 25,000 will have been included in the Family Nurse Partnership."]
["Description of confidential patient information used"," Name – linkage (FNP and HES)\n NHS number – linkage (FNP and HES)\n GP Registration – linkage (FNP and HES)\n Date of birth – all linkages,\n Postcode – all linkages and analysis (converted to district level for deprivation\nscoring),\n Sex – all linkages and analysis,\n Ethnicity – for analysis,\n Date of death – will be provided in MM/YY format for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-11"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in October 2022 that ‘s251’ support is no longer required, as all identifiers have been destroyed by DfE (who were doing the linkage). The research team retains pseudonymised data for analysis stored on the ONS SRS, and they do not have any means to re-identify. \n\nIn terms of public benefits, the applicants hope that the findings from the study will inform the commissioning of the Family Nurse Partnership in the future. \n\n29 January 2021 - Annual Review approved\n\nSpecific conditions of support (updated)\nThe following sets out the updated specific conditions of support applied against this application reference.\n1. Patient and Public Involvement and Engagement – a report will be required at the next annual review regarding the recruitment of additional lay people to sit on the Study Steering Committee. \n\n08 July 2019 – Amendment supported to include the Department for Education (DfE) as a data source and processor. Name, date of birth, postccode and sex will be disclosed to facilitate linkage with the following datasets held by DfE: \n• Mother and Child: The School Census (formerly PLASC), the Pupil Referral Unit (PRU) Census, and Alternative Provision, The Children Looked After (CLA) return and The Children in Need Census (CINC),\n• Mothers only: Key Stages 4-5 data,\n• Children only: The Early Years Census and Early Years Foundation Stage Profile (EYFSP).\n\nSpecific conditions of support\n\n1. Patient and Public Involvement and Engagement – a report will be required at the\ntime of first annual review around the activity which has been undertaken in this area\ntogether with any feedback. If the responses given are negative, the CAG will take\nthis into account when considering whether support should continue, or whether\nfurther actions are necessary.\nCondition met as part of annual review, submitted a PPI report on 26 January 2021\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed – 22 January 2018.\n\n3. Confirmation from the IGT Team NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission. \n(Confirmed – University College London, School of Life and Medical Science and NHS Digital have reviewed reported satisfactory grades on Version 14.1, 2017-18)."]

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[]
[]
["Application Number","02354"]
["Reference","18/CAG/0207"]
["Other Refs","IRAS project ID: 252956, REC reference: 18/YH/0486"]
["Application Title","Defining delirium and its impact in Parkinson’s Disease (DELIRIUM-PD)"]
["Application Summary","This application from Newcastle University set out the purpose of medical research which\naims to follow-up on a previous study, DETERMINE-PD (17/CAG/0191), which was a\npilot study that aimed to understand the incidence of delirium in Parkinson’s disease.\nThe aim of the project is to find out how common delirium is in people with Parkinson’s,\nrecord and describe the symptoms of delirium in Parkinson’s. Patients with Parkinson’s\nwho are admitted to hospitals in Newcastle upon Tyne will be invited to take part. An\nelectronic alert will notify researchers of their admission; this system is already in use b y\nthe hospitals. The applicant will visit participants who consent to participate over\nconsecutive days whilst in hospital and will complete a delirium assessment. Three\nmonths after participants’ discharge from hospital, they will be invited to a follow up visit\nwhere these assessments will be repeated. To find out about people’s unique experience\nof delirium in hospital participants, their relative/carer and healthcare professionals will be\ninvited to take part in interviews. Outputs from the study will include an assessment tool\nto identify delirium in Parkinson’s and dementia, and educational material for people with\nParkinson’s, their relatives/carers and health professionals. Raising awareness and\ncorrectly identifying delirium in Parkinson’s could reduce adverse outcomes, such as\nincreased risk of death and dementia.\nAll patients who attend movement disorder services in Newcastle upon Tyne in treatment\nof Parkinson’s disease will receive a letter and information sheet about the study which\nwill explain that, should they be admitted to hospital, they will be approached by a\nresearcher about the study. Support is requested to disclose confidential patient\ninformation from the Newcastle upon Tyne Hospitals Foundation Trust to the research\nteam to facilitate postal invitations and to enable alerts to be made upon admission to\nhospitals. This follows the same recruitment methodology that was used in the pilot study,\nwhich was supported under reference 17/CAG/0191 which was carried out to inform this\nlarger scale trial.\nA recommendation for class 3 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Alison Yarnall"]
["Address","Newcastle University, Clinical Ageing Research Unit"]
[null,"Campus for Ageing and Vitality"]
[null,"Newcastle upon Tyne"]
["Postcode","NE4 5PL"]
["Telephone"]
["Email","alison.yarnall@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with a diagnosis of Parkinson's disease or Parkinson’s disease dementia\naccording to UK Brain Bank Criteria made by a movement disorder specialist, who have\nattended the Newcastle-upon-Tyne Hospital (NuTH) Foundation NHS Trust movement\ndisorder clinics for the management of their Parkinson’s within 18 months of the start of\nthe study. Patients who are subsequently admitted to a hospital within NuTH during the\n20 month recruitment period will be approached to participate in the study."]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed from Newcastle\nupon Tyne Hospitals Foundation Trust to facilitate the recruitment process:\n Name – sample validation and invitation process,\n Hospital Number – sample validation and invitation process,\n Full address and postcode – sample validation and invitation process."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-11"]
["Next Review Date","N/A"]
["Notes","May 2022 - Support Expired\nApplicant has confirmed May 2022 that ‘s251’ support no longer required, as they are not using confidential patient information to facilitate postal invitations/enable alerts of admissions any longer. Alters have been disabled.\n\nRegarding public benefit, the study will aid in the better recognition and diagnosis of delirium in people with Parkinson’s disease and the effect this has on them and their families. \n\n16 June 2021 - Amendment supported\nSupport provided to extend the period of support until October 2021.\n\n29 September 2020 - Amendment supported\nThe amendment, to extend the duration of support until 1 June 2021 and to collect additional data items as part of a Covid-19 medical note review to understand the impact of Covid-19 in inpatients with Parkinson’s disease and to identify all cases of delirium, is fully supported, subject to compliance with the standard conditions of support\n\nSpecific conditions of support \n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n\nConfirmed:\nThe NHS Digital 2018/19 DSPT review for Newcastle Upon Tyne Hospitals NHS Foundation Trust was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked 17 August 2020). Please note the updated specific condition of support below.\n\nNewcastle Upon Tyne Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n21 August 2020 - Additional DSPT condition added:\nNewcastle Upon Tyne Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 10/01/19).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed – Newcastle upon\nTyne Hospitals NHS Foundation Trust has a published satisfactory reviewed\nscore on V14.1, 2017/18)."]

{"sheet":"A02355","index":398,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02355"]
["Reference","18/CAG/0142"]
["Other Refs","IRAS project ID: 228577, REC reference: 99/5/007"]
["Application Title","A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast, Ovarian & Endometrial Cancer"]
["Application Summary","This application from the University of Cambridge sets out the purpose of medical research which is part of the overarching SEARCH programme, which is a study which is investigating the role of inherited genetic variation in cancer risk and clinical outcomes. The focus of this study is breast, ovarian and endometrial cancers. Potentially eligible patients will be identified and invited to participate in the study which will require provision of a tumour sample and completion of questionnaires. The primary research question is to investigate the role of germline genetic variation in susceptibility to breast, endometrial and ovarian cancer; predisposing to different molecular subtypes of breast, endometrial and ovarian cancer; and their determining of clinical outcomes.\nThe SEARCH study started recruiting breast cancer cases from the region served by the former East Anglian Cancer Registry in 1996. The study was expanded to include ovarian cancer in 1999 and endometrial cancer in 2001. In the following 20 years the study has recruited over 15,000 patients into the breast cancer study and over 3,500 patients into each of the endometrial and ovarian cancer studies. It is stated that larger genome-wide association studies (GWAS) are required to provide evidence and identify additional common risks across cancers, which is the justification provided to support the ongoing recruitment into the studies. Historically, the study has recruited via the cancer networks; however, the proposed application proposed a change in methodology to facilitate recruitment via the NCRAS database.\nThe purpose of the application to the CAG is to seek support under the Regulations to support the identification of eligible participants and recruitment process. There are two proposed recruitment pathways for the study, only one of which requires CAG consideration. These are as follows:\n Public Health England will identify potentially eligible patients from the NCRAS database (National Cancer Registration and Analysis Service). This list of eligible patients would be disclosed to NHS Digital to enable list cleaning to undertaken and updated contact details for the patient and their GP to be added to the sample, prior to its release to the research team. This process will be undertaken on an annual basis and support is requested on an ongoing basis to facilitate this recruitment method. This recruitment pathway requires to the establishment of a legal basis under the common law duty of confidentiality to legitimise processing.\n Local cancer networks identify eligible patients and invite them to take part in the study by providing the study information leaflet.\nA recommendation for class 3 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","University of Cambridge Department of Public Health and Primary Care, Department of Oncology"]
[null,"Strangeways Research Laboratory, Worts Causeway"]
[null,"Cambridge"]
["Postcode","CB1 8RN"]
["Telephone"]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Eligible participants are men and women diagnosed with breast cancer and women diagnosed with endometrial or epithelial ovarian cancer in England, Wales and Scotland. Patients must be aged between 18 and 69 at diagnosis, and have been diagnosed during the last five years."]
["Description of confidential patient information used","The following items of confidential patient information are required to facilitate the recruitment of patients and will be provided by Public Health England’s NCRAS database and detail cleaned by NHS Digital prior to recruitment:\n Name,\n NHS Number,\n GP Registration and address details,\n Date of birth,\n Full Address and Postcode."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-01-21"]
["Next Review Date","2025-01-21"]
["Notes","Amendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n15 December 2022 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), and a change in data processor from NHS Digital to NHS England (previously NHS Digital), regarding demographics information\n\n13 January 2022 - Support Expired:\nApplicant confirmed 13 January 2022 that support no longer required as all identifiable data was anonymised. No identifiable data has been retained.\n\nIn terms of public benefit, the applicant has provide the following information;\nApplicants were able to show that there was an all-cause mortality increase of 57%. Increased deaths occurred due to malignancy, accidents/suicides, respiratory disorders and digestive diseases. \nIt appeared that by employing screening tests for diagnosing coeliac disease thus making the diagnosis earlier, mortality might be reduced. \nThese data also indicate that there is an opportunity to reduce mortality in coeliac disease by increasing vaccination rates for pneumococcus and the earlier and more aggressive treatment of liver disease in coeliac disease. \n\nA second paper was published that reports the epidemiology of coeliac disease in Southern Derbyshire based on the same series of patients. It does appear that the less deprived the area is where people live the greater the prevalence of coeliac disease. \nThe results in this paper will give an indication to clinicians as to how many patients with coeliac disease they should be diagnosing in their own centres. Efforts to diagnose the condition in elderly Asian men and white young men should be strengthened.\n\n\n28 July 2020 - Annual Review:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Public Health England (X25) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee (Confirmed – issued 04/09/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed - NHS Digital, Public Health England and University of Cambridge – School of Clinical Medicine all have a published satisfactory reviewed grade on V14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02356","index":399,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02356"]
["Reference","18/CAG/0199"]
["Other Refs","IRAS project ID: 237959, REC reference 18/LO/2062"]
["Application Title","The effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage: A pilot cluster randomised trial."]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research which aims to investigate the feasibility of administering cryoprecipitate early (within 90 minutes of major haemorrhage protocol activation) in pregnant women who are actively bleeding and who require blood transfusion within 24 hrs of delivery, as compared to standard treatment, where cryoprecipitate is given later or not at all.\nThere will be four participating sites within the study (three within Barts Trust) and randomisation will occur at site level (cluster randomisation). The intervention group will deliver cryoprecipitate within 90 minutes to any women who meet the eligibility criteria. The control arm will continue to give cryoprecipitate in response to low fibrinogen level or if they have received massive transfusion, defined as greater than eight units of red blood cells. The study will be fully unblinded to participants, clinical staff and the central research team.\nData will be collected retrospectively to enable this to be undertaken with patient consent. Routine baseline and clinical information will also be collected from all women who fulfil study criteria up to hospital discharge, or 28 days post-delivery (whichever is sooner).\nThe application has been submitted to seek support under the Regulations to allow the research team access to patient records to identify those eligible for inclusion to enable an approach for consent to be made. Support is also sought for a sub-cohort of women who die or are discharged from hospital prior to the approach to consent and/or the approach to a personal/professional consultee being made, in the event that the patient is seemed to lack capacity to consent.\nThere are further future elements to the study which will be undertaken on a consented basis which will include collection of outcome data at three months, MFI Questionnaire, qualitative interviews and collection of residual blood samples from hospitals. These are out of scope for the CAG consideration as patients will consent to these elements.\nA recommendation for class 1 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Dr Laura Green"]
["Address","Centre for Trauma Sciences, Blizard Institute"]
[null,"4 Newark Street London"]
[null,"London"]
["Postcode","E1 2AT"]
["Telephone"]
["Email","Laura.Green@bartshealth.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Pregnant women at greater than 20 weeks gestation who are actively bleeding after childbirth (up to 24 hrs), and for whom major haemorrhage protocol has been activated, and/or transfusion of at least one unit of red blood cells has been started for treatment of bleeding. 200 patients will be recruited to the study across the two participating Trusts. The scope of support under the Regulations extends to the collection of data in relation to women who die or are discharged from hospital before an approach for consent is made.\n"]
["Description of confidential patient information used","The research team would have access to complete patient records of all women who deliver at the participating sites. The following items of confidential patient information are required for the purposes of sample validation and to enable an approach for consent to be made:\n Name,\n NHS Number,\n Hospital ID Number,\n Date of birth,\n Date of death,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-22"]
["Next Review Date","N/A"]
["Notes","Support expired 08 June 2020\n\nSpecific conditions of support (Final)\n1. A report should be provided at the time of first annual review around the number of patients who died or were discharged prior to a formal approach for consent being made.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 15 January 2019).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Barts Health NHS Trust and Homerton University Hospital NHS Foundation Trust both have a published reviewed grade on V14.1 2017/18)."]

{"sheet":"A02357","index":400,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02357"]
["Reference","18/CAG/0200"]
["Other Refs","IRAS project ID: 246411, REC reference: 18/SS/0095"]
["Application Title","Longitudinal study of pelvic floor dysfunction, and its relationship with childbirth (ProLong20+)"]
["Application Summary","This application from the Glasgow Caledonian University set out the purpose of medical research which aims to follow-up the UK-based participants of the Pro-Long study, which originally recruited 8,000 women across England (Birmingham), Aberdeen (Scotland) and Dunedin (New Zealand) three months after giving birth, to study the effects of childbirth on pelvic floor dysfunction (urinary and faecal incontinence, pelvic organ prolapse and sexual dysfunction). The previous study showed a steady increase in the reporting of problems from the patient cohort up to 12 years post birth.\nThe proposed study will trace the previous participants, who are likely to be around the age of the menopause, when pelvic floor dysfunction is thought to be even more common and invite them to take part in a postal questionnaire and attend for a pelvic floor examination. The application has been made to the CAG to enable the patients to be traced via NHS Digital, prior to circulation of invitations, to enable mortality status to be checked via ONS and address details to be updated via the Patient Demographics Service. The application relates only to English patients – a separate application is being made to the Public Benefit and Patient Privacy Panel on Scotland. The applicants are also seeking to update records via linkage with NHS administrative datasets; however, this linkage would only be carried out for patients who provided consent to this data linkage.\nA recommendation for class 2, 3, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Glasgow Caledonian University"]
["Contact Name","Professor Suzanne Hagen"]
["Address","Glasgow Caledonian University,"]
[null," NMAHP Research Unit\n"]
[null,"Glasgow"]
["Postcode","G4 0BA"]
["Telephone"]
["Email","S.Hagen@gcu.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women who previously consented to participate in the ProLong study. The CAG application extends to patients in England."]
["Description of confidential patient information used","Confidential patient information will be released by the Glasgow Caledonian University to NHS Digital to facilitate linkage with ONS and PDS datasets. For patients found to be deceased, only fact of death would be reported and no updated address details provided. The following items of confidential patient information are required for the study purposes:\n ProLong Study ID – sample validation and return of linked data,\n Name – sample validation and linkage – updated by NHS Digital and returned to facilitate invitation process,\n NHS Number – sample validation and linkage,\n Date of birth – sample validation and linkage,\n Sex– sample validation and linkage,\n Postcode – sample validation and linkage,\n Current address and postcode – to facilitate invitation process,\n Mortality status – sample validation – fact of death only."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-29"]
["Next Review Date","N/A"]
["Notes","March 2022 - Support Expired\nThe applicant confirmed March 2022 that support could be expired, as all confidential patient information collected with ‘s251’ support has been deleted;\n\nUp-to-date names and address from NHS Digital for study cohort members were used to mail out study invitation letters, questionnaires and reminder letters to cohort members. Once the postal survey was complete, this data was deleted. \n\nRegarding public benefit, the study is not yet complete, but there are some initial findings;\n\n- Levels of pelvic floor dysfunction in this group of women were higher than the previous follow-up 14 years ago: 61% of women in the group reported at least some level of urinary incontinence in the previous 4 weeks, and 38% reported moderate to very severe urinary incontinence symptoms. 22% reported faecal incontinence and 17% reported symptoms of prolapse.\n\n- A lower level of pelvic floor dysfunction was apparent in those women who delivered babies using caesarean section alone. \n\n\n17 January 2020 – Amendment supported to extend the study duration from March 2020 to 28 February 2021, due to delays experienced by the study team in obtaining the appropriate governance approvals.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation of satisfactory security assurance from NHS Digital (Confirmed – Glasgow Caledonian University has DSPT has been reviewed as standards met (equivalent of satisfactory reviewed grade on IGTK) and NHS Digital has a published satisfactory reviewed grade on V14.1 2017/18 of the IG Toolkit)."]

{"sheet":"A02358","index":401,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02358"]
["Reference","18/CAG/0202"]
["Other Refs","IRAS project ID: 252545, REC reference: 18/LO/2027"]
["Application Title","Emergency Medical Dispatcher recognition of maternity emergencies using the International Academy Medical Priority Dispatch System: a mixed methods study"]
["Application Summary","This application from London Ambulance Service NHS Trust (LAS) set out the purpose of medical research which aims to evaluate how accurately emergency medical dispatchers triage pregnancy, childbirth and miscarriage related emergency calls by linking information recorded at the time of emergency call with outcome data recorded in the HES database held by NHS Digital. These calls are triaged via questions provided in ‘Protocol 24’. The study will also include a qualitative element, of focus groups with emergency medical dispatch staff; however, this be will operated on a consented basis and is out of scope for the CAG consideration.\nPatients will be retrospectively included in the study, using the previous 3,000 calls which were triaged via protocol 24. The CAD reference (Computer Assisted Dispatch) will be used together with wider variables collected at the time of the emergency call to identify patients from wide records and access confidential patient information required to facilitate linkage with wider datasets. Information will be disclosed by LAS to NHS Digital in order to link with the HES dataset in order to extract relevant information about the care provided.\nA recommendation for class 1, 2, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","London Ambulance Service NHS Trust (LAS)"]
["Contact Name","Professor Rachael Fothergill"]
["Address","London Ambulance Service NHS Trust"]
[null,"8-20 Pocock Street"]
[null,"London"]
["Postcode","SE1 0BW"]
["Telephone"]
["Email","Rachael.Fothergill@lond-amb.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The inclusion criteria for the retrospective data will be any adult patient (>16 years) triaged using MPDS protocol 24 by the London Ambulance Service NHS Trust during the data collection period. Neonatal data (such as date of birth/death and level of neonatal care) will be used to help determine the emergency situation for the mother at the time of 999 call. The most recent 3,000 eligible calls will be included in the study."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes cited:\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage,\n Date of birth – sample validation and linkage,\n Postcode (unit level) – sample validation and linkage,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-28"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, recommendations have been made to improve the telephone triage emergency calls related to pregnancy, childbirth and miscarriage. \n\n\nSpecific conditions of support (Final)\n1. Project-specific patient and public involvement and engagement activity should be carried out to test the acceptability of using confidential patient information without consent for the study purposes. Feedback from this activity is required within six months of support coming into effect. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee (Confirmed).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed - NHS Digital and London Ambulance Trust NHS Foundation Trust have published satisfactory reviewed grade on V14.1 2017/18)."]

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[]
[]
["Application Number","02359"]
["Reference","18/CAG/0203"]
["Other Refs","IRAS project ID: 239197, REC reference: 18/LO/0871"]
["Application Title","Not Intervening as a form of care: an ethnographic study of palliative care"]
["Application Summary","This application from London School of Hygiene and Tropical Medicine set out the purpose of medical research which aims to investigate the importance of actively not doing something when caring for patients, which is in contrast to the common assumption that good and appropriate medicine is always about acting and intervening. To investigate this, the applicants will compile detailed case studies of palliative care at University College Hospitals London NHS Foundation Trust. This will involve the applicants undertaking observations at the Trust site of palliative care team meetings and the daily routines of staff members. There will also be wider interview activity undertaken for which consent will be provided and is thus out of scope for the consideration of the CAG.\nThe study involves three phases:\n1) Shadowing palliative care staff in their daily work on pre-arranged days – verbal consent will be sought from patients and relatives during this element and is out of scope for CAG considerations,\n2) Consented interviews with patients about their care and\n3) Observations at staff meetings to understand how care, treatments and interventions are discussed and how and when decisions are made by staff. It is this final observation element which involves a breach of the common law duty of confidentiality for which the application has been submitted to the CAG.\nDuring the observations of the palliative care staff meetings and other professional meetings where patient care strategies are discussed, attending researchers may be incidentally exposed to confidential patient information during the course of the discussions. As there will be no patient consent for this observation element, this presents a breach of patient confidence for which the applicants are seeking support under the Regulations to legitimise the access. Confidential patient information is not required for the purposes of the study and will not be recorded by attending researchers. Over the course of a 12 month observation period, the applicants intend to observe around 80 staff meetings, which are held twice weekly (one relating to hospital care and one to community care).\nA recommendation for class 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","LSTHM"]
["Contact Name","Professor Simon Cohn"]
["Address","15-17 Tavistock Place"]
[null,"London"]
[]
["Postcode","WC1N 9SH"]
["Telephone"]
["Email","Simon.Cohn@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study focus is patients who are under the care of the Palliative care teams under study (University College Hospitals London and Camden/Islington Community team)."]
["Description of confidential patient information used","Confidential patient information is not required for the purposes of the study; however, is likely to be disclosed during the course of the staff meetings."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-28"]
["Next Review Date","N/A"]
["Notes","This research project has now formally ended. Section 251 support was only ever obtained because researchers may hear specific patient details, without obtaining their prior consent, whilst attending and observing clinical multidisciplinary team meetings. There was no occasion when any such details were recorded, or used as data in the project.\n\nOutputs are still being in production. In addition to academic presentations and publications, the study held a number of workshops to feed back to relevant clinical staff, has produced two short animation films that have been used in clinical teaching nationally and have been disseminated widely to the public via social media, as well as contributed to a recent The Parliamentary Office of Science & Technology briefing on end of life care. \n\nWe anticipate further dialogue with a number of palliative care and end of life NGOs as a route to disseminate our findings, catalyse further discussions, and contribute to future campaigns.\n\nSpecific conditions of support (Confirmed)\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University College London Hospitals NHS Foundation Trust has a published satisfactory reviewed grade on V14.1, 2017/18)."]

{"sheet":"A02360","index":403,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02360"]
["Reference","19/CAG/0004"]
["Other Refs","IRAS project ID: 243829, REC reference: 18/LO/2001"]
["Application Title","Follow up of young people treated in CAEDS 2009-2014.Longitudinal Follow Up of Eating Disorder Treatment (L-FED)"]
["Application Summary","This application from South London and Maudsley NHS Foundation Trust set out the purpose of medical research which aims to follow-up a cohort of people who were treated for an eating disorder when they were in their childhood or adolescence, to gain understanding of their health, wellbeing and use of other services since discharge. The study aims to bring the gap between the follow-up carried out as part of a randomised-controlled trial and population-based longitudinal studies. This will aid a greater understanding of the maintenance of treatment effects beyond initial trial follow-up and identification of factors predicting chronicity which will inform further treatment development.\nA Research Associate/Assistant Psychologist will be appointed for the purposes of the study to the clinical care team; however, this individual will not be known to the former patients. Support has been requested under the Regulations to legitimise this individual’s access to confidential patient information in order to facilitate the invitation process for the follow-up study. Former patients will initially be contacted by postal invitation letter, which will be followed-up by telephone and email contact. A maximum of four attempts to contact the patient would be made across all four communication mechanisms.\nA recommendation for class 2, 3 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","South London and Maudsley NHS Foundation Trust"]
["Contact Name","Dr Catherine Stewart"]
["Address","Michael Rutter Centre"]
[null,"DeCrespigny Park"]
[null,"London"]
["Postcode","SE5 8AZ"]
["Telephone"]
["Email","Catherine.Stewart@slam.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","358 patients treated in the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust (CAEDS) between 01/08/2009 and 31/01/2014. These patients would now be aged 16-27 years."]
["Description of confidential patient information used","The following items of confidential patient information are requested for sample validation and to facilitate the invitation process:\n Name,\n Date of birth,\n Full address and postcode,\n Email address,\n Telephone number."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-29"]
["Next Review Date","N/A"]
["Notes","Specific conditions of support (Final)\n1. Revise the patient invitation letter to include a sentence around the patient’s right to object to their participation in the study. Confirmation should be provided within one month of the date of this outcome letter that this has been actioned, and a revised document provided for information Confirmed – 28/02/2019.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 20 December 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – South London and Maudsley NHS Foundation Trust has a published satisfactory reviewed grade on V14.1, 2017/18).\n\nThe applicant confirmed that support can be expired as of 01 August 2022."]

{"sheet":"A02361","index":404,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02361"]
["Reference","19/CAG/0013"]
["Other Refs","IRAS project ID: 256104, REC reference: 18/EM/0403"]
["Application Title","Cerebrovascular accident and Acute coronary syndrome and Peri-operative Outcomes Study"]
["Application Summary","This application from the University of Nottingham sets out the purpose of medical research which aims to better understand the link between poor surgical outcomes for patients who have previously suffered a heart attack or stroke.\nThe study will link together information from the following four data sources:\n Sentinel Stroke National Audit Programme (SSNAP) – Healthcare Quality Improvement Partnership (HQIP – controller) carried out by King’s College London,\n Myocardial Ischaemia National Audit Project (MINAP) Healthcare Quality Improvement Partnership (HQIP – controller) carried out by the NICOR (National Cardiovascular Outcomes Research) team at Bart’s Health NHS Trust,\n Hospital Episodes Statistics (HES) – NHS Digital,\n ONS Mortality Data – NHS Digital.\nConfidential patient information will be disclosed from SSNAP at King’s College London and MINAP by NICOR at Bart’s Health NHS Trust to NHS Digital, which will act as trusted third party and facilitate linkage with the wider datasets and disclose a pseuodnymised dataset to the University of Nottingham for analysis.\nA recommendation for class 1, 2, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Iain K Moppett"]
["Address","University of Nottingham"]
[null,"Queen's Medical Centre"]
[null,"University of Nottingham"]
["Postcode","NGH 2UH"]
["Telephone"]
["Email","iain.moppett@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged over 18 years listed with one or more surgical episode in the HES dataset between 01/01/2007 and 31/12/2017. It is estimated that this primary cohort would include 44 million patients in this initial primary cohort of which, around 400,000 patients would be expected to have undergone surgery having previously suffered a stroke or heart attack."]
["Description of confidential patient information used","The following items of confidential patient information will be released from both the Sentinel Stroke National Audit Programme at King’s College London and Myocardial Ischaemia National Audit Project from the National Cardiovascular Outcomes Research team at Bart’s Health NHS Trust to NHS Digital to facilitate linkage and other purposes where specified:\n NHS Number – sample validation and linkage,\n Date of birth – sample validation and linkage,\n Postcode – sample validation and linkage,\n Date of death – analysis,\n Hospital Trust – analysis,\n Sex – analysis,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-29"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and identifiers deleted.\n\nIn terms of public benefit, there is potential to benefit future patients by better informing decisions on risks and timing of surgery for those with a history of stroke or heart attack.\n\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January 2022 to remove Sentinel Stroke National Audit Programme (SSNAP) data from the data sources and data flows.\n\nSpecific conditions of support\n1. Confirmation of the project’s communication strategy, established with Barts Health NHS Trust and King’s College London should be provided within three months of this outcome letter. This should include details of the project-specific dissenting mechanism together with copies of any patient-facing documentation for review.\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 19 December 2018).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University of Nottingham (controller) and NHS Digital (processor) have published satisfactory reviewed grades on V14.1, 2017/18)."]

{"sheet":"A02362","index":405,"n_rows":3,"n_cols":2,"rows_kept":3,"cut":false,"hidden":false,"merged":[[2,1,2,4]]}
[]
[]
["Duplicate file","Go to application A02364"]

{"sheet":"A02363","index":406,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02363"]
["Reference","18/CAG/0184"]
["Other Refs","IRAS project ID: 252035, REC reference: 18/LO/1688 A02365 duplicate page"]
["Application Title","Using National Congenital Heart Diseases Audit data to explore the impact of non-medical risk factors on late post-operative outcomes for children with complex congenital heart defects."]
["Application Summary","This application from Great Ormond Street Hospital for Children NHS Foundation Trust set out the purpose of medical research which aims to undertake follow-up of children who underwent surgery for complex heart defect since 2000 to assess longer term health outcomes in this patient group.\nThe patient cohort will be identified from the National Congenital Heart Diseases Audit, which is commissioned by the Healthcare Quality Improvement Partnership (HQIP) and carried out as part of the NICOR (National Institute for Cardiovascular Outcomes Research) programme by Barts Health NHS Trust. The NICOR audit programme operates with support under the Regulations via reference 17/CAG/0071 (non-research activity) and 17/CAG/0078 (extended uses of audit data for research purposes). Confidential patient information will be disclosed to NHS Digital to facilitate linkage with ONS mortality information. The applicants will undertake analysis on a pseudonymised dataset.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Great Ormond Street Hospital for Children NHS Foundation Trust"]
["Contact Name","Dr Katherine L Brown"]
["Address","Office 3.9 Zayed Rare Diseases Research Building,"]
[null,"Guildford Street"]
[null,"London"]
["Postcode","WC1N 1DZ"]
["Telephone"]
["Email","Katherine.Brown@gosh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients recorded within the National Congenital Heart Diseases Audit between 01 April 2000 and 31 March 2018 as having procedures (both surgery and catheter) for complex heart defects. The audit contains an estimated 120,000 patients."]
["Description of confidential patient information used","Confidential patient information will be identified from the National Congenital Heart Diseases Audit held by Barts Health NHS Trust to be released to NHS Digital for linkage.\nThe following items of confidential patient information are required for the purposes stated:\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage,\n Hospital ID – sample validation and linkage,\n Date of birth – sample validation and linkage,\n Postcode – sample validation and linkage,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-02-15"]
["Next Review Date","2025-02-15"]
["Notes","Amendment supported 16 March 2023 to extend the duration of ‘s251’ support to 30 September 2024\n\n24\tFebruary 2023 - change in data processor from;\n\n•\tBarts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits, specifically the National Congenital Heart Disease Audit (NCHDA),\n\n•\tNHS Digital to NHS England, regarding data source Civil Registration Deaths.\n\n\nSpecific conditions of support (Final)\n1. The existing patient-facing information leaflet should be revised to make the language more accessible and to ensure that the description of the data flows and organisations involved in the study was easily understood. The review of the text should form part of the patient and public involvement and engagement activity which is already planned. A revised document should be provided for consideration within three months of this outcome letter.\n2. Consider ways to include young persons and adults who underwent surgery for complex heart defect when they were young within the patient and public involvement and engagement activities for the study. Feedback should be provided at the time of annual review around the progress which has been made here, together with an overview of any activity carried out.\n3. Favourable opinion from a Research Ethics Committee (Confirmed).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed: Barts Health NHS Trust (covering NICOR), and NHS Digital – published satisfactory reviewed grade on v14.1, 2017/18)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02364","index":407,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02364"]
["Reference","18/CAG/0164"]
["Other Refs","IRAS project ID: 248748, REC reference: 18/LO/1679"]
["Application Title","Use and impact of the pre-hospital 12-lead electrocardiogram in the primary PCI era. Mixed method study (PHECG-2)"]
["Application Summary","This application from Kingston University and St George's, University of London set out the purpose of medical research which aims to assess the association Pre-Hospital 12-lead electrocardiogram (PHECG) with patient outcomes, and research patient, practitioner and contextual factors contributing to the decision to record (or not) a PHECG. The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance clinicians assess patients with suspected acute coronary syndrome (heart attack), and helps to inform ongoing care, such as direct transfer to a specialist heart attack centre. All NHS emergency ambulances carry this equipment. This project builds on previous work by this team, which found that one in three eligible patients did not receive a PHECG, but those that did had a lowered risk of short-term death. Women, the elderly and people with more complex health status were less likely to receive PHECG. The dominant treatment for heart attack at the time of the earlier analysis was 'clot buster' drug therapy (fibrinolysis). This study will update that work, in the context of the shift in recent years to a more interventional strategy for treatment of heart attack (angioplasty and stents), and explore reasons for variations in practice-highlighting opportunities to improve care and outcomes.\nThe study will involve the use of data collected within the Myocardial Infarction National Audit Project (MINAP) dataset, collected with support as part of the National Institute for Cardiovascular Outcomes Research NICOR programme (17/CAG/0071), which is managed by Bart’s Health NHS Trust, linked with ONS mortality information held by NHS Digital for the purposes of analysis."]
["Applicant Organisation Name","Faculty of Health, Social Care and Education, Kingston University & St George's, University of London"]
["Contact Name","Professor Tom Quinn"]
["Address","Faculty of Health, Social Care and Education"]
[null,"Kingston University & St George's, University of London"]
[null,"6th Floor, Hunter Wing, St George's Campus, Cranmer Terrace, London"]
["Postcode","SW17 0RE"]
["Telephone","07717 541 159"]
["Email","t.quinn@sgul.kingston.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","• Work Package One: Patients aged 18 years or older when admitted with heart attack between 01/01/2010 and 31/12/2017 to one of 228 participating hospitals in England, Wales and Northern Ireland. For patients with multiple admissions, only the earliest record of their ACS event will be included. Approximately 420,000 patients to be included.\n• Work Package Two: Patients with confirmed diagnosis of heart attack (STEMI and nSTEMI) on MINAP database and taken to hospital by one of the three participating ambulance services (Welsh, West Midlands and South West). Approximately 1,800 patients to be included identified from patients in WP1.\n"]
["Description of confidential patient information used","The following items of confidential patient information will be released from the MINAP audit held by NICOR to NHS Digital for the purposes described:\n\n• Name – sample validation and linkage,\n• NHS Number – sample validation and linkage,\n• Date of birth – sample validation,\n• Date of death – sample validation and analysis,\n• Postcode (northing and easting references) – analysis,\n• Ambulance Job Number – sample validation and linkage, \n• Sex – analysis,\n• Ethnicity – analysis. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-02-15"]
["Next Review Date","N/A"]
["Notes","27 October 2020 - Support expired. Applicant confirmed by email that support is no longer required, as the dataset has been anonymised. \n\n14 July 2020 - Amendment supported to extend the duration of support until 30 September 2020.\n\nSpecific conditions of support (Final) \n\n1. Planned patient and public involvement and engagement activity should be progressed, with feedback on the actual activity undertaken provided at the time of first annual review. If the responses given were negative, this would be taken into account by the CAG when considering whether support can continue, or whether further action is required. \n2. Favourable opinion from a Research Ethics Committee (Confirmed).\n3. Confirmation from appropriate security assurance for organisations processing confidential patient information with support under the Regulations (Confirmed:\n• NHS Digital, South Western Ambulance Services NHS Foundation Trust and West Midlands Ambulance Services NHS Foundation Trust all have satisfactory reviewed grades on V14.1, 2017/18,\n• Welsh Ambulance Services NHS Trust – Caldicott Principles into Practice report received with an assessment score of 92.3% NHS Wales Informatics Service confirmed approval via email on 15/02/2019). \n"]

{"sheet":"A02365","index":408,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02365"]
["Reference","18/CAG/0184"]
["Other Refs","IRAS project ID: 252035 REC reference: 18/LO/1688"]
["Application Title","Using National Congenital Heart Diseases Audit data to explore the impact of non-medical risk factors on late post-operative outcomes for children with complex congenital heart defects"]
["Application Summary","This application from Great Ormond Street Hospital for Children NHS Foundation Trust set out the purpose of medical research which aims to undertake follow-up of children who underwent surgery for complex heart defect since 2000 to assess longer term health outcomes in this patient group.\nThe patient cohort will be identified from the National Congenital Heart Diseases Audit, which is commissioned by the Healthcare Quality Improvement Partnership (HQIP) and carried out as part of the NICOR (National Institute for Cardiovascular Outcomes Research) programme by Barts Health NHS Trust. The NICOR audit programme operates with support under the Regulations via reference 17/CAG/0071 (non-research activity) and 17/CAG/0078 (extended uses of audit data for research purposes). Confidential patient information will be disclosed to NHS Digital to facilitate linkage with ONS mortality information. The applicants will undertake analysis on a pseudonymised dataset."]
["Applicant Organisation Name","Great Ormond Street Hospital for Children NHS Foundation Trust"]
["Contact Name","Dr Katherine L Brown"]
["Address","Office 3.9 Zayed Rare Diseases Research Building,"]
[null,"Guildford Street,"]
[null,"London"]
["Postcode","WC1N 1DZ"]
["Telephone","02078138180"]
["Email","Katherine.Brown@gosh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients recorded within the National Congenital Heart Diseases Audit between 01 April 2000 and 31 March 2018 as having procedures (both surgery and catheter) for complex heart defects. The audit contains an estimated 120,000 patients.\n"]
["Description of confidential patient information used","Confidential patient information will be identified from the National Congenital Heart Diseases Audit held by Barts Health NHS Trust to be released to NHS Digital for linkage. The following items of confidential patient information are required for the purposes stated:\n Name – sample validation and linkage,\n NHS Number – sample validation and linkage,\n Hospital ID – sample validation and linkage,\n Date of birth – sample validation and linkage,\n Postcode – sample validation and linkage,\n Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","N/A - duplicate"]
[]
["Outcome Date","2019-02-15"]
["Next Review Date","N/A"]
["Notes","Specific conditions of support (Final)\n1. The existing patient-facing information leaflet should be revised to make the language more accessible and to ensure that the description of the data flows and organisations involved in the study was easily understood. The review of the text should form part of the patient and public involvement and engagement activity which is already planned. A revised document should be provided for consideration within three months of this outcome letter.\n2. Consider ways to include young persons and adults who underwent surgery for complex heart defect when they were young within the patient and public involvement and engagement activities for the study. Feedback should be provided at the time of annual review around the progress which has been made here, together with an overview of any activity carried out.\n3. Favourable opinion from a Research Ethics Committee (Confirmed).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed: Barts Health NHS Trust (covering NICOR), and NHS Digital – published satisfactory reviewed grade on v14.1, 2017/18)."]

{"sheet":"A02366","index":409,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02366"]
["Reference","19/CAG/0011"]
["Other Refs","IRAS reference: 242230 REC reference: 18/LO/2100"]
["Application Title","British Ophthalmic Surveillance Unit: National Surveillance of the Incidence of Fungal Keratitis in the United Kingdom"]
["Application Summary","This application from the London School of Hygiene & Tropical Medicine set out the purpose of medical research which aims to evaluate the incidence of Fungal Keratitis in the UK. The study will use the established British Ophthalmological Surveillance Unit (BOSU) methodology to support data collection for the study.\nThe BOSU reporting card system, a methodology approved in principle by the CAG, would be used: this is a compulsory reporting system for ophthalmologists who are obliged to report an incidence of any of the rare conditions currently under surveillance. For this proposal, when a case of Fungal Keratitis is encountered, the clinician would record this on a monthly reporting card which is returned to BOSU. BOSU then notify the research team, who would send a questionnaire to every clinician for each reported case of this condition. The clinician enters clinical data in relation to the patient on the questionnaire and returns it to the research team. A follow-up questionnaire is sent after six months. Fungal Keratitis will be included on the BOSU card for a 13 month reporting period. The study will involve all UK nations; however, the remit of the CAG extends to England and Wales only."]
["Applicant Organisation Name","London School of Hygiene & Tropical Medicine"]
["Contact Name","Professor Matthew Burton"]
["Address","International Centre for Eye Health"]
[null,"Faculty of Infectious and Tropical Diseases London School of Hygiene & Tropical Medicine"]
[null,"Keppel Street, London"]
["Postcode","WC1E 7HT"]
["Telephone","02079272329"]
["Email","matthew.burton@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients diagnosed with acute fungal keratitis in England and Wales across the 13 month reporting period. It is estimated that around 300 cases would reported within this time period."]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed by the treating ophthalmologists to the applicants at the London School of Hygiene & Tropical Medicine for the purposes specified:\n Hospital ID – sample validation and linkage,\n Month and year of birth – analysis,\n Postcode (Sector Level) – analysis,\n Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-02-19"]
["Next Review Date","N/A"]
["Notes","Expired\n\nThe study has now closed.  Only 2 participants out of 20 were recruited and thus the study did not produce meaningful results.   It will be restarted in future under a fresh application. \n\n\nSpecific conditions of support (Final)\n1. Revise the patient information leaflet to clearly explain that limited items of confidential patient information would be disclosed by the treating clinician to the research team for the purposes of the study. A copy of the revised document should be provided within two months of the date of this letter together with evidence that this document has been accepted by the reviewing Research Ethics Committee.\n2. Support extends to England and Wales only.\n3. Favourable opinion from a Research Ethics Committee (Confirmed).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed - London School of Hygiene & Tropical Medicine has a published satisfactory reviewed grade on V14.1 2017/18)."]

{"sheet":"A02367","index":410,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02367"]
["Reference","18/CAG/0206"]
["Other Refs","IRAS reference: 242100 REC reference: 18/YH/0478"]
["Application Title","Dose Reductions in Palliative Lung Cancer following an episode of Neutropenia"]
["Application Summary","This application from the University of Bradford set out the purpose of medical research which aims to evaluate the factors responsible for increasing the risk of neutropenia in palliative lung cancer patients and if dose reducing appropriately, will lower further incidences of neutropenia. This will reduce neutropenia related hospital admissions and also improve patient outcome by reducing chemotherapy delays.\nThe study will involve a retrospective case note analysis of patients on palliative lung cancer treatment who have undergone a dose reduction for neutropenia. The project aims to understand whether a predictive model can be designed to recommend a dose reduction based on patient factors such as kidney/ liver impairment or co-morbidities. Eligible patients will be identified from the Chemocare database, the electronic prescribing software for all chemotherapy treatment, by the database manager. Confidential patient information relating to the eligible patient cohort will be transferred to the main applicant, to enable wider patient records to be accessed to extract relevant information for analysis."]
["Applicant Organisation Name","The Rotherham Foundation Trust"]
["Contact Name","Mr Khuram Moaz Ahmad Amini"]
["Address","The Rotherham Foundation Trust"]
[null,"Moorgate road"]
[null,"Rotherham"]
["Postcode","S60 2UD"]
["Telephone","07809208106"]
["Email","khuram.amini@rothgen.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","This application from the University of Bradford set out the purpose of medical research which aims to evaluate the factors responsible for increasing the risk of neutropenia in palliative lung cancer patients and if dose reducing appropriately, will lower further incidences of neutropenia. This will reduce neutropenia related hospital admissions and also improve patient outcome by reducing chemotherapy delays.\nThe study will involve a retrospective case note analysis of patients on palliative lung cancer treatment who have undergone a dose reduction for neutropenia. The project aims to understand whether a predictive model can be designed to recommend a dose reduction based on patient factors such as kidney/ liver impairment or co-morbidities. Eligible patients will be identified from the Chemocare database, the electronic prescribing software for all chemotherapy treatment, by the database manager. Confidential patient information relating to the eligible patient cohort will be transferred to the main applicant, to enable wider patient records to be accessed to extract relevant information for analysis."]
["Description of confidential patient information used","The cohort would consist of palliative lung cancer patients who received chemotherapy in the 2017 calendar year at any hospital in South Yorkshire. 385 patients in total will be included in the study (360 phase one and 15 phase 2)."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-02-26"]
["Next Review Date","N/A"]
["Notes","17 December 2021 - Support expired:\nAll patients are pseudonymised and all identifiable data is now deleted. Only data retained is the pseudonymised collection.  \n\nAppropriate dose reductions play a vital role in preventing secondary neutropenic events and delivering optimal RDIs. The results of this study can aid in identifying high-risk patients.\n\nThe work demonstrates what factors are important when deciding on dose reduction, namely type of neutropenia (depth and length of suppression) (p=0.003), dose reduction of drug, the platinum agent (p=0.042), average dose reduction (p=0.019), and cumulative dose reduction (p=0.018). Other variables were not significant in reducing the risk. The research also showed that inappropriate dose reduction resulted in further neutropenia’s and therefore resulted in an lower dose intensity adversely affecting the patient outcome according to previous research. \n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 19/12/2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Sheffield Teaching Hospitals NHS Foundation Trust has a published satisfactory reviewed grade on V14.1, 2017/18. The Rotherham NHS Foundation Trust has a satisfactory score on V14.1 2017/17 – confirmed by NHS Digital email 15/02/2019)."]

{"sheet":"A02368","index":411,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02368"]
["Reference","19/CAG/0006"]
["Other Refs","IRAS reference: 249203 REC reference: 18/WS/0239"]
["Application Title","How have electronic prescribing and medication administration systems transformed pharmacists’ communication in an inpatient setting? A multi-site observational study"]
["Application Summary","This application from University College London set out the purpose of medical research which aims to explore how pharmacists communicate with each other and wider healthcare professionals in an inpatient setting and how electronic prescribing and medication systems may affect this.\nDuring the study, the Student Investigator will observe pharmacists on general medical and surgical wards in three NHS hospital Trusts. Two of the participating Trusts will use differing electronic prescribing and medication administration systems and the third site will operate a paper-based prescribing system. The Student Investigator will follow pharmacists during the course of their daily duties, including prepping for wards rounds, time on the ward and any follow-up activities. Observations will be recorded on a paper data collection form. The observer will follow-up any queries identified around the observation with the pharmacists to gain a greater understanding. During the course of the observations, patient bed number will be recorded to enable the communications relating to the same patient to be clustered for follow-up and analysis.\nUp to 20 pharmacists will be observed at each participating Trusts in order to collect information on the required number of communication events, which has been calculated as 1,089 events per Trust. It estimated that the observations will last up to four hours per day, across 20 working days per site.\nConfidential patient information is not required for the purposes of the project analysis and will not be recorded during the observation field work. However, as the observer will be shadowing pharmacists during the course of their daily activities, there is a risk that the observer may be exposed to confidential patient information for which there is no established lawful basis, under the common law duty of confidentiality, for the individual to receive."]
["Applicant Organisation Name","UCL School of Pharmacy"]
["Contact Name","Professor Bryony Dean Franklin"]
["Address","Mezzanine Floor, BMA House, Entrance A"]
[null,"Tavistock Square"]
[]
["Postcode","WC1H 9JP"]
["Telephone","07908202383"]
["Email","soomal.shaikh.11@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The pharmacist observations will be undertaken on general medical and surgical wards within the three participating Trusts: Imperial College Healthcare NHS Trust, London North West University Healthcare NHS Trust and Whittington Hospital NHS Hospital NHS Trust. The patient cohort would involve all inpatients resident within the participating wards during the course of the staff observations."]
["Description of confidential patient information used","No direct patient identifiers would be recorded as the focus of the study is the pharmacists; however, it is stated that patient bed number would be retained to enable communications relating to the same patient to be clustered."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-02-26"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed support expired April 2020\nSupport from CAG is no longer required as the research has finished. No patient details were recorded, and the incidental disclosure has finished.\n\nIn terms of public benefits, the findings are being used by both the participating NHS Trusts and by NHS England /NHS Improvement in their review of how pharmacy services are provided to best benefit hospital inpatients\n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 14 December 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Imperial College Healthcare NHS Trust, London North West University Healthcare NHS Trust and Whittington Hospital NHS Hospital NHS Trust all have published satisfactory reviewed grades on V14.1, 2017/18)."]

{"sheet":"A02369","index":412,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A2369"]
["Reference","19/CAG/0018"]
["Other Refs","IRAS reference 253381 REC reference: 19/LO/0103"]
["Application Title","Understanding the health needs of mothers involved in family court case: A research study exploring linkage between family court and health data"]
["Application Summary","This application from the University College London Great Ormond Street Institute of Child Health set out the purpose of medical research which aims to generate evidence about the extent to which the healthcare needs of mothers are being addressed before, during and after court involvement among mothers subject to care proceedings. Care proceedings are family court cases where the Local Authority applies to the court to have a child removed from parental supervision because they believe a child is at risk of significant harm.\nThe project will link health and family court administrative data in order explore risk factors known at delivery (such as maternal age, parity, (history of) mental health related admissions, underlying long-term conditions, adversity-related injury admissions) and their association with (recurrent) care proceedings.\nThe application will link information from Children and Family Court Advisory and Support Service (Cafcass) around care proceedings to the Hospital Episodes Statistics (HES) database. The identifiable information disclosed by Cafcass will be used by NHS Digital to facilitate linkage with the Personal Demographics Service (PDS) data in order to identify patients. Support under the Regulations is sought to legitimise this data processing which will be undertaken by NHS Digital.\nNHS Digital will create two files – the first will link Cafcass with PDS data. The second will link PDS-HES. Following the internal linkages, NHS Digital will disclose two lists to the applicant. The first will contain the Cafcass pseudonymised IDs for all women which were successfully linked. The second will contain pseudonymised HES-IDs for women who link and do not link.\nThe applicant currently holds an extract from HES and ONS, which contains the pseudonymised HES-IDs (NHS Digital reference: NIC-393510). NHS Digital will disclose a file of pseudonymised HES-IDs for women within the Cafcass dataset to the applicants to enable linkage with this existing HES-ONS extract. The applicants have applied to NHS Digital to extend the purpose of use for the data extract to the proposed study."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Ruth Gilbert"]
["Address","University College London"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1X 9ED"]
["Telephone",2079052101]
["Email","r.gilbert@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women aged between 15 and 50 years, with at least one live birth recorded in the Hospital Episodes Database between 01/04/1997 and 31/03/2017. It is estimated that there will be a maximum of 12 million women in this cohort. This cohort of women will be linked to Cafcass data on women involved in care proceedings between 01/04/2007 and 31/03/2018, which is estimated to be 90,000 women. Those women who are not linked to Cafcass data will act as a control cohort for analysis."]
["Description of confidential patient information used","The following items of confidential patient information are requested to facilitate the linkage process between Cafcass and HES data and to create the analysis dataset:\n Name (First and Surname),\n NHS Number,\n Date of birth – truncated for analysis,\n Date of death – truncated for analysis,\n Postcode (existing/historic) – translated into deprivation scoring for analysis."]
["S251 Class(es)","Y","Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-03-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, this study aims to generate evidence to inform healthcare professionals, service providers and policy makers about the healthcare needs of mothers in the family court system and their interaction with healthcare services. Analysis is underway. \n\n\n26 February 2021 - Amendment supported\nThe amendment, to extend the study cohort to include women with a live birth recorded in the Hospital Episode Statistics (HES) Database, and women involved in care proceedings up to 31st March 2019, and to extend the duration of support until 31st May 2022, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support (Final)\n1. Revise the data flow chart to remove the inaccurate reference to deletion of the studyspecific\nID within the UCL Safe Haven. The revised document should be provided\nwithin two months of the date of this letter, together with relevant evidence that this\nhas been received by the reviewing Research Ethics Committee. (Condition Met: 25/04/2019)\n\n2. Revise the patient-facing website text (Paragraph 1.4) to read: ‘…with support from\nthe Health Research Authority via the Confidentiality Advisory Group (CAG\nReference: 19/CAG/0018)’. The revised document should be provided within two\nmonths of the date of this letter, together with relevant evidence that this has been\nreceived by the reviewing Research Ethics Committee.  (Condition Met: 25/04/2019)\n\n3. Favourable opinion from a Research Ethics Committee (Confirmed).\n\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via\nInformation Governance Toolkit (IGT) submission (Confirmed – University College\nLondon, School of Life and Medical Sciences (Controller) and NHS Digital\n(Processor) have published satisfactory reviewed grades on V14.1, 2017/18)."]

{"sheet":"A02370","index":413,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02370"]
["Reference","19/CAG/0012"]
["Other Refs","IRAS reference: 19338 REC reference: 19/CAG/0012"]
["Application Title","Long-term outcomes in Hirschsprung's and anorectal malformations"]
["Application Summary","This application from Alder Hey Children’s Hospital NHS Foundation Trust set out the purpose of establishing a long-term follow-up of patients born with Hirschsprung’s disease (HSCR) or an anorectal malformation (ARM) who were previously treated at the site.\nThe application has been submitted to the CAG in order to seek support under the Regulations to trace past patients, who were previously treated at the Alder Hey Children’s Hospital, but have been discharged into the care of adult services, to enable these patients to be invited to participate in the study. A pre-survey card will be sent to adult patients, together with an information sheet, informing them of the study. This includes a consent form and also a means to raise an objection. Following this initial approach in writing, if no response is received within 30 days, patients will be contacted by telephone a maximum of three times, following which they will be assumed to dissent to participation. Patients who are still under the care of the Alder Hospital will be approached in clinic or in writing by their current clinician."]
["Applicant Organisation Name","Alder Hey Children’s NHS Foundation Trust"]
["Contact Name","Mr Colin Baillie"]
["Address","Alder Hey Children’s NHS Foundation Trust"]
[null,"Eaton Road"]
[null,"Liverpool"]
["Postcode","L12 2AP"]
["Telephone","01512525434"]
["Email","colin.baillie@alderhey.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study will include all patients who have been treated at the Alder Hey Children’s Hospital since 1991 with histologically confirmed Hirschsprung’s Disease and those diagnosed with anorectal malformation on the basis of the position of the anus in relation to the external sphincter. It is anticipated that the patient sample will include 1,200 patients, of which it is anticipated that 720 will participate. The CAG application relates to a sub-cohort of these patients who are now adult and have been discharged from the care of the Alder Hey Hospital."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set out:\n Name – sample validation, linkage and invitation process,\n NHS Number – sample validation, linkage and invitation process,\n Hospital ID – sample validation, linkage and invitation process,\n Full address and postcode – sample validation, linkage and invitation process,\n Telephone number – invitation process.\n\nPatient identifiers are required for analysis purposes; however, these will be retained with patient consent as the lawful basis in relation to the common law duty of confidentiality."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-03-13"]
["Next Review Date","2025-03-13"]
["Notes","Specific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 20 December 2018).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Alder Hey Children’s Hospital NHS Foundation Trust has a published satisfactory (with improvement plan) reviewed grade on V14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02371","index":414,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02371"]
["Reference","18/CAG/0186"]
["Other Refs","IRAS project ID: 236522, REC reference: 18/NW/0606"]
["Application Title","Angiography-based functional assessment of coronary artery disease in patients with aortic stenosis: predictive prognostic value in patients undergoing TAVI"]
["Application Summary","This application from King´s College Hospital set out the purpose of medical research which aims to assess the importance narrowing in the blood vessels that supply the heart muscle in patients with aortic stenosis (narrowing of the aortic valve) with a new test which uses specialist computer software applied to pictures of the coronary arteries (coronary angiography). It is currently unknown how patients with blood vessel narrowing are affected, particularly in patients who are treated with keyhole surgery for aortic stenosis (TAVI). The study aims to increase understanding of the significance of coronary artery narrowings in patients with aortic stenosis and to provide information on how these patients would be best treated. \n\nThe applicants will screen local hospital records for all patients treated with TAVI over the previous eight years in order to identify the cohort eligible for inclusion in the study. The research team are members of the clinical care team and have legitimate access to patient records; however, mortality checks will be undertaken via linkage with NHS Digital in order to determine which patients are alive in order to contact them to seek consent to participate in the study. Support under the Regulations is sought to support the disclosure of confidential patient information from King’s College Hospital to NHS Digital and linkage with mortality information. \n"]
["Applicant Organisation Name","King´s College Hospital "]
["Contact Name","Dr Fernando Macaya-Ten "]
["Address","Alder Hey Children’s NHS Foundation Trust"]
[null,"Denmark Hill"]
[null,"Brixton, London "]
["Postcode","SE5 9RS "]
["Telephone","02032994248"]
["Email","fernando.macaya-ten@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who underwent keyhole surgery for aortic stenosis (TAVI), between 29 August 2007 and 06 October 2017, at King’s College Hospital. It is estimated that 600 patients would be included in the sample."]
["Description of confidential patient information used","Confidential patient information will be disclosed by the direct care team at King’s College Hospital to NHS Digital in order to linkage with ONS mortality information and HES data. The following items of confidential patient information are cited as necessary for the purposes specified:\n\n• NHS number – sample validation and linkage,\n• Hospital ID – sample validation,\n• Date and cause of death – sample validation and analysis,\n• Postcode – sample validation and linkage,\n• Date and cause of death – analysis. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-03-28"]
["Next Review Date","N/A"]
["Notes","The study never took place, as the Fellow who was to do the work returned to Spain. \n\nSpecific conditions of support\n1. Further information regarding patient notification and dissent needs to be provided. Information about the study needs to be included on the Trust website, including that the study is a retrospective study that will not be publishing any identifiable data, together with provision of opt-out details. Feedback around the mechanism which was established together with sight of any text which supported this should be provided at the time of first annual review.\n2. Favourable opinion from a Research Ethics Committee. (Confirmed – Favourable Opinion issued by the London – Dulwich REC on 08/11/2018)\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – NHS Digital has a published satisfactory reviewed grade on V14.1, 2017/18)."]

{"sheet":"A02372","index":415,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02372"]
["Reference","18/CAG/0125"]
["Other Refs","IRAS project ID: 229396. REC reference: 18/LO/1530."]
["Application Title","Predicting recovery and treatment responses in post-stroke aphasia"]
["Application Summary","This application from University College London set out the purpose of medical research which aims to explain the variability in recovery of speech and language capabilities in patients who have suffered a stroke. It is stated that this variation in recovery has traditionally been treated as a fixed limit on the available understanding of the recovery process from stroke. However, a differing view is now emerging in that, as different regions of the brain serve different functions, it is suggested that the consequences of stroke should depend on the details of the brain regions which were damaged or preserved. High-resolution imaging technology can be used to measure these details non-invasively and in large numbers of patients whose are outcomes are already known.\n\nThe proposed research will employ similar techniques to relate the details of brain lesions caused by a patient’s stroke to both the recovery of their language skills and response to speech and language therapy in the first weeks after the stroke occurred. This will involve the use of high resolution brain images and associated clinical notes for patients who were treated for stroke at University College Hospitals London NHS Trust to see if details of the brain damage that stroke survivors have suffered can be used to predict likely recovery trajectories and responses to therapeutic interventions. Support is requested to allow access by the main applicant to confidential patient information held at University College Hospitals NHS Trust, to enable brain scans to be linked with information from clinical notes. A pseudonymised dataset would be extracted for analysis.\n"]
["Applicant Organisation Name","University College London "]
["Contact Name","Dr Thomas M. H. Hope "]
["Address","12 Queen Square "]
[null,"Bloomsbury "]
[]
["Postcode","WC1N 3AR"]
["Telephone",7956580926]
["Email","t.hope@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","• Stroke patients, aged 18 and over, who were treated at the University College Hospitals NHS Trust Hyper-Acute Stroke Unit and transferred to the Acute Brain Injury Unit between 01/01/2008 and 31/12/2017. \n• Eligible patients must have an acute structural MRI scan and MDT meeting notes recorded on file.\n• It is anticipated that 1,500 patients will be included in the study.\n"]
["Description of confidential patient information used","• Hospital ID number – linkage,\n• Date of birth – to calculated age at stroke onset (to nearest year) for analysis.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-03-29"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in March 2022 that ‘s251’ support can be expired as identifiers have been \nanonymised.\n \nThe public benefits accrued so far follow from the demonstration that trajectories on the ward are somewhat predictable – including recovery from paralysis and cognitive impairment. These models are now being validated by others, on other data. \n\nSpecific Conditions of Support (Final)  \n\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University College London Hospitals NHS Foundation Trust shows a reviewed satisfactory grade on Version 14.1, 2017/18).\n"]

{"sheet":"A02373","index":416,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[33,1,33,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[21,1,21,4],[22,1,22,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4]]}
[]
[]
["Application Number","A02373"]
["Reference","18/CAG/0078"]
["Other Refs","IRAS project ID: 238514. REC reference: 18/WS/0052."]
["Application Title","Prospective epidemiological surveillance of Retinal Dialysis in the United Kingdom: Incidence, demographics and clinical features"]
["Application Summary","The application from NHS Greater Glasgow and Clyde set out the purpose of medical research which would utilise the established BOSU methodology to investigate incidence of retinal dialysis in the UK. Reporting Ophthalmologists will report to the BOSU unit that they have seen a case within their clinic. The BOSU unit will pass details of the reporting clinician to the researcher, to enable follow-up with a data collection questionnaire. \n\nThe applicants will record incidence across England, Wales and Scotland over a one year reporting period. Follow-up will be undertaken at six months following initial incidence report. The remit of the CAG extends to the data reported from England and Wales only – the applicant has been advised to make alternative arrangements for the reporting in Scotland and Northern Ireland. \n"]
["Applicant Organisation Name","NHS Greater Glasgow and Clyde "]
["Contact Name","Miss Pallavi Tyagi "]
["Address","Tennent Institute of Ophthalmology "]
[null,"Gartnavel General Hospital "]
[null,"Glasgow"]
["Postcode","G12 0YN"]
["Telephone","07903611261"]
["Email","Pallavi.Tyagi@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All newly reported incidence of retinal dialysis across the UK within a one year reporting period, with the CAG remit extending to cases reported within England and Wales only."]
["Description of confidential patient information used","The following items of confidential patient information are requested for case identification and to prevent duplication: \n\n• Hospital Number (England and Wales),\n• Month and Year of birth – retained for analysis, \n• First half postcode, \n• Sex – retained for analysis.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-03-26"]
["Next Review Date"]
["Notes","The applicant confirmed in August 2023 that ‘s251’ support can be expired, as of December 2021, as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, the study was undertaken in collaboration with British Ophthalmic surveillance unit (BOSU) to identify rare ocular diseases of public importance. ‘Retinal Dialysis’ is rare cause of retinal detachment. It is associated with trauma and its prevalence in younger individuals makes it significant. The condition can result in loss of vision in younger and working age group individuals. The study helped to understand the extent of disease, its presentation and outcomes. It would improve public awareness of condition and steps to avoid eye injuries that can cause the condition and identify its presentation. It would also help clinicians to choose better management strategies based on outcomes. \n\n\nSpecific conditions of support (Final)\n\n1. Support extends to information generated in England and Wales only. \n2. Favourable opinion from a Research Ethics Committee (Confirmed – 26 March 2018). \n3. Final approval letter from the Scottish Public Benefit and Privacy Panel (PBPP) in relation to this study (Received – submission of the most current and up-to-date outcome letter from PBPP should also be provided at the time of annual review as evidence of continuing support). \n"]

{"sheet":"A02374","index":417,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02374"]
["Reference","19/CAG/0014"]
["Other Refs","IRAS project ID: 254483. REC reference: 19/EE/0012. "]
["Application Title","Anticipatory Prescribing in Terminal Care Study (APT Study)"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research which aimed to evaluate the use of anticipatory prescribing. The study would involve patients treated by 12 GP practices in Cambridgeshire and Hertfordshire. Anticipatory prescribing (AP) is the prescription and dispensing of injectable medications to a named patient, in advance of clinical need, for administration by nurses or General Practitioners (GPs) if symptoms arise in the last days of life. The practice is endorsed by national policy; however, it is unclear which patients could or do benefit from the practice. \n\nThe study will involve a retrospective medical record review to gather detailed data on the frequency of issuing and use of anticipatory prescribing across a range of illnesses for patients in the community at the end of life. The 30 most recent eligible deceased patients will be included from each GP practice. The student investigator will visit the GP practices and two associated community nursing organisations in order to review patient records and extract relevant information for analysis. Pseudonymised data will be collected on to an electronic case report form from patient records. Confidential patient information will also be extracted and stored within a master file, separate from analysis information, and retained for a period of six months following the data extraction from the relevant study site.\n"]
["Applicant Organisation Name","University of Cambridge "]
["Contact Name","Dr Stephen Barclay "]
["Address","Primary Care Unit, Institute of Public Health, "]
[null,"Forvie Site, Robinson Way, "]
[null,"Cambridge"]
["Postcode","CB2 0SR"]
["Telephone","01223 763082 "]
["Email","sigb2@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 or above, who were registered at a participating GP practice at the time of their death and received anticipatory prescribing at part of end of life care. Participating GP practices will be located in the Cambridgeshire and Hertfordshire district. 360 patients will be included within the study. "]
["Description of confidential patient information used","The following items of confidential patient information will be provided by the GP practices in order to identify patient records, facilitate linkage with community nursing records and to create the pseudonymised dataset which will be used in the study analysis:  \n\n• Name – sample validation and linkage,\n• NHS number – sample validation, linkage and analysis,\n• Date of death – sample validation, linkage and analysis, \n• Sex – sample validation, linkage and analysis,\n• Ethnicity – sample validation, linkage and analysis. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-03-25"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in February 2022 that ‘s251’ support can be expired as identifiers have been permanently deleted. \n \nIn terms of public benefit, this research has significantly advanced clinical and research communities understanding of community end-of-life anticipatory medication prescribing practices and the associated financial costs of these medications. Seven invited oral conference presentations and the following published papers (two to date) detailing the research findings have been well received by researcher and clinician communities and are informing improvements in patient care and clinical practices. \n\n18 October 2019: Amendment supported to extend the scope of patient records to be accessed from the final 12 months of life, to the final 36 months of life, for patients whose anticipatory prescribing care decision was taken within this timeframe.  \n\nSpecific conditions of support (Final)\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed):  \na. University of Cambridge Clinical School has a published satisfactory reviewed grade on V14.1, 2017/18,\nb. 12 GP practices and two associated community nursing organisations – Not requested for each site; support is based on the assumption that the applicant will ensure that satisfactory security assurances are in place for each site. \n"]

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[]
[]
["Application Number","A02375"]
["Reference","18/CAG/0185"]
["Other Refs","IRAS project ID: 161432. REC reference: 14/WA/1211"]
["Application Title","At-Risk Registers Integrated into primary care to Stop Asthma crises in the UK (ARRISA-UK): A pragmatic cluster randomised trial with nested economic and process evaluations examining the effects of integrating at-risk asthma registers into primary care with internet-based training and support"]
["Application Summary","This application from the University of East Anglia set out the purpose of medical research which aims to assess whether care provided to patients with asthma, which are at greater risk of hospital admissions and dying from their condition, can be improved via a GP-practice led intervention. The study has recruited 270 GP practices across England, Wales and Scotland in an attempt to identify approximately 10,000 patients who are at-risk of having severe asthma attacks. Half of these practices were randomised to receive a computerised alert message whenever one of the at-risk patients made contact with any member of the practice staff. Practice staff received training in how to manage the alert system, which included making urgent appointments, advising patients to take their medication and follow their written asthma action plans and pharmacists to ensure patients take their medication. The study will follow-up all patients within participating practices with an asthma diagnosis to ensure the intervention is workable for all patients and does not divert resources away from the wider asthma patient population. \n\nThis application has been submitted to the CAG to enable follow-up of patients at participating GP practices via administrative datasets held by NHS Digital. The application relates only to the sites in England. Information will be collected on A&E attendance, hospital admissions and deaths due to asthma. Practices will be followed up for a 12 month period. The applicants will also measure asthma control, medications prescribed, attendance for routine appointments and smoking cessation. This information will be used to calculate how much this costs and whether it improves (or interferes with) the care of other patients with asthma in the practices. The study also involves a consented qualitative element which will involve focus groups and interviews for patients and staff, to discuss thoughts about the at-risk registers, the training, and how it worked in practice. This element is out of scope for the CAG application as it will be operated on a consented basis. \n"]
["Applicant Organisation Name","University of East Anglia"]
["Contact Name","Professor Andrew Wilson"]
["Address","Norwich Medical School"]
[null,"University of East Anglia"]
[]
["Postcode","NR4 7TJ"]
["Telephone","01603 591257"]
["Email","a.m.wilson@uea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with an asthma diagnosis across 222 English and 10 Welsh border GP practices recruited to the study. It is estimated that there will be 147,000 patients in total within this sample, of which, 10,000 will be at-risk of severe asthma attacks."]
["Description of confidential patient information used","Confidential patient information will be disclosed from participating GP Practices to NHS Digital, via Harvey Walsh, in order to facilitate linkage with administrative datasets. The following items of confidential patient information are requested for the purposes set out:\n\n• NHS Number – sample validation and linkage, \n• Date of birth – sample validation and linkage,\n• Sex – sample validation and linkage.\n• Date and cause of death (MM/YY format) – analysis,\n• Registered GP practice code – analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","University of East Anglia"]
["Status","Expired"]
[]
["Outcome Date","2019-04-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, applicants anticipate that this study is sufficiently robust to change practice within a year of publication. Therefore, significant public benefit is still anticipated, after the primary results are released in late 2024. \n\n\nAmendment supported 15 June 2023 to extend the duration of the study until 31 October 2023\n\n13\tJune 2023 - change in data processors from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES), and ONS Mortality data\n\n\nAmendment supported 17 November 2022 to extend the duration of the study until 30 April 2023\n\n21 October 2021 - Amendment supported to extend the duration of the study until 31 October 2022\n\n17 August 2020 - Amendment supported to extend the duration of the study until 31 October 2021.\n\n05 August 2019 - Amendment supported to extend the patient cohort to those registered at 10 Welsh-border GP practices, for whom hospital admissions are made in England. Data linkage undertaken by NHS Digital is extended to in scope to now include all deaths, not just those specified as linked to asthma, within ONS Mortality information and all outpatients and criticial care appointments recorded for patients. \n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed). \n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – NHS Digital has a published satisfactory reviewed grade on V14.1, 2017/18 and Harvey Walsh Ltd. have submitted a DSPT 2018/19 – NHS Digital confirmed by email 12/11 that standards have been met (equivalent of satisfactory rating on IGTK). \n"]

{"sheet":"A02376","index":419,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02376"]
["Reference","19/CAG/0024"]
["Other Refs","IRAS project ID: 244748. REC reference: 19/LO/0035"]
["Application Title","The Sub30 feasibility study of a pre-hospital extra-corporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 minutes of collapse in patients with refractory out-of-hospital cardiac arrest."]
["Application Summary","This application from the Barts Health NHS Trust set out the purpose of medical research which aims to evaluate the impact of early administration of Extracorporeal Cardiopulmonary Resuscitation (ECPR) to patients suffering cardiac arrest on survival outcomes. The active study will involve the recruitment of a six patients across a 12 month study period, who will receive ECPR within 30 minutes of the call for emergency services pre-hospital admission. This study aims to assess the feasibility and safety of operating this protocol in order to inform a future larger-scale trial.\n\nThe six active patients which will be included in the trial are being recruited under the emergency research provisions of the Mental Capacity Act 2005. The applicant has stated that the request for support under the Regulations does not extend to the active cohort of patients.\n\nThe applicants intend to create a control cohort of patients as a comparator group to the active patient cohort for analysis. The research team will send matching variables based on the active patient cohort to the London Ambulance Service to enable linkage with the dispatch data and cardiac arrest database. These variables will be used to match with wider patients managed by London Ambulance Service on non-study days to provide the researchers with a comparator cohort in order facilitate analysis. Whilst the variable included in this database have been limited, this will include date of incident, location of collapse (which may or may not be the patient’s home address) and date of death as appropriate. The applicants are seeking support under the Regulations for the processing which would be undertaken by the London Ambulance Service and the subsequent disclosure of the database to the research team.  \n"]
["Applicant Organisation Name","St Bartholomew's Hospital"]
["Contact Name","Dr Simon Finney"]
["Address","St Bartholomew's Hospital"]
[null,"West Smithfield"]
[null,"London"]
["Postcode","EC1A 7BE"]
["Telephone",2073777000]
["Email","simon.finney@bartshealth.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 18-65 years who suffer an out of hospital cardiac arrest and are attended by London Ambulance Service across the study duration (maximum 12 months) who were not included in the study as an active patient. Patients would be required to meet the standard inclusion criteria which have been established for active patient recruitment including receipt of bystander chest compressions within three minutes of collapse and remain in cardiac arrest at 20 minutes following the call to emergency services. Based on numbers of cardiac arrests attended in 2017/18, it is estimated that this patient cohort will include a maximum of 592 patients. "]
["Description of confidential patient information used","London Ambulance Service will perform matching on active patients based on age (closest match to five years), time of first LAS resource attendance on scene (closest match to five minutes) and presumption of the cardiac aetiology (cause) of the arrest. The following items of information will be released in relation to the matched comparator cohort:\n\n• Location of the cardiac arrest – provided as GPS Location which will be converted into sector level postcode for analysis,\n• Date of the cardiac arrest – analysis,\n• Date of death – analysis,\n• Age – analysis, \n• Sex – analysis. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor","Queen Mary University of London"]
["Status","Expired"]
[]
["Outcome Date","2019-04-09"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in March 2024 that ‘s251’ support could be expired as the activity did not commence.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Ambulance London Service NHS Trust and Barts Health NHS Trust both have published satisfactory reviewed grades on V14.1, 2017/18). \n"]

{"sheet":"A02377","index":420,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02377"]
["Reference","19/CAG/0048"]
["Other Refs","Resubmission of 19/CAG/0016, IRAS project ID: 258258, REC reference: 19/NW/0150"]
["Application Title","Patient perceived outcomes after Sub-acromial Decompression surgery #1"]
["Application Summary","This application from the University of Liverpool sets out the purpose of medical research\nwhich aims to evaluate local practice and explore the outcomes of arthroscopic subacromial\ndecompression surgery (to release a ligament from the front of the shoulder blade)\nfrom a patient’s perspective via targeted questionnaire.\nAll patients who underwent the surgical procedure at Leighton Hospital, within the Mid\nCheshire Hospitals NHS Foundation Trust, during 2016 and 2017 will be invited to take part\nin the questionnaire. An application has been made to the CAG to seek support under the\nRegulations to support the disclosure of confidential patient information from medical\nrecords to facilitate the invitation process. The Student Investigator, whilst an employee of\nMid Cheshire Hospitals NHS Foundation Trust, is not considered to be part of the direct\ncare team for this patient population. Patients will provide their consent to participate in the\nstudy.\nA recommendation for class 3, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Dr Mark Pinnington "]
["Address","School of Health Sciences, University of Liverpool"]
[null,"1.18 Brownlow Hill"]
[null,"Liverpool"]
["Postcode","L69 3GB"]
["Telephone","0151 7949806"]
["Email","m.a.pinnington@liverpool.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All living patients aged 18 years and over who underwent primary arthroscopic subacromial\ndecompression surgery at Leighton Hospital in the calendar years 2016 and 2017\nwill be invited to participate in the study. It estimated that fewer than 100 patients will meet\nthe inclusion criteria."]
["Description of confidential patient information used","The following items of confidential patient information are required to identify and validate\nthe patient sample to be invited to participate in the study and to facilitate the invitation\nprocess:\n• Name,\n• Hospital ID,\n• Full Address and Postcode."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-04-11"]
["Next Review Date","N/A"]
["Notes","This application reference expired with effect from 31/10/2019.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed - Mid Cheshire Hospitals NHS Foundation Trust has a satisfactory reviewed grade on V14.1, 2017/18). \n"]

{"sheet":"A02378","index":421,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02378"]
["Reference","18/CAG/0168"]
["Other Refs","IRAS project ID: 243889, REC reference: 18/EE/0318"]
["Application Title","Clinical outcomes of a PPS program undertaken in a large UK cohort"]
["Application Summary","This application from St George’s University of London set out the purpose of medical research which aims to follow-up a cohort of patients who underwent voluntary cardiac screening with the voluntary organisation, Cardiac Risk in the Young (CRY). CRY is a charitable organisation that offer pre-participation screening to young adults aged between 14 and 35 years. Since 2008, CRY has screened over 100,000 patients with a health questionnaire and 12 lead electrocardiogram (ECG).\nThis proposes study aims to ascertain from those patients screened, how many went on to suffer a sudden cardiac arrest and/or sudden cardiac death via linkage of confidential patient information held within the CRY database with HES and ONS Mortality statistics databases held by NHS Digital. The findings will contribute to the ongoing research into the risks of sudden cardiac arrests and deaths in young apparently fit and healthy individuals. The research will build on a previous study (supported via CAG reference 16/CAG/0042), which followed up 5,000 patients within the CRY database.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","St George's University of London"]
["Contact Name","Dr Hamish MacLachlan"]
["Address","Cardiovascular Sciences Department"]
[null,"St George's University of London"]
[null,"London"]
["Postcode","SW17 0QT"]
["Telephone","07715482170\n"]
["Email","hmaclach@sgul.ac.uk\n"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 14 and 35 years who underwent voluntary cardiac screening via Cardiac Risk in the Young from 2008 onwards. This will involve approximately 120,000 patients."]
["Description of confidential patient information used","The following items of confidential patient information will be released from the Cardiac Risk in the Young database to St George’s University London. Further disclosure from St George’s University London to NHS Digital is then required to enable follow-up via HES and ONS Mortality information.\n• Name,\n• GP Registration,\n• Date of birth,\n• Date of death,\n• Postcode (Unit Level),\n• Gender,\n• Ethnicity."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-04-05"]
["Next Review Date","2024-04-05"]
["Notes","12 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil registration deaths data\n\nConditions of support - final:\n1. The study-specific website text should be revised to relocate the information about a patient’s right of object to an earlier place in the text. This revised document should be provided within one month of the date of this outcome letter. (Condition met 14 October 2019)\n2. Patient engagement activity should be progressed as part of the online booking system in order to explore the views around the use of confidential patient information provided as part of the screening programme for wider research purposes without seeking consent from the patients. Feedback around this activity is required at an interim report which should be provided within six-months of the date of this outcome. (Condition met 14 October 2019)\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 15 October 2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – St George’s Hospital Medical School (covering St George’s University of London) and NHS Digital have a published satisfactory reviewed grade on Version 14.1, 2017/18)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02379","index":422,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02379"]
["Reference","19/CAG/0008 "]
["Other Refs","IRAS project ID: 214527, REC reference: 18/WA/0324"]
["Application Title","Determination of genetic, transcriptomic and proteomic pharmacological targets for the treatment of ovarian cancer"]
["Application Summary","This application from the Leeds Teaching Hospitals NHS Trust set out the purpose of\nmedical research which aims to gain further understanding around the genetic blueprint\ndefects and pathways leading to abnormal protein expressions in patients with ovarian\ncancer. This project aims to address both of these strategies by providing surplus archival\novarian cancer tissue samples with anonymised case-specific demographic annotations to\na commercial partner who is funding the project, TriStar. In turn, TriStar will distribute this\nmaterial to pharmaceutical companies actively engaged in ovarian cancer drug\ndevelopment programmes, whilst returning a replica of all the material collected and\nprocessed to Leeds, where it will be made available for academic research programmes.\nThe application has been submitted for review by the CAG to seek support under the\nRegulations to enable the patient cohort to be identified from records held at Leeds\nTeaching Hospitals NHS Trust and to facilitate the extraction of the pseudonymised data\nset which will be shared with the study partner TriStar. Archival diagnostic tumour samples\nwill also be provided to the TriStar study partner – these will be linked to the pseudonymised\ndataset. A link file will be maintained at the hospital Trust site, to enable any returned\nsurplus samples to be returned to the correct patient record.\nEligible patients will be identified by the main applicant in the first instance from the CoPath\ndatabase (pathology diagnosis reporting software). These cases will be retrieved from the\narchive by a biomedical scientist appointed solely for the study purposes. The main\napplicant will be responsible for determining which patients from the overarching sample\nhad sufficient diagnostic tissue stored in the archive to be eligible for inclusion in the study.\nThe biomedical scientist will then access the PPM+ database (patient information storage\ndatabase) in order to extract the relevant clinical information to support the samples. The\nmain applicant will retain an independent, link-anonymised database which contains the\nstudy numbers and patient identifiers.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application form."]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Trust"]
["Contact Name","Dr Nicolas M Orsi, Clinical Lecturer"]
["Address","University of Leeds/Leeds Teaching Hospitals Trust, Department of Histopathology, Level 5,\n"]
[null,"Bexley Wing, St James's University Hospital,"]
[null,"Beckett Street, Leeds"]
["Postcode","LS9 7TF"]
["Telephone","0113 3438625 "]
["Email","n.m.orsi@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female patients who received a surgical resection for a range of ovarian cancers and were\ntreated at the Leeds Teaching Hospitals NHS Trust. 500 patients will be included in the\nstudy from existing records spanning a 25 year time period."]
["Description of confidential patient information used","The following items of confidential patient information will be extracted from CoPath records\nto enable the identification of the associated tissue samples and to create the anonymised\nclinical database to be used to support analysis:\n• NHS Number – sample validation and linkage,\n• Date of birth – converted to years for analysis,\n• Date of death – used to calculate survival time for analysis,\n• Sex – sample validation,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-04-18"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as all identifiable patient information held without consent under this support has been removed, and any information that continues to be held is pseudonymised. Appropriate technical and organisational controls are in place so that it is not possible to reidentify the clinical information for those people who do not have an existing legal basis to access identifiable data.\n\nIn terms of public benefit, there are several benefits to the availability of clinical tissue and metadata, including the provision to pharmaceutical companies developing novel drugs for treatment-resistant ovarian cancer, and to support research projects into ovarian cancer at Leeds Teaching Hospitals Trust, with attendant benefits to the development of academic histopathology and other clinical disciplines.\n\n18 January 2022 - Further condition applied for next annual review due 18 April 2022:\n1. Further evidence of additional Patient and public involvement is required at the next annual review, with feedback surrounding specific details of the acceptability of using data without consent.\n\nConditions of support\n1. Patient and public involvement and engagement activity should be undertaken on an ongoing basis to seek views on the study progress, findings and the subsequent dissemination. Feedback should be provided at the time of annual review around additional activity undertaken in this area and the feedback provided. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\nCondition met as part of annual review January 2022\n\n2. Favourable opinion from a Research Ethics Committee (Confirmed).\n\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Leeds Teaching Hospitals NHS Foundation Trust has a published satisfactory reviewed grade on V14.1, 2017/18). \n"]

{"sheet":"A02380","index":423,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02380"]
["Reference","19/CAG/0049"]
["Other Refs","Previously: 18/CAG/0162, IRAS project ID: 250076, REC reference: 18/NS/0107"]
["Application Title","ECG Parameters predicting Adverse Events in Congenital Heart Disease"]
["Application Summary","This application from Newcastle University set out the purpose of medical research which aims to investigate whether there is a way to predict which children and adults who have previously undergone surgery for congenital heart disease are at higher risk of developing abnormal heart rhythms (arrhythmias), including ventricular tachycardia (VT), ventricular fibrillation (VF) and sudden cardiac death. This is a retrospective record review only. Records from the congenital heart disease database at the Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, will be accessed to extract a pseudonymised dataset to be used in the study analysis.\nA recommendation for class 1 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Louise Coats, Clinical Intermediate Fellow and Honorary Consultant Adult Congenital Heart Disease"]
["Address","Institute of Genetic Medicine\n"]
[null,"Newcastle University "]
[null,"Central Parkway, Newcastle upon Tyne"]
["Postcode","NE1 3BZ"]
["Telephone",1912336161]
["Email","lecoats@doctors.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female deceased patients, who underwent surgery at Newcastle upon Tyne Hospitals NHS Foundation Trust to treat congenital heart disease between 01/01/1965 and 01/01/2021."]
["Description of confidential patient information used","Access to the complete medical records is required. The following items of confidential patient information are required for the purposes described:\n• NHS Number – linkage,\n• Date of birth – analysis,\n• Date of death – analysis,\n• Sex – analysis,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-04-23"]
["Next Review Date","N/A"]
["Notes","10 February 2022 - Support Expired\nAll data has been pseudoanonymised and that the study numbers held against the PID (on Trust computers) will be disposed of according to Trust Policy on 10/2/22.\n\nThe public benefits arising from this work include:\n\n• Teaching of undergraduate and masters students the mechanisms of research as well as increasing exposure to the issues related to adult congenital heart disease\n\n• Research, the data that has been interrogated as part of this project is planned for publication and in addition the findings feed into present grant applications (including recently successful BHF CRC grant focused on ambulatory care delivery for adults with CHD)\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Newcastle upon Tyne Hospitals NHS Foundation Trust has a satisfactory reviewed grade on V14.1, 2017/18).\n"]

{"sheet":"A02381","index":424,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02381"]
["Reference","19/CAG/0040"]
["Other Refs","Replacement of CAG 4-09(a)/2013, IRAS project ID: 253767, REC reference: 19/LO/0086 "]
["Application Title","Translational Research in Pulmonary Hypertension at Imperial College (TRIPHIC"]
["Application Summary","Background to Submission  \n The TRIPHIC research database received a recommendation of support under the Regulations on 18 September 2013. The purpose of the project was to establish a research database from established datasets at Imperial College Healthcare Trust which were linked with datasets at NHS Digital (then the HSCIC). The database included information on approximately 2000 patients who had been referred to the National Pulmonary Hypertension Service at Imperial over the preceding decade.  \n \nPurpose of this Application  \n This application from Imperial College Healthcare NHS Trust set out the purpose of medical research through the ongoing retention of the TRIPHIC research database for a further fiveyear duration in line with the refreshed research database application which had been submitted for ethical review, in line with NHS REC Standard Operating Procedure requirements.  \n \nA recommendation for class 1, 3, 4 and 6 support was requested to cover activities as described in the application.  \n "]
["Applicant Organisation Name","Imperial College Healthcare NHS Trust"]
["Contact Name","Professor Martin R Wilkins\nCentre for Pharmacology & Therapeutics\nICTEM Building, Hammersmith Hospital\nDu Cane Road, London\nW12 0HS"]
["Address","Room 2S4, Commonwealth Building"]
[null,"Faculty of Medicine, Hammersmith Hospital"]
[null,"Du Cane Road, London"]
["Postcode","W12 0NN"]
["Telephone","020 3313 2049"]
["Email","m.wilkins@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support under the Regulations currently extends to the following sub-cohorts of patients: \n \n• living patients who previously donated biological samples and were then discharged prior to the introduction of TRIPHIC (n=374),  • living patients with CMR images who were also discharged (n=177),  • a further 152 patients remain under care of the Pulmonary Hypertension Service and are being approached directly, seeking face-to-face TRIPHIC consent during clinical follow-up."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes set out: \n \n• NHS Number – sample validation and linkage, \n• Date of birth – sample validation, linkage and analysis, \n• Date of death – sample validation, linkage and analysis, \n• Sex – analysis, \n• Ethnicity – analysis.  "]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-04-26"]
["Next Review Date","2024-04-26"]
["Notes","12 August 2020 - Amendment to introduce an opt-out approach, and to update the protocol with various revisions, is supported.\n\nConditions of support:\n1. All pre-existing conditions of support related to CAG 4-09(a)/2013 remain applicable. \n2. The pre-existing annual review cycle remains applicable, with the next annual review to be received four weeks before 18/09/2019, and then on an annual basis to this schedule.\n3. Feedback around the consenting pilot should be provided at the time of next annual review, including an overview of how many patients responded to the request and those which were lost. Confirmation should also be provided at that time around whether the patient approach would continue on a consenting basis, or whether adoption of the opt-out mechanism has been agreed.\n4. Patients who do not respond to the consent approach in the pilot study would need to be removed from the database. Confirmation should be provided at the time of next annual review around this. \n5. Favourable opinion from a Research Ethics Committee (Confirmed).\n6. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Imperial College Healthcare NHS Trust has a published satisfactory reviewed grade on V14.1, 2017/18). \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02382","index":425,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02382"]
["Reference","18/CAG/0205"]
["Other Refs","IRAS project ID: 241147, REC reference: 18/YH/0310"]
["Application Title","International Surgical Outcomes Study: Long-term survival"]
["Application Summary","This application from Queen Mary University of London on behalf of Bart’s Health NHS Trust set out the purpose of medical research to follow-up patients who were enrolled in the International Surgical Outcomes Study (ISOS). ISOS was an international seven-day cohort study of adults undergoing in-patient elective surgery that provided detailed data describing post-operative complications and associated mortality.\nPart of the planned analysis of ISOS was to follow up patients by linking to national datasets via confidential patient information to determine the long-term survival. ISOS completed patient recruitment, and closed, in 2014 and patient consent for linkage to national datasets to enable long term follow-up of those recruited within England was obtained. NHS Digital has subsequently advised the applicant that the historic consent is no longer deemed to be valid for the purposes of linkage, which brought about the application to the CAG.\nA recommendation for class 1and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Professor Rupert Pearse\nProfessor of Intensive Care Medicine"]
["Address","Queen Mary University of London, Royal London Hospital"]
[null,"Whitechapel"]
[null,"London"]
["Postcode","E1 1BB"]
["Telephone",2035940352]
["Email","rupert.pearse@bartshealth.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who consented to participate in the International Surgical Outcomes Study. The original study inclusion criteria was any patient aged over 18 undergoing elective surgery."]
["Description of confidential patient information used","Confidential patient information will be released from Barts Health NHS Trust to NHS Digital to facilitate linkage with HES and ONS information. The following items of confidential patient information are required for the purposes specified:\n• ISOS Study ID – sample validation and linkage,\n• NHS Number – sample validation and linkage,\n• Sex – sample validation and linkage,\n• Date of birth – sample validation and linkage,\n• Postcode – sample validation and linkage,\n• Date of death – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-05-14"]
["Next Review Date","2024-05-14"]
["Notes","5 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil registration mortality data. \n\nConditions of support:\n1. Support will extend to the provision of follow-up data for years two and three only.\n2. Support does not extend to the provision of the first 12 months follow-up data as a practicable alternative of valid consent under the common law already exists for this activity. Note that support cannot be provided where an alternative lawful basis is already in place. The activity in relation to the initial 12-month follow-up can proceed on the basis of the informed consent provided by participants. \n3. Favourable opinion from a Research Ethics Committee (Confirmed).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed - NHS Digital and Barts Health NHS Foundation Trust have published satisfactory reviewed grade on V14.1. 2017/18).\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02383","index":426,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02383"]
["Reference","18/CAG/0195"]
["Other Refs","IRAS project ID: 249685, REC reference: 18/LO/1866"]
["Application Title","Does surgery for asymptomatic carotid stenosis reduce the long term risk of dementia, stroke, death and other important health outcomes? Extended UK post-trial follow-up of the Asymptomatic Carotid Surgery Trial (ACST-1). Phase 2"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which\naims to undertake a follow-up of patients who were previously consented participants in the\nACST-1 trial, to evaluate the prevalence of dementia in this patient cohort. The ACST-1\ntrial randomly allocated participants with tight narrowing of the carotid artery to either\nimmediate carotid surgery (endarterectomy) or to avoid surgery unless they had symptoms.\nThe trial recruited patients between 1993 and 2003 and reported findings, for patients who\nunderwent endarterectomy, that the risk of stroke was reduced by five years and for at least\n10 years after the operation. There is suggestion that the narrowing of the carotid artery\ncarries a higher risk of developing dementia.\nThe proposed follow-up study will measure cognitive impairment in living patients within the\noriginal ACST-1 patient cohort, via a single postal assessment requesting completion of a\nvalidated questionnaire ‘Informant Questionnaire on Cognitive Decline in the Elderly’. The\napplication has been submitted to the CAG to enable the survival status to be checked for\nthe historic participant cohort and contact information held with consent to be updated via\nthe NHS Spine by NHS Digital, to enable postal invitations and questionnaires to be\ndistributed. Longer term follow-up of the ACST-1 cohort was carried out in 2016, via linkage\nwith administrative datasets held by NHS Digital. This linkage confirmed that a proportion\nof the original cohort was now deceased – these individuals would not be included in the\nproposed application activity.\nA recommendation for class 2, 3 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Alison Halliday, Professor of Vascular Surgery"]
["Address","University of Oxford, Nuffield Department of Surgical Sciences"]
[null,"Level 6, John Radcliffe Hospital"]
[null,"Headington, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865617978"]
["Email","alison.halliday@nds.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The historic patient cohort of the ACST-1 trial. 195 patients from the original cohort of 230\nwere known to be alive at last follow-up. This sub-cohort would be followed up via NHS\nDigital, prior to invitation to the proposed study"]
["Description of confidential patient information used","Confidential patient information will be disclosed from the University of Oxford to NHS\nDigital to facilitate linkage with NHS Spine and ONS information to perform survival\nchecking. The following items of confidential patient information are required for the\npurposes stated:\n• Name – linkage,\n• NHS Number – linkage\n• Date of birth – linkage,\n• Full postal address – to facilitate postal invitation,\n• Date of death – analysis,\n• Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-05-15"]
["Next Review Date","2021-05-15"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – University of Oxford- Medical Sciences Division-Nuffield Dept. of Population Health-Clinical Trials Service Unit and NHS Digital both have a published satisfactory reviewed grade on version 14.1, 2017/18). "]

{"sheet":"A02384","index":427,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02384"]
["Reference","19/CAG/0060"]
["Other Refs","IRAS project ID: 257174, REC reference: 19/NS/0054"]
["Application Title","Lancashire ANCA Vasculitis and Glomerulonephritis Study"]
["Application Summary","This application from Lancashire Teaching Hospitals NHS Foundation Trust aims to review\nthe epidemiology and outcomes of patients with small vessel vasculitis from a single centre\nby undertaking a retrospective observational study to help address current knowledge\ngaps. Pauci-immune small vessel vasculitis is a rare disease with a peak incidence of\nbetween 65-74 years.\nPatients will be identified from Department of Renal Medicine at Lancashire Teaching\nHospitals NHS Foundation Trust as part of a single centre study. A participant list will be\nidentified from a kidney biopsy registry dated from 1994 - 2017 and at a local registry of\npatients with vasculitis, which is held by the Renal Department at the participating Trust.\nInformation will be extracted from patient records to create a pseudonymised data set for\nanalysis.\nA recommendation for class 1, 4, 5 and 6 support was requested to allow activities as\ndescribed in the application."]
["Applicant Organisation Name","Lancashire Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Dr Kina Bennett, Research Operations Manager"]
["Address","Royal Preston Hospital"]
[null,"Sharoe Green Lane"]
[null,"Fulwood"]
["Postcode","PR2 9HT"]
["Telephone","01772 524 611"]
["Email","Kina.Bennett@lthtr.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with biopsy proven ANCA-associated small vessel vasculitis treated at\nLancashire Teaching Hospitals NHS Foundation Trust between 01 January 1994 and 31\nDecember 2017. The definition of ANCA-associated small vessel vasculitis as outlined by\nthe 2012 Chapel Hill Consensus Conference will be used. There are 287 eligible patients\nto be included."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes as set\nout below:\n• Name – sample validation and linkage,\n• NHS number – sample validation and linkage,\n• Date of birth – sample validation and linkage,\n• Date of death – anonymised for analysis,\n• Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-05-24"]
["Next Review Date","2024-05-24"]
["Notes","16 March 2022 - Amendment supported\nAmendment supported to change the Chief investigator to Dr Lauren Floyd.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. (Confirmed)\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Lancashire Teaching Hospitals NHS Foundation Trust has a satisfactory reviewed grade on V14.1, 2017/18)."]

{"sheet":"A02385","index":428,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02385"]
["Reference","19/CAG/0056"]
["Other Refs","IRAS project ID: 255676, REC reference: 19/NW/0178"]
["Application Title","Using Health Informatics to Improve Neurological Services"]
["Application Summary","This application from Lancashire Teaching Hospitals NHS Foundation Trust set out the purpose of medical research which aims to assess neurological services in the Trust area. Areas which will be explored include an analysis of diagnosis by geographical area and GP, an investigation of appointment types and patient pathways and an exploration of appointment attendance, non-attendance and cancellation. This will provide evidence for future service redesign and the provision of more efficient care.\nThe applicant will collate routinely collected information from outpatient neurology appointments linked with data extracted from the wider business intelligence data at Lancashire Teaching Hospitals NHS Foundation Trust to create a pseudonymised dataset to be used for analysis. The clinical data would also be linked to publicly available Census information using Lower Super Output Areas (LSOA) for population-based analysis.\nAttention was brought to the state of neurological services in 2011 by a National Audit Office (NAO) report entitled ‘Services for people with neurological conditions’. The issues highlighted by this report include delays in diagnoses, incorrect GP referrals, geographical inequalities in access to consultant neurological care, and the lack of good quality data on neurological conditions. Previous studies in other areas such as cardiology have demonstrated that routinely collected patient data can be used to investigate issues like these. Research has been conducted into areas including re-visit patterns in outpatient clinics, and the effect that diagnosis has on appointment attendance.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover the disclosure of specified confidential patient information from Lancashire Teaching Hospitals NHS Foundation Trust to the student investigator in order to facilitate linkage with wider hospital data sources in order to create a pseudonymised data set for analysis."]
["Applicant Organisation Name","Lancashire Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Professor Hedley Emsley - Professor of Clinical Neuroscience"]
["Address","Royal Preston Hospital"]
[null,"Neurology"]
[]
["Postcode","PR2 9HT"]
["Telephone",1772523621]
["Email","hedley.emsley@lthtr.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who were offered an appointment with neurological services in Lancashire Teaching Hospitals NHS Foundation Trust between the 18 September 2015 and 15 January 2019. There were 5,800 appointments offered within this study period."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes set out below:\n• NHS number – sample validation and linkage,\n• Hospital Number – sample validation and linkage,\n• GP registration – analysis,\n• Date of birth – accessed to calculate age for analysis,\n• Postcode – accessed to calculate Lower Super Output Area (LSOA) for analysis,\n• Sex – analysis,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-05-30"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed March 2023 that ‘s251’ support could be expired because anonymised data was extracted at the beginning of the study, and all analysis has been carried out on anonymised data. Any future analysis will be carried out on this anonymised dataset, there will be no access to identifiable patient information.\n\nIn terms of public benefit, the analysis of this data has resulted in the publication of several scientific papers and has led to a move towards the coding of outpatient diagnoses. This coding of diagnoses allows for a greater understanding of who is visiting neurology services, and how they are being used. Greater understanding of how neurology services are being used can lead to changes being made which improve access to neurology services for those who need them most.\n\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. (Confirmed)\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed - Lancashire Teaching Hospitals NHS Foundation Trust has a satisfactory grade on V14.1, 2017/18)."]

{"sheet":"A02386","index":429,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02386"]
["Reference","19/CAG/0046"]
["Other Refs","REC Reference: 19/WA/0079, IRAS Project ID: 259360"]
["Application Title","Deciphering AMD by deep phenotyping and machine learning - PINNACLE retrospective study"]
["Application Summary","This application from the University of Southampton set out the purpose of medical research which aims to use retrospective medical imaging and clinical data understand whether machine learning computer algorithms can be used to discover imaging markers of retinal aging and to predict individual progression and conversion to late Age-Related Macular Degeneration. This is a collaborative project which involves sites in Vienna and Switzerland combining anonymised patient images and information to test computer software.\nUniversity Hospital Southampton Foundation Trust and Moorfields Eye Hospital will be providing patient images and data in England. Optical Coherent imaging tomograms (OCT) images will be extracted from clinical databases on site the company which created the imaging software. The images will include confidential patient information which cannot be removed prior to extraction. The research team will use the confidential patient information present on the OCT images to wider clinical information within the patient’s hospital record. Once linked, all items of confidential patient information will be removed from the dataset which will be used in the study analysis. A linkage file will be created and held onsite by a member of the clinical care team.\nThe study will also request supplementary information and samples from the UK Biobank; however, this information will be released to the applicant in an anonymised format and is out of scope of the CAG application.\nSupport is requested to allow the extraction of confidential patient information from patient records at University Hospital Southampton Foundation Trust and Moorfields Eye Hospital by the software company which designed the OCT imaging software. Support is also required to enable the research team to use specified items of confidential patient information to facilitate the linkage of OCT images and wider clinical data held within patient’s medical records.\nA recommendation for class 1, 4, and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Southampton"]
["Contact Name","Professor Andrew Lotery"]
["Address","Clinical Neurosciences, Room LD75, Level D, Lab and Path Block,"]
[null,"Southampton General Hospital, Mail Point 806"]
[null,"Tremona Road, Southampton"]
["Postcode","SO16 6YD"]
["Telephone",2381205049]
["Email","A.J.Lotery@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged over 50 years who underwent OCT imaging at University Hospital Southampton Foundation Trust and Moorfields Eye Hospital. It is estimated that 72,000 scans will be included from these sites. The time frame for patient inclusion is 01/01/08-31/12/18."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes described:\n• Name – present on extracted OCT images,\n• Hospital ID – to facilitate linkage,\n• Sex – analysis,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-05-30"]
["Next Review Date","N/A"]
["Notes","06 January 2022 - Support Expired:\nAll the data has been pseudonymised and the original identifiers are no longer being processed. The key is still being stored in a secure location as per the original application, in the event the data steering group find any issues with the processed data that need to be clarified.  The key is only accessible to the direct care team with an existing legal basis to access.\n\nThe data provided us with a prediction model for Age Related Macular Degeneration (AMD), which we are validating with a separate prospective study. This will hopefully transfer into standard NHS care and allow a more personalised and effective level of care for individuals with the disease.\n\nSpecific Conditions of Support\n1. The website notification text should be revised to address the following points. A copy of the final draft should be provided within two months of the date of this letter for review.\na. Provide a clearer explanation that confidential patient information would be processed in order to create the analysis dataset,\nb. Explain that a legal basis in relation to the common law duty of confidentiality had been established to legitimise this processing without seeking direct consent from patients,\nc. Information around the patient’s right to object to the inclusion of their data in this study should be relocated to an earlier point in the text,\nd. It is recommended that the reference to the Information Commissioner’s Office is explained. \n2. Favourable opinion from a Research Ethics Committee (Confirmed 20 March 2019)\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed: University Hospital Southampton Foundation Trust and Moorfields Eye Hospital both have published satisfactory reviewed grades on V14.1, 2018/18.)"]

{"sheet":"A02387","index":430,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02387"]
["Reference","19/CAG/0053"]
["Other Refs","IRAS project ID: 261989, REC reference: 19/LO/0495"]
["Application Title","Myeloproliferative neoplasms Associated SplanChnic vein Thrombosis: Mascot Registry"]
["Application Summary","This application from the University College Hospitals London NHS Trust set out the purpose of medical research which aims to establish a research database of patients with Myeloproliferative neoplasms Associated SplanChnic vein Thrombosis (MPN-SVT) to use this to investigate demographics, clinical features, co-morbidities, outcomes & UK treatment practices for MPN-SVT enable future clinical trial design and facilitate regulatory approval decision-making. MPN-SVT is rare. It is life-long, affects young people, especially women and comprises three separate but connected set of problems occurring more or less simultaneously: bone marrow cancer, severe thrombosis, liver plus intestinal damage. The database will enable documentation of the prevailing situation and prospective information in UK and can help improve care pathways in UK for these patients.\nData will be collected from participating sites in England and Wales and entered directly into an online data platform hosted by Dendrite Clinical Systems Ltd. Information from the research database would only be released in an anonymised format to any applying researchers.\nA recommendation for class 1, 2, 3, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University College Hospitals London NHS Trust"]
["Contact Name","Dr Malika Sekhar, Consultant Haematologist"]
["Address","Department of Haematology, 3rd Floor West"]
[null,"250 Euston Road"]
[null,"London"]
["Postcode","NW1 2PG"]
["Telephone","02034 477 101 / 07802 531 885"]
["Email","mallika.sekhar@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients, aged 18 years and over, treated at participating Trusts throughout England and Wales, who have the relevant clinical characteristics to confirm a Myeloproliferative neoplasms Associated SplanChnic vein Thrombosis (MPN-SVT) diagnosis. Patients will be included both retrospectively and prospectively for newly diagnosed patients.\n"]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed by treating clinicians to Dendrite Clinical Systems Ltd for inclusion in the research database. The items of information are required for the purposes set out below:\n• NHS Number – sample validation and linkage,\n• Hospital ID – sample validation and linkage,\n• Date of birth – sample validation, linkage and analysis,\n• Date of death – analysis,\n• Postcode (District Level) – analysis,\n• Sex – analysis,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-06-13"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the data from the Mascot registry analysis has provided information regarding long term outcomes of MPN related splanchnic vein thrombosis. MPN-SVT is a rare condition, and the pooled UK-wide data from this registry has contributed to one of the largest such studies worldwide to date. The MPN community has been particularly concerned about current UK practice in anticoagulation, chemotherapy and the overall picture of UK practice in the area of MPN-SVT. The data from this registry has shed light on current practice across UK. This can help to design ongoing clinical trials in this area.\n\n\n13 December 2021 - Amendment supported\nAmendment supported to extend the duration of support until March 2023.\n\n20 July 2020 - Amendment supported to extend the duration of the study until 1 February 2022, and to update the protocol with a number of changes to Principal Investigators is supported.\n\nConditions of support\n1. Support extends to data generated in England and Wales only. \n2. Favourable opinion from a Research Ethics Committee (Confirmed 21 May 2019).\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Dendrite Clinical Systems Ltd. has a published satisfactory reviewed grade on V14.1, 2017/18)"]

{"sheet":"A02388","index":431,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02388"]
["Reference","19/CAG/0061"]
["Other Refs","IRAS project ID: 191925, REC reference: 15/NW/0818"]
["Application Title","Salford Kidney Study"]
["Application Summary","This application from Salford Royal NHS Foundation Trust set out the purpose of medical\nresearch which aims to follow-up historic deceased participants of the CRISIS study to\nestablish a cause of death.\nThe CRISIS study was a consented longitudinal study which merged, along with other\nkidney-based research projects, into the Salford Kidney Study. At this stage, patients were\nre-consented to their ongoing involvement in the refreshed project. However, there were a\nsmall number of patients who were originally recruited to the CRISIS study that were\ndeceased at this stage for whom cause of death has not been recorded. This application\nhas been submitted to seek support under the Regulations to legitimise the disclosure of\nconfidential patient information from the Salford Royal NHS Foundation Trust to NHS\nDigital to facilitate linkage with ONS Mortality information to establish cause of death.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","Salford Royal NHS Foundation Trust"]
["Contact Name","Professor Philip Kalra"]
["Address","Salford Royal NHS Foundation Trust"]
[null,"Department of Renal Medicine"]
[null,"Stott Lane, Salford"]
["Postcode","M6 8HD"]
["Telephone",1612060509]
["Email","philip.kalra@srft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","500 patients identified as part of the CRISIS study who were diagnosed with chronic kidney\ndisease who died between 1 January 2012 and 31 January 2016."]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed from Salford Royal\nNHS Foundation Trust to NHS Digital to facilitate linkage with ONS Mortality information:\n• Study ID,\n• NHS Number,\n• Date of birth,\n• Date of death,\n• Cause of death."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-06-14"]
["Next Review Date","2020-06-14"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee. (Confirmed: 11 February 2019). \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. (Confirmed - the NHS Digital has a confirmed ‘Standards Met’ grade on its DSPT submission)."]

{"sheet":"A02389","index":432,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02389"]
["Reference","19/CAG/0042 "]
["Other Refs","IRAS project ID:250064, REC reference: 19/WM/0019"]
["Application Title","Anti-thyroid Drug (ATD) Study"]
["Application Summary","This application from Royal Devon and Exeter NHS Trust set out the purpose of medical research which aims to follow-up patients who have suffered a reaction to anti-thyroid drugs which led to a very low white blood cell count or liver injury. The study will recruit across a two year window, in which time participating sites will be asked to report eligible patient details for a retrospective cohort across the previous ten years. Patients will also be recruited prospectively from clinic.\nThe application has been submitted to the CAG to facilitate the recruitment of retrospective patients and patients who are found to be deceased. The applicant has stated that the retrospective patient cohort would no longer be considered to be under the direct care of the hospital clinicians and thus support under the Regulations would be required to enable the patient recruitment process. For historical patients who are deceased, support under the Regulations is requested to access patient records to extract information to be included in the study analysis.\nA recommendation for class 1, 3 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Royal Devon and Exeter NHS Trust"]
["Contact Name","Bijay Vaidya"]
["Address","Royal Devon and Exeter NHS Trust"]
[null,"Royal Devon and Exeter Hospital "]
[null,"University of Exeter Medical School, Exeter"]
["Postcode","EX2 5DW"]
["Telephone",1392403082]
["Email","Bijay.Vaidya@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients treated at the 11 participating sites in England and Wales who were treated with anti-thyroid drugs and suffered a severe reaction which led to a very low white blood count or liver. A two year recruiting period would be established where prospectively diagnosed patients would be recruited. A retrospective patient cohort will also be included comprising of eligible patients treated across the previous ten years."]
["Description of confidential patient information used","The following items of confidential patient information are requested to facilitate the postal invitation process for the retrospective patient cohort. Wider items of clinical information would also be extracted in relation to the deceased patient cohort for analysis:\n• Full name and title – facilitate invitation process,\n• Full address and postcode – facilitate invitation process,\n• Date of birth – accessed to confirm age eligibility and retained for analysis,\n• Date of death – analysis,\n• Sex – analysis,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-06-26"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and identifiers only retained by direct care team.\n\nIn terms of public benefit, ‘s251’ support has allowed the study of rare but severe life-threatening adverse effects (agranulocytosis and severe liver toxicity) of the commonly used antithyroid drugs, carbimazole and propylthiouracil, including the risk factors for the adverse effects, how these adverse effects present and what treatment strategies for the adverse effects work or don’t work.\n\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission for sites in England (Not checked – the study will be carried out across nine Trusts in England– security assurance would not be checked for all participating sites. Support is recommended on the basis that the applicant is responsible for seeking assurance that the appropriate security arrangements are in place). \n3. Confirmation from NHS Wales Informatics Service that the appropriate security assurance is in place for the two Health Board sites in Wales via the Caldicott Principles into Practice report (Confirmed – CPIP Assurance received by direct email from NHS Wales Informatics Service 15 April 2019)."]

{"sheet":"A02390","index":433,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02390"]
["Reference","17/CAG/0050"]
["Other Refs","IRAS project ID: 186458, REC reference: 17/LO/0344"]
["Application Title","Educational Outcomes in Children Born after ART"]
["Application Summary","This application from University College London Institute of Child Health set out the purpose of researching whether children born after assisted reproductive technology are at a higher risk of developing learning or behavioural problems. To date this question has not been adequately answered because existing studies have been small, and have not included adequate comparison groups.\nThis project proposed combining and analysing data from two existing large research databases: the Human Fertilisation and Embryology Authority (HFEA) Register and the National Pupil Database (NPD). Comparison of the educational and behavioural outcomes in children born following ART will be undertaken with two comparison groups of naturally conceived children. The project will make use of a previously established database of linked records from the Human Fertilisation and Embryology Authority (HFEA) and ONS data, for which support was recommended under application ECC 4-03(g)/2012. This application proposes to extend the use of this existing data to investigate educational outcomes in children born after ART.\nNearly 1 in 50 children in the UK are born to parents who have benefited from fertility treatments and this number is increasing year on year. Worldwide there are already over 5 million such children. The main applicant is a Paediatrician who has studied children born after assisted reproductive therapy (ART) and their families for over 20 years, and over this time, has developed insights into the concerns that these families have.\nAs the number of children born after ART is increasing, the need to monitor their long-term health and development becomes increasingly important. There are various reasons why the development of children born after ART may differ from naturally conceived children. Children born after ART are more likely to be born smaller in size, are more likely to be born premature, and are more likely to be born as part of a multiple birth (e.g. twins) when compared to naturally conceived children. These factors are known to have adverse effects on children’s neurodevelopment. Furthermore, during ART embryos are exposed to unnatural environments and high doses of powerful hormones, which may have important effects on the developing embryo, including the brain. There is evidence that changes during this critical stage of early development can have long-term effects.\nThe applicants reference historic studies which have been undertaken in a similar area; however, it is explained that these were of limited scope and the methodology was questionable.\nA recommendation for class 4 and 6 support was requested to cover activities as described in the application, in relation to the transfer of information from the established database held by NHS Digital to the Office of National Statistics, for linkage with the National Pupil Database. The request for support extends only to the transfer of confidential patient information from NHS Digital to the Office for National Statistics and the transfer of linked-anonymised information from NHS Digital to University College London. Information from the National Pupil Database is outside the scope for support as this is not patient information, as defined at Section 251(10) of the NHS Act 2006.\nIt was acknowledged that the previously established database held by NHS Digital contained linked information from the Human Fertilisation and Embryology Authority (HFEA) Research Register and ONS. No further access was required to the HFEA Research Register for the project; however, an extension to the purpose of use of this data was recommended to the HFEA Research Register Panel."]
["Applicant Organisation Name","University College London Institute of Child Health"]
["Contact Name","Professor Alastair G Sutcliffe"]
["Address","UCL Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone",2079052367]
["Email","a.sutcliffe@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The three cohorts to be compared in the study are as follows:\n1. All children born in England following non-donor ART procedures recorded in the HFEA database between 1992 and September 2009.\n2. Any naturally conceived siblings of these children will also be included and will form one of the control groups.\n3. A second control group will consist of unrelated naturally conceived children, matched to a sample of the ART children. The inclusion criteria for this group will be that they have the same age and sex, and attend the same school, as the ART child to whom they are matched. This cohort will be identified by staff responsible for the NPD within the Office for National Statistics.\nThe applicant clarified that the cohort sizes for each group were as follows:\n1. ART Children with educational outcome information – 86,064,\n2. Naturally Conceived siblings of ART children – 23,299,\n3. Unrelated children control cohort – for each level of Key Stage outcome data available for each child in the ART cohort, one unrelated naturally conceived control will be identified and randomly selected from the NPD database, with matching by school, age, and sex."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes detailed:\n• Name – linkage,\n• Date of Birth – linkage and analysis (truncated to MM/YY format for analysis),\n• Postcode (unit level) – required for socio-economic deprivation scoring calculation,\n• Gender – linkage and analysis,\n• Ethnicity – analysis,\n• Unique study member number – for linkage of returned datasets.\nWith reference cohorts one and two identified above, this information is already held in an established database by NHS Digital. The database identifying cohorts one and two detailed above was established under study reference ECC 4-03(g)/2012. NHS Digital is the controller for this established database.\nThis information will be utilised by staff at the Office for National Statistics to create cohort three as detailed above; however, the identifiable information in relation to this cohort will be transferred in a pseudonymised format to researchers at University College London.\nThe applicants will also require access to parental infertility diagnosis and fertility treatment to enable stratification of these variables in secondary analysis.\nEducational achievements will be ascertained by the outcomes of Key Stage Assessments. This information will be provided by the Department for Education, via the Office for National Statistics, through the linkage of patient records with the National Pupil Database.\nNHS Digital will transfer confidential patient identifiable information to the Office for National Statistics to enable linkage with the National Pupil Database. Support is requested to cover the transfer of patient identifiers; however, it was noted that information returned from the Office for National Statistics was outside the scope of support as this was not classed as patient information.\nThis application is to be considered separately to the existing application, ECC 4-03(g)/2012, which will continue. This application was submitted to cover an extension in purpose of the use of database which had been established under this previous approval."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-07-03"]
["Next Review Date","2024-07-03"]
["Notes","15 March 2021 - Amendment supported\nAmendment supported to include patients “other name”, birth weight, multiple birth indicator and maternal month and year of birth in the data flow from NHS Digital to DfE and, apart from “other name”, in the data flow from DfE to the ONS-SRS for access by the UCL research team for analysis in the ONS-SRS.\n\n24 September 2020 - Amendment supported\nAmendment supported to:-\n\n• Add the Department for Education as an additional data processor in order to undertake linkage of the assisted reproductive therapy (ART) database (a previously established database held by NHS Digital containing linked information from the Human Fertilisation and Embryology Authority (HFEA) Research Register and ONS for which support was recommended under application ECC 4-03(g)/2012) with the National Pupil Database, \n• Add postcode as an additional linkage variable, \n• Extend the duration of support until 31 December 2021, \n• Reflect these changes in an updated flow chart and protocol\n\n24 September 2020 - Annual Review: Specific conditions of support updated\n\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Patient and Public Involvement and Engagement – activity as specified should continue throughout the project and a report provided for consideration at next annual review around actual activities achieved and any further planned activities. \n\n2. Patient Notification and Dissent – at next annual review, provide copies of patient notification materials in line with the planned activities, together with a report around the actual activity undertaken and an update on the management of patient objections.\n\n\nSpecific conditions of support (updated):\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Patient and Public Involvement and Engagement – activity as specified should continue throughout the project and a report provided for consideration at next annual review around actual activities achieved and any further planned activities. \n\n2. Patient Notification and Dissent – at next annual review, provide copies of patient notification materials in line with the planned activities, together with a report around the actual activity undertaken and an update on the management of patient objections.\n\nConditions of support:\n1. Patient and Public Involvement and Engagement – activity as specified should continue throughout the project and a report provided for consideration at first annual review around actual activities achieved and any further planned activities.\n2. Patient Notification and Dissent – at first annual review, provide copies of patient notification materials in line with the planned activities, together with a report around the actual activity undertaken and an update on the management of patient objections.\n3. Favourable opinion from a Research Ethics Committee. (Confirmed – 17 June 2019)\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. (Confirmed – UCL School of Life and Medical Sciences Data Safe Haven, NHS Digital and the Office for National Statistics have confirmed standards met grades)\n"]

{"sheet":"A02391","index":434,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02391"]
["Reference","19/CAG/0054"]
["Other Refs","IRAS project ID: 260499, REC reference: 19/SC/0139"]
["Application Title","An evaluation of knee arthroplasty fixation in an evolving challenging population"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to undertake a comparison of outcomes for patients undergoing cemented versus uncemented knee replacements in England.\nThe patient cohort will be identified by the National Joint Registry (NJR), which is a national audit programme commissioned by the Healthcare Quality Improvement Partnership. The NJR operates partially with support under the Regulations, via application 18/CAG/0146 and on a consented basis.\nNorthgate, processor for the NJR, will identify the relevant patient cohort within their dataset. Pseudonymised data from the NJR dataset will be disclosed to the applicant, with a corresponding NJR ID. Northgate will simultaneously disclose confidential patient information, together with NJR ID, to NHS Digital in order to facilitate linkage with the HES and ONS datasets, to collate inpatient data, patient reported outcome measures and mortality data. NHS Digital would disclose a pseudonymised linked dataset, with NJR ID back to the applicant. This would be linked with data from the NJR to create a pseudonymised data set for analysis. The applicant will see receive additional information on patients within the wider UK nations who underwent a knee replacement within the study timeframe; however, this data will be provided in an anonymised format and will not be linked with wider datasets. This wider cohort is out of scope of the CAG application.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Hasan Mohammad "]
["Address","University of Oxford"]
[null,"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences"]
[null,"Botnar Research Centre"]
["Postcode","OX3 7LD"]
["Telephone","01865 (2)27457"]
["Email","hasanmohammad@doctors.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who have undergone a knee replacement since 01 April 2003 to 31 December 2018 who are registered within the National Joint Registry. Sample size is estimated at 1,087,611 patients. Data linkage will only be facilitated for patients in England."]
["Description of confidential patient information used","Data Sources:\n1. Electronic Health records held within the National Joint Registry (NJR)\n2. HES and ONS data held in electronic records by NHS Digital\nIdentifiers required for linkage purposes:\n1. Surname\n2. NHS Number\n3. Date of birth\n4. Postcode\n5. Sex\nIdentifiers required for analysis purposes:\n1. Sex\nAdditional information\nThe application set out a consented arm; this is not within the scope of the proposed support."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-07-17"]
["Next Review Date","2024-07-17"]
["Notes","15 July 2020 – Amendment supported to include an additional data item, “Date of knee replacement surgery” in the data extract shared from Northgate Public Services, processor for the National Joint Registry, to NHS Digital in order to facilitate linkage with HES and ONS datasets\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 26 June 2019 \n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – NHS Digital has a reviewed “standards met” grade on the Data Security and Protection Toolkit). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02392","index":435,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02392"]
["Reference","19/CAG/0092"]
["Other Refs","IRAS project ID: 257332  REC reference: 19/LO/0498"]
["Application Title","The ‘OxMIV’ violence risk assessment tool: an external validation study in patients referred to Early Intervention in Psychosis services using routine documentation in Electronic Patient Records."]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to assess the accuracy of a tool which is used to assess the risk of patients, who are under the care of the community mental health teams as part of the Early Intervention in Psychosis program, turning violent.\nThe OxMIV tool has previously been trialled in Sweden and the applicant wishes to test its efficacy in England. It utilises data which is routinely collected by clinicians to predict the likelihood of patients turning violent. This study aims to test the accuracy of the tool’s estimations on a historic patient cohort. To achieve this, routine information from electronic healthcare records for patients who were previously treated under the Oxford Health NHS Foundation Trust’s Early Intervention in Psychosis (EIP) services will be accessed in order to calculate the OxMIV score. Police and health care records will then be checked for evidence of subsequent violence which will be utilised to evaluate the accuracy of the tool.\nThe applicant will require access to patient’s medical records for the 12-month period following the EIP referral to examine for incidents of violence. Access to police records for the same duration would also be required to establish a complete picture of patient violence following the intervention.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described it the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Daniel A Whiting - NIHR Doctoral Research Fellow"]
["Address","University of Oxford"]
[null,"Department of Psychiatry, Warneford Hospital"]
[null,"Oxford"]
["Postcode","OX3 7JX"]
["Telephone",1865613165]
["Email","daniel.whiting@psych.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1300 consecutive referrals EIP referrals, up to May 2018, within the Oxford Health NHS Foundation Trust will be accessed in order to identify approximately 1000 eligible patients for inclusion."]
["Description of confidential patient information used","Access to the complete patient record will be required in order to identify eligible patients for inclusion in the study and to enable wider data required for analysis to be extracted. The following items of confidential patient information are specifically required for the purposes set out below:\n• Name – sample validation and linkage,\n• Date of birth – sample validation and linkage,\n• Date of Early Intervention Service referral – analysis,\n• Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-07-25"]
["Next Review Date","N/A"]
["Notes","Expire support Confirmed July 2021\n\n•\tPlease may you confirm the reason that support is no longer required? \n\nThe identifiers that were supported (name and date of birth) have been securely deleted and are not being processed/retained.\n\n•\tPlease may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency. \n\nIn terms of public benefits, this data is now being used to validate and update a violence risk assessment tool (OxMIV) that has the potential to improve risk assessment and management within Early Intervention in Psychosis services. \n\nConditionally Supported - 31 July 2020\nNew conditions in letter sent. The following sets out the updated specific conditions of support applied against this application reference.\n\n1. All pre-existing conditions of support remain applicable.\n2. Wider patient and public involvement and engagement activity should be carried out to test the acceptability of the project and its methodology with a wider group. Feedback about the activity undertaken and the views expressed is required within 3 months, [31 October 2020]. If the views provided were negative, the CAG would take this into account when considering whether support can continue.\n\n23 October 2020 - The CAG accepted the response to annual review condition, and were happy to recommend support until the next annual review date.\n\nConditions of support:\n1. Support extends to the processing of confidential patient information from records at the Oxford Health NHS Foundation Trust only. An alternative legal basis has been established to legitimise access to and extraction from the Thames Valley Police database. \n2. Support extends to the use of confidential patient information and supporting clinical information extracted from medical records at Oxford Health NHS Foundation Trust within the scope of this project only. Data cannot be used by the applicant or the Thames Valley Police for any wider purposes. \n3. Wider patient and public involvement and engagement activity should be carried out to test the acceptability of the project and its methodology with a wider group. Feedback about the activity undertaken and the views expressed is required at the time of first annual review. If the views provided were negative, the CAG would take this into account when considering whether support can continue or whether further work is required.\n4. Favourable opinion from a Research Ethics Committee (Confirmed).\n5. Confirmation from the IG Delivery Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission (Confirmed – University of Oxford Medical Sciences Division, Standards Met confirmed 21/06/2019 and Oxford Health NHS Foundation Trust, Standards Met confirmed 01/07/2019)."]

{"sheet":"A02393","index":436,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02393"]
["Reference","19/CAG/0077"]
["Other Refs","IRAS project ID: 116856, REC reference: 19/WA/0066"]
["Application Title","Enhanced surveillance of neonatal herpes simplex disease in UK and Irish infants less than 90 days of age."]
["Application Summary","This application from the Royal Alexandra Children’s Hospital, Brighton & Sussex University Hospitals NHS Trust set out the purpose of medical research, where the applicants are seeking to determine whether infants who receive prompt treatment for Herpes simplex virus (HSV) have a better outcome that those whose treatment is delayed.\nThe applicants aim to study all cases of neonatal HSV in infants under 90 days of age in the UK and Ireland over a 2-year period between 2019 - 2021. Paediatricians will be asked to notify the applicants of cases of neonatal HSV as they occur via a routine reporting source called the British Paediatric Surveillance Unit (BPSU). The usual BPSU methodology will be followed. The condition will be included on the BPSU “Orange Card” sent to members monthly by e-mail. The investigator will then send the study questionnaire directly to the reporting clinician. The questionnaire asks for clinical details of the case and for minimal identifiers. The questionnaire can be completed online, via the REDCap system, or sent by secure email.\nThe study will also investigate how each child has been in the year following their diagnosis. Reporting clinicians will be sent a follow-up questionnaire after one year by the study team (this will be sent via a secure link to a REDCap questionnaire, or to secure nhs.net email if preferred). The case will have been assigned a unique study number by the BPSU: The reporting clinician will be given this number as a point of reference, in case they identify more than one case during the study period. This unique number and DOB only will be referred to when requesting follow-up information.\nThe applicants intend to collaborate with the RCOG UKOSS (UK Obstetric Surveillance System) to ensure that obstetric data are complete. The applicant confirmed that confidential patient information will not be shared with RCOG UKOSS. UKOSS has confirmed that, for all BPSU studies including this one, anonymous data (including names, hospital numbers, maternal DOB, etc.) is not collected / recorded. Their sole role is to facilitate contact with reporting clinicians in relevant local hospitals (there is one UKOSS reported for each hospital). The applicants will then liaise directly with the local team, using only infant and maternal DOB to link cases in order to request missing obstetric information.\nHES/ONS data on cases of neonatal HSV will be requested to ensure the completeness of the data collected (i.e. to ensure that the number of cases reported via the BPSU system is equivalent to the number reported by these sources). This will provide reassurance that information on all cases of neonatal NHS during the study period have been captured; this is particularly important given the small number of cases expected. No confidential data will be disclosed to NHS Digital: cases will be linked using name of hospital, age & sex of baby only.\nLocal laboratories will be contacted by the study team in the uncommon event that there is incomplete information provided on the BPSU questionnaire (for example, HSV typing & CSF cell counts). The study team will contact the laboratory via telephone (to identify a senior lab member) and then an email will be sent by nhs.net mail to this team member, requesting missing data. Cases will be linked using the minimal patient identifiers, including DOB / date of sample.\nA recommendation for class 2, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Royal Alexandra Children’s Hospital, Brighton & Sussex University Hospitals NHS Trust"]
["Contact Name","Dr Katy Fidler, Chief Investigator, Senior Clinical Lecturer in Paediatrics &\nHonorary Consultant in Paediatric Infectious Diseases, Brighton & Sussex Medical School and Royal Alexandra Children’s Hospital.\n"]
["Address","Academic Department of Paediatrics"]
[null,"Level 6, Royal Alexandra Children's Hospital"]
[null,"Eastern Road, Brighton"]
["Postcode","BN2 5BE"]
["Telephone","01273 696 955 x62409"]
["Email","katy.fidler@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Infants of 90 days or younger diagnosed with Herpes Simplex Virus infection between 2019-2021. It is estimated that between 90 – 130 cases would be reported over the two-year period. This is anticipated to be June 2019-June 2021."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes specified:\n• NHS number – sample validation and linkage,\n• Hospital ID number – sample validation and linkage,\n• Date of birth - sample validation, linkage and analysis,\n• Date of death - sample validation, linkage and analysis,\n• Hospital name and postcode - sample validation and linkage,\n• Gender - sample validation, linkage and analysis,\n• Postcode (district level) – analysis\n• Ethnicity - analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-07-26"]
["Next Review Date","2024-07-26"]
["Notes","03 August 2021 - Amendment supported to increase the duration of the surveillance period by 6 months until January 2022, send an additional follow-up questionnaire at 24 months post illness, and to extend the study duration until January 2024\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (IGT) submission (Brighton And Sussex University Hospitals NHS Trust – Standards met confirmed by NHS Digital email on 26 July 2019).\n"]

{"sheet":"A02394","index":437,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02394"]
["Reference","19/CAG/0043"]
["Other Refs","REC Reference: 19/YH/0076 IRAS Project ID: 255767"]
["Application Title","Telephone triage of critical illness using NHS Pathways"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research which aims to investigate whether NHS Pathways, the decision support system from NHS Digital used for telephone triage by NHS 111 and five 999 Ambulance Trusts in England introduced in 2018, can identify cases of potential critical illness with enough sensitivity and specificity, measured by equivalence with the National Early Warning Score 2 (NEWS2) acuity. This will help to understand if the new triage algorithms can identify persons at risk of clinical deterioration from an illness and in need of emergency care without over-triage to the finite resources of the emergency ambulance service.\nThe study will use a retrospective patient cohort who was triaged using the new algorithms following a 111 or 999 call received by the North East Ambulance Service NHS Foundation Trust and treated at James Cook University Hospital. The study will compare NHS Pathways triage to an ambulance response against the initial NEWS2 recorded by the attending NEAS clinician and to non-ambulance care disposition against any subsequent attendance or admission at James Cook University Hospital within 12 hours of the first 111/999 call and the initial NEWS recorded by the hospital.\nSupport is requested to allow the processing of confidential patient information by a Senior Information Analyst at North East Ambulance Service in order to identify the eligible patient cohort to be included in the study. North East Ambulance Service will link information for patients who received an ambulance to the electronic patient care records in order to extract relevant clinical information for analysis. This linked dataset will be anonymised by NEAS prior to disclosure to the applicant.\nSupport is also requested to allow the disclosure of specified items of confidential patient information from NEAS to James Cook University Hospital in order to facilitate linkage with wider clinical information required for analysis for the sub-cohort of patients who received non-emergency triage disposition. An anonymised dataset would then be disclosed to the applicant for analysis.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Suzanne Mason"]
["Address","School of Health and Related Research (ScHARR)"]
[null,"The University of Sheffield"]
[null,"30 Regent Street"]
["Postcode","S1 4DA"]
["Telephone",1142220694]
["Email","s.mason@sheffield.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 or over, residing at a postcode covered by the South Tees CCG, who were triaged by a non-clinical 111/999 call handler using one of 24 pre-defined NHS Pathways illness symptom groups to receive either emergency ambulance or non-ambulance care. Patient sample is estimated at 7,400 patients. The planned period of retrospective data collection is a six-month period, between 01/01/2019 and 30/06/2019."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes set out below:\n• Surname – sample validation and linkage,\n• NHS number – sample validation and linkage,\n• Date of birth – sample validation and linkage,\n• Postcode (Unit Level) – sample validation and linkage,\n• Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-08-02"]
["Next Review Date","N/A"]
["Notes","31 October 2019 - Support expired:\nData processing of identifiable data by the 2 NHS Trusts named in the study ended by October 2019. As the researcher the only data held is the fully anonymised outputs including age (years) and gender. \n\nThe results from the aggregated data were finalised in February 2020.\n\nThe results of this work have been presented to clinical colleagues at NHS Pathways and more widely at NHS Digital and have, as part of a range of different information from other sources, helped inform improvements to the national triage algorithms (NHS Pathways) used by 111 and 999 across England as part of the internal ‘critical illness’ review (during 2021). \n\nThere is a plan to publish a summary of the research in a peer review journal for wider system learning. Likely to be in 2022.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed 21 March 2019)\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission (Confirmed: \n• North East Ambulance Service NHS Foundation Trust – Standards not fully met (plan agreed) NHS Digital provided assurance for the purposes of the CAG application, NHS Digital email 02/08/2019. \no Applicant to ensure that all staff processing confidential patient information for the purposes of this application activity have undertaken the mandatory Information Governance training prior to commencing processing. \n• South Tees Hospital NHS Trust – confirmed Standards Met achieved by NHS Digital email 20/06/2019. "]

{"sheet":"A02395","index":438,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02395"]
["Reference","19/CAG/0035"]
["Other Refs","IRAS project ID: 259898 REC reference 19/LO/0426"]
["Application Title","Updating cancer survival index trends for England and Wales to 2016"]
["Application Summary","This application from the London School of Hygiene and Tropical Medicine set out medical research which aims to update trends in the index of survival from all cancers combined in England and Wales, up to 10 years after diagnosis. The purpose is to assess progress in survival up to 10 years after cancer diagnosis, for all cancers combined, since the index was last published for patients who had been diagnosed up to 2010, as part of Cancer Research UK’s (CRUK) research strategy launch in 2014. CRUK has set a target of improving 10 year survival in England and Wales for all cancer combined to 75% by 2030.\nThe proposed study will be an update of previous research which has been carried out by the same research team and will update the index of cancer survival for patients who received a first primary cancer diagnosis from 1971 to 2016. Information relating to patients in England would be provided by the National Cancer Registration and Analysis Service (NCRAS) at Public Health England. Information relating to patients in Wales would be provided by Welsh Cancer Intelligence and Surveillance Unit (WCISU). Confidential patient information will be transferred to the London School of Hygiene and Tropical Medicine for analysis.\nA recommendation for class 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Professor Michel Coleman - Professor of Epidemiology and Vital Statistics "]
["Address","London School of Hygiene and Tropical Medicine"]
[null,"Cancer Survival Group, Department of Non-Communicable Disease Epidemiology "]
[null,"Keppel Street "]
["Postcode","WC1E 7HT"]
["Telephone",2079272551]
["Email","michel.coleman@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All adult patients aged 15 – 99 years, who were diagnosed with a first, primary invasive cancer from 1971 to 2016. The study involves a complete population-based set of cancer patient data which is expected to include over 10 million patients."]
["Description of confidential patient information used","The following items of confidential patient information are required for the purposes of sample validation and analysis:\n• Date of birth,\n• Date of death,\n• Date of cancer diagnosis,\n• Sex."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-08-05"]
["Next Review Date","2024-08-05"]
["Notes","17 August 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source  National Cancer Registration and Analysis Service (NCRAS).\n\n10 December 2020 - Amendment supported\nThe amendment, to update the data requested to include a cohort of all adult patients aged 15 – 99 years, who were diagnosed with a first, primary invasive cancer from 1971 to 2018, is supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Cancer Survival Group at London School of Hygiene and Tropical Medical has a Standards Met Grade on DSPT). "]

{"sheet":"A02396","index":439,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02396"]
["Reference","19/CAG/0117 (Replacement of PIAG 4-05(e)/2007)"]
["Other Refs","IRAS project ID: 256164 REC reference: 19/SW/0001"]
["Application Title","IMS Health and HES Data Linkage"]
["Application Summary","This application from IQVIA Solutions Ltd. set out the purpose of medical research which aims to create a research database which links hospital pharmacy data with Hospital Episodes Statistics at NHS Digital. The extracts combine information on hospital drug usage with information on hospital activity. The combination of these two data sources creates insight into the interaction in secondary care between disease, treatment and prescribing.\nThis is a unique database because it is the only source of hospital medicine usage linked to hospital diagnosis and can be used for conducting timely analysis of the outcomes associated with hospital treatments. All confidential patient information is handled by NHS Digital – the applicant receives only an anonymised download for the purposes of analysis. The study has operated with support under the Regulations since 2008.\n\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","IQVIA Ltd."]
["Contact Name","Ms Hassy Dattani, Data Controller"]
["Address","IQVIA Ltd."]
[null,"The Point"]
[null,"37 North Wharf Road, London"]
["Postcode","W2 1AF "]
["Telephone","0203 564 4649 "]
["Email","hassy.dattani@iqvia.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients that have visited a hospital in England"]
["Description of confidential patient information used","Data sources;\n1. Hospital pharmacy data from Trusts in England\n2. Hospital Episodes Statistics (HES) data, NHS Digital\nIdentifiers required for linkage purposes:\n1. NHS Number\n2. Date of birth\n3. Postcode\n4. Sex\n5. Hospital ID\nIdentifiers required for analysis purposes:\n1. Sex\n2. Ethnicity\n3. Date of death\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-19"]
["Next Review Date","2024-11-19"]
["Notes","03 October 2023 - change in data processor from NHS Digital to NHS England, regarding data source Hospital Episode Statistics (HES) \n\n1. All pre-existing conditions of support related to PIAG 4-05(e)/2007 remain applicable. Condition accepted \n\n2. The pre-existing annual review cycle remains applicable, with the next annual review to be received four weeks before 19/11/2019, and then on an annual basis to this schedule. Condition accepted \n\n3. The Trust level patient information poster should be reinstated and should describe how patients can raise a project-specific dissent. A copy of this document should be submitted at the time of next annual review, together with an overview of how the project-specific dissenting would operate.\nCondition met as part of first annual review\n \n4. Provide an overview of disclosures which have been made from the database by IQVIA within the previous year for consideration by the CAG. This should be provided at the time of next annual review. \nCondition met as part of first annual review\n\n5. Provide further information around when it would be appropriate to facilitate linkage with the CPRD database. \nCondition met as part of first annual review\n\n6. Provide assurance that data disclosed for inclusion in this database is not linked with wider data held by IQVIA. \nCondition met as part of first annual review\n\n7. Feedback should be provided at the time of next annual review around whether the views of the study’s lay representatives or wider patient groups had been sought around the use of confidential patient information without consent for the study aims. An overview of the feedback provided should be included for consideration. \nCondition met as part of first annual review\n\n8. Favourable opinion from a Research Ethics Committee. Confirmed 19 February 2019 \n\n9. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. It was confirmed that the relevant DSPT submission related only to NHS Digital. "]

{"sheet":"A02397","index":440,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02397"]
["Reference","19/CAG/0119 "]
["Other Refs","IRAS project ID:  254609,  REC reference: 19/YH/0197"]
["Application Title","MATTS (Major Trauma Triage Tool Study)"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research which aims to develop a new and more accurate triage tool to be used by paramedics when assessing patients for signs of major trauma.\nThe study is planned in three phases. The first phase will involve assessment of existing triage tools to evaluate how they perform. The applicants will also use a computer model simulates the costs and outcomes of using the different triage tools. The resulting information will be presented to a group of experts who will be asked to develop a new major trauma triage tool. This phase of the study will not involve any access to confidential patient information and is out of scope for the CAG application.\nThe best performing tools will then be introduced into an area of each of the ambulance service to test their performance in a real-life situation in phase two of the project. This is a prospective study which will involve research paramedics accessing ambulance records and hospital records to test the tools. A deterministic matching process will be used using ambulance identifiers to link records and will be supported by the local TARN administrator. The applicants are seeking support under the Regulations to legitimise access to hospital records by research paramedics, who will be assisting local Trauma August and Research Network (TARN) coordinators in identifying patients and extracting pseudonymised patient data to be used in analysis. Support is also sought under the Regulations to use pseudonymised patient information collected by the TARN with support under the Regulations via application ECC 7-05(g)/2011 for wider research purposes.\nPhase three of the project will involve the implementation of the best performing tool at phase two into real life practice within the participating ambulance Trusts to enable an evaluation of the performance to be undertaken. This will follow the same methodology as phase two of the project and required ‘section 251 support’ to legitimise processing.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Dr Gordon Fuller, NIHR Clinical Lecturer in Emergency Medicine "]
["Address","University of Sheffield, School of Health and Related Research (ScHARR)"]
[null,"30 Regent Street, Regent Court, 3rd floor, Room 3036"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone","0114 222 0842"]
["Email","g.fuller@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients of any age who are attended by Emergency Medical Services (EMS) following non-trivial injury within a participating trauma network across the following ambulance services, between November 2019 and February 2020.\n• West Midlands Ambulance Service,\n• Yorkshire Ambulance Service,\n• London Ambulance Service,\n• South Western Ambulance Service."]
["Description of confidential patient information used","Data sources:\n1. Ambulance Computer Aided Dispatch (CAD) data\n2. Ambulance (Electronic)Patient Report Forms (PRFs)\n3. Hospital administrative systems\n4. Hospital Patient case notes\n\nIdentifiers required for linkage purposes\n1. Computer-aided despatch reference\n2. Ambulance incident number\n3. Incident date/time\n4. Call sign numbers\n5. Age\n6. Gender\n7. Hospital destination\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Age at event\n3. Date and time of incident\n4. Date and time of arrival at destination hospital\n\nAdditional information\nThe first phase of the study involves access to retrospective pseudonymised data patient which is out of scope for the CAG application.\nWhilst the patient identifiers requested are not standard items of confidential patient information, there would be wider access to confidential patient information contained in patient records both within the Ambulance Trusts and Hospital records during the data extraction process."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-08-22"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant has no access to the key. \n\n27 January 2022 - Amendment supported:\nAmendment supported 27 January to clarify that the timeframe for data collection for phase 3 will be between 1st October 2021 and 31st May 2022.\n\nConditions of support:\n1.Favourable opinion from a Research Ethics Committee. Confirmed 28 June 2019.\n2.Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Not checked due to the number of sites involved in the study. Support is recommended on the basis that it is the applicant’s responsibility to ensure that the required security assurance standards have been met at each site prior to processing any confidential patient information with support under the Regulations. "]

{"sheet":"A02398","index":441,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02398"]
["Reference","19/CAG/0082"]
["Other Refs","IRAS project ID: 247059, REC reference: 19/SW/0059"]
["Application Title","Feasibility cohort study: Serum mid-luteal progesterone versus ultrasound for monitoring first-cycle clomifene citrate."]
["Application Summary","This application from the University of Sunderland set out the purpose of medical\nresearch which aims to explore the feasibility of conducting a full retrospective cohort\nstudy to compare multiple pregnancy rates between those patients whose first cycle of\ntreatment is monitored with ultrasound, and those who are not monitored with ultrasound.\nClomifene is a medication used to trigger the ovary to ovulate. Guidelines state that\nultrasound should be used after clomifene is first given, to assess how many eggs have\ndeveloped. Where there are multiple eggs, there may be an increased likelihood of\nmultiple pregnancy, and the couple would be advised to avoid unprotected intercourse\nthat month. This is because multiple pregnancies carry extra risks to mother and baby.\nThe guidance to use ultrasound for this purpose is not based on any research evidence,\nas no evidence is currently available. Progesterone is a hormone produced in the ovary\nfollowing ovulation. Using a blood test for progesterone can indicate if clomifene has\nsuccessfully triggered ovulation, but gives no information about multiple pregnancy risk.\nThe secondary aim is to assess the clinical and financial implications of using a blood test\n(progesterone level) as an alternative monitoring method.\nThis study will comprise various strategies of data collection from the medical records of\npatients who have completed treatment with clomifene. They will be split into two arms,\nmonitored with ultrasound and not monitored with ultrasound, then the pregnancy\noutcomes will be compared based on the data gathered. This will be followed by an initial\ncost effectiveness analysis for each study arm.\nTreatment with clomifene is not a treatment regulated by the Human Fertility and\nEmbryology Authority (HFEA) and the data collected will be from NHS patient records.\nThere will be three possible ways in which departments can contribute data to the study.\nIn some units, clinical staff will extract and anonymise the data and enter it into the\nstandardised Excel spreadsheet, which is then returned to the research team. An\nalternative method is that the clinical team will be provided with an audit package, which\nis completed by staff members to contribute to governance/educational needs within the\ndepartment, as well as providing anonymised data back to the research team. The\napplicants will not require access to confidential patient information without consent if\neither of these methods is used. The applicants are seeking support to follow a third\nmethod of data collection, where the applicant will access confidential patient information\nin medical records on site at participating centres to record relevant non-identifiable\npatient data directly onto the research spreadsheet.\nA recommendation for class 1 and 6 support was requested to cover access to the\nrelevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Sunderland "]
["Contact Name","Dr Heather Garthwaite - Academic GP Registrar"]
["Address","Health Education England (North East) , Faculty of Health Sciences and Wellbeing "]
[null,"City Campus, University of Sunderland "]
[null,"Sunderland "]
["Postcode","SR1 3SD"]
["Telephone",7896017269]
["Email","heather.garthwaite@doctors.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female patients between 18 and 50 years of age who have completed treatment with clomifene. It is estimated 40 patients will be selected from each of the 17 sites.\nData Sources\nPatient Health records held within the following participating Trusts:\na. Newcastle upon Tyne Hospitals NHS Foundation\nTrust\nb. Gateshead Health NHS Foundation Trust\nc. Liverpool Women’s Hospital NHS Foundation\nTrust\nd. University Hospital’s Bristol NHS Foundation Trust\ne. Manchester University NHS Foundation Trust\nf. Nottingham University Hospitals\ng. Derby Teaching Hospitals NHS Trust\nh. University Hospitals of Derby and Burton\ni. North Tees and Hartlepool NHS Foundation Trust\nj. Isle of Wight NHS Trust\nk. Seven further hospital Trusts to be confirmed."]
["Description of confidential patient information used","The applicants will have access to the complete record to enable relevant clinical information to be extracted for analysis; however, no items of confidential patient information will be collected for sample validation, linkage or analysis purposes. The only data retained and used in analysis will be anonymous clinical data, which will not contain any confidential patient information."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-06"]
["Next Review Date","N/A"]
["Notes","The data was anonymised on collection and no identifying information was stored.  Participants were assigned an ID number, and this is held with their related data used in the study (age bracket, treatment received, investigations and results, and pregnancy outcomes).\n\nThe study showed that it is not feasible to collate adequately-powered quantitative data to support or refute current NICE guidance to monitor some cycles of clomifene citrate treatment with transvaginal ultrasound scans.  This has confirmed the need for any future review of the guideline to be based upon scientific hypothesis, non-numerical data, and anecdotal experience.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 02 September 2019. \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold (Due to the number of sites to be accessed, individual DSPT submissions are not required for the purpose of the application.  Each site is expected to have achieved a ‘standards met’ in relation to their organisational DSPTs). "]

{"sheet":"A02399","index":442,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02399"]
["Reference","19/CAG/0129"]
["Other Refs","IRAS project ID: 259034, REC reference: 19/NW/0311"]
["Application Title","Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA)."]
["Application Summary","This application from Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust set out the purpose of medical research which aims to use artificial intelligence to interpret Endovascular Aneurysm Repair (EVAR) x-rays performed in the Trust with a deep-learning algorithm to evaluate whether this could be used to interpret the x-rays.\nThe proposal is a proof of concept feasibility study. Abdominal aortic aneurysm (AAA) is a condition in which the largest blood vessel in the body becomes weak and forms a bulge. If it becomes large enough, the AAA can burst, often leading to death. Clinicians repair AAAs before they burst by undertaking EVAR, which is a standard treatment in the majority of patients. It is a keyhole technique that reinforces the aorta with a synthetic tube called a “stent-graft”. EVAR is a safer option in the short-term compared to traditional open surgery. However, in the longer term, 1 in 5 patients require further surgery to correct problems developing with the stent-graft such as loss of position and integrity of the stent-graft. Therefore, patients are followed up for life after EVAR with scans performed, usually on an annual basis, to look for signs of a failing stent-graft. Stent-grafts are visible on x-rays of the belly and by comparing series of images taken over time, it is possible to diagnose a myriad of stent-graft problems including loss of positioning, disintegration of the stent-graft material as well as stent-graft distortion. But these changes can be subtle and difficult to spot, even to the trained human eye. As a result, patients undergo more detailed scans that carry a risk of kidney damage and radiation-induced cancer.\nThe applicant will identify a retrospective patient cohort who have undergone an EVAR procedure at the Royal Liverpool Hospital via the clinical database within the Liverpool Vascular and Endovascular Service. Radiographs which have been undertaken as part of routine post-EVAR surveillance will be obtained from the NHS PACS (Picture Archiving and Communication System). Support under the Regulations is sought for this initial patient identification process and the extraction of radiographs and supporting clinical information. This would be pseudonymised prior to use for analysis purposes at the University of Liverpool at the Institute of Ageing and Chronic Disease.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust"]
["Contact Name","Professor SR Vallabhaneni - Prof of Vascular Surgery"]
["Address","Royal Liverpool University Hospital "]
[null,"Link 8c, Royal Liverpool University Hospital "]
[null,"Prescot Street, Liverpool"]
["Postcode","L7 8XP"]
["Telephone","01517063457"]
["Email","fempop@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who underwent an Endovascular Aneurysm Repair procedure at the Royal Liverpool Hospital between 01 January 2005 and 31 December 2013. It is estimated that there will be 800 patients in the cohort.\n\nInclusion in the study requires a minimum of five-year post-procedure follow-up to be available.\n\nData Sources\n1. Electronic Health records held within the Liverpool Vascular and Endovascular Service at the Royal Liverpool Hospital.\n2. NHS PACS (Picture Archiving and Communication System) records at the Royal Liverpool Hospital."]
["Description of confidential patient information used","1. Name\n2. NHS Number\n3. Hospital ID\n4. Date of Birth"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-09"]
["Next Review Date","N/A"]
["Notes","10 February 2022 - Support Expired:\nApplicant confirmed support can be expired 10 Feb 2022 - CAG support is no longer required because all of the data has been irreversibly pseudonymised and the analysis completed.\n\nPublic benefit acheived: We were able to develop and demonstrate new approaches for automated surveillance of key-hole aneurysm repair patients based on artificial intelligence (AI), in addition to making methodology contributions to AI and automated medical diagnosis. These approaches require further refinement and validation before introducing them into clinical practice, but the study conducted under CAG support represents a significant advance.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 05 July 2019 \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. (Confirmed: Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust (by NHS Digital e-mail 30 August 2019)  has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19)."]

{"sheet":"A02400","index":443,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02400"]
["Reference","19/CAG/0148"]
["Other Refs","IRAS project ID: 248332, REC reference:19/LO/0073"]
["Application Title","Parents' and children's informed and voluntary consent to heart surgery"]
["Application Summary","This application from University College London set out the purpose of medical research\nto explore the views and experience of children referred for heart surgery. Children and\ntheir parents will be observed before and after surgery, and they will be interviewed postsurgery.\nForty clinical staff will also be interviewed and selected discussions between\nstaff and families will be recorded. Interviews will also be audio-recorded and transcribed.\nWards, out-patient clinics and multi-disciplinary team (MDT) meetings, where the care of\nthe patient will be discussed, will also be observed. Patients recruited into the study, their\nfamilies/carers and staff will be consented for the above aspects.\nThe applicant explained that, due to the nature of multi-disciplinary meetings, it is\npossible that researchers will be present when doctors talk about patients who are not in\nthe study. The researchers will not make any written notes of confidential information of\npatients who are not enrolled in the study. Medical meetings will not be audio-recorded.\nRegarding the observation of daily activities in the wards and outpatient clinics, those\npresent will be informed that they are being observed and of their right to opt out. Some\nfamilies and children might find it difficult to opt out from being observed by directly\nsaying this to the researcher or to a member of the staff. Red-stop cards will be provided,\nwhich they can display as an alternative to opt out. The researchers will wear a\n‘Researcher’ badge, and display posters and give handouts to inform them about the\nresearch.\nA recommendation for class 1, 2 5 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Katy Sutcliffe"]
["Address","University College London, UCL Institute of Education"]
[null,"18 Woburn Square"]
[null,"London"]
["Postcode","WC1H 0NS"]
["Telephone",2076126239]
["Email","katy.sutcliffe@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","220 participants in total.\n60 - patients between 6 and 15 years of age, who have undergone heart surgery at Great Ormond Street Hospital NHS for Children and Evelina Children’s NHS Hospital. The age limit is for child participants is 15 years at the time of recruitment. The reason for not setting an upper age limit is\nthat parents and healthcare staff are also participants.\n120 - Parents/guardians\n40 – staff\n\nData Source - 1. MDT meetings and ward observations at Great Ormond Street Hospital NHS for Children and Evelina Children’s NHS Hospital."]
["Description of confidential patient information used","The applicants do not require access to confidential patient information without consent for the purposes of the study analysis. Support is being sought in case of incidental disclosures during multi-disciplinary team meeting observations."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-02"]
["Next Review Date","N/A"]
["Notes","05 May 2021 - Support expired\nOriginal identifiers which were supported are no longer being processed. We retain anonymised and pseudonymised interview transcripts and observation notes because we are still writing journal papers.\n\nThe public benefits of the observations include that they:\n• helped to validate interviewees' accounts of the events and routines we observed;\n• drew our attention to important features of the events and routines that were not reported in interviews;\n• provided important examples of the detailed practical context within which children's consent or refusal were respected; and\n• provided evidence that is contrary to accounts that dominate much of the law, ethics and medical literature.\n\nOur work is ground-breaking in that, while the mainstream literature tends to assume that children cannot refuse recommended non-urgent surgery, and cannot consent until they are about 12-years old, we found that surgeons respect the consent or refusal of children from around 4-years of age, and they criticise coercion and enforced interventions as harmful to children's physical and mental wellbeing. We aim to update the mainstream literature and opinion with our reports of current actual practice. Heart surgery is a useful example because it is complex high-risk treatment. If young children can be involved in these decisions, this makes the case for informing and involving them in many other types of treatment.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 18 February 2019 \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. (Confirmed: Great Ormond Street Hospital for Children (by NHS Digital e-mail 09 August 2019) and Guy’s and St Thomas’ NHS Foundation Trust (by NHS Digital e-mail 09 August 2019) have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19).\n"]

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[]
[]
["Application Number","02401"]
["Reference","19/CAG/0088 "]
["Other Refs","IRAS project ID: 258489, REC reference: 19/YH/0033"]
["Application Title","Realist Evaluation of Pressure Ulcer Risk Assessment Instruments in Clinical Practice: Theory Testing"]
["Application Summary","This application from the University of Leeds set out the purpose of medical research which\naims to develop understanding of how risk assessment tools to assess pressure ulcers\n(PU) are used in clinical care.\nTwo tools will be assessed. The standard form is the Pressure Ulcer Risk Assessment (PURAI)\nforms, which help nurses to identify patients ‘at risk’ to prompt preventative measures\n(e.g. nursing care, mattresses). The Pressure Ulcer Risk Primary or Secondary Evaluation\nTool (PURPOSE-T) was robustly developed/evaluated and has since been implemented\nin several NHS acute hospitals. A realist evaluation will be undertaken to understand how\ndifferent contexts influence particular nursing team responses and give rise to different\noutcomes when using PURPOSE-T and standard forms. The realist evaluation\nincorporates four phases; ward based theory testing, wider interviews with staff from other\nhospitals, a focus group held with the Pressure Ulcer Service User Network (PURSUN),\nand a guideline development stakeholder focus group.\nThe application to the CAG focuses on one element of the first project phase which will be\nundertaken prior to patients being approached for consent. The researcher will observe\nstaff handover and ward meetings where patient details will be discussed, including\nmedical details and care planned and delivered. The applicant will utilise these\nobservations to identify and discuss patients who maybe potentially suitable to be\napproached for consent for the wider elements of the study.\nA recommendation for class 3, 5 and 6 support was requested to cover access to the\nrelevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Susanne Coleman - NIHR Post-doc Research Fellow"]
["Address","CTRU,"]
[null,"Level 10 Worsley Building"]
[null,"University of Leeds"]
["Postcode","LS2 9JT"]
["Telephone","0113 343 1491"]
["Email","S.B.Coleman@leeds.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients within the following treatment wards during the time of staff observations at each of the two participating Trusts. Eight wards will be included in the research observations, including two high-risk elderly medical wards (one admission, one medical) and two varied-risk adult surgical wards (one surgical admission, one general surgical).\nData sources - 1. Observations of staff handovers and meetings held within Leeds Teaching Hospitals NHS Foundation Trust and Bradford Teaching Hospitals NHS Foundation Trust"]
["Description of confidential patient information used","Confidential patient information will be disclosed during the observations of staff handover and ward meetings. Nothing will be recorded at this stage and is not required for the purposes of analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-08-30"]
["Next Review Date","N/A"]
["Notes","31 March 2020 - Support Expired:\nThis CAG application concerns one aspect of the ward-based data collection that occurred prior to patients having given consent (but after the ward manager has consented to ward involvement in the study and staff have agreed to be observed by the researcher). It relates to listening to staff handover and ward meetings where patient details are discussed (including medical details and care planned and delivered)in keeping with Precedent set category 10, Incidental disclosures of identifiable information made to an applicant who is observing practices and procedures within a health and social care setting . This was undertaken to understand the nature of communication between staff about pressure ulcer risk assessment but did not involve the processing (audio or written) of patient identifiable information.\n\nListening to staff handover also provided the opportunity to identify and discuss potential suitable patients to approach for observation, record review and interview with the ward manager/nurse in charge. No patient identifiable information was recorded by the researcher for this purpose.  \n\nThe study will inform the ongoing evaluation of Risk Assessment Instruments and will ultimately lead to guidance for health care providers of how to better target their use to local circumstance.        \n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. (Confirmed 15 April 2019).\n2 Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. (Confirmed: Leeds Teaching Hospitals NHS Trust (by NHS Digital email 12 July 2019) and Bradford Teaching Hospitals NHS Foundation Trust (by NHS Digital email 14 August 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

{"sheet":"A02402","index":445,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02402"]
["Reference","19/CAG/0135 (Previously PIAG 4-06(FT2)/2006)"]
["Other Refs","IRAS project ID: 268714, REC reference: 06/Q2401/84"]
["Application Title","Derby Monitoring Study of Self-harm"]
["Application Summary","This application from Derbyshire Healthcare NHS Foundation Trust set out the purpose of medical research which aims to undertake a series of studies on the epidemiology, clinical management, outcome and prevention of self-harm and suicide. The project is a multi-centre study carried out in collaboration with the University of Oxford and the University of Manchester.\nThe study includes all patients who present at the Derbyshire Healthcare NHS Foundation Trust having self-harmed. Patients are either included following completion of a study form by the treating clinician if they are seen by a member of the CAMHS or adult liaison psychiatry team during hospital attendance to undergo psychological assessment. The study team also check hospital records for wider self-harm attendees who do not undergo psychological assessment.\nAll patients included in the study are flagged within NHS Digital to enable ongoing mortality status follow-up to be carried out.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Derbyshire Healthcare NHS Foundation Trust"]
["Contact Name","Jennifer Ness, Lead Health Services Researcher "]
["Address","Derbyshire Healthcare NHS Foundation Trust Research and Development Centre"]
[null,"Kingsway Hospital"]
[null,"Derby"]
["Postcode","DE22 3LZ"]
["Telephone","01332 623700 ext. 33681"]
["Email","jennifer.ness@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged six years and over attending the Royal Derby Hospital following an episode of self-harm, which is defined as an intentional act of self-poisoning or self-injury regardless of the motivation. This encompasses approximately 2,500 patients each year.\nData Sources:\n1. Emergency department patient records at Derby Teaching Hospitals NHS Foundation Trust,\n2. Mental health patient records at Derbyshire Healthcare NHS Foundation Trust\n3. ONS Mortality Dataset, NHS Digital"]
["Description of confidential patient information used","Identifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of Birth\n4. Postcode\n5. Last known postal address\nIdentifiers required for analysis purposes\n1. Postcode – deprivation scoring\n2. Gender\n3. Ethnicity\n4. Age in years"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-09-04"]
["Next Review Date","2025-02-20"]
["Notes","11 September 2023 - change in data processor from NHS Digital to NHS England, regarding data source.\n\nAmendment supported 21 February 2023  to extend the duration of support for five years, until 31 March 2028\n\n12 April 2022 - Amendment supported to extend the duration of support until 31 March 2023.\n\n18 June 2020 - Amendment supported to extend the study end date from 31 March 2020 to 31 March 2021 and to change the Chief Investigator (CI) from Keith Waters to Jennifer Ness\n\nConditions of support:\n1. Prepare patient information materials for the child cohort and their parents/carer. These documents should be submitted for review within three months of the final outcome for this refreshed application. (Condition met: 15 November 2019)\n2. The project manual should be updated in line with the wider study documentation. This should be provided for review within three months of the final outcome for this refreshed application. (Condition met: 15 November 2019)\n3. An amendment should be submitted to request an extension to the duration of support in place for the activity should additional funding be provided past 31 March 2020. \n4. All pre-existing conditions of support related to PIAG 4-06(FT2)/2006 remain applicable.\n5. The pre-existing annual review cycle remains applicable, with the next annual review to be received 4 weeks before 20/02/2020, and then on an annual basis to this schedule.\n6. Favourable opinion from a Research Ethics Committee. Confirmed\n7. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  Derbyshire Healthcare NHS Foundation Trust), Derby and Burton NHS Foundation Trust (both confirmed via NHS Digital email 16 August 2019) and NHS Digital have confirmed ‘Standards Met’ grade on DSPT 2018/19. \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02403","index":446,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02403"]
["Reference","19/CAG/0110"]
["Other Refs","IRAS project ID: 250319, REC reference: 19/EM/0187"]
["Application Title","Investigating all-cause mortality in the substance misuse treatment population"]
["Application Summary","This application from Derbyshire Healthcare NHS Foundation Trust set out the purpose of medical research which aims to investigate identified risk factors associated with patients dying from drug related death, whilst also attempting to predict their impact on early mortality.\nThe rising rate of drug-related deaths has precipitated a need for greater understanding of the factors that influence them. The applicant aims to investigate the epidemiology of all service users, clinical outcomes, and the risk factors associated with service user deaths in treatment or up to a year after discharge. A cohort study design will be implemented, analysing data routinely collected for patient care in Derbyshire Healthcare NHS Foundation Trust Substance Misuse Services (SMS) from 2012 to 2020, supplemented by mortality follow-up data from NHS Digital.\nData available on SystmOne from 2012 will be extracted by the Trust's IT department on to excel spreadsheets for further analysis by the research team using statistical software. Data from PARIS, the Trust’s electronic patient record system for mental health services, will be extracted for patients who had accessed mental health services, in order to obtain more detailed information on mental health diagnoses and treatment. Any variables missing from the patient data will be manually checked on SystmOne or PARIS by a researcher assigned to the project. Information held on SystmOne and PARIS relates only to patients seen within Derbyshire Healthcare NHS Foundation Trust. The SMS Recovery Lead, working within Derbyshire Healthcare NHS Foundation Trust, will provide routinely collected demographic and sociodemographic information on service users who died whilst in treatment or within 12 months of discharge or disengagement across Derby City and Derbyshire. The Multi-Agency Drug-related Deaths Panel, administrated by Derby Local Authority, will also share information collected from the police and ambulance services and coroner’s reports on drug-related deaths in the region. The applicant confirmed that no items of confidential patient information will be shared from Derbyshire Healthcare NHS Foundation Trust to the Multi-Agency Drug-related Deaths Panel. Confidential patient information will be shared with NHS Digital to be linked with Office of National Statistics mortality data in order to obtain cause of death information for all service users who die in or subsequent to substance misuse service engagement, to ensure a full dataset.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Derbyshire Healthcare NHS Foundation Trust"]
["Contact Name","Ms Jenny Ness - Lead Health Services Researcher"]
["Address","Deryshire Healthcare NHS Foundation Trust "]
[null,"Research and Development Centre, Kingsway Hospital "]
[null,"Derby"]
["Postcode","DE22 3LZ"]
["Telephone","07585 124 629"]
["Email"," jennifer.ness@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","24,300 female and male patients aged 18 or more years of age, who are previous or active service users of Derbyshire Healthcare NHS Foundation Trust Substance Misuse Services (SMS) between 01/01/2012 and 31/12/2020."]
["Description of confidential patient information used","Data sources\n1. Electronic Health records held within Derbyshire Healthcare NHS Foundation Trust\n2. ONS mortality data held by NHS Digital\n3. Multi-Agency Drug-related Deaths Panel held by Derby Local Authority\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of Birth\n\nIdentifiers required for analysis purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of Birth\n5. Date of Death\n6. Postcode (unit level)\n7. Gender\n8. Occupation\n9. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-18"]
["Next Review Date","N/A"]
["Notes","Applicant advised that support was no longer required as of 23 October 2020\n\nSpecific conditions of support \n1. Favourable opinion from a Research Ethics Committee. Confirmed: 4 September 2019. \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed - Derbyshire Healthcare NHS Foundation Trust (NHS Digital e-mail 19 August 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

{"sheet":"A02404","index":447,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02404"]
["Reference","19/CAG/0072"]
["Other Refs","IRAS project ID: 206694, REC reference: 16/NE/0213"]
["Application Title","Validation of a novel scoring system to predict inpatient mortality in exacerbations of Chronic Obstructive Pulmonary Disease requiring assisted ventilation with supplementary longitudinal assessment of quality of life and other patient-centred outcomes over one year."]
["Application Summary","This application from Northumbria Healthcare NHS Foundation Trust sets out the purpose of medical research which aims to assist decision-making in the treatment of exacerbations in Chronic Obstructive Pulmonary Disease (COPD).\nExacerbations of COPD account for 12% of UK hospital admissions. During an exacerbation, the lungs may be unable to adequately clear carbon dioxide (“waste gas”) and the blood becomes more acidic as it accumulates (termed respiratory acidaemia). Respiratory acidaemia has a high mortality and non-invasive ventilation (NIV) can be lifesaving.\nClinicians currently lack a simple method to accurately predict outcome and often overestimate the risk of death, resulting in under-use of NIV. The applicants aim to assist decision making by developing a simple prognostic tool, used to inform discussions about treatment options with patients/families, resulting in increased use of NIV in those who will benefit, and enhanced palliative care provision in those who will not.\nThe applicants collected survival and readmission data for up to 12 months post-discharge. Consent was not required from patients as the direct care teams at each site collected the patient information and only anonymised data was shared with the host site. The applicants had not accounted for the possibility that patients would be readmitted to a hospital that was not participating in the research, or die within the community, and now required the disclosure of confidential patient information from participating trusts to the host site, Northumbria Healthcare NHS Foundation Trust, for collation. The collated confidential patient information was then disclosed to NHS Digital and NHSWIS for linkage to Hospital Episode Statistics (HES) and Patient Episode Database Wales (PEDW) respectively, so that data including emergency department attendance, hospital admission, including to intensive care admission, length of stay and cause of/reason for admission can be accessed. De-identified data was then returned to the host site.\n"]
["Applicant Organisation Name","Northumbria Healthcare NHS Foundation Trust"]
["Contact Name","Professor Stephen Bourke - Consultant Respiratory Physician"]
["Address","Northumbria Healthcare NHS Foundation Trust,"]
[null,"North Tyneside General Hospital"]
[null,"Rake Lane, North Shields"]
["Postcode","NE29 8NH"]
["Telephone","0191 2934026"]
["Email","stephen.bourke@northumbria-healthcare.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 35 years and over, diagnosed with Chronic Obstructive Pulmonary Disease. with an exacerbation complicated by respiratory acidaemia and which is treated with assisted ventilation."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records at participating Trusts in England and Health Boards in Wales\n2. HES, NHS Digital\n3. PEDW, NHS Wales Informatics Service\n\nIdentifiers required for linkage purposes\n1. NIVO study-specific ID\n2. NHS number\n3. Date of birth\n4. Date of death\n5. Postcode\n\nIdentifiers required for analysis purposes\n6. NIVO study-specific ID\n7. NHS number\n8. Date of birth\n9. Date of death\n10. Postcode\n11. Admission Hospital\n12. Gender\n13. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-09-18"]
["Next Review Date","2020-09-18"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 06 July 2019.\n2. Confirmation of suitable security arrangements for organisations processing confidential patient information with support (Confirmed: NHS Digital has a confirmed “Standards Met” grade on DSPT submission 2018/19. NHS Wales Informatics Service has a satisfactory CPIP Assurance Report. Northumbria Health Care (by NHS Digital 02 September 2019) has a confirmed “Standards Met” grade on DSPT submission 2018/19)."]

{"sheet":"A02405","index":448,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02405"]
["Reference","19/CAG/0136"]
["Other Refs","IRAS project ID: 238879, REC reference: 19/SC/0356"]
["Application Title","Acute Leukemia in Pregnancy Registry Study"]
["Application Summary","This application from the Hull and East Yorkshire Hospitals NHS Trust set out the purpose of medical research which aims to establish a research database focussed on women who were diagnosed with acute leukaemia or high-risk myelodysplasia in pregnancy or who have later conceived after receiving previous treatment for either condition.\nThis is an observational study which aims to monitor and record the current treatment and outcomes of patients diagnosed with acute leukaemia during or prior to pregnancy since August 2009, and any new cases that are diagnosed during the period of the study with a view to informing a standardised approach to patient care. Patients will receive the treatment recommended by their doctor, the study will not alter the treatment pathway of participants. Prospectively diagnosed patients, or those still undergoing active treatment will be approached for consent by a member of their clinical care team. Patients who have been discharged and those who are no longer in active follow-up or contact with the clinical care team will not be approached for consent.\nResearch data collected during this study will not be released to other researchers or research organisations outside of the immediate study team for the duration of the study. Subject to further funding being obtained it is envisaged that the LIPS database and data collection will continue and may be expanded outside the UK. Request for access to the data for research purposes beyond the scope of the initial study will be managed by the Hull Health Trials Unit within the University of Hull.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Hull and East Yorkshire Hospitals NHS Trust"]
["Contact Name","Dr Judith Cohen, Director, Hull Health Trials Unit / ICAHR Information Governance Lead\n"]
["Address","Hull Health Trials Unit, 3rd Floor, Allam Medical Building"]
[null,"University of Hull"]
[null,"Cottingham Road, Hull"]
["Postcode","HU6 7RX"]
["Telephone","01482 463 382 "]
["Email","judith.cohen@hyms.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients diagnosed with acute leukaemia or high-risk myelodysplasia during or prior to pregnancy since August 2009 across 24 Trusts in England and one Health Board in Wales who are no longer under active follow-up, have been discharged from treatment or are known to be deceased. It is anticipated that there will be 50 patients within this cohort."]
["Description of confidential patient information used","Data sources\n24 Trusts in England and 1 Health board in Wales\n\nIdentifiers required for linkage purposes\n1. Year of birth (mother)\n2. Date of birth (child)\n3. Date of death (mother and/or child)\n4. Sex of child\n\nIdentifiers required for analysis purposes\n1. Year of birth (mother)\n2. Date of birth (child – DD/MM/YY)\n3. Date of death (mother and/or child – DD/MM/YY)\n4. Sex of child\n\nAdditional information\nThe following additional cohorts will be included on the basis of informed consent:\n• Current patients: defined as those who are receiving treatment and are now pregnant or those who have previously received treatment and are now pregnant,\n• Historical patients: defined as those who had treatment whilst pregnant and are still in active follow-up or contact with the clinical care team or those who had an active acute leukaemia diagnosis and became pregnant post-treatment and are still in active follow-up or contact with the clinical care team."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-18"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, there is no clear evidence-based guidance on how to treat patients who are diagnosed with leukaemia during pregnancy. Therefore, the information collected by the leukaemia in pregnancy database, once published, adds to the limited evidence base that currently exists. In combination with the other literature that has previously been published, clearer guidance in the treatment of patients who are diagnosed with leukaemia during pregnancy may be published enabling healthcare professionals to have greater confidence in managing these patients, leading to a more standardised approach to providing high quality care. This will benefit National Health Service (NHS) Trusts and patients across the UK through more informed clinical decision making with regards to the care they receive. \n\n\nAmendment supported 07 March 2023 to extend the duration of support until end of August 2023\n\nAmendment supported 17 November 2022 to extend the duration of support until February 2023\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January 2022 to extend the duration of support until November 2022, and to change the Chief Investigator to Dr David Allsup.\n\n11 March 2021 - Amendment supported\nThe amendment, to extend the duration of support until May 2022, is supported, subject to compliance with the standard conditions of support.\n\n7 October 2020 - Annual Review Complete\nSpecific conditions of support (updated)\n\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. All staff at Nottingham University Hospitals NHS Trust that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\n10 December 2019 – Amendment supported to include additional clinical information within the analysis dataset around any subsequent pregnancies extending over 24 weeks following leukaemia treatment during the four-year follow-up period. \n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 02 August 2019.\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Hull Health Trials Unit has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital e-mail 26 July 2019)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02406","index":449,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02406"]
["Reference","19/CAG/0105"]
["Other Refs","IRAS project ID: 253343, REC reference: 19/WA/0162"]
["Application Title","Partners at Care Transitions (PACT): Improving patient experience and safety at transitions of care - Assessing the feasibility of using the PACT intervention to improve safety and experience of the transition process in a randomised controlled trial setting."]
["Application Summary","This application from the University of Leeds set out the purpose of medical research to\nimprove the safety of experience of transitions from hospital to home for patients aged 75\nyears and over.\nTransitions of care from hospital to home can be risky, especially for older people with\nmultiple health conditions. Previous research has suggested that the post-discharge\nperiod may be improved by better involving patients and families in their care. This study\nforms part of a programme of research which aims to develop an intervention to improve\nthe safety and experience of transitions from hospital to home for people aged 75 years\nand over. In this study a feasibility cluster Randomised Control Trial will be conducted to\nexplore the feasibility of using the intervention and trial methodology. As the applicants\nhave progressed through this programme of work they have identified a problem in\naccessing accurate routine readmission data, as the way in which hospitals code\ndischarge information does not always accurately record whether patients were admitted\nfrom and discharged to their own home, rather than a nursing or care home. This\nprogramme of work is designed to assist patients discharged home, therefore the\napplicants intend to assess the extent to which this coding issue will affect the accuracy\nof the primary outcome measure for the target population.\nIn order to test the processes as part of the full cluster Randomised Control Trial, the\napplicant first intends to identify the most efficient, cost effective and accurate way of\nidentifying readmission data for patients who are discharged to their own homes rather\nthan other usual places of residence, such as nursing homes. Information Services in\neach Trust will create a list of 10 patients per participating ward who are aged 75 years or\nover, consecutively admitted to the participating ward, and discharged from anywhere in\nthe hospital to ‘usual place of residence’ as per hospital coding. Confidential patient\ninformation on these patients will be shared with a Trust research nurse. The research\nnurse will then check the medical records and categorise patients as discharged to either\ntheir own/a relative’s home, a nursing home, intermediate care or another residence. This\ndata will be aggregated at ward level and all personal information removed before the\ndata is shared with the research team.\nA recommendation for class 1, 2 and 6 support was requested to cover access to the\nrelevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Rebecca Lawton - Professor, Psychology of Healthcare"]
["Address","University of Leeds, School of Psychology"]
[null,"University of Leeds"]
[null,"Leeds"]
["Postcode","LS29JT"]
["Telephone","0113 3435715"]
["Email","r.j.lawton@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 male and female participants, aged 75 years and over, admitted to 10 participating wards."]
["Description of confidential patient information used","Data sources\nElectronic and paper records held in participating Trusts.\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Hospital ID Number\n3. Date of birth\n4. Postcode (unit level)\n5. Address of patients’ usual residence\n6. Date of admission to hospital\n7. Ward admitted to\nIdentifiers required for analysis purposes\nThe applicant confirmed that no items of confidential patient information were required for analysis purposes\nAdditional information\nThe overarching research programme will operate on a consented basis and is out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-09-24"]
["Next Review Date","2020-09-24"]
["Notes","25 October 2019 – amendment supported to include the Airedale NHS Foundation Trust as additional site wtihin the scope of support.  NHS Digital confirmed the DSPT 2018/19 for the Trust had achieved ‘Standards Met’ via email dated 03 October 2019. \n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 27 June 2019.\n2. Confirmation from the IG Delivery Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit submission. (Confirmed: Leeds Teaching Hospitals NHS Trust (by NHS Digital email 12 July 2019) and Mid Yorkshire Hospitals NHS Trust (by NHS Digital email 09 August 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). \n"]

{"sheet":"A02407","index":450,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02407"]
["Reference","19/CAG/0112"]
["Other Refs","IRAS project ID: 260056, REC reference: 19/LO/0942"]
["Application Title","Assessment of the de-identification algorithm in UKCRIS"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to investigate the efficacy of the de-identification algorithm used in Clinical Records Interactive Search (CRIS) at Oxford Health NHS Foundation Trust.\nCRIS extracts data from NHS Trusts’ electronic health records for research purposes. A key step in making these data available to researchers is the robust de-identification of data to protect patients’ right to privacy. The data in CRIS contains both structured and unstructured fields. While de-identifying structured fields, such as the field labelled ‘patient name’, is easy, de-identifying free text, such as clinical notes and correspondence, is much harder. Mistakes can occur for many reasons, such as misspellings. In CRIS, the de-identification is currently done using a bespoke algorithm. The algorithm finds all words it considers personal identifiers and masks them with “ZZZZ”. The efficacy of this de-identification algorithm has not been explicitly studied to date. This is a problem, since it means that the patients and Trusts can only be offered estimated information about the robustness of the de-identification.\nThis project aims to fill this knowledge gap by assessing performance of the de-identification algorithm used in CRIS. This is done by comparing a sample of historic unmasked free text notes with the same notes which have been de-identified by the algorithm. The applicants will use an SQL query to sample the CRIS database for 500 randomly selected, adult patients. For each of the participants, the researchers will access two free-text patient notes and filenames for any attachments in their record in CRIS. The de-identified data will then be manually compared with the original notes, which have the identifiers intact. The patient identifiers present in the text and instances where the algorithm has masked or not masked an identifier, or mistakenly masked a word that is not an identifier will help the applicants determine how well the algorithm de-identifies patient data. The data analysis will be conducted entirely on these fully anonymous counts. The applicants will assess the performance of the algorithm using two measures: recall and precision. Recall describes what portion of the identifiers were masked. Precision describes what portion of the masked words were truly identifiers.\nA recommendation for class 1 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Mr Mike Denis"]
["Address","University of Oxford"]
[null,"Warneford Hospital"]
[null,"Warneford Lane, Oxford"]
["Postcode","OX3 7JX"]
["Telephone","01865 613171"]
["Email","mike.denis@medsci.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","500 randomly selected patients, male or female, aged 18 years and above, who are included on the CRIS database at Oxford Health NHS Foundation Trust. Two records will be identified undergo accuracy checking for each patient included in the study."]
["Description of confidential patient information used","Data sources\n1. Electronic Health records held within Oxford Health NHS Foundation Trust\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Hospital ID number\n4. Date of birth\n5. Postcode- unit level\nIdentifiers required for analysis purposes\n1. Postcode - unit level"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-24"]
["Next Review Date","N/A"]
["Notes","The activity did not commence.   \n\nThe project was unable to be completed due to being unable to recruit enough staff (in Oxford Health NHS Foundation Trust) to be able to review the data being processed by Akrivia Health for the purposes of this projoect.  After one extension application through IRAS -- and given interruption due to Covid -- it was determined the project was low priority and closed in October 2021.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 19 August 2019.\n2. Confirmation from the IG Delivery Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit submission. (Confirmed: Oxford Health NHS Foundation Trust (‘Standards Met’ 2018/19 by NHS Digital email dated 01 July 2019). "]

{"sheet":"A02408","index":451,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02408"]
["Reference","19/CAG/0114"]
["Other Refs","IRAS project ID: 256786, REC reference: 19/EM/0143"]
["Application Title","Evaluation of adults admitted to hospital with community acquired pneumonia and non-cystic fibrosis bronchiectasis: a multicentre, retrospective observational cohort study."]
["Application Summary","This application from the University Hospitals Birmingham NHS Foundation Trust set out the purpose of medical research which aims to evaluate the utility of biomarkers that predict clinical outcomes and evaluate the association between morphology of underlying lung disease and clinical outcome, for patients admitted to hospital with community acquired pneumonia (CAP) and non-cystic fibrosis (non-CF) bronchiectasis.\nThis multicentre, retrospective observational cohort study will include all adult patients admitted with CAP and non-CF bronchiectasis to one of three hospital sites within the University Hospitals Birmingham NHS Foundation Trust between 2010 to 2017. Routinely collected clinical data will be extracted from electronic patient records. No additional interventions/procedures will be performed.\nInitial data extraction will be facilitated by the trusts clinical coding team. Characteristics which are not extractable by the clinical coding team will be collected manually by review of electronic patient records by a designated member of the research team. Source data obtained from electronic patient records will be recorded using an Excel spreadsheet. The master file containing confidential patient information collected in the study will be kept on a server accessible only via a Trust computer, encrypted and protected by password. A separate dataset used for statistical analyses, derived from the master file, will be stored in pseudonymous format and protected by password. A member of the research team will perform pseudonymisation for the purposes of statistical analysis. Only pseudonymised data will be exchanged between authorised individuals for data analysis. NHS.NET email (encrypted) will be used for data exchange.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University Hospitals Birmingham NHS Foundation Trust"]
["Contact Name","Dr Alice M. Turner - Reader in Respiratory Medicine / Honorary Consultant Respiratory Physician"]
["Address","University Hospitals Birmingham NHS Foundation Trust"]
[null,"MIDRU Building, Birmingham Heartlands Hospital"]
[null,"Bordesley Green East"]
["Postcode","B95SS"]
["Telephone","+44 (0)1214240734"]
["Email","alice.turner2@heartofengland.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A maximum of 700 patients, aged 18 years and over, admitted to Birmingham Heartlands Hospital, Good Hope Hospital and Solihull Hospital between 01/01/2010 – 01/01/2017 with a primary diagnosis of CAP and co-morbid non-cystic fibrosis bronchiectasis."]
["Description of confidential patient information used","Data sources\n1. Electronic and paper Health records held within University Hospitals Birmingham NHS Foundation Trust\nIdentifiers required for linkage purposes\n1. Hospital ID number\n2. Date of death\nIdentifiers required for analysis purposes\n1. Hospital ID number\n2. Date of death\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-18"]
["Next Review Date","N/A"]
["Notes","09 February 2022 - Support Expired:\nApplicant confirmed 09 February 2022 that study never took place.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 9 May 2019\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed – University Hospitals Birmingham NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 27 June 2019). "]

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[]
[]
["Application Number","02409"]
["Reference","19/CAG/0105"]
["Other Refs","IRAS project ID: 253343, REC reference: 19/WA/0162"]
["Application Title","Partners at Care Transitions (PACT): Improving patient experience and safety at transitions of care - Assessing the feasibility of using the PACT intervention to improve safety and experience of the transition process in a randomised controlled trial setting."]
["Application Summary","This application from the University of Leeds set out the purpose of medical research to improve the safety of experience of transitions from hospital to home for patients aged 75 years and over.\nTransitions of care from hospital to home can be risky, especially for older people with multiple health conditions. Previous research has suggested that the post-discharge period may be improved by better involving patients and families in their care. This study forms part of a programme of research which aims to develop an intervention to improve the safety and experience of transitions from hospital to home for people aged 75 years and over. In this study a feasibility cluster Randomised Control Trial will be conducted to explore the feasibility of using the intervention and trial methodology. As the applicants have progressed through this programme of work they have identified a problem in accessing accurate routine readmission data, as the way in which hospitals code discharge information does not always accurately record whether patients were admitted from and discharged to their own home, rather than a nursing or care home. This programme of work is designed to assist patients discharged home, therefore the applicants intend to assess the extent to which this coding issue will affect the accuracy of the primary outcome measure for the target population.\nIn order to test the processes as part of the full cluster Randomised Control Trial, the applicant first intends to identify the most efficient, cost effective and accurate way of identifying readmission data for patients who are discharged to their own homes rather than other usual places of residence, such as nursing homes. Information Services in each Trust will create a list of 10 patients per participating ward who are aged 75 years or over, consecutively admitted to the participating ward, and discharged from anywhere in the hospital to ‘usual place of residence’ as per hospital coding. Confidential patient information on these patients will be shared with a Trust research nurse. The research nurse will then check the medical records and categorise patients as discharged to either their own/a relative’s home, a nursing home, intermediate care or another residence. This data will be aggregated at ward level and all personal information removed before the data is shared with the research team.\nA recommendation for class 1, 2 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Rebecca Lawton - Professor, Psychology of Healthcare"]
["Address","University of Leeds, School of Psychology"]
[null,"University of Leeds"]
[null,"Leeds"]
["Postcode","LS29JT"]
["Telephone","0113 3435715"]
["Email","r.j.lawton@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 male and female participants, aged 75 years and over, admitted to 10 participating wards."]
["Description of confidential patient information used","Data sources\nElectronic and paper records held in participating Trusts.\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Hospital ID Number\n3. Date of birth\n4. Postcode (unit level)\n5. Address of patients’ usual residence\n6. Date of admission to hospital\n7. Ward admitted to\nIdentifiers required for analysis purposes\nThe applicant confirmed that no items of confidential patient information were required for analysis purposes\nAdditional information\nThe overarching research programme will operate on a consented basis and is out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-09-24"]
["Next Review Date","N/A"]
["Notes","December 2021 - Support Expired:\nApplicant confirmed expiry of support December 2021.\n\nApplicant confirmed all data has been pseudonymised. None of the original identifiers are being processed / retained by the research team. \n\nIn terms of public benefit, the study was a feasibility trial of an intervention to improve the safety and experience of older people as they transitions from hospital to home. The applicants were able to identify the most efficient, cost effective and accurate way of identifying readmission data for patients who are discharged to their own homes. Applicants are now able to proceed to a full trial to test the effectiveness and cost effectiveness of the intervention, which it is hoped will reduce emergency hospital readmissions and improve the safety and experience of older people (75yrs+) as they transition from hospital to home. \n\n25 October 2019 – Amendment supported to include the Airedale NHS Foundation Trust as additional site wtihin the scope of support.  NHS Digital confirmed the DSPT 2018/19 for the Trust had achieved ‘Standards Met’ via email dated 03 October 2019. \n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 27 June 2019.\n2. Confirmation from the IG Delivery Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit submission. (Confirmed: Leeds Teaching Hospitals NHS Trust (by NHS Digital email 12 July 2019) and Mid Yorkshire Hospitals NHS Trust (by NHS Digital email 09 August 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

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[]
[]
["Application Number","A02410"]
["Reference","19/CAG/0129"]
["Other Refs","IRAS project ID: 259034, REC reference: 19/NW/0311"]
["Application Title","Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA)."]
["Application Summary","This application from Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust set out the purpose of medical research which aims to use artificial intelligence to interpret Endovascular Aneurysm Repair (EVAR) x-rays performed in the Trust with a deep-learning algorithm to evaluate whether this could be used to interpret the x-rays.\nThe proposal is a proof of concept feasibility study. Abdominal aortic aneurysm (AAA) is a condition in which the largest blood vessel in the body becomes weak and forms a bulge. If it becomes large enough, the AAA can burst, often leading to death. Clinicians repair AAAs before they burst by undertaking EVAR, which is a standard treatment in the majority of patients. It is a keyhole technique that reinforces the aorta with a synthetic tube called a “stent-graft”. EVAR is a safer option in the short-term compared to traditional open surgery. However, in the longer term, 1 in 5 patients require further surgery to correct problems developing with the stent-graft such as loss of position and integrity of the stent-graft. Therefore, patients are followed up for life after EVAR with scans performed, usually on an annual basis, to look for signs of a failing stent-graft. Stent-grafts are visible on x-rays of the belly and by comparing series of images taken over time, it is possible to diagnose a myriad of stent-graft problems including loss of positioning, disintegration of the stent-graft material as well as stent-graft distortion. But these changes can be subtle and difficult to spot, even to the trained human eye. As a result, patients undergo more detailed scans that carry a risk of kidney damage and radiation-induced cancer.\nThe applicant will identify a retrospective patient cohort who have undergone an EVAR procedure at the Royal Liverpool Hospital via the clinical database within the Liverpool Vascular and Endovascular Service. Radiographs which have been undertaken as part of routine post-EVAR surveillance will be obtained from the NHS PACS (Picture Archiving and Communication System). Support under the Regulations is sought for this initial patient identification process and the extraction of radiographs and supporting clinical information. This would be pseudonymised prior to use for analysis purposes at the University of Liverpool at the Institute of Ageing and Chronic Disease.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust"]
["Contact Name","Professor Jack Cuzick - Post John Snow Professor of Epidemiology\nQueen Mary University London\nWolfson Institute for Cancer Prevention\nQueen Mary University London\nLondon\nEC1M 6BQ\n\nTel: 02078823504\nE-mail: j.cuzick@qmul.ac.uk"]
["Address","Wolfson Institute for Cancer Prevention"]
[null,"Queen Mary University London"]
[null,"London"]
["Postcode","EC1M 6BQ"]
["Telephone",2078823504]
["Email","j.cuzick@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who underwent an Endovascular Aneurysm Repair procedure at the Royal Liverpool Hospital between 01 January 2005 and 31 December 2013. It is estimated that there will be 800 patients in the cohort."]
["Description of confidential patient information used","Data sources\n1. Electronic Health records held within the Liverpool Vascular and Endovascular Service at the Royal Liverpool Hospital.\n2. NHS PACS (Picture Archiving and Communication System) records at the Royal Liverpool Hospital.\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID\n4. Date of Birth\nIdentifiers required for analysis purposes\nNot applicable\nAdditional information\nInclusion in the study requires a minimum of five-year post-procedure follow-up to be available."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-09-20"]
["Next Review Date","2020-09-20"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 06 September 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: Public Health England (by NHS Digital email 04 August 2019) and Bart’s Cancer Institute, Queen Mary University of London (by NHS Digital email 04 August 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

{"sheet":"A02411","index":454,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02411"]
["Reference","19/CAG/0139"]
["Other Refs","IRAS project ID: 263682, REC reference: 19/EM/0253"]
["Application Title","The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research which aims to evaluate two testing approaches to identify Group B Streptococcus in pregnant women.\nGroup B Streptococcus is a bacterium present in the vagina of approximately 1 in 4 pregnant. Currently women whose babies are at higher risk of developing the infection based on maternal risk factors are given antibiotics in labour to reduce the risk of babies developing GBS infection. This current approach is not ideal as some babies born to mothers without risk factors still develop an infection and many women with risk factors do not carry GBS but receive antibiotics unnecessarily. A better solution is “routine testing” of every pregnant woman and offering antibiotics in labour to those who are carrying GBS.\nThis study will test the two methods of routine testing which are available against a control cohort who will proceed on the administration of antibiotics based on maternal risk factor. 80 maternity units will be recruited and randomised to one of three treatments at unit level. This will compare standard care with two methods of routine testing using vaginal-rectal swabs either at 35-37 weeks of pregnancy or in labour using a rapid test. As randomisation is being carried out at a site level, the applicants request the disclosure of confidential patient information in relation the mother and child on a quarterly basis from various datasets held by NHS Digital, NHS Wales Informatics Service, the National Neonatal Research Database, Public Health England and Public Health Wales. The applicants will facilitate linkage between the various datasets upon receipt and will pseudonymise the dataset for analysis.\nIn the initial stage of the study, a pilot trial will be run concurrently to enable the accuracy of data reported from the national administrative datasets to be checked. This will involve confidential patient information being disclosed direct from the maternity units to the applicants for 100 women, to enable checks against the administrative data to be undertaken. This sub-cohort of patients will also form the basis of health economics analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Jane Daniels - Professor of Clinical Trials, University of Nottingham"]
["Address","Nottingham Clinical Trials, Building 42, Room"]
[null,"University Park, University of Nottingham,"]
[null,"Nottingham"]
["Postcode","NG7 2RD"]
["Telephone","0115 82 31619"]
["Email","jane.daniels2@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Pregnant women in England and Wales. 320,000 women will be included in the study. 74 sites will be included in England and Wales – it is estimated that 97% of the patient cohort will be found at these sites."]
["Description of confidential patient information used","Data sources\n1. Electronic health records from participating maternity units in England and Wales\n2. English Maternity Services Dataset, NHS Digital\n3. National Neonatal Research Database\n4. Hospital Episodes Statistics, NHS Digital\n5. Patient Episodes Dataset Wales, NHS Wales Informatics Service\n6. Group Strep B Infant Sepsis reports, Public Health England\n7. Group Strep B Infant Sepsis reports, Health Protection Wales\nIdentifiers required for linkage purposes\n1. NHS Number – mother and child\n2. Date of birth – mother and child\n3. Postcode – mother and child\nIdentifiers required for analysis purposes\n1. Mother’s age\n2. Ethnicity\n3. Index of multiple deprivation\n4. Neonatal sex\nAdditional information\n• The study will also receive data in relation to a Scottish patient cohort which is out of scope for the application to the CAG and will be managed via application to the Public Benefit and Patient Privacy Panel.\n• The study also involves a supplementary qualitative interview study which will be carried out with patient consent and is out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-07"]
["Next Review Date","2024-10-07"]
["Notes","Amendment supported 13 February 2024 \n•\tTo alter the data flow so that NHS England send confidential patient information regarding solely the GBS3 cohort to the Health Informatics Centre at the University of Dundee (reversing CAG supported amendment 09 June 2023), \n•\tFor The Health Informatic Centre (HIC) TRE data manger to carry out the anonymisation (instead of the NCTU data manager),\n•\tTo provide CAG with updated patient notification materials and data flow diagrams\n\n\n09 June 2023 - change in data processors from; \n•\tNHS Digital to NHS England, regarding data sources English Maternity Services Dataset, Hospital Episodes Statistics (HES), and ONS Mortality data\n•\tPublic Health England (PHE) to UK health Security Agency (UKHSA), regarding lab test results.\n\nAmendment supported 09 June 2023 to alter the data flow so that NHS England send confidential patient information regarding the financial years 20-24 from the Maternity Service Data Set (MSDS) to the Health Informatics Centre at the University of Dundee\n\nAmendment supported 12 January 2023\n\nTo include two new participating sites (Bedfordshire Hospitals NHS Foundation & Manchester University NHS Foundation Trust) as data processors\n\nAmendment supported 16 December 2022 \n\nTo include five new participating sites (Salisbury NHS Foundation Trust, Southport and Ormskirk NHS Trust , Stockport NHS Foundation Trust, The Princess Alexandra NHS Trust, Betsi Cadwaladr University Health Board) as data processors\n\nAmendment supported 27 October 2022 \n\nTo include four new participating sites (Worcestershire Acute Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Hywel Dda University Health Board and Cardiff and Vale University Health Board) as data processors\n\nAmendment supported 03 October 2022\n\nTo include four new participating sites (Airedale NHS Foundation Trust, West Suffolk NHS Foundation Trust, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, United Lincolnshire Hospitals NHS Trust) as data processors\n\nAmendment supported 03 October 2022\n\nTo include five new participating sites (Royal Berkshire NHS Trust, Mid Cheshire Hospitals NHS Foundation Trust, Countess of Chester Hospital NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Newham Hospital (Barts Health NHS Trust)), as data processors.\n\n15 February 2022 - Amendment supported:\nAmendment supported to:-\n• extend the duration of support until 31 May 2024,\n• change the location of where data is stored and analysed to an accredited Trusted Research Environment (TRE) managed by the Health Informatics Centre (HIC), located at University of Dundee, \n• allow the TRE to disclose confidential patient information to process 2 databases in order to request clinical information about individuals in the GBS3 database,\n• include Office for National Statistics (ONS) mortality data (from NHS Digital) as a new routine data source. (Data items requested are date of death and cause of death),\n• include two new participating sites as data processors - Homerton University Hospital NHS Foundation Trust and Kettering General Hospital NHS Foundation Trust. \n• Accept as notifications, minor changes to study documents including protocol\n\n\n10 August 2021 - Amendment supported to add Northumbria Healthcare Foundation Trust and Frimley Health NHS Foundation Trust as additional data processors\n\n16 April 2021 - Amendment supported\nThe amendment, to retain the identifiable dataset in order to undertake future linkages, is supported for five years, subject to compliance with the standard and specific conditions of support.\n\nConditions:\n1. Support for the retention of confidential patient information in order to undertake future linkages, is supported for a time limited period of five years from the date of this letter, and an amendment should be submitted at this time to extend the support further. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold:\n\nConfirmed: The NHS Digital 19/20 DSPT review for the University of Nottingham and the DSPT equivalent for NHSS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 17 March 2021)\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed: Favourable opinion 1 April 2021\n\n18 September 2020 - Amendment supported to include the Paediatric Intensive Care Audit Network (PICANet) and Badgernet (Maternity and Neonatal) as data sources and to include additional sensitive data items.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 13 September 2019. \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: Nottingham Clinical Trials Unit at the University of Nottingham has a confirmed ‘Standards Met’ grade on DSPT 2018/19 via NHS Digital email dated 04 August 2019. NHS Digital has a confirmed ‘Standards Met’ grade on DSPT 2018/19. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","A02412"]
["Reference","19/CAG/0033"]
["Other Refs","IRAS project ID: 248372, REC reference: 19/LO/0184"]
["Application Title","A multi-point survey to investigate the incidence and outcome of patients who doctors or nurses feel are unlikely to leave hospital alive from intensive care and the rate of agreement between doctors and the bedside nurse"]
["Application Summary","This application from Taunton and Somerset NHS Foundation Trust set out the purpose of medical research which aims to evaluate what proportion of patients in intensive care receive treatment which is deemed inappropriate and determine whether doctors and nurses have differing views on what is considered inappropriate care.\nThe study will be operated on an observational basis whereby doctors and nurses caring for patients will be asked to complete a study questionnaire around the care they have provided to a patient in the intensive care environment and whether they believed the care provided was inappropriate. The questionnaire will be anonymously completed by the hospital staff; however, this will record details of the patient to enable follow-up at six months to confirm outcome status to enable comparison with the views expressed by clinical staff. Data will be collected on eight specified days across an eight week period, from 12 treating hospitals.\nLimited follow-up information will be collected at six months following completion of clinician questionnaire – this will record the following only: mortality status at hospital discharge, mortality status at six months post-discharge, for those alive at six months: discharge destination. Contact would be made with the patient’s registered GP if discharge destination is unknown from hospital records.\nA recommendation for class 1, 2, 3, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Taunton and Somerset NHS Foundation Trust"]
["Contact Name","Dr Richard Innes - Consultant Intensive Care\nTaunton and Somerset NHS Trust\nMusgrove park\nTaunton\nTA15DA"]
["Address","Taunton and Somerset NHS Trust"]
[null,"Musgrove park"]
[null,"Taunton"]
["Postcode","TA15DA"]
["Telephone",1823342114]
["Email","richard.innes@tst.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged over 18 years being treated within general, neurosurgical and cardiothoracic intensive cares throughout the South West, requiring one or more of the following organ supports: respiratory, cardiovascular or renal replacement therapy, across an eight week data collection period. It is anticipated that information in relation to 900 patients would be collected across the study duration."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records general, neurosurgical and cardiothoracic intensive cares throughout the South West\nIdentifiers required for linkage purposes\n1. Name\n2. Hospital ID\n3. GP Registration\n4. Date of birth\n5. Date of death\nIdentifiers required for analysis purposes\n1. Date of death\n2. Sex\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-10-09"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised. Clinical information without patient identifiers is held on a REDCAP data base supervised by Somerset Foundation Trust. Direct identifiers are held by the direct care team at individual trusts. This patient data relates only to patient data for that individual trust and is held on individual trust’s secure site which is password protected.\n\nIn terms of public benefit, this piece of research demonstrated much lower levels of inappropriate or futile care within intensive care compared with US data and large discrepancy between nursing and medical staff. It also demonstrated that a significant proportion of patients considered to be having futile care within intensive care actually went onto survive and live independently suggesting that clinical staff are potentially not good at predicting outcome of patients critically ill on intensive care and therefore need to exercise caution when deciding this.\n\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 11 July 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Due to the number of sites at which data will be accessed, individual DSPT submissions are not required for the purpose of the application.  Each site is expected to have achieved a ‘standards met’ in relation to their organisational DSPTs). "]

{"sheet":"A02413","index":456,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02413"]
["Reference","19/CAG/0027"]
["Other Refs","IRAS project ID: 228786, REC reference: 19/NE/0032"]
["Application Title","A diagnostic evaluation of malaria detection in patients presenting to the emergency department - a large teaching hospital retrospective cohort study"]
["Application Summary","This application from Manchester University NHS Foundation Trust set out the purpose of medical research which aims to assess the necessity of the three routinely repeated blood tests carried out on patients who have presented to the emergency department with suspected malaria.\nThe applicants will identify patients from the laboratory database at Manchester University NHS Foundation Trust who have presented in the emergency department in the previous five years with suspected malaria. Confidential patient information, together with a study-specific ID number, will then be transferred to Public Health England, in order to facilitate linkage with the National Malaria Registry. Applicants will be working on site at Public Health England to carry out the data linkage directly; however, confidential patient information would be temporarily stored on Public Health England networks during this process. The applicants will have access to the National Malaria Registry whilst on site at Public Health England – the database is outside of the scope of information for which they would ordinarily have legitimate access. Linked information will be returned to the applicant in a pseudonymised format by study-ID only for analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Manchester University NHS Foundation Trust"]
["Contact Name","Dr Charles Reynard - Academic Clinical Fellow, Honorary lecturer in Cardiovascular sciences"]
["Address","Manchester University NHS Foundation Trust"]
[null,"Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9WL"]
["Telephone",1612765072]
["Email","charlie.reynard@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who presented to Manchester Royal Infirmary's Emergency Department or Manchester Children's Hospital Emergency Department (within Manchester University NHS Foundation Trust) in the last five years and underwent investigation for suspected malaria. It is estimated that approximately 1,200 patients would be included in the study."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records at Manchester University NHS Foundation Trust\n2. National Malaria Registry, Public Health England\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Postcode\nIdentifiers required for analysis purposes\n1. Sex\n2. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-10-10"]
["Next Review Date","N/A"]
["Notes","21 March 2022 - Support Expired:\nApplicant confirmed ‘s251’ support can be expired 21 March 2022, as all data has been deleted as per UKHSA requirements. \n\nWith regards to public benefit, the applicant explained that this project has helped to build the evidence base for a single malaria testing strategy in the returning traveller. This is in contrast to the currently recommended three consecutive tests. If this study is further supported in the literature it may lead to a change in practice reducing unnecessary visits. This would ensure earlier reassurance for patients, and would have a cost benefit for the NHS.\n\n09 August 2021 - Amendment supported to extend the duration of support until June 2022\n\n Conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 17 June 2019.\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via data Security and Protection Toolkit (DSPT) submission. Confirmed – Public Health England have a confirmed ‘Standards Not Fully Met – Improvement Plan in Place’ grade on DSPT 2018/19, which was accepted by the CAG on 05 September 2019. "]

{"sheet":"A02414","index":457,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02414"]
["Reference","19/CAG/0132"]
["Other Refs","IRAS project ID: 253229, REC reference: 19/SC/0190"]
["Application Title","Frequency of observations (FOBS)"]
["Application Summary","This application from the University of Portsmouth sets out the purpose of medical research which aims to investigate how often a patient’s vital signs need to be monitored to track progress to recovery or to highlight a deterioration in condition.\nThe Royal College of Physicians and the National Institute for Clinical Excellence (NICE) recommend that vital signs observations are combined into a single score (NEWS) that shows when the measurements are abnormal. There is now some evidence to support using the NEWS score to identify patients at increased risk of cardiac arrest, death or unexpected transfer to intensive care, so that staff can take preventative action. The guidance is also that the higher the NEWS score, the more often a patient should be observed. Although it is recommended that people with higher scores need more frequent observation, there is no direct evidence for this. The study will investigate how often patients need to be monitored and seek to evidence whether some observations could be unnecessary or too far apart to be useful in spotting deterioration. The aim of the application is to develop a protocol for how frequently observations should be made.\nThis application is a retrospective study and will take place across all general adult wards, excluding maternity, intensive care and other wards where continuing monitoring is in regular use. Data for the retrospective study will be derived from repositories of vital signs obtained using the Vitalpac (PHT) and SEND (OUHT) systems, both of which enable nursing staff to record physiological measurements at the bedside using electronic devices. Vital signs would be linked to local patient databases for administration, theatre management, intensive care and cardiac arrest. The combined database will then be used to investigate the variation in the rate of critical changes in vital signs over the course of the patient’s hospital stay and how this relates to the risk of adverse outcomes. The applicants will design monitoring protocols to detect significant patient deterioration and calculate the total number of observations required for each ward on a typical day.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Portsmouth"]
["Contact Name","Professor Jim Briggs"]
["Address","University of Portsmouth, Buckingham Building"]
[null,"Lion Terrace"]
[null,"Portsmouth"]
["Postcode","PO1 3HE"]
["Telephone","023 9284 6438"]
["Email","Jim.Briggs@port.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients admitted to the Oxford University Hospitals NHS Foundation Trust (between 2017 - 2020) or Portsmouth Hospitals NHS Trust (between 2014 and 2020), excluding maternity, intensive care and other wards where continuing monitoring is in regular use. It is estimated that 200,000 patients will be included in the study database"]
["Description of confidential patient information used","Data sources\n1. Electronic patient record system (SEND) and clinical information systems at Oxford University Hospitals NHS Foundation Trust\n2. Electronic patient record system (PAS) and clinical information systems at Portsmouth Hospitals NHS Trust\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital Number\n4. Date of Birth\nIdentifiers required for analysis purposes\n1. Date of Death\n2. Gender – analysis\n3. Ethnicity – analysis\n4. Year of birth – analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-10-11"]
["Next Review Date","N/A"]
["Notes","18 November 2021 - Applicant confirmed support expired.\n\nSupport is no longer required because no further data is being collected. All data was pseudonymised on extraction.. \n\nThe public benefit is that forthcoming publications will advise clinicians and hospital managers on the risks/benefits of changing the frequency at which in-hospital patients have their vital signs observed.\n\n09 July 2021 - amendment support to extend the duration of support until 30 September 2021, is supported, subject to compliance with the standard conditions of support.\n\n\nSpecific conditions of support\n1. Further patient and public involvement and engagement activity specific to the project should be carried out as the project progressed. Feedback should be provided at the time of first annual review around the activity carried out and the views expressed by those involved.\n2. Favourable opinion from REC Received 10 June 2019\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Oxford University Hospitals NHS Foundation Trust and Portsmouth Hospitals NHS Foundation Trust - NHS Digital have confirmed qualified assurance against both organisation’s 2018/19 DSPT submission, via email dated 07 October 2019, on the basis that the Trust has not met the 95% standard relating to staff security awareness training."]

{"sheet":"A02415","index":458,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02415"]
["Reference","19/CAG/0101"]
["Other Refs","IRAS project ID: 252873, REC reference: 19/SW/0104"]
["Application Title","Oxford Cerebrovascular Research Database"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to establish a research database of patients who suffered a stroke or mini-stroke (TIA) in the past 10 years who have an interest in being invited to participate in future research studies.\nSupport is requested to allow access to medical records on site at Oxford University Hospitals NHS Trust to enable the research team to identify eligible patients using lists of those who had been discharged from a stroke unit or have attended a specialist stroke/TIA clinic. Medical details will not be analysed at this initial stage.\nPatients will be invited to provide their consent for inclusion on the registry so that they could be contacted in future if a research study begins for which they would be eligible to participate. Patients would be invited up to twice, by postal contact only, a minimum of one month apart. Once these initial invitations have been sent, the initial screening data would be deleted. Inclusion within the registry would be dependent upon on the individual returning the consent materials. Patients who are newly diagnosed or are under continued clinical care will be approached by the direct care team for consent. As such support is requested only for the retrospective patient cohort. Once the database has been established, the research team will have a defined and eligible cohort of patients who can be approached about strokes-specific research projects.\nA recommendation for class 1, 2, 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Alastair Webb"]
["Address","Centre for the Prevention of Stroke and Dementia"]
[null,"University of Oxford"]
[null,"Level 6, West Wing, John Radcliffe Hospital"]
["Postcode","OX39DU"]
["Telephone",1865231601]
["Email","alastair.webb@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged over 18 diagnosed as suffering a cerebrovascular event (Stroke or TIA) from 01/09/2009 to 01/09/2019 at Oxford University Hospitals NHS Trust. It is expected that 5000 patients would be invited to participate in the research database."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records at Oxford University Hospitals NHS Trust.\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of Birth\n4. Full address and postcode\n5. Vital status.\nIdentifiers required for analysis purposes\nNot applicable – all data will be retained on the basis of consent from patients.\nAdditional information\nPatients who are newly diagnosed or remain under continued clinical care will be approached for consent by the direct care team. This sub-cohort is not within the scope of the proposed support."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-14"]
["Next Review Date","2024-10-14"]
["Notes","Amendment supported 17 August 2023 to expand the cohort to allow retrospective identification of patients who have had a cerebrovascular event between 01 September 2019 and 30 December 2023, and to increase the total number of patients contacted to approximately 8500 (increased from 5000)\n\nConditions of support:\n1. Support does not extend the wider recruitment mechanism following data disclosure from HES at NHS Digital. An amendment would be required at a future point if this additional mechanism is deemed necessary. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 11 July 2019\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed as follows:\n• Oxford University Hospitals NHS Foundation Trust (RTH) NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. \n• University of Oxford Medical Sciences Division has confirmed ‘Standard Met’ on DSPT 2018/19 by NHS Digital email dated 19 September 2019"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02416","index":459,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02416"]
["Reference","19/CAG/0125"]
["Other Refs","IRAS project ID: 252915, REC reference: 19/LO/0862"]
["Application Title","The Incidence and epidemiology of Eyelid Melanoma in the UK"]
["Application Summary","This application from Kings College NHS Foundation Trust set out the purpose of medical research which aims to establish the incidence of malignant eyelid melanoma. The study will follow the established British Ophthalmologist Surveillance Unit (BOSU) methodology, using the monthly reporting card amongst UK ophthalmologists.\nThe BOSU methodology is established and has received support in principle from the CAG. Ophthalmologists will indicate that they have seen a new eyelid melanoma case through the BOSU. The BOSU collects no patient identifying information but will notify the study investigator of all ophthalmologists who report new cases. The researcher will then contact the reporting ophthalmologist directly and will be sent a questionnaire requesting information to determine the incidence, but also secondary aims of histological subtype, the treatment given, prognosis and the effect on vision. The primary questionnaire will be completed at the point of notification with follow-up at 12 months.\nResearch analysis will be carried out at one site at Kings College Hospital (Princess Royal University Hospital (PRUH)). Analysis will be descriptive and all findings reported in an aggregated format and at no point will the patient’s routine standard care be altered or impacted as a result of this study.\nA recommendation for class 1, 2, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Kings College NHS Foundation Trust"]
["Contact Name","Dr John Bladen - Consultant Ophthalmologist"]
["Address","Kings College NHS Foundation Trust"]
[null,"PRUH, Farnborough Common"]
[null,"Orpington, Kent "]
["Postcode","BR6 8ND"]
["Telephone","01689 865681 "]
["Email","john.bladen1@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients identified by participating ophthalmologists in England and Wales with malignant eyelid melanoma. It is estimated that there will be approximately 156 patients reported per year."]
["Description of confidential patient information used","Data sources\n1. Local clinical records at participating Eye Hospitals.\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Postcode\n3. Month and year of birth\nIdentifiers required for analysis purposes\n1. Month and year of birth\n2. Postcode\n3. Gender\n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-14"]
["Next Review Date","2020-10-14"]
["Notes","Conditions of support:\n1. Support extend to England and Wales only. \n2. Favourable opinion from a Research Ethics Committee. Confirmed: 04 June 2019\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Kings College NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02417","index":460,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02417"]
["Reference","19/CAG/0111"]
["Other Refs","IRAS project ID: 149581, REC reference: EE/18/0199"]
["Application Title","Cambridge Blood and Stem Cell Biobank"]
["Application Summary","This application from the University of Cambridge set out the purpose of creating a research tissue bank, which aims to provide tissue for use in research into blood or stem cell related disorders, or the study of normal developmental processes.\nThere will be four broad groups of samples in this biobank. The first group are samples collected prospectively from healthy bone marrow, lymph node biopsy, stem cell harvest and normal cord donors. The second group is comprised of samples collected from patients with haematological malignancies, immunological disease and related disorders. These samples will be obtained from diagnostic/surgical routes, or as an additional peripheral blood sample or buccal swab. Group 3 are samples obtained from staff, unaffected relatives and other individuals recruited to donate normal blood and buccal swabs only. The fourth group are existing materials imported from other ethically approved studies and clinical trials.\nThe CAG application concerns eligible patients in Groups 1 and 2. These patients will be identified by research staff, who will review clinic lists and hospital medical records only for patient identifying data by screening potential participants beforehand and may also note anyone deemed not appropriate for research. In line with hospital policy, potential participants will then be approached by members of the clinical care team in the first instance. The research team will be involved both in identification of patient participants with the relevant condition and taking informed consent.\nSome cases will be more sensitive, and the clinical care team will direct the whole consent process as they will have a far better understanding of which donors might be appropriate for the research. The relatives of existing patient donors will be identified by a member of the clinical care team caring for the donor, and appropriate information will be given to them. Also, prospective stem cell harvest donors will be identified by a member of the clinical care team on the wards or in the out-patient clinic where the donor is being assessed for stem cell harvest. The research team will only look at these records after consent has been given.\nAll data will be link-anonymised using a unique code so that researchers do not receive identifying information. Identifying information held will be name, MRN and date of birth for NHS patients, and name only for staff donors. Samples transferred from other studies and outside the UK are anonymised on arrival if not already anonymised at source. Identifying data will be held in NHS systems only.\nA recommendation for class 1, 3 and 6 support was requested to the activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Elizabeth Joanna Baxter, Senior Research Associate"]
["Address","Cambridge Blood and Stem Cell Biobank"]
[null,"NHS-BT Cambridge Centre"]
[null,"Long Road, Cambridge "]
["Postcode","CB2 0PT"]
["Telephone","01223 588048 "]
["Email","cbsb_admin@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with haematological malignancies, immunological disease and related disorders, and healthy volunteers who have donated umbilical cord blood, bone marrow, lymph node biopsy and stem cell harvest donors."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes set out below:\n• Name – sample linkage and validation\n• NHS Number – sample linkage and validation\n• Hospital Number – sample linkage, validation and analysis\n• Date of birth – sample linkage, validation and analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-10"]
["Next Review Date","2024-10-10"]
["Notes"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02418","index":461,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02418"]
["Reference","19/CAG/0096"]
["Other Refs","IRAS project ID: 255660, REC reference: 19/NS/0085"]
["Application Title","A randomised pilot study of a pharmacist-led retrospective review of prescribing by general practitioners in training (REVISiT) intervention"]
["Application Summary","This application from University of Nottingham set out the purpose of medical research which aims to identify errors in prescribing by GP Trainees in the East Midlands and Dorset and provide prescribing training based on the errors identified. The study will be a randomised controlled trial, which is a pilot to test the REVISiT intervention, which involves a Pharmacist-led review of GPs in training prescribing practices.\nThe study follows on from a pilot study which was carried out following a recommendation of the CAG in 2014 under reference CAG 9-03(PR2)/2013. The pilot study has informed the design and methodology of this study, which will be carried out on a much larger scale. This second pilot will inform the design (including sample size) for the definitive controlled trial which would follow.\nThe application is seeking support under the Regulations to legitimise access to confidential patient information on site at GP practices by the Pharmacist undertaking the review of the GP trainee prescribing practices. The study views the GP Trainees and practices as the participants within the study; however, access to confidential patient information is required to inform the training intervention. There will be two arms to the study – the first will be the intervention arm where GP trainees will receive the REVISiT intervention. The second arm will be a control arm whereby GP trainees will continue with training as normal. The purpose of the study is inform the development of a definitive trial to test the intervention to see whether this would lead to improvements in prescribing practices.\nA recommendation for class 1, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Dr Richard Knox, Clinical Associated Professor"]
["Address","University of Nottingham, Division of Primary Care"]
[null,"Room C39 Medical School, Queen’s Medical Centre"]
[null,"Nottingham"]
["Postcode","NG7 2UH"]
["Telephone","0115 823 0422"]
["Email","Richard.Knox@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who have been prescribed medication by a GP Trainee within a participating practice during the study duration. There will be 20 GP trainees recruited to the study and 200 prescriptions will be assessed per trainee, requiring access to approximately 4,000 patient records."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records onsite at the participating GP practices in the East Midlands and Dorset in the first instance. Following advertisements training practices in other parts of the country may participate.\n\nIdentifiers required for linkage purposes\n1. Name - extracted in certain practices for linkage with study-specific ID\n2. Date of birth - extracted in certain practices for linkage with study-specific ID\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Age\n\nAdditional information\nAccess will be required to the complete patient record within the GP practice. The pharmacist who normally works with the practice will carry out the extraction in most practices. Where this is not possible a contractual arrangement will be made with a local pharmacist to carry out this task."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired "]
[]
["Outcome Date","2020-11-01"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed that ‘s251’ support can be expired from 16 December 2022, as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, the applicants now have a fully functional database which can be utilised for prescribing review with quality assurance. This database may prove useful for prescribing review processes involving other prescribers in the future. \n\n11 October 2022 – amendment supported\nTo extend the duration of ‘s251’ support until 31 March 2023\n\n17 February 2022 - Amendment supported:\nAmendment supported to clarify that the 20 recruited GP trainees can be ST2s as well as ST3s, and to include 10 CCGs as additional data processors.\n\n15 June 2021 - Amendment supported:\nSupport provided to extend timeframe of support until October 2022 due to COVID delays.\n\n20 July 2020 - Amendment supported:\nThis amendment extends support for the pharmacist undertaking the review to also include pharmacists employed by Primary Care Networks. The amendment is also for updated patient information documents (poster advert and patient information leaflet).\n\nConditions of support:\n1. Favourable opinion from REC Received 10 October 2019 \n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Not checked due to the number of research sites involved. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to accessing confidential patient information with support under the Regulations."]

{"sheet":"A02419","index":462,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02419"]
["Reference","19/CAG/0108"]
["Other Refs","IRAS project ID: 218202, REC reference: 17/SC/0667"]
["Application Title","Utility of biomarkers for ovarian cancer risk assessment in primary care: a pilot study"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research which aims to assess the efficacy of a blood test, known as CA125, versus testing for presence of a biomarker known as HE4, in the identification and diagnosis of ovarian cancer.\nThe study was designed in two phases. The first phase involved comparing the performance of the HE4 and CA125 tests in the samples of 1200 symptomatic women who presented to their GP. CA125 samples underwent additional testing for HE4 at Central Manchester University Hospitals NHS Foundation Trust. As this additional testing was undertaken on the surplus routine sample material and research was led by members of the usual gynaecological clinical care team, consent was not taken from patients for this phase of the study.\nIn order to complete this phase of the study, the applicant intends to follow-up the patient cohort via the National Cancer Registration and Analysis Service at Public Health England, in order to determine which patients have subsequently been diagnosed with cancer. The application has been submitted to the CAG to seek support under the Regulations to legitimise the disclosure of NHS Numbers to Public Health England in order to facilitate linkage with the NCRAS database and collate the required follow-up data. The second phase of the study is out of scope for the application to the CAG as, whilst based on the initial phase of the study, this will involve a separate patient cohort which will be approached for consent to participate in the study by a member of the clinical care team at Manchester Central University Hospitals NHS Foundation Trust.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Dr Emma Crosbie, NIHR Clinician Scientist, Senior Lecturer & Honorary Consultant Gynecological Oncologist"]
["Address","5th Floor - Research, St Mary's Hospital"]
[null,"Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9WL"]
["Telephone",1617016942]
["Email","Emma.Crosbie@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1227 women who were included in phase one of the trial, following presentation at their GP practice symptomatic of ovarian cancer and were referred to the Manchester Central University Hospitals NHS Foundation Trust to undergo CA125 testing between 03/04/18 and 18/04/19."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records held at Manchester Central University Hospitals NHS Foundation Trust,\n2. National Cancer Registration and Analysis Service database held by Public Health England.\nIdentifiers required for linkage purposes\n1. NHS Number.\nIdentifiers required for analysis purposes\nThe applicant advised that no items of confidential patient information would be required for analysis.\nAdditional information\nThe study involves a second phase which will be operated on a consented basis and is out of scope of the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-11-05"]
["Next Review Date","N/A"]
["Notes","Following approval from CAG to link our data with the National Cancer Registry (NCRAS), the COVID-19 pandemic occurred, and as such, there was a significant delay in collection of the relevant data by NCRAS. These delays meant that we were unable to access the required data within the time frame of the research study. As such, we sought an alternative amendment that did not require data linkage and processing of confidential information without consent.\n\nConditions of support:\n1. Revise the patient-facing text for both the Cancer Research UK and Manchester Central University Hospitals NHS Foundation Trust websites to provide a clearer overview of the study, how patients can identify themselves within the cohort and how objections can be raised. This revised text should be drafted in conjunction with patient representatives to ensure that this can be clearly understood by a lay audience. The revised text should be provided for consideration within one month of the date of this outcome letter. \n2. Favourable opinion from a Research Ethics Committee. Received – 24 June 2019.\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed – NHS Digital confirmed the ‘Standards Met’ assurance for DSPT 2018/19 as follows: Public Health England (email received 02 September 2019) and University of Manchester (email received 07 October 2019). "]

{"sheet":"A02420","index":463,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02420"]
["Reference","19/CAG/0115"]
["Other Refs","IRAS project ID: 261563, REC reference: 19/NI/0115"]
["Application Title","Suspected Stroke Clinical and radiological data base (SSCRaD)"]
["Application Summary","This application from Ashford & St Peter's Hospitals NHS Foundation Trust set out the purpose of establishing a research database of patients with suspected stroke or intracranial haemorrhage.\nOnly pre-existing clinical data will be collected for patients who have undergone radiological imaging due to suspicion of stroke or to investigate a known stroke. The data collected will include fully anonymised radiological images, including CT and MRI scans, and the anonymised radiological report. The patients age, gender, presenting symptoms, treatment and clinical outcome will also be collected and included in the database. Any identifiable or sensitive information would be removed.\nThis data will be used for research purposes to apply computational analysis to explore if the radiological images can be automatically diagnosed, or if lesions in the images can be automatically segmented. This could potentially lead to computer programmes that can reduce radiological reporting time for stroke and increase understanding of the brain and how it is affected by stroke.\nThe data will be collected at Ashford & St Peter's Hospitals NHS Foundation Trust. Data will be collected up to 10 years in the past and up to five years in the future.\nA recommendation for class 1 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Ashford and St Peter's NHS Foundation Trust"]
["Contact Name","Dr Jordan Colman "]
["Address","Ashford and St Peter's NHS Foundation Trust "]
[null,"St Peter's Hospital, Guildford Road "]
[null,"Chertsey"]
["Postcode","KT16 0PZ "]
["Telephone","01932872000"]
["Email","jordan.colman@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients admitted to Ashford & St Peter's Hospitals NHS Foundation Trust with known or suspected stroke from 01/01/2009 to 31/12/2018."]
["Description of confidential patient information used","Data sources\n1. Clinical data, radiology imaging and neuroimaging in patient records held at Ashford & St Peter's Hospitals NHS Foundation Trust\nIdentifiers required for linkage purposes\n1. Hospital Number\n2. Gender\n3. Date of scan\n4. Age at time of scan\nIdentifiers required for analysis purposes\n1. Gender\n2. Age at time of scan\nAdditional information\nThe study will also include a prospective patient cohort seen by the Trust from 01/01/2019 to 31/12/2024; however, this sub-group will be collected by the direct care team and it out with the application for support."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-28"]
["Next Review Date","2024-10-28"]
["Notes","Specific conditions of support \n\n1. Patient and public involvement is to be undertaken around the development of a study poster. Feedback, including the poster, is to be submitted to the CAG within six months of the issuing of this outcome letter. Conditions met 22 July 2020.\n\n2. Favourable opinion from a Research Ethics Committee. (Confirmed - 05 July 2019). \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed – Ashford and St Peter’s Hospitals NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 02 October 2019). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02421","index":464,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02421"]
["Reference","19/CAG/0172"]
["Other Refs","IRAS project ID: 228578, REC reference: 00/5/030"]
["Application Title","A POPULATION BASED STUDY OF GENETIC PREDISPOSITION AND GENE-ENVIRONMENT INTERACTIONS IN ENDOMETRIAL CANCER"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research which seeks to determine the role of germline genetic variation in susceptibility to breast, endometrial and ovarian cancer. This application covers the endometrial arm of the SEARCH study.\nThe SEARCH study has been running since 1996. Support under Section 251 has not previously been required as patients were recruited via a local cancer registry, the Eastern Cancer Registration and Information Centre, which has now been amalgamated to the National Cancer Registration and Analysis Service (NCRAS). In line with advice received from Public Health England, the applicants are seeking support to revise the recruitment process, so that patients are identified by NCRAS.\nNCRAS will identify suitable patients and then disclose the patient list to NHS Digital, who will remove patients who are deceased, have moved away from the UK or who have registered a dissent. The revised list will then be disclosed to the NHS Digital Personal Demographics Service (PDS), who will attach patients’ addresses and the name and address of patients’ GP. This list will then be sent to the SEARCH study co-ordinator to facilitate the invitation process.\nThe SEARCH study co-ordinator will contact the GPs of eligible patients, asking them to invite patients to take in the study. The GP will be provided with the study information leaflet, a letter of introduction from the study team and a reply slip for the patients to return to the SEARCH team if they wish to take part. Patients participation in the project will then proceed on a consented basis. Patients will not be approached if the GP indicated that the patient was under the age of 18 or unfit to participate for any reason.\nA recommendation for class 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","University of Cambridge"]
[null,"Department of Public Health and Primary Care, Department of Oncology"]
[null,"Strangeways Research Laboratory, Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone",1223761926]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","4,000 SEARCH Study participants with endometrial cancer and 3,500 controls who have already taken part in the study and completed a consent form."]
["Description of confidential patient information used","Data sources\n1. The National Cancer Registration and Analysis Service held by Public Health England (PHE)\n2. Patient Demographics Service - NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. GP Registration\n4. Date of birth\n5. Postcode\n6. GP name and address\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-29"]
["Next Review Date","2024-10-29"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), and a change in data processor from NHS Digital to NHS England regarding demographics information\n\nAmendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n03 December 2020 - Specific conditions of support updated:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Further Patient and Public Involvement is to be carried out, with feedback to be provided 6 months from the date of this letter, continuing to explore different methods of notifying patients and ways to facilitate dissent.\n\n2. All staff at National Cancer Registration and Analytical Services (Public Health England) (X25)   that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support\n1. Further patient and public involvement is to be carried out with feedback to be provided at the time of first annual review. This activity should explore different methods of notifying patients that the study is being undertaken and ways of facilitating study specific dissent.\n2. Favourable opinion from REC. (Confirmed 21 February 2019).\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. (Confirmed: University of Cambridge (by NHS Digital email 08 July 2019), Public Health England (by NHS Digital email 02 September 2019) and NHS Digital (by NHS Digital email 10 June 2019)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02422","index":465,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02422"]
["Reference","19/CAG/0146"]
["Other Refs","IRAS project ID: 260639, REC reference: 19/LO/1064"]
["Application Title","The TIGHT-K STUDY. Dysrhythmias on the cardiac\nintensive care unit - does maintenance of high-normal\nserum potassium levels matter?"]
["Application Summary","This application from Bart’s Health NHS Trust set out the purpose of medical research\nthat seeks to determine whether maintaining a normal level of potassium in the blood\ncan help to prevent a fast, irregular heartbeat in patients following CABG surgery just as\nwell as maintaining a high level of potassium.\nA fast, irregular heartbeat can occur after heart surgery. This may be dangerous and\nkeep patients in hospital longer. Many doctors believe giving patients potassium helps\nprevent these irregular heartbeats. However, there is no scientific evidence that such\ntreatment works. Potassium can also be unpleasant for patients to take and expose\npatients to additional risk. The aim of this study is to investigate whether it is necessary\nto administer additional potassium to prevent fast, irregular heartbeats after heart\nsurgery. Maintaining potassium levels at the high end of the normal range is the current\nstandard care for these patients.\nThe patients approached for this trial would be scheduled to have coronary artery\nbypass graft (CABG) surgery at participating NHS hospitals. This trial builds on a\nprevious feasibility study, which operated with s251 support under the reference\n17/CAG/0087. The feasibility study tested the recruitment methodology which will be\noperated in this larger scale trial. Members of the research team would screen patients\nfor suitability and make the initial approach about the study. The applicants were seeking\nsupport to use the same methodology in this larger-scale trial. Patients would be\napproached by a member of the research team when they attended clinic prior to\nsurgery. If they are happy to take part, they would be asked to sign a consent form at a\nclinic visit or when admitted for surgery. As in the feasibility study, screening will be\nlimited to delegated members of the local research team.\nA recommendation for class 3 and 6 support was requested to cover access to the\nrelevant unconsented activities as described in the application."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Prof Benjamin O'Brien, Professor of Perioperative Medicine / Consultant in Intensive Care Medicine and Cardiac Anaesthesia\n"]
["Address","Barts Health NHS Trust, Department of Perioperative Medicine"]
[null,"St Bartholomew's Hospital"]
[null,"London"]
["Postcode","EC1A 7BE"]
["Telephone",7813608428]
["Email","ben.obrien@bartshealth.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1684 patients aged 18 years and over, undergoing isolated\ncoronary artery bypass grafting (CABG) surgery"]
["Description of confidential patient information used","Data sources\nMedical records held within participating Trusts\nIdentifiers required for linkage purposes\n1. Name\n2. Hospital ID number\n3. Date of birth\n4. Postcode – district level\nIdentifiers required for analysis purposes\n1. Hospital ID number"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-05"]
["Next Review Date","2024-11-05"]
["Notes","Conditions of support:\n1. Favourable opinion from REC (Confirmed 16 August 2019)\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. (Confirmed – Bart’s Health NHS Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 19 September 2019). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02423","index":466,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02443"]
["Reference","19/CAG/0086"]
["Other Refs","IRAS project ID: 262692, REC reference: 19/EE/0143"]
["Application Title","Pre-operative CPEX and 90-day mortality after oeosphagectomy"]
["Application Summary","This application from the Norfolk and Norwich University Hospitals NHS Foundation\nTrust set out the purpose of medical research to determine whether a fitness test\nprior to surgery to treat oesophageal cancer can identify patients most at risk of\ndying.\nIn the UK, 25 people are diagnosed with oesophageal cancer every day, but only\nthree will be still be alive within five years. Surgery can cure oesophageal cancer.\nHowever, out of 100 people who undergo surgery, four die within the first three\nmonths. Fitter patients may have a better chance of surviving their operation. The\napplicants seek to determine if a single exercise bike test before surgery can\nidentify the patients most at risk of dying and if improving the fitness level of\npatients can help them to survive after surgery.\nTo measure this association, the applicants will use a national audit dataset, the\nNational Oeosphago-gastric Cancer Audit (NOGCA) held by NHS Digital, which has\ninformation on all oesophagectomies undertaken in the UK. NHS Digital will be\nasked to provide NHS numbers of patients to be included in the dataset. All other\nvariables will relate to their clinical care e.g. date of operation and histology of their\noesophageal cancer.\nThis dataset will allow the applicants to identify all oesophagectomies undertaken in\nthe UK between 2012 to 2018 by hospital site. NOGCA does not measure CPEX\nscores. Therefore, the only way to link oeosphagectomy patients with their CPEX\ndata is to use their NHS number as an identifier. The NHS number will be given to\nthe care team of the patient at each hospital, so the care team can link the dataset\nwith CPEX values. Each participating site will receive a login for REDCap, which will\nhave a list of NHS numbers requiring CPEX data to be linked. Once the applicants\nreceive this data from each site, the NHS number will be removed and the dataset\nwill be anonymised for subsequent data analyses. If 90-day mortality data is\nmissing from NOGCA, the local participating NHS site may be asked to supply this.\nBy analysing the subsequently anonymised data, the applicants will determine\nwhether CPEX scores (fitness) are associated with 90-day risk of death.\nA recommendation for class 1, 4 and 6 support was requested to cover the activities\nas described in the application."]
["Applicant Organisation Name","Norfolk and Norwich University Hospitals NHS Foundation Trust"]
["Contact Name","Professor Andrew Hart"]
["Address","Norfolk and Norwich Hospital, Department of Gastroenterology"]
[null,"Colney Lane"]
[null,"Norwich"]
["Postcode","NR4 7UY"]
["Telephone",1603287408]
["Email","andrew.hart@nnuh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients between the ages of 18 and 100 who underwent an\noesophagectomy between 1 April 2012 to 31 March 2018. Cohort size is 3278\npatients."]
["Description of confidential patient information used","The following items of confidential patient information are requested the purposes\nset out below:\n• NHS Number – sample validation and linkage\n• Hospital in which the operation was performed – sample validation, linkage\nand analysis\n• Date of death – analysis\n• Gender – analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-11-05"]
["Next Review Date","N/A"]
["Notes","The applicant confirmed in July 2023 that ‘s251’ support is no longer required. The project did not commence due to Covid-19 related pressures and the retirement of the Chief Investigator.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 10 May 2019\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. (Confirmed: Norfolk and Norwich University Hospitals NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 30 October 2019).\n"]

{"sheet":"A02424","index":467,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02424"]
["Reference","19/CAG/0150"]
["Other Refs","IRAS project ID: 260986, REC reference: 19/EE/0263"]
["Application Title","Long-term vascular complications in young people with childhood-onset type 1 diabetes"]
["Application Summary","This application from the University of Cambridge set out set out the purpose of medical research that seeks to determine the prevalence of diabetic nephropathy, retinopathy, neuropathy and cardiovascular events, as well as mortality rates in adults with childhood-onset Type 1 diabetes (T1D). The overall aim of this project is to obtain data on complication outcomes in young adults with T1D, who were previously recruited to two cohort studies and extensively studied during childhood and adolescence.\nType 1 diabetes is associated with an increased risk of developing long-term micro- and macro-vascular complications, affecting the kidneys, eyes and cardiovascular system. Risk of these complications is higher in people who develop T1D before the age of 16 years, compared to people who develop the disease during adult life. There is little data on the prevalence of these complications during adult life in people with an early diagnosis of T1D and limited knowledge as to which are the main risk factors during childhood and adolescence influencing the long-term risk for developing complications.\nThe main applicant previously ran the Oxford Regional Prospective Study (ORPS), Nephropathy Family Study (NFS) and the UK Genetic Resource Investigating Diabetes (GRID) studies, which took place between 1986 and 2005. Patients in these studies gave consent for the collection, storage and use of their data, including blood, urine and DNA samples, for the purpose of studying diabetes and its complications. Following discussion with NHS Digital and HQIP regarding linkages to the National Diabetes Audit (NDA) and National Paediatrics Diabetes Audit (NPDA), HES and ONS data, it was determined that the consent given for the original studies was not valid for the proposed data linkages. Support under the Regulations was sought to legitimise this processing.\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Loredana Marcovecchio"]
["Address","University Department of Paediatrics"]
[null,"Level 8, Box 116,"]
[null,"Cambridge Biomedical Campus, Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223 769291"]
["Email","cad50@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and over who were recruited into the\nOxford Regional Prospective Study, Nephropathy Family Study and the UK Genetic Resource Investigating Diabetes. Recruitment took place between 1986 and 2005.\n10647 patients will be included."]
["Description of confidential patient information used","Data sources\n1. Study databases for the Oxford Regional Prospective Study (ORPS), Nephropathy Family Study (NFS) and UK Genetic Resource Investigating Diabetes (GRID), held at University of Cambridge\n2. The National Diabetes Audit held by NHS Digital\n3. HES and ONS datasets held by NHS Digital\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of Birth\n3. Study specific ID\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – unit level\n4. Gender\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-12"]
["Next Review Date","2024-11-12"]
["Notes","23 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - National Diabetes Audit, HES and Civil registration mortality data\n\nAmendment supported 11 January 2023:\nTo change the Chief Investigator from Professor David Dunger, to Dr Loredana Marcovecchio\n\nSpecific conditions of support\n1. Favourable opinion from REC. Confirmed 28 October 2019.\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. (Confirmed – University of Cambridge – School of Clinical Medicine (by NHS Digital e-mail 09 June 2019) and NHS Digital (by NHS Digital email 10 June 2019) have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02425","index":468,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02425"]
["Reference","19/CAG/0104"]
["Other Refs","IRAS project ID: 212034, REC reference: 17/NE/0080"]
["Application Title","OPTIPREM: Optimising neonatal service provision for preterm babies born between 27 and 31 weeks of gestation in England using national data, qualitative research and economic analysis."]
["Application Summary","This application from the Royal Wolverhampton NHS Trust set out the purpose of\nmedical research to determine if babies born at 27-31 weeks of gestation and admitted\nto a Neonatal Intensive Care Unit (NICU) show improved survival and reduced major\nmorbidity compared to babies admitted to a Local Neonatal Unit (LNU).\nIt was explained that new evidence had shown that for babies born at between 23 and\n26 weeks, care in one of two types of neonatal units, NICU, as compared to an LNU\nimproves survival to discharge. In contrast, there is no evidence to guide location of care\nfor the next most vulnerable group, babies born between 27 and 31 weeks, whose care\nis currently spread between 45 NICU and 84 LNU in England. This group accounts for\nfour times more neonatal unit admissions than those born at 23 to 26 weeks, and 12% of\nall preterm births in England. The primary objective in this study is to assess, for babies\nborn at 27 to 31 weeks and admitted to a neonatal unit, whether care in a NICU versus a\nLNU impacts on survival and key morbidities up to two years of age at each gestational\nage in weeks.\nThe project will analyse routinely recorded data extracted from real-time, point-of-care\npatient management systems and held in the National Neonatal Research Data (NNRD),\nHospital Episode Statistics (HES) and Office for National Statistics (ONS).\nInformation on all admissions to NHS neonatal units in England, Wales and Scotland are\nheld in the National Neonatal Research Database (NNRD), established and managed at\nthe Neonatal Data Analysis Unit (NDAU), an academic research group from Imperial\nCollege London, which is based within the Chelsea and Westminster Hospital NHS\nFoundation Trust. Project-specific objections will be applied to the dataset by the NNRD,\nfollowing which, confidential patient information relating to the study cohort will be\ndisclosed to NHS Digital. NHS Digital will apply any national opt-outs and undertake\nlinkage to HES and ONS data for up to two years. Pseudonymised linked data will then\nbe returned to NDAU to be linked with its data. The linked pseudonymised data will then\nbe distributed by NDAU to the Opti-Prem teams working at the Universities of Leicester\nand Oxford.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Royal Wolverhampton NHS Trust"]
["Contact Name","Dr T Pillay, Clinical Lead Neonatologist, Royal Wolverhampton NHS Trust"]
["Address","Royal Wolverhampton NHS Trust"]
[null,"New Cross Hospital"]
[null,"Wolverhampton"]
["Postcode","WV10 0QP"]
["Telephone","07791936718"]
["Email","tilly.pillay@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","30,000 male and female pre-term babies, aged 27+0 to 31+6 weeks, born in England and admitted to neonatal units, and whose records are held in the National Neonatal Research database, between 01/01/2014 and 31/12/2018."]
["Description of confidential patient information used","Data sources\n1. The National Neonatal Research Database (NNRD), held by Chelsea & Westminster Hospital NHS Foundation Trust,\n2. HES and ONS data held by NHS Digital\nIdentifiers required for linkage purposes\n1. NHS number\n2. Hospital ID number\n3. Date of birth\n4. Date of death\n5. Postcode – unit level\n6. Date of event\n7. Age at event\n8. Type of event\n9. Type of care\n10. Hospital of care\n11. NHS number of mother\n12. Ethnicity of Mother\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – unit level\n4. Gender\n5. Ethnicity\n6. Date of admission and discharge from NIC/LNU\n7. Date of event up to second year of life\n8. Type of event\n9. Type of care received\n10. Hospital of care\n11. NHS number of mother"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-07"]
["Next Review Date","2024-11-07"]
["Notes","Amendment supported 11 October 2023 to extend the duration of support until 31 December 2027\n\nAs of 01 February 2023, NHS England replaced NHS Digital as data processor for the HES and ONS data sets.\n\n24 January 2020 – Amendment supported for OPTIPRIM to obtain postcode data from the National Neonatal Research Database in order to employ an instrumental variable method, comprised of the distance between the mother’s residential postcode and the\nnearest Neonatal Intensive Care Unit and Local Neonatal Unit, on the condition that the postcodes is destroyed within three months of the applicants’ receipt of this data. An amendment to revise work stream 2, so that unit questionnaires were no longer linked to the Opti-Prem database and literature evidence was used instead, was also supported. \n\nConditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 23 May 2019\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: NHS Digital and Chelsea & Westminster Hospital NHS Foundation Trust (provision of NHS Digital email on 4 November 2019) have confirmed ‘Standards Met’ assurance on DSPT 2018/19. "]

{"sheet":"A02426","index":469,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02426"]
["Reference","19/CAG/0160"]
["Other Refs","Resubmission: PIAG 3-07(g)/2002, IRAS project ID: 238962, REC reference: 02/1/064"]
["Application Title","BRCOH - Evaluation of the NHS Breast Screening Programme"]
["Application Summary","This application from the Queen Mary University of London set out the purpose of medical research which aims to evaluate the impact of the NHS Breast Screening Programme on breast cancer mortality in England and Wales. This is a longitudinal programme which had initially been carried out by the Cancer Screening Evaluation Unit and was transferred to the Queen Mary University of London in 2014. The study population comprised over 2 million women aged 49–64 in 1988. Individual-level breast screening histories have been linked to individual-level mortality and breast cancer incidence data from national registers. Risk of death from breast cancer has been investigated in relation to intention to screen and in first round screening attendance.\nThe applicants are now seeking support to flag the remainder of the cohort who have not been flagged previously in order to obtain up-to-date cancer incidence and mortality follow-up to conduct analysis on a longer-term basis. The objectives of this follow-up phase are to further assess the effectiveness of the screening programme by comparing risk of death from breast cancer in woman who were invited for screening with those who were not invited in the same period for follow-up over a 25-year period and wider objectives related to the impact of the screening programme on diagnosis of breast cancer.\nThe study database includes details of approximately 2.7 million women (n=2,669,328) born between 1923 and 1945, resident in the study area and eligible for at least one invitation by the NHSBSP between January 1988 and December 1994. The study area covered 22 Local Health Boards (LHBs) in Wales and 137 PCTs in England, and the study therefore included approximately 38% of the population of England and Wales who were eligible for invitation to NHS breast screening between these dates.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Professor Stephen Duffy, Professor of Cancer Screening "]
["Address","QMUL, Wolfson Institute of Preventive Medicine"]
[null,"Charterhouse Square"]
[null,"London"]
["Postcode","EC1M 6BQ"]
["Telephone","02078823535"]
["Email","s.w.duffy@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","2.7 million women (n=2,669,328) born between 1923 and 1945, resident in the study area and eligible for at least one invitation by the NHSBSP between January 1988 and December 1994. The study area covered 22 Local Health Boards (LHBs) in Wales and 137 PCTs in England."]
["Description of confidential patient information used","Data sources\n1. Study cohort, Queen Mary University of London\n2. ONS Cancer Registration and Mortality Data, NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Date of death\n5. Postcode\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode\n4. Sex"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-03-17"]
["Next Review Date","2024-03-17"]
["Notes","29 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Office for National Statistics (ONS) mortality data, and cancer registry data\n\nConditions of support:\n1. Patient name should be deleted from the dataset and destroyed. Confirmation should be provided at the time of next annual review that this condition has been met. \n2. The revised privacy notice, describing the patient objection mechanism, should be submitted alongside the next annual review for consideration. \n3. All wider specific conditions of support attached to the application under reference PIAG 3-07(g)/2002 remain valid. \n4. The pre-existing annual review cycle remains applicable, with the next annual review to be received four weeks before 17/03/2020, and then on an annual basis to this schedule.\n5. Favourable opinion from a Research Ethics Committee. Confirmed \n6. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: NHS Digital and Barts Cancer Centre both have confirmed ‘Standards Met’ grades on DSPT 2018/19 (Confirmed on DSPT tracker 10 September 2019)."]

{"sheet":"A02427","index":470,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02427"]
["Reference","19/CAG/0118"]
["Other Refs","IRAS project ID: 140998, REC reference: 19/LO/0994"]
["Application Title","The Orchid Research Tissue Bank - Collection of Genito-urinary tissue"]
["Application Summary","This application from Barts Health NHS Trust set out the purpose of medical research through the ongoing management of the Orchid Research Tissue Bank. The tissue bank collects genito-urinary tissue. The collection includes fresh frozen and formalin fixed paraffin embedded tissue (FFPE) of prostate, testis, penile, kidney and bladder. The tissue collected are anonymised using specific ORTB ID codes breaking the link with patient identification details.\nThis tissue bank has operated under a favourable ethical opinion since 2004. However, at the point of renewal, the applicant had made changes to the process by which patients are identified to be approached for consent to have their tissue and data included within the tissue bank. The applicants are seeking support under the Regulations to allow access by up to four members of the tissue banks designated staff to access the medical records of patients being treated by, together with clinic lists of, urology consultants to enable potentially eligible patients to be identified for consent to participate in the tissue bank. The specific focus of this is to identify prostate cancer patients who may be eligible for inclusion.\nA recommendation for class 1, 3, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Professor Daniel Berney (Principal Investigator for The Robert Lane Tissue Bank) "]
["Address","The Robert Lane Tissue Bank (RLTB), Centre for Molecular Oncology                        "]
[null,"Barts Cancer Institute, Joseph Rotlat Building"]
[null,"Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone","020 7882 3551 "]
["Email","daniel.berney@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"|Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients diagnosed with or suspected urological cancers at Barts Health NHS Trust."]
["Description of confidential patient information used","Data sources\n1. Electronic Patient Records at Barts Health NHS Trust\n2. Urological clinic lists at Barts Health NHS Trust\n3. Care Record Service records at Barts Heath NHS Trust\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital Number\n4. Date of birth\n5. Ethnicity\n6. Gender\nIdentifiers required for analysis purposes\n1. Name\n2. Date of birth\n3. Date of death\n4. Gender\n5. Ethnicity\nAdditional information\nData would only be retained for analysis with patient consent."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-08"]
["Next Review Date","2024-11-08"]
["Notes","Conditions of support:\n1. Favourable opinion from REC. Received 06 November 2019\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Barts Health NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02428","index":471,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02428"]
["Reference","18/CAG/0204"]
["Other Refs","IRAS project ID: 244694, REC reference: 18/SS/0138"]
["Application Title","When to suspect Cauda Equina Syndrome in patients presenting to the Emergency Department with back pain"]
["Application Summary","This application from the University of Birmingham set out the purpose of medical research which aims to investigate whether there is any difference in presenting symptoms for patients who received an MRI scan to assess for potential Cauda Equina Syndrome, which is compression of the lower spinal cord, between patients who received a positive and negative diagnosis in order to assess whether there are features which are more specific to a positive diagnosis.\nThe student applicant will retrospectively review patient records of those who underwent an MRI scan following presentation at the emergency department, for suspected cauda equina syndrome over a two year period. Access to the full patient record is required to enable a pseudonymised dataset to be extracted for analysis.\nA recommendation for class 1, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Mrs Rosalie Alpine"]
["Address","Flat 4 Cunningham Court"]
[null,"Cunningham Park"]
[null,"Harrow"]
["Postcode","HA1 4QN"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort consists of patients presenting to the Emergency Department at London North West Healthcare NHS Trust with back pain and neurological signs or symptoms for suspected cauda equina syndrome, who underwent an MRI scan over a two year period between 2016 and 2018."]
["Description of confidential patient information used","Access is required to the full hospital record to enable relevant clinical details to be extracted for analysis. The analysis dataset would not include any items of confidential patient information."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-01-29"]
["Next Review Date","N/A"]
["Notes","This application reference expired with effect from 07/07/2019.\n\nSpecific conditions of support (Confirmed)\n1. Project-specific patient and public involvement and engagement activity should be carried out to test the acceptability of using confidential patient information without consent for the study purposes. Feedback from this activity is required within six months of support coming into effect. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Favourable opinion from a Research Ethics Committee (Confirmed).\n3. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – London North West Healthcare NHS Trust has a published satisfactory reviewed grade on V14.1 2017/18)."]

{"sheet":"A02429","index":472,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02429"]
["Reference","19/CAG/0191"]
["Other Refs","IRAS project ID: 254207, REC reference: 19/NW/0627"]
["Application Title","Glucocorticoid induced adrenal suppression in the UK and Ireland"]
["Application Summary","This application from Newcastle University set out the purpose of medical research that seeks to determine how many patients present to healthcare providers with adrenal suppression (AS) due to current or previous use of glucocorticoid (GC) medication.\nGlucocorticoids are steroid hormones produced by the adrenal glands. Natural GCs keep the body working normally and deal with the stress of trauma and infections. GCs are often used to treat diseases in children, such as eczema, asthma or arthritis, and medication can be applied to the skin, inhaled or swallowed. The absorption of large amounts of GC medication can prevent patients from producing GC naturally, which is known as adrenal suppression (AS). This can be a particular problem if a patient has an infection, as natural GC would usually be produced as part of the stress response. If additional GC is not given at this time to patients with AS, then they may become very unwell and develop adrenal crisis, which can be fatal. Health professionals may not remember that GC medication can prevent natural GC production and that additional GC may be needed. AS may also persist if a patient has recently stopped taking GC medication. The applicants will investigate how commonly children present at hospital due to AS in order to develop ways of preventing adrenal crisis.\nThe study will be conducted retrospectively using British Paediatric Surveillance Unit (BPSU) methodology. Paediatricians will be contacted via BPSU and asked if they have seen a patient aged under 16 years with AS caused by GC medication. If the paediatrician reports such a case, they will be sent an in-depth questionnaire regarding the patient and their presentation to healthcare professionals. The questionnaire can be returned via REDCap software, returning the questionnaire via secure NHS.net email addresses or by post. The questionnaire data will be pseudonymised at the earliest opportunity. The applicants will also obtain HES data relating to cases of drug induced adrenocortical insufficiency, in order to gauge the size of the at-risk population. The data supplied by HES will be aggregated.\nOnly summary data regarding age, gender and ethnicity of identified individuals will be used in any presentations or publications.\nA recommendation for class 2, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Tim Cheetham"]
["Address","Office Block 1, Level 3,"]
[null,"Royal Victoria Infirmary,"]
[null,"Newcastle-upon-Tyne"]
["Postcode","NE1 4LP"]
["Telephone","0191 282 9562"]
["Email","tim.cheetham@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and under treated or recently treated with glucocorticoid therapy who has adrenal suppression in England.\nIt was expected 30-40 cases per year would be reported Across the 25-month reporting period."]
["Description of confidential patient information used","Data sources\n1. Medical records at participating Trusts in England.\n2. HES data held by NHS Digital\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n3. Postcode – unit level\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Postcode – unit level\nAdditional information\nThe HES data provided by NHS Digital will be in aggregated form only."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-11-19"]
["Next Review Date"]
["Notes","Applicant confirmed in March 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant does not have the means to re-identify\n\nIn terms of public benefit, a peer reviewed publication being prepared - this will include information about the incidence of glucocorticoid induced adrenal suppression and the circumstances leading to its development.  This information can be used as a platform for education tools in future. \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 07 November 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: Newcastle University (by NHS Digital email 05 July 2019) and NHS Digital (by NHS Digital email 10 June 2019)."]

{"sheet":"A02430","index":473,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02430"]
["Reference","19/CAG/0094"]
["Other Refs","IRAS project ID: 241475, REC reference: 19/LO/0906"]
["Application Title","A national mixed methods study to evaluate whether out of hospital oral anticoagulation programs for children and young people with congenital heart disease are safe, high quality and effective."]
["Application Summary","This application from Great Ormond Street Hospital for Children NHS Foundation Trust set out the purpose of medical research which aims to evaluate whether out of hospital oral anti-coagulation programs for children and young people with congenital heart disease are safe, high-quality and effective.\nThe study will be carried out in three phases. The second phase involves a review of patient records across the 10 national children’s heart disease service centres. This element of the study has been described in the application as a national audit of children receiving out of hospital oral anti-coagulation treatment programs, in order to create a baseline for the purposes of this research study. This activity is being undertaken solely for the purposes of this research application and does not have any non-research audit purposes.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Great Ormond Street Hospital for Children NHS Foundation Trust"]
["Contact Name","Ms Liz Smith, Lead Advanced Nurse Practitioner \nRoom D3008, Level 3, West Link, \nGreat Ormond Street NHS Foundation Trust. \n34 Great Ormond Street, London\nWC1N 3JH\nTel: 0207 405 9200 ext 5955\nEmail: liz.smith@gosh.nhs.uk"]
["Address","Room D3008, Level 3, West Link, "]
[null,"Great Ormond Street NHS Foundation Trust."]
[null,"34 Great Ormond Street, London"]
["Postcode","WC1N 3JH"]
["Telephone","0207 405 9200 ext 5955"]
["Email","liz.smith@gosh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children aged over four months, and young people in England with congenital heart disease on oral anticoagulation medication (warfarin) for more than four months and discharged home. There are estimated to be 300 eligible patients to be included in the sample."]
["Description of confidential patient information used","Data sources\n1. Electronic Health records held within 10 specialist children’s heart disease centres in England.\nIdentifiers required\n1. Name\nfor linkage purposes\n2. Hospital Number\n3. Date of birth\nIdentifiers required for analysis purposes\n1. Age\n2. Gender\n3. Ethnicity\n4. County or similar geographical boundary\nAdditional information\nThe application also involves two wider phases:\n• Parent/patient interviews – the applicant will not have any access to confidential patient information for this element prior to consent. This element is out of scope of the CAG application.\n• Parent/parent questionnaire – distribution of the questionnaires will be undertaken by site-based members of the clinical team. This element is out of scope of the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-15"]
["Next Review Date","2022-11-15"]
["Notes","Conditions of support:\n1. Favourable opinion from REC Received 24 October 2019\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Not checked due to the number of sites involved. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]

{"sheet":"A02431","index":474,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02431"]
["Reference","19/CAG/0144"]
["Other Refs","Resubmission of ECC 5-07(a)/2009, IRAS project ID: 261853, REC reference: 14/SC/1069"]
["Application Title","Infections in Oxfordshire: a Research Database (IORD)"]
["Application Summary","This application from the Oxford University Hospitals NHS Foundation Trust set out the medical purpose of medical research via the ongoing maintenance of the Infections in Oxfordshire Research Database (IORD), which collects information on the treatment of infection in Oxfordshire. This application has operated within support under the Regulations since October 2009 under the CAG reference ECC 5-07(a)/2009.\nThe primary aim of the database is to use routinely recorded electronic data on hospital administration records, electronic medical records, pathology tests, radiology and other imaging data to prospectively investigate predictors of and instances of infection and infection-associated syndromes within Oxfordshire from 1998. This will also include investigating trends, the severity of presentation and any adverse outcomes following the infection. This also includes investigation of incidence of and outcomes following infection in populations particularly at risk of infections, including, for example, those with cancer or chronic kidney disease.\nThe database links together a wide range of standard healthcare records from Oxford University Hospitals Foundation NHS Trust for inclusion in the database. These include patient administration records, pathology records, clinical assessments, electronic prescribing, data interactions with primary care, Oxford maternity database and infection control databases which are linked within the Oxford University Hospitals Clinical Systems Data Warehouse. Once linked, a dataset is disclosed to the Infections in Oxfordshire Research Database, which is held within a separate NHS server. Limited items of confidential patient information are included within the dataset disclosed to the research database for the purposes of informing analysis datasets.\nA recommendation for class 1, 2 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Ann Sarah Walker, Professor of Medical Statistics and Epidemiology"]
["Address","University of Oxford"]
[null,"Microbiology Level 7 Research, John Radcliffe Hospital"]
[null,"Headley Way, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","(0)1865 220851"]
["Email","sarah.walker@ndm.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients admitted/attended Oxford University Hospitals NHS Foundation Trust as an inpatient, outpatient, at A&E or who provided a specimen to be processed within the pathology laboratories from 01 January 1997 onwards. It is estimated that approximately 4 million patients are included in the database."]
["Description of confidential patient information used","Data sources\n1. Oxford University Hospitals Clinical Systems Data Warehouse (OUH CSDW)\nIdentifiers required for linkage purposes\nNo identifiers are needed for validation or linkage. Linkage is carried out by Oxford University Hospitals Clinical Systems Data Warehouse (OUH CSDW)\nIdentifiers required for analysis purposes\n1. IORD identifier\n2. Date of birth (MM/YY format)\n3. Date of death\n4. Gender\n5. Ethnicity\n6. Electoral ward\n7. Postcode district\n8. GP practice code\n9. Strategic health authority"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-10-07"]
["Next Review Date","2024-10-07"]
["Notes","28 September 2020 - Specific conditions of support (updated):\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. Oxford University Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\nConditions of support:\n1. All pre-existing conditions of support related to ECC 5-07(a)/2009 remain applicable.\n2. The pre-existing annual review cycle remains applicable, with the next annual review to be received 4 weeks before 07/10/2020, and then on an annual basis to this schedule.\n3. Favourable opinion from REC Received 07 October 2019 \n4. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Oxford University Hospitals NHS Foundation Trust – NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. As a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data."]

{"sheet":"A02432","index":475,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02432"]
["Reference","19/CAG/0173"]
["Other Refs","IRAS project ID: 260317, REC reference: 19/SC/0465"]
["Application Title","Critical illness related cardiac arrest (CIRCA): an investigation of the incidence and outcome of cardiac arrest within Intensive Care Units in the United Kingdom."]
["Application Summary","This application from North Bristol NHS Trust set out the purpose of medical research which aims to gain a wider understanding on prevalence and outcomes of patients who experience cardiac arrest whilst a patient in an intensive care unit.\nData is currently collected via national clinical audit programmes, which operate with support under the Regulations, in relation to patients who experience cardiac arrest (National Cardiac Arrest Audit, ECC 2-06(n)/2009) and intensive care patients (Case Mix Programme PIAG 2-10(f)/2005). Both audit programmes are operated by the Intensive Care National Audit and Research Centre (ICNARC). However, these audits do not capture data on patients who suffer a cardiac arrest whilst within an intensive care unit.\nAll sites which participate in the Case Mix Programme will be invited to participate. This study will utilise data from the two established audit programmes to identify a cohort of patients who suffered a cardiac arrest whilst within intensive care, for those sites which agree to participate. ICNARC will utilise data which is collected in the Case Mix Programme to facilitate linkage with the National Cardiac Arrest Audit. Once linked, confidential patient information will be disclosed to NHS Digital in order to facilitate linkage with ONS Mortality information.\nThe study has a secondary element which aims to follow-up quality of life and wellbeing of patients who survive cardiac arrest in intensive care at 3, 6 and 12 months following this incident. Patients will also be invited to ask a family member or friend who cared for them whilst in the intensive care unit to participate also. This element of the study will be undertaken on a consented basis. There is a lack of clarity around how these patients would be invited and whether access to confidential patient information will be accessed by researchers onsite at the participating Trusts. It is also unclear whether, for the cohort of patients who survive, whether consent can be sought for the data linkage which would be undertaken via NHS Digital.\nA recommendation for class 2, 3, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","North Bristol NHS Trus"]
["Contact Name","Dr Matt Thomas, Consultant in Intensive Care Medicine"]
["Address","Southmead Hospital"]
[null,"Bristol"]
[]
["Postcode","BS10 5NB"]
["Telephone",7551399000]
["Email","matt.thomas@nbt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 and over who suffer a cardiac arrest whilst being treated within an intensive care unit across 80 sites in England and 15 sites in Wales from December 2019 for 12 months. It is estimated that 1320 patients will be included in the study."]
["Description of confidential patient information used","Data sources\n1. Hospitals records at participating intensive care units\n2. National Cardiac Arrest Audit, ICNARC\n3. Case Mix Programme records, ICNARC\n4. ONE Mortality Data, NHS Digital\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Date of death\n4. Postcode (unit level)\n5. Case Mix Programme ID\n6. Sex\nIdentifiers required for analysis purposes\n1. Date of death\n2. Lower Layer Super Output Area (LSOA) – derived from postcode\n3. Sex\n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-15"]
["Next Review Date","2024-11-15"]
["Notes","Amendment supported 27 November 2023 to extend the duration of support until 7 October 2024\n\n23 February 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES) and ONS mortality data.\n\nAmendment supported 23 February 2023 \n\nTo extend the duration of support until 02 October 2023\n\n16 April 2021 - Amendment supported:\nThe amendment, to extend the duration of support until 4 October 2022, is supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 23 September 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed as follows:\n• Intensive Care National Audit and Research Centre (ICNARC) has a confirmed ‘Standards Met’ grade on DSPT 2018/19 – confirmed 29/05/2019 via DSPT tracker.\n• NHS Digital has a confirmed ‘Standards Met’ grade on DSPT 2018/19.\n• Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application.  Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02433","index":476,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02433"]
["Reference","19/CAG/0019"]
["Other Refs","IRAS project ID: 246849, REC reference: 18/YH/0449"]
["Application Title","Button Batteries: The unintentional ingestion, inhalation or insertion of button batteries in children requiring removal or attempted removal"]
["Application Summary","This application from the Leeds Teaching Hospitals NHS Foundation Trust set out the\npurpose of medical research which aims to investigate the prevalence and severity of injury\ncaused to children who have accidentally ingested or inhaled button batteries. Button\nbatteries are small, round batteries used to power devices such as toys and greetings\ncards.\nThe study will operate via the approved BPSU methodology: the BPSU ‘orange card’\nreporting system, which is approved in principle by the CAG. All UK and Ireland\npaediatricians participate in the compulsory reporting system over a 13 month period,\nwhere they are asked to return a card to BPSU stating whether or not they have observed\na case of the disease under observation (in this case button battery ingestion or inhalation).\nBPSU then provides details of clinicians who have reported a case of the disease to the\nresearch team, who send a questionnaire for the clinician to fill in.\nThe study consists of single questionnaire which will be returned by the treating clinician.\nLimited confidential patient information would be collected to facilitate sample validation\nand to remove any duplicate entries, following which confidential patient information would\nbe destroyed.\nThe BPSU methodology covers the UK and Republic of Ireland; however, the remit of the\nCAG extends to information generated in England and Wales only. The applicant will need\nto make alternative arrangements for the wider nations involved in the study. The applicant\nhas confirmed that an application is being made to the PBPP in Scotland.\nA recommendation for class 1, 2, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Dr Suvradeep Basu, Paediatric Emergency Medicine Fellow"]
["Address","Leeds Teaching Hospitals NHS Trust"]
[null,"X38 Jubilee Wing"]
[null,"Great George Street, Leeds"]
["Postcode","LS1 3EX"]
["Telephone","0113 3928537"]
["Email","suvradeep.basu4@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any presentation of any child under the age of 16 years who has ingested or aspirated a button battery of any description requiring hospital admission (including A&E) including those that were admitted for only observation across the 13-month reporting period. It is anticipated that 300 cases will be reported to the study."]
["Description of confidential patient information used","Data sources\n1. Electronic hospital records from participating Trusts in England and Wales.\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n3. Date of death\n4. Postcode (district level)\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode (district level)\n4. Sex\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-18"]
["Next Review Date","2020-11-18"]
["Notes","Specific conditions of support (Final)\n1. Support extends to England and Wales only.\n2. Favourable opinion from a Research Ethics Committee (Confirmed 03 December 2018).\n3. Confirmation from the IG Delivery Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission (Confirmed: Leeds Teaching Hospitals NHS Trust has a ‘Standards Met’ grade on DSPT 2018/19 via tracker 11 November 2019)."]

{"sheet":"A02434","index":477,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02434"]
["Reference","19/CAG/0023 "]
["Other Refs","IRAS project ID: 253951, REC reference: 19/NW/0034"]
["Application Title","Naevoid Melanoma: Prognosis between two subtypes"]
["Application Summary","This application from the Royal Surrey County Hospital set out the purpose of medical research which aims to investigate whether there is a prognostic difference between two sub-types of naevoid melanoma. These comprise of papillomatous and maturing naevoid melanomas, both with distinct clinical, histopathological and immune-histochemical features that may also be prognostically significant.\n\nThe eligible patient cohort will be identified from records and sample slide review by the Chief Investigator at the Royal Surrey County Hospital. Once the patient cohort has been identified, wider patient records will be accessed by the named study coordinator in order to extract wider clinical information for analysis and to enable patient outcomes to be followed up with their referring clinician. Support is requested under the Regulations to extend to the study coordinator’s access to confidential patient information, as this individual is not deemed to be part of the direct care team. \n\nA recommendation for class 1, 4 and 6 support was requested to cover activities as described in the application. "]
["Applicant Organisation Name","Royal Surrey County Hospital "]
["Contact Name","Professor Martin Cook, Consultant Histopathologist"]
["Address","Royal Surrey County Hospital"]
[null,"Guildford"]
[]
["Postcode","GU2 7XX"]
["Telephone",1483464065]
["Email","m.cook@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 and over who have been diagnosed with naevoid melanoma, following treatment at the Royal Surrey County Hospital. 151 patients would be included in the study, identified retrospectively between 01/04/2004 and 30/06/2017. "]
["Description of confidential patient information used","Data sources\n1.\tPathology records, Royal Surrey County Hospital\n2.\tElectronic and paper medical records, Royal Surrey County Hospital \nIdentifiers required for linkage purposes \n1.\tName \n2.\tNHS Number \n3.\tHospital ID \n4.\tGP Registration (Name and Address) \n5.\tDate of birth\nIdentifiers required for analysis purposes \n1.\tDate of birth (MM/YY format)\n2.\tDate and cause of death (calculated to age) \n3.\tSex "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the analysis is still in the process of being undertaken\n\n\n09 October 2020 - Amendment conditionally supported\nThe amendment to support the disclosure of confidential patient information of patients diagnosed with naevoid melanoma between January 2004 to July 2017 at Royal Surrey County Hospital NHS Trust from the hospital to NHS Digital, for the purposes of linkage with ONS mortality data held by NHS Digital, is conditionally supported.\n\nSpecific conditions of support:\n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n\nConfirmed: NHS Digital have equivalent security assurances for 2018/19. \n\nThe 2018/19 NHS Digital DSPT review for Royal Surrey County Hospital NHS Trust was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 08 September 2020). Please note the updated specific condition of support below.\n\nAll staff at Royal Surrey County Hospital NHS Trust that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\nConditions of support:\n\n1.\tFavourable opinion from REC. Confirmed: 10 October 2019.\n\n2.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Royal Surrey County Hospital NHS Trust – NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training (NHS Digital email 28 November 2019). \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02435","index":478,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02435"]
["Reference","19/CAG/0164"]
["Other Refs","IRAS project ID: 214031, REC reference: 19/LO/1396 "]
["Application Title","Investigation of gender mortality differences in children admitted to UK Paediatric Intensive Care Units"]
["Application Summary","This application from the University College London Great Ormond Street Institute of Child Health set out the purpose of medical research that seeks to investigate why girls admitted to Paediatric Intensive Care Units (PICU) in England and Wales have a higher mortality rate than boys. \n\nPrevious, small-scale studies had shown that infant girls may have higher mortality than infant boys in PICU. The applicants had previously carried out an analysis of all babies aged 0-12 months admitted to PICU’s over an 11-year period. The rates of death between girls and boys during their admission to PICU were compared and it was found that girls had a higher death rate than boys. This differed from the general population, where infant boys had a higher death rate than infant girls. The applicants intend to examine these findings in greater detail. \n\nSupport is sought for data from PICAnet for all children aged 0-17 years of age who have been admitted to PICU to be disclosed to NHS Digital for the purposes of linkage with HES and ONS mortality data. A pseudonymised dataset, “Dataset A,” will be created and sent to the study team based at the UCL GOS Institute of Child Health. NHS Digital will also provide UCL with a pseudonymised dataset of maternity data from HES. UCL will then link the pseudonymised maternity data with Dataset A using probabilistic linkage.\n\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University College London Great Ormond Street Institute of Child Health "]
["Contact Name","Professor Bianca De Stavola"]
["Address","UCL GOS Institute of Child Health"]
[null,"Faculty of Population Health Science"]
[null,"30 Guilford Street"]
["Postcode","WC1N 1EH"]
["Telephone",7969417554]
["Email","o.almossawi@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 0 – 17 years admitted to a Paediatric Intensive Care Unit in the UK between 01 January 2010 and 31 December 2019. It is expected that around 90,000 patients would be included, once exclusions and repeat admissions had been accounted for."]
["Description of confidential patient information used","Data sources \n1.\tPICAnet national audit data for paediatric intensive care admissions\n2.\tHES and ONS data held by NHS Digital \n\nIdentifiers required for linkage purposes \n\n1.\tNHS number\n2.\tDate of birth\n3.\tDate of death\n4.\tPostcode – unit level \n\nIdentifiers required for analysis purposes \n\n1.\tDate of birth\n2.\tDate of death\n3.\tPostcode – District level\n4.\tGender \n5.\tOccupation\n6.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-11-21"]
["Next Review Date","2024-11-19"]
["Notes","16 January 2023 – amendment supported: \nTo allow the retention of patient dates of birth and death until 01 March 2025, and the retention of these dates converted to month and year only until 31 August 2026.\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January to extend the duration of support until 28 February 2023.\n\n31 July 2020 - Accepted notification of a clarified flow chart v3, and associated protocol v3. No changes to data flow or CAG support.\n\nSpecific conditions of support:\n1. Favourable opinion from REC Confirmed 19 September 2019.\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance\nrequirements’ for further information. It was confirmed that the relevant DSPT submission related only to NHS Digital."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02436"]
["Reference","19/CAG/0183"]
["Other Refs","IRAS project ID: 265862, REC reference: 19/NW/0513"]
["Application Title","Are children with a history of Cleft Palate and/or Lip from a non-English language speaking homes more susceptible to atypical speech sound errors at 3 and 5 years old?"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research that seeks to determine whether children with a history of Cleft Palate and/or Lip from a non-English language speaking homes more susceptible to atypical speech sound errors at 3 and 5 years old.\n\nIn primary schools the number of children believed to be exposed to a language other than English is 21.2%. A proportion of these children will also have been born with Cleft Palate or Lip and will make use of NHS cleft services. Previous research conducted had suggested that typically developing bilingual children may develop different rates of speech sound or phonological development compared to monolingual children, and that more advanced speech sound development was seen in bilingual groups. No research has previously been conducted into clinical speech outcomes for children born with cleft or lip palates, comparing the outcomes for children exposed to England at home and those exposed to non-English languages. \n\nThe applicant is seeking support to search records at Birmingham Children’s Hospital to identify patients who meet the inclusion criteria and to extract qualitative and quantitative data from speech assessment outcomes at 3 and 5 years. The extracted data will be stored in an anonymised format against a study ID number assigned to patients, and no confidential patient information will be extracted or retained. \n\nA recommendation for class 1 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Sheffield "]
["Contact Name","Miss Sophie Bourne"]
["Address","3 Clark Drive"]
[null,"Melton Mowbray"]
[]
["Postcode","LE13 1HU"]
["Telephone",1788555107]
["Email","sophie.bourne@swft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","200 children aged between 3 and 6 years of age with a history of cleft and/or lip palate born between 01 January 2011 and 31 December 2012 and treated and Birmingham Children’s Hospital. "]
["Description of confidential patient information used","Data sources \n1.\tElectronic and paper records held at Birmingham Children’s Hospital  \n\nIdentifiers required for linkage purposes \n\n1.\tName \n\nIdentifiers required for analysis purposes \n\nNo identifiers will be retained for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-11-22"]
["Next Review Date","N/A"]
["Notes","Only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete. \n\nUnfortunately the project wasn’t completed in full as we went into lock down of the March as I was collecting data.  However, there was a significant difference between my 2 groups at age 3 years so I am now adapting the Cleft Care pathway to offer more support for children with CLP from non English speaking homes.  \n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. (Confirmed 25 September 2019).\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed – Birmingham Women and Children’s Hospital NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 06 August 2019). "]

{"sheet":"A02437","index":480,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02437"]
["Reference","19/CAG/0185"]
["Other Refs","IRAS project ID: 257872, REC reference: 19/WM/0285"]
["Application Title","Understanding Multidisciplinary approaches and Parental Input in perinatal mortality Review  "]
["Application Summary","This application from the University of Leicester set out the purpose of medical research that seeks to explore how the implementation of the Perinatal Mortality Review Tool (PMRT) has influenced the multi-disciplinary approach to perinatal mortality review and engagement with bereaved parents.\n\nThe PRMT was introduced in 2018 as a web-based tool for maternity and neonatal units in England, Scotland and Wales to review all stillbirths, neonatal deaths and death of babies within the post-neonatal period who had received neonatal care. The PRMT was commissioned by the Healthcare Quality Improvement Partnership (HQIP) and led by MBRRACE-UK, in order to address inconsistencies in the incidence and quality of review carried out within and between hospitals when a baby died. In this study the applicants intend to explore how the introduction of the PMRT had affected whether the expertise of different healthcare professionals and the views of bereaved parents were included in the review. The aim is to inform professional guidelines around improved multi-disciplinary review and how to better support bereaved parents. \n\nThis is a multi-centre study using qualitative and ethnographic methodologies. Direct observations of perinatal mortality review meetings will be undertaken, as well as interviews with healthcare professionals and bereaved patients. The project is comprised of three stages.\n\nStage One – the researcher will observe a minimum of two perinatal mortality review meetings at each participating site in order to observe how the reviews are carried out by the healthcare professionals. This involves the incidental disclosure of confidential patient information to the researcher while observing. No confidential patient information will be recorded during these observations. \n\nIn Stages Two and Three the researcher will conduct face-to-face interviews with healthcare professionals involved in perinatal mortality review and with parents whose babies were stillborn or who died. Support under Section 251 is not required for these stages. \n\nA recommendation for class 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Leicester "]
["Contact Name","Mrs Joanne R W Dickens"]
["Address","Department of Health Sciences, George Davies Building, "]
[null,"University of Leicester"]
[null,"University Road, Leicester"]
["Postcode","LE1 7RH"]
["Telephone",1162297280]
["Email","jrwd1@leicester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","It is anticipated that between 5 to 12 eligible cases will be discussed per perinatal mortality review meeting.\n\nThe timeframe for inclusion in the study is not yet known, as it is dependent on when the observation period in each participating trust takes place.  "]
["Description of confidential patient information used","Data sources \n1.\tMaternal and neonatal medical details discussed during the perinatal mortality review meetings \n\nIdentifiers required for linkage purposes \nNo identifiers will be collected for linkage purposes \n\nIdentifiers required for analysis purposes \nNo identifiers will be retained for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-04"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as the UMPIRE study involved ethnographic observations where incidental disclosure would have taken place.  The UMPIRE study is now closed and so no further observations will be carried out.\n\nIn terms of public benefit, the observational activities undertaken within the UMPIRE Study were part of the Chief Investor’s qualitative research and exploration into the standardised review of care that takes place in NHS Trusts in England when a baby dies during pregnancy or shortly after birth.  This research will be published in her Thesis and will also contribute towards recommendations for healthcare professionals when undertaking review and how to improve communication and feedback to the parents of a baby who has died.\n\n25 August 2021 - amendment supported  to add Hampshire Hospitals Foundation Trust, University Hospitals of Leicester NHS Trust and University Hospitals Coventry & Warwickshire NHS Trust as new data processors, is supported, subject to compliance with the standard conditions of support.\n\n01 March 2021 - Amendment supported\nThe amendment, to add Newcastle upon Tyne Hospitals NHS Foundation Trust as a new data processor is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support \n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold: \n\nConfirmed: \nNewcastle upon Tyne Hospitals NHS Foundation Trust (RTD) has a confirmed ‘Standards Not Fully Met (Plan Agreed) grade on DSPT submission 2019/20 (by check of NHS Digital DSPT tracker on 01 March 2021). Please note the updated specific condition of support below.\n\nNewcastle upon Tyne Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n2. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed non substantial by email 10 November 2020\n\nConditions of support:\n\n1. Favourable opinion from REC. Confirmed 13 November 2019\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed – Kettering\nGeneral Hospital NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 20 November 2019.\n\n25 August 2021 - amendment supported to add Hampshire Hospitals Foundation Trust, University Hospitals of Leicester NHS Trust and University Hospitals Coventry & Warwickshire NHS Trust as new data processors"]

{"sheet":"A02438","index":481,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02438"]
["Reference","19/CAG/0190"]
["Other Refs","IRAS project ID: 263328, REC reference: 19/SW/0197"]
["Application Title","A prospective surveillance study of conservatively managed children with end-stage kidney disease in the United Kingdom and Republic of Ireland. "]
["Application Summary","This application from the Renal Association set out the purpose of medical research that seeks to identify incidences of new cases of children who progress to end stage kidney disease (ESKD) for whom a decision is made not to start long-term renal replacement therapy and instead manage their kidney disease conservatively.\n\nKidney disease is a major health problem for children, their families and the NHS. Progression to ESKD means that renal replacement therapy (RRT), as either dialysis or a kidney transplant, is considered. RRT offers a level of survival but isn’t a cure. Long-term treatment can also be burdensome and technically challenging, and conservative care may be a better option. Conservative care is active support of the kidney condition, without RRT, and may include palliative, end of life care. National registries collected information on children with ESKD receiving RRT, but not children with ESKD who were not receiving RRT. It was not known how many children were in the latter group within the UK, the kidney conditions they had and the reasons for opting for conservative care. The applicants aim to identify children who were progressing to ESKD who had not yet made a decision regarding long-term RRT. \n\nBritish Paediatric Surveillance Unit (BPSU) methodology will be used and cases reported through their e-card reporting system. Doctors are asked to identify patients aged 16 years and under who have progressed to ESKD and for whom a decision has been made to follow conservative care. The doctors will be asked to complete a questionnaire about the child and the care they received. A follow-up questionnaire will also be completed at 12-months. \n\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","UK Renal Registry, UK Kidney Association "]
["Contact Name","Lucy Plumb, Chief Investigator of study, Paediatric clinical research fellow "]
["Address","UK Kidney Association, Brandon House Building 20A1"]
[null,"Southmead Road"]
[null,"Filton, Bristol"]
["Postcode","BS34 7RR "]
["Telephone","07834 987966 "]
["Email","lucy.plumb@nhs.net  "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and under, diagnosed with End Stage Kidney Disease, who are receiving conservative treatment.\n\nThe number of patients managed conservatively would be similar or fewer to the number of patients receiving RRT, which was 99 children across the UK in 2017. The applicant anticipates that 300 children will be included. "]
["Description of confidential patient information used","Data sources \n1.\tMedical records in participating Trusts across England and Wales \n\nIdentifiers required for linkage purposes \n1.\tNHS Number\n2.\tDate of birth\n3.\tDate of death\n4.\tPostcode – unit level \n\nIdentifiers required for analysis purposes \n1.\tGender\n2.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-02"]
["Next Review Date","2024-12-02"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from REC. Confirmed 28 November 2019.\n\n2.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: The Renal Association has a confirmed ‘Standards Met’ grade on DSPT submission by 2018/19 by NHS Digital email dated 14 October 2019."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02439","index":482,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02439"]
["Reference","19/CAG/0166"]
["Other Refs","IRAS project ID: 268340, REC reference: 19/SW/0116"]
["Application Title","HPS2-THRIVE trial legacy study: long-term follow-up of participants using electronic health records"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to undertake long-term follow-up of patients who were previously recruited to the HPS2-THRIVE Trial to see if differing levels of LDL-cholesterol amongst the participants affected their longer-term risk up to 40 years post-trial of dementia, major diseases such as heart attack, stroke or kidney disease or death.\nDementia is a leading cause of death in the UK and affects many people. Dementia is a condition that develops over a long period before symptoms lead to diagnosis. Cardiovascular risk factors, such as LDL-cholesterol (an essential component of blood, which at increased levels can build up on the walls of arteries increasing the risk of heart disease), are associated with the risks of developing dementia. It is as yet unknown whether increased levels of LDL cholesterol in older people are associated with increased risk of dementia, say 15-20 years later or longer. By using established patient cohorts from existing long-term follow-up studies, such as the HPS2-THRIVE trial, the applicants would be able to examine long-term outcome data in the older population now.\nThe HPS2-THRIVE trial recruited 8,035 patients between 2007 and 2010 to a randomised controlled trial looking at the impact of cholesterol on risk of heart attack and stroke. Existing study records will be linked with routinely collected health data held by NHS Digital and NHS Wales Informatics Service to form a legacy study database. This database will be utilised together with existing stored blood and urine samples of HPS2-THRIVE participants to study the effect of LDL-cholesterol lowering on reducing the risk of developing dementia and other diseases such as the long-term risk of death, other important diseases and healthcare use in the UK.\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Jane Armitage, Professor of Clinical Trials and Epidemiology"]
["Address","University of Oxford, Nuffield Department of Population Health, Richard Doll Building"]
[null,"Old Road Campus, Headington"]
[null,"Oxford"]
["Postcode","OX3 7LF"]
["Telephone","(0)1865 743743"]
["Email","jane.armitage@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients from England and Wales who were recruited to the HPS2-THRIVE trial."]
["Description of confidential patient information used","Data sources\n1. Existing HPS2-THRIVE Trial data\n2. HES, NHS Digital,\n3. Mental Health Minimum Dataset, NHS Digital\n4. ONS Mortality Information, NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Date of death\n5. Postcode (district level)\n6. Sex\n7. Study ID\nIdentifiers required for analysis purposes\n1. Study ID\nAdditional information\n• The study involves a historic patient cohort in Scotland and Northern Ireland which are out of scope for the CAG remit. Separate applications have been made to the appropriate bodies in these nations in relation to the application.\n• The study also involves the use of historic patient samples on the basis of consent which is out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-06"]
["Next Review Date","2024-12-06"]
["Notes","5 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Civil registration mortality, Cancer registration data, Mental Health Minimum Dataset, Bridge File: Hospital Episode Statistics to Mental Health Minimum Data Set, Mental Health Services Data Set, Mental Health and Learning Disabilities Data Set, and Demographics data. \n\n03 August 2021 - Amendment supported to clarify the data sources required to include: \n\n•\tMental Health Minimum Dataset;\n•\tBridge File: Hospital Episode Statistics to Mental Health Minimum Data Set;\n•\tMental Health Services Data Set;\n•\tMental Health and Learning Disabilities Data Set;\n•\tDemographics dataset; \n\nAnd to support the flow of identifiable information back from NHS Digital to the applicants at University of Oxford\n\n10 November 2020 - Amendment supported to extend the scope of the existing Section 251 support to include Welsh data and Cancer Registration data, including data from Welsh patients which is held by NHS Digital, linkage to HES by NHS Digital and PEDW, access to NHS Digital provided Cancer Registration data for analysis purposes and linkage to cancer registration data from Public Health Wales and the SAIL databank (held by WCISU).\n\nConditions of support:\n1. Support currently only extends to patients in England. Applications have been made to the appropriate bodies in Scotland and Northern Ireland for patients in these nations. \n2. Favourable opinion from a Research Ethics Committee. 23 October 2019 \n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: University of Oxford - Medical Sciences Division – Nuffield Department of Primary Care Health Sciences (EE133863-MSD-NDPCHS – NHSD Tracker 01/11/2019) and NHS Digital have confirmed ‘Standards Met’ grade on DSPT 2018/19. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02440","index":483,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02440"]
["Reference","19/CAG/0167"]
["Other Refs","IRAS project ID: 266042, REC reference: 19/WS/0115"]
["Application Title","SEARCH trial legacy study: long-term follow-up of participants using electronic health records"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to undertake long-term follow-up of patients who were previously recruited to the SEARCH Trial to see if differing levels of LDL-cholesterol lowering amongst the participants affected their longer-term risk up to 40 years post-trial of dementia, major diseases such as heart attack, stroke or kidney disease or death.\nDementia is a leading cause of death in the UK and affects many people. Dementia is a condition that develops over a long period before symptoms lead to diagnosis. Cardiovascular risk factors, such as LDL-cholesterol (an essential component of blood, which at increased levels can build up on the walls of arteries increasing the risk of heart disease), are associated with the risks of developing dementia. It is as yet unknown whether increased levels of LDL cholesterol in older people are associated with increased risk of dementia, say 15-20 years later or longer. By using established patient cohorts from existing long-term follow-up studies, such as the SEARCH trial, the applicants would be able to examine long-term outcome data in the older population now.\nThe SEARCH trial recruited 12, 064 patients between 1998 and 2008 to a randomised controlled trial looking at the impact of cholesterol-lowering drugs versus placebo in patients who had suffered myocardial infarction. Existing study records will be linked with routinely collected health data held by NHS Digital and NHS Wales Informatics Service to form a legacy study database. This database will be utilised together with existing stored blood and urine samples of SEARCH participants to study the effect of LDL-cholesterol lowering on reducing the risk of developing dementia and other diseases such as the long-term risk of death, other important diseases and healthcare use in the UK.\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Jane Armitage, Professor of Clinical Trials and Epidemiology"]
["Address","University of Oxford, Nuffield Department of Population Health, Richard Doll Building"]
[null,"Old Road Campus, Headington"]
[null,"Oxford"]
["Postcode","OX3 7LF"]
["Telephone","(0)1865 743743"]
["Email","jane.armitage@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients from England and Wales who were recruited to the main SEARCH trial."]
["Description of confidential patient information used","Data sources\n1. Existing SEARCH Trial data\n2. HES, NHS Digital,\n3. Mental Health Minimum Dataset, NHS Digital\n4. ONS Mortality Information, NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Date of death\n5. Postcode (district level)\n6. Sex\n7. Study ID\nIdentifiers required for analysis purposes\n1. Study ID\nAdditional information\n• The study involves a historic patient cohort in Scotland and Northern Ireland which are out of scope for the CAG remit. Separate applications have been made to the appropriate bodies in these nations in relation to the application.\n• The study also involves the use of historic patient samples on the basis of consent which is out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-06"]
["Next Review Date","2024-12-06"]
["Notes","5 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Civil registration mortality, Cancer registration data, Mental Health Minimum Dataset, Bridge File: Hospital Episode Statistics to Mental Health Minimum Data Set, Mental Health Services Data Set, Mental Health and Learning Disabilities Data Set, and Demographics data. \n\n03 August 2021 - Amendment supported to clarify the data sources required to include: \n\n•\tMental Health Minimum Dataset;\n•\tBridge File: Hospital Episode Statistics to Mental Health Minimum Data Set;\n•\tMental Health Services Data Set;\n•\tMental Health and Learning Disabilities Data Set;\n•\tDemographics dataset; \n\nAnd to support the flow of identifiable information back from NHS Digital to the applicants at University of Oxford\n\n10 November 2020 – Amendment supported to extend the scope of the existing Section 251 support to include Welsh data and Cancer Registration data, including data from Welsh patients which is held by NHS Digital, linkage to HES by NHS Digital and PEDW, access to NHS Digital provided Cancer Registration data for analysis purposes and linkage to cancer registration data from Public Health Wales and the SAIL databank (held by WCISU).\n\nConditions of support:\n1. Support currently only extends to patients in England. Applications have been made to the appropriate bodies in Scotland and Northern Ireland for patients in these nations. \n2. Favourable opinion from a Research Ethics Committee. 23 October 2019 \n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: University of Oxford - Medical Sciences Division – Nuffield Department of Primary Care Health Sciences (EE133863-MSD-NDPCHS – NHSD Tracker 01/11/2019) and NHS Digital have confirmed ‘Standards Met’ grade on DSPT 2018/19. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02441","index":484,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02441"]
["Reference","19/CAG/0059"]
["Other Refs","IRAS project ID: 255396, REC reference: 19/EE/0082"]
["Application Title","National Early Inflammatory Arthritis Audit Research Database"]
["Application Summary","This application from King’s College London set out the purpose of medical research which aims to establish a research database from data collected under the National Early Inflammatory Arthritis Audit, which is commissioned by the Healthcare Quality Improvements Partnership (HQIP) as part of the programme of national audits, which operates with support under the Regulations via application 18/CAG/0063.\nKing’s College London would not receive any confidential patient information; however, support under the Regulations is required to allow the data which is collected for audit purposes to be utilised for wider research purposes. The National Early Inflammatory Arthritis Audit dataset represents the largest early inflammatory arthritis cohort of its kind globally, which the applicant states would have enormous research potential to help understand and improve the care of people presenting for the first time with inflammatory arthritis if made available for use in research.\nA recommendation for class 1, 2 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Kings College Hospital"]
["Contact Name","Dr James Galloway, Senior Lecturer and Honorary Consultant"]
["Address","Kings College Hospital"]
[null,"10 Cutcombe Road"]
[null,"Room 3.46, Academic Department Rheumatology "]
["Postcode","SE5 9RJ"]
["Telephone","020 3 299 7772"]
["Email","james.galloway@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who are included within the National Early Inflammatory Arthritis Audit programme."]
["Description of confidential patient information used","Data sources\n1. National Early Inflammatory Arthritis Audit programme\nIdentifiers required for linkage purposes\nNot applicable\nIdentifiers required for analysis purposes\n1. Sex,\n2. Ethnicity,\n3. Audit specific ID.\nAdditional information\nConfidential patient information is not required within this application; however, support is required to be recommended for research purpose which is not covered (and cannot be covered) within the scope of the existing audit application 18/CAG/0063, as this is a non-research application supported for non-research purposes only."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-06"]
["Next Review Date","2024-08-14"]
["Notes","20 October 2023 - change in data processors from NHS Digital to NHS England, regarding data sources Hospital episode Statistics (HES) and Office for National Statistics (ONS) mortality data.\n\nAmendment supported 20 October 2023 to extend the duration of support until September 2025, and to extend the scope of the NEIAA to include all patients with any rheumatological immune mediated inflammatory disease (IMID), which includes rare IMID in addition to confirmed EIA\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 03 July 2019 \n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed – Kings College Hospital NHS Foundation Trust received qualified ‘Standards Met’ assurance on DSPT 2018/19 (NHS Digital email dated 31 July 2019) on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02442","index":485,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02442"]
["Reference","19/CAG/0149"]
["Other Refs","IRAS project ID: 260722, REC reference: 19/WS/0112"]
["Application Title","Mammographic Predictors of Cancer Recurrence after Breast Conservation and Adjuvant Endocrine Therapy"]
["Application Summary","This application from the University of Dundee set out the purpose of medical research which aims to prove whether a reduction in breast density is a physiological sign that endocrine treatment provided to women with breast cancer is effective in keeping the cancer away.\nThe study will involve wider analysis of mammograms taken from women who are recruited to the Mammo50 research project. The patient cohort includes women who are all over 53 years old and have had a lump removed. 2000 are on endocrine therapy and did not have chemotherapy. Mammograms were taken at baseline, one year and three years post-diagnosis. The mammograms will be transferred to a central imaging centre to enable radiologists to assess if the breast tissue has become more or less dense. The study will also include mammograms from 500 similar women who did not have endocrine therapy as a control group. The progress of these women would then be followed to see if a change in density of the breast tissue is related to the effectiveness of the endocrine therapy.\nA recommendation for class 1 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Dundee"]
["Contact Name","Dr Kulsam Ali Project Manager"]
["Address","Breast Imaging Research Group"]
[null,"School of Medicine, "]
[null,"Mailbox 4, Level 7, Ninewells Hospital & Medical School, Dundee"]
["Postcode","DD1 9SY"]
["Telephone","+44(0)1382 383967 "]
["Email","k.z.ali@dundee.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","2450 female patients who were recruited into the Mammo50 trial and underwent endocrine treatment for breast cancer. 500 female patients with breast cancer who did not undergo endocrine treatment will also be included as a control cohort."]
["Description of confidential patient information used","Data sources\n1. Mammo50 trial database held at the Warwick Clinical Trials Unit\n2. Mammogram records held within the PACS systems at individual Mammo50 trial sites in England (93 sites) and Wales (1 site)\nIdentifiers required for linkage purposes\n1. Patient ID\n2. Name\n3. NHS Number\n4. Hospital ID\n5. Date of birth\nIdentifiers required for analysis purposes\nNot applicable – no data items are required for the purposes of the study analysis.\nAdditional information\nThe applicant has made associated applications to the Public Benefit and Patient Privacy Panel (Scotland) and the Privacy Advisory Committee (Northern Ireland) in respect of patients within these nations."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-06"]
["Next Review Date","2024-12-06"]
["Notes","Amendment supported 16 December 2022 - for a temporary change of Chief Investigator from Mrs E. Jane Macaskill to Dr Sarah Savaridas\n\nAmendment supported 16 December 2022 - to extend the duration of support until 31 August 2024\n\n04 December 2020 - Specific conditions of support updated:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. All staff at Royal Surrey NHS Foundation Trust (RA2)  that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\nConditions of support:\n1. Support extends to data generated in England and Wales only. The applicant has made separate applications to the appropriate bodies in respect of data generated in Scotland and Northern Ireland. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 12 August 2019 \n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: Royal Surrey NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training (NHS Digital email 28 November 2019). As a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02443","index":486,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02443"]
["Reference","19/CAG/0131"]
["Other Refs","IRAS project ID: 257816, REC reference: 19/LO1063"]
["Application Title","Systems research into child-centred medical education v1.0"]
["Application Summary","This application from the Queen’s University Belfast set out the purpose of medical research which aims to evaluate child-centred medical education methods. This will be carried out via observation of medical research encounters between undergraduate and post-graduate medical trainees with patients and their parents/carers and wider clinical staff supporting their educational training.\nMedical trainees will be observed in the clinical setting. Stage 2a of the study will involve observation of medical training encounters direct with patients and their parents/carers. These observations will be consented and are therefore out of scope for the CAG application. Medical trainees will also be observed during multi-disciplinary meetings and handover meetings, which is the element for which the application has been submitted to the CAG. During these staff observations, the researcher will be incidentally exposed to confidential patient information during the discussion of patient’s care. Patient details are not the focus of the observations and will not be recorded in anyway. The research observations will be carried out at University Hospitals Southampton NHS Foundation Trust in England and Royal Belfast Hospital for Sick Children in Northern Ireland. The applicant has applied to the Privacy Advisory Committee in Northern Ireland to legitimise these activities at the Belfast site.\nA recommendation for class 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Queen’s University Belfast"]
["Contact Name","Professor Timothy Dornan"]
["Address","Centre for Medical Education"]
[null,"Queen's University Belfast"]
[null,"97 Lisburn Road, Belfast"]
["Postcode","BT9 7BL"]
["Telephone",2890972157]
["Email","t.dornan@qub.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children aged 6-17 years who are receiving treatment from a healthcare professional providing training to a medical trainee at the University Hospitals Southampton NHS Foundation Trust site. 75 hours of observational activity will be carried out at this site."]
["Description of confidential patient information used","Data sources\nNo data will be directly accessed during the course of the study; however, the applicant will present to observe multidisciplinary team meetings and staff handover meetings.\nIdentifiers required for linkage purposes\nNot applicable – no confidential patient information will be recorded within the staff observation stage of study.\nIdentifiers required for analysis purposes\nNot applicable – identifiers will not be recorded.\nAdditional information\nThe study involves a wider observational element of direct patient care, which will be undertaken on a consented basis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-06"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, outcomes will be disseminated.\n\n\n02 August 2021 - Amendment supported to extend the study duration until 30 March 2022\n\nSpecific conditions of support\n1. Support extends to the application activities being carried out at the University Hospitals Southampton NHS Foundation Trust site only.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 12 August 2019\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: University Hospitals Southampton NHS Foundation Trust received ‘Standards Met’ assurance on DSPT 2018/19 by NHS Digital email dated 29 November 2019."]

{"sheet":"A02444","index":487,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02444"]
["Reference","18/CAG/0141"]
["Other Refs","IRAS project ID: 238169 REC reference: 18/LO/1746"]
["Application Title","CLASSIFYING STRUCTURE AND JOINT FEATURES IN EXTREMITIES USING STATISTICAL LEARNING METHODS TO ASSIST DIAGNOSIS"]
["Application Summary","This application from Imperial College London set out the purpose of medical research\nwhich aims to develop automated data-driven software to assist with diagnosis of\ndisorders in joint extremities. This will be used to develop a learning tool for junior\ndoctors and an assisting tool for pre-surgical planning.\nA selection of 2,200 scans (CT, X-Ray or MRI scans) would be selected for inclusion in\nthe study from patients who were referred by either their GP or consultant to Imperial\nNHS Trust with lower limb extremity issues. The CAG is being asked to provide a\nrecommendation of support to enable the research team to access NHS PACS database\n(Primary and Acute Care Systems) in order to identify the scans to be included in the\nstudy and export these scans and associated data from the radiology report in an\nanonymised format for analysis.\nA recommendation for class 1 and 6 support was requested to cover activities described\nin the application form."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Mariam Al-Laith, Clinical Project Manager"]
["Address","MSk Lab 2nd Floor, Sir Michael Uren Hub"]
[null,"Imperial College London, White City Campus"]
[null,"86 Wood Lane, London "]
["Postcode","W12 0BZ"]
["Telephone","020 7594 2697"]
["Email","m.al-laith@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 18 and over who underwent a standard departmental x-ray, CT or MRI scan at Imperial NHS Trust for medical issues regarding bones or joints in upper or lower extremities between 01 January 2013 and 28 February 2022.\n2,200 scans will be included in the study."]
["Description of confidential patient information used","Data sources\n1. NHS PACS database, Imperial NHS Trust\nIdentifiers required for linkage purposes\nAccess is required to full patient record within the NHS PACS database to enable extraction of an anonymised scan and associated clinical information.\nIdentifiers required for analysis purposes \nNo confidential patient information will be extracted for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-09"]
["Next Review Date","2024-12-09"]
["Notes","18 March 2022 - Amendment supported\nAmendment supported to change the Chief Investigator from Professor Justin Cobb to Mr Gareth Jones.\n\nConditions of support:\n1. Feedback from ongoing patient and public involvement and engagement activity is required at the time of first annual review. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. Patient-facing information materials should be revised with the guidance of the patient and public involvement group to ensure that these are acceptable for a lay audience. The revised documentation should be provided within three months of this outcome letter. \n3. Favourable opinion from a Research Ethics Committee. Confirmed 01 November 2019.\n4. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed - Imperial College Healthcare NHS Trust has a confirmed ‘Standards Met’ grade on DSPT 2018/19, confirmed by NHS Digital email dated 21 November 2019. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02445"]
["Reference","19/CAG/0201"]
["Other Refs","IRAS project ID: 271249, REC reference: 19/CAG/0363"]
["Application Title","The PREDICT Study"]
["Application Summary","This application from the North East Ambulance Service NHS Foundation Trust set out\nthe purpose of medical research that seeks to determine if a lactate measurement, taken\nby a paramedic during an out of hospital cardiac arrest, can predict survival to hospital.\nCardiac arrests occur when the heart suddenly stops beating. NHS ambulance services\nattend approximately 30,000 incidents of cardiac arrest each year. Currently, less than\n10% of patients who have a cardiac arrest outside of hospital survive. When a patient’s\nheart stops, the body becomes deprived of oxygen, causing a rise in lactic acid (lactate).\nLactate is used to identify patients at the highest risk of death in various emergency\nsituations, such as sepsis and in hospital cardiac arrest. No evidence currently exists to\nindicate if a lactate measurement taken in the ambulance can be used to identify those\nmost at risk of death in out of hospital cardiac arrest. Lactate can be measured in the\nambulance by using a blood sample and a small hand-held device, and the results are\nquickly available. One lactate measurement will be taken when a blood glucose test is\ncarried out as part of standard care. All other care will be as standard.\nPatients will be enrolled prior to consent being taken, due to the emergency nature of the\ncardiac arrest. The paramedics who take the blood sample and lactate measurement will\nbe part of the direct care team. The electronic patient record at the North East\nAmbulance Service NHS Foundation Trust will be updated and the research team\nnotified that a suitable patient has been recruited. The research team will then access\nthe electronic record to collect confidential patient information. Full consent will be\nsought at a later date from patients who survive the cardiac arrest, however the\napplicants expect that the majority of patients eligible for this study will die before\nconsent can be obtained and are therefore seeking support under Section 251 to access\nthe confidential patient information from the ambulance care records of patients who die\neither at home or in the emergency department, before consent can be obtained.\nPatient identifiers will then be sent to the audit department at Newcastle upon Tyne\nHospitals NHS Foundation Trust to determine if the patient survived until they reached\nhospital and their 30-day mortality outcome. If the patient died before reaching hospital,\ntheir date of death will be the only further information requested from the audit\ndepartment. If the patient died within hospital, the audit team will also be asked to\nconfirm the date of death.\nA recommendation for class 4, 5 and 6 support was requested to cover access to the\nrelevant unconsented activities as described in the application."]
["Applicant Organisation Name","North East Ambulance Service NHS Foundation Trust"]
["Contact Name","Mr Karl Charlton"]
["Address","North East Ambulance Service NHS Foundation Trust"]
[null,"Ambulance HQ, Berncia House, "]
[null,"Goldcrest Way, Newburn Riverside"]
["Postcode","NE15 8NY"]
["Telephone",1914302295]
["Email","karl.charlton@neas.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients over the age of 18, who have suffered a cardiac arrest outside of hospital in the catchment area of Newcastle Upon Tyne Hospitals NHS Foundation Trust, and are eligible for resuscitation, as determined by current Resuscitation Council guidelines.\nThe total number of patients is 100."]
["Description of confidential patient information used","Data sources\n1. The ambulance care record at North East Ambulance Service NHS Foundation Trust.\n2. Electronic patient records at Newcastle upon Tyne Hospitals NHS Foundation Trust.\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Date of death\n4. Postcode – district level\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode –"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-10"]
["Next Review Date","N/A"]
["Notes","21 December 2021 - Support Expired:\nApplicant confirmed that all study data has been anonymised and no identifiers have been retained. \n\nRegarding the public benefits; There are around 60,000 out of hospital cardiac arrests (OHCA’s) annually and NHS ambulance services attempt resuscitation in around 30,000 cases, but the survival rate remain very poor.  Given that resuscitation is an aggressive treatment that is of no clinical benefit to most people, any intervention that could predict those who would and would not benefit, is advantageous to patients, in that it could potentially avoid unnecessary treatments and unintentional harm that arises from CPR.  This also has benefits to family and friends of patients suffering OHCA, who often witness resuscitation efforts and find the experience distressing.           \n\n12 August 2020 - Amendment supported to extend the duration of data collection for the study until 30 April 2021.\n\nAdditional DSPT condition:\nNewcastle Upon Tyne Hospitals NHS Foundation Trust and North East Ambulance Services NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n11 June 2020 - an amendment to extend the study duration to 31 August 2020 and to include patients treated at Gateshead Health NHS Foundation Trust was supported. \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 01 November 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: North East Ambulance Services NHS Foundation Trust (by NHS Digital email 23 July 2019) and Newcastle Hospitals NHS Foundation Trust (by NHS Digital email 30 August 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

{"sheet":"A02446","index":489,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number",2446]
["Reference","19/CAG/0065"]
["Other Refs","IRAS project ID: 235279, REC reference: 19/ES/0016"]
["Application Title","Causes of sixth nerve palsies in children: a retrospective study"]
["Application Summary","This application from University Hospitals Southampton NHS Foundation Trust set\nout the purpose of medical research which aims to report the incidence and causes\nof sixth nerve palsies in children presenting to Southampton General Hospital over\nthe past ten years. The applicants aim to highlight the most common causes of\nsixth nerve palsy, the most common path of presentation and other common\nassociated signs and symptoms in order to guide future clinical practice in the UK.\nConfidential patient information will be collected retrospectively, using a diagnostic\nsearch tool on the electronic record systems, E-Docs and Medisoft, used by\nUniversity Hospitals Southampton and Southampton Eye Unit. Only data sufficient\nto answer the research question will be collected from the electronic records of\neligible patients. If the required information is not available in electronic records,\npaper based medical notes may be accessed. Once data has been extracted, no\nfurther access to participants notes will be needed.\nA recommendation for class 1, 4 and 6 support was requested to cover activities as\ndescribed in the application."]
["Applicant Organisation Name","University Hospitals Southampton NHS Foundation Trust"]
["Contact Name","Mr. James Self, Paediatric Ophthalmology Consultant"]
["Address","University Hospitals Southampton"]
[null,"Room OC16, Eye unit"]
[null,"Southampton"]
["Postcode","SO16 6YD"]
["Telephone","02381208183"]
["Email","j.e.self@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients under the age of 18 years old at diagnosis, diagnosed with unilateral or\nbilateral sixth nerve palsy between 02 January 2007 – 01 January 2017 and seen\nat Southampton General Hospital as an inpatient or an outpatient."]
["Description of confidential patient information used","Access to the complete patient record is requested to enable the wider clinical\ninformation required for analysis to be extracted, the following specific items of\nconfidential patient information are requested for the purposes set out below:\n• Hospital number – sample validation and linkage\n• Gender - analysis\n• Ethnicity - analysis\n• Age at diagnosis - analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-19"]
["Next Review Date","N/A"]
["Notes","December 2021 - Support Expired:\nApplicant confirmed expiry of support December 2021.\n\nApplicant confirmed that hospital numbers were the only identifiable information retained during this study to ensure no data was duplicated. These have now been deleted.\n\nIn terms of public benefits, the results from the study are currently being written for publication. This data will show the incidence and causes of sixth nerve palsies in children presenting to Southampton general hospital over the past ten years with an aim to highlight the most common causes of sixth nerve palsy, the most common path of presentation and other common associated signs and symptoms in order to guide future clinical practice in the UK.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. (Confirmed: 18 February 2019).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission (Confirmed: University Hospitals Southampton NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 29 November 2019)."]

{"sheet":"A02447","index":490,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02447"]
["Reference","19/CAG/0079"]
["Other Refs","IRAS project ID: 107227, REC reference: E3244,  Previously: ECC 4-03(h)/2012"]
["Application Title","International Breast Cancer Intervention Study (IBIS-I) - Epidemiological Cohort Study."]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research to undertake an epidemiological follow-up of female patients who were previously consented to participate in the IBIS-I study. IBIS-I trial was the largest European breast cancer prevention trial investigating whether tamoxifen (a hormonal drug) can prevent breast cancer in pre- and post-menopausal women at high risk of developing breast cancer. It was a randomised clinical trial that internationally recruited 7,154 women aged 35-70 years (of which 4,277 were UK participants).\nThis study was converted into an epidemiological follow-up in 2008, to enable ongoing analysis of patient outcomes via questionnaire and flagging with NHS Digital and NHS Wales Informatics Service to follow-up via NHS administrative datasets to received comprising HES/PEDW, cancer registration and mortality data. Further information that completes missing data relating to endpoints, such as tumour-specific data, is also requested from participants’ GPs.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Nadia Haidar. Biospecimens Data Manager"]
["Address","Centre for Evaluations and Methods"]
[null,"Queen Mary University of London, Wolfson Institute of Preventive Medicine"]
[null,"Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone","0207 882 2930 "]
["Email","n.haidar@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","4,277 female patients who were previously recruited to the IBIS-I trial."]
["Description of confidential patient information used","Data sources\n1. IBIS-I trail database\n2. HES, ONS and Cancer registration, NHS Digital\n3. PEDW, NHS Wales Informatics\nIdentifiers required for analysis purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Address and Postcode (Unit level)\nAdditional information\n1. Date of death\n2. Place of death\n3. Cause of death\n4. Study ID"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-04-22"]
["Next Review Date","2024-04-22"]
["Notes","17 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources - Hospital Episode Statistics (HES), cancer registration and ONS mortality data.\n\nConditions of support:\n1. Patient and public involvement and engagement activity should be carried out with an appropriate group to seek views around the longitudinal study. Feedback is required at the time of next annual review around the activity which was carried out and the format which this took, the demographics of the group involved together with an overview of the feedback which was provided. If the responses given are negative, the CAG will take this into account when considering whether support should continue, or whether further actions are necessary.\n2. All pre-existing conditions of support related to ECC 4-03(h)/2012 remain applicable.\n3. The pre-existing annual review cycle remains applicable, with the next annual review to be received 4 weeks before 22/04/2020, and then on an annual basis to this schedule. \n4. Favourable opinion from a Research Ethics Committee (Confirmed).\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: \n• Barts Cancer Centre (Queen Mary University of London) , DSPT 2018/19 confirmed ‘Standards Met’ assurance by NHS Digital email dated 04 August 2019,  \n• NHS Digital – Data Security and Protection Toolkit, Confirmed Standards Met,\n• NHS Wales Informatics Service – Satisfactory CPIP Assessment. "]

{"sheet":"A02448","index":491,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02448"]
["Reference","19/CAG/0002"]
["Other Refs","IRAS project ID: 217396, REC reference: 17/SS/0009"]
["Application Title","Outcome of resuscitated term babies with no heart rate detected at 10 minutes of age."]
["Application Summary","This application from NHS Lothian set out the purpose of medical research which aims to identify the incidence of babies born at term which received prolonged resuscitation after delivery and have no heart rate detected at 10 minutes. The study will collate information around the demographics, clinical features and initial management of this patient population. The study also aims to describe the mortality rate, timing and cause of death for those patients within this cohort which do not survive.\nThis study is run through the British Paediatric Surveillance Unit (BPSU) \"Orange Card\" notification scheme. The BPSU methodology has received support in principle from the CAG. All senior paediatricians in the UK are sent a monthly email asking if they have seen any cases that match the definition of currently running studies. The BPSU informs the research team of potential cases and the team will approach the notifying clinician for further details. The study will run a 24 month reporting period. An initial assessment questionnaire will be completed at birth. For those babies who survive, follow-up will be carried out at one and two years to assess the neurodevelopmental outcome.\nCase ascertainment will be maximised by flagging the study with the MBRRACE-UK (Mothers and Babies: Reducing Risk through Audit and Confidential Enquiries across the UK) audit programme, to ensure that babies who die are also captured in the project. Any infant captured via the MBRRACE-UK audit would be reported to the study as standard via the orange card system.\nA recommendation for class 1, 5 and 6 was requested to cover activities as described in the application."]
["Applicant Organisation Name","NHS Lothian"]
["Contact Name","Dr Gemma Sullivan, Neonatal Grid Specialist Trainee"]
["Address","NHS Lothian, Dept of Neonatology, Simpson Centre for Reproductive Health,"]
[null,"Edinburgh"]
[null,"Scotland"]
["Postcode","EH16 4SA"]
["Telephone","01312422567"]
["Email","gemma.sullivan@nhslothian.scot.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Term infants who are resuscitated at birth and have no detectable heart beat at 10 minutes. It is anticipated that around 300 babies would be reported across the 24 month reporting period."]
["Description of confidential patient information used","The following items of confidential patient information will be released from participating Trusts and Health Boards in England and Wales to the applicants for the purposes set out below:\n• NHS number – sample validation,\n• Hospital Number – sample validation and follow-up,\n• Date of birth – sample validation and analysis,\n• Date of death – sample validation and analysis,\n• Sex – analysis,\n• Ethnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-12-16"]
["Next Review Date","2024-12-16"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee (Confirmed – 08 March 2017). \n2. Final approval letter from the Scottish Public Benefit and Privacy Panel (PBPP) in relation to this study. (Confirmed 29 November 2019). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","02449"]
["Reference","19/CAG/0217"]
["Other Refs","IRAS project ID: 232381, REC reference: 19/LO/1765"]
["Application Title","Risk-stratified screening for breast cancer: modelling natural history and screening strategies"]
["Application Summary","This application from University College London set out the purpose of medical research which aims to examine whether a breast cancer screening programme that personalises or tailors the timing and frequency of screening according to a women’s risk level has a more positive outcome whilst maintaining value for money for the NHS.\nThe applicant will utilise information collected within the SEARCH (Studies of Epidemiology and Risk Factors in Cancer Heredity) study, which is a population-based case control study of women under the age of 70, with and without a diagnosis of breast cancer between 1996 and 2013, in the East Anglia area. The SEARCH research programme is operated by the University of Cambridge and covers a number of different cancers. The programme also operates a number of section 251 support applications for participant identification and linkage of historic cohorts.\nThe application has been submitted to seek support to link the SEARCH breast cancer and control cohorts to breast cancer screening and outcome data information held by Public Health England in order to create an anonymised dataset to be disclosed to the applicant for analysis. The existing SEARCH programme dataset, whilst linked to certain elements of the National Cancer Registration and Analysis (NCRAS) dataset at PHE, does not currently link with screening data, which will be facilitated specifically for this project, which is the rationale behind the specific application.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Nora Pashayan - Professor of Applied Cancer Research"]
["Address","UCL, Department of Applied Health Research"]
[null,"1-19 Torrington Place "]
[null,"London "]
["Postcode","WC1E 7HB"]
["Telephone",2031083255]
["Email","n.pashayan@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patient and control cohort members of the SEARCH breast research programme. This covers 15,484 women in East Anglia under the age of 70 who were diagnosed with breast cancer between 1996 and 2013 and 1,922 women in the control cohort."]
["Description of confidential patient information used","Data sources\n1. SEARCH breast research dataset, University of Cambridge\n2. National Cancer Registration and Analysis (NCRAS) dataset, Public Health England\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n3. Date of breast cancer diagnosis\nIdentifiers required for analysis purposes\nNot applicable – no identifiers will be retained for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-18"]
["Next Review Date","N/A"]
["Notes","23 July 2021 - Support expired\nApplicant confirmed on 23 July 2021 that support no longer required. \n\n1. Please may you confirm the reason that support is no longer required \nTo confirm, the one off linkage of SEARCH dataset to NHS BSP dataset was done by the SEARCH team in February 2021, and the SEARCH team provided us in May 2021 anonymised dataset with prespecified variables, as set by DTA between UCL and the University of Cambridge. \nAt UCL, we have not received any identifiers. The variables we have received from the SEARCH team are:  age at every screening episode attendance, screening outcome, cancer characteristics (stage, morphology, subtype), and polygenic risk score (logarithmic number). We will retain this anonymised dataset for 4 years (as per the DTA), allowing time for publication of the results and responding to any post-publication queries. \n \n3. Please may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency\nAs we have received the dataset only couple of months ago, we are still in the process of developing statistical models for the analysis.  We do anticipate the findings to inform the breast screening programme:\nThis study will inform whether and how the natural history of breast cancer (sojourn time) and mammogram sensitivity vary by polygenic risk score. There are no published studies yet in breast cancer or other cancers on whether and how the natural history varies with polygenic risk scores. These findings will be important in deciding whether women with low / high polygenic risk score should receive less / more frequent breast screening.  Furthermore, we will use the findings in decision modelling of risk-stratified screening strategies to identify the strategies that improve the benefit-harm balance and the cost effectiveness of the NHS Breast Screening Programme. \n\nSpecific conditions of support\n1. Provide confirmation at a six-month interim point that the project-specific user involvement group has been established. It is recommended that group consider the patient notification text to review for suitability. \n2. Favourable opinion from a Research Ethics Committee. Confirmed 22 November 2019\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed - University of Cambridge and Public Health England has a confirmed ‘Standards Met’ grade on DSPT 2018/19 – confirmed by NHS Digital email on 02 September 2019. \n"]

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[]
[]
["Application Number","A02450"]
["Reference","19/CAG/0220"]
["Other Refs","Replaced PIAG 2-08(e)/2002, IRAS project ID: 188069, REC reference: 16/EM/0440"]
["Application Title","Linked de-identified research database for congenital\nanomaly outcomes"]
["Application Summary","This application from St George’s University of London set out the purpose of medical\nresearch through the creation of a research database into the outcome of children\naffected by congenital abnormalities registered in the UK prior to 01 April 2015. The\napplication has existing support under application reference PIAG 2-08(e)/2002;\nhowever, a refreshed application became necessary due to a change in controller for the\nproposal.\nThe application support to enable the BINOCAR regional registers to transfer specified\nlegacy data to St George’s University of London to enable linkage with health, mortality\nand educational data with a view to creating a congenital anomaly outcomes research\ndatabase to facilitate research into the outcomes of children affected by congenital\nanomalies. Support is also requested to enable the disclosure of complete BINOCAR\nlegacy datasets relating to the Northern Congenital Abnormality Survey (NoCAS) and the\nSouth West Congenital Anomaly Register (SwCAR) from Public Health England.\nOngoing linkages are proposed with administrative health datasets, mortality data and\neducational outcomes. The applicant is seeking support for the ongoing processing and\nretention of confidential patient information for the complete BINOCAR legacy dataset\nuntil June 2021. The database will only contain legacy information registered prior to 01\nApril 2015; no newly registered congenital anomalies will be included.\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover access to\nthe relevant unconsented activities as described in the application."]
["Applicant Organisation Name","St George’s University of London"]
["Contact Name","Professor Joan K Morris"]
["Address","Population Health Research Institute"]
[null,"St George's University of London"]
[null,"Cranmer Terrace"]
["Postcode","SW17 0RE"]
["Telephone",2087251324]
["Email","jmorris@sgul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients registered in the following regional congenital anomaly registers will be transferred into the database:\n1. Congenital Anomaly Register for Oxfordshire, Berkshire and Buckinghamshire (CAROBB) - births from 1991 to 31 March 2015;\n2. East Midlands and South Yorkshire Congenital Anomaly Register (EMSYCAR) - births from 1997 to 31 March 2015;\n3. South West Congenital Anomaly Register (SWCAR) – births from 2002 to 31 March 2015;\n4. Northern Congenital Abnormality Survey (NorCAS) – births from 1985 to 31 March 2015;\n5. Wessex Antenatally Detected Anomalies Register (WANDA) – births from 1994 to 31 March 2015."]
["Description of confidential patient information used","Data sources\n1. Hospital Episodes Statistics (HES), NHS Digital\n2. ONS mortality data, NHS Digital\n3. National Pupil Database, Department for Education\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID\n4. Date of birth\n5. Date of death\n6. Postcode (Unit level)\n7. Ethnicity\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode (Unit level)\n4. Sex\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired\n\n\n"]
[]
["Outcome Date","2019-12-19"]
["Next Review Date","N/A"]
["Notes","Expired\n\nApplicant confirmed in June 2023 that ‘s251’ support can be expired as all confidential patient information including names, NHS numbers, dates of birth and postcodes belonging to children and their mothers (where present) have been deleted.\n\nIn terms of public benefit, the use of patient identifiers has enabled linkage of historical congenital anomaly (CA) data to death registrations, hospital admissions and educational databases. Researchers were able to evaluate the survival, health and educational achievement of approximately 35,000 children born with major CAs in England, as well as contribute findings to a multi-centre European project which compared and synthesised outcomes from infancy to childhood across several countries. At least 16 research papers have been published in academic journals to date, enhancing the evidence base for long-term outcomes associated with different CAs. Detailed information about the needs and prospects of affected children will benefit parents and clinicians following diagnosis of a CA, and also paves the way for the provision of appropriate support for these children to attain their full potential as they grow and develop.  \n\n\n*This application supersedes PIAG 2-08(e)/2002*\n\n15 December 2021 - Amendment supported\nAmendment supported to extend the duration of support until 01 June 2023.\n\n03 August 2021 - Amendment supported to extend the duration of support until November 2021\n\nSpecific conditions of support \n\n1. Provide an updated copy of the website text for review within three months of the date of the final outcome letter. Conditions met 22 July 2020.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 04 February 2019 \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: NHS Digital and St George’s Medical School have confirmed ‘Standards Met’ grades on DSPT 2018/19 (NHS Digital email 11 September 2019). Department for Education has confirmed assurance (NHS Digital email 11 September 2019). \n"]

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[]
[]
["Application Number","A02451"]
["Reference","19/CAG/0221"]
["Other Refs","IRAS project ID: 264745, REC reference: 19/YH/0235"]
["Application Title","Association between tumour amphiregulin, epiregulin and epidermal growth factor receptor (EGFR) expression and response to anti-EGFR agents in colorectal cancer"]
["Application Summary","This application from University of Leeds set out the purpose of medical research which aims to develop a test for the chemical proteins AREG, EREG and EGFR on colorectal cancer cells. These proteins are known to make some cancer cells multiply. Drugs have been developed to block these proteins, so the cancer cells will stop multiplying; however, these drugs are not effective in all patients. This is a problem as the drugs have unpleasant side effects which patients are suffering for no added benefit.\nThis study will aim to develop a test to predict which patients would benefit from these drugs before they are prescribed. The study will include retrospective patients who have already been treated with these drugs and follow patients newly starting on treatment. All patients will be identified by members of the direct clinical care team. Living patients would be approached for their consent by a member of the direct clinical care team. The application has been submitted to the CAG to seek support for the deceased patient cohort.\nWhen an eligible deceased patient is identified, the direct care team will disclose confidential patient information to research nurses working on site. The application states that these are likely to be research nurses appointed by the Trust which provided care to the patient, but are unlikely to have been part of the clinical care team. The patient’s record will be accessed to enable linked anonymised data to be extracted from the records to be included in the study for analysis purposes. The overarching research team would only have access to the linked anonymised data.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Philip Quirke - Professor of Pathology and Data Analytics"]
["Address","Level 4, Wellcome Trust Brenner Building"]
[null,"St James's University Hospital"]
[null,"Beckett Street, Leeds"]
["Postcode","LS9 7TF"]
["Telephone",1133438408]
["Email","P.Quirke@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult deceased patients treated at one of the 33 participating Trusts who had biopsy proven colorectal cancer which was treated with cetuximab or panitumumab. 960 patients will be included within the study of which 480 will be deceased."]
["Description of confidential patient information used","Data sources\n1. Electronic medical records at the 33 participating Hospital Trusts\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\nIdentifiers required for analysis purposes\nNot applicable – nothing will be retained for analysis.\nAdditional information\nThe study also involves the recruitment of living patients, who would be identified and approached for consent by a member of the direct clinical care team. This wider cohort is not within the scope of the application for section 251 support."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2019-12-20"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised.  No ability to identify individual patients is retained by the University of Leeds, only the NHS Trusts where patients received treatment under their care team.\n\nIn terms of public benefit, the work forms part of the background research to the ongoing ARIEL trial, which seeks to determine whether patients with advanced bowel cancer that originated on the right side of the colon, with high tumour AREG/EREG expression, obtain benefit from anti-EGFR therapy.\n\n\n12 November 2020 - Amendment supported to add South Tees Hospital NHS Trust and University Hospitals of Derby and Burton NHS Foundation Trust as additional data processors.\n\n08 July 2020 - Amendment supported to add Portsmouth Hospitals NHS Trust as an additional data processor.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 27 November 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Not checked due to the number of sites which will be processing with support under the Regulations. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with section 251 support."]

{"sheet":"A02452","index":495,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02452"]
["Reference","19/CAG/0162"]
["Other Refs","IRAS project ID: 262367, REC reference: 19/LO/1443"]
["Application Title","Accuracy, impact and cost-effectiveness of prehospital clinical early warning scores for adults with suspected sepsis"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research\nwhich aims to test the efficacy of early warning scores in the identification of sepsis. It is\nnoted that an accurate early warning score could help clinicians ensure that patients with\nsepsis are identified and treated quickly. Conversely, an inaccurate early warning might\ncause sepsis to be missed or patients with other conditions to be falsely diagnosed.\nWorkstream one is a retrospective cohort study using routing data sources to estimate\nthe accuracy of prehospital early warning scores (index test) for predicting potential to\nbenefit from time-critical treatment for sepsis (reference standard) in adults with possible\nsepsis who are attended by emergency ambulance. This will involve retrospectively\nidentifying the patient cohort from ambulance records and linking with wider follow-up\ndata from and local hospital Trusts.\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the\nrelevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Steve Goodacre"]
["Address","University of Sheffield"]
[null,"School of Health and Related Research (ScHARR)"]
[null,"Regent Court, 30 Regent Street, Sheffield"]
["Postcode","S1 4DA"]
["Telephone","0114 222 0842"]
["Email","s.goodacre@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All adults with possible sepsis transported by emergency ambulance to four acute hospitals over the course of the year 01/04/2018 to 31/03/2019. It is estimated that this will include 46,000 patients."]
["Description of confidential patient information used","Data sources\n1. Yorkshire Ambulance Service NHS Trust electronic\npatient records\n2. West Midlands Ambulance Service University NHS\nFoundation Trust electronic patient records,\n3. Sheffield Teaching Hospitals NHS Foundation Trust\nelectronic patient records\n4. Barnsley Hospital NHS Foundation Trust electronic\npatient records\n5. Emergency Care Data Set, NHS Digital\n6. Hospital Episodes Statistics (HES), NHS Digital\n7. ONS mortality data, NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital Number\n4. Date of birth\n5. Hospital site attended\nIdentifiers required for analysis purposes\n1. Hospital site attended\n2. Sex\n3. Ethnicity\n4. Age at event\n5. Time of day of event"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-01-13"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, findings will inform National Institute for Health and Care Excellence forthcoming guidance on Suspected sepsis: recognition, diagnosis and early management. The study will therefore help ambulance services to use early warning scores to identify patients with possible sepsis and prioritise their treatment at the emergency department.\n\n\n31 October 2022 – amendment supported to include an additional data flow of confidential patient information from the Northern General Hospital to the study team at Sheffield Clinical Trials Research Unit (CTRU) at Sheffield University for patients who could not be matched to an attendance record at the Northern General Hospital or did not have a diagnostic code for the matched attendance.\n\nAmendment supported 26 July 2022 to include an additional alternative data flow to allow disclosure of confidential patient information from Yorkshire Ambulance Service (YAS) to the study team at Sheffield University, and onwards disclosure to The Northern General Hospital (NGH)\n\n08 June 2022 - Amendment supported:\nAmendment supported to extend the duration of support by 12 months, until 30 June 2023.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 06 September 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Due to the number of sites involved in processing data with section 251 support, individual DSPT submissions are not required for the purpose of the application.  Each site is expected to have achieved a ‘standards met’ in relation to their organisational DSPTs.\n\n07 September 2021 - amendment supported to extend the data collection period from April 2018 – March 2019, so that the new end date is 31 December 2019, and to add Doncaster & Bassetlaw Hospitals NHS Trust, The Rotherham NHS Foundation Trust and South Warwickshire NHS Foundation Trust as data processors"]

{"sheet":"A02453","index":496,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02453"]
["Reference","19/CAG/0198"]
["Other Refs","IRAS project ID: 259615, REC reference: 19/EM/0317"]
["Application Title","Evaluation of an aid to diagnosis for congenital dysplasia of the hip in general practice: controlled trial randomised by practice"]
["Application Summary","This application from Great Ormond Street Hospital for Children NHS Foundation Trust set out the purpose of medical research that seeks to determine whether use of a diagnostic aid for developmental dysplasia of the hip (DDH) reduces the number of clinically insignificant referrals from primary to secondary care and the number of cases of late diagnosis of DDH.\nDevelopmental dysplasia of the hip (DDH) is one of the most common inborn diseases. Early diagnosis of this condition is very important and it can be harmful both to miss DDH and label normal infants as having DDH. Why DDH can be missed or labelled to normal children is not well understood but can be related to the doctor's knowledge, skill and the way the hip consultation is conducted. This research aims to help overcome these issues and proposes the use of a diagnostic aid for DDH in general (GP) practices.\nGP practices in England, who carry out the 6-week hip check on infants, will be divided into two groups. Eligible participants will be identified by general practice patient registers and infants will be invited to attend a 6-week check at the practice. One group of GP practices will be given the applicant’s checklist to use in all hip checks they carry out. The other group will screen for DDH as normal, without the use of the checklist. The two groups will then be compared to see if the first group better identified infants with DDH than the second group. The applicants will also evaluate whether using the checklist reduces costs for families around trips to doctors or hospitals, and costs to the NHS. GPs, health visitors and carers of infants will be interviewed to elicit their perceptions about the intervention. The applicants are seeking Section 251 support to access the confidential patient information for infants who received the 6-week check at participating GP practices. The NHS numbers of the infants will be used by the applicant to link to HES data, via NHS Digital, in order to check the 2-year outcomes.\nA sample of one in 10 parent or carers will be contacted within two weeks of infants undergoing the routine 6-week check, to complete a set of standardised questionnaires. Staff within the GP practices will forward a letter of invitation via post from the respective practices to the selected parents or carers, alongside a parents or carers consent form for questionnaires, parent or carer information sheet for questionnaires and 5 validated questionnaires. The letter will clarify that the participants are under no obligation to enter the trial and that they can withdraw at any time. Only completed questionnaires returned with a signed consent form will be accepted for use in the trial.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Great Ormond Street Hospital for Children NHS Foundation Trust"]
["Contact Name","Professor Andreas Roposch"]
["Address","Great Ormond Street Hospital for Children, Department of Orthopaedic Surgery, "]
[null,"Great Ormond Street"]
[null,"London"]
["Postcode","WC1N 3JH"]
["Telephone","02078138451"]
["Email","a.roposch@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Infants between 42 and 70 days old, invited for the 6-week hip check at participating GP surgeries in England\n152 practices will be included in the study.\nApproximately 21,888 infants will be included. 12 infants per month per practice (12x12 months recruitment x 152 practices)."]
["Description of confidential patient information used","Data sources\n1. Electronic and paper records held in participating GP surgeries\n2. HES data held by NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Hospital ID number\n4. Date of birth\nIdentifiers required for analysis purposes\n1. Name\n2. Date of birth\n3. Gender\n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-01-13"]
["Next Review Date","2025-01-13"]
["Notes","Amendment supported on 09 October 2023 to reduce the estimated sample size from 21,888 infants to 16,720.\n\nAmendment supported 21 June 2023 to amend the study data flow to include collecting 2 year outcome data directly from participating secondary care hospitals\n\n15 June 2023 - change in data processor from NHS Digital to NHS England, regarding data source Hospital Episode Statistics (HES)\n\nAmendment supported 15 June 2023 to increase the number of participating GP practices from 152 to maximum of 172 and to increase the number of months infants are recruited from 15 months to 18 months\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 12 December 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n• Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02454"]
["Reference","18/CAG/0179"]
["Other Refs","IRAS project ID: 237331, REC reference: 18/WM/0292"]
["Application Title","IMproving the practice of foetal heartrate MOnitoring with cardiotocography for safer childbirth"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research which aims to advance current knowledge of the types of errors, hazards and failure modes that may occur in the process of classifying, interpreting, and responding to, CardioTocoGraphy traces when monitoring foetal heart rate during labour.\nThis will be undertaken via researcher observation of staff within the clinical maternity setting – women will not be asked to consent to participate in the study. The application has been submitted for consideration by the CAG under precedent set category 10 – incidental disclosures, which may occur during the course of the staff observations. There is a further interview element to the study which will be undertaken on consented basis with staff only and is out of scope for CAG consideration.\nObservations will be undertaken a three sites – one in England, which will be Sheffield Teaching Hospitals NHS Foundation Trust. The wider research sites will be based in Scotland and Northern Ireland which are out of the remit of the CAG to consider.\nA recommendation for class 5 and 6 support was requested to cover activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Mary Dixon-Woods - Director of THIS Institute, Health Foundation Professor of Healthcare Improvement Studies"]
["Address","THIS Institute, University of Cambridge"]
[null,"Cambridge Biomedical Campus, Clifford Allbutt building"]
[null,"Cambridge"]
["Postcode","CB2 0AH"]
["Telephone","01223 761841"]
["Email","director@thisinstitute.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The participants in the study are NHS staff members in participating maternity units who are involved in continuous electronic foetal heartrate monitoring using cardiotocography, especially midwives and obstetricians. The patients will be those receiving care from these participating individuals."]
["Description of confidential patient information used","No confidential patient information is required for the purposes of the study; however, it is recognised that there will be incidental disclosures during the course of staff observation."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-10-29"]
["Next Review Date","N/A"]
["Notes","24 September 2020 - Support expired.\n\n15 January 2020 – Amendment supported to extend the end date of support under Section 251 from 30 June 2020 until 30 June 2021, due to delays experienced by the researchers when seeking the appropriate governance approvals.\n\nSpecific conditions of support (Final)\n1. Support extends to the research site located in England only.\n2. Revise the patient information sheet to move the bullet point from page three of the document (‘The researchers will maintain your confidentiality…’) to the cover summary page. This should be actioned prior to commencing observations; however, assurance can provided at the time of first annual review that this was undertaken.\n3. Favourable opinion from a Research Ethics Committee (Confirmed – 24 September 2018).\n4. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed – Sheffield Teaching Hospitals NHS Foundation Trust have a published satisfactory reviewed grade V14.1, 2017/18)."]

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[]
[]
["Application Number","A02455"]
["Reference","19/CAG/0219"]
["Other Refs","IRAS project ID: 249837, REC reference: 19/EE/0163"]
["Application Title","Epidemiology of Pancreatic Cancer Using Longitudinal Electronic Health Record Data"]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research which aims to study risk factors related to pancreatic cancer on the diverse patient population based in East London. The study primarily aims to discover and evaluate novel and known risk factors associated with pancreatic cancer, and lay the foundation for potential integration with molecular data for further stratification of pancreatic cancer patients.\nThe study will link health care records across primary, secondary and tertiary care data of patients diagnosed or reported with pancreatic or biliary diseases within Barts Health NHS Trust since 2007. A case-control study will be conducted, based on the retrospective data, between pancreatic cancer diagnosed and other patients, matched by the appropriate demographics, focusing on various epidemiological factors and clinical data. The study will collate information from HES, commissioning datasets and GP records.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Dr Abu Zafer M Dayem Ullah Senior Health Data Science Specialist                \n"]
["Address","Old Anatomy Building"]
[null,"Barts Cancer Institute"]
[null,"Charterhouse Square"]
["Postcode","EC1M 6BQ"]
["Telephone",2078823831]
["Email","d.ullah@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The following patient cohorts will be included in the study from the Barts Health NHS Trust who were treated from 01/01/2007 to 31/12/2021:\n• Patients, aged over 18 years, diagnosed with pancreatic cancer,\n• Control group one – patients with cancer in small intestine, duodenum, liver, gallbladder and bile duct,\n• Control group two - Patients with hernia and other diseases of pancreas, liver, gallbladder, biliary tract and spleen.\nIt is estimated that there will be 3,750 patients in each cohort."]
["Description of confidential patient information used","Data sources\n1. Patient identification list, Barts Health NHS Trust (Cerner Millennium System Business Intelligence tool),\n2. Coded Commissioning Data Sets within Barts Health NHS Trust (Cerner Millennium System Business Intelligence tool),\n3. Free text within Barts Health NHS Trust (Cerner Millennium System Business Intelligence tool),\n4. GP data, NHS Discovery East London Programme\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\nIdentifiers required for analysis purposes\n1. Date of birth – calculation of analysis information\n2. Date of death – calculation of analysis information\n3. Gender\n4. Ethnicity.\nAdditional information\nThe application set out a consented arm; this is not within the scope of the proposed support."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-01-17"]
["Next Review Date"]
["Notes","Applicant confirmed in March 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the long-term public benefit from the project is still anticipated.\n\n\n08 June 2022 - Amendment supported\nAmendment supported to extend the duration of support until 31 December 2023 and to allow the applicants to collect the postcodes of patients’ registered GPs, to aid in assessing links between areas of deprivation and incidence and outcome of pancreatic cancer. \n\nSpecific conditions of support \n1. Further patient and public involvement and engagement activity should be carried out to explore the views of using confidential patient information without consent as described in the study and what steps can be taken to address any concerns which are raised around this. An interim report should be provided within six-months of the final outcome letter for consideration by a sub-committee of reviewing members. This should provide an overview of the activity, the feedback provided and how this has been acted upon. Confirmation of the appointed patient representatives should also be provided. \n\n03 August 2020 – Conditions met; this was met 3 August 2020, however the CAG applied a further condition for the first annual review:\n\nThe CAG noticed the difficult in recruiting to patient and public involvement due to the Covid-19 pandemic. The Group asked that continuing patient and public involvement was undertaken and feedback provided at the annual review. This needed to include clarity over the use of the data gathered, whether any data security breaches had occurred, as this was a concern expressed during the patient and public involvement, and confirmation of the active involvement of the patient representatives in the management of the project.\n\nAnnual review submitted 12 August 2021, and the CAG considered responses. The CAG felt that given the circumstances, particularly the restrictions the Covid pandemic has placed on activities, that the applicant has complied with the conditions that CAG imposed. The CAG recommend continued support and would like to accept the offer to resume the survey with the Royal London Hospital patients from August 2021 and provide the aggregated responses in the next annual review. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 17 May 2019 \n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n• Barts Cancer Centre (Queen Mary University of London) has a confirmed ‘Standards Met’ grade on DSPT 2018/19 by NHS Digital email 04 August 2019,\n• NHS Discovery East London – has a confirmed ‘Standards Met’ grade on DSPT 2018/19 by NHS Digital email 16 January 2020."]

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[]
[]
["Application Number",2456]
["Reference","15/CAG/0005"]
["Other Refs","IRAS Project ID: 167242  REC Reference: 10/H1102/25"]
["Application Title","Research to identify measures of quality and safety of healthcare"]
["Application Summary","This application from Imperial College London set out the purpose of the establishment of two databases. The first database would include a monthly and annual pseudonymised extract of Hospital Episode Statistics (HES) from the Health and Social Care Information Centre (HSCIC) on English NHS hospitals for the purpose of research. Data from this database would be provided to the Dr Foster Unit at Imperial College in a pseudonymised format.\n\nThe second database would hold a limited set of identifiable fields including NHS number and local patient ID to allow acute provider trusts to identify their own patients contributing to mortality alerts or other quality and safety alerts for the purpose of case note audits and mortality reviews."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Paul Aylin"]
["Address","Dr Foster Unit, School of Public Health"]
[null,"Imperial College London"]
[null,"3 Dorset Rise, London"]
["Postcode","EC4Y 8EN"]
["Telephone","0207 594 3334"]
["Email","p.aylin@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients admitted to hospitals by the HSCIC to Imperial College"]
["Description of confidential patient information used","Access was requested to monthly and annual extracts of HES, including Hospital Consultant Code, General Practitioner Code and Referring Practitioner Code and NHS number, Local Patient ID (LOPATID) and date of death (these three data items would be included on the second database only) "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2015-07-30"]
["Next Review Date","N/A"]
["Notes","Support expired, confirmed 15 October 2021\n\nApplicants confirm they have deleted and destroyed all identifiers (The local patient identifier LOPATID and the NHS Number) \n\n•\tPlease may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency.\n\nThe alerting service and re-identification service have benefited patients through improvement of care processes \n\n29 July 2019 - Amendment supported\nThe amendment to change the processing site to Imperial College London, Faculty of Medicine, School of Public Health (Primary Care and Public Health, Dr Foster Unit) is fully supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support:\n1. Confirmation of suitable security arrangements via Data Security and Protection Toolkit submission \nConfirmed – Imperial College London, Faculty of Medicine, School of Public Health (Primary Care and Public Health, Dr Foster Unit).\n2. Confirmation of a favourable opinion from a Research Ethics Committee \nConfirmed"]

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[]
[]
["Application Number","02457"]
["Reference","19/CAG/0226"]
["Other Refs","IRAS project ID: 272184, REC reference: 19/LO/1597"]
["Application Title","The SAFER Trial: Screening for Atrial Fibrillation with ECG to Reduce stroke - a randomised controlled trial"]
["Application Summary","This application from University of Cambridge set out the purpose of medical research which aims to evaluate whether screening for atrial fibrillation (AF) in patients aged 65 and over prevents stroke, heart attacks and other problems and does not cause significant harm to patients and represents good value for money for the NHS.\nThe study is a large eight-year research programme which involves an internal pilot, which will compare the outcomes for patients who are screened for AF against a control cohort in a randomised controlled trial. Randomisation will occur at GP practice level. The majority of the study will be undertaken on a fully consented basis; however, there is a qualitative sub-study element which involves observations for which consent will not be sought.\nThere are two elements to the observational element – the first involves observations in GP practice waiting rooms, practice meetings and administrative offices. The applicant will not be seeking consent from any patients in connection with these observations; however, it is identified that confidential patient information may be incidentally disclosed during the course of these observations which the researcher has no legal basis to receive. It is confirmed that no data will be recorded during these observations and patient information is not the focus of the observations.\nA second observational element is described whereby researchers will observe staff interactions with patients in order to observe how the intervention is being delivered. In this circumstance, the patient would be asked to provide verbal consent to the researcher’s presence prior to the observations commencing, much in the same way as medical student observations are handled. Any objections would be respected. However, the applicant has requested that section 251 support extends to these observations also, as there is potential that clinicians running screening clinics may disclose confidential patient information before an individual patient joins the consultation.\nA recommendation for class 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Jonathan Mant - Professor of Primary Care Research"]
["Address","Primary Care Unit"]
[null,"Strangeways Research Laboratory"]
[null,"2 Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone","01223 330325"]
["Email","jm677@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients of the 11 GP practices participating in the ethnographic observational research element of the overarching SAFER trial study."]
["Description of confidential patient information used","Data sources\nNo confidential patient information will be recorded during the observations.\nIdentifiers required for linkage purposes\nNo confidential patient information is required for the observational element – any disclosure will be incidental.\nIdentifiers required for analysis purposes\nNo patient information will be recorded during the observational elements of the study.\nAdditional information\nAll wider elements of the study take place with patient consent and are out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-01-17"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in November 2022 that ‘s251’ support can be expired, as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, ethnographic observations are a vital part of understanding the context in which a screening programme for the condition atrial fibrillation is being delivered in the SAFER trial and hence the context in which a future national screening programme would be implemented (if recommended by the trial results).\n\n26 February 2021 – Amendment supported\nAmendment supported to allow the option of remote observations of practice meetings and training sessions and of staff interactions with patients.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 23 October 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Not checked due to the number of sites involved. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]

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[]
[]
["Application Number","A02458"]
["Reference","19/CAG/0084"]
["Other Refs","IRAS project ID: 256309, REC reference: 19/EM/0162"]
["Application Title","Developing Diagnostic and Prognostic Algorithms Using Digital Pathology and Artificial Intelligence"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research with the aim of establishing a research database to aid the development of artificial intelligence for use in the diagnosis of breast cancer.\n\nDigital images are becoming an increasingly important medium for diagnostic histopathology, making the process more efficient and facilitating consultation between practising pathologists. There is a pressure to develop artificial intelligence (AI) guided systems to aid diagnosis by developing objective tools for disease recognition and characterisation. Data is required both to train the AI systems and to test their performance and accuracy. This database, comprising high quality digital images with linked data from a large patient cohort, will be used to train AI systems to recognise disease states and distinguish between them, validate algorithms derived from the training process and aid the discovery of novel prognostic and diagnostic biomarkers. The resulting database would comprise one of the largest and most unique breast tissue databases in the world, which also has linked patient follow-up. The addition of high-resolution digital images would increase the usability of the database in terms of bringing together morphological and biological data as well as aiding in the development of AI and other computational approaches to further improve digital pathology and ultimately transform digital pathology practice.\n\nA data acquisition team, comprised of employees of the University of Nottingham, will collect the relevant data using NHS Trust computer systems at the Nottingham University Hospitals NHS site. The data acquisition team will be responsible for pseudonymisation of the data, prior to its release to the data manager at the University of Nottingham. Data will only be released to researchers in a pseudonymised form. \n\nThe applicant had identified three cohorts within the overarching patient cohort to be included in the study. These were described as follows:\n\n1. Patients diagnosed with breast disease prior to 2006 (This cohort was the subject of the application to the CAG)\n\n2. Patients diagnosed with breast disease between 2006 and 2011 (This cohort was the subject of the application to the CAG)\n\n3. Patients diagnosed with breast disease between 2011 and 2019"]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Emad Rakha, Professor of Breast Cancer Pathology"]
["Address","University of Nottingham, NUH Trust, Pathology Department"]
[null,"Nottingham City Hospital"]
[null,"Hucknall Road, Nottingham"]
["Postcode","NG5 1PB"]
["Telephone","01159691169 Ext 56416"]
["Email","emad.rakha@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The application covered three cohorts. The CAG was being asked only to consider of sub-group of patients within cohort one, which consisted of:\n\n• Patients diagnosed with breast disease prior to 2006 at the Nottingham University Hospitals NHS Trust (Between 1 January 1976 to 31 August 2006)\n• Generic consent had been provided however the applicant was unsure on the validity of the consent given, and could not find adequate documentary evidence.\n\nCohort two, which consisted of:\n\n• All patients, male and female, diagnosed with breast disease at the Nottingham University Hospitals NHS Trust, from 2006 to 2011.\n• These patients would have undergone surgical treatment, as part of their routine care, and have clino-pathological data available and tissue material surplus to diagnostic pathology needs. \n• A sub-group of 1200 patients within this cohort who had not been approached for consent previously are the subject to the application to the CAG. "]
["Description of confidential patient information used","Data sources\n1. Electronic Health records held within Nottingham University Hospitals NHS Trust.\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Gender\nIdentifiers required for analysis purposes\n1. Gender\n\nAdditional Information\nThe application set out a further cohort for which support was not requested at this time as follows:\n• Cohort three: patients diagnosed with breast cancer between 2011 – 2019 – to be included on the basis of consent"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-01-22"]
["Next Review Date","2025-01-22"]
["Notes","04 December - Specific conditions of support updated:\nThe following sets out the updated specific conditions of support applied against this application reference.\n\n1. All staff at Nottingham University Hospitals NHS Trust (RX1) that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 04 July 2019\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\n(Confirmed - Nottingham University Hospitals NHS Trust NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02459"]
["Reference","19/CAG/0170"]
["Other Refs","IRAS project ID: 243026, REC reference: 19/EM/0283"]
["Application Title","Evaluating the effectiveness, and cost-effectiveness, of a pharmacist-led IT-based intervention (PINCER) when widely implemented in general practices to reduce the prevalence of patient exposure to hazardous prescribing, and the incidence of serious harm"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research which aims to evaluate the effectiveness and cost-effectiveness of a pharmacist-led IT-based intervention (PINCER) when widely implemented in general practices. The PINCER system searches computer records to find patients who have already received medications which might harm them. The previous PINCER study found that the number of patients at risk of harm is reduced when GPs use this approach, along with the support of a pharmacist to correct any problems found.\nThe PINCER tool is a new model of care and has been incorporated into national guidelines to support medicines optimisation by both NICE and NHS England. The PINCER Tool is made available to general practices via CHART, a GP practice software tool owned by PRIMIS. This study aims to evaluate whether the PINCER tool reduces the prevalence of patient exposure to hazardous prescribing, reduced the incidence of serious harm in patients at risk of hazardous prescribing and provides value for money for the NHS.\nThe application will involve the extraction of confidential patient information from up to 350 GP Practices in the East Midlands area for patients seen between 28 February 2013 and 31 August 2019, who were prescribed certain medications and were at increased risk of one or more of the following conditions: asthma attacks, stroke, gastric/stomach bleeding, worsening kidney disease and heart failure. This data will be linked with HES and ONS to enable primary care prescribing practices to be evaluated against hospital admissions and mortality in patients.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Anthony J Avery - Professor of Primary Health Care"]
["Address","University of Nottingham, Division of Primary Care, School of Medicine"]
[null,"Room 1301, Tower Building"]
[null,"University Park, Nottingham"]
["Postcode","NG7 2RD"]
["Telephone",1158231010]
["Email","tony.avery@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients of up to 350 GP practices across 11 Clinical Commissioning Groups in the East Midlands area seen between 28 February 2013 and 31 August 2019 will be included in the study. Up to 2.8 million patient records will be included from these GP practices from which the at-risk patient groups for prescribing issues would be identified. It is estimated that this will include 900,000 patients."]
["Description of confidential patient information used","Data sources\n1. GP Practice Records\n2. HES, NHS Digital\n3. ONS Mortality Data, NHS Digital\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n3. Post code (unit level)\n4. Sex\n5. Study ID\nIdentifiers required for analysis purposes\n1. Sex\n2. Age\n3. Study ID"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-01-23"]
["Next Review Date","N/A"]
["Notes","26 June 2020 - applicant confirmed that support is no  longer required\n\n18 June 2020 - Amendment supported to extend the duration of support until 31 December 2020 and to make minor amendments to patient and practice facing documentation\n\nConditions of support:\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 02 December 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n• NHS Digital has confirmed ‘Standards Met’ on DSPT 2018/19.\n• University of Nottingham has confirmed ‘Standards Met’ on DSPT 2018/19 (DSPT Tracker 23.09.2019)\n• Nottingham University Hospitals NHS Trust – Confirmed: Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. \n• PRIMIS (University of Nottingham) – has confirmed ‘Standards Met’ on DSPT 2018/19 (by NHS Digital email dated 04 August 2019)."]

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[]
[]
["Application Number","02460"]
["Reference","20/CAG/0010"]
["Other Refs","IRAS project ID: 269963, REC reference: 19/EM/0331, Resubmission of 19/CAG/0218"]
["Application Title","Pulmonary Hypertension (PH) population characterisation and epidemiological analysis"]
["Application Summary","This application from Sheffield Teaching Hospitals NHS Foundation Trust, IQVIA and Janssen set out the purpose of medical research which aims to gain an understanding of the profile and care pathway for patients with Pulmonary Arterial Hypertension (PAH), which is a progressive and rare disease caused by constriction of the pulmonary arteries. There are other types of Pulmonary Hypertension, including Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Sarcoidosis-Associated Pulmonary Hypertension (SAPH). Due to the complexity, late diagnosis and absence of real-world studies there is currently a lack of understanding regarding the clinical pathway leading to diagnosis and post-diagnosis. There is also the need to further explore and study patient related outcomes associates with these diseases in routine clinical practice.\nThe applicants propose to investigate these aims by undertaking a non-interventional retrospective database analysis of a patient cohort with pulmonary hypertension and its sub-types identified from the Pulmonary Vascular Disease Unit at Sheffield Teaching Hospitals NHS Foundation Trust. This data will be linked with wider clinical information within the HRA dataset retained by NHS Digital.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Foundation Trust, IQVIA and Janssen"]
["Contact Name","Professor David Kiely - Consultant Respiratory Physician, Director of the Sheffield Pulmonary Vascular Disease Unit (SPVDU)"]
["Address","Sheffield Teaching Hospitals NHS Foundation Trust, Pulmonary Vascular Disease Unit\nRoyal Hallamshire Hospital\nGlossop Road, Sheffield"]
[null,"Royal Hallamshire Hospital"]
[null,"Glossop Road, Sheffield"]
["Postcode","S102JF"]
["Telephone","(0114) 271 2132"]
["Email","d.kiely@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with Pulmonary Hypertension, including Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Sarcoidosis-Associated Pulmonary Hypertension (SAPH) managed at the Sheffield Teaching Hospitals NHS Foundation Trust since 01/01/2010 to 17/09/2019. It is estimated that 5,000 patients will be included in the study."]
["Description of confidential patient information used","Data sources\n1. Electronic health records, Sheffield Teaching Hospitals NHS Foundation Trust\n2. Hospital Episodes Statistics, NHS Digital\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\nIdentifiers required for analysis purposes\nNot applicable – no data items retained for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-01-23"]
["Next Review Date","N/A"]
["Notes","12 January 2022 - Support Expired:\nApplicant confirmed 12 January 2022 that support no longer required as all identifiable data had been deleted. \n\nIn terms of public benefit, the applicant has provide the following information;\n• The healthcare community & academia could gain a better understanding of the diagnosis and treatment of PH patients in England, providing opportunities to identify areas to improve services, improve the patient journey, provide earlier treatment and to improve quality of life for patients.\n• Participants and non-participants could have increased access to information about their disease from the production of publications of study findings, which will be made available through the listed IQVIA Ltd website (noted on the posters at the STHFT), and potentially other channels e.g. PHA UK who support this research.\n• The evidence produced could help inform research direction for novel treatment in this severely under-served disease.\n\n\nSpecific conditions of support\n1. Favourable opinion from REC Confirmed 28 November 2019.\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. It was confirmed that the relevant DSPT submission related only to NHS Digital."]

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[]
[]
["Application Number","A02461"]
["Reference","19/CAG/0161"]
["Other Refs","IRAS project ID: 210735, REC reference: 17/SC/0164"]
["Application Title","CRYOSTAT-2: A multi-centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation"]
["Application Summary","This application from Queen Mary University of London and NHS Blood and Transplant set out the purpose of medical research which aims to undertake a randomised-controlled trial evaluating two treatment methods for patients who suffer uncontrolled bleeding following a major trauma incident.\nPatients who have severe bleeding after injury develop a problem with their clotting system which means that they tend to bleed more. One of the main problems is due to low levels of fibrinogen, a clotting protein normally circulating in the bloodstream. Fibrinogen acts as the ‘glue’ which holds a blood clot together and at low levels, blood clots don’t form properly, and bleeding can continue. Cryoprecipitate is a frozen blood component prepared from plasma and rich in fibrinogen. By transfusing cryoprecipitate early to replace fibrinogen levels in bleeding trauma patients, it is predicted that blood clots will be more stable and reduce bleeding. The study involves two patient cohorts – the first is treated with standard of care treatment involving blood transfusions, the second involves administration of cryoprecipitate and standard treatment with normal blood transfusions, to see if cryoprecipitate can improve survival in trauma patients with severe bleeding. The cryoprecipitate treatment will be administered to patients within 90 minutes of an eligible patient’s admission to hospital.\nThe study commenced in August 2017 and aims to recruit 1142 patients from 24 major trauma centres across the UK. Due to the emergency situation, patients are recruited to the study on the basis of personal and/or professional consultee’s advice, under the emergency provision of the Clinical Trial Regulations until the patient regains capacity and fully informed consent can be obtained direct from the patient. The applicants have subsequently found that there is a subset of patients (76 patients from the current\nrecruited cohort of 273, 28% of overall cohort) from whom it was not possible to obtain fully informed consent. The application has been submitted to the CAG to seek support under the Regulations to enable linkage with wider administrative datasets held by NHS Digital and the Trauma and Audit Research Network to enable follow-up of this cohort of patients.\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Queen Mary University of London and NHS Blood and Transplant"]
["Contact Name","Professor Karim Brohi - Chair of Trauma Science - Queen Mary's University of London"]
["Address","Bart's & the London NHS Trust"]
[null,"Trauma Sciences, Royal London Hospital"]
[null,"Whitechapel, London, UK"]
["Postcode","E1 1BB"]
["Telephone","02078822200"]
["Email","k.brohi@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 and over who suffered a major trauma haemorrhage from August 2017 onwards in England and Wales, who were recruited to the CRYOSTAT2 trial on the basis of personal/professional consultee from whom formal informed consent was not provided for the ongoing participation in the study. 28% of the recruited patient cohort do not have a recorded consent."]
["Description of confidential patient information used","Data sources\n1. CRYOSTAT2 study records held at participating Trusts\n2. ONS Mortality data, NHS Digital\n3. Patient reported outcome measures (PROMS) data, Trauma and Audit Research Network\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Postcode (unit level)\n5. Sex\nIdentifiers required for analysis purposes\n1. Date of death\n2. Cause of death\n3. Sex\nAdditional information\nThe study also involves patients in Northern Ireland which are out of scope for the CAG application."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-01-28"]
["Next Review Date","2023-01-28"]
["Notes","05 May 2022 - Amendment supported\nAmendment supported to include quality of life data and injury severity data, to increase the number of participants from 1142 to 1556, and to extend the duration of support to 31 August 2022.\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 25 September 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n• Trauma and Audit Research Network has a confirmed ‘Standards Met’ grade on DSPT 2018/19 (Checked via tracker on 30/09/2019),\n• NHS Digital has a confirmed ‘Standards Met’ grade on DSPT 2018/19,\n• NHS Blood and Transplant Service a confirmed ‘Standards Met’ grade on DSPT 2018/19 (by NHS Digital email dated 09 January 2020)."]

{"sheet":"A02462","index":505,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02462"]
["Reference","20/CAG/0003"]
["Other Refs","IRAS project ID: 242187, REC reference: 20/WM/0002"]
["Application Title","Study of cancer risks in ataxia telangiectasia heterozygotes"]
["Application Summary","This application from the University of Birmingham set out the purpose of medical research which seeks to determine whether carriers of an ATM (Ataxia Telangiectasia Mutated) mutation have an increased risk of developing cancer.\nThe study began in 1998 and recruited the parents of children identified as carrying ATM as participants. At that time, the research team were aware of 100 families with ATM. The parents of patients with ATM were identified from the AT-Society Register and their GPs were contacted by the research team to seek permission to contact the parents. For parents of children not on the AT-Register, the researchers contacted both the referring clinician and then the GP for permission to contact the parent. Both groups of parents were then contacted by the researchers and their participation proceeded on a consented basis. Patients with ATM were not contacted unless neither parent could be contacted, the patient was over 18 years of age and the GP gave consent for the contact.\nParticipants completed questionnaires, providing details on their parents, siblings and children, and the details of more distant relatives who were known to have had cancer. The questionnaire also asked a series of questions related to known or suspected risk factors for breast or other cancers, including smoking, alcohol consumption, radiation exposure, hormonal and reproductive factors. The research team then confirmed the incidences of cancer and deaths reported in participants’ relatives via the NHS Central Register (NHSCR) and flagged these cohorts of relatives. This was done to provide longer term prospective follow up. Only the participants completing the questionnaires consented to inclusion and the relatives were not approached for consent.\nIn 2003, the University of Cambridge securely transferred the name, date of birth, address and sex of individuals in the cohort to the Office of National Statistics (ONS) to confirm details on cancer diagnoses and causes of death that were already held on these individuals. The individuals were also flagged on the ONS central register so that the researchers could be informed of any future cancers or deaths. Information was transferred from ONS to the University of Cambridge at regular intervals.\nIn this application, the applicants are seeking support to access data held by NHS Digital for both participants in the study and their relatives since 2004, as the consent given by\nparticipants for the original study did not cover this linkage and the relatives of participants were not approached for consent to inclusion in the study. The participants in the original study will not be re-contacted.\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Professor A.M.R. Taylor - Professor of Cancer Genetics"]
["Address","University of Birmingham"]
[null,"Institute of Cancer & Genomic Sciences"]
[null,"Vincent Drive, Edgbaston, Birmingham"]
["Postcode","B15 2TT"]
["Telephone","01214144488"]
["Email","amalcolmrtaylor47@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Members of 139 families in the UK where one of the children had ataxia telangiectasia and who were invited to be part of the original study, which began in 1998. 1700 patients will be included. The original participants were recruited between 10/06/1998 and 31/12/2002. The cohort is now closed and no new participants will be included.\nBlood relatives of the affected children were invited to take part."]
["Description of confidential patient information used","Data sources\n1. ONS data held by NHS Digital\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Date of death\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-02-03"]
["Next Review Date","2025-02-03"]
["Notes","27\tJanuary 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – cancer registrations and mortality data. \n\nSpecific conditions of support\n1. Favourable opinion from REC. Confirmed 30 January 2020.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. (Confirmed: University of Cambridge School of Clinical Medicine (by NHS Digital email 08 July 2019) and NHS Digital (by NHS Digital email 10 June 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02463","index":506,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02463"]
["Reference","19/CAG/0224"]
["Other Refs","IRAS project ID: 272811, REC reference: 19/WS/0171"]
["Application Title","Health Pathfinder: An evaluation of health-based domestic abuse interventions"]
["Application Summary","This application from SafeLives set out the purpose of medical research which aims to undertake an evaluation of the Health Pathfinder project which is operated by Cardiff University. The aims of the evaluation are to recommend comprehensive health practice and a model health response in relation to domestic abuse and wider issues related to Violence Against Women & Girls. This research, funded by the Pathfinder Project, will assess the effectiveness of the interventions by evaluating overall change created. It will also assess the overall systemic change in referral pathways.\nSafeLives have a very specific role in the evaluation; to collect and analyse quantitative data which will feed into Cardiff University’s external evaluation. This data will be derived and analysed from patient medical records. This data will allow the evaluation to consider the impact that Pathfinder has made to the number of patients who are asked about domestic abuse in the health setting, the number of patients who disclose domestic abuse in a health setting and the number of patients who are referred to specialist services.\nThe applicants are seeking to access patient medical records on site at the trusts participating in the Pathfinder project to evaluate the efficacy of the programme. A minimum of two days (where patients are admitted or treated by the health setting) will be selected. The first date will be selected from the six-month period prior to the start of the Pathfinder project and the second date will be from after the Pathfinder project has been implemented (between 6 and 12 months, depending on how long Pathfinder has been active in the site). Once the dates have been selected, all male patients and patients under the age of 16 would be removed from the medical records to confirm the study sample. A minimum of 50 cases will be researched in each health setting (a minimum of 25 on the date before the start of Pathfinder and 25 on the date after). If there are fewer than 25 patients in the sample on the date chosen, an additional day will be picked, and the days amalgamated.\nWhilst sites are being advised to redact confidential patient information from the records which are being made available to researchers, this will not be possible at all sites. It is also noted that the researchers will have access to free text information which may also contain confidential patient information. The application has been submitted to seek section 251 support to legitimise access to patient records by the research team to enable an anonymised dataset to be extracted for analysis.\nA recommendation for class 1 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","SafeLives"]
["Contact Name","Mrs Nanya Coles - Research Manager"]
["Address","SafeLives, Suite 2a, Whitefriars"]
[null,"Lewins Mead"]
[null,"Bristol"]
["Postcode","BS1 2NT"]
["Telephone","07763 582 671"]
["Email","nanya.coles@safelives.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female patients aged over 16 years treated at one of the named 13 sites on the two specified review dates around the implementation of the Pathfinder study. A minimum of 50 records per site will be accessed."]
["Description of confidential patient information used","Data sources\nPatient medical records at the following sites:\n1. Royal Devon and Exeter NHS Trust\n2. Northern Devon Healthcare Trust\n3. Barnet, Enfield And Haringey Mental Health NHS Trust\n4. North Middlesex University Hospital Trust\n5. Somerset Partnership & Taunton and Somerset NHS Foundation Trusts\n6. Yeovil District Hospital NHS Foundation Trust\n7. Camden and Islington Mental Health Foundation Trust\n8. North Staffordshire Combined Healthcare NHS Trust\n9. Southern Health NHS Foundation Trust\n10. Blackpool Teaching Hospitals NHS Foundation Trust\n11. Imperial College Healthcare NHS Trust\n12. West London NHS Trust\n13. Chelsea and Westminster Hospital NHS Foundation Trust\nIdentifiers required for linkage purposes\nNot applicable – Trusts will identify the patient cohort and provide the applicant with patient records. All key items of confidential patient information will be redacted from the records.\nIdentifiers required for analysis purposes\n1. Age\n2. Ethnicity\n3. Sex"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-02-03"]
["Next Review Date","N/A"]
["Notes","Support expired July 2020\n\nSpecific conditions of support\n1. Further patient and public involvement and engagement activity should be undertaken with the SafeLives Pioneer group as planned. Feedback should be provided at the time of first annual review of the activities undertaken and overview of the views expressed. It is recommended that the group be consulted on the suitability of the patient-facing materials.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 06 November 2019\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Not checked due to the number of sites at which confidential patient information would be processed with support under the Regulations. Support would be recommended on the basis that the applicant would be responsible for ensuring that the appropriate security assurance standards had been met at each site, prior to undertaking any processing."]

{"sheet":"A02464","index":507,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02464"]
["Reference","19/CAG/0228"]
["Other Refs","IRAS project ID: 248052 REC reference: 18/NW/0856"]
["Application Title","Impact & acceptability of 10-year risk at breast cancer screening v1"]
["Application Summary","This application from University of Manchester set out the purpose of medical research which aims to test the effect of communicating personalised estimates of breast cancer risk (BC-Predict) on acceptability, informed choices and possible harms to women offered personalised risk estimates. This project will examine the benefits to service users of introducing BC-Predict as part of the NHS Breast Screening Programme (NHSBSP) and identify the potential impact of BC-Predict on healthcare resource use and NHS workload.\nThe National Institute for Health and Care Excellence (NICE) states that women at high-risk of breast cancer should have more frequent breast mammography (x-ray) screening and be offered risk-reducing treatment with the medicines tamoxifen, raloxifene or anastrozole. However, women at increased risk of breast cancer in the NHSBSP cannot be offered prevention drugs or extra screening as the screening programme does not currently estimate or inform women of their risk. Breast Cancer (BC) Predict will automate the breast cancer risk estimation process so that it is feasible for roll-out in the wider NHSBSP.\nA proportion of women invited to participate in the BC-Predict study and a proportion who received standard breast screening will be invited to participate in the questionnaire study. Those opting to participate will join via online consent, following which they will a questionnaire asking about anxiety, worry, risk, attitudes to screening, intentions, capability, health status, and healthcare resource use. Women will be asked to complete the questionnaire at two future time points (3 and 6 months post mammogram). It is this element which required consideration by the CAG as access to confidential patient information would be required to facilitate the invitation process. Support is sought to legitimise access to confidential patient information contained on the NHS Breast Screening Programme database to enable eligible patients to be identified and invited to participate. The NHSBSP database will be accessed remotely from the Manchester University NHS Foundation Trust site.\nThis project will also use individual interviews to explore how women feel about receiving their 10-year risk of developing breast cancer as part of the NHSBSP. The applicants will also conduct focus groups with healthcare professionals to examine the perceived\nimpact that providing 10-year risk of breast cancer to women in the NHSBSP has on the screening programme, General Practice, and Secondary Care (breast cancer Family History Clinics; FHCs). This element is out of scope for CAG consideration as these women will be approached on the basis of consent which was provided.\nA recommendation for class 1, 2, 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Dr Lorna McWilliams, Research Fellow "]
["Address","University of Manchester"]
[null,"Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9PL"]
["Telephone","0161 275 2555 "]
["Email","lorna.mcwilliams@manchester.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women aged between 57 and 63 years, who are invited for their first breast screening appointment with the Greater Manchester, East Cheshire or East Lancashire breast screening programmes or for a mammogram at East Cheshire or East Lancashire. 527 patients will be recruited in each group. It is anticipated that 1054 women will be invited to achieve the required cohort size."]
["Description of confidential patient information used","Data sources\n1. NHS Breast Screening Programme database - accessed remotely from the Manchester University NHS Foundation Trust site\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Full address and postcode\nIdentifiers required for analysis purposes\nNot applicable – information will only be retained with the consent for those individuals who participate.\nAdditional information\nThe BC-Predict database will also be accessed in order to invite 1054 women to participate in this proposed study from this cohort; however, section 251 support is not required to access this database as patients have consented to their inclusion on this database and to be approached about this wider research."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-02-04"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised, as of December 2021.\n\nIn terms of public benefit,  the activity taken under Regulation 5 support has helped applicants to better understand the impact of potential changes to the health and care system if risk-stratified breast cancer screening were to be introduced to replace the current programme. The findings contribute to the evidence that a risk-stratified breast cancer screening programme is unlikely to produce major psychological harms related to anxiety and cancer worry for those who receive it. \n\n\n14 September 2020 - Amendment supported to extend the duration of study support until December 2021.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 25 February 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed – Manchester University NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 29 January 2020)."]

{"sheet":"A02465","index":508,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02465"]
["Reference","19/CAG/0209"]
["Other Refs","IRAS project ID: 244799, REC reference: 19/WA/0311"]
["Application Title","Advanced cardiovascular risk prediction in the acute care setting"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to determine whether a diagnostic chest pain algorithm can be updated with machine learning techniques to prevent known loss in accuracy over time.\nThe Troponin-only Manchester Acute Coronary Syndromes (T-MACS) decision aid allows clinicians to rapidly “rule out” the diagnosis of a heart attack when patients present to the Emergency Department with chest pain or similar symptoms. Research from over 4,000 patients has shown the algorithm is accurate, allowing over 40% of patients to be safely reassured following a single blood test that they are not having a heart attack and discharged from A&E. Research suggests that locality and different patient populations may have an important impact on the accuracy of the T-MACS algorithm. In addition, as patient demographics and standards of care evolve with the passage of time, the accuracy of the algorithm is likely to decline (a phenomenon known as 'calibration shift'). T-MACS has taken 14 years and seven clinical studies to be clinically ready and the applicants explained that repeating this process would be expensive, resource intensive and unfeasible.\nLong term heart disease risk factors are routinely measured in the emergency department, and could be used to predict long term risk. 23.4 million patients attend ED each year, ED attenders are often less engaged with primary care and Greater Manchester has double the national average of preventable heart disease deaths. The applicants will use routinely collected retrospective data to refine the T-MACS algorithm and examine long-term risk factors. Confidential patient information will be linked to HES data to determine patient’s outcomes and machine-learning to identify the best ways to continuously update T-MACS.\nThe study is comprised of three stages and support under Section 251 is required for the three stages:\nStage 1 – data for three patient cohorts who attend emergency departments with chest pain will be examined and linked to HES data at NHS Digital. Approximately 9000 patients will be included.\nStage 2 – data from approximately 12000 patients who were treated in practice using T-MACS will be used to determine the best statistical approaches to allow the algorithm to evolve over time and to be tailored to different local populations.\nStage 3 - a further retrospective analysis of the advanced machine learning enhanced algorithm will be conducted in the 11 hospitals using T-MACS in Greater Manchester. A pilot evaluation of its impact on resource utilisation and patient outcomes will then be undertaken.\nA recommendation for class 1, 2, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Manchester "]
["Contact Name","Dr Charles Reynard"]
["Address","Division of Cardiovascular Sciences"]
[null,"University of Manchester "]
[null,"Oxford Road, Manchester"]
["Postcode","M13 9WL"]
["Telephone"]
["Email","charlie.reynard@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","51,000 patients aged 18 years and older who are included on the Greater-Manchester hospitals Troponin-only Acute Coronary Syndromes database (GMTMACS) between 2011-2019, and patients presenting to Manchester University NHS Foundation Trust with suspected cardiac chest pain for the years 2008 and 2011.\nStage 1 : Long term cardiovascular risk prediction\nJanuary 2008 - January 2009 [~3,000 patients]\nDecember 2011 - December 2012 [~3,000 patients]\nAugust 2016 - August 2017 [~3,000 patients]\nStage 2: Training/optimization phase\nJune 2016 - October 2019 [~24,000 patients]\nStage 3: Validation phase\nOctober 2019 - October 2020 [~30,000 patients]"]
["Description of confidential patient information used","Data sources\n1. Greater-Manchester hospitals Troponin-only Acute Coronary Syndromes database (GMTMACS)\n2. Electronic and paper records at Manchester University NHS Foundation Trust, Stockport NHS Foundation Trust, Wrightington, Wigan and Leigh NHS Foundation Trust and East Lancashire Hospitals NHS Foundation Trust\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Postcode – sub-sector level\nIdentifiers required for analysis purposes\n1. Postcode – sector level\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,"Y","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-02-05"]
["Next Review Date","2025-02-05"]
["Notes","17 August 2023 - change in data processor from NHS Digital to NHS England regarding data source Hospital Episode Statistics (HES)\n\n17 February 2022 - Amendment supported:\nAmendment supported to extend the duration of support until 22 December 2023.\n\n13 October 2020 – Amendment supported\nThe amendment has been submitted to correct an oversight in the initial application. The applicants stated that they would be obtaining patients' mortality, but had not made it explicit that they would be obtaining this data from the civil registration dataset at NHS Digital. The applicants have revised the protocol to make it clear that both the civil registration and HES datasets at NHS Digital will be linked to. \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 06 January 2020.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold:\n• Confirmed – the University of Manchester (by NHS Digital email dated 04 October 2019), Wrightington, Wigan and Leigh NHS Foundation Trust (by NHS Digital email dated 23 January 2020), Stockport NHS Foundation Trust (by NHS Digital email dated 23 January 2020), East Lancashire Hospitals NHS Foundation Trust (by NHS Digital email dated 24 January 2020) and Manchester University NHS Foundation Trust (by NHS Digital email dated have confirmed ‘Standards Met’ grades on DSPT submission 2018/19.\n• Confirmed - Manchester University NHS Foundation Trust NHS Digital (by NHS Digital email dated 29 January 2020) have confirmed qualified assurance against\nthe organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training.\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02466","index":509,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02466"]
["Reference","19/CAG/0189"]
["Other Refs","IRAS project ID: 167498, REC reference: 15/EE/0151"]
["Application Title","Bart’s Gynae Tissue Bank"]
["Application Summary","This application from the Bart’s Cancer Institute at the Queen Mary University of London, sets out the purpose of medical research that seeks to continue the Bart’s Gynae Tissue Bank, which was established to provide tissue samples to be used in specific research programmes aimed at improving the treatment of patients with gynaecological cancer.\nThe applicants will collect gynaecological cancer samples, including ascites, blood and urine for research purposes. In addition to this, they will collect blood, urine and tissue from patients with surgical pathology (benign or malignant), as well as blood and urine from healthy volunteer donors. Tissue samples will be collected via a diagnostic or therapeutic procedure and will include tissue derived from the primary site and from metastatic spread. Fresh tissue will be harvested at the time of biopsy or surgery.\nPatients at sites other than Bart’s Health NHS Trust will be identified by a suitably trained member of the direct care team at their appointment when the ascitic drain, biopsy or surgical procedure is discussed or when the patient's case is reviewed at a gynaecology-oncology or other multidisciplinary team meeting (MDT). Members of the healthcare team will discuss blood, urine and tissue collection with patients during routine clinical consultations.\nAt Bart’s Health NHS Trust sites, patient records held on electronic and paper records will be screened to identify suitable patients. In this application, support is sought for members of the Research Tissue Bank team, as well as the direct care team to screen and approach suitable patients. Once a member of the Research Tissue Bank team has identified a suitable patient, they will ask a member of the direct care team if it is appropriate to approach the patient. If so, the patient will then be approached for consent and their inclusion in the tissue bank will proceed on a consented basis.\nA recommendation for class 1, 3, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Bart’s Cancer Institute at the Queen Mary University of London"]
["Contact Name","Dr Michelle Lockley"]
["Address","Queen Mary, University of London"]
[null,"Bart’s Cancer Institute, John Vance Science Centre"]
[null,"Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone",2078823582]
["Email","m.lockley@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients diagnosed with gynaecological cancer and treated within Bart’s Health NHS Trust.\nThe applicants anticipated that 35 patients per month would be deemed eligible for inclusion in the tissue bank."]
["Description of confidential patient information used","Data sources\n1. Electronic and paper records held within Bart’s Health NHS Trust.\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n6. Ethnicity\nIdentifiers required for analysis purposes\n1. Name\n2. Date of birth\n3. Date of death\n4. Gender\n5. Ethnicity\nAdditional information\nThe analysis dataset will be retained on the basis of patient consent."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-02-07"]
["Next Review Date","2024-02-07"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 22 January 2020.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \na. Confirmed: Bart’s Cancer Centre has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 04 August 2019. \nb. Confirmed: Bart’s Health NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02467","index":510,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02467"]
["Reference","19/CAG/0163"]
["Other Refs","IRAS project ID: 253147, REC reference: 18/SW/0260"]
["Application Title","Developing new care pathways for women at low risk of breast cancer"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research which sought to determine if it is safe, feasible and acceptable to reduce the frequency at which women at low risk of developing breast cancer are called from screening. The applicants also seek to design and refine information materials which highlight the benefits and harms of breast screening for women with a low risk of developing breast cancer.\nIn 2013, the National Institute of Care Excellence (NICE) indicated that women at high/moderate risk of breast cancer should receive the option to take chemoprevention medication, and that women at high risk should receive screening more frequently. These guidelines have not been implemented into the NHS Breast Screening Programme (NHSBSP) as women are not given information of their risk. Providing women with their breast cancer risk is currently being piloted in 5 screening sites across the North West of England by the BC-Predict study, with the primary aim of identifying women at high risk so that the NICE guidelines can be implemented. If a sizeable proportion of women at high risk opt for additional screening it is likely that compensations will need to be made elsewhere to facilitate this. Before recommending that the frequency of screening for low risk women is reduced, the applicants intend to examine the safety, feasibility and acceptability of reducing the frequency of screening by holding interviews with relevant groups.\nThe project is comprised of three phases.\n1. In the first phase, prominent professionals with a significant role in the NHSBSP will be interview. Support under Section 251 is not required for this aspect of the study. For the second and third phases, interviews will be held with women at low risk of developing breast cancer.\n2. Interviews will be held with women at low risk of developing breast cancer.\na. One group will be women identified via BC-Predict, who will have consented to take part in other, related, research project. Support under Section 251 is not required for this group.\nb. Women approaching the screening age (46-52) will be identified from the NHS National Breast Screening Service (NBSS) database by members of the low risk study team at Manchester University NHS Foundation Trust, and invited to take part. Support under Section 251 is sought to include this group.\n3. “Think aloud” interview, where women are asked to read information out loud and share their views, will be held.\na. One group will be women identified via BC-Predict, who will have consented to take part in other, related, research project. Support under Section 251 is not required for this group.\nb. Women who are currently engaging in the NHS Breast Screening Programme will be identified via the NHS NBSS database. The low risk study team at Manchester University NHS Foundation Trust will contact this group to invite them to take part. Support under Section 251 is sought to include this group.\nA recommendation for class 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor David French - Professor of Health Psychology"]
["Address","The University of Manchester"]
[null,"School of Psychological Sciences"]
[null,"Coupland 1 Building, Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone","01612752605"]
["Email","david.french@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Phase 2:\n15-20 women approaching screening age, living in the Greater Manchester, East Lancashire and Central Cheshire areas\nPhase 3:\n15-20 women active in the NHSBSP and living in the Greater Manchester area"]
["Description of confidential patient information used","Data sources\n1. The NHS National Breast Screening Service database\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Full address and postcode\nIdentifiers required for analysis purposes\n1. Postcode"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"Y","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-02-11"]
["Next Review Date","N/A"]
["Notes","Expire support Confirmed December 2020\n\n•\tPlease may you confirm the reason that support is no longer required? all data has been pseudonymised; and identifiable data deleted.\n\n•\tPlease may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency. We were able to explore the acceptability of changing the way the NHS breast screening programme is delivered depending on an individual woman’s risk of breast cancer. The findings are being used to inform a large study where women are offered the opportunity to receive their breast cancer risk and which could change the way the breast screening programme is delivered in the future.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. (Confirmed 26 June 2019).\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: Manchester University NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training.\n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data."]

{"sheet":"A02468","index":511,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02468"]
["Reference","19/CAG/0154"]
["Other Refs","IRAS project ID: 265331, REC reference: 19/EE/0244"]
["Application Title","The CANDID study: Understanding how to improve making, communicating and recording a medical (differential) diagnosis in the acute care setting through institutional, legal and ethical drivers."]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that seeks to determine whether the making, communicating and recording of a medical (differential) diagnosis in the acute care setting can be improved through institutional, legal and ethical drivers.\nGood processes to achieve diagnosis are essential for healthcare, but are challenging due to the complex interplay of practical, social, legal, and ethical issues involved. This application is seeking to examine the process of making, communicating and recording a differential diagnosis in the acute care setting. The project also aimed to investigate the institutional and legal influences on making diagnoses, and the ethical and philosophical influences on making and communicating diagnoses.\nThe study proposed five workstreams, of which only two require consideration by the CAG.\nWorkstream two is a qualitative study of differential diagnosis. Support under Section 251 is sought to conduct observations of the diagnostic process in three acute care settings. Interviews will also be carried out, but support is not required for this aspect of the workstream.\nWorkstream four is a medical record review feasibility study. Support under Section 251 is sought to allow a quantitative note review to be conducted to examine the reach and permanence of diagnostic labels assigned in acute care settings.\nThe wider workstreams in the project, which do not require support, involved an ethical and philosophical literature review (WS1) and a legal analysis of diagnostic practices (WS3) which do not involve the processing of confidential patient information and are out of scope for this application. The final workstream (five) intended to develop an ethical and legally grounded framework for making, communicating and recording diagnosis based on analysis from the earlier workstreams.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Zoe Fritz - Consultant Physician"]
["Address","THIS institute"]
[null,"Clifford Allbutt Building Cambridge Biomedical Campus, "]
[null,"Cambridge"]
["Postcode","CB2 0AH"]
["Telephone",7811173307]
["Email","zbmf2@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","It was anticipated that 250 patients would be involved in the observations.\nThe records of 120 patients would be accessed at each site, in order to allow for 20 opt-outs at each site. The applicants aimed to include 200 records at each site."]
["Description of confidential patient information used","Data sources\n1. Medical records held at University Hospitals Cambridge NHS Foundation Trust\n2. Medical records held at GP practices\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID Number\n4. GP registration\nIdentifiers required for analysis purposes\n1. Name\n2. Date of birth\nAdditional information\nNo confidential patient information will be collected from the patient observations.\nConfidential patient information without consent will only be collected for patients included in the medical records review for Work Package 4"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-02-17"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as the activity did not commence. During the pandemic, applicants were unable to access GP practices or emergency departments. They therefore opted to do two vignette studies, instead of the planned note analysis. Because of this, no part of the project involved or involves unconsented use of identifiable patient data. \n\nSpecific conditions of support\n1. Further patient and public involvement needs to be undertaken and feedback provided to the CAG when the annual review is submitted.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 18 December 2019.\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed - Cambridge University Hospitals NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 19 September 2019."]

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[]
[]
["Application Number","02469"]
["Reference","18/CAG/0201"]
["Other Refs","IRAS project ID: 226468, REC reference: 18/LO/2159"]
["Application Title","Retinal injuries resulting from handheld laser devices: Incidence and epidemiology"]
["Application Summary","This application from the Leeds Teaching Hospitals NHS Foundation Trust set out the purpose of medical research which aims to establish the incidence of laser-related retinal injuries in the UK, the range of presenting symptoms and signs, natural history, prognosis and complication rates. In addition the information generated could support changes to regulation of manufacture and sale of laser devices as well as providing an evidence base for future public health campaigns.\nThe study will operate via the established BOSU methodology, which has been approved in principle by the CAG, to enable treating ophthalmologists to report to the BOSU unit that they have seen a case within their clinic. The BOSU unit will pass details of the reporting clinician to the applicant, to enable follow-up with a data collection questionnaire. Reporting will be carried out across a 13 month period, beginning in early 2019. A follow-up questionnaire will also be shared six months following initial reporting.\nA recommendation for class 1, 5 and 6 support was requested to cover activities as described in the application form."]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Dr Ruth Darbyshire - ST3 Specialty Registrar Ophthalmology"]
["Address","Leeds Teaching Hospitals Trust"]
[null,"Ophthalmology Department"]
[null,"St James University Hospitals Trust, Beckett Street, Leeds"]
["Postcode","LS9 7TF"]
["Telephone",7761420646]
["Email","ruthdarbyshire@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","An individual of any sex or age with a unilateral or bilateral retinal lesion with changes in visual function and fundal examination consistent with macular thermal injury in England and Wales, treated in a participating site across the 13-month reporting period. It is estimated that there would be approximately 90-150 cases across the UK per annum."]
["Description of confidential patient information used","The following items of confidential patient information will be disclosed from treating ophthalmologists to the applicants at Leeds Teaching Hospital NHS Trust to enable sample validation, removal of duplicate entries and facilitation of the six month follow questionnaire:\n• Date of birth (in MM/YY format only),\n• Postcode,\n• Sex."]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-02-17"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed expiry of support 26 October 2021. \nThe study never began due to the pandemic. \n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee (Confirmed 09 December 2019).\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission (Confirmed: Leeds Teaching Hospitals NHS Trust (by NHS Digital email 12 July 2019) has confirmed ‘Standards Met’ grade on DSPT 2018/19)."]

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[]
[]
["Application Number","A02470"]
["Reference","19/CAG/0197"]
["Other Refs","IRAS project ID: 209347, REC reference: 19/EM/0351"]
["Application Title","Vaccination timeliness in preterm infants"]
["Application Summary","This application from the University of Hull set out the purpose of medical research that seeks to investigate the timeliness of primary vaccinations given to preterm infants.\nAll infants born in England are invited to be vaccinated according to an established schedule, however some evidence suggests that preterm infants (infants born at 37 weeks gestation or less) are not being vaccinated in a timely manner. This is a population particularly at risk of infection, and the applicant seeks to understand whether vaccinations are delayed and the reasons why this might be. The applicant has already undertaken and published a literature review, in which 14 studies were identified as demonstrating that preterm infants did experience delays in receiving vaccinations. Additionally, infants with the lowest gestational ages and the lowest birth weights experienced the greatest delays. The last UK study into this was undertaken in 2000 and the vaccination schedule has changed considerably since then.\nThe applicant will analyse existing data, routinely collated via established databases. The datasets used are the Maternity Services Data Set (MSDS), Child Health Information Service (CHIS), to access vaccination details for full term and preterm infants, and the National Neonatal Research Database (NNRD), for details on preterm infants. Data for infants due their primary vaccinations between 01 January 2018 and 30 June 2018 in the Humber Coast and Vale Local Maternity System will be requested from the corresponding MSDS and sent to Information Services at Hull University Teaching Hospitals NHS Trust. Information Services will then send the NHS numbers of identified patients to CHIS, to link with the infant’s vaccination status, and to corresponding preterm data held in the NNRD. The NNRD operates with support under Section 251 and its Regulations under reference ECC 8-05(f)/2010. The CHIS and MSDS databases operate under directions from NHS England, with The Health and Social Care Act 2012, section 254, section 259(1), section 259(5) as the legal basis for processing. Support under Section 251 was therefore requested for data from the three databases to be linked in the trial dataset. The full dataset will then be anonymised before it is sent to the applicant for analysis.\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Hull"]
["Contact Name","Miss Helen Sisson"]
["Address","Faculty of Health Sciences"]
[null,"University of Hull"]
[null,"Cottingham Rd, Hull"]
["Postcode","HU67RX"]
["Telephone",1482464538]
["Email","h.sisson@hull.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All infants born between 06 November 2017 and 05 May 2018 within the region covered by the Humber Coast and Vale Local Maternity System who are due their primary vaccinations (those offered at 8, 12 and 16 weeks of age) over a six-month period from January 1st 2018 to June 30th 2018.\nThe total sample size is estimated as 6000 patients."]
["Description of confidential patient information used","Data sources\n1. Maternity Services data set (MSDS), provided by Northern Lincolnshire and Goole (NLAG) NHS Foundation Trust, York Teaching Hospital NHS Foundation Trust and Hull University Teaching Hospitals (HUTH) NHS Trust.\n2. Child Health Information Service (CHIS), provided by Harrogate and District NHS Foundation Trust, Humber NHS Foundation Trust, NLAG NHS Foundation Trust and North East Lincolnshire Council\n3. The National Neonatal Research Database (NNRD), managed by the Neonatal Data Analysis Unit (NDAU) at Imperial College London and Chelsea and Westminster NHS Foundation Trust.\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth (infants and mothers)\n3. Date of death\n4. Gender\n5. Ethnicity\nIdentifiers required for analysis purposes\n1. Date of birth (infants and mothers)\n2. Date of death\n3. Neonatal Unit Location\n4. Gender\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-02-17"]
["Next Review Date","2021-02-17"]
["Notes","09 October 2020 - Amendment supported to remove York Teaching Hospitals NHS Trust and Harrogate and District NHS Foundation Trust as data processors.\n\nSpecific conditions of support\n1. Favourable opinion from REC Confirmed 04 December 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nDue to the number of sites processing under the application scope, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to accessing confidential patient information with support under the Regulations. This would need to be established at the following sites:\n\n• Northern Lincolnshire and Goole (NLAG) NHS Foundation Trust\n• York Teaching Hospital NHS Foundation Trust\n• Hull University Teaching Hospitals (HUTH) NHS Trust.\n• Harrogate and District NHS Foundation Trust\n• Humber NHS Foundation Trust,\n• North East Lincolnshire Council\n• Chelsea and Westminster NHS Foundation Trust.\n• Imperial College London."]

{"sheet":"A02471","index":514,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02471"]
["Reference","19/CAG/0211"]
["Other Refs","IRAS project ID: 270697, REC reference: 19/LO/1699"]
["Application Title","Improving the effectiveness of cancer multidisciplinary team meetings (MDTMs) in Surrey and Sussex"]
["Application Summary","This application from the University of Surrey set out the purpose of medical research that seeks to determine whether use of the intervention package improve the effectiveness and efficiency of cancer multidisciplinary team meetings (MDTMs) in routine NHS practice in Surrey and Sussex.\nThe current cancer strategy for England recommends reform to priorities complex cases for discussion during cancer MDTMs, but lacks guidance in how to do so. There were also concerns that meetings were not run as efficiently as they could be. The applicants will implement and evaluate an intervention package comprising three tools within 11 MDTMs across three tumour types. Two of the three tools have already been developed; the MDT-FIT to help teams evaluate and plan improvements to their teamworking and MDT-QulC to support teams in ensuring the adequacy of patient information in MDTMs. A third component will involve the development of a streamlining protocol to prioritise complex patient cases using a modified Delphi consensus. A range of outcome measures will be collected and compared pre and post intervention implementation, with the primary measure being the change in percentage of decisions changed following MDTMs as a result of information not being available to the MDT.\nSupport under Section 251 is being requested as members of the research team, who are not members of the direct care team, will need to access computerised and paper notes systems to extract outcome data. This data will be pseudonymised at the point of extraction and no items of confidential patient information will be included in the study database. Researchers will also observe MDTM meetings where patients are discussed, in order to observe the process, complete the MDT-QulC and time the length of discussions.\nA recommendation for class 1, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Surrey"]
["Contact Name","Dr Cath Taylor - Reader in Healthcare Workforce Organisation and Wellbeing"]
["Address","School of Health Sciences, Kate Granger Building"]
[null,"University of Surrey"]
[null,"Guildford"]
["Postcode","GU2 7XH"]
["Telephone","01483688862"]
["Email","cath.taylor@surrey.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"Y","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over with a suspected diagnosis of lung, oeosphago-gastric or hepatobiliary and pancreatic cancer.\n1220 patients are estimated to be included, comprised of 800 lung cancer, 160 oeosphago-gastric cancer and 260 hepatobiliary and pancreatic cancer."]
["Description of confidential patient information used","Data sources\n1. Paper and electronic records held at participating Trusts:\na. Royal Surrey County NHS Foundation Trust\nb. Frimley Health Foundation Trust\nc. Surrey and Sussex Healthcare NHS Trust\nd. Brighton and Sussex University Hospitals NHS Trust\ne. Western Sussex Hospitals NHS Trust\nf. East Sussex Healthcare NHS Trust\ng. Ashford and St Peters Hospital NHS Foundation Trust\n2. Information on patients discussed at MDTMs held at the above participating Trusts.\nIdentifiers required for linkage purposes\n1. NHS number\nIdentifiers required for analysis purposes\n1. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"Y","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-02-18"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed support expired October 2021:    \nThe research team are only used de-identified data.   The results are still to be analysed, and the public benefits will be made clear in a report to the funder in due course. \n\n\n17 May 2021 - Amendment supported:\nThe amendment, to remove the oeosphago-gastric cancer and hepatobiliary and pancreatic cancer tumour pathways, meaning that only the lung cancer pathway will now be the focus of the application, to reduce the sample size from 2440-3660 to 1200-2400, and to extend the end date of the study from 31 August 2021 to 31 October 2021, is fully supported, subject to compliance with the standard conditions of support.\n\n18 February 2020 - Application supported\n\nSpecific conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 13 February 2020.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]

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[]
[]
["Application Number","02472"]
["Reference","19/CAG/0230"]
["Other Refs","IRAS Project ID: 235520 REC reference: 17/SC/0666"]
["Application Title","Advanced analytics in primary care: provision of actionable information for quality improvement for antibiotic reduction, care advice and medication safety (ACTION)"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to evaluate the impact of online feedback dashboards, used by health professional, on improvements in patient care, the rate of antibiotic prescriptions and the incidence of potentially hazardous prescribing and monitoring. \n\nThe applicants are seeking to make better use of the data available in Electronic Health Records (EHRs) and to present it in more user-friendly ways to health professionals. Three eLab dashboards will be created, the PINGR (Performance Improvement plaN GeneratoR), SMASH (Smart MedicAtion Safety dashboard) and Building Rapid Interventions to reduce antimicrobial resistance & over-prescribing of antibiotics (BRIT). GP practices and other NHS sites in Greater Manchester and the Wirral will be recruited to the study and sign up to the service. Each practice involved will receive the eLab dashboards. The effectiveness of using the intervention will be evaluated quantitatively using an interrupted time series study design, by comparing the numbers of patients who receive an appropriate antibiotic in each practice before and after implementation of the eLab dashboards. Log files of the eLab dashboards will be examined to investigate the frequency with which the dashboards are used and how this varies between practices and over time. \n\nResearchOne will generate pseudonyms for primary care data, using a SALT, and transfer this to NHS Digital, who will generate HES data with pseudonyms and the research team at the University of Manchester will receive de-identified primary and secondary care data. It would be technically possible for NHS Digital to identify patients in the ResearchOne cohort, therefore the applicants sought support under Section 251 for this data linkage.  "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Tjeerd van Staa"]
["Address","University of Manchester"]
[null,"Vaughan House\nPortsmouth Street"]
[null,"Manchester"]
["Postcode","M13 9PT"]
["Telephone","01613060662\n\nGreater Manchester and Wirral has a population of 3 million people, and the applicant noted that this was the potential maximum number of patients whose data would be included. "]
["Email","tjeerd.vanstaa@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients from birth upwards with an infection whose data was included in ResearchOne.\n\nGreater Manchester and Wirral has a population of 3 million people, and the applicant noted that this was the potential maximum number of patients whose data would be included. "]
["Description of confidential patient information used","Data sources\n\n1.\tResearchOne\n2.\tHES data held by NHS Digital \n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information are required for data linkage. Linkage will be performed using a SALT ID number.\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be required for analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","N/A"]
["Notes","NB - study has two entries in the register\nApplicant advised that support was no longer required as of 26 October 2021. The study was unable to start due to the coronavirus pandemic. \n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 09 March 2020.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. It was confirmed that the relevant DSPT submission related only to NHS Digital. "]

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[]
[]
["Application Number","A02473"]
["Reference","19/CAG/0208"]
["Other Refs","IRAS Project ID: 244359 REC reference: 19/LO/1704"]
["Application Title","Aetiology, timing and risk factors for tuberculosis-associated deaths in London: a retrospective, case-control study"]
["Application Summary","This application from the London North West University Healthcare NHS Trust set out the purpose of medical research that seeks to investigate the causes and timing of death for people with a diagnosis of tuberculosis who either die during tuberculosis treatment or in the six months following the end of treatment.\n\nTuberculosis is an infection, usually occurring in the lungs, that affects approximately 5,000 people within the UK each year. Patients are generally treated with a course of antibiotics over at least six months. This treatment will cure the majority of patients, but around 5% will die during the treatment. Some deaths will be related to the tuberculosis infection itself or the treatment. \n\nThe applicants will carry out a retrospective review of case notes and other specified medical records for patients who have died of tuberculosis and a control group, age-matched to the patient group. Public Health England will generate a list of patients who died from tuberculosis independently of the London Tuberculosis Register. These data will be sent to the Chief Investigator, who will cross check it with a list of patients known to have died from TB generated from each of the local London Tuberculosis Registers, held at London North West University Healthcare NHS Trust and Bart’s Health NHS Trust, to check for omissions.  Age matched controls will be randomly selected from the local London Tuberculosis Registers as well.  The Chief Investigator will then access electronic confidential patient records at the two Trusts involved. The records of patients at London North West University Healthcare NHS Trust will be accessed by the Chief Investigator for this project, who is also a member of the direct care team. The Chief Investigator will also access patient records held at Bart’s Health NHS Trust, where they are not a member of the direct care team. Paper records may need to be requested, if the electronic record is incomplete, but the applicant anticipated that this would happen rarely. "]
["Applicant Organisation Name","London North West University Healthcare NHS Trust"]
["Contact Name","Dr Jessica Barrett"]
["Address","TB Services"]
[null,"London North West University Healthcare NHS Trust"]
[null,"Watford Road"]
["Postcode","HA1 3UJ"]
["Telephone",7779110992]
["Email","jessica.barrett5@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","225 Male and female patients aged 16 years and over, diagnosed with tuberculosis and who died during treatment for tuberculosis, prior to the start of treatment or in the six months following the end of treatment\n\n225 Age-matched controls who survived treatment for tuberculosis will also be included. "]
["Description of confidential patient information used","Data sources\n\n1.\tThe London Tuberculosis Register, held at London North West University Healthcare NHS Trust and Bart’s Health NHS Trust\n2.\tPublic Health England record of tuberculosis related deaths in London\n3.\tElectronic and paper records held at London North West University Healthcare NHS Trust\n4.\tElectronic and paper records held at Bart’s Health NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS number\n3.\tHospital ID number\n4.\tDate of birth\n5.\tDate of death\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n2.\tGender \n3.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","2024-03-10"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 10 December 2019.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed: Bart’s Health NHS Trust (by NHS Digital email dated 18 September 2019) and Public Health England (by NHS Digital emailed dated 02 September 2019) have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19. \n\n•\tConfirmed: London North West Healthcare NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\n•\tAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

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[]
[]
["Application Number","02474"]
["Reference","19/CAG/0187"]
["Other Refs","IRAS Project ID: 44297 REC reference: 10/H1207/22"]
["Application Title","Multifrequency Bioimpedance in the Early Detection of Lymphoedema after Axillary Surgery"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to determine whether bioimpedance electrical analysis (BEA) or perometer assessment is the optimal technique to predict early development of lymphoedema and to determine the optimum cut-off value for either multi-frequency bioimpedance or perometer arm swelling.\n\nThe original trial was a clinical investigation of a medical device, set up to determine whether multi-frequency bioimpedance electrical analysis (multi-frequency BEA) could be used instead of a fixed perometer to detect early arm swelling and predict lymphoedema development 2 years after axillary surgery. Lymphoedema (arm swelling greater than 10% volume increase) occurs in up to 35% of patients after removal of all axillary lymph nodes during treatment for breast cancer. Lymphoedema is difficult to treat and prevention would be a better and more cost-effective strategy. Current methods for measuring lymphoedema are based on tape measurement of arm circumference or perometer arm measurements, which involves 3D scanning of the arm, using non-invasive techniques, to measure the arm volume. Perometer measurement, to generate a 3D profile of the arm and look at changes over time from before surgery, has suggested that early increases in arm volume within 6 months of surgery predict the later development of lymphoedema by 18 months or 2 years. Multi-frequency BEA is a non-invasive technique developed to measure total water content, which involves passing an extremely small electrical current through the body and measuring the impedance (or resistance) of the flow of this current. \n\nPatients in the trial were identified and approached by members of the direct care team and their participation proceeded on a consented basis. The original trial required a 60-month follow-up period to look for lymphoedema and recurrence. The applicants now plan to link the data collected during the original trial to the following NHS databases: Hospital Episodes Statistics (HES), Multiple Index Deprivation Domain (MIDD), the Office of National Statistics (ONS), National Radiotherapy Dataset (RTDS) and National Cancer Registration and Analysis Service (NCRAS). The linkage will be undertaken by Public Health England (PHE). The applicants had not always received notification that participants had died, experienced recurrence or been lost to follow-up and the data linkages via PHE would be undertaken in order to establish a fully saturated follow-up dataset for the study. PHE had determined that patients in the original trial had not been sufficiently informed of the scope of the follow-up involved and that the consent given did not cover the planned follow-up. The applicants are therefore seeking support under Section 251 and its Regulations to undertake the data linkages. "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Hayley Brooks, Clinical Trials Manager            "]
["Address","1st Floor NIHR Building, Wythenshawe Hospital, "]
[null,"Manchester University NHS Foundation Trust"]
[null,"Southmoor road"]
["Postcode"," M23 9QZ"]
["Telephone","0161 291 2433"]
["Email","Hayley.brooks@mft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1232 participants in the Multifrequency Bioimpedance in the Early Detection of Lymphoedema. The study began in 23/07/2010 and closed to recruitment in February 2016.  The study is currently in active follow-up."]
["Description of confidential patient information used","Data sources\n\n1.\tHospital Episodes Statistics (HES)\n2.\tMultiple Index Deprivation Domain (MIDD)\n3.\tOffice of National Statistics (ONS) Mortality data\n4.\tNational Cancer Registration and Analysis Service (NCRAS)\n5.\tNational Radiotherapy Dataset (RTDS)\n6.\tCancer Waiting Times\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tDate of birth\n4.\tDate of death\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","N/A"]
["Notes","Support expired September 2021 - Applicant confirmed October 2021:\n\nDates of birth and dates of death converted to age in the anonymised dataset provided to the research team.   Confidential Patient Information held was destroyed in September 2021\n\nIt was envisaged that the study’s findings would identify any potential delays in vaccinating preterm infants so that efforts to increase uptake could be targeted. The findings did in fact reveal that certain preterm infants receive their vaccines later than their peers, and this highlighted the potential for further work to address this issue.\n\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 14 June 2019.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed – Public Health England has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 02 September 2019.\n\n•\tPending - Manchester University NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 29 January 2020."]

{"sheet":"A02475","index":518,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02475"]
["Reference","19/CAG/0225"]
["Other Refs","IRAS Project ID: 264416 REC reference: 19/NW/0695"]
["Application Title","Raised intracranial pressure following intracerebral haemorrhage: association with survival and physiological variables"]
["Application Summary","This application from University of Manchester set out the purpose of medical research which aims to explore whether increase intracerebral pressure increases the risk of death. Spontaneous intracerebral haemorrhage (ICH) accounts for 1 in 5 of all strokes. Caused by bleeding into brain tissue, it carries a high risk of death or disability. The brain sits tightly inside the skull, so any increase in pressure on the brain structure, known as raised intracranial pressure (ICP), resulting from high blood pressure, the blood clot itself or swelling of brain tissue after the bleed, may cause a worsening of stroke-symptoms. Treatments, which aim to reduce pressure in the brain after ICH, have been a target for stroke physicians but there is currently no evidence that these measures improve outcome for patients.\n\nThe study will use existing clinical data to compare measurements of blood pressure recording from time of admission and from the first 72 hours of presentation with measurements of ICH, to assess if lowering blood pressure has an impact on ICH and patient recovery. The project will analyse patients within an existing dataset of 1500 records of patient admitted to Salford Royal NHS Foundation Trust (SRFT) following ICH, some of whom will have been treated in intensive care for the first 72 hours of their stay and had ICP measured. A patient cohort is already established for inclusion in the study, having been identified through the provision of direct care. \n\nIn order to meet the aims and objectives of this project, it will be necessary to extract additional data on a sub-set of patients (approximately 400 patients), who were treated within the intensive care unit (ITU) during the first 72 hours after ICH. The applicants will also extract all blood pressure recording for the first 72 hours of care for patients admitted to the ward. This additional clinical data, specifically clinical observation data e.g. pulse and blood pressure readings along with other measurements of central venous pressure (CVP) and intracranial pressure monitoring recorded during the first 72 hours after admission; will be extracted from the electronic patient record (EPR) and added to the research dataset. The data extraction will be undertaken by a member of the research team who is not part of the direct clinical care team."]
["Applicant Organisation Name","Salford Royal NHS Foundation Trust"]
["Contact Name","Dr Adrian Parry-Jones"]
["Address","Salford Royal NHS Foundation Trust"]
[null,"Stott Lane"]
[null,"Salford"]
["Postcode","M6 8HD"]
["Telephone",1612064458]
["Email","adrian.parry-jones@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1500 patients aged over 18 years, who were treated onsite at Salford Royal NHS Foundation Trust between 01 June 2013 to 31 May 2019 for acute intracerebral haemorrhage confirmed by brain imaging. The CAG remit extends to a sub-cohort of approximately 400 patients who were treated in the critical care area. "]
["Description of confidential patient information used","Data sources\n\n1.\tQI database of eligible patients, Salford Royal NHS Foundation Trust\n2.\tElectronic patient records, Salford Royal NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tHospital ID\n\nIdentifiers required for analysis purposes\n\n1.\tSex\n2.\tEthnicity \n3.\tAge "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed support expired from 2/11/2021\nAll data collection has been completed and the data are pseudonymised. The original identifiers which were supported are no longer being processed/retained. Applicants have retained the pseudonymised data collected as part of the project, which were haemodynamic and intracranial pressure measures for patients where an intracranial pressure monitor was inserted. \n\nApplicants will be preparing the work for submission to peer-reviewed journals and it may inform future studies. \n\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 November 2019\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – Salford Royal NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by \nNHS Digital email dated 19 November 2019. "]

{"sheet":"A02476","index":519,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02476"]
["Reference","20/CAG/0028"]
["Other Refs","IRAS Project ID: 219598 REC reference: 17/LO/0846"]
["Application Title","Small Area Health Statistics Unit Research Database"]
["Application Summary","This application from Imperial College London sets out the purpose of medical research which aims to maintain a research database focussing on research of environmental health risks.\n\nThis is a request for renewal of s251 support from the CAG for the Small Area Health Statistics Unit (SAHSU) Research Database. SAHSU has been ongoing since 1987, and this request is to allow continued collection and linkage of a number of datasets (listed below). The database will be used by research studies, primarily focussing on environmental health risks.\n\nSupport is requested to allow the disclosure of the following confidential information to SAHSU for linkage and research purposes:\n•\tHES data from NHS Digital containing details of all admissions (inpatient and day cases), critical care and Accident and Emergency attendances for patients treated in NHS hospitals in England. This includes the linked HES/Civil Registration mortality data for out of hospital deaths.\no\tConfidential information provided: date of birth, mother’s date of birth, gender, ethnicity and NHS number. Geographical information includes patient residential postcode.\n•\tData from the Office for National Statistics (ONS) on live births, stillbirths, and mortality registration data. (Note: SAHSU is currently in negotiation with NHS Digital to provide future access to this registration data, in addition to the health data described above).\no\tConfidential information provided: date of birth/death, age at the event, spouse’s age, parental ages and occupations, socioeconomic status, gender, ethnicity, and NHS number. Geographical information includes patient residential address\n•\tPHE provides SAHSU with annual extracts of cancer incidence/treatment data for the resident population of England.\no\tConfidential information provided: NHS number, date of birth, ethnicity, gender. Geographical information includes patient residential postcode. \n•\tWCISU provides SAHSU with an annual extract of cancer incidences data for the resident population of Wales.\no\tConfidential information provided: NHS number, date of birth, ethnicity, gender. Geographical information includes patient residential address"]
["Applicant Organisation Name","Imperial College London "]
["Contact Name","Professor Paul Elliott"]
["Address","Imperial College London, \nSchool of Public Health, St Mary's Campus "]
[null,"Norfolk Place"]
[null,"London"]
["Postcode","W2 1PG"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients in England and Wales."]
["Description of confidential patient information used","Data sources\n\n1.\tNHS Digital\n2.\tPublic Health England\n3.\tOffice for National Statistics\n4.\tPublic Health Wales NHS Trust (Welsh Cancer Intelligence & Surveillance Unit)\n\nIdentifiers required for linkage purposes\n\n1.\tNHS number\n2.\tDate of Birth\n3.\tDate of Death\n4.\tAddress\n5.\tPostcode \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-03-24"]
["Next Review Date","2024-03-24"]
["Notes","29 March 2023 - change in data processors from;\n•\tPublic Health England (PHE) to NHS England (previously NHS Digital), regarding data source National Cancer Registration and Analysis Service (NCRAS),\n•\tNHS Digital, to NHS England regarding data sources - Hospital Episode Statistics (HES), Office for National Statistics (ONS) data on live births, stillbirths, and mortality registration data, & General Practice Extraction Service (GPES).\n\n\n10 March 2021 - Amendment supported\nThe amendment, to include General Practice Extraction Service (GPES) data as a data source, and allow the transfer of identifiers from NHS Digital to the Small Area Health Statistics Unit (SAHSU) alongside other GPES data items, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support \n\n1.\tApplicants to consider a shorter, simpler form of privacy notice in lay format, linking to the full privacy notice. \n\n2.\tApplicants to consider more publicity of the work of SAHSU to the wider public\n\n3.\tApplicants to consider a project specific opt out. Applicants should either commit to doing so in a specific time frame, or provide justification why this will not be undertaken.\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed June 2017\n\n5.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed"]

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[]
[]
["Application Number","02477"]
["Reference","19/CAG/0230"]
["Other Refs","IRAS Project ID: 235520 REC reference: 17/CAG/0666"]
["Application Title","Advanced analytics in primary care: provision of actionable information for quality improvement for antibiotic reduction, care advice and medication safety (ACTION)"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to evaluate the impact of online feedback dashboards, used by health professional, on improvements in patient care, the rate of antibiotic prescriptions and the incidence of potentially hazardous prescribing and monitoring. \n\nThe applicants are seeking to make better use of the data available in Electronic Health Records (EHRs) and to present it in more user-friendly ways to health professionals. Three eLab dashboards will be created, the PINGR (Performance Improvement plaN GeneratoR), SMASH (Smart MedicAtion Safety dashboard) and Building Rapid Interventions to reduce antimicrobial resistance & over-prescribing of antibiotics (BRIT). GP practices and other NHS sites in Greater Manchester and the Wirral will be recruited to the study and sign up to the service. Each practice involved will receive the eLab dashboards. The effectiveness of using the intervention will be evaluated quantitatively using an interrupted time series study design, by comparing the numbers of patients who receive an appropriate antibiotic in each practice before and after implementation of the eLab dashboards. Log files of the eLab dashboards will be examined to investigate the frequency with which the dashboards are used and how this varies between practices and over time. \n\nResearchOne will generate pseudonyms for primary care data, using a SALT, and transfer this to NHS Digital, who will generate HES data with pseudonyms and the research team at the University of Manchester will receive de-identified primary and secondary care data. It would be technically possible for NHS Digital to identify patients in the ResearchOne cohort, therefore the applicants sought support under Section 251 for this data linkage.  "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Tjeerd van Staa"]
["Address","University of Manchester"]
[null,"Vaughan House"]
[null,"Portsmouth Street, Manchester"]
["Postcode","M13 9PT"]
["Telephone",1613060662]
["Email","tjeerd.vanstaa@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients from birth upwards with an infection whose data was included in ResearchOne.\n\nGreater Manchester and Wirral has a population of 3 million people, and the applicant noted that this was the potential maximum number of patients whose data would be included. "]
["Description of confidential patient information used","Data sources\n\n1.\tResearchOne\n2.\tHES data held by NHS Digital \n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information are required for data linkage. Linkage will be performed using a SALT ID number.\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be required for analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","N/A"]
["Notes","NB - study has two entries in the register\n\nApplicant advised that support was no longer required as of 26 October 2021. The study was unable to start due to the coronavirus pandemic. \n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 09 March 2020.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. It was confirmed that the relevant DSPT submission related only to NHS Digital. "]

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[]
[]
["Application Number","A02478"]
["Reference","19/CAG/0208"]
["Other Refs","IRAS Project ID: 244349 REC reference: 19/LO/1704"]
["Application Title","Aetiology, timing and risk factors for tuberculosis-associated deaths in London: a retrospective, case-control study"]
["Application Summary","This application from the London North West University Healthcare NHS Trust set out\nthe purpose of medical research that seeks to investigate the causes and timing of death\nfor people with a diagnosis of tuberculosis who either die during tuberculosis treatment\nor in the six months following the end of treatment.\nTuberculosis is an infection, usually occurring in the lungs, that affects approximately\n5,000 people within the UK each year. Patients are generally treated with a course of\nantibiotics over at least six months. This treatment will cure the majority of patients, but\naround 5% will die during the treatment. Some deaths will be related to the tuberculosis\ninfection itself or the treatment.\nThe applicants will carry out a retrospective review of case notes and other specified\nmedical records for patients who have died of tuberculosis and a control group, agematched\nto the patient group. Public Health England will generate a list of patients who\ndied from tuberculosis independently of the London Tuberculosis Register. These data\nwill be sent to the Chief Investigator, who will cross check it with a list of patients known\nto have died from TB generated from each of the local London Tuberculosis Registers,\nheld at London North West University Healthcare NHS Trust and Bart’s Health NHS\nTrust, to check for omissions. Age matched controls will be randomly selected from the\nlocal London Tuberculosis Registers as well. The Chief Investigator will then access\nelectronic confidential patient records at the two Trusts involved. The records of patients\nat London North West University Healthcare NHS Trust will be accessed by the Chief\nInvestigator for this project, who is also a member of the direct care team. The Chief\nInvestigator will also access patient records held at Bart’s Health NHS Trust, where they\nare not a member of the direct care team. Paper records may need to be requested, if\nthe electronic record is incomplete, but the applicant anticipated that this would happen\nrarely."]
["Applicant Organisation Name","London North West University Healthcare NHS Trust"]
["Contact Name","Dr Jessica Barrett"]
["Address","TB Services"]
[null,"London North West University Healthcare NHS Trust"]
[null,"Watford Road"]
["Postcode","HA1 3UJ"]
["Telephone",7779110992]
["Email","jessica.barrett5@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","225 Male and female patients aged 16 years and over,\ndiagnosed with tuberculosis and who died during treatment\nfor tuberculosis, prior to the start of treatment or in the six\nmonths following the end of treatment\n225 Age-matched controls who survived treatment for\ntuberculosis will also be included."]
["Description of confidential patient information used","Data sources\n\n1. The London Tuberculosis Register, held at London North\nWest University Healthcare NHS Trust and Bart’s Health\nNHS Trust\n2. Public Health England record of tuberculosis related\ndeaths in London\n3. Electronic and paper records held at London North West\nUniversity Healthcare NHS Trust\n4. Electronic and paper records held at Bart’s Health NHS\nTrust\n\nIdentifiers required for linkage purposes\n\n1. Name\n2. NHS number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n\nIdentifiers required for analysis purposes\n\n1. Date of death\n2. Gender\n3. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","2021-03-10"]
["Notes","Specific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 10 December\n2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the\nrelevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved\nthe ‘Standards Met’ threshold. See section below titled ‘security assurance\nrequirements’ for further information.\n• Confirmed: Bart’s Health NHS Trust (by NHS Digital email dated 18\nSeptember 2019) and Public Health England (by NHS Digital emailed\ndated 02 September 2019) have a confirmed ‘Standards Met’ grade on\nDSPT submission 2018/19.\n• Confirmed: London North West Healthcare NHS Trust - NHS Digital have\nconfirmed qualified assurance against the organisation’s 2018/19 DSPT\nsubmission on the basis that the Trust has not met the 95% standard\nrelating to staff security awareness training.\n• As a result, the following specific condition of support has been added:\nall staff involved in processing data under this section 251 support\nmust have successfully completed local security awareness training\nbefore processing any data."]

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[]
[]
["Application Number","A02479"]
["Reference","19/CAG/0187"]
["Other Refs","IRAS Project ID: 244349 REC reference: 19/LO/1704"]
["Application Title","Multifrequency Bioimpedance in the Early Detection of Lymphoedema after Axillary Surgery"]
["Application Summary","This application from the University of Manchester set out the purpose of medical\nresearch that seeks to determine whether bioimpedance electrical analysis (BEA) or\nperometer assessment is the optimal technique to predict early development of\nlymphoedema and to determine the optimum cut-off value for either multi-frequency\nbioimpedance or perometer arm swelling.\nThe original trial was a clinical investigation of a medical device, set up to determine\nwhether multi-frequency bioimpedance electrical analysis (multi-frequency BEA) could\nbe used instead of a fixed perometer to detect early arm swelling and predict\nlymphoedema development 2 years after axillary surgery. Lymphoedema (arm swelling\ngreater than 10% volume increase) occurs in up to 35% of patients after removal of all\naxillary lymph nodes during treatment for breast cancer. Lymphoedema is difficult to\ntreat and prevention would be a better and more cost-effective strategy. Current\nmethods for measuring lymphoedema are based on tape measurement of arm\ncircumference or perometer arm measurements, which involves 3D scanning of the arm,\nusing non-invasive techniques, to measure the arm volume. Perometer measurement, to\ngenerate a 3D profile of the arm and look at changes over time from before surgery, has\nsuggested that early increases in arm volume within 6 months of surgery predict the later\ndevelopment of lymphoedema by 18 months or 2 years. Multi-frequency BEA is a noninvasive\ntechnique developed to measure total water content, which involves passing an\nextremely small electrical current through the body and measuring the impedance (or\nresistance) of the flow of this current.\nPatients in the trial were identified and approached by members of the direct care team\nand their participation proceeded on a consented basis. The original trial required a 60-\nmonth follow-up period to look for lymphoedema and recurrence. The applicants now\nplan to link the data collected during the original trial to the following NHS databases:\nHospital Episodes Statistics (HES), Multiple Index Deprivation Domain (MIDD), the\nOffice of National Statistics (ONS), National Radiotherapy Dataset (RTDS) and National\nCancer Registration and Analysis Service (NCRAS). The linkage will be undertaken by\nPublic Health England (PHE). The applicants had not always received notification that\nparticipants had died, experienced recurrence or been lost to follow-up and the data\nlinkages via PHE would be undertaken in order to establish a fully saturated follow-up\ndataset for the study. PHE had determined that patients in the original trial had not been\nsufficiently informed of the scope of the follow-up involved and that the consent given did\nnot cover the planned follow-up. The applicants are therefore seeking support under\nSection 251 and its Regulations to undertake the data linkages."]
["Applicant Organisation Name","Manchester University NHS Foundation Trust"]
["Contact Name","Professor Nigel Bundred"]
["Address","2nd Floor, Education and Research Centre"]
[null,"Manchester University NHS Foundation Trust"]
[null,"Wythenshawe Hospital, Southmoor Road"]
["Postcode","M23 9LT"]
["Telephone",1612915859]
["Email","bundredn@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1232 participants in the Multifrequency Bioimpedance in the\nEarly Detection of Lymphoedema. The study began in\n23/07/2010 and closed to recruitment in February 2016. The\nstudy is currently in active follow-up."]
["Description of confidential patient information used","Data sources\n\n1. Hospital Episodes Statistics (HES)\n2. Multiple Index Deprivation Domain (MIDD)\n3. Office of National Statistics (ONS) Mortality data\n4. National Cancer Registration and Analysis Service\n(NCRAS)\n5. National Radiotherapy Dataset (RTDS)\n6. Cancer Waiting Times\n\nIdentifiers required for linkage purposes\n\n1. Name\n2. NHS Number\n3. Date of birth\n4. Date of death\n\nIdentifiers required for analysis purposes\n\n1. Date of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","2021-03-10"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 14 June 2019.\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the\nrelevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the\n‘Standards Met’ threshold. See section below titled ‘security assurance requirements’\nfor further information.\n• Confirmed – Public Health England has a confirmed ‘Standards Met’ grade\non DSPT submission 2018/19 by NHS Digital email dated 02 September\n2019.\n• Pending - Manchester University NHS Foundation Trust has a confirmed\n‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email\ndated 29 January 2020."]

{"sheet":"A02480","index":523,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02480"]
["Reference","19/CAG/0225"]
["Other Refs","IRAS Project ID: 264416 REC reference: 19/NW/0695"]
["Application Title","Raised intracranial pressure following intracerebral haemorrhage: association with survival and physiological variables"]
["Application Summary","This application from University of Manchester set out the purpose of medical research which aims to explore whether increase intracerebral pressure increases the risk of death. Spontaneous intracerebral haemorrhage (ICH) accounts for 1 in 5 of all strokes. Caused by bleeding into brain tissue, it carries a high risk of death or disability. The brain sits tightly inside the skull, so any increase in pressure on the brain structure, known as raised intracranial pressure (ICP), resulting from high blood pressure, the blood clot itself or swelling of brain tissue after the bleed, may cause a worsening of stroke-symptoms. Treatments, which aim to reduce pressure in the brain after ICH, have been a target for stroke physicians but there is currently no evidence that these measures improve outcome for patients.\n\nThe study will use existing clinical data to compare measurements of blood pressure recording from time of admission and from the first 72 hours of presentation with measurements of ICH, to assess if lowering blood pressure has an impact on ICH and patient recovery. The project will analyse patients within an existing dataset of 1500 records of patient admitted to Salford Royal NHS Foundation Trust (SRFT) following ICH, some of whom will have been treated in intensive care for the first 72 hours of their stay and had ICP measured. A patient cohort is already established for inclusion in the study, having been identified through the provision of direct care. \n\nIn order to meet the aims and objectives of this project, it will be necessary to extract additional data on a sub-set of patients (approximately 400 patients), who were treated within the intensive care unit (ITU) during the first 72 hours after ICH. The applicants will also extract all blood pressure recording for the first 72 hours of care for patients admitted to the ward. This additional clinical data, specifically clinical observation data e.g. pulse and blood pressure readings along with other measurements of central venous pressure (CVP) and intracranial pressure monitoring recorded during the first 72 hours after admission; will be extracted from the electronic patient record (EPR) and added to the research dataset. The data extraction will be undertaken by a member of the research team who is not part of the direct clinical care team."]
["Applicant Organisation Name","Salford Royal NHS Foundation Trust"]
["Contact Name","Dr Adrian Parry-Jones"]
["Address","Salford Royal NHS Foundation Trust"]
[null,"Stott Lane"]
[null,"Salford"]
["Postcode","M6 8HD"]
["Telephone",1612064458]
["Email","adrian.parry-jones@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1500 patients aged over 18 years, who were treated onsite at Salford Royal NHS Foundation Trust between 01 June 2013 to 31 May 2019 for acute intracerebral haemorrhage confirmed by brain imaging. The CAG remit extends to a sub-cohort of approximately 400 patients who were treated in the critical care area. "]
["Description of confidential patient information used","Data sources\n\n1.\tQI database of eligible patients, Salford Royal NHS Foundation Trust\n2.\tElectronic patient records, Salford Royal NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tHospital ID\n\nIdentifiers required for analysis purposes\n\n1.\tSex\n2.\tEthnicity \n3.\tAge \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-03-10"]
["Next Review Date","2021-03-10"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 November 2019\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – Salford Royal NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by \nNHS Digital email dated 19 November 2019. "]

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[]
[]
["Application Number","A02481"]
["Reference","20/CAG/0049"]
["Other Refs","IRAS Project ID: 270871 REC reference: 20/LO/0298"]
["Application Title","PREDICT Study: RaDaR and UKRR Linked Dataset"]
["Application Summary","This application from King's College Hospital set out the purpose of medical research which aims to create a new dataset to aid in developing a predictive tool to estimate the degree of pregnancy-associated progression and adverse pregnancy outcomes in women with CKD, including those with rare renal disease.\n\nModerate-severe chronic kidney disease (CKD) affects approximately 0.9 – 3.1% of women of childbearing age and is associated with higher rates of adverse pregnancy outcomes compared to healthy women. Approximately one in three women with moderate-severe kidney disease will require dialysis or lose at least 25% of kidney function within six months of delivery. It is estimated that over 1000 pregnancies per year in the UK are affected by moderate-severe CKD. This number is set to rise due to maternal factors associated with CKD, such as obesity and advancing maternal age, and the accessibility of assisted conception. Current risk estimates for pregnancy-associated pregnancies are based on a small, single centre study examining pregnancies between 1971 and 1997, which does not reflect contemporaneous practice or enable accurate individual risk prediction. There is also no up to date information for patients with rare renal disease, including those already receiving renal replacement therapy and kidney transplants. \n\nTwo renal datasets, the National Registry of Rare Kidney Diseases (RaDaR) and the UK Renal Register (UKRR), will be linked with two pregnancy data sets, Hospital Episodes Statistics and Maternity Services Data Set, by NHS Digital. The linked data will form a new dataset, to be used to create a prediction tool to improve the accuracy of information and the communication of risk between pregnant women with CKD and their clinicians. The datasets will be linked using NHS number and date of birth and pseudonymised linked data reported to the UK Renal Registry who will further link the data with UK Renal Registry records for renal outcomes. The UK Renal Registry will then transfer an anonymised dataset to the King's College Hospital research team."]
["Applicant Organisation Name","King's College Hospital "]
["Contact Name","Dr Kate Bramham"]
["Address","Weston Education Centre"]
[null,"King's College Hospital"]
[null,"10 Cutcombe Road, London "]
["Postcode","SE5 9RJ"]
["Telephone",2078480439]
["Email","kate.bramham@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","An estimated 750 pregnant women with Chronic Kidney Disease in England"]
["Description of confidential patient information used","Data sources\n\n1.\tNational Registry of Rare Kidney Diseases, held by the Renal Association and the UK Renal Registry, held by the Renal Association\n2.\tHES and Maternity Services Dataset at NHS Digital\n\nIdentifiers required for linkage purposes\n\n1.\tNHS number\n2.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-04-29"]
["Next Review Date","2024-04-22"]
["Notes","24 July 2023 - change in data processor from NHS Digital to NHS England regarding data sources Hospital Episodes Statistics and Maternity Services Data Set\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January 2022 to extend the duration of support until 31 December 2023.\n\n10 December 2020 - Amendment supported\nThe amendment, to clarify the estimated cohort of pregnant women with CKD with linked records to up to approximately 6000, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support:\n\n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold:\n\nConfirmed:\nThe NHS Digital 2019/20 DSPT review for NHS Digital, and The Renal Association were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 03 November 2020)\n\nThe NHS Digital 2018/19 DSPT review for King’s College Hospital NHS Foundation Trust was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking security awareness training’ on the NHS Digital DSPT Tracker (checked 03 November 2020). Please note the updated specific condition of support below.\n\nAll staff at King’s College Hospital NHS Foundation Trust that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\n2. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 10 December 2020\n\nSpecific conditions of support\n\n1.\tFavourable opinion from REC 15 Received April 2020\n\n2.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as ‘Standards Met’ for the duration of support, and at time of each annual review. King’s College Hospital NHS Foundation Trust, NHS Digital and The Renal Association have been confirmed as ‘Standards Met’ by NHS Digital. Confirmed via DSPT tracker, checked 23 March 2020."]

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[]
[]
["Application Number","02482"]
["Reference","20/CAG/0050"]
["Other Refs","IRAS Project ID: 265014 REC reference: 20/WM/0008"]
["Application Title","What is the prevalence of distal surface caries (DSC) in the lower second molar when screening patients with bitewing radiographs: A multi-center study"]
["Application Summary","This application from the University of Manchester sets out the purpose of medical research which aims to investigate the prevalence of distal surface caries (DSC) in the second mandibular molar adjacent to an impacted wisdom tooth.\nIn the UK, clinical guidelines state that impacted wisdom teeth should be left in place unless strict criteria are met. As a result, some clinicians feel that there is an increasing incidence of caries that develops in both teeth. Evidence suggests a high reported prevalence of distal surface caries (DSC) in second mandibular molars. But this prevalence may be high because it represents a population of referred hospital patients and does not relate to the prevalence in the general population. The wisdom tooth guidelines in the USA and Brazil recommend early removal of wisdom teeth with an emphasis on prevention unlike the UK.\nThis study proposes to investigate the prevalence of distal surface caries (DSC) in the second mandibular molar adjacent to an impacted wisdom tooth by examining existing radiographs of patients who attended the Manchester Dental Hospital for routine dental examination. The researcher will access the Trust Picture Archiving and Communication System (PACS) and review radiographs of 1012 consecutive patients meeting the inclusion/exclusion criteria. The hospital ID will also be provided to the student supervisor and head of the radiology department to also review the radiographs to ensure the findings are accurately recorded.\nIn addition, the study is working with centres in Brazil and the USA to compare the prevalence of DSC in the UK vs US and Brazil, due to differing guidelines."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Dr Verena Toedtling"]
["Address","Division of Dentistry, School of Biology, Medicine and Health"]
[null,"The University of Manchester"]
[null,"Coupland 3 Building, Coupland Street, Manchester"]
["Postcode","M13 9PL"]
["Telephone",7733320995]
["Email","verena.toedtling@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1012 consecutive patients meeting the inclusion/exclusion criteria between 01/01/2009 – 31/12/2019."]
["Description of confidential patient information used","Data sources\n\n1. Manchester University NHS Foundation Trust (Manchester Dental Hospital)\n\nIdentifiers required for linkage purposes\n\n1. Hospital ID\n\nIdentifiers required for analysis purposes\n\n1. Postcode (to calculate deprivation scores on site)"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-05-12"]
["Next Review Date","N/A"]
["Notes","The study did not commence, as the student concerned left the University of Manchester.\n\n1. Favourable opinion from REC Confirmed 30 January 2020\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. University of Manchester (email received from NHS Digital) and Manchester University NHS Foundation Trust (email received from NHS Digital 21 April 2020) have been confirmed as ‘Standards Met’ by NHS Digital."]

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[]
[]
["Application Number","A02483"]
["Reference","19/CAG/0195"]
["Other Refs","IRAS Project ID: 262419 REC reference: 19/WA/0216"]
["Application Title","STRETCHED: Strategies to Manage Emergency Ambulance Telephone Callers With Sustained High Needs - An Evaluation Using Linked Data"]
["Application Summary","This application from Swansea University set out the purpose of medical research that seeks to evaluate the effectiveness, safety and efficiency of case management approaches to the care of people who frequently call the emergency ambulance service. \n\nAmbulance services are under pressure to maintain a high quality and efficient service, in the face of increasing call numbers and growing patient expectations. The applicants noted that it was important to investigate how the efficiency of services could be improved and how priorities can be determined, in order to avoid conflicting priorities. Pre-hospital care is under-researched and there is a deficit in evidence relating to the establishment of effective ambulance responses offering a safe alternative to transportation to hospital. Frequent callers to emergency ambulance services may be vulnerable and experience difficulty in accessing more appropriate services, such as primary care, and seek help via 999 calls because other services are not meeting their complex needs, but this may not be the most efficient way to seek help. Multi-disciplinary case management approaches may reduce demand on emergency services and emergency hospital admissions. These approaches are not based on rigorous evidence of what works best for this patient group and adequate evidence to inform commissioning, policy or practice development does not currently exist. This study has been devised to gather evidence about the factors needed to be considered in case management intervention and cross-sector working. \n\nThe characteristics of people who call 999 frequently, what is currently done for them, what helps them to stay well and how well case management currently helps them will be studied. The applicants will use routinely collected NHS data within four ambulance services that have introduced a new case management system in some parts of their catchment areas, but retain the standard 999 service in others, to assess if frequent callers have fewer emergency episodes when case management is available. Research paramedics and Frequent Caller Leads, who are considered to be members of the direct care team at participating Trusts, will access confidential patient information for patients who meet the UK-wide definition of a ‘Frequent Caller’ from the ‘Frequent Caller’ case lists kept by the four participating ambulance services. Confidential patient information will be disclosed to NHS Digital and NHS Wales Informatics Service and linked to information on the outcomes for patients during the six months prior and the six months after a patient’s inclusion on the Frequent Callers list. The information will then be anonymised and transferred to the Secure Anonymised Information Linkage (SAIL) Databank. Patients deemed to be frequent callers will also be selected to take part in interviews and contacted for consent by the research paramedics. Interviews and focus groups will also be held with ambulance services staff, and partner clinical and managerial staff and commissioners to understand issues to do with implementation. The interviews with frequent callers and staff are outside the scope of the Section 251 support. "]
["Applicant Organisation Name","Swansea University"]
["Contact Name","Professor Alan J Watkins"]
["Address","Swansea University"]
[null,"209, ILS2, Singleton Park"]
[null,"Swansea"]
["Postcode","SA2 8PP"]
["Telephone",1792513410]
["Email","a.watkins@swansea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 18 years and over who meet the UK-wide definition of a 'Frequent Caller' (five or more calls in a one-month period or 12 or more calls per quarter).\n\n1264 patients (316 at each of the 4 ambulance services) will be included in the quantitative aspect. \n\nIn the quantitative element of the study, data will be collected by the research paramedics on new frequent callers added to lists between 1st January 2018 to 31st December 2018, including clinical data covering six months before to six months after inclusion on the list. The data collected covers the period from 1st July 2017 to 30th June 2019.\n\n68 additional patients will be included in the qualitative interviews, but this is outside the scope of the Section 251 support sought."]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic records kept at the Welsh Ambulance Services NHS Trust\n2.\tElectronic records kept at the East of England Ambulance Service NHS Trust\n3.\tElectronic records kept at the West Midlands Ambulance Service NHS Foundation Trust \n4.\tElectronic records kept at the London Ambulance Service NHS Trust\n5.\tEmergency Care Data Set (ECDS), Patient record data (PRD), Hospital Episode Statistics (HES), Office of National Statistics (ONS) and General Practice Data held by NHS Digital\n6.\tPatient Episode Dataset Wales (PEDW), Emergency Department Dataset (EDDS), General Practice data, Office of National Statistics (ONS) and Patient Record Data (PRD) held by NHS Wales Informatic Service (NWIS)\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tDate of birth\n4.\tDate of death\n5.\tPostcode – district level\n6.\tEthnicity\n7.\tGender\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death\n3.\tPostcode – district level\n4.\tGender\n5.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-05-27"]
["Next Review Date","2024-05-27"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 01 October 2019.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed – NHS Digital (by NHS Digital email dated 10 June 2019), East of England Ambulance Service NHS Trust (by NHS Digital email dated 02 November 2019), West Midlands Ambulance Service NHS Foundation Trust (by NHS Digital email dated 12 February 2020) and London Ambulance Service NHS Trust (by NHS Digital email dated 03 February 2020), have confirmed ‘Standards Met’ grade on DSPT submission 2018/19.\n•\tConfirmed - Caldicott: Principles into Practice (CPIP) assurance was confirmed for the Welsh Ambulance Services NHS Trust 06 April 2020. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","02484"]
["Reference","19/CAG/0227"]
["Other Refs","IRAS Project ID: 2497999 REC reference: 20/YH/0002"]
["Application Title","Oral Health, Dental Care and Aspiration History of Tube Fed Patients"]
["Application Summary","This application from Bradford Community NHS Trust set out the purpose of medical research which aims to determine the oral health of tube-fed children, oral health care regimens, dental care history and identify the dental treatment needs of the local tube fed paediatric population in Bradford.\n\nThe patient cohort will be identified using the Bradford Royal Infirmary’s locally devised tube-fed database. This dataset will be cross-referenced with the Bradford Community Dental Service database to identify individuals who are already known to the dental service. Patients known to both services would become part of a retrospective case note review, which will inform the study. Support is sought to legitimise access to electronic patient records within the Bradford Teaching Hospitals NHS Foundation by the student applicant. This database will include wider clinical records for patients who are not directly within the care of the applicant for dental treatment. Section 251 support is sought to legitimise the applicant’s access to these wider clinical records to enable the eligible patient cohort to be identified. Following the identification of the patient cohort, the requirement for support will cease as only patients within the direct clinical care of the applicant will continue to be included in the study. \n\nThe study also involves a secondary element where a sub-cohort of 50 of the identified patients would undergo an additional clinical examination to assess their oral condition. This element is out of scope for the CAG application as consent will be sought from the patient’s parent/guardian and assent from the patient for their participation."]
["Applicant Organisation Name","Bradford Community NHS Trust"]
["Contact Name","Dr Frankie Soldani"]
["Address","Bradford Community NHS Trust"]
[null,"Horton Park Health Centre"]
[null,"Dental Department, Bradford"]
["Postcode","BD7 3EG "]
["Telephone",1274259253]
["Email","frankie.soldani@bdct.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged from 4 to 16 years who are currently under the care of the Bradford Teaching Hospitals NHS Foundation Trust ‘Feeding Action Clinic’ and are currently artificially tube fed. There are approximately 400 patients within the cohort. From this database, patients will be matched to records held by the Bradford Community Dental Service in order to identify the eligible patient for inclusion in the study, which is estimated to include 200 patients. "]
["Description of confidential patient information used","Data sources\n\n1.\tTube-fed patient database, Bradford Teaching Hospitals NHS Foundation Trust \n2.\tElectronic and paper patient records, Bradford Community Dental Service \n\nIdentifiers required for linkage purposes\n\n1.\tNHS Number \n2.\tPatient name \n3.\tDate of birth\n4.\tHospital Number \n\nIdentifiers required for analysis purposes\n\n1.\tNHS Number "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-05-27"]
["Next Review Date","N/A"]
["Notes","Applicant advised that support was no longer required as of 29 October 2021\n\nSpecific conditions of support\n\n1.\tFeedback from the patient and public involvement carried out is to be provided with the submission of the first annual review. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 21 April 2020. \n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed - Bradford District Care NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT 2018/19 by NHS Digital email dated 14 November 2019. "]

{"sheet":"A02485","index":528,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02485"]
["Reference","20/CAG/0001"]
["Other Refs","IRAS Project ID: 257064 REC reference: 19/YH/0280"]
["Application Title","Functional outcomes In Trauma (FIT) Study"]
["Application Summary","This application from the University of Leeds set out the purpose of medical research that seeks to assess the impact of major trauma, especially polytrauma, on the physical aspect of functional outcome and how this changes over time.\n\nLittle information is available in the UK on how well patients who sustain major trauma function afterwards. Major trauma is defined as significant injuries with a calculated ‘injury severity score’ (ISS) over 15 and a maximum score of 75. The applicants will assess how well patients function physically, psychologically and socially after trauma.  The study is comprised to two phases, involving two patient cohorts, a prospective cohort and a retrospective cohort. \n\nPatents in the Phase 1 prospective cohort will complete questionnaires at 3. 6. 9 and 12 months. Patients in this group will be identified by the research team, who are also members of the direct care team, from the daily trauma meeting and major trauma ward lists and will be approached while on the ward in the weeks following the trauma. Patients will be given a participant information sheet. If interested, they then complete the consent form on the online questionnaire service, QTool, and their participation will proceed on a consented basis. Because the research team are part of the direct care team and therefore regular attendees at these meetings Section 251 support is not required for this cohort.\n\nThe Phase 1 retrospective cohort will be comprised of patients who sustained major trauma between 1 and 10 years previously. The research team will screen the Trauma Audit Research Network (TARN) database and Electronic Hospital Records (EHR) at Leeds Teaching Hospitals NHS Foundation Trust to identify suitable patients. A recruitment pack, containing an invitation letter, participant information sheet and instructions on how to access QTool to complete the questionnaires will be sent to selected patients. Patients will be contacted up to 4 times by post and also contacted by telephone at least 14 days after the pack was sent to see if they are happy to take part or if they would like further information. Their participation will then proceed on a consented basis. Section 251 support is sought for members of the research team to screen the records for suitable patients and make contact to seek consent. \n\n5 to 10 patients from each cohort will also be invited to take part in qualitative interviews. Section 251 support is not sought for this aspect of the study. \n\nIn Phase 2, patients who have taken part in Phase 1 will automatically be enrolled to take part. New prospective patients will be recruited into the study, using the same methodology as in Phase 1, and support under Section 251 was required for this. These patients will be known as Group A. Group A will complete the same set of questionnaires as the prospective patients in Phase 1. Once completed, the patients will then be included in Group B, along with the prospective patient group from Phase 1. Group B will repeat the standard PROMs, however one questionnaire, the Leeds Trauma Questionnaire, will have been amended slightly so that questions are not repeated. "]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Professor Peter Giannoudis"]
["Address","University of Leeds/Leeds Teaching Hospitals"]
[null,"Leeds General Infirmary, Great George Street"]
[null,"Leeds"]
["Postcode","LS1 3EX"]
["Telephone","0113 3922750"]
["Email","pgiannoudi@aol.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","440 patients aged between 18 and 65 who have sustained a major trauma and have an injury severity score of over 15.\n\n320 patients will be recruited to the retrospective cohort.  \n\nThe120 patients recruited to the prospective study do not require s251 support"]
["Description of confidential patient information used","Data sources\n\n1.\tTrauma Audit Research Network (TARN)\n2.\tElectronic Health Records (EHR) at Leeds Teaching Hospitals NHS Foundation Trust\n3.\tMajor trauma ward lists at Leeds Teaching Hospitals NHS Foundation Trust\n4.\tDaily trauma meetings held at Leeds Teaching Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID number\n4.\tGP registration\n5.\tDate of birth\n6.\tDate of death\n7.\tPostcode – unit level\n8.\tAddress\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tPostcode – sub-sector level\n3.\tGender\n4.\tOccupation \n5.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-05-27"]
["Next Review Date","2024-05-27"]
["Notes","Amendment supported 25 May 2023 to extend the duration of the ‘s251’ support until 1 October 2026\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 22 May 2020. \n\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: University of Leeds (by NHS Digital email 28 August 2019) and Leeds Teaching Hospitals NHS Foundation Trust (by NHS Digital email 12 July 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

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[]
[]
["Application Number","A02486"]
["Reference","20/CAG/0020"]
["Other Refs","IRAS Project ID: 266209 REC reference: 19/LO/1944"]
["Application Title","Healthcare Usage of Bariatric/Metabolic Surgery"]
["Application Summary","This application from King’s College London set out the purpose of medical research that seeks to assess the overall long-term healthcare usage of bariatric and metabolic surgery.\n\nCurrently, less than 0.2% of patients who meet the NICE and international criteria for surgical treatment of obesity and Type 2 Diabetes undergo surgery in the UK. Widespread misperceptions about the relative risks of bariatric surgery may be a barrier to access to surgical treatment. No study has previously been conducted to compare the perioperative safety and long-term healthcare utilization of bariatric or metabolic surgery with those of other commonly performed elective surgical procedures.\n\nThe applicants will carry out a retrospective review of data from 100 consecutive patients who underwent bariatric surgery and other types of elective surgical interventions for benign diseases at King’s College Hospital NHS Foundation Trust between February 2014 and March 2015. The outcomes of these patients will be compared with those of 700 consecutive patients who underwent other types of elective surgeries for benign diseases at the same Hospital. The applicants will examine the long-term rate of re-admissions and the related length of stay, emergency department attendances and GP encounters over a period of 5-year from the index surgery. \n\nData from NHS Digital on nationwide healthcare utilization will be obtained to ensure that accurate data on post-operative healthcare usage can be collected. This data would contain NHS numbers and would be anonymised by the applicants once received and patient identifiers, NHS numbers, will be replaced by study specific identifiers. "]
["Applicant Organisation Name","King’s College London "]
["Contact Name","Professor Francesco Rubino"]
["Address","1st floor James Black Centre"]
[null,"Denmark Hill Campus"]
[null,"King’s College London, 125 Coldharbour, London "]
["Postcode","SE5 9NU"]
["Telephone","0207 848 5217"]
["Email","Francesco.rubino@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort\n\n800 patients who underwent surgery at King's College Hospital NHS Foundation Trust. This number is comprised of:\n\n•\t100 consecutive patients who underwent bariatric surgery and other types of elective surgical interventions for benign diseases at King’s College Hospital NHS Foundation Trust between February 2014 and March 2015. \n\n•\t700 consecutive patients who underwent other types of elective surgeries for benign diseases at the same Hospital\n\n"]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic patient records at King's College Hospital NHS Foundation Trust\n2.\tHES data at NHS Digital\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID number\n4.\tDate of birth\n5.\tDate of death\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death\n3.\tGender\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-06-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in September 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant does not have means to re-identify. \n\nIn terms of public benefit, the analysis has shown the bariatric surgery is safe and cost effective and comparable to routine general surgery operation such as gallbladder and hernia. This outcome will hopefully have significant impact on policy making and resource allocation in the NHS, and possibly in other healthcare system that will support access to bariatric surgery, and it is hoped this will have positive impact on the health and quality of life of patients suffering from clinical obesity.\n\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January to extend the duration of support until 30 June 2022.\n\n21 April 2021 - Amendment supported\nThe amendment, to amend the dates during which the operations took place for benign diseases to between January 2006 and December 2015, and to extend the duration of support until December 2021, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 21 January 2020\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed: NHS Digital has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 10 June 2019.\n \n•\tConfirmed: King’s College Hospital NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02487","index":530,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02487"]
["Reference","20/CAG/0009"]
["Other Refs","IRAS Project ID: 258761 REC reference: 20/LO/0104"]
["Application Title","The Cambridge Cohort - Mammography East-Anglia Digital Imaging Archive (CC-MEDIA)"]
["Application Summary","This application from the University of Cambridge sets out the purpose of creating a research database, containing mammographic images to be used as a resource for the development, testing and creation of artificial intelligence algorithms.\n\nAll women aged 50 – 70 years who attended breast screening at the Cambridge Breast Screening Programme, part of the National Health Service Breast Screening Programme (NHSBSP) conducted by Public Health England, between 2011/2012 and 2021/2022 from whom a mammogram was acquired at either mobile or static units will be included.\n\nThe mammographic screening image for each patient and corresponding clinical, radiological and histopathological information, already stored in patients records at the Cambridge University Hospitals NHS Foundation Trust, will be extracted. This will include information from Picture Archiving and Communication System (PACS), Electronic Health Records (EHR) and National Breast Screening System (NBSS) and Breast Screening Select (BSS). Support under s251 is required as the staff undertaking the processing of confidential patient information will be research staff, who are not members of the direct care team. "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Fiona J Gilbert"]
["Address","University of Cambridge School of Clinical Medicine"]
[null,"Box 218, Cambridge Biomedical Campus"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone",1223336890]
["Email","fjg28@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All women aged between 50 – 70 years who attended breast screening at the Cambridge Breast Screening Programme, part of the National Health Service Breast Screening Programme (NHSBSP) conducted by Public Health England, between 2011/2012 and 2021/2022 from whom a mammogram was acquired at either mobile or static units."]
["Description of confidential patient information used","Data sources\n\nAll women aged between 50 – 70 years who attended breast screening at the Cambridge Breast Screening Programme, part of the National Health Service Breast Screening Programme (NHSBSP) conducted by Public Health England, between 2011/2012 and 2021/2022 from whom a mammogram was acquired at either mobile or static units.\n\nIdentifiers required for linkage purposes\n\n1.\tNHS Number\n2.\tHospital ID number\n3.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tYear of birth"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-11"]
["Next Review Date","2024-06-11"]
["Notes","29 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - National Cancer Registration and Analysis Service (NCRAS) and Screening Histories Information Manager (SHIM).\n\n16 May 2022 - Amendment supported\nAmendment supported to increase the size of the cohort from 150,000 to over 250,000.\n\n16 March 2022 - Amendment supported\nAmendment supported for the disclosure of confidential patient information from Cambridge University Hospitals NHS Foundation Trust and Norfolk and Norwich University Hospital NHS Foundation Trust to NHS Digital for the purposes of linkage with NCRAS and SHIM, and for the disclosure of confidential patient information from Cambridge University Hospitals NHS Foundation Trust to Addenbrookes for the purposes of linkage with EPIC.\n\nAnnual review letter sent 24 May 2021 - Condition of support added; \n1.\tNorfolk & Norwich University Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n03 December 2020 - Amendment supported\nThe amendment, to;\n• Change the title of the database to “The Cambridge Cohort - Mammography East-Anglia Digital Imaging Archive (CC-MEDIA)”,\n• Add Norfolk and Norwich University Hospital NHS Foundation Trust as an additional data processor,\n• Update the data flow with additional identifiers to be extracted, updated data fields for collection, updated personnel undertaking the data extraction, and an additional route to the Data Access Committee, \n• Updating the cohort age range to 47 and above,\n• Provide updated documents including protocol, data flow diagram, and additional patient facing documentation, \n• And providing additional updates for notification only (as described in the amendment request),\nis supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support \n1. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold: Confirmed:\n\nThe 2018/19 NHS Digital DSPT review for Cambridge University Hospitals NHS Foundation Trust (RGT) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 11 November 2020) The 2019/20 DSPT is yet to be reviewed by NHS Digital. \n\nThe 2019/20 NHS Digital DSPT review for Norfolk & Norwich University Hospitals NHS Foundation Trust (RM1) was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked 11 November 2020). Please note the updated specific condition of support below.\n\nNorfolk & Norwich University Hospitals NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support.\n\n2. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 24 November 2020\n\n\n\nSpecific conditions of support\n\n1.\tProvide an update to further patient and public involvement and engagement event specific to breast cancer patients in the first annual review.\n\nConfirmed 24 May 2021: The applicants have responded to the condition in their first annual review, providing the results of significant patient and public involvement that has been undertaken. An online survey has been developed for patient and public involvement purposes only, and applicants have also conducted face to face meetings. They provided a detailed summary for CAG review.   \n\nThe Vice-Chair reviewed the response to the condition, and commented that the applicants had provided a good amount of structured, very well documented and admirable PPI. He confirmed that the applicants have definitely met the condition of support and have reported it very transparently. The Vice-Chair was very happy to recommend that support continues.\n\n2.\tThe applicants to review and provide further justification to retaining identifiable information in the five year annual review.\n\n3.\tFavourable opinion from REC Confirmed 3 April 2020.\n\n4.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. (Confirmed – Cambridge University Hospitals NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital DSPT Tracker checked 17 March 2020)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02488"]
["Reference","19/CAG/0196"]
["Other Refs","IRAS Project ID: 256876 REC reference: 19/NW/0606"]
["Application Title","Evaluating prescribing safety indicators embedded in computerised clinical decision support software OptimiseRx"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to evaluate the effectiveness of the computerised clinical decision support system OptimiseRx on improving prescribing safety in general practices and the associated costs to the NHS.\n\nPatients can sometimes be harmed by their medication due to inappropriate prescribing. Computer programmes had been implemented in many general practices to aid in clinical decision making. These computer programmes automatically check the patient’s electronic health record to identify potential factors that may influence the safety of the medication being prescribed. These factors include other medications and diagnoses. An alert is sent to the prescriber if the prescription has been identified as potentially hazardous. OptimiseRx is one such programme and the applicants are seeking to determine whether its use has led to a reduction in the number of potentially harmful prescriptions. \n\nFirstDatabank, the vendor of OptimiseRx, will inform TPP, the owner of ResearchOne, which general practices are using OptimiseRx, as well as the start date for when each practice started to use OptimiseRx and when they stopped, if applicable. ResearchOne will identify primary care practices using OptimiseRx who have agreed to be included on the ResearchOne database. Pseudonymisation methodology will be used to link information on each cohort from ResearchOne to HES, ONS and IMD (Index of Multiple Deprivation) data from NHS Digital. A pseudonymisation process will be used by the processors to facilitate linkage, using a SALT key across all datasets. Support is sought for ResearchOne and NHS Digital to generate project-specific patient pseudonyms and share non-identifiable data with the University of Manchester."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Niels Peek"]
["Address","Health eResearch Centre, The University of Manchester"]
[null,"Vaughn House, Portsmouth Street"]
[null,"Manchester"]
["Postcode","M13 9PL"]
["Telephone","01613060674"]
["Email","niels.peek@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","577500 individuals registered at practices using the OptimiseRx programme and which also contribute data to ResearchOne."]
["Description of confidential patient information used","Data sources\n1.\tResearchOne\n2.\tHES, ONS and IMD data at NHS Digital\n\nIdentifiers required for linkage purposes\n1.\tNHS Number\n2.\tDate of birth\n3.\tPostcode – district level\n4.\tGender\n\nIdentifiers required for analysis purposes\n1.\tGender\n2.\tAge"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-17"]
["Next Review Date","2024-06-17"]
["Notes","Amendment supported 27 February 2024 to extend the study duration to 31 January 2025\n\n10 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES), ONS Mortality data and IMD (Index of Multiple Deprivation) data.\n\nAmendment supported 10 March 2023 to extend the study duration to 31 December 2023\n\n03 December 2020 - Amendment supported\nThe amendment, to flow full NHS numbers rather than pseudonymised NHS numbers from TPP/ResearchOne to NHS Digital for the purposes of linkage with datasets held by NHS Digital, and to include a wider proportion of GP practices to now include those who started using OptimiseRx from September 2013 until the end of February 2019, is supported, subject to compliance with the standard conditions of support.\n\n21 July 2020 – Amendment supported to expand to the range of serious harm outcomes linked with hazardous prescribing which will be examined and to change the location where confidential patient information will be processed and stored from the University of Manchester’s Data Safe Haven to the University of Manchester Research Data Storage Service.\n\nSpecific conditions of support\n\n1.\tThe patient and public involvement group are to be re-consulted after the study has begun to assess whether the arrangements for patient notification and opt-out are working well, and a report on this feedback is to be provided when the annual review is submitted to CAG. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 29 October 2019.\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed – NHS Digital has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by email dated 10 June 2019.\n\n•\tConfirmed - The Phoenix Partnership (TPP) has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by email dated 09 March 2020.\n\n27 August 2021 - amendment supported to include the University of Nottingham as joint data controller, alongside the University of Manchester.\n\n31 August 2021 - amendment supported to revert to the original method of data linkage, so the ResearchOne and NHS Digital data would be linked via patient pseudonyms generated from NHS numbers, rather than using the actual NHS numbers, to remove linkage to ONS mortality data, and to extend the study duration to 28 February 2023 "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02489","index":532,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02489"]
["Reference","19/CAG/0050"]
["Other Refs","IRAS Project ID: 235586 REC reference: 18/NE/0098"]
["Application Title","Service User Perspectives of the Transition from Medium Security to Lower Security and Community Services"]
["Application Summary","This application from Nottinghamshire NHS Foundation Trust set out the purpose of medical research which aims to understand the patient’s perspective around the transfer from medium secure services to lower secure hospital. The applicant intends to interview patients who were discharged from Wathwood Hospital, a medium secure hospital that is part of the Nottinghamshire NHS Foundation Trust, during the period of July 2012 to July 2017, having been detained under the Mental Health Act 2005. Support under the Regulations is required to identify an eligible patient cohort from medical records to be invited to participate in the study."]
["Applicant Organisation Name","Nottinghamshire NHS Foundation Trust"]
["Contact Name","Rebecca Dalby"]
["Address","Wathwood Hospital"]
[null,"Gipsy Green Lane"]
[null,"Wath-upon-Dearne"]
["Postcode","S63 7TQ"]
["Telephone","01709870800"]
["Email","rebecca.dalby@nottshc.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult male offenders detained under the Mental Health Act 2003 at Wathwood Hospital and discharged to step-down conditions (i.e. low security, locked rehabilitation, supported accommodation) between December 2012 and December 2017. It is estimated that 100 patient records would be screened in order to recruit between 15 and 29 patients to the study. \n\nThe following items of confidential patient information will be accessed from health records at Nottinghamshire NHS Foundation Trust in order to identify and facilitate invitation of eligible patients to the study:\n\n•\tName,\n•\tNHS Number, \n•\tFull address and postcode,\n•\tNamed clinician at discharge. \n"]
["Description of confidential patient information used","The following items of confidential patient information will be accessed from health records at Nottinghamshire NHS Foundation Trust in order to identify and facilitate invitation of eligible patients to the study:\n\n•\tName,\n•\tNHS Number, \n•\tFull address and postcode,\n•\tNamed clinician at discharge. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-23"]
["Next Review Date","2021-06-23"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee (Confirmed 23 August 2019).\n\n2.\tConfirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – Nottinghamshire Healthcare NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital check of the NHS Digital tracker on 23 June 2020)."]

{"sheet":"A02490","index":533,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02490"]
["Reference","20/CAG/0015"]
["Other Refs","IRAS Project ID: 268201 REC reference: 20/LO/0159"]
["Application Title","Clinical outcome modelling of rapid dynamics in acute stroke with joint-detail, remote, body motion analysis"]
["Application Summary","This application from King's College Hospital NHS Foundation Trust set out the purpose of medical research which aims to capture high-resolution joint-level motor function in acute stroke and correlate it with clinical outcome measures and neuroimaging.\n\nStroke is characterised by rapid changes over time and marked variability in outcomes. Patients may improve or deteriorate within minutes, and optimal treatment requires both detailed characterisation of the patient’s clinical picture and its pattern of change over time. The most important aspect of the patient’s clinical picture, body movement, remains poorly documented, quantified subjectively and at infrequent intervals in the patient’s clinical evolution. Artificial intelligence, combined with high-performance computing, has enabled the automatic extraction of a patient’s skeletal frame, down to major joints, delivered simply, safely and inexpensively, without the use of body worn markers. The skeletal frame is extracted in real time, ensuring no video data, from which patients can be identified, to be stored or transmitted by the device. The prototype motion categorisation system, MoCat, will be used to study the rapid dynamics of acute stroke. Changes in motor deficit over time will be quantified, so that the relationship between the trajectories and the clinical outcomes can be examined and predictive models developed to support clinical management. \n\nThe applicants will conduct a prospective observational study, in which patients admitted to the stroke unit will be monitored using the MoCat motion capture device for the length of their acute admission. All patients admitted to the unit will be eligible for the study. Following the patient’s discharge, the motion capture data will be linked to the clinical outcome data of interest and routinely collected clinical data obtained via the hospital electronic medical records and picture archiving and communication system (PACS). On completion of linkage, the data will be pseudonymised, and allocated a unique study identifier."]
["Applicant Organisation Name","King's College Hospital NHS Foundation Trust"]
["Contact Name","Dr Yee Mah"]
["Address","King's College Hospital"]
[null,"Denmark Hill"]
[null,"London"]
["Postcode","SE5 9RS"]
["Telephone","02032996509"]
["Email","yee.mah@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1000 patients aged over 18 years admitted to the stroke unit of King's College Hospital NHS Foundation Trust with a possible diagnosis of acute stroke."]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic Health records held within King's College Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tHospital number\n2.\tDate of birth \n3.\tNHS number\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tGender\n3.\tDate of death"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-21"]
["Next Review Date","2024-06-21"]
["Notes","Specific conditions of support\n\n1.\tAt the date of the first annual review confirm the understanding that, by opting out, the patient can opt out of the research use of data collected for clinical purposes as well as opting out of the motion capture.\nApplicant provided results to a patient survey to CAG as part of the 2021 annual review to evidence this condition. Condition met 23 July 2021.\n\n2.\tAt the date of the first annual review provide consideration as to whether the description of motion data capture is understandable to everyone in the setting of admission to a stroke ward in patient facing materials. Provide updated patient facing materials if the wording changes as a result of this consideration.\nApplicant provided results to a patient survey to CAG as part of the 2021 annual review to evidence this condition. Condition met 23 July 2021.\n\n3.\tFavourable opinion from REC Confirmed 27 April 2020\n\n4.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \n\nConfirmed: King's College Hospital NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02491","index":534,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02491"]
["Reference","20/CAG/0039"]
["Other Refs","IRAS Project ID: 275470 REC reference: 20/LO/0344"]
["Application Title","Phenotyping individuals with elevated mean pulmonary arterial pressure and elevated pulmonary vascular resistance in the United Kingdom"]
["Application Summary","This application from Royal Free London NHS Foundation Trust set out the purpose of medical research which aims to compare patient and clinical outcomes, treatments, hospitalisation and mortality in patients with different levels of dynamic blood flow to their mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance measurements and diagnosis (PVR).\n\nPulmonary hypertension (PH) has long been defined by the presence of mean pulmonary arterial pressure (mPAP) ≥25 mm Hg as measured by resting right heart catheterization (RHC). However, accumulating evidence suggests that individuals with a lower mPAP or pulmonary vascular resistance (PVR) could be considered abnormal and at risk of disease progression. This study aims to describe and compare patient and clinical characteristics, biomarkers, therapies, quality of life, and prognosis among patients categorized in cohorts based on different levels of mPAP and PVR.\n\nCare teams at six hospitals (Royal Free London NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Royal Brompton and Harefield NHS Foundation Trust, Royal Papworth Hospital NHS Foundation Trust, The Newcastle Upon Tyne Hospitals NHS Foundation Trust) will collect data from all patients who had a Right Heart Catheterisation (RHC) between January 1, 2009 - December 31, 2016 (approximately 2900). Data will be encrypted and provided to the study team at the Royal Free London NHS Foundation Trust. The data will include confidential information (Name, date of birth and NHS number). The Royal Free will collate the data from the hospitals and request linkage with HES data (for Date(s) of hospitalization) and ONS data (for date of death)."]
["Applicant Organisation Name","Royal Free London NHS Foundation Trust"]
["Contact Name","Dr Gerry Coghlan"]
["Address","Cardiology Department"]
[null,"Royal Free London NHS Foundation Trust"]
[null,"Pond Street, London"]
["Postcode","NW3 2QG"]
["Telephone","02073177544"]
["Email","gerry.coghlan@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who had a Right Heart Catheterisation (RHC) between January 1, 2009 - December 31, 2016 at one of participating hospitals. Approximately 2900 patients."]
["Description of confidential patient information used","Data sources\n\n1.\tRoyal Free London NHS Foundation Trust\n2.\tSheffield Teaching Hospitals NHS Foundation Trust (Royal Hallamshire Hospital)\n3.\tImperial College Healthcare NHS Trust (Hammersmith Hospital)\n4.\tRoyal Brompton and Harefield NHS Foundation Trust (Royal Brompton Hospital)\n5.\tRoyal Papworth Hospital NHS Foundation Trust\n6.\tThe Newcastle Upon Tyne Hospitals NHS Foundation Trust (Freeman Hospital)\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS number\n3.\tDate of birth \n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-21"]
["Next Review Date","2024-06-21"]
["Notes","Specific conditions of support\n\n1.\tAdd a telephone contact number for opt outs to the patient notification materials. \nApplicant provided the updated notification materials to CAG as part of the 2021 annual review. Condition met 30 June 2021\n\n2.\tFavourable opinion from REC Confirmed 23 March 2020\n\n3.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02492","index":535,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02492"]
["Reference","19/CAG/0109"]
["Other Refs","IRAS Project ID: 255320 REC reference: 19/NW/0156 Previous CAG reference: 19/CAG/0045"]
["Application Title","Suicide by middle-aged men"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research which aims to examine the characteristics of middle-aged men who die by suicide, determine how frequently suicide is preceded by factors more often associated with suicide by men than by women, examine the role of support services and make recommendations to strengthen suicide prevention for middle-aged men. The study has been funded by the Health Quality Improvement Partnership (HQIP). \n\nThis will be a UK wide, multi-agency study. Data will be collated from various official bodies including: coroner inquest hearings, police sudden death reports, criminal justice reports, safeguarding adult reviews, National Confidential Inquiry into Suicide and Safety in Mental Health data and Serious Incident reports. Data will be extracted from these sources onto a standardised database for analysis.\n\nThe study will collect data about men aged 40-54 who died by suicide (including probable suicide) across the UK. This is the age group, in males, with the highest suicide rate in the UK. Suicides and probable suicides (undetermined deaths) will be identified from general population mortality data received by the NCISH from the Office of National Statistics (ONS; for deaths registered in England and Wales), National Records of Scotland (NRS; for deaths registered in Scotland) and the Northern Ireland Statistics and Research Agency (NISRA; for deaths registered in Northern Ireland). The application to the CAG extends to the data released by the ONS relating to patients in England and Wales only. \n\nThe study will collect data on a stratified random sample of 20% of deaths of men aged 40-54 from all suicides in this age group (approximately 1,527 per year) in a one-year period (based on dates of death between 1st January 2017 and 31st December 2017), equating to approximately 300 deaths per year. Oversampling will be employed to take into account coroners who may not wish to participate in the study. \n\nSupplementary information will be requested on the stratified sample from both health and non-health data sources to be utilised in analysis. The remit of the CAG extends to the disclosures from health sources only. An alternative legal basis would need to be established by the applicant to support disclosures from the non-health sources."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Louis Appleby"]
["Address","The National Confidential Inquiry into Suicide and Safety in Mental Health"]
[null,"Centre for Mental Health and Safety, The University of Manchester"]
[null,"2nd Floor Jean McFarlane Building, Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone","0161 275 0700/01"]
["Email","ncish@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male aged 40-54 years, who died by suicide (including probable suicide/undetermined conclusion) in any UK country between 1st January 2017 and 31st December 2017. It is estimated that 300 patients will be included in the study. "]
["Description of confidential patient information used","•\tName – sample validation and linkage and analysis,\n•\tDate of birth – sample validation and linkage and analysis,\n•\tDate of death – sample validation and linkage and analysis,\n•\tPlace of death – sample validation and linkage,\n•\tPostcode – sample validation and linkage and analysis,\n•\tSex – sample validation and linkage and analysis,\n•\tEthnicity – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2019-07-29"]
["Next Review Date","2024-07-29"]
["Notes","22 October 2020 - Amendment supported to extend the duration of support until 31 March 2021.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee (Confirmed).\n2.\tConfirmation from the IG Delivery Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission (Confirmed – University of Manchester – National Confidential Inquiry NHS Digital confirmed ‘Standards Met’ 22/07/2019’). "]

{"sheet":"A02493","index":536,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02493"]
["Reference","19/CAG/0194"]
["Other Refs","IRAS Project ID: 262143 REC reference: 19/YH/0258"]
["Application Title","Identifying models of care to improve outcomes for older people with emergency and urgent care needs."]
["Application Summary","This application from the University of Leicester set out the purpose of medical research that seeks to determine what aspects of interventions, context and approaches to implementation both facilitate and hinder delivery of emergency and urgent care interventions for older people in emergency departments. \n\nThe care delivered by health care professionals in 4-6 emergency departments in the Yorkshire and Humber region will be observed. 60-120 clinicians, managers and other staff will be interviewed in order to capture what they are trying to achieve, and also how and why. The focus will be on identifying factors that either enhance or impair the delivery of care. The observations and interactions will be analysed along with relevant documents, such as meeting minutes and policies, to create an overall view of what seems to help in getting these approaches to care to work well, and how such approaches might be used in other emergency department settings. \n\nThe interviews held with the health care professionals are outside the scope of Section 251 support. Support is sought for the incidental exposure to confidential patient information that will occur during the observations of staff carrying out their clinical work and discussions of patients. The staff observed will receive written information about the project. Posters will also be displayed in the emergency departments where observations are taking place and any objections would be respected. Field notes taken during observations would be recorded in situ and supplemented immediately following data collection via an audio-recorded account by the researcher which will subsequently be transcribed. The audio-recording will be of an account by the researcher made after the observation has ended (which will not include any personal identifiable information), not of the observation itself. No items of confidential patient information will be retained by the researcher."]
["Applicant Organisation Name","University of Leicester "]
["Contact Name","Professor Simon Conroy"]
["Address","Room 3.37"]
[null,"George Davies Centre"]
[null,"University of Leicester"]
["Postcode","LE1 7RH"]
["Telephone",1162525992]
["Email","spc3@le.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The researchers would be observing staff discussions regarding patients and care carried out by staff on emergency departments. This may mean that researchers are incidentally exposed to confidential patient information for any of the patients being treated, but no items of confidential patient information would be recorded by the researchers. \n\nThe applicant advised that it was not possible to give a total number of patients who will be observed and noted that hundreds of patients may pass through the department during each 4-hour period of observation."]
["Description of confidential patient information used","Data sources\n\n1.\tConfidential patient information incidentally disclosed during observation of clinical care on the emergency departments of participating hospitals.\n2.\tConfidential patient information incidentally disclosed during the observation of staff meetings about service delivery at participating hospitals.\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be collected for linkage purposes.\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be retained for analysis purposes. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-06-23"]
["Next Review Date","N/A"]
["Notes","April 2022 - Support Expired\nApplicant confirmed April 2022 that ‘s251’ support is no longer required and the application can be expired.\n\nNo confidential patient information was ever collected, as CAG application was for incidental disclosure whilst observing clinician-clinician interactions, which in fact did not ever happen. \n\nIn terms of public benefit, applicants have produced a System Dynamics tool that allows NHS teams to compare different types of emergency care intervention – so called ‘what-if’ scenarios. What if we put in place an emergency department frailty service, or what if we focused upon hospital at home. This work will help team better care for older people accessing emergency care. The dissemination process is underway, aiming primarily at clinical teams. The specific output relating to this CAG application will be accompanying implementation guidance, which should be ready in the next few months – this will accompany the tool, which applicants will be making widely available via the Acute Frailty Network, a national improvement collaborative.\n\n22 February 2021 - Amendment supported\nThe amendment, to add Harrogate and District NHS Foundation Trust as a data processor, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 24 September 2019.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – Barnsley Hospital NHS Foundation Trust, Airedale NHS Trust, York Teaching Hospitals NHS Foundation Trust and Sheffield Teaching Hospitals NHS Foundation Trust, have confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital DSPT Tracker checked 23 June 2020)."]

{"sheet":"A02494","index":537,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02494"]
["Reference","20/CAG/0013"]
["Other Refs","IRAS Project ID: 269802 REC reference: 20/LO/0149"]
["Application Title","Correlates of cognitive changes in epilepsy"]
["Application Summary","This application from University College London set out the purpose of medical research that seeks to determine whether cognitive changes can be predicted following treatments of epilepsy by either medication or surgery. \n\nThe quality of life of patients with epilepsy is not limited to the seizures they suffer, but extends to psychological issues, including cognitive difficulties and co-morbidities such as depression. These cognitive issues are primarily related to memory and language-related issues, impacting on their personal lives. The applicants seek to assess the role of these cognitive impairments on patients’ lives and investigate the factors that may drive these issues. Two main treatments given with the aim of stopping seizures are anti-epileptic medication and surgical intervention. The applicants will use existing clinical and non-clinical data to assess which patient-related factors are associated with cognitive changes over time, in order to determine which factors can predict decline. \n\nSupport is sought for the applicant, who is not a member of the direct care team, to access confidential patient information, including clinical examinations, MRI, EEG, neuropsychology and treatments, for patients treated at the National Hospital for Neurology and Neurosurgery."]
["Applicant Organisation Name","University College London Institute of Neurology"]
["Contact Name","Ms J de Tisi, Data Manager "]
["Address","DCEE"]
[null,"UCL Queen Square Institute of Neurology"]
[null,"London "]
["Postcode","WC1N 3BG"]
["Telephone","020 3448 8612 "]
["Email","j.detisi@nhs.net  &  john.duncan@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 18 and 75 years of age, who were treated for their epilepsy by a physician at, or affiliated with, the National Hospital for Neurology and Neurosurgery. \n\n2000 patients will be included."]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic patient records at the National Hospital for Neurology and Neurosurgery\n\nIdentifiers required for linkage purposes\n\n1.\tHospital ID number\n2.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n\nNo other identifiers will be retained for analysis purposes. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-23"]
["Next Review Date","2024-06-24"]
["Notes","Specific conditions of support\n\n1.\tFeedback on the discussions of the patient notification and dissent materials held at a meeting of the BBUK initiative needed to be provided at the first annual review for this application.\nCAG confirmed condition met 16 February 2022\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 30 March 2020. \n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – University College London Hospitals NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 30 August 2019. "]

{"sheet":"A02495","index":538,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02495"]
["Reference","19/CAG/0223"]
["Other Refs","IRAS Project ID: 263979 REC reference: 19/NW/0187"]
["Application Title","TwinsUK: Phenotypic enrichment of the TwinsUK cohort through linkage to electronic health records and other databases."]
["Application Summary","This application from King’s College London set out the purpose of medical research which aims to undertake record-based follow-up of patients recruited to the Twins UK trial. The Twins UK study was established in 1992 and is the largest longitudinal cohort of community dwelling adult twins in the UK, comprising over 14,000 volunteer twins in predominantly midlife. All patients are included within the main study on the basis of informed consent. \n\nParticipants have provided self-reported questionnaires, physical/cognitive measures and biological samples through clinical visits approximately every four years, for researchers to investigate how environmental factors and genetics interact to impact health over the life course. The longitudinal biobanking of samples over the last 25 years has enabled research on early detection of disease. TwinsUK participants have, from enrolment, given their informed consent for these data to be used for health research. \n\nThis application has been submitted to seek section 251 support to enable the Twins UK cohort to be linked with primary and secondary care records, cancer registration and mortality data held in a variety of data sources. Wider linkage with educational records held by Department for Education is also requested.  The application has been informed by the ALSPAC (Avon Longitudinal Study of Parents and Children) programme which operates with support under the Regulations via reference ECC 1-05(b)/2012."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Claire Steves"]
["Address","Department of Twin Research, St Thomas' Hospital"]
[null,"3rd Floor South Wing Block D, London"]
[]
["Postcode","SE1 7EH"]
["Telephone",2071885396]
["Email","Claire.j.steves@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All participants within the Twins UK trial. This encompasses 14,400 patients. "]
["Description of confidential patient information used","Data sources\n\n1.\tHospital Episodes Dataset, NHS Digital \n2.\tMental Health Minimum dataset (MHMDS), NHS Digital\n3.\tOffice for National Statistics (ONS) Mortality Data, NHS Digital \n4.\tCancer registration, NHS Digital \n5.\tPatient Demographics Service, NHS Digital \n6.\tPatient Episodes Dataset Wales (PEDW), NHS Wales Informatics Service \n7.\tGP Practice records, various providers\n8.\tEducational data, Department for Education\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID\n4.\tGP Registration \n5.\tDate of birth\n6.\tDate of death \n7.\tPostcode (unit level)\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death\n3.\tPostcode (unit level)\n4.\tSex\n5.\tEthnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-25"]
["Next Review Date","2024-06-25"]
["Notes","13 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episodes Dataset (HES), Mental Health Minimum dataset (MHMDS), Office for National Statistics (ONS) Mortality Data, Cancer registration, & Patient Demographics Service (PDS) data\n\n04 May 2021 - Amendment supported\nThe amendment, to update the TwinsUK participant notification materials to include information about TwinsUK participation in the UK LLC, is supported, subject to compliance with the standard conditions of support.\n\n27 April 2021 - Amendment supported\nAmendment supported to allow the fair processing materials to be made available online as well as in hard copy.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from REC Confirmed 19 February under IRAS reference 258513 (REC 19/NW/0187). The applicant has confirmed that the REC opinion extends to the scope of the CAG application.\n\n2.\tDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]

{"sheet":"A02496","index":539,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02496"]
["Reference","20/CAG/0034"]
["Other Refs","IRAS Project ID: 271822 REC reference: 20/EM/0064"]
["Application Title","Detecting clinical deterioration in respiratory hospital patients using machine learning"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research that aims to develop a new early warning score to detect when patients who are in hospital with respiratory problems are getting worse and may need extra treatment. \n\nEarly warning scores are used in NHS hospitals to detect when patients are deteriorating and might need extra medical treatment. Currently used scoring systems are good at detecting sepsis and internal bleeding but sometimes they can fail to pick up breathing problems. They also don't work very well in some patients with long-term breathing problems because the score can be high all the time, even when patients are stable. This can result in doctors being called to see patients who don't need any extra treatment which can distract them from those who really need help. This project has been funded by the Medical Research Council and aims to develop a better scoring system for monitoring people with breathing problems in hospital. \n\nThe applicants will examine how often doctors are called to see patients with breathing problems each day and the extra treatments given as a result. Information about 22,000 patients who were admitted to hospital with breathing problems will be collected and 1000 cases examined in detail. Support under s251 is sought in order for researchers, who are not members of the direct care team, to access electronic and paper records within Nottingham University Hospitals NHS Trust for patients under the care of adult respiratory medicine services from 2014 until the present day. An anonymised dataset will then be provided to the University of Nottingham for analysis. "]
["Applicant Organisation Name","University of Nottingham "]
["Contact Name","Dr Sherif Gonem (Consultant Respiratory Physician)"]
["Address","Nottingham City Hospital"]
[null,"Hucknall Road"]
[null,"Nottingham"]
["Postcode","NG5 1PB"]
["Telephone","0115 969 1169"]
["Email","sherif.gonem@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 22,000 patients aged 18 years and over who were admitted to Nottingham University Hospitals NHS Trust under the care of respiratory medicine services between 2014 and the present day."]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic and paper medical records held within Nottingham University Hospitals NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tHospital ID number\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n2.\tGender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-29"]
["Next Review Date","2024-06-29"]
["Notes","Amendment supported 16 August 2023 to extend the duration of ‘s251’ support until 30 June 2024\n\n06 October 2022 – amendment supported to expand the patient cohort to include patients at Nottingham University Hospitals NHS Trust when under the care of any specialty, not just respiratory medicine\n\n24 March 2022 - Amendment supported\nAmendment supported to extend the duration of support to 31 March 2023.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 18 March 2020. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: Nottingham University NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02497","index":540,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02497"]
["Reference","20/CAG/0055"]
["Other Refs","IRAS Project ID: 279552 REC reference: 20/SC/0156"]
["Application Title","Can clinical and biochemical variables be used innovatively to improve risk modelling of mortality in patients undergoing emergency abdominal surgery?"]
["Application Summary","This application from the Portsmouth Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to investigate and test innovative ways of using clinical data and blood tests to predict the risk of death for patients who undergo emergency abdominal surgery. \n\nEmergency abdominal surgeries are performed to treat bowel emergencies, such as a bowel blockage or perforation. This is a high-risk surgery for many patients and has a mortality rate of 10%. Risk models are routinely used within the NHS to predict a patient’s risk of death prior to carrying out the laparotomy. This information can then be used by clinicians to help discuss the risks of surgery with patients and plan their care before and after surgery. The applicants plan to investigate and test ways of using clinical data and blood tests to improve the accuracy of models used to predict the risk of death for patients who undergo emergency laparotomy. The applicants plan to use the results of this study to guide the development of a larger, multi-site study. \n\nThe applicants seek support to process confidential patient information for patients who underwent emergency laparotomy at Queen Alexandra Hospital from December 2013 onwards. Data for these patients was entered into the National Emergency Laparotomy Audit (NELA) database. The student researcher, who is not a member of the direct care team, will extract the confidential patient information from the NELA database. The NELA database for Queen Alexandra Hospital is stored on Portsmouth Hospital NHS Trust servers. The patient’s NHS or Medical Records Number (MRN) will be used to extract clinical and biochemical data from electronic hospital records into datasets. Logistic regression analysis and other classification algorithms will be used to assess the predictive value of novel variables."]
["Applicant Organisation Name","Portsmouth Hospitals NHS Foundation Trust "]
["Contact Name","Mr Alexander Darbyshire"]
["Address","Research Department, Lancaster House"]
[null,"Queen Alexandra Hospital"]
[null,"Southwick Hill Road, Portsmouth"]
["Postcode","PO6 3LY"]
["Telephone",7980322141]
["Email","alexander.darbyshire@porthosp.nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and over who have had an emergency laparotomy for an intestinal emergency at Queen Alexandra Hospital from December 2013 onwards.\n\nThe applicants anticipate that 2000 patients will be included. "]
["Description of confidential patient information used","Data sources\n\n1.\tThe National Emergency Laparotomy Audit (NELA) database within Portsmouth Hospitals NHS Trust \n2.\tElectronic patient records within Portsmouth Hospitals NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tDate of birth\n4.\tDate of death\n5.\tPostcode\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-01"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised.\n\nIn terms of public benefit, the data was used to conduct exploratory data analysis modelling the risk of 30-day mortality after emergency bowel surgery, and the results have been published.\n\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 30 April 2020.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\n• Confirmed – Portsmouth Hospitals NHS Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by a check of the NHS Digital tracker on 20 May 2020."]

{"sheet":"A02498","index":541,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02498"]
["Reference","20/CAG/0007"]
["Other Refs","IRAS Project ID: 272374 REC reference: 19/EM/0321"]
["Application Title","Professional work in austere healthcare in the UK- the case of physiotherapy."]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research that seeks to investigate how the physiotherapy healthcare profession, as a healthcare profession outside of medicine and nursing, responds to austerity measures and financial pressures in the National Health Service in the UK. \n\nAfter the 2008 global financial crisis, widespread austerity measures were imposed across the public sector, including the NHS, in the UK. Research has been conducted in examining how medicine and nursing have adapted to austerity measures and financial pressures, but very little research has been done outside of these professions. The applicants had selected the physiotherapy profession to examine in this study in order to assess how different professions, which may have different resources, skills and abilities, respond to the challenges that austerity measures can provide. \n\nThis is a single centre, organisational, ethnographical study. The researcher will observe the practices within a physiotherapy department within an NHS organisation for 4-6 months. Physiotherapists will be observed in their normal working day and may also discuss their working life with the researcher. The physiotherapist may also be invited to take part in an interview, where they will be asked questions about their experience of working in the NHS during times of financial pressure. The researcher will not observe direct contact with patients, services users or relatives. Physiotherapists will be observed during team meetings, handover, interactions between members of the physiotherapy team, for example during prioritisation of caseload and allocation of workload, general presence in clinical areas and staff breaks. The observations will take place onsite at Nottingham University Hospitals NHS Trust in both inpatient and outpatient departments. This may include observations on general medical wards, specialist departments such as burns and plastics and musculoskeletal outpatients. The researcher may be exposed to confidential patient information during these observations and support under Section 251 and its Regulations is sought to cover these incidental disclosures. "]
["Applicant Organisation Name","University of Nottingham "]
["Contact Name","Professor Stephen Timmons"]
["Address","Nottingham University Business School "]
[null,"Jubilee Campus"]
[null,"Nottingham"]
["Postcode","NG81BB"]
["Telephone",1158466635]
["Email"," stephen.timmons@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The participants are 50 physiotherapists, recruited from Nottingham University Hospitals NHS Trust. No patients will be recruited into the research. "]
["Description of confidential patient information used","Data sources\n\nNo confidential patient information will be collected\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information are required for data linkage purposes.\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information are required for analysis purposes. \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-01"]
["Next Review Date","N/A"]
["Notes","Support expired 24 August 2021\n\nDue to COVID-19, the research that was supported by CAG was not completed- CAG support was required for the participant observations, which did not take place. The interview component of the study did take place and participants (healthcare professionals) provided written consent. \n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 14 January 2020. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: Nottingham University Hospitals NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. \n"]

{"sheet":"A02499","index":542,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02499"]
["Reference","20/CAG/0021"]
["Other Refs","IRAS Project ID: 272374 REC reference: 19/EM/0321"]
["Application Title","Breast Reconstruction: InvestigatinG long-term clinical and cost-effectiveness in tHe National MasTectomyand BrEast Reconstruction Audit cohort"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research that seeks to compare long-term clinical and cost-effectiveness of implant based and autologous breast reconstruction to help patients, health professionals and commissioners make more informed decisions about reconstructive breast surgery.\n\nThe majority of the 55,000 women diagnosed with breast cancer each year will be long-term cancer survivors but up to 40% will still require a mastectomy. Breast reconstruction is routinely taken in order to improve quality of life for patients.  Decision-making for breast reconstruction is complex. Reconstruction can be performed using implants or the patient’s own tissue from the back, abdomen or buttocks either at the time of mastectomy or at a later date, often after necessary cancer treatments have been completed. Each technique has different short-term risks and benefits, such as the duration of recovery, number and position of scars and surgical complications. Patients and surgeons need to balance these factors against the long-term outcomes of different procedures to make fully informed decisions about surgery. There is currently a shortage of evidence for patients and surgeons on which method of breast reconstruction after a mastectomy may be the best for patients in the long term. There is some evidence on the risks and benefits for each method of reconstruction during the next few years after the operation, but there is little evidence yet to say how patients will fare in the years further into the future.\n\nThe applicants will seek views from women who have undergone a mastectomy with and without breast reconstruction 10 years ago. Patients who underwent a mastectomy for breast cancer or a delayed breast reconstruction following a previous breast cancer diagnosis in an NHS setting between 1 January 2008 and 31 March 2009 will be identified within HES and data for this cohort extracted up until 31 March 2019. An up to date list of contact details for surviving patients will then be provided from National Cancer Registration and Analysis Service (NCRAS) via PHE. The research team at the University of Bristol will then contact the patients to invite them to complete questionnaires about their experience. Their involvement will then proceed on a consented basis."]
["Applicant Organisation Name","University of Bristol "]
["Contact Name","Miss Shelley Potter"]
["Address","University of Bristol"]
[null,"Office 2.14, Canynge Hall"]
[null,"Bristol"]
["Postcode","BS8 2PS"]
["Telephone",1179287218]
["Email","shelley.potter@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who underwent a mastectomy for breast cancer or a delayed breast reconstruction following a previous breast cancer diagnosis in an NHS setting between 1 January 2008 and 31 March 2009. The applicants expect that 16212 patients will be included. "]
["Description of confidential patient information used","Data sources\n\n1.\tHES and NCRAS data held by Public Health England\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS number\n3.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tRegion of NHS care provider\n3.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-03"]
["Next Review Date"]
["Notes","Applicant confirmed in september 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the study will directly strengthen the evidence base for treatment of patients undergoing mastectomy and breast reconstruction surgery following a diagnosis of breast cancer, enabling better informed decisions which affect the clinical outcomes and quality of life of tens of thousands of women each year in the UK.\n\n\n03 December 2020 - Amendment supported\nAmendment supported to include NHS Digital as a data processor and to give support for the disclosure of confidential patient information from the HES, PDS and cancer registry datasets held by NHS Digital to the University of Bristol.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 02 July 2020. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: University of Bristol – Bristol Medical School (by NHS Digital email dated 17 December 2019), Public Health England (by NHS Digital email dated 02 September 2019) and NHS Digital (by NHS Digital email dated 10 June 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]

{"sheet":"A02500","index":543,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02500"]
["Reference","19/CAG/0192"]
["Other Refs","IRAS Project ID: 258813 REC reference: 19/WM/0209"]
["Application Title","IgG4-related Orbital Disease (IgG4-ROD): A Surveillance Study"]
["Application Summary","This application from University Hospitals Bristol NHS Foundation Trust set out the purpose of medical research which aims to establish the incidence, case mix management of probable or definite orbital IgG4-related disease. The study will follow the established British Ophthalmologist Surveillance Unit (BOSU) methodology, using the monthly reporting card amongst UK ophthalmologists. \n\nThe BOSU methodology is established and has received support in principle from the CAG. Ophthalmologists will indicate that they have seen a new of probable or definite orbital IgG4-related disease case through the BOSU. The BOSU collects no patient identifying information but will notify the study investigator of all ophthalmologists who report new cases. The researcher will then contact the reporting ophthalmologist directly and will be sent a questionnaire requesting information to determine the incidence, but also secondary aims of histological subtype, the treatment given, prognosis and the effect on vision. The primary questionnaire will be completed at the point of notification with follow-up at 12 months.\n\nThe aim of the project is to identify factors that might lead to an increased risk of severe, or relapsing disease, and whether there are any links between the orbital and systemic forms of the disease, in order to inform risk assessment and management of patients in the future. The applicants anticipate that the study would also help to raise awareness of a relatively newly recognised disorder, which may previously have been labelled as ‘idiopathic orbital inflammatory disease’ so that this subset of patients can be appropriately identified and managed. "]
["Applicant Organisation Name","University Hospitals Bristol NHS Foundation Trust "]
["Contact Name","Samantha Hunt,Ophthalmologist"]
["Address","Bristol Eye Hospital"]
[null,"Lower Maudlin Street"]
[null,"Bristol"]
["Postcode","BS1 2LX"]
["Telephone",7761463811]
["Email","samantha.hunt@uhbw.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any patient presenting to a participating ophthalmologist with probable or definite IgG4-related orbital disease. It is anticipated that this will include 60-75 patients in the 12-month reporting period. "]
["Description of confidential patient information used","Data sources\n\n1.\tPatient medical records, Hospital Eye Units in England and Wales \n\nIdentifiers required for linkage purposes\n\n1.\tHospital ID\n2.\tMonth and year of birth \n\nIdentifiers required for analysis purposes\n\n1.\tSex\n2.\tEthnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-06"]
["Next Review Date","2024-07-06"]
["Notes","Conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 26 September 2019\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: University Hospitals Bristol NHS Foundation Trust (by NHS Digital email dated 06 July 2020) has confirmed ‘Standards Met’ grade on DSPT 2018/19)."]

{"sheet":"A02501","index":544,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02501"]
["Reference","20/CAG/0072"]
["Other Refs","IRAS Project ID: 274705 REC reference: 20/NE/0144"]
["Application Title","How effective and cost-effective is water fluoridation for adults? A 10-year retrospective cohort study"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to determine whether water fluoridation for adults is affects the invasive dental treatments received by adults attending NHS dental practices, and whether water fluoridation is cost-effective. \n\nTooth decay is common and is costly both to the NHS and patients. The NHS currently spends £3.4 billion on NHS dental services, and patients pay another £653 million in patient charges. The majority of these costs are spent on the treatment of tooth decay and its consequences. Fluoride has been added to some public water supplies since the 1940’s and has been added to toothpastes since the 1970’s. In America and Australia, fluoride is added to almost all public water supplies, while 10% of water supplies in England contain fluoride. It is the decision of Local Councils whether fluoride should be added to the water supply and currently little modern research has been carried out that supports the benefit of water fluoridation. \n\nThe applicants are seeking support to process confidential patient information collected in NHS dental practice records in order to understand the impact of water fluoridation on adults. The number and type of dental treatments provided to approximately 6 million people living in fluoridated or non- fluoridated areas over a ten-year period will be compared. Anonymised, patient-level dental data will be provided from the NHS Business Services Authority to the research team at the University of Manchester. Patients in fluoridated or non- fluoridated areas will be ‘matched’ so that patients can be compared to other patients who as similar as possible."]
["Applicant Organisation Name","University of Manchester "]
["Contact Name","Professor Iain Pretty "]
["Address","The University of Manchester "]
[null,"Dental Health Unit, Williams House"]
[null,"Lloyd Street North"]
["Postcode","M156SE"]
["Telephone",1612324711]
["Email","iain.a.pretty@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Six million patients who attended a dental practice within England at least twice between 2010 and 2020. Patients will have been aged 12 years and over at the start of the time period. \n\nThe applicants anticipate that twenty million patient records will be included in the transfer to anonymised patient records from NHS BSA to the University of Manchester. The six million patients required will be selected from this, according to which individuals best meet the matching requirements. \n\nThe applicants will request a full ten years of retrospective data. Specific dates could not be provided, as the extract would be ten years from the date that NHS BSA accessed the system and extracted the dataset."]
["Description of confidential patient information used","Data sources\n\n1.\tInformation on dental care held by NHS Business Services Authority\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tDate of birth\n4.\tPostcode\n5.\tComposite ID used by NHS BSA, composed using patient surname, first initial, gender and date of birth\n\nIdentifiers required for analysis purposes\n\n1.\tPostcode – sub-sector level\n2.\tLower Super Output Area of postcode\n3.\tGender\n4.\tEthnicity\n5.\tNHS dental charges exemption category"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-07"]
["Next Review Date","N/A"]
["Notes","23 July 2021 - Support expired\nApplicant confirmed on 23 July 2021 that support no longer required. \n\n1. Please may you confirm the reason that support is no longer required.\nAll identifying information has been modified and removed, and there is no key retained. There is no longer any processing of confidential patient information without consent. \n\n2. Please may you summarise the public benefits that arose from this work? It is important to demonstrate the public benefits of work undertaken through support and this will be included on the expired record for transparency.\n\nCAG support enabled the use of anonymised NHS dental payment data to inform a publicly-funded research study on the effectiveness and cost-effectiveness for adults. The effectiveness of water fluoridation has been mostly studied in children, and in 2002 the UK Medical Research Council stated that more research on adults was needed. Adults have been very rarely studied because recruiting a representative sample to include in dental surveys is more difficult than it is for children, who are often included through schools. Using NHS data that has already been collected means that obtaining information about the dental health of adults is faster and less costly, compared to surveys. This study will investigate whether adults receiving fluoridated water have fewer NHS fillings and extractions over ten years than those who do not receive fluoridated water. The study will also investigate whether water fluoridation results in costs savings for the NHS, and for patients themselves. This will help decision-makers and the public to understand the costs and benefits of water fluoridation. The results of the study are expected in 2022. \n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 May 2020. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed – NHS Business Services Authority has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 06 September 2019)."]

{"sheet":"A02502","index":545,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02502"]
["Reference","20/CAG/0079"]
["Other Refs","IRAS Project ID: 272082 REC reference: 20/EE/0013"]
["Application Title","Long-term safety of cabergoline in hyperprolactinaemia"]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research which aims to determine whether there is a link between cabergoline at low doses and the development of fibrotic heart disease.\n\nThe drug cabergoline is used in low doses for the treatment of benign pituitary tumours called 'prolactinoma’. There is evidence that the drug may cause heart valve disease so anyone taking cabergoline has heart scans every 6-12 months. This project seeks to determine if there is a link at low doses. To do this the project team seeks to use the Discovery data service to identify all eligible patients taking cabergoline (cases) and 5 matched controls for each case. The bulk of this data will be pseudonymised. Only when a case took cabergoline and subsequently developed a cardiac problem will the NHS number of that patient be collected in order to determine if that patient had an echocardiogram at Bart’s Health NHS Trust. If so, the scans will be re-reviewed by a consultant cardiologist.  \n\nSection 251 support is requested for use of the NHS number to access patient records and collect echocardiograms. Whilst the applicant is employed by Bart’s Health NHS Trust and works in the same department, he may not necessarily have been providing direct care to the patients. Section 251 support is also requested for a consultant cardiologist from Queen Elizabeth Hospital Birmingham to come to Bart’s Health NHS Trust to re-review scans. Whilst every effort will be made to minimise access to identifiable data, the consultant will likely see names, dates of birth and NHS/hospital numbers as this information is embedded on to the images."]
["Applicant Organisation Name","Queen Mary University of London "]
["Contact Name","Dr Craig Stiles"]
["Address","St Bartholomew's Hospital"]
[null,"West Smithfield"]
[null,"London"]
["Postcode","EC1A 7BE"]
["Telephone",2073777000]
["Email","c.stiles@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","From previous work on anonymised data, the team estimate 24 patients that have taken cabergoline and developed heart problems."]
["Description of confidential patient information used","Data sources\n\n1.\tDiscovery Data Service (data service of all hospital and GP records in North East London)\n2.\tBart’s Health NHS Trust \n\nIdentifiers required for linkage purposes\n\n1.\tNHS Number\n\nIdentifiers required for analysis purposes\n\n1.\tName\n2.\tDate of birth\n3.\tNHS/Hospital number\n(The above are embedded onto the images that will be re-reviewed)"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-06-26"]
["Next Review Date","2021-06-20"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee (Confirmed – 12 June 2020).\n2.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Bart’s Health NHS Trust and NHS Tower Hamlets Clinical Commissioning Group (checked on DSPT tracker 16 June 2020) have been confirmed as ‘Standards Met’ by NHS Digital. "]

{"sheet":"A02503","index":546,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02503"]
["Reference","20/CAG/0035"]
["Other Refs","IRAS Project ID: 260505 REC reference: 19/YH/0360"]
["Application Title","Safety INdEx of Prehospital On Scene Triage (SINEPOST): The derivation and validation of a risk prediction model to support ambulance clinical transport decisions on scene"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research which aims to determine whether ambulance service clinical data can predict an avoidable attendance at the Emergency Department in adults using classification models.\n\nParamedics have specialist knowledge and skills in helping people in emergencies. The bulk of ambulance service patients who call have problems that are described as ‘urgent’. These are cases where the patient may need access to healthcare and medical help, but there is only a very small chance that the problem is life threatening. The care of urgent patients is complex and trying to find the right place for their care can be hard. In 2014 in Yorkshire, up to 16.9% of patients could have avoided being taken by ambulance to the Emergency Department (ED). This group of patients had no special tests or treatments and were sent home. This means they had a minor problem that could have been managed elsewhere. When the ED is busy, ambulances have to wait a long time to handover the care of their patients. This delay stops ambulances being free to respond to the next emergency. These problems mean paramedics need to make sure the ED is the right place for their patient before they take them there. This project aims to develop a tool to help with that decision by showing the paramedic the likelihood of treatment at an ED being of benefit to the patient.\n\nThe applicants are seeking support under s251 to access the Electronic Patient Care Record at Yorkshire Ambulance Service NHS Trust and to obtain Emergency Department Care data from NHS Digital. The first stage of the study requires that data from the Yorkshire Ambulance Service NHS Trust is linked to data from a large hospital via NHS Digital, in order to provide show us the complete patient journey from their call for help through to leaving the ED. An anonymised dataset will then be provided to the applicants at the University of Sheffield. This information will be used to create a tool that identifies patients who may not need to be taken to the ED. The public will be invited to face-to-face meetings to help the researcher produce a lay summary of this phase. In the second stage, data from the Yorkshire Ambulance Service NHS Trust will be linked to Emergency Department Care data from NHS Digital for a different hospital, to see if the test can work in different settings. "]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Suzanne Mason"]
["Address","University of Sheffield, CURE, ScHARR"]
[null,"30 Regent Street"]
[null,"Sheffield"]
["Postcode","S1 4DA"]
["Telephone"]
["Email","jamie.miles@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","467329 patients treated by Yorkshire Ambulance Service NHS Trust and by the two participating Trusts."]
["Description of confidential patient information used","Data sources\n1. Electronic Patient Care Record at Yorkshire Ambulance Service NHS Trust\n2. Emergency Department Care data provided by NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Date of death\n5. Postcode -unit level\n\nIdentifiers required for analysis purposes\n1. Postcode – sector level"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-14"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and identifiers deleted.\n\nIn terms of public benefit, applicants were able to successfully create a risk prediction algorithm that could predict whether a patient would need to be transported to the ED. This study provided significant proof of concept for the ability of an AI algorithm to find patterns in ambulance patients that can be used to make predictions.  Applicants are in the process of working on a future research project that would see the development of a more complex algorithm that can predict what the care needs are of all ambulance patients so that pathways and services can be developed around them. Without the use of unconsented identifiable patient data, applicants could never have developed such a powerful algorithm, nor further this into a more clinically meaningful future iteration.\n\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 08 November 2019.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: NHS Digital (by NHS Digital email 10 June 2019) and Yorkshire Ambulance Service NHS Trust (by NHS Digital email 07 January 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). \n\n\nDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]

{"sheet":"A02504","index":547,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02504"]
["Reference","20/CAG/0029"]
["Other Refs","IRAS Project ID: 270686 REC reference: 20/LO/0195"]
["Application Title","Incidence of Chronic Recurrent Multifocal Osteomyelitis (CRMO) in the United Kingdom (UK) and Republic of Ireland (ROI)"]
["Application Summary","This application from the Cambridge University Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to determine the incidence of Chronic Recurrent Multifocal Osteomyelitis (CRMO) within the UK. \n\nCRMO, also known as chronic non-bacterial osteomyelitis (CNO), is a rare auto-inflammatory condition affecting the bones. It occurs primarily in children and teenagers, although cases in adults have been reported. Its clinical presentation is characterised by bone pan and swelling, in the absence of infection or tumour. Milder cases require treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) for disease control, while more serious cases more require treatment with multiple medications, including treatments that suppress the immune system. CRMO was first identified over 40 years ago, but it is now known how common it is. The applicants seek to gather information about the prevalence of CRMO.\n\nThe study will be conducted using British Paediatric Surveillance Unit (BPSU) methodology. Each month the BPSU will send an eReporting card to all consultant paediatricians across the UK and Republic of Ireland. The card will list the conditions currently being studies, including CRMO. If a clinician has seen a child affected by CRMO they tick the corresponding box on the card and return it to BPSU. BPSU then notify the applicants and provide the contact details of the reporting clinician. The applicants then contact the clinician with a confidential case report form requesting further information, including the child’s demographic details, presentation, investigations and initial management. Reporting paediatricians will be contacted again 12 months later to collect follow up information on treatment received and outcome. Some patients with CRMO are referred to and managed by paediatric orthopaedic surgeons, without input from paediatricians, therefore the applicants will also run a parallel surveillance study through the British Society for Children’s Orthopaedic Surgery (BSCOS), surveying all paediatric orthopaedic surgeons. The same case report and follow-up forms from the BPSU survey will be used for initial case identification and follow-up. "]
["Applicant Organisation Name","Cambridge University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Chenqu Suo"]
["Address","Wellcome Trust Clinical PhD Fellow"]
[null,"Wellcome Genome Campus"]
[null,"Hinxton, Cambridge"]
["Postcode","CB10 1HH"]
["Telephone","01223 348 577"]
["Email","chenqu.suo@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","135 patients diagnosed with CRMO."]
["Description of confidential patient information used","Data sources\n1. Clinicians reporting cases via British Paediatric Surveillance Unit (BPSU)\n2. Clinicians reporting cases via the British Society for Children’s Orthopaedic Surgery (BSCOS)\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth \n3. Date of death\n4. Postcode – sector level\n5. Ethnicity\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – sector level\n4. Gender\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-12"]
["Next Review Date","2024-07-12"]
["Notes","Amendment supported 20 June 2023 to allow the transfer of radiological images for the study review via an encrypted DVD in cases where the use of the Image Exchange Portal is not available at the reporting hospital, and to include two further radiologists to the radiological review panel\n\n08 April 2022 - Amendment Supported:\nAmendment supported to extend the surveillance sampling phase until November 2022, extend the follow up duration of the entire cohort, (until 2 years post diagnosis - November 2024), and for the additional temporary disclosure of confidential patient information within radiological images from reporting clinicians to Addenbrooke’s Hospital.\n\nSpecific conditions of support:\n1. Favourable opinion from REC Confirmed 06 March 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. (Confirmed – Cambridge University Hospitals NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 08 July 2019)."]

{"sheet":"A02505","index":548,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02505"]
["Reference","20/CAG/0027"]
["Other Refs","IRAS Project ID: 266393 REC reference: 20/NS/0022"]
["Application Title","Congenital Heart Audit: Measuring Progress In Outcomes Nationally"]
["Application Summary","This application from University College London set out the purpose of medical research which aims to develop tools for routinely measuring congenital heart disease outcomes that are considered meaningful and appropriate by stakeholders and can inform the delivery and commissioning of services for patients.\n\nCongenital heart disease requires lifelong clinical input and significant healthcare utilisation.  In 2015, NHS England called for better reporting of quality of services, beyond the current focus on 30-day survival following paediatric cardiac surgery. This project will draw on a number of data sources to:\n\n• Define the scope of adult procedures for national reporting, identify what outcomes to measure;\n• Explore potential risk factors, and develop a fair way of reporting surgical outcomes;\n• Investigate longer-term outcomes tracking people with representative diagnoses through a combined dataset, describing their long-term survival, and the number of operations within and outside the anticipated treatment plan;\n• Develop prototype software tools to calculate and display longer-term and adult outcomes providing meaningful information to patients and commissioners of CHD services."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Sonya Crowe, Co-PI of CHAMPION and Professor of Operational Research "]
["Address","Clinical Operational Research Unit"]
[null,"Department of Mathematics, University College London"]
[null,"4 Taviton Street, London"]
["Postcode","WC1H 0BT"]
["Telephone","02076794953 "]
["Email","sonya.crowe@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 130,000 children and adults with congenital heart disease. From birth, no upper age limit. England only."]
["Description of confidential patient information used","Data sources\n1. The LAUNCHES dataset [18/CAG/0180]\n2. National Adult Cardiac Surgery Audit (NACSA) [17/CAG/0071] – pseudonymised, linked to the LAUNCHES dataset.\n3. National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) [CAG 10-02(d)/2015] – pseudonymised, not linked\n4. Clinical audit data from Barts Health NHS Trust – pseudonymised, not linked\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Hospital ID no.\n4. Date of birth\n5. Postcode\n\nIdentifiers required for analysis purposes\n1. Hospital Name\n2. Place of occurrence of death (categorical: one of home/hospice/hospital/care home)\n3. Gender\n4. Ethnicity\n5. Month and year of birth (not day).\n6. Age at procedures, hospital admissions etc (to four decimal places). Age to 4 decimal places is needed to sequence events that happen on the same day (e.g. two procedures on the same day)."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-12"]
["Next Review Date","2024-07-12"]
["Notes","20 June 2023 - change in data processors from;\n•\tPublic Health England (PHE) to NHS England, regarding the data source National Congenital Anomaly and Rare Disease Registration Service (NCARDRS),\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research (NICOR), National Congenital Heart Disease Audit (NCHDA).\n\n\nAmendment supported 20 June 2023 \n\n•\tto extend the duration of ‘s251’ support until 31 May 2024, \n\n•\tTo receive 2020 NCARDRS (National Congenital Anomaly and Rare Disease Registration Service) data from NHS England,\n\n•\tTo clarify that applicants are also requesting month and year of estimated delivery date for non-live births from NCARDRS. Time points have been requested as age in gestation weeks if pre-natal events, and in days if post-natal events,\n\n•\tTo remove ONS linkage as a separate data flow, as the life status fields are available with the NCARDRS data itself and therefore will be requested within the updated NCARDRS extract, \n\n•\tAnd to include work on the reporting and risk adjustment of postoperative complications in children as a new additional purpose of the audit, \n\n\nAmendment supported 19 July to update the dataset to include new patients registered in National Congenital Heart Disease Audit (NCHDA) who have had their first procedure from March 2017, up to and including March 2021, (March 2022 if available), and for NHS Digital to link to updated ONS mortality data, and to additionally link NCARDRS (National Congenital Anomaly and Rare Disease Registration Service) data to NCHDA and ONS outcome data\n\n\n16 June 2021 - Amendment supported\nSupport provided to extend the period of support until 30 September 2023.\n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 14/02/2020.\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: University College London (by NHS Digital email 02 July 2019), University of Leeds (by NHS Digital email 28 August 2019), ICNARC (by NHS Digitial email 29 May 2019), NHS Digital (by NHS Digital email 10 June 2019) and Public Health England (by NHS Digital email 02 September 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19. \n\nConfirmed: Barts Health NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. "]

{"sheet":"A02506","index":549,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02506"]
["Reference","20/CAG/0031"]
["Other Refs","IRAS Project ID: 249148 REC reference: 18/LO/1039"]
["Application Title","Self-management and support programme for COPD (EDGE2)"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to determine the feasibility of integrating hospital data with data collected by patients at home. \n\nChronic Obstructive Pulmonary Disease (COPD) is the name for a number of lung conditions. Individuals with COPD find breathing increasingly difficult due to the affect that the condition has on the lungs. COPD is a long-term disease without a known cure and is likely to become the third leading cause of death worldwide by 2020. Current treatments are focused on avoiding deterioration, minimising risk factors and reducing symptoms. Approximately 1 in 4 COPD patients in the NHS are re-admitted to hospital within 3 months of a previous visit. The applicants are seeking ways that digital technologies can be used by patients to monitor their condition at home and provide regular updates to their care team, so that the care team are aware if patients condition is deteriorating at home. \n\nPotentially eligible patients attending or admitted to Oxford University Hospitals NHS Foundation Trust due to COPD exacerbation or a pulmonary infection will be identified by the clinical research team or by the clinical care team by accessing confidential patient information. If the clinical care team identify a suitable patient they will flag this with the research team who will approach the patient with verbal and written information about the study. Patients participation will then proceed on a consented basis. Patients will be given a tablet computer running the EDGE mHealth application and asked to wear the monitoring device as often as possible to monitor their physical activity levels for two weeks after being discharged from hospital."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Andrew Farmer"]
["Address","Professor of General Practice"]
[null,"Nuffield Department of Primary Care Health Sciences"]
[null,"Radcliffe Observatory Quarter, Woodstock Road"]
["Postcode","OX2 6GG"]
["Telephone","01865 617 492"]
["Email","andrew.farmer@phc.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","200 patients, who have been admitted to hospital with a diagnosis of COPD, will be invited to take part. \n\n15 health professionals will also be invited, but this is outside the scope of s251 support. "]
["Description of confidential patient information used","Data sources\n1. Electronic and paper patient records held at Oxford University Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Postcode – district level\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Age "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-16"]
["Next Review Date","N/A"]
["Notes","Expired support July 2022\n\n\tApplicant confirmed June 2022 that ‘s251’ support no longer required. Support had been provided for the process of potential participant identification (via record search) and initial screening. The EDGE2 study ended active recruitment and entered follow up only activities on the 31st of March 2022, and are no longer identifying new patients to approach.  \n \nIn terms of public benefit, COPD is a chronic health condition that can drastically effect patient quality of life and create a huge burden for the NHS via frequent hospital admissions and regular community management. Approximately 1 in 4 COPD patients are re-admitted within 3 months; highlighting that efforts to target the prevention of hospital re-admissions by spotting health declines prior to the point of hospitalisation could be of great benefit. The COVID-19 pandemic further highlighted the need for regular, reliable at home monitoring to allow NHS community respiratory teams to safely and efficiently care for their patients in an environment that saw COPD sufferers become even more vulnerable to disease and prevented healthcare workers from face-to-face engagement. The provision of daily community data via EDGE2 to the Oxford NHS respiratory team has made management of vulnerable patients safer and easier. \n\t\t\n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 27 February 2020.\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Oxford University Hospitals NHS Foundation Trust has confirmed ‘Standards Met’ grade on DSPT 2018/19 (by NHS Digital email dated 17 September 2019)."]

{"sheet":"A02507","index":550,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02507"]
["Reference","20/CAG/0054"]
["Other Refs","IRAS Project ID: 252801 REC reference: 19/SC/0026"]
["Application Title","Screening for Hypertension in the INpatient Environment (SHINE): A Diagnostic Accuracy Cohort Study"]
["Application Summary","This application from University of Oxford set out the purpose of medical research which aims to determine the optimal in-hospital blood pressure threshold above which to undertake community ambulatory blood pressure monitoring to detect hypertension.\n\nHypertension is the leading risk factor for death globally, with 12.8% of global deaths annually attributable to hypertension. Increased blood pressure measurements in the hospital setting are frequently dismissed, possibly due to clinicians attributing raised blood pressure to anxiety, pain or White Coat Hypertension. Clinicians usually expect that a patient’s blood pressure will normalise following discharge, however limited data suggests that those with elevated blood pressure in hospitals frequently remain hypertensive in the community. Untreated hypertension is associated with a progressive increase in blood pressure that can become very difficult to treat. This means that hospital detection and timely management of hypertension offer an important intervention opportunity of address this major and global cause of illness and mortality. Recognition and documentation of elevated blood pressure readings in hospital is lacking, and referral for community follow-up of these patients to determine cases of persistent hypertension is low\n\nThe Oxford University Hospitals NHS Foundation Trust introduced the NIHR-funded System for Electronic Notification and Documentation (SEND) in 2015. SEND is a tailored software service, which links hospital bedside monitoring devices, including blood pressure monitors, with a tablet computer to accurately record vital observations of patients. This enables clinical researchers to access and analyse patient observation data at a population level, as well as an individual level. SEND has monitored observations for more than 100,000 patients so far and links patient observations to their Electronic Patient Record (EPR). This presents Oxford University Hospitals NHS Foundation Trust with an opportunity to screen all admitted patients for hypertension, with the potential of providing preventative medicine to patients. \n\nThe applicants intend to conduct a twelve-month prospective study. Eligible patients will be identified during their hospital admission by an algorithm run across the EPR. Selected patients will then be screened against the inclusion and exclusion criteria by members of the research team. Patients meeting these criteria will then be approached for consent to take part in the study. Support is sought for the screening of patient records for suitability prior to consent being obtained."]
["Applicant Organisation Name","Oxford University NHS Foundation Trust"]
["Contact Name","Professor Peter Watkinson"]
["Address","Professor of Intensive Care Medicine, Oxford Hospitals NHS Foundation Trust"]
[null,"Level 3, Kadoorie Centre, John Radcliffe Hospital"]
[null,"Headley Way, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865 572 609"]
["Email","peter.watkinson@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients treated at Oxford University NHS Foundation Trust and identified as meeting the inclusion criteria and identified as potential participants by the SEND algorithm"]
["Description of confidential patient information used","Data sources\n1. Electronic patient records held at Oxford University NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. GP Registration\n5. Date of death\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Postcode – district level\n2. Gender\n3. Age"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-16"]
["Next Review Date","N/A"]
["Notes","The applicant confirmed in July 2023 that ‘s251’ support is no longer required. All confidential patient information is now processed under patient consent. Confidential patient information for patients screened but not enrolled has now been deleted. \n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 18 May 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Confirmed: Oxford University Hospitals NHS Foundation Trust has confirmed ‘Standards Met’ grade on DSPT 2018/19 (by NHS Digital email dated 17 September 2019)."]

{"sheet":"A02508","index":551,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02508"]
["Reference","19/CAG/0207"]
["Other Refs","IRAS Project ID: 260953 REC reference: 97/7/02"]
["Application Title","Survival of people with screen-detected heart failure (ECHOES-Survive)"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to undertaken longitudinal follow-up of patients who were recruited on a fully consented basis to the historic ‘Echocardiographic Heart of England Screening (ECHOES) Study’. The ECHOES study was carried out between 1995 and 1999 in 16 General Practices around the West Midlands region. The purpose of the study was to establish the prevalence of heart failure in the general population over the age of 45 and involved assessment of detailed clinical history and examination, 12 lead ECG, and echocardiography.\n\nAll patients who participated in this trial are flagged with NHS Digital to enable follow-up via civil registration data to ascertain which members of the cohort have died and when, together with the cause of death. NHS Digital reassessed the consenting materials for the study in 2018 and determined that these were no longer valid, in relation to the common law duty of confidentiality, to support the ongoing processing of patient information and disclosure of mortality data. The applicant was advised to submit an application to the CAG to seek section 251 support to legitimise the longitudinal follow-up of the patient cohort to undertake 20-year survival analysis."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Richard Hobbs, General Practitioner and Head of Department"]
["Address","University of Oxford, Nuffield Department of Primary Care Health Sciences"]
[null,"Radcliffe Primary Care Building"]
[null,"Radcliffe Observatory Quarter, Oxford"]
["Postcode","OX2 6GG"]
["Telephone","01865 617 851"]
["Email","richard.hobbs@phc.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","6,162 patients who were recruited to the ECHOES trial between 1995 and 1999 on a fully consented basis from 16 GP practices in the West Midlands."]
["Description of confidential patient information used","Data sources\n1. ECHOES trial dataset, University of Oxford\n2. ONS mortality data, NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n\nIdentifiers required for analysis purposes\n1. Date of birth and death – calculation of survival \n2. Postcode – deprivation scoring\n3. Cause of death\n4. Sex \n5. Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-22"]
["Next Review Date","2024-07-22"]
["Notes","Specific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 23 April 2020\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: NHS Digital (by check of the NHS Digital DSPT tracker on 22 July 2020) has a confirmed ‘Standards Met’ grade on DSPT 2018/19. The University of Birmingham (by check of the NHS Digital DSPT tracker on 22 July 2020) have confirmed ‘Standards Met’ grade on DSPT 2019/20. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02509","index":552,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02509"]
["Reference","19/CAG/0205"]
["Other Refs","IRAS Project ID: 269473 REC reference: MREC/00/7/17"]
["Application Title","A large randomised assessment of the relative cost-effectiveness of different classes of drugs for Parkinson’s disease"]
["Application Summary","This application from the University of Birmingham set out the purpose of medical research that seeks to determine the relative cost-effectiveness of different classes of drugs for both early and later Parkinson’s Disease (PD).\n\nParkinson's disease (PD) is one of the commonest causes of disability in older people with at least 8000 new cases diagnosed each year in the UK alone. Levodopa (LD) controls symptoms for most patients but long-term use is associated with motor complications. A number of other drugs have been used, either alone or with reduced doses of LD, in an attempt to delay the onset of motor complications, or to control complications in later disease once they have developed. The PD MED trial began in 2000 as a large, simple, \"real-life\" trial that aimed to determine which class of drug provided the most effective control, with the fewest side-effects, for both early and later PD. Patients with early PD were randomised between dopamine agonists (DA), monoamine oxidase type B inhibitors (MAOBI) and categhol-O-methyltransferase inhibitors (COMTI) with the option to omit either the MAOBI or LD alone arm. Those whose disease was no longer controlled by their first class of drug, after dose titration or addition of LD, were randomised between COMTI, MAOBI and DA, with the option to omit either the MAOBI or the DA arm. The main outcome measure was the patient-rated PDQ-39 quality of life scale, which assessed all aspects of the patient's life. Patients were followed-up by questionnaires given when they entered the study, and then repeated at 6 and 12 months, and then once a year for at least another 4 years. Their carer, if they had one, was also asked to answer questions to find out how looking after someone with PD had affected their life. The questionnaires were sent by post. \n\nInformation on hospital admissions and mortality was also requested from HES and ONS data, held by NHS Digital. When consenting to take part in the study, patients had been informed that this follow-up would continue until they died. The PD MED team were recently informed by NHS Digital that IGARD had deemed that the trial’s consent form did not explicitly ask participants for permission for their confidential patient information to be disclosed to NHS Digital for linkage of HES and ONS data. Re-consenting participants in the trial would be difficult, therefore the applicants were seeking support under Section 251 to continue to collect follow-up data."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Dr Carl Clarke"]
["Address","University of Birmingham"]
[null,"Edgbaston"]
[null,"Birmingham"]
["Postcode","B15 2TT"]
["Telephone","01215 075 442"]
["Email","c.e.clarke@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over, diagnosed with Parkinson’s Disease and recruited into the PD MED trial.\n\n2500 patients were recruited into the original trial."]
["Description of confidential patient information used","Data sources\n1. HES and ONS data held by NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of Birth\n4. Date of Death\n\nIdentifiers required for analysis purposes\n1. Date of Death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-23"]
["Next Review Date"]
["Notes","Applicant confirmed May 2023 that ‘s251’ support can be expired, as all information collected under ‘s251’ support has been deleted.\n\nWith regards to public benefit, the major conclusion which resulted from the analyses of 10 years of follow-up was that levodopa is the most cost-effective therapy for early onset Parkinson's disease. This resulted in an update of the 2017 NICE guidelines for the treatment of Early Parkinson's Disease.  Because levodopa is more cost-effective, this will be economically more beneficial for the NHS. Other analyses were also undertaken and have indicated results that may change practice.\n\n\n21 October 2021 - Amendment supported \nto allow the PD Med team at University of Birmingham to receive confidential patient information from NHS Digital in the form of outcome updates from cancer registry data and mortality data between September 2018 up to the latest available data at the point of reporting.\n\n13 April 2021 - Amendment supported\nThe amendment, to provide Regulation 5 support for the disclosure of confidential patient information from NHS Digital to the PD Med research team at the University of Birmingham, is supported, subject to compliance with the standard conditions of support.\n\n16 October 2020 - Amendment supported to:\n\n• Undertake further linkages with cancer registry data, Office for National Statistics (ONS) mortality data, and Personal Demographics Service (PDS) demographics data held by NHS Digital. Support is required to allow the disclosure of confidential patient information to NHS Digital from the PD MED team at University of Birmingham for the purposes of undertaking these linkages. \n\n• Support the retention of cancer registry data and demographics data already received\n\n• Extend the duration of study support until 1 November 2022, \n\nSpecific conditions of support \n1. Favourable opinion from a Research Ethics Committee. Confirmed 02 December 2019. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\na. Confirmed – NHS Digital has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 23 May 2019. \n\nb. Confirmed – the University of Birmingham has a confirmed ‘Standards Met’ grade on DSPT submission 2019/20 by NHS Digital email dated 15 July 2020. \n\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. "]

{"sheet":"A02510","index":553,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02510"]
["Reference","20/CAG/0030"]
["Other Refs","IRAS Project ID: 254073 REC reference: 19/SS/0108"]
["Application Title","Optimal management of lymphoedema: do attitudes towards body weight and experiences of practitioners and patients affect patient engagement and guideline adherence?"]
["Application Summary","This application from the University of Glasgow set out the purpose of medical research that seeks to develop understanding of the barriers and enablers of including body weight within the lymphoedema assessment and management plan. \n\nLymphoedema is a chronic, incurable condition which can seriously impact upon quality of life. It results from an impaired lymphatic system and can lead to swelling, pain, mobility problems, increased risk of infections and skin texture changes. Lymphoedema prevalence is rising in the developed world due to an ageing population and growing rates of obesity, chronic illness and cancer. Whilst there are a number of strategies which can be employed to manage lymphoedema, there is no known cure. Obesity has been identified as a risk factor and, as a result, lymphoedema management guidelines recommend that those presenting with lymphoedema who are overweight or obese are encouraged and supported to work towards achieving a healthy weight. However, no evidence has been published to ascertain whether body weight is a considered part of the lymphoedema assessment and management process, and the barriers and supports that can affect this aspect of care from a patient or practitioners’ perspective. The applicants seek to address this gap by conducting a study, where interviews and questionnaires will be completed by practitioners treating lymphoedema and through an online questionnaire and interviews with patients treated for lymphoedema within the UK.\n\nThe study is comprised of three phases, involving multiple data collection processes. Consent from patients will be sought for each phase, apart from a retrospective revie of lymphoedema records that will be conducted within two Welsh Health Boards, the Hywel Dda Health Board and Swansea Bay University Health Board. A member of the direct care team will select the records of up to 30 suitable patients at each board. The research staff will then access the confidential patient information on site in order to extract an anonymised dataset.  "]
["Applicant Organisation Name","University of Glasgow"]
["Contact Name","Dr Rhian Noble-Jones"]
["Address","School of Medicine, Dentistry, and Nursing"]
[null,"University of Glasgow"]
[null,"59 Oakfield Avenue, Glasgow"]
["Postcode","G12 8LL"]
["Telephone","0141 330 2972"]
["Email","Rhian.Noble-Jones@glasgow.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","60 patients diagnosed with lymphoedema at Hywel Dda Health Board and Swansea Bay University Health Board"]
["Description of confidential patient information used","Data sources\n1. Hywel Dda Health Board\n2. Swansea Bay University Health Board\n\nIdentifiers required for linkage purposes\nNo identifiers are required for linkage purposes.\n\nIdentifiers required for analysis purposes\nNo identifiers are required for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-24"]
["Next Review Date","N/A"]
["Notes","Expiry of support – 30 September 2020 \n\nSupport is no longer required as applicant has confirmed all data has been pseudonymised with original identifiers no longer being retained. \n\nThe data collected has the potential to support individuals living with lymphoedema to better manage this long-term condition. \n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 29 September 2019.\n\n2. Confirmation from NHS Wales Informatics Service that the appropriate security assurance is in place for the two Health Board sites in Wales via the Caldicott Principles into Practice report. Confirmed for Hywel Dda Health Board and Swansea Bay University Health Board by CPiP Out-turn reports received 20 July 2020."]

{"sheet":"A02511","index":554,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02511"]
["Reference","20/CAG/0012"]
["Other Refs","IRAS Project ID: 271895 REC reference: 20/LO/0073"]
["Application Title","A Retrospective Cohort Study of Treatment Outcomes Among Adult Patients with Refractory or Relapsed Follicular Lymphoma"]
["Application Summary","This application from King's College Hospital NHS Foundation Trust set out the purpose of medical research which aims to estimate the Complete Response Rate (CRR) in adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) treated with standard therapies.\n\nNon-Hodgkin's Lymphoma (NHL) is a type of blood cancer that originates in the lymphatic system. There are various sub types of NHL, one of which includes Follicular Lymphoma (FL). Approximately 20% of all NHL and 60% of indolent NHL cases are Follicular Lymphoma (FL). FL is a disease considered treatable, but not curable with current therapeutic options. Patients with FL who relapse (when the disease comes back after treatment) or who are refractory (when the disease does not respond to treatment) to chemotherapy and other non-chemotherapy treatments are rare, and their prognosis is poor. Whilst recently approved drugs show evidence of efficacy, their use is limited by severe side effects. There is therefore a high unmet need for newer treatments with novel mechanisms of action to offer potentially curative options for these patients. Tisagenlecleucel is a cellular immunotherapy that uses autologous blood cells that have been genetically modified. Preliminary data indicates a good response in FL patients. The applicants plan to conduct a retrospective study in order to provide a historical cohort for a planned clinical trial. It is not feasible to include a placebo-controlled arm in the trial, hence this design has been chosen. \n\nThe applicants will conduct a retrospective medical record review of a patient cohort with Follicular Lymphoma. Suitable patients will be identified using a controller data extraction from the participating Trust’s electronic medical records, using a technique called ‘Cogstack.’ Cogstack will identify suitable patients and provide a proportion of the clinical data required. The applicants will then review each potential patient. Patients deemed unsuitable at this point will be deleted from the report. The applicants will complete an eligibility worksheet for suitable patients. A unique study ID will be assigned and non-identifiable data will be entered into the Electronic Data Capture System. The patients' unique study ID, name and hospital number will be entered into a password-protected document. Once all data queries have been resolved by the research site, the pseudo-link document will also be destroyed and there will be no identifiable data retained by sites at the end of the study."]
["Applicant Organisation Name","King's College Hospital NHS Foundation Trust"]
["Contact Name","Dr Piers Patten"]
["Address","Haematology Consultant"]
[null,"King's College Hospital NHS Foundation Trust"]
[null,"Denmark Hill, London"]
["Postcode","SE5 9RS"]
["Telephone","02032 993 250"]
["Email","piers.patten1@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data will be collected from patients from multiple oncology centres with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) treated between 1998 and 2019"]
["Description of confidential patient information used","Data sources\n1. Electronic and paper patient records held at King's College Hospital NHS Foundation Trust and Guy's and St Thomas' Hospital  \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID Number\n4. GP Registration\n5. Date of birth\n6. Date of death\n7. Postcode \n\nIdentifiers required for analysis purposes\n1. Gender\n2. Year of birth\n3. Month and year of death"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-07-24"]
["Next Review Date","N/A"]
["Notes","15 December 2021 - Support expired:\nApplicant confirmed support expired 15 December 2021\n\nSupport is no longer required as all data have been pseudonymised, and applicant confirms that the original identifiers which were supported are no longer being processed/retained. \n\nPublic benefits; Applicant confirmed there is a potential public benefit, as outcomes in the relapsed/refractor follicular lymphoma patients receiving usual/standard of care have been evaluated, and the availability of such data may help support the availability of new therapeutic options for these patients.\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 04 February 2020 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: The NHS Digital DSPT review for King’s College Hospital NHS Foundation Trust (checked 17/03/2020) and Guy’s and St Thomas’ Hospital NHS Foundation Trust (check (13/05/2020) were confirmed as ‘Standards Met’ on the NHS DSPT Tracker "]

{"sheet":"A02512","index":555,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02512"]
["Reference","19/CAG/0182"]
["Other Refs","IRAS Project ID: 271895 REC reference: 20/LO/0073"]
["Application Title","National Joint Registry – Research Database"]
["Application Summary","This application from the Healthcare Quality Improvement Partnership set out the purpose of medical research through the secondary use of information collated for audit purpose by the National Joint Registry, under reference 18/CAG/0146, for research purposes. \n\nThe CAG’s remit only extends to the secondary use of data for research purposes for those patients, within England and Wales, whose consent status is not known within the National Joint Registry. This currently extends to approximately 6% of records within the NJR. Those patients who have consented to the use of their information within the National Joint Registry have provided consent in relation to research purposes. The latest consent rate states 92.3% of patients have provided consent to their inclusion. Those patients who have declined consent would not be included in the research database."]
["Applicant Organisation Name","Healthcare Quality Improvement Partnership"]
["Contact Name","Alyson Ottley, Research and Governance Programme Manager "]
["Address","27A Harley Place"]
[null,"London"]
[]
["Postcode","W1G 8LZ "]
["Telephone"]
["Email","alyson.ottley@njr.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who are included on the National Joint Registry following a hip, knee, ankle, elbow and shoulder replacement operations carried out in NHS and independent sector hospitals and treatment centres in England and Wales from 1 April 2003 onwards on the basis of section 251 support via application 18/CAG/0146."]
["Description of confidential patient information used","Data sources\n1. National Joint Registry dataset\n\nIdentifiers required for linkage purposes\n1. Name \n2. NHS Number\n3. Date of birth\n4. Postcode (unit level)\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Age\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-24"]
["Next Review Date","2024-07-24"]
["Notes","Amendment supported 18 August 2023 to clarify that the data items submitted to NHS England for linkage will be surname, forename, date of birth, home address including postcode, NHS number and gender, to include additional data items - LOPATID (local patient identifier) and PROCODE (identity of provider hospital) to the cohort submitted to NHS England for the purposes of linkage to HES, National PROMs and Civil Registration data, and to extend the cohort of patients submitted to NHS England for the purposes of linkage to Civil Registration data to include patients treated in Wales, and patients receiving independently funded surgery in private hospitals in England\n\n18 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources – Hospital Episode Statistics (HES), Patient Recorded Outcome Measures (PROMs) and Civil Registration mortality data\n\n10 December 2021 - Amendment supported to change the data flow for the linked Patient Reported Outcome Measures (PROMs), Hospital Episode Statistics (HES), and Civil Registry (formerly ONS) data so that confidential patient information flows from NEC Software Solutions (UK) Ltd (NECSWS) (on behalf of the National Joint Registry) to NHS Digital for the purposes of data linkage.\n\nSpecific conditions of support\n\n1. Provide a revised data flow chart at the time of annual review which sets out the data flows for research purposes only. Condition met at first annual review\n\n2. Figures should be reported back within future annual reviews around the number of patients which are included within the research database under the provisions of the Mental Capacity Act 2005, together with the number included on the basis of unknown consent. Condition met at first annual review\n\n3. Favourable opinion from a Research Ethics Committee. Confirmed 12 November 2019. \n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – Northgate, processor for the NJR and research database, has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital DSPT Tracker checked 24 July 2020."]

{"sheet":"A02513","index":556,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02513"]
["Reference","19/CAG/0210"]
["Other Refs","IRAS Project ID: 262534 REC reference: 03/018"]
["Application Title","Discovery and Analysis Of Novel Biomarkers In Urological Diseases (DIAMOND STUDY)"]
["Application Summary","This application from University of Cambridge set out the purpose of medical research which aims to evaluate the utility of biomarkers to improve the screening, diagnosis, prognosis and treatment of urological cancers. The applicants wish to identify a cohort of patients which were referred to undergo an MRI scan as part of the diagnostic process for prostate cancer, in order to invite them to provide a sample to be used in the biomarker analysis. A sub-cohort of patients who were referred for an MRI, which was found to be inconclusive, and were subsequently discharged back into the community has been identified, which are not currently included in the analysis and may be causing bias in the reported results.\n\nThe application has operated since 2003 with the applicants approaching patients at the point they are attending their outpatient appointment and have been focussing on biomarkers within patients with localised or advanced disease. In recent years, the focus for prostate cancer has changed to early detection and applicants are now looking to test biomarkers in the early stage of the disease. This has led to the change in methodology which requires an application for section 251 support. The applicants are seeking support to access medical records on site at Cambridge University Hospitals NHS Trust to identify patients who have been invited for a pre-biopsy MRI scan, so these individuals can be invited to attend the early diagnostic research clinic alongside their scheduled MRI appointment. Support is sought to access the medical records and invite eligible men to participate in the study."]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Vincent Gnanapragasam"]
["Address","University Lecturer in Uro-oncology and Consultant Urological Surgeon"]
[null,"Cambridge Urology Translational Research and Clinical Trials Office, S2"]
[null,"Cambridge Biomedical Campus, Addenbrookes Hospital, S Wards Building, Keith Day Road, Cambridge, "]
["Postcode","CB2 0SL"]
["Telephone","01223 348176 (PA to Prof Gnanapragasam)"]
["Email","vjg29@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients being referred from their GPs to the MRI department or to Outpatient Urology clinics at Cambridge University Hospitals NHS Trust for a suspected urological cancer. "]
["Description of confidential patient information used","Data sources\n1. Electronic patient records for MRI outpatient appointments\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID \n4. Full address and postcode\n\nIdentifiers required for analysis purposes\nNot applicable – all identifiers retained for analysis will be done so under patient consent. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-15"]
["Next Review Date","2024-07-15"]
["Notes","Specific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 11 February 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed - Cambridge University Hospitals NHS Trust has a confirmed Standard Met grade on DSPT 2018/19 (NHS Digital Tracker 05 November 2019). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02514","index":557,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02514"]
["Reference","20/CAG/0045"]
["Other Refs","IRAS Project ID: 149278 REC reference: 14/EE/0108"]
["Application Title","An evaluation of a water fluoridation scheme in Cumbria: A population based comparative cohort study of systemic and topical fluoride exposure"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to assess the effects and costs of systemic and topical exposure to water fluoridation following a reintroduced Water Fluoridation scheme on a cohort of contemporary children.\n\nTooth decay is the commonest disease of childhood. Fluoride can prevent tooth decay. Water fluoridation has a 70-year history. Unfortunately the scientific evidence demonstrating how well water fluoridation works and how cost-effective it is in the current climate of falling decay levels is lacking. A new plant opened in May 2013, giving the applicants an opportunity to study the impact of water fluoridation in West Cumbria. The applicant will investigate the effects of a new water fluoridation scheme on young children by recruiting groups of children born over the period of a year and following up over a five to six-year period. All children born from September 2014 to September 2015 were recruited and their teeth examined at 3 and 5 years of age to assess the affects of fluoridation on the deciduous teeth. The number of children who developed tooth decay in fluoridated and non-fluoridated areas. \n\nSupport is sought for the applicants to link the previously collected confidential patient information collected for the study to dental health data from NHS Business Services Authority (BSA) and HES data from NHS Digital. NHS BSA and NHS Digital had deemed the existing consent obtained in 2013 to be insufficient for this planned data linkage. The applicants also seek support to obtain anonymised data from NHS BSA for children born between September 2014 and September 2015, within the same geographic location, Cumbria East and West, as the children consented into the study.  "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Tanya Walsh"]
["Address","University of Manchester - Dental Health Unit"]
[null,"Williams House, Lloyd Street North Williams House"]
[null,"Manchester Science Park, Manchester"]
["Postcode","M15 6SE"]
["Telephone","0161 232 4711"]
["Email","tanya.walsh@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","3200 children aged 4 -12 years and living in West Cumbria; Cornhow and Ennerdale, who were consented into the original study.\n\nAnonymised data will also be obtained for children born between September 2014 and September 2015, within the same geographic location, Cumbria East and West, as the children consented into the study.  "]
["Description of confidential patient information used","Data sources\n1. Dental Health Data held by NHS BSA\n2. HES data held by NHS Digital \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Postcode\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Postcode\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-07-20"]
["Next Review Date","2024-07-20"]
["Notes","01 March 2021 - Amendment supported\nThe amendment, to replace NHS Digital as a data processor with North Cumbria Integrated Care NHS Foundation Trust, and to change to data flow from the University of Manchester to North Cumbria Integrated Care NHS Foundation Trust (instead of NHS Digital), for the purposes of linkage to data for dental general anesthetics (instead of HES), is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 20 July 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – University of Manchester (by NHS Digital email dated 04 October 2019), NHS Digital (by NHS Digital email dated 10 June 2019) and NHS Business Services Authority (by NHS Digital email dated 06 September 2019) have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19. "]

{"sheet":"A02515","index":558,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02515"]
["Reference","20/CAG/0033"]
["Other Refs","IRAS Project ID: 270204 REC reference: 20/LO/0012"]
["Application Title","An anthropological study of the early detection of cancer"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that seeks to develop understanding of the practices, perceptions and experiences of scientists, health professionals and research volunteers, who are involved in scientific and clinical research studies related to the early detection of cancer in Cambridge.\n\nThe applicant will conduct interviews with clinical scientists, health professionals and research volunteers. The interviews will take place on a consented basis and support under s251 is not required for this activity. The applicants will also observe scientific practices and meetings in academic and clinical settings, shadow research dynamics in clinical research facilities and observe research volunteers outside clinical spaces. During the observation of health professionals in clinical research meetings and multi-disciplinary team meetings, where the researchers and clinicians may discuss aspects of research volunteers’ participation in relevant studies, the applicant may be exposed to confidential patient information and support is sought for these incidental disclosures."]
["Applicant Organisation Name","Cambridge University NHS Foundation Trust"]
["Contact Name","Dr Ignacia Arteaga, Research Associate"]
["Address","Department of Social Anthropology"]
[null,"Free School Lane"]
[null,"Cambridge"]
["Postcode","CB2 3RF"]
["Telephone","07443 333 936"]
["Email","mia42@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female healthy volunteers and patients diagnosed with cancer, who have finished cancer treatment but are at risk of recurrence."]
["Description of confidential patient information used","Data sources\n1. Confidential patient information for patients discussed during clinical research meetings and multi-disciplinary team meetings at Cambridge University Hospitals NHS Foundation Trust.\n\nIdentifiers required for linkage purposes\nNo identifiers will be required for linkage purposes.\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-08-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed support expired 1 November 2021\n\nNo incidental disclosure to confidential patient information occurred, as study was undertaken without this requirement. \n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 19 February 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – Cambridge University NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 19 September 2019."]

{"sheet":"A02516","index":559,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02516"]
["Reference","20/CAG/0046"]
["Other Refs","IRAS Project ID: 131824 REC reference: 13/NW/0494"]
["Application Title","An evaluation of a water fluoridation scheme in Cumbria: population based comparative cohort studies of topical fluoride exposure alone"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to assess the effects and costs of systemic and topical exposure to water fluoridation following a reintroduced Water Fluoridation scheme on a cohort of contemporary children.\n\nTooth decay is the commonest disease of childhood. Fluoride can prevent tooth decay. Water fluoridation has a 70-year history. Unfortunately the scientific evidence demonstrating how well water fluoridation works and how cost-effective it is in the current climate of falling decay levels is lacking. A new plant opened in May 2013, giving the applicants an opportunity to study the impact of water fluoridation in West Cumbria. The applicant will investigate the effects of a new water fluoridation scheme on young children by recruiting groups of children born over the period of a year and following up over a five to six-year period. All children born from September 2014 to September 2015 were recruited and their teeth examined at 3 and 5 years of age to assess the affects of fluoridation on the deciduous teeth. The number of children who developed tooth decay in fluoridated and non-fluoridated areas. \n\nSupport is sought for the applicants to link the previously collected confidential patient information collected for the study to dental health data from NHS Business Services Authority (BSA) and HES data from NHS Digital. NHS BSA and NHS Digital had deemed the existing consent obtained in 2013 to be insufficient for this planned data linkage. The applicants also seek support to obtain anonymised data from NHS BSA for children born between September 2014 and September 2015, within the same geographic location, Cumbria East and West, as the children consented into the study.  "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Tanya Walsh"]
["Address","University of Manchester - Dental Health Unit"]
[null,"Williams House, Lloyd Street North Williams House"]
[null,"Manchester Science Park, Manchester"]
["Postcode","M15 6SE"]
["Telephone","0161 232 4711"]
["Email","tanya.walsh@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","3200 children aged 4 -12 years and living in West Cumbria; Cornhow and Ennerdale."]
["Description of confidential patient information used","Data sources\n1. Dental Health Data held by NHS BSA\n2. HES data held by NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Postcode\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-08-03"]
["Next Review Date","2024-08-03"]
["Notes","01 March 2021 - Amendment supported\nThe amendment, to replace NHS Digital as a data processor with North Cumbria Integrated Care NHS Foundation Trust, and to change to data flow from the University of Manchester to North Cumbria Integrated Care NHS Foundation Trust (instead of NHS Digital), for the purposes of linkage to data for dental general anesthetics (instead of HES), is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 29 July 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed – University of Manchester (by NHS Digital email dated 04 October 2019), NHS Digital (by NHS Digital email dated 10 June 2019) and NHS Business Services Authority (by NHS Digital email dated 06 September 2019) have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19."]

{"sheet":"A02517","index":560,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02517"]
["Reference","20/CAG/0038"]
["Other Refs","IRAS Project ID: 274165 REC reference: 20/SC/0105"]
["Application Title","The C3 Study - Version 1 (The short and long-term cardiovascular consequences of critical illness: The C3 Study)"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to establish if it is possible to predict who is at risk of subsequent strokes and heart attacks and their likelihood of survival, and to discover if there is any association between these adverse events and the care patients have received whilst they were unwell.\n\nThe benefit of care in Intensive Care Units (ICU) has historically been measured as survival. Over the last three decades, the survival of patients admitted to ICU has improved markedly and attention is now focused on the long-term health problems related to ICU care in survivors. Many of these problems significantly impact patients’ lives and the associations with the ICU stay are poorly understood, partly as they may occur many years later. \n\nThe applicants will study strokes and diseases of the heart and blood vessels, conditions that are common after treatment on ICU. Evidence from other countries suggests that these may be more common after care on ICU, possibly due to the patients’ underlying illnesses and the long-term effects of ICU treatments during critical illness. It is not currently possible to identify which patients are at risk of heart attacks and strokes. There are well established treatments to avoid these conditions in the community and this research will help decide who should be considered for these treatments following a critical illness. \n\nThe applicants will create a new database, containing data routinely collected in ICU, such as patients’ vital signs, treatments and blood tests. These records will be linked to NHS long-term follow-up data, so that it can be established which patients are at risk of heart attacks and strokes up to several years after discharge from ICU. How much the treatments patients received on ICU contributed to this risk will also be explored. Support is sought for the applicants to link confidential patient information from six participating Trusts to the National Institute for Cardiovascular Outcomes Research (NICOR) Audit database and linkages to HES and ONS data at NHS Digital. "]
["Applicant Organisation Name","Oxford University Hospitals NHS Foundation Trust"]
["Contact Name","Dr Robert Hatch"]
["Address","Nuffield Department of Clinical Neurosciences, Oxford University"]
[null,"Kadoorie Centre - Level 3, John Radcliffe Hospital"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865 231 456"]
["Email","robert.hatch@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and over, admitted to an intensive care unit for greater than 24 hours. Two cohorts were included, a retrospective cohort of patients treated between 01 January 2006 and 31 October 2020. The prospective cohort will include patients treated between 1 November 2020 to 31 July 2023\n\n120,000 patients were expected to be included."]
["Description of confidential patient information used","Data sources\n1. Intensive care Clinical Information System (CIS) at 6 participating Trusts\n2. Hospital electronic patient records at 6 participating Trusts\n3. HES and ONS data at NHS Digital\n4. National Institute for Cardiovascular Outcomes Research Audit database, hosted by Barts Health NHS Trust on behalf of HQIP\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Date of death\n5. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Date of death\n2. Postcode – unit level\n3. Gender \n4. Occupation \n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-08-10"]
["Next Review Date","2024-08-10"]
["Notes","14 August 2023 - change in data processor from\n•\tNHS Digital to NHS England regarding data sources – Hospital Episode Statistics (HES) and office for National Statistics (ONS) Mortality Data\n•\tBarts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, (NICOR) database\n\n\nAmendment supported 15 August 2023  to extend the duration of ‘s251’ support until 30 June 2026, confirm that the data flow regarding linkage with NICOR data will be direct with NICOR rather than via NHS England, and include first name and surname as additional data items for linkage with NHS England datasets\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 02 April 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: Oxford University Hospitals NHS Foundation Trust (by NHS Digital email 08 November 2019), Imperial College Healthcare NHS Trust (by NHS Digital email dated 21 November 2019), Barts Health NHS Trust (NHS Digital DSPT Tracker checked 10 March 2020) Royal Berkshire NHS Foundation Trust (by NHS Digital DSPT Tracker checked 10 August 2020) and NHS Digital (by NHS Digital email 10 June 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). \n\n• Confirmed: Kings College Hospital NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data."]

{"sheet":"A02518","index":561,"n_rows":36,"n_cols":6,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02518"]
["Reference","20/CAG/0063"]
["Other Refs","IRAS Project ID: 190514 REC reference: 20/EM/0105"]
["Application Title","A population-based comprehensive lymphoma registry"]
["Application Summary","This application from Nottingham University Hospitals NHS Trust set out the purpose of medical research with the aim of creating and managing a lymphoma registry.\n\nThe incidence of lymphoma is rising faster than any other common cancer in the Western world and there is increasing awareness of the complex abnormalities driving these diseases, permitting rapid therapeutic advances. However, the paucity of large, high-quality population-based datasets remains a clear area of unmet research need within the UK. The applicants envisage this database as a pioneering effort in the UK to better catalogue and understand lymphomas on a very large scale. Large volume, population-based, ‘real world’ data will allow accurate descriptions of natural history and clinical outcomes, with sufficient follow-up duration to allow identification of unmet clinical need and thus inform therapeutic options for clinicians worldwide. National bodies (such as the Public Health England National Cancer Registration and Analysis Service) already require individual hospitals to collect data on individual patients with lymphoma.  However, there are significant issues with the granularity and accuracy of data collected. Diagnostics are not well recorded, in particular the many (>60) subtypes of lymphoma as well as response and outcome data being incomplete. Our definitive database, also able to constantly collect new prognostic indices, as they are reported in the literature, as well as report outcomes for specific patient groups, diseases and therapies, will significantly enhance the quality of data available for research.\n\nThis registry is being developed by Nottingham University Hospitals NHS Trust to collect data on all new lymphoma cases from January 2020. This database would start with patients from Nottingham University Hospitals NHS Trust (for which support is not requested for) and extend to other Trusts in the East Midlands region. This would begin with University Hospitals Leicester NHS Trust and Sherwood Forest Hospitals NHS Trust (for which support is being requested) and extend thereafter. At each external Trust, an employee from Nottingham University Hospitals NHS Trust, would access confidential information of patients to identify eligible patients and record the required information into the database. The database would contain age at diagnosis and gender only, as well as a pseudonymised identifier. The key to link the patients (accessible by only the database manager) would be stored securely at Nottingham University Hospitals NHS Trust. The applicants expect to access and upload the data from each Trust to the central database on a yearly basis, with no determined end date. External parties would be able to access the pseudonymised database, subject to the access processes the applicants have put in place. "]
["Applicant Organisation Name","Nottingham University Hospitals NHS Trust"]
["Contact Name","Dr Mark Bishton"]
["Address","Nottingham University Hospitals NHS Trust"]
[null,"Clinical Haematology Building, City Campus"]
[null,"Hucknall Road, Nottingham"]
["Postcode","NG5 1PB"]
["Telephone","01159 655 564"]
["Email","mark.bishton@nuh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients newly diagnosed with lymphoma from 01 January 2020 at University Hospitals Leicester NHS Trust and Sherwood Forest Hospitals NHS Trust. "]
["Description of confidential patient information used","Data sources\n1. Patient medical records at University Hospitals Leicester NHS Trust and Sherwood Forest Hospitals NHS Trust\n\nIdentifiers required for linkage purposes\n1. Hospital Number\n2. NHS Number\n3. Name\n\nIdentifiers required for analysis purposes\n1. Age at diagnosis\n2. Gender",null,null,null,"u"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-02"]
["Next Review Date","2024-09-02"]
["Notes","Specific conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. 01 May 2020 \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\t• University Hospitals Leicester NHS Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by checking the NHS Digital DSPT Tracker on 21 May 2020. \n\n•\t• Nottingham University Hospitals NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. As a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data. \n\n•\t• Sherwood Forest Hospitals NHS Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by checking the NHS Digital DSPT Tracker on 02 September 2020. "]

{"sheet":"A02519","index":562,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02519"]
["Reference","20/CAG/0086"]
["Other Refs","IRAS Project ID: 264776  REC Reference: 20/WM/0120"]
["Application Title","YouScreen: A pragmatic implementation feasibility clinical trial of offering HPV self-sampling to cervical screening non-attenders within the NHS cervical screening programme in England"]
["Application Summary","This application sets out the medical purpose to provide evidence that self-sampling can improve cervical screening coverage in England and can increase detection and treatment of high grade Cervical Intraepithelial Neoplasia.\n\nIn England, a national cervical screening programme offers screening to all women aged 25-64 using a call/recall system. A challenge with introducing new tests into call/recall-based screening programmes is establishing robust pathways for accurately identifying the relevant population, recording and reporting test results and setting the correct recall intervals. It is clear that different interventions are needed to address non-participation; but little is known about which approaches might be most suitable for which women. The longstanding issues with low coverage in North East London and North Central London provide an impetus to start offering self-sampling ahead of the national screening programme. The project will serve to test the new pathways for delivery, establish robust pathways for accurately identifying the relevant population, recording and reporting test results and setting the correct recall intervals, generate lessons to help ensure a smooth transition for a national or London-wide roll-out and provide the evidence-base for implementing self-sampling at scale.\n\nParts of this study are consented. However, the applicants are seeking support for three elements. \n\n• Identification of patients for mailout. Eligible women will be identified through the national cervical screening database, NHAIS, which is owned by NHS England and Public Health England. Each month from the date the practice is included in the study, a list of women who reach the 15 month anniversary of their last test due date without being screened (by self-sample or by standard cervical screening -HPV primary testing) will be extracted from NHAIS. NHAIS will send the list of eligible women to the Cervical Screening Administration Service (CSAS) who are responsible for sending invitations and reminders for the call/recall Cervical Screening Programme in England. CSAS will then send the list to a Docmail with the appropriate level of information governance standards to securely handle NHS data The print company will send a pre-notification letter to women (on behalf of the GP practices and the Cervical Screening Programme) informing them that they are overdue cervical screening and that a self-sampling kit will be posted to them. Within 1-2 weeks of sending the letter, Docmail will send women a self-sampling kit along with a brief invitation letter.\n\n• For NHAIS to search and extract data of all eligible women at participating GP practices on all cervical screening test dates and results (including self samples, cytology and HPV tests) during the study, date of last cervical screening test prior to study and other related information. A pseudonymised dataset will be provided to KCL.\n\n• For CCGs to use confidential patient information to collect information around when sampling kits were offered, who offered the kit, test dates and results during the study and free text information on the reason for declining a kit. Processors will access the dataset to collect the required information and provide this in a pseudonymised format to the research team. Support is required as the processors do not have a legal basis to access the NHS Number of participants – which is required to translate into the common pseudonym. Data collection will be three to four times during the study, and will include free text."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Anita Lim"]
["Address","King's College London"]
[null,"Cancer Prevention Group"]
[null,"Guy's Hospital, London"]
["Postcode","SE1 9RT"]
["Telephone","020 784 84475 (YouScreen clinical project manager)"]
["Email","anita.lim@kcl.ac.uk / YouScreen@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Mailout: Women aged >=25 and <=64 years old registered at one of the participating practices, who are eligible for cervical screening under the NHS Cervical Screening Programme (NHSCSP) in England and have reached the 15-month anniversary of their last test due date without being screened. (estimated 19000 women).\n\nLinkage for all eligible women: Women aged >=25 and <=64 years old registered at one of the participating practices, who are eligible for cervical screening under the NHS Cervical Screening Programme (NHSCSP) in England and who are overdue by at least 6 months (estimated 95000 women)"]
["Description of confidential patient information used","Data sources\n1. NHS Digital (National Health Application and Infrastructure Services)\n2. Clinical Effectiveness Group (on behalf of Tower Hamlets CCG)\n3. North East London Commissioning Support Unit (on behalf of Barnet and Islington CCG)\n4. Camden GP IT (on behalf of Camden CCG)\n\nIdentifiers required for linkage purposes\n1. Full name\n2. Address including postcode\n3. NHS number\n4. GP practice National Code (Organisational Code)\n\nIdentifiers required for analysis purposes\n1. Regional level postcode\n2. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-08-27"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefits, the unconsented use of identifiable patient data has provided the following benefit: \n1)\tContacting under-screened women and other people with a cervix to offer them the chance to have a more convenient and less invasive cervical screening test known as “self-sampling”. Enabling more people to be screened is important because regular cervical screening substantially reduces the risk of developing cervical cancer. \n2)\tA better understanding of people who do not regularly take part in cervical screening and which groups may be more or less likely to respond to the offer of self-sampling. This in turn has helped the researchers to assess the impact of self-sampling on addressing inequalities in cervical screening. \n3)\tBy collecting demographic data on individuals who did participate in the trial has allowed the researchers to understand the potential impact of this intervention on diverse ethnic groups, the findings of which will inform self[1]sampling implementation pilots and wider roll-out. \n4)\tEvidence from the trial will be presented to the UK National Screening Committee with the aim of justifying a policy change to introduce self- sampling for screening non-attenders in the UK. This would bring substantial public benefit by reducing the incidence of cervical cancer.\n5)\tFeedback from trial participants and GP primary care staff has been overwhelmingly positive. The trial received informal feedback from people who have traditionally struggled with having the conventional cervical screening test. These people were relieved to be able to take their own sample and get protected from cervical cancer. GPs and nurses reported that the trial managed to screen individuals who are underserved by conventional screening such as those with mental health issues, neurodiverse and LGBTQ+ populations.\n\n\n21 October 2021 - Amendment supported\nto include Barnet Federated GPs Ltd, Islington GP Group Ltd, Camden Health Evolution Ltd and Camden Health Partners as data processors, (and to remove North Central London Central Commissioning Group and North East London Commissioning Support Unit as data processors)\n\nSpecific conditions of support (Final):\nThe following sets out the specific conditions of support. \n\n1. Review the accuracy of the wording in the patient information sheet around access to records and update the information sheet as necessary\n\n2. Provide further consideration into using drop-down menus for recording the reasons for women declining a test. Detail into the progress of this consideration should be provided at the first annual review.\n\n3. Ensure that GPs make aware to opportunistic patients that the approach is part of a research study, not as part of a new service.\n\n4. This support does not extend to processing North Central London Central Commissioning Group, because satisfactory NHS Digital review of their Data Security and Protection Toolkit (DSPT) is not in place. The applicants are advised to seek 19/20 NHS Digital assurances for this organisation, and submit an amendment to add this to the scope of support once NHS Digital has satisfactorily reviewed the 19/20 submission.\n\nCondition is now met as part of amendment supported 21 October 2021\n\n5. It is recommended, but not a condition of support, that information around pregnancy is moved to earlier in the patient information sheet.\n\n6. Favourable opinion from a Research Ethics Committee. Confirmed 28 April 2020\n\n7. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital 18/19 DSPT review for NHS Digital, CFH Docmail, North of England CSU, Clinical Effectiveness Group at QMUL, and North East London Commissioning Support Unit were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 04 August 2020).\n\nThere is no record of 18/19 NHS Digital review for North Central London Central Commissioning Group. The applicants are advised to request this review from NHS Digital."]

{"sheet":"A02520","index":563,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02520"]
["Reference","19/CAG/0214"]
["Other Refs","IRAS Project ID: 262138  REC Reference: 19/WA/0291"]
["Application Title","Understanding the scale and nature of avoidable harm in prison healthcare (Phases 2 & 3: Case note review and qualitative interviews)"]
["Application Summary","This application from University of Manchester set out the purpose of medical research which aims to determine the frequency and nature of avoidable patient harm in prison healthcare. \n\nPeople in prison should receive the same standard of care as people in the community. However, the demand for services and lack of adequate resources is challenging for prison healthcare providers. A large systematic review and meta-analysis examining the prevalence, severity and nature of avoidable harm found that 5% of patients experience avoidable harm and that 14% of this harm causes permanent disability or patient death. None of the studies included prisons. Whilst there are some prison-based studies on avoidable types of harm (e.g. self-harm), wider evidence on the scale, severity and nature of avoidable harm does not exist. Understanding the frequency and causes of avoidable harm in prison healthcare will inform policy to improve patient safety.\n\nThis application covers phases two and three of the overarching research programme. Phase two will use a definition of avoidable harm developed in an earlier phase of the research to screen records of 15,000 patients in a sample of prisons in England to identify and collect data on possible cases of avoidable harm. This information will be utilised to estimate the incidence of avoidable harm and quantify, classify and describe the nature of severity of these cases. This element of the study requires section 251 support to legitimise researcher access to confidential patient information within the medical records. From the 15,000 records, it is anticipated that 2,250 records will be identified for an enhanced review, following identification of harm. A control cohort of 1,500 patients not selected for enhanced review will also be selected for review by a second nurse. All prisoner records will be accessed on a ‘census date’, which will be determined when all relevant approvals are in place for the study. The previous 12 months recorded from this date will be accessed for information. \n\nPhase 3 of the project involves semi-structured interviews with staff and prisoners to explore perspectives on the nature of harm incidents which will be conducted on the basis of informed consent and are out of scope for this application."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Jennifer Shaw"]
["Address","University of Manchester, Division of Psychology & Mental Health"]
[null,"2.317 Jean McFarlane Building, Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9PL"]
["Telephone"]
["Email","jen@jenshaw.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All prisoners present on a defined census day within 17 prisons across England. It is anticipated that this will include 15,000 patients."]
["Description of confidential patient information used","Data sources\n1.\tElectronic and paper medical records managed by a number of healthcare providers who deliver services at the physical locations of the 17 prisons in England. The healthcare providers who are responsible for the medical records that will be accessed for this application are:\nAvon and Wiltshire Mental Health Partnership NHS Trust\nBirmingham and Solihull Mental Health NHS Foundation Trust\nBridgewater Community Healthcare NHS Foundation Trust\nBristol Community Health\nCambridgeshire and Peterborough NHS Foundation Trust\nCare UK\nCentral and North West London NHS Foundation Trust\nCity Health Care Partnership CIC \nEssex Partnership University NHS Foundation Trust\nG4S\nGreater Manchester Mental Health NHS Foundation Trust\nHertfordshire Community NHS Trust\nInspire Better Health\nIntegrated Care 24 Ltd\nLeeds Community Healthcare NHS Trust\nLeicestershire Partnership NHS Trust\nMersey Care NHS Foundation Trust\nMidlands Partnership NHS Foundation Trust \nMitie Care & Custody Health Ltd\nNorth Cumbria Integrated Care NHS Foundation Trust\nNorthamptonshire Healthcare NHS Foundation Trust\nNottinghamshire Healthcare NHS Foundation Trust\nOxleas NHS Foundation Trust\nShropshire Community Health NHS Trust\nSodexo\nSouth London and Maudsley NHS Foundation Trust\nSpectrum Community Health CIC\nSussex Partnership NHS Foundation Trust\nThe Phoenix Partnership (TPP)\nVirgincare\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth \n4. Prison Number\n5. SystmOne Patient Identifier\n\nIdentifiers required for analysis purposes\n1. Patient age \n2. Sex"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-04-07"]
["Next Review Date","2025-04-07"]
["Notes","Amendment supported 23 August 2022\nTo cross-reference census lists from participating prisons via HMPSS, to identify individuals on ACCTs (Assessment, Care in Custody and Treatment), and to access ACCT documentation\n\n14 June 2022 - Amendment supported:\nAmendment supported to allow access to the ‘frozen’ SystmOne record, in addition to the live SystmOne record.\n\n27 August 2020 - Amendment supported:\nAmendment supported to add an additional method of remote data collection via a locally agreed protocol with each prison/healthcare provider.\n\nSpecific conditions of support:\n\n1. Confirmation should be provided at the time of first annual review of all prison locations and the healthcare providers who are responsible for the medical records at those locations who are participating in the study via the agreed methodology. An amendment would be required to access the medical records of any healthcare providers that have not been specified in the original application.\n\n2. Favourable opinion from REC Received 15 November 2019\n\n3. Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02521","index":564,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02521"]
["Reference","20/CAG/0097"]
["Other Refs","IRAS Project ID: 271851  REC Reference: 20/ES/0033"]
["Application Title","Breast Cancer Metastasis"]
["Application Summary","This application from the Institute of cancer Research sets out the purpose of medical research which aims to use tissue samples to identify molecular mechanisms driving breast cancer metastasis.\n\nBreast cancer is a leading cause of cancer death in women. However, invariably death does not result from the primary tumour in the breast, rather it is caused by secondary (metastatic) tumours which spread to, and colonise, secondary sites in the body. The applicant’s laboratory-based research is focussed towards understanding how primary breast tumours acquire the additional properties which allow them to invade into the surrounding tissue, enter the circulation, and establish themselves at metastatic sites. The long-term aim is to identify suitable targets for therapeutic intervention and/or prognostic screening in breast cancer metastasis. Advances in molecular technologies now provide the applicants with an opportunity to interrogate the genetic changes associated with breast cancer metastasis, and in the response and resistance to therapy.\n\nThe applicants previously collected 19 samples between 2002 and 2004 from women with metastatic breast cancer, under consent. The Institute of Cancer Research (ICR) hold the identifiable data these women in a pseudonymised form. Support is requested for the applicant to deidentify the personal information and transfer the name, hospital ID and date of birth to a clinical fellow at the Royal Marsden NHS Foundation Trust. The clinical fellow at the Royal Marsden: \n\n• Will collect age at diagnosis, original tumour diagnosis, burden of disease – primary and site of metastatic disease, details of prior breast cancer treatment including systemic treatment, surgery and radiotherapy, histological tumour type, size, grade, hormone receptor status, HER2 status) and provide this data in a pseudonymised format (using laboratory ID) to the applicants.\n \n• Will return the identifiable data to the applicant in a pseudonymised format (using the laboratory ID). This is to enable the data held at the ICR to be linked with the data held at the Royal Marsden NHS Foundation Trust and the archival tissue samples.\n\n• Will request that the archival tissue blocks from the histopathology department(s) of the relevant NHS Trust(s) be sent to the CI in secure post. These Trusts will not be able to be identified until this point.\n\nThe identifiable information will be deidentified once the sampled and data are collected.\nThe applicants also note that the existing holding of confidential patient information since 2002 does not have a legal basis under the common law duty of confidentiality. As such, the applicants also request support for the holding of the confidential patient information prospectively in order to allow the above activities to be undertaken legally."]
["Applicant Organisation Name","Institute of Cancer Research (ICR)"]
["Contact Name","Professor Clare Isacke"]
["Address","Institute of Cancer Research (ICR)"]
[null,"237 Fulham Road"]
[null,"London"]
["Postcode","SW3 6JB"]
["Telephone","02071 535 510"]
["Email","clare.isacke@icr.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Nineteen women with breast cancer metastasis that originally provided sample between 2002-2004 under consent."]
["Description of confidential patient information used","Data sources:\n1. Institute of Cancer Research\n2. Royal Marsden NHS Foundation Trust\n\nIdentifiers required for linkage purposes:\n1. Name\n2. Hospital Number\n3. Date of Birth\n\nIdentifiers required for analysis purposes:\nNo identifiers are required for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-13"]
["Next Review Date","2024-09-13"]
["Notes","Specific conditions of support\n\n1. Favourable opinion from REC Received 23 March 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT review for the Institute of Cancer research and the Royal Marsden NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 18 August 2020)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02522","index":565,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02522"]
["Reference","20/CAG/0071"]
["Other Refs","IRAS Project ID: 246575  REC Reference: 20/WM/0071"]
["Application Title","Birmingham and Lambeth Liver Evaluation Testing Strategies - 10 Year Follow Up"]
["Application Summary","The application from University Hospitals Birmingham NHS Foundation Trust sets out the purpose of medical research to determine the extent to which a 'fatty liver' leads to serious liver disease later in life.\n\nNon-alcoholic fatty liver disease (NAFLD) is the most common liver condition in high-income countries, affecting 25% to 30% adults. There is no doubt that NAFLD can progress to more severe diseases; first to a condition called ‘steatosis’ and then to established cirrhosis. While the possibility of such progression is not in doubt, the risk of progression is unclear and disputed. It is important to provide scientific evidence regarding the magnitude of the risk of progression since the recommendation has been made that all people with NAFLD should be investigated by means of serial blood tests and scans of the liver. Such a policy would have massive implications in terms of costs and harms resulting from serial investigation of a fruitless ‘treadmill’ of investigations for about one third of the entire adult population. The BALLETS study provides a population of patients typical of those that might be identified in the course of routine primary care practice. To our knowledge, our proposed study would be much the largest cohort study of people with NAFLD.\n\nThe BALLETS study consented participants in 2005-2008 to participate and have been characterised into one of four groups. The group represents a ideal opportunity to determine the risk of progression. Whilst applicants consented to future follow up, the researchers at the time did not know what form that follow up would take, and the original consent is not deemed sufficient for the proposed study. This study wishes to link the original study data (held by University of Birmingham and passed to University Hospitals Birmingham NHS Foundation Trust) with ONS and HES data from NHS Digital to create a pseudonymised dataset for analysis."]
["Applicant Organisation Name","University Hospitals Birmingham NHS Foundation Trust"]
["Contact Name","Professor Richard Lilford "]
["Address","Room 108, First Floor Murray Learning Centre "]
[null,"Institute of Applied Health Research"]
[null,"University of Birmingham, Edgbaston "]
["Postcode","B15 2TT"]
["Telephone","+44 (0)121 414 6772"]
["Email","r.j.lilford@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All participants that consented to participate in the original BALLETS study. (1290 participants)"]
["Description of confidential patient information used","Data sources:\n1. University of Birmingham – Trial Data\n2. NHS Digital – ONS and HES datasets\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS Number\n3. Date of Birth\n4. Hospital Number \n\nIdentifiers required for analysis purposes:\n1. Date of Birth\n2. Date of Death\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-09-15"]
["Next Review Date","N/A"]
["Notes","Application expired 16 December 2022 as superseded by 23CAG0006 due to a change in controllership arrangements\n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 26 March 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT review for University Hospitals Birmingham NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 10 June 2020). \n\nThe NHS Digital DSPT review for University Hospitals Birmingham NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 15 September 2020)."]

{"sheet":"A02523","index":566,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02523"]
["Reference","20/CAG/0073"]
["Other Refs","IRAS Project ID: 279986  REC Reference: 20/EM/0109"]
["Application Title","Assessing the cancer risks due to occupational exposure to styrene"]
["Application Summary","This is an application from the Institute of Occupational Medicine (IOM) which sets out the medical purposes to determine whether workers in the British glass reinforced plastic manufacturing industry are at an increased cancer incidence or mortality risk from their occupational exposure to styrene. Whilst this is a UK study, the resultant pseudonymised dataset will be transferred to Denmark to feed into a wider international study.\n\nStyrene is a high-production high-volume chemical with about 18 thousand tonnes produced annually in the manufacture of plastic and synthetic rubber products worldwide.  The general population is exposed to very low levels of styrene while occupationally exposed workers may encounter much higher levels of exposure. High exposures to styrene occur in the reinforced plastics industry, and co-exposures to other known and suspected carcinogens are limited, making this industry ideal for studying the carcinogenicity of styrene.  The Health and Safety Executive (HSE) styrene cohort has previously been included in an international pooled cohort study coordinated by the International Agency for Research on Cancer (IARC) but has never separately been analysed. This study will use the HSE styrene cohort data and link this with cancer and mortality data held by NHS Digital to determine whether these workers are at an increased risk of cancer incidence.\n\nThe HSE will transfer the study dataset (including name, date of birth, gender and address) to IOM. IOM will then request cancer and mortality data from NHS Digital, using their name, NHS number and date of birth, which will be transferred back to IOM. The data from NHS Digital will be linked to the HSE dataset to produce the final pseudonymised dataset."]
["Applicant Organisation Name","Institute of Occupational Medicine (IOM)"]
["Contact Name","Prof. Damien McElvenny"]
["Address","Institute of Occupational Medicine"]
[null,"Research Avenue North"]
[null,"Riccarton, Edinburgh"]
["Postcode","EH14 4AP"]
["Telephone","01314 498 085"]
["Email","Damien.McElvenny@iom-world.org"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Workers at a glass reinforced plastics manufacturer, aged 18 and over (1807 workers)"]
["Description of confidential patient information used","Data sources:\n1. Health & Safety Executive\n2. NHS Digital (cancer registration data and mortality data)\n\nIdentifiers requried for linkage purposes:\n1. Name\n2. Date of Birth\n3. Gender\n4. Address \n\nIdentifiers required for analysis purposes:\n1. Date of birth (month and year)\n2. Date of Death (month and year)\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-15"]
["Next Review Date","2024-09-15"]
["Notes","24 October 2023 - change in data processors from NHS Digital to NHS England, regarding data sources Civil registration deaths, Cancer registrations, and demographic data\n\n10 May 2022 - Amendment supported\nAmendment supported to include patients’ full date of birth in the disclosure of confidential patient information from NHS Digital to the Institute of Occupational Medicine.\n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 05 May 2020.\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. Institute of Occupational Medicine and NHS Digital (checked on DSPT tracker 11 June 2020) have been confirmed as ‘Standards Met’ by NHS Digital."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02524","index":567,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02524"]
["Reference","20/CAG/0044"]
["Other Refs","IRAS Project ID: 278592  REC Reference: 20/LO/0428"]
["Application Title","Revision Hip and Knee Replacement: Evaluation of Clinical, Psychological and Surgical Outcomes"]
["Application Summary","This application from the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford set out the purpose of medical research that seeks to investigate how satisfied patients are following revision hip or knee replacement, and whether the reason for surgery affected this. \n\nHip and knee replacement implants are designed to last a long time, but they do not last forever. A revision joint replacement is a procedure to replace an implant that is no longer functioning correctly. These procedures are major surgery because performing a joint replacement can be much more complicated the second or third time. This may be due to the presence of infection or formation of scar tissue and loss of bone over time. Around 13,000 revision operations are performed each year in the United Kingdom at a cost of up to £200 million. The majority of these procedures are successful and many cannot be avoided. Other revision procedures are discretional and depend on a discussion of risks versus benefits between a patient and their surgeon. In the discretional group, up to one-in-three patients who undergo revision surgery do not experience any benefit and the reasons for this are not well understood.\n\nIn this application, anonymised data will be obtained from several sources in the NHS that routinely collect information related to revision joint replacement. Data on Patient Reported Outcome Measures and from the National Joint Registry, alongside HES and ONS data from NHS Digital, will be collected and analysed in order to describe patient satisfaction and function following revision surgery, medical risks, and the need for further surgery and identify the factors that underpin each of these. Confidential patient information will be disclosed from the National Joint Registry (NJR) to NHS Digital for data linkage to HES, ONS and Patient Reported Outcome Measures (PROMS). "]
["Applicant Organisation Name","Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford"]
["Contact Name","Professor Andrew Price"]
["Address","Price Knee Group - Botnar Research Building"]
[null,"Nuffield Orthopaedic Centre"]
[null,"Oxford"]
["Postcode","OX3 7LD"]
["Telephone","01865 223421"]
["Email","andrew.price@ndorms.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","150,000 patients, who have undergone revision hip or knee replacement from April 2003 to the present and the procedure recorded on either HES or the National Joint Registry. "]
["Description of confidential patient information used","Data sources:\n1. The National Joint Registry, held by Northgate Public Services\n2. PROMs, HES and ONS data held by NHS Digital\n\nIdentifiers required for linkage purposes:\n1. NHS Number\n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes\n1. Date of death\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-10"]
["Next Review Date","2024-11-21"]
["Notes","05 March 2021 – Amendment supported \nAmendment supported to revise the data flows so that Northgate Public Services disclose confidential patient information from the NJR to NHS Digital for linkage to HES, PROMS and ONS datasets, and then the disclosure of a pseudonymised dataset to the University of Oxford.\n\nSpecific conditions of support \n\n1. Favourable opinion from REC. Confirmed 01 April 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: Northgate Public Services (by NHS Digital email dated 07 February 2020) and NHS Digital (by NHS Digital email dated 10 June 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02525","index":568,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02525"]
["Reference","20/CAG/0002"]
["Other Refs","IRAS Project ID: 259580  REC Reference: 19/LO/1958"]
["Application Title","Investigating the incidence of radiation-related cancer following endovascular aortic aneurysm repair compared to open aneurysm repair"]
["Application Summary","This application from King’s College London set out the purpose of medical research which aims to determine whether radiation exposure during X-ray guided endovascular aortic report and follow-up lead to an increased risk of cancer. \n\nPatients undergoing X-ray guided endovascular aortic aneurysm repair are exposed to a dose of radiation during their initial operation and then during annual follow-up CT scans. Those who have their aneurysms repairs by an open approach instead are not exposed to this dose of radiation during surgery or follow-up. The applicants will compare the incidence of cancer between these two groups to determine whether this radiation exposure increases the risk of malignancy. \n\nSupport is sought to link data from the Hospital Episode Statistics (HES) database with the National Cancer Registration and Analysis Service (NCRAS) registry. Patients undergoing aortic aneurysm repair either by an open approach (OAR) or endovascular approach (EVAR) will be identified by NHS Digital from the Hospital Episode Statistics (HES) dataset. A list of the remaining patient NHS numbers, dates of birth and a unique pseudonymised ID will be transferred to Public Health England (PHE) by secure electronic transfer agreed between NHS Digital and PHE. At PHE, the National Cancer Registration and Analysis Service (NCRAS) will perform a look up on the cancer registry using deterministic matching based on NHS number and date of birth. This process will identify which patients developed cancer after their procedure. Follow-up on NCRAS will continue to December 2020 such that any patients from the original HES dataset who have a diagnosis of a primary tumour as per future NCRAS data releases can be included in the analysis. PHE will then send the cancer data including date of diagnosis, type and stage of cancer to King’s College London (KCL) in a depersonalised format. NHS digital will also send the demographic and operative details to KCL in a depersonalised format linked by the pseudonymised ID."]
["Applicant Organisation Name","King's College London (KCL)"]
["Contact Name","Professor Bijan Modarai, KCL Chair of Vascular Surgery"]
["Address","King's College London"]
[null,"St Thomas Hospital"]
[null,"Westminster Bridge Road"]
["Postcode","SE1 7EH"]
["Telephone","02071880216"]
["Email","bijan.modarai@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","40,170 patients, aged 50 years and over, who underwent elective open abdominal aortic aneurysm repair or EVAR between January 2000 and December 2016. "]
["Description of confidential patient information used","Data sources:\n1. HES data held by NHS Digital\n2. NCRAS data held by Public Health England\n\nIdentifiers required for linkage purposes:\n1. NHS number\n2. Date of birth\n\nIdentifiers required for analysis purposes:\n1. Date of birth \n2. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-11"]
["Next Review Date","2024-09-11"]
["Notes","19 January 2023 - change in data processors from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source National Cancer Registration and Analysis Service (NCRAS), and a change in data processor from NHS Digital, to NHS England regarding data source Hospital Episode Statistics (HES)\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 15 January 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. (Confirmed: King’s College London (by check of the NHS Digital DSPT tracker dated 11 September 2020), NHS Digital (by NHS Digital email dated 10 June 2019) and National Cancer Registration and Analysis Services (Public Health England) (NHS Digital DSPT tracker checked 16 March 2020) have confirmed ‘Standards Met’ grade on DSPT 2018/19). "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02526","index":569,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02526"]
["Reference","20/CAG/0069"]
["Other Refs","IRAS Project ID: 260555  REC Reference: 19/EE/0210"]
["Application Title","C&I CRIS Linkage with HES and Mortality"]
["Application Summary","This application from University College London (with the controller for the activity confirmed to be Camden and Islington NHS Foundation Trust) set out the purpose of medical research which aims to establish a research database linking the mental health records of patients treated within the Camden and Islington (C&I) NHS Foundation Trust area with data from NHS Digital. \n\nThe Camden and Islington Research Database is already established and contains mental health data generated within the boroughs of Camden and Islington. This database was established using the South London and Maudsley NHS Foundation Trust (SLaM) Clinical Records Interactive Search (CRIS) methodology in 2012. South London and Maudsley NHS Foundation Trust acts as processor for the Camden and Islington Research Database. \n\nConfidential patient information in relation to patients treated by mental health services in the Camden and Islington boroughs will be disclosed by South London and Maudsley NHS Foundation Trust (SLaM) Clinical Data Linkage Service (CLDS) to NHS Digital in order to facilitate linkage with Hospital Episodes Database and ONS mortality data. This information will be supplemented by anonymised information from HES and ONS relating to patients within the named London boroughs who were not detailed within the existing mental health database."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor David Osborn"]
["Address","Wing B Floor 6, Maple House"]
[null,"University College London"]
[null,"Tottenham Court Road, London"]
["Postcode","W1T 7NF"]
["Telephone","0207 472 6177"]
["Email","d.osborn@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort in the proposed study linkage will include patients of Camden and Islington NHS Foundation Trust with active records during the period from 1 January 2012 to 31 December 2018.\n\nIt is estimated that 140,000 patients were included in the Camden and Islington NHS Foundation Trust CRIS database."]
["Description of confidential patient information used","Data sources:\n1. Camden and Islington NHS Foundation Trust C&I Database records.\n\nIdentifiers required for linkage purposes:\n1. Full name \n2. NHS number \n3. Date of birth\n4. Sex \n5. Postcode\n\nIdentifiers required for analysis purposes:\n1. Sex \n2. Postcode \n3. Date of death \n4. Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-14"]
["Next Review Date","2024-09-14"]
["Notes","Specific conditions of support \n\n1. The applicants are to consider whether an address for patients to register dissent could be included in the patient notification materials, and to provide feedback on this at the time of the first annual review. \n\nThe applicant explained that opt-out was already possible via email, telephone and via discussion with a clinician. The patient-facing materials had been amended to include an address for patients to register dissent as reflected in the attached documents. The CAG reviewed this information and raised no further queries. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 25 August 2020. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nCamden and Islington NHS Foundation Trust (by check of the NHS Digital DSPT tracker on 25 August 2020), South London and Maudsley NHS Foundation Trust (by check of the NHS Digital DSPT tracker on 21 May 2020), and NHS Digital (by check of the NHS Digital DSPT tracker on 21 May 2020), have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19. \n\nAmendment outcome 05 August 2022\n\n•\tThe amendment, to;\n\n1.\tInclude Microsoft as a data processor - Microsoft Azure is a sub-processor of SLaM,\n\n2.\tChange the data flow to minimise SLaM’s role as a third-party Data Processor for the purpose of data linkage, limited to now only hosting data. Camden and Islington NHS Foundation Trust will now undertake the linkage.\n\n3.\tExpand the patient/case cohort to be patients of Camden and Islington NHS Foundation Trust with active records during the period from 1 January 2012 - April 30 2022,\n\n4.\tExtend the linked outcome data regarding HES and ONS data received from NHS Digital – up to and including the day the data is extracted, is supported, subject to compliance with the standard conditions of support.\n\n•\tThe amendment, to;\n\n5.\tReceive HES/ONS linked data from NHS Digital regarding a matched cohort of non-patients resident in the London boroughs of Camden & Islington during the time period 1 January 2012 - April 30 2022, is not supported, on the basis that the CAG were not clear on the scope of support requested, and were not convinced there was no practicable alternative to ‘s251’ support. \n\n\n"]

{"sheet":"A02527","index":570,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02527"]
["Reference","20/CAG/0096"]
["Other Refs","IRAS Project ID: 147310  REC Reference: 19/LO/0091"]
["Application Title","Royal Free HIV Cohort Study"]
["Application Summary","This application from University College London set out the purpose of medical research to address critical questions regarding the natural history and prognosis of HIV.\n\nThe Royal Free HIV Cohort Study (RFHCS) is an ongoing study of people with diagnosed HIV attending the Royal Free Hospital HIV clinic, also known as the Ian Charleson Day Unit. The RFHCS has been running since 1995 and information is currently held on patients until 31 January 2018. In this application support is sought for the ongoing retention of previous information collected to date, where public interest had been relied upon as the legal basis for processing. Support is also sought for the ongoing prospective collection of data in relation to newly diagnosed patients.  Confidential patient information would be transferred from the Royal Free Hospital to the UCL Data SafeHaven in order to enable creation of a non-identifiable analysis dataset. The applicants are also seeking support to prospectively enrol all new patients who attend the HIV clinic. \n\nThe database includes all individuals who have ever attended the Royal Free HIV outpatient clinic, unless they have opted out. Data relating to individuals that have since died or have stopped attending the clinic are included, up until the date of their last Royal Free clinic visit. The RFHCS only includes data from the individual’s Royal Free Hospital clinical record already collected as part of routine care, and data is not collected from other hospitals or other sources. "]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Fiona Lampe"]
["Address","University College London"]
[null,"Royal Free Campus"]
[null,"Rowland Hill Street, London"]
["Postcode","NW3 2PF"]
["Telephone","0207 830 2859"]
["Email","f.lampe@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals who attended the Ian Charleson Day Centre since 01/01/1991, unless they have opted out. This includes those individuals that have since died or have stopped attending the clinic."]
["Description of confidential patient information used","Data sources:\n1. Royal Free HIV outpatient clinic (Ian Charleson Day Centre)\n\nIdentifiers required for linkage purposes:\n1. NHS Number\n2. Hospital ID Number\n3. Date of birth\n4. Postcode – unit level\n5. Soundex\n\nIdentifiers required for analysis purposes:\n1. Date of death\n2. Postcode – unit level\n3. Gender\n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-16"]
["Next Review Date","2024-09-16"]
["Notes","Specific conditions of support\n\n1. Applicant to review the patient notification materials to ensure that the opt out information is more prominent and fix broken web lnks\n\n2. Applicant to detail how they intend to attempt to notify the cohort of patients who may not attend the clinic regularly about the work of the database.\n\n3. The conditions should be reported against at the first annual review.\n\n4. Favourable opinion from REC Confirmed 01 March 2019\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The 18/19 NHS Digital DSPT review for University College London was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 10 September 2020).\n\nThe 18/19 NHS Digital DSPT review for Royal Free London NHS Foundation Trust was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked date). Please note the updated specific condition of support below. Royal Free London NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support."]

{"sheet":"A02528","index":571,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02528"]
["Reference","20/CAG/0051"]
["Other Refs","IRAS Project ID: 247410  REC Reference: 20/NE/0096"]
["Application Title","Exploring the impact of mental health services in reducing suicide risk for those accused of online sexual offences against children within the Cleveland area."]
["Application Summary","This application from Tees, Esk and Wear Valleys NHS Foundation Trust (TEWV) sets out the purpose of medical research which aims to compare the outcomes of people arrested on child sex offences between those who accepted or declined the involvement of mental health services, following their initial arrest.\n\nSuicide prevention is seen as a national priority within the United Kingdom, with reduction in the numbers of suicides being part of Government policy and subject to regular report.  Within the group accused of online child sexual offences, known as child sex offenders (CSO), the rate of suicide is higher. Estimates of increased risk of suicide in the CSO group range from 183 to 230 times higher when compared to the general population, with the greatest risk of suicide between 48 hours and one month of disclosure or discovery of the crime. Public benefit is highlighted as the National Police Chiefs’ Council (NPCC) report regards increased suicide risk in this group, indicating the need to understand what measures may improve this outcome and understand whether the intervention carried out in TEWV is having a positive impact on suicide.\n\nCSO cases matching the inclusion criteria will be identified using the Cleveland Police Database (approval obtained). The investigators will record name, date of birth and date of death (where applicable), as well as any other key demographic data available (e.g. yes/no answer to whether the individual is a professional) on an NHS laptop (or the police will send this data using an encrypted email). The researchers, who are not part of the direct care team and potentially from external organisations, will link this with data on Tees, Esk and Wear Valleys NHS Foundation Trust PARIS IT system, in order to collect the data required for the research. Identifiable data will be stored on a separate spreadsheet to the study data, which will be identified purely by a study code. The resultant dataset will be used to highlight key factors that may make individuals arrested by the Cleveland Police more vulnerable to committing suicide and also highlight whether involvement of mental health services at an early stage is of benefit in this particular group. There is also the potential for service improvement, dependent on the outcomes of the research."]
["Applicant Organisation Name","Tees, Esk and Wear Valleys NHS Foundation Trust"]
["Contact Name","Dr Paul Cooper"]
["Address","Tees, Esk and Wear Valleys NHS Foundation Trust"]
[null,"Roseberry Park Hospital"]
[null,"Marton Road, Middlesbrough"]
["Postcode","TS4 3AF"]
["Telephone","0164 283 7300"]
["Email","pcooper6@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any individual that was arrested by the Cleveland Police Paedophile and Online Investigation Team (POLIT) between 2015-2018."]
["Description of confidential patient information used","Data sources:\n1. Tees, Esk and Wear Valleys NHS Foundation Trust\n\nIdentifiers required for linkage purposes:\n1. Name\n2. Date of birth\n3. Date of Death (where applicable)\n\nIdentifiers required for analysis purposes:\n1. Date of arrest, \n2. Ethnicity\n3. Gender \n4. Aged between 40 and 60 years of age (yes/no)\n5. Married or residing with a partner (yes/no)\n6. A parent (yes/no)\n7. Employed (yes/no)\n8. Not previously known to the police (yes/no)\n9. Suffering from a mental health issue (yes/no)\n10. Previously known to attempt suicide(yes/no)\n11. Participants live in the Cleveland area \n\nAdditional information:\nDue to the relatively small population size and the sensitivity of the work, the above may potentially be identifiable."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-09-16"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as the activity did not commence. The research was led by Dr Paul Cooper who left the team in April 2021. The service did not have the resources to commence the research after this time. Therefore, recruitment and data collection did not commence. \n\nSpecific conditions of support\n\n1. Favourable opinion from REC Confirmed 20 May 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT review for Tees, Esk and Wear Valleys NHS Foundation Trust was confirmed as ‘Standards Met’. Email from NHS Digital received on 04 May 2020."]

{"sheet":"A02529","index":572,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02529"]
["Reference","20/CAG/0088"]
["Other Refs","IRAS Project ID: 284172  REC Reference: 20/YH/0213"]
["Application Title","Antihypertensive Treatment in Elderly Multimorbid Patients: a pilot study"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to address a gap in understanding of the treatment effects of blood pressure lowering treatment in older patients with many underlying health conditions, and in particular when their blood pressure is not very high.\n\nThe beneficial effects of blood pressure (BP) lowering treatment are well understood. However, the importance of BP lowering treatment in certain patient groups remains uncertain. One such group includes older patients with many underlying health problems, in particular when their blood pressure is not very high. Little research has been conducted with this group, due to the difficulty of recruiting sufficiently large numbers of older and co-morbid patients into clinical trials. The applicants are seeking to recruit 200 patients aged 65 years and over, and who have a least 3 long-term health conditions or are taking at least 5 medications in addition to being taken to manage blood pressure, into a pilot study. Participants will be randomised to receive up to 2 additional or 2 fewer classes of BP lowering medication over the course of the study with their treatment assess every 4 weeks with the aim of testing whether the intervention can lead to important changes in blood pressure. The findings from the study will be used to establish the feasibility of a larger home-based study to assess the effect of treatment changes on patient-important outcomes.\n\nThe applicants are seeking support for the disclosure of confidential patient information from NHS Digital to the research team at the University of Oxford. The study team will provide NHS Digital with a search query to select individuals aged 65 years or more with three or more chronic conditions diagnosed within a 5-year time window prior to the latest assessment date. The selection of chronic conditions of interest will be based on 3-character ICD codes and individuals with a recorded diagnosis of heart failure will be excluded. The search query will be provided on a number of occasions, each time restricted to individuals who live within different regions in the Thames Valley area and are alive at the time of data sharing with the research team. Patients will then be contacted by post by the research team and their involvement will then proceed on a consented basis. \n\nPatients who are registered with online pharmacy, Pharmacy 2U, and who reside in the Thames Valley area, will also be included. This recruitment pathway was outside the scope of the s251 support sought, as patients will be contacted by Pharmacy 2U in order to seek consent for the sharing of their contact details with the study team. A website would also be made available for patients to register their interest in taking part. This was also outside the scope of support. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Kazem Rahimi, Associate Professor of Cardiovascular Medicine "]
["Address","University of Oxford"]
[null,"Nuffield Department of Women's and Reproductive Health"]
[null,"Hayes House, 75 George Street"]
["Postcode","OX1 2BQ"]
["Telephone","01865 617 200"]
["Email","kazem.rahimi@wrh.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 65 years and over, and who have a least 3 long-term health conditions or are taking at least 5 medications in addition to being taken to manage blood pressure.\n\nConfidential patient information for over 10,000 patients will be disclosed from NHS Digital, from which the applicants anticipate that 200 will consent to take part. "]
["Description of confidential patient information used","Data sources\n1. NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth \n4. Postcode – unit level\n5. Address\n6. Gender\n\nIdentifiers required for analysis purposes\n1. Postcode – unit level"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-10-01"]
["Next Review Date","N/A"]
["Notes","18 January 2022 - Support Expired:\nApplicant confirmed 18 January 2022 that support can be expired as all the demographic data provided by NHS Digital (with ‘s251’ support) to aid recruitment has been destroyed. \n\nIn terms of public benefits, many participants appear to have relished the opportunity to be actively be involved in the management of their own blood pressure at a time when access to GPs and other healthcare professionals has been limited. Applicants  believe that the trial has demonstrated the desire of patients to engage with research trials if the process is made easier for them by taking advantage of digital technology and has been shown to be particularly beneficial in a group of patients that historically have been underrepresented in trials. Follow up of participants in the trial is currently still ongoing but further benefits of this research with respect to the management of blood pressure in older adults with other underlying health conditions may be realised once the trial has finished and results are analysed.\n\n15 June 2021 - Amendment supported::\nSupport provided to remove the need for NHS number to be shared between NHS Digital and University of Oxford, to change the time which identifiable information is transferred to the study database to the point of consent, to extend the study duration until March 2022, to update patient notification materials and to undertake other minor changes is supported.\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 29 September 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold (Confirmed – University of Oxford Medical Sciences Division and NHS Digital (by check of the NHS Digital DSPT tracker on 17 July 2020) have confirmed ‘Standards Met’ grade on DSPT submission 2018/19). "]

{"sheet":"A02530","index":573,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02530"]
["Reference","20/CAG/0084"]
["Other Refs","IRAS Project ID: 279353  REC Reference: 20/EM/0158"]
["Application Title","PIONEER: The UK Health Data Research Hub for Acute Care"]
["Application Summary","This application from University Hospitals Birmingham NHS Foundation Trust set out the purpose of medical research which aims to create and manage the PIONEER database, which will be used to understand and inform acute healthcare processes and long-term consequences for patients admitted to hospital which can inform current and future patient health care and health processes.\n\nAcute care traditionally has not been the subject of research or innovation, despite its scale and the costs involved, and acute care records are traditionally siloed within individual NHS organisations. Linking records at a population level and allowing use of this data for research purposes could provide significant benefits. PIONEER will gather and link data from across acute care providers to become the first such research database to combine routine acute care provision. Using linked organisation level data, rather than national level data will provide a greater granularity of data and greater utility. \n\nThe PIONEER database will be managed within University Hospitals Birmingham NHS Foundation Trust. Initially, routinely collected acute care data from University Hospitals Birmingham NHS Foundation Trust data will be linked with routinely collected data from West Midlands Ambulance Service NHS Foundation Trust. It is expected that the database will expand the number of NHS organisations submitting routine clinical care data over time, although future unspecified organisations were not considered within this application. \n\nProcessing elements requiring support\n\nThe application indicated that, in most instances, the data to be transferred from participating organisations to University Hospitals Birmingham NHS Foundation Trust will be in a pseudonymised format. Upon receipt University Hospitals Birmingham NHS Foundation Trust will process this data through briefly reidentifying three identifiable fields (NHS number, postcode and date of birth) in order to link the data to that of other organisations. This element of processing for the purpose of linkage would require a lawful basis.\n\nWhere participating organisations do not have the capacity to pseudonymise the data prior to transfer, they would send the data in an identifiable format to University Hospitals Birmingham NHS Foundation Trust to undertake the pseudonymisation. A lawful basis would be required for this sub-set of organisations to disclose this identifiable information to University Hospitals Birmingham NHS Foundation Trust for this purpose.\n\nResearchers can apply for data extracts for specific research projects, which will undergo a defined application process, including scrutiny by lay members, before released in an anonymised form (for example, only age will be provided, not date of birth). Support would be required to process and render relevant information fully anonymous prior to disclosure. "]
["Applicant Organisation Name","University Hospitals Birmingham NHS Foundation Trust"]
["Contact Name","Professor Elizabeth Sapey "]
["Address","University Hospitals Birmingham NHS Foundation Trust"]
[null,"Birmingham Acute Care Research Group"]
[null,"Edgbaston, Birmingham"]
["Postcode","B15 2TH"]
["Telephone","0121 414 2000"]
["Email","e.sapey@bham.ac.uk | pioneer@uhb.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who have undergone an acute care contact, within University Hospitals Birmingham NHS Foundation Trust or West Midlands Ambulance NHS Trust. Data will be collected retrospectively (from 01 January 2000 at the earliest) and prospectively."]
["Description of confidential patient information used","Data sources\n1. University Hospitals Birmingham NHS Foundation Trust\n2. West Midlands Ambulance NHS Trust\n\nIdentifiers required for linkage purposes\n1. NHS Number \n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes\n1. Postcode \n2. Date of birth \n3. Gender\n4. Ethnicity\n5. Diagnosis information (including rare diseases)\n\nAdditional information\nPostcode is not provided to researchers. Instead, a less specific geographical unit such as the Lower layer Super Output Area (LSOA), or the associated data of interest such as the Index of Multiple Deprivation score will be provided.\n\nDate of birth is not provided to researchers. It will be used to calculate the age of the patient at the time of interest to the researcher."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-28"]
["Next Review Date","2024-09-28"]
["Notes","Amendment supported 09 February 2024 to add GP patient level data from the Hall Green Health as an additional data source\n\nAmendment supported 21 November 2023 to add Birmingham Community Healthcare NHS Foundation Trust as an additional data source.\n\n06 January 2022 - Amendment supported:\nAmendment supported to allow University Hospitals Birmingham NHS Foundation Trust to disclose confidential patient information to NHS Digital, in order to link to COVID-19 Vaccine status and COVID-19 Vaccine adverse reaction datasets, and for NHS Digital to disclose confidential patient information back to the applicants at University Hospitals Birmingham NHS Foundation Trust.\n\nSpecific conditions of support\n\n1. Support is limited to the involvement of West Midland Ambulance Trust initially. Prior to the addition of subsequent external organisations, a report should be sent to the CAG for consideration on the success of the processes with this Trust, detailing any issues that have arisen in the initiation of the database, and how these have been resolved. \na. This report should include details of the percentages of mismatch using linkage through reidentification, linkage through a common pseudonym, and the impact of returning pseudonymised rejected linkages to the original Trust. The effectiveness of each method, and as well as a summary of the benefits and challenges encountered with each should be included.\n\nConfirmed\n\n2. Support is limited to the use of structured data and unstructured medical image data only. \n\n3. Support is not provided for the use of unstructured free text data. Where the applicants wish to use this form of data in the future, a detailed amendment/paper should be submitted to the CAG, providing information on how the applicants have considered the pseudonymisation methods of free text data at source, and how they demonstrate its effectiveness in deidentification.\n\n4. Support is not currently provided for participating organisations to transfer identifiable information to University Hospitals Birmingham NHS Foundation Trust to undertake the pseudonymisation process. Where this situation is expected to occur, an amendment should be submitted to the CAG, providing assurances on the minimisation of identifiable information and the further detail on the processes that will be used.\n\n5. Within three months of the final outcome letter date, provide the CAG with a comprehensive media and communications strategy. This should include details on how the applicants will maintain patient notification to the wider public throughout the lifetime of this project, and how the applicants will handle media enquiries.\nConfirmed 06 January 2021\n\n6. Support is given for the use of data for medical research purposes only. \n\n7. Favourable opinion from REC.\nConfirmed 21 August 2020\n\n8. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT review for West Midlands Ambulance Service NHS Trust was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 29 June 2020).\n\nThe NHS Digital DSPT review for University Hospitals Birmingham NHS Foundation Trust was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS DSPT Tracker (checked 29 June 2020). Support is conditional upon organisation meeting the action plan, as agreed with NHS Digital, and maintaining the agreed standard for the duration of support. All University Hospitals Birmingham staff handling information under this support must act in accordance with all details specified in the application."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02531","index":574,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02531"]
["Reference","20/CAG/0078"]
["Other Refs","IRAS Project ID: 261506  REC Reference: 20/SC/0129"]
["Application Title","Accuracy of using crown rump length measurements in dating pregnancies"]
["Application Summary","This application from University Hospital Southampton NHS Foundation Trust sets out the purpose of medical research to whether the due date of an IVF pregnancy is better determined by measuring crown-rump length on ultrasound or using the conception dates from IVF (known as 'dating' a pregnancy), and to if the measurements of unborn babies at 12-weeks of pregnancy which generates a due date from population data from the 1970s, are still accurate.\n\nCalculating an accurate estimated due date (EDD) is paramount in providing optimal maternity care. For example, for making decisions at the extremes of viability, legalities for terminating the pregnancy, as well as many other aspects of antenatal care.  Crown-rump length (CRL) measurements are undertaken before 14 weeks of pregnancy to determine an EDD for the baby. However, the charts used to determine the EDD from the CRL are based on data from the 1970s, which likely used less accurate technology than today. Further, IVF conceived embryos may develop at a different rate in pregnancy compared with natural conceptions. If this rate effects the size of the fetus at 12 weeks, then the calculated EDD will be inaccurate using naturally conceived pregnancy data. In IVF pregnancies, the exact date of conception is known.  This is because the date of collection of the egg from a woman, the fertilisation and growth stages of the early embryo are witnessed. Using CRL to calculate an EDD is more accurate than relying on a menstrual history, but whether it is more accurate than using the IVF conception dates is not known. This study hopes to demonstrate whether IVF pregnancies have equivalent growth to spontaneous conceptions by 12-weeks, how to calculate the EDD for women who undergo IVF and hopes to claim that the currently used methods for calculating EDDs for spontaneous conceptions, is still relevant and accurate.\n\nThis study has three cohorts, of which only the first two require support. The first cohort will look at pregnancy data from all IVF pregnancies delivered in University Hospital Southampton NHS Foundation Trust between 2011-2018. The second cohort will look at the pregnancy data from all pregnancies that had a dating scan and were delivered spontaneously in University Hospital Southampton NHS Foundation Trust in the past 20 years. This data is held within a number of separate databases within University Hospital Southampton NHS Foundation Trust and a member of staff, who is not a member of the direct care team and does not have a legal basis, will access the confidential information of patients in order to link the data together to create a dataset to be used for analysis in this study. Additional confidential patient information is requested from Portsmouth Hospitals NHS Trust and Complete Fertility Southampton, which will be linked with data collected from University Hospital Southampton NHS Foundation Trust."]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust"]
["Contact Name","Dr Linden Stocker"]
["Address","Southampton University Hospital"]
[null,"Princess Anne Hospital"]
[null,"Southampton"]
["Postcode","SO16 5YA"]
["Telephone","07515 798 116"]
["Email","l.stocker@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort 1:\nAll IVF pregnancies conceived at Complete Fertility, having a 12-week USS and delivered in University Hospital Southampton NHS Foundation Trust (2011-2020). (n=1000)   \n\nCohort 2:\nAll babies of women who had a dating ultrasound scan in University Hospital Southampton NHS Foundation Trust between 2006-2020 who underwent spontaneous labour and delivered in University Hospital Southampton NHS Foundation Trust. (n=100,000)"]
["Description of confidential patient information used","Data sources\n1. University Hospital Southampton NHS Foundation Trust\n2. Portsmouth Hospitals NHS Trust\n3. Complete Fertility Southampton\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital Number\n4. Date of Birth \n\nIdentifiers required for analysis purposes\n1. Gender\n2. Occupation\n3. Ethnicity\n4. Other demographic data (including date of birth of child?)"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-29"]
["Next Review Date","2024-09-29"]
["Notes","Specific conditions of support\n\n1. Favourable opinion from REC Confirmed 11 May 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT review for University Hospitals Southampton NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 10 June 2020)."]

{"sheet":"A02532","index":575,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02532"]
["Reference","20/CAG/0103"]
["Other Refs","IRAS Project ID: 252831  REC Reference: 19/NW/0009"]
["Application Title","UK National Haemophilia Research Registry"]
["Application Summary","This application from United Kingdom Haemophilia Doctors Organisation set out the purpose of medical research which aims to use the data collected within the National Haemophilia Database as a research registry.\n\nThe UK National Haemophilia Database (NHD) is a long running national database that was established in 1968. Whilst the database maybe used for direct clinical care, it is also used extensively for national audit purposes. The database has a long history of working with national bodies to further patient care by assisting continuity of care and monitoring safety through the provision of accurate data, and this information informs and shapes national policy. This activity is working under support (20/CAG/0102).\nThe applicants request support for using the National Haemophilia (NHD) as a research registry. Given the data held by the NHD dates back over 50 years, the registry can play an important role in the research of bleeding disorders. Applications for use of the data for research purposes will be reviewed by the Data Analysis Group (DAG), a sub-committee of the Data Management Working Party (DMWP) within the National Haemphilia Database. The DMWP includes a number of stakeholders including a patient representative. Once approved, the data will be released in a pseudonymised or anonymised format and is generally accessed directly from the N3 servers and is not transferred."]
["Applicant Organisation Name","United Kingdom Haemophilia Doctors Organisation "]
["Contact Name","Professor Charles Hay"]
["Address","UKHCDO Ltd."]
[null,"City View House, Union Street"]
[null,"Ardwick, Manchester"]
["Postcode","M12 4JD"]
["Telephone","0161 277 7924"]
["Email","Charles.Hay@mft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with a bleeding disorder in England and Wales"]
["Description of confidential patient information used","Data sources\n1. National Haemophilia Database\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Postcode\n3. Ethnicity\n4. Date of Death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-30"]
["Next Review Date","2024-09-30"]
["Notes","18 August 2023 - change in data processor from NHS Digital to NHS England, regarding mortality data\n\nSpecific conditions of support\n\n1. Provide, within six months of the final support letter, updated patient notification materials that have undergone review by a patient group.\n   a. These materials should include a central telephone and email address for patients to opt out of their use of data.\n\nCondition met 06 July 2021\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 15 April 2019\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital DSPT review for Manchester University NHS Foundation Trust was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking security awareness training’ on the NHS Digital DSPT Tracker (checked 14 August 2020). All staff at Manchester University NHS Foundation Trust that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support.\n\nThe NHS Digital DSPT review for the National Haemophilia was confirmed as ‘standards met’ (by email from NHS Digital 18 September 2020)."]

{"sheet":"A02533","index":576,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02533"]
["Reference","20/CAG/0057"]
["Other Refs","IRAS Project ID: 275039  REC Reference: 10/H1070/70"]
["Application Title","PEARL s251 Sensitive Health Records Template (Incidence of psychosis and measures of psychotic experiences within the ALSPAC)"]
["Application Summary","This application from University of Bristol set out the purpose of medical research to examine the proportion of children and adolescents with psychotic experiences (PEs) who transition to clinical disorder in adulthood, and estimate the extent to which they are identified by primary (PC)/secondary care (SC) services highlighting potential unmet need.\n\nPEs are reported by 5-10% of the general population. Although usually transient, they are associated with increased risk of schizophrenia, but the natural progression of PEs and transition to schizophrenia in adulthood has not been examined in detail. Estimates of incidence are usually obtained from people presenting to clinical services and thus individuals who have not sought help would be missed from these estimates. Linking ALSPAC data with primary and secondary care records will allow the researchers to examine, prospectively, which early symptoms are most predictive of developing a psychotic disorder.\n\nThe applicants seek support to process confidential patient information from GP records, NHS Digital (HES data, the Mental Health Services Data Set) and data from the Avon and Wiltshire Mental Health Partnership, in line with ALSPAC’s existing approval.\n\nALSPAC wish to:\n•\tIf the required sensitive data has already been collected through a previous project specific s251 support, repurpose the data for this purpose, in order to reduce flow of confidential information.\n•\tFor data not already collected though a previous project specific s251 support, request data from GP providers, NHS Digital and Avon and Wiltshire Mental Health Partnership using existing processes.\n\nThe data will then combined/anonymised by the ALSPAC team within UKSeRP (hosted by the University of Swansea but managed by ALSPAC staff). ALSPAC staff will then make the anonymised combined data available to the research team for this project."]
["Applicant Organisation Name","Avon Longitudinal Study of Parents and Children (University of Bristol) "]
["Contact Name","Mark Mumme (ALSPAC Data Linkage Manager) "]
["Address","ALSPAC"]
[null,"Oakfield House"]
[null,"Oakfield Grove, Bristol"]
["Postcode","BS8 2BN"]
["Telephone","01173 313 359"]
["Email","mark.mumme@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All people enrolled in ALSPAC, excluding those who have explicitly withdrawn from the study, declined consent to linkage to their health record, have not received ALSPAC fair processing information or have consented to data linkage."]
["Description of confidential patient information used","Data sources\n1. NHS Digital (HES and MHSDS data)\n2. GP software providers \n3. Avon and Wiltshire Mental Health Partnership NHS Trust \n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n3. Date of death\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Date of Birth will be used (by ALSPAC) to derive 'Age at Event' (expressed in days, minutes, seconds) and time intervals. This allows ALSPAC to provide information to researchers in event sequence order without disclosing Date of Birth or event date.\n\nAdditional information\nOf the 15,000 ALSPAC participants, around 5500 have consented to data linkage and are not part of this request for support."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-04"]
["Next Review Date","2024-10-04"]
["Notes","Specific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed February 2011\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital DSPT review for University of Bristol, The Phoenix Partnership and the EMIS Group was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 10 May 2020). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02534","index":577,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02534"]
["Reference","20/CAG/0087"]
["Other Refs","IRAS Project ID: 236644  REC Reference: 17/EE/0442"]
["Application Title","Research database for Cambridgeshire & Peterborough NHS FT (CPFT)"]
["Application Summary","This application from Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) sets out the purpose of medical research which aims to link data from a research database with nationally held datasets to enhance the database. The CPFT Research Database has been established since 2012 acting under a consented model to (a) use CPFT data for research purposes and (b) use CPFT data to identify and approach patients for direct research.\n\nHowever, given the current research database only contains data from CPFT, there are limitations in the usefulness of the database. As such, the applicants request support to extend the database by linking data held by NHS Digital (HES and ONS mortality data) and the Department of Education (National Pupil Database). For each, identifiable data will be sent to NHS Digital and Department of Education. Each body will link to the data they hold, remove identifiers and return the data using the CPFT database pseudonym, at which point the data will be linked with existing CPFT data. Note that the applicants are also linking with PHE (NCRAS) data, but this does not involve the transfer of patient identifiable information and support is not requested for this aspect.\n\nThe research database will be used for epidemiological research purposes. Those wishing to apply for access will be required to have a contractual relationship with CPFT and will need to apply to the CPFT Research Database Oversight Committee (with representation including patients/carers, clinicians, and R&D/information governance staff). Once access is granted, researchers will not have access to any identifiable information, and will need to access the data through the CPFT network (and are not sent the data)."]
["Applicant Organisation Name","Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) "]
["Contact Name","Dr Rudolf Cardinal"]
["Address","Liaison Psychiatry Service, Cambridgeshire and Peterborough NHS Foundation Trust"]
[null,"Box 190, Cambridge Biomedical Campus"]
[null,"Cambridge"]
["Postcode","CB2 0QQ"]
["Telephone","01223 216 167"]
["Email","rnc1001@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with a record at Cambridgeshire and Peterborough NHS Foundation Trust, except those that have opted out."]
["Description of confidential patient information used","Data sources\n1. Cambridgeshire and Peterborough NHS Foundation Trust\n2. NHS Digital\n3. Department of Education\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Name\n3. Date of birth\n4. Postcode\n\nAdditional information\nWhilst the data is pseudonymised and may be reidentified by Cambridgeshire and Peterborough NHS Foundation Trust, as data controller, researchers will not have the key to reidentify patients date of birth/death changed to month and year of birth/death and postcodes are truncated to the district level and Office of National Statistics (ONS) Lower Level Super Output Area (LSOA) codes.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-04"]
["Next Review Date","2024-10-04"]
["Notes","15 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil registration – deaths dataset\n\n16 March 2021 - Amendment supported\nAmendment supported to amend the identifiers used to facilitate linkages between the CPFT database and the ONS and HES data sets at NHS and the National Pupil Database at the Department for Education.\n\nSpecific conditions of support\n\n1. Provide the updated website text within one month of the date of this letter. \n\n22 October 2020 - the applicant responded to the condition of support by sending CAG an updated website text. The CAG were content with this response and this was confirmed by email on 3 November 2020. \n\n2. Favourable opinion from REC Received 06 August 2020\n\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT reviews for Cambridgeshire and Peterborough NHS Foundation Trust, NHS Digital and Department for Education were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 03 August 2020)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02535","index":578,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02535"]
["Reference","20/CAG/0110"]
["Other Refs","IRAS Project ID: 283808  REC Reference: 20/EE/0220"]
["Application Title","Understanding the epidemiology in the transition from neonatal to paediatric care: a data linkage study"]
["Application Summary","This application from University of Leicester sets out the purpose of medical research that aims to describe and understand the epidemiology of children who receive neonatal and/or paediatric care by linking together information about the care they have received. The aim is to understand which children who receive neonatal care also go on to need paediatric care, how this affects service providers, and how patients and families can be best supported.\n\nFollowing birth, around one in seven babies are admitted for specialist neonatal care in the UK. Admission rates to neonatal care have increased, partly due to improved survival of the most vulnerable babies, particularly those born very prematurely or those with serious health problems. More of these babies now survive, but the impact of their health and the care received immediately after birth can be lifelong. There has also been an increase in admissions to Paediatric Intensive Care Units (PICU) in the last ten to fifteen years. Many admissions relate to children who received neonatal care immediately after birth, although the exact number is not known. Very little is known about what happens between neonatal and paediatric care including which children are likely to experience both types of care, and how clinical services, parents and professionals manage the transition. \n\nThis study will use information from two established databases, both of which have a legal basis to collect confidential patient information under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002: the National Neonatal Research Database (NNRD) (CAG ref: ECC 8-05(f) / 2010) and the Paediatric Intensive Care Audit Network (PICANet) (CAG ref: PIAG 4-07(c)/2002). The NNRD captures information about all babies admitted for neonatal care after birth. PICANet captures information related to referrals, transports and admissions to PICU. Applicants will focus on care received in the first two years of life but for those children who were also subsequently admitted in later years, information relating to later admissions will also be received.\n\nEach database will provide the identifiers from their datasets to NHS Digital, who will link the 2 data sets together as a trusted third party. NHS Digital will establish three datasets - those only in the NNRD, those only in PICANet, and those common to both datasets. NHS Digital will then link these data to Hospital Episodes Statistics (HES) and mortality data (ONS). The datasets from NNRD and PICANet will also be linked to Patient Episode Database for Wales (PEDW) by NHS Wales Informatics Service (NWIS), to collect information about admissions in Wales. The pseudonymised linked datasets will be transferred from NHS Digital and NWIS to the researchers at University of Leicester. Pseudonymised clinical datasets will also be transferred directly from the NNRD/PICANet to the research team at the University of Leicester, containing data related to demographics, care, treatment and outcomes. The researchers will then link the clinical datasets to the pseudonymised linked (to HES, ONS, and PEDW) NNRD/PICANet datasets, using a pseudonymised identifier.\n \nAll data provided to the team at the University of Leicester will be pseudonymised. The pseudonymised data can only be linked to personal data by NHS Digital or the teams at the NNRD or PICANet. The University of Leicester cannot link back to any personal data and will not hold any of the primary datasets."]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Dr Sarah Seaton"]
["Address","Department of Health Sciences"]
[null,"University of Leicester"]
[null,"University Road, Leicester"]
["Postcode","LE1 7RH"]
["Telephone","0116 252 5434"]
["Email","sarah.seaton@leicester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children admitted to neonatal care in England and Wales from 1 January 2013 to 31 December 2018 (~480,000 babies) and all children aged <2 years admitted to PICU from 1 January 2013 to 31 December 2020 (~ 80,000 admissions)."]
["Description of confidential patient information used","Data sources\n1. National Neonatal Research Database (NNRD): (Chelsea & Westminster Hospital NHS Foundation Trust)\n•\tInformation about all babies admitted for neonatal care.\n2. Paediatric Intensive Care Audit Network (PICANet): (University of Leeds)\n•\tInformation about children aged <2 years admitted for paediatric intensive care, \n•\tand Information about children who were subsequently admitted after age two years for relevant children.\n3. NHS Digital:\n•\tMortality data (Office for National Statistics - ONS) \n•\tHospital Episode Statistics (HES) data \n4.\tNHS Wales Informatics Service (NWIS): \n•\tPatient Episode Database for Wales (PEDW) data\n\nIdentifiers required for linkage purposes\n1. NHS Digital will complete linkage using:\n•\tNHS number\n•\tDate of birth\n•\tSex\n•\tPostcode \n\n2. The NHS Wales Informatics Service will complete the linkage using only NHS number\n\n\nIdentifiers required for analysis purposes\n1. Age\n2. Sex\n3. Ethnicity\n4. Date of death (modified to age of child at time of death)\n\nAdditional information\nAll records transferred to NHS Digital will include a pseudo-anonymised identifier to allow linkage back to the clinical data by the team at the University of Leicester. No clinical data will be transferred from the NNRD or PICANet to NHS Digital."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-09-29"]
["Next Review Date","N/A"]
["Notes","Applicant has confirmed May 2023 that ‘s251’ support can be expired, as direct identifiers (e.g., NHS number) are held by PICANet and NNRD. It is not possible for the applicant to link back to the original identifiers without involving the teams at PICANet or NNRD. \n\nWith regards to public benefit, once the results have been analysed, this study we will investigate the need for hospital care in the first two years of life after admission to neonatal care. This information can be used to counsel parents about the potential for their child to be readmitted to hospital. It can also be used for healthcare services to improve their planning of resources.\n\nSpecific conditions of support\n\n1. The patient notification text, to be displayed on the University of Leicester, NNRD and PICANet websites, to be provided to CAG within three months from the date of this letter. This notification should include clear details for a study specific dissenting mechanism.\nConfirmed 02 December 2020\n\n2. Provide a report, within three months from the date of this letter, detailing the Patient and Public Involvement and Engagement undertaken that describes the acceptability of using identifiable data without consent, including the number of participants. \nConfirmed 02 December 2020\n\n3. Provide a report, at the first annual review, of the ongoing activities of the parent advisory group. \n\n4. Favourable opinion from a Research Ethics Committee \n(Confirmed 28 September 2020).\n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold Confirmed:\n•\tUniversity of Leicester - College of Life Sciences (EE133832-CMBSP), \n•\tChelsea & Westminster Hospital NHS Foundation Trust (RQM), \n•\tUniversity of Leeds -SEED (8E218-SEED) and \n•\tNHS Digital (X26) –Equivalent to DSPT) have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 (Confirmed by check of DSPT tracker 22 September 2020) \n•\tSecurity assurances for NHS Wales Informatics Service (NWIS) have also been provided in the form of a CPiP out-turn report dated 15th June 2020. "]

{"sheet":"A02536","index":579,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02536"]
["Reference","20/CAG/0064"]
["Other Refs","IRAS Project ID: 274941  REC Reference: 20/LO/0640"]
["Application Title","Health, education and social outcomes of children with visual impairment and blindness (VI/SVIBL)"]
["Application Summary","This application from the University College London set out the purpose of medical research that seeks to investigate the health, educational and social outcomes of children who are newly diagnosed with full spectrum visual impairment. \n\nSevere visual impairment and blindness in childhood (SVIBL) is uncommon but has a significant impact on all aspects of life. Children diagnosed with SVIBL are likely to have worse health outcomes and therefore experience poorer health compared to children without a visual disability. The applicants aim to explore outcomes for children diagnosed with SVIBL and visual impairment within England. \n\nSocio-demographic and clinical data collected in two previous national surveillance studies, BCVIS and BCVIS 2, will be linked to administrative hospital and school records by NHS Digital in order to obtain long-term follow up data for the cohorts involved in the two studies. BCVIS 2 had support under s251, under CAG reference 14/CAG/1028, to collect the confidential patient information required via the British Ophthalmological Surveillance Unit and the British Paediatric Surveillance Unit.  BCVIS was started in 1998, prior to the creation of s251. The longitudinal linked data collected during these studies will be used to develop understanding of the health and educational trajectories of children with visual disability, from the point of diagnosis throughout their childhood. The applicants aim to identify factors associated with few hospital admissions and better school attendance and educational attainment. Two representative cross-sectional samples of the general child population will also be sought from NHS Digital as control groups for the BCVIS and BCVIS 2 cohorts. The control groups will be selected to mimic the cross-sectional design of the BCVIS studies and reflect the distribution across age groups. \n\nThe applicants also seek support to disclose items of confidential patient information, including patients’ date of birth, full postcode, sex and ethnicity, and the study ID for participants in the British Childhood Visual Impairment and Blindness Study (BCVIS) to be sent via a secure transfer system to the ONS Secure Research Service. The ONS Secure Research Service will carry out the data linkage to the National Pupil Database (NPD) and return a pseudonymised extract from the NPD, alongside the study ID, to the research team at University College London."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Jugnoo Rahi"]
["Address","UCL Great Ormond Street Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone","020 7905 2250"]
["Email","j.rahi@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1074 patients whose data was collected during the BCVIS and BCVIS 2 studies. \n\nControl group for BCVIS cohort – all children 0-16 years of age with any outpatient hospital attendance between 01 January 2003 and 21 December 2003. The applicants anticipate that approximately 544,000 visits will have been made to ophthalmology departments. \n\nControl group for BCVIS 2 cohort – all children 0 – 18 years of age with any outpatient hospital attendance between 01 January 2003 and 31 December 2003. The applicants anticipate that approximately 814,448 visits will have been made to ophthalmology departments."]
["Description of confidential patient information used","Data sources\n1. Data collected for the BCVIS study, held at University College London Great Ormond Street Institute of Child Health. \n2. Data collected for the BCVIS 2 study, held at University College London Great Ormond Street Institute of Child Health. \n3. HES data held by NHS Digital\n4. The National Pupil Database, held by the Department for Education\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Hospital ID number\n3. Date of birth\n4. Postcode – unit level\n5. Sex\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – district level\n4. Name of hospital where treatment took place\n5. Gender\n6. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-08"]
["Next Review Date","2024-10-08"]
["Notes","15 December 2023 - change in data processors from NHS Digital to NHS England, regarding data source Hospital Episode Statistics (HES)\n\nSpecific conditions of support\n\n1. Provide to CAG the final patient notification materials, following review by relevant user groups.\n\nCondition met 12 December 2022\n\n2. Favourable opinion from REC Confirmed 8 June 2020\n\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital DSPT review was confirmed as ‘Standards Met’ for University College London Great Ormond Street Institute of Child Health (DSPT Tracker checked 22 May 2020), NHS Digital (confirmed by email 10 June 2019) and Department for Education (confirmed by email 26 June 2020)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02537","index":580,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02537"]
["Reference","20/CAG/0122"]
["Other Refs","IRAS Project ID: 264286  REC Reference: 20/LO/0347"]
["Application Title","The Prognostic Performance of the Enhanced Liver Fibrosis Test in UK Patients with Chronic Liver Disease Assessed 20 Years After Recruitment to the EUROGOLF study (EVenti)"]
["Application Summary","This application from the Royal Free London NHS Foundation Trust set out the purpose of medical research which aims to determine the value of using the enhanced liver fibrosis test (ELF) as part of an evaluation of liver disease risk in middle life.\n\nAn original cohort of 921 participants (497 in the UK) were consented into the EUROGOLF study between 1998 and 2000, which identified and validated the ELF test. In 2008/09 the investigators interrogated the 497 records in the UK which established it was at least equal, if not superior to, a liver biopsy in predicting liver related and all cause mortality at 7 years. It has now been 20 years since participants were enrolled and many patients have likely reached clinical endpoint. The applicants wish to use confidential patient information related to these 497 patients held by the Royal Free London NHS Foundation Trust to link to HES, cancer registry and mortality data from NHS Digital. The resulting data will be used to understand the value of the ELF test as part of an evaluation of liver disease in middle life.\n\nSince the previous deferral the applicants have consulted with legal advice to determine the legal basis, under the common law duty of confidentiality, for holding of the existing data. This concluded that there is no legal basis, and the applicants additionally request support prospectively for the data to be held by the Royal Free London NHS Foundation Trust."]
["Applicant Organisation Name","Royal Free London NHS Foundation Trust"]
["Contact Name","Prof. William Rosenberg"]
["Address","UCL Medical School"]
[null,"Royal Free London NHS Foundation Trust"]
[]
["Postcode","NW3 4PF"]
["Telephone","0207 794 0500"]
["Email","william.rosenberg@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All 497 patients recruited into the original EUROGOLF study"]
["Description of confidential patient information used","Data sources\n1. NHS Digital\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of Birth\n3. Gender\n\nIdentifiers required for analysis purposes\n1. Date of birth \n2. Date of death\n3. Postcode"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired "]
[]
["Outcome Date","2020-10-12"]
["Next Review Date","N/A"]
["Notes","Application expired on 15 June 2023 via an amendment, to amend the data controller from Royal Free London NHS Foundation Trust to University College London. This application is superseded by 23/CAG/0082.\n\n24 January 2022 - Amendment supported:\nAmendment supported 24 January 2022 to clarify that support is in place for study ID, NHS number, date of birth and gender to be disclosed from Royal Free London NHS Foundation Trust to NHS Digital, in order for NHS Digital to supply the applicant with a dataset linked to Study ID, (but with NHS Number, date of birth and gender removed).\n\nSpecific conditions of support\n\n1. Favourable opinion from REC \nConfirmed 23 April 2020\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \n\nConfirmed - The NHS Digital DSPT review for Royal Free London NHS Foundation Trust and NHS Digital were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 04 October 2020)"]

{"sheet":"A02538","index":581,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02538"]
["Reference","20/CAG/0068"]
["Other Refs","IRAS Project ID: 279403  REC Reference: 20/SC/0194"]
["Application Title","South London and Maudsley NHS Foundation Trust CRIS data linkage with the National Pupil Database"]
["Application Summary","This application from King’s College London (with the controller for the activity confirmed to be South London and Maudsley NHS Foundation Trust) set out the purpose of medical research which aims to create a linked education and mental health dataset for research purposes.\n\nIn 2016 the South London and Maudsley (SLaM) NHS Trust created a linked education and mental health research database of nearly 30,000 patients (s251 support provided). However, the current database only contains information regarding young people in the SLaM region up to and including 2013. Given a variety of factors, this resource is significantly more outdated than would initially be expected. The applicants now wish to update this database to create dataset which covers all school-aged children and young people (between 4 and 19 years) who reside in the SLaM and local catchment area in order to undertake further research. \n\nSLaM will identify the cohort and provide (a) a pseudonymised dataset (data for the cohort identified only by a pseudonym) to Office for National Statistics (ONS) and (b) identifiable information (including the allocated pseudonym) to the Department for Education (DfE). DfE will use the identifiable information to access corresponding pupil data on the National Pupil Database (NPD). DfE will transfer the cohort dataset (identified only by the allocated pseudonym) to the ONS, who will link the SLaM and DfE data into one dataset. Any researchers wishing to access this dataset will have to gain permission from the oversight committees of SLaM, DfE and ONS."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Johnny Downs"]
["Address","Department of Child and Adolescent Psychiatry"]
[null,"King's College London"]
[null,"16 De Crespigny Park, London"]
["Postcode","SE5 8AZ"]
["Telephone","07951 273 511"]
["Email","johnny.downs@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children and young persons between 4-19 years who have accessed SLaM services between 1 January 2008 and 31 August 2019."]
["Description of confidential patient information used","Data sources\n1. Medical records in the SLaM CRIS database\n2. National Pupil Database held by DfE\n\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth \n3. Address\n4. Sex\n5. Postcode\n\nIdentifiers required for analysis purposes\n1. Year of birth\n2. Postcode (at district level)\n3. Gender\n4. Ethnicity\n\nAdditional information\nBecause of the changes related to DfE data hosting policies, the applicants require a complete refresh of the linkage as the DfE from 1 January 2008, not from the end of the previous data collection."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-08"]
["Next Review Date","2024-10-08"]
["Notes","Conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n• South London and Maudsley NHS Foundation Trust and the Office for National Statistics have a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by checking the NHS Digital DSPT Tracker on 21 May 2020. \n\n• Security assurances for the Department for Education has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by check of the DSPT Tracker on 11 June 2020. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02539"]
["Reference","20/CAG/0081"]
["Other Refs","IRAS Project ID: 275254  REC Reference: 20/LO/0510"]
["Application Title","Predicting vascular complications in diabetes"]
["Application Summary","This application from Barts Health NHS set out the purpose of medical research to determine whether artificial intelligence (AI) can identify and predict the progression of diabetes foot disease.\n\nDiabetes is an important public health problem. It currently affects almost 3.7 million people in the UK, with 12.3 million at increased risk of type 2 diabetes. Vascular complications include diabetic foot disease, which, in the three-year period 2013-2016 was responsible for 121,067 hospital admissions and 1,688,699 days spent in hospital in England by 73,388 patients, 31% of whom had more than one admission. Over the same time period, 7119 major amputation procedures were performed, an age and ethnicity standardised rate of 8.1 major amputations per 10,000 population-years. This project has been created to contribute towards improving the health of the public by using natural language processing (NLP) and machine learning methods, applied to text rich hospital records and to develop predictive tools with which to identify those at high risk of an active diabetic foot problem and/or amputation at an earlier stage than currently possible. The applicants aim to enable newer interventions to prevent or delay disease progression to be tested and management of diabetes to be optimised.\n\nThe research team will extract the structured and free text records from case patients (diabetics who developed foot disease) and controls (diabetics who did not develop foot disease) at Barts Health NHS Trust into a study database, held within Barts Health NHS Trust. The free text data will be run through a natural language processing program to turn the free text into structured codes (Snomed codes). The research team will then compare the codes extracted from free text data against the structured data within the patient medical records to determine the effectiveness of the program in predicting onset of diabetic foot disease."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Dr Charles Gutteridge"]
["Address","Barts Health NHS Trust"]
[null,"Royal London Hospital"]
[null,"Whitechapel, London"]
["Postcode","E1 1FR"]
["Telephone","07977 530 178"]
["Email","charlesgutteridge@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Matched groups of equal size of patients at Bart’s Health NHS Trust that have either diabetes foot disease or diabetes that have not developed diabetes foot disease. Patients are over 18 years old and must have had at least one encounter with Bart’s Health NHS Trust since 2014 which produced free-text data. The applicants anticipate that approximately  5000 patients will be included. "]
["Description of confidential patient information used","Data sources\n1. Bart’s Health NHS Trust\n\nIdentifiers required for linkage purposes\n1. Hospital ID\n\nIdentifiers required for analysis purposes\n1. Date of death\n2. Gender\n3. Occupation\n4. Ethnicity\n5. Postcode \n\nAdditional information\nAll free text information from patient records would be temporarily processed for this research. Once retrieved the free text data will be run through natural language processing to turn it into structured data codes. Free text data will be deleted following this process."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-13"]
["Next Review Date","2024-10-13"]
["Notes","Specific conditions of support:\n\n1. The poster needs to be revised as follows and the revised poster submitted to the CAG within one month of the issuing of this letter: \n\n a. Email, phone and postal contacts for the study team need to be provided. \n\n b. Further details need to be provided on the confidential patient information that will be processed. \n\n c. The poster needs to explain that patients can dissent and contain an assurance that dissenting will not affect patients’ care. \n\nConditions met 23 November 2020\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 13 April 2020. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: Barts Health NHS Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02540","index":583,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02540"]
["Reference","20/CAG/0125"]
["Other Refs","IRAS Project ID: 229256  REC Reference: MREC 00/5/031"]
["Application Title","A population based study of genetic predispositions and gene-environment interactions in colorectal cancer - SEARCH Colorectal"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that aims to determine the contribution of cancer predisposing genes to cancer incidence, and their possible interaction with other known risk factors. The SEARCH study obtains epidemiological information and biological material on a population-based series of colorectal cancer cases, for the purpose of investigating the role of inherited genetic variation in cancer risk and clinical outcomes.\n\nThe SEARCH study began in 1996. Participants were identified by local cancer registry, the Eastern Cancer Registration and Information Centre (ECRIC). Participants were asked to provide a blood sample, from which the research team extracted DNA for genetic analyses, to complete a comprehensive questionnaire on their lifestyle and family history of cancer and gave consent for the research team to access their medical records and to retrieve pathology material. The applicants ceased recruiting new participants to the colorectal arm of SEARCH in March 2013, due to funding. The data already collected is still used for research and the applicants are seeking support to link this data to National Cancer Registration and Analysis Service (NCRAS) data held by Public Health England in order to update the data. NCRAS will also provide regular updates on vital status from routine death notification data. \n\nThe original consent form for the application contained a clause giving consent for access to patient medical records. Due to recent developments and in accordance with guidance from the Medical Research Council and the HRA on the preparation of participant information, the participant information sheets and consent forms for arms of SEARCH where new participants are still being recruited have been updated to fully explain the access to patient records and data linkages required, including specifying that patient’s electronic patient records would be accessed. The applicants have determined that it would be impracticable to recontact and consent the existing participants in the SEARCH colorectal study, and were therefore seeking support under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 to continue to send confidential patient information to Public Health England (PHE) Cancer Registry and receive updated sensitive clinical information from the Public Health England (PHE) Cancer Registry.  \n\nApplicants are additionally seeking support for the linkage of data from the cohort of SEARCH colorectal cancer recruits to National SARS-CoV2 testing data which is also held by PHE, to identify currently unknown predisposing factors affecting the response of cancer survivors to SARS-CoV-2, and which might influence long term morbidity and mortality. \n\nThe applicants are also seeking support to receive Electronic Health Record (EHR) data, which is also held by PHE. This was queried with the applicants to clarify the data flows. PHE are able to collect electronic health records from hospitals who have an automatic feed in to PHE. Any relevant EHR data is already included into the NCRAS data which applicants receive back from PHE, so support for EHR data is already included in the flow of NCRAS data from PHE back to the SEARCH study team. It was further clarified that this is the same arrangement for HES data, which applicants are receiving, but it is included in the NCRAS data from PHE and applicants do not receive this from NHS Digital. "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Public Health and Primary Care, Department of Oncology"]
[null,"Strangeways Research Laboratory"]
[null,"Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone","01223 761 926"]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","4,800 Cases of primary malignant colorectal cancers diagnosed between ages 18 - 69 years, who had already consented to take part in SEARCH colorectal."]
["Description of confidential patient information used","Data sources\n1. Public Health England:\n   • National Cancer Registration and Analysis Service (NCRAS) data \n   • National SARS-CoV2 testing data \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Cancer Registration identifier\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis purposes.\n\nAdditional information\nPotentially sensitive data items required by applicants for analysis include:\n\n•\tTumour site \n•\tTumour morphology, grade and receptor status \n•\tTumour size Number of positive nodes \n•\tStage Treatment data \n•\tVital status \n•\tCause of death \n•\tSARS-CoV-2 testing data, \n•\tElectronic Health Record (EHR) for   long term morbidity and mortality\n\nIn order to track participants’ health over the long-term and enable investigations into the determinants of health outcomes of cancer survivors in relation to the 2019 Covid19 pandemic multiple requests for morbidity data will be required:  Applicants estimate that requests for National SARS-COV testing data would be made quarterly and additional health outcomes data (through NCRAS) annually for a minimum of 5 years."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-20"]
["Next Review Date","2024-10-20"]
["Notes","Amendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n15\tDecember 2022 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), (including National SARS-CoV2 testing data (Hospital Episode Statistics (HES) and Electronic Health Record (EHR) as part of NCRAS)\n\nSpecific conditions of support\n\n1. Applicants are required to provide to the CAG Sub-Committee updated information to go on the website, which makes it clear what information is being linked, why, and how to raise objections, within one month from the date of this letter.\n\nConfirmed - 17 November 2020: \nApplicant has responded to condition of support in application regarding updated website text. CAG content with response.  \n\n2. Favourable opinion from a Research Ethics Committee \nConfirmed – 18 August 2020\n\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission \n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331)  was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02541","index":584,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02541"]
["Reference","20/CAG/0126"]
["Other Refs","IRAS Project ID: 229258  REC Reference: 05/MRE05/01"]
["Application Title","A Population-based Study of Genetic Predisposition to Cancer (SEARCH) (Oesophageal Cancer, Pancreatic Cancer, Brain tumours, Non-Hodgkins, Lymphoma, Melanoma, Kidney Cancer, Bladder cancer - SEARCH Multi"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that aims to determine the contribution of cancer predisposing genes to cancer incidence, and their possible interaction with other known risk factors. The SEARCH study obtains epidemiological information and biological material on a population-based series of multi cancer cases, for the purpose of investigating the role of inherited genetic variation in cancer risk and clinical outcomes.\n\nThe SEARCH study began in 1996. Participants were identified by local cancer registry, the Eastern Cancer Registration and Information Centre (ECRIC), or at participating hospitals in England or Wales which recruited patients via the Cancer Research Networks. The following cancer types were studied as part of the SEARCH Multi research: bladder, kidney, oesophagus, pancreas, brain, malignant melanoma and lymphoma. Participants were asked to provide a blood sample, from which the research team extracted DNA for genetic analyses, to complete a comprehensive questionnaire on their lifestyle and family history of cancer and gave consent for the research team to access their medical records and to retrieve pathology material. The applicants ceased recruiting new participants to the multi arm of SEARCH in March 2013, due to funding. The anonymised data already collected is still used for research and the applicants are seeking support to link this data to National Cancer Registration and Analysis Service (NCRAS) data held by Public Health England in order to update the data. NCRAS also provide regular updates on vital status from routine death notification data. \n\nThe original consent form for the application contained a clause giving consent for access to patient medical records. Due to recent developments and in accordance with guidance from the Medical Research Council and the HRA on the preparation of participant information, the participant information sheets and consent forms for arms of SEARCH where new participants are still being recruited have been updated to fully explain the access to patient records and data linkages required, including specifying that patient’s electronic patient records would be accessed. The applicants have determined that it would be impracticable to recontact and consent the existing participants in the SEARCH colorectal study, and were therefore seeking support under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 to continue to send confidential patient information to Public Health England (PHE) Cancer Registry and receive updated sensitive clinical information from the Public Health England (PHE) Cancer Registry.  \n\nApplicants are additionally seeking support for the linkage of data from the cohort of SEARCH colorectal cancer recruits to National SARS-CoV2 testing data which is also held by PHE, to identify currently unknown predisposing factors affecting the response of cancer survivors to SARS-CoV-2, and which might influence long term morbidity and mortality. \n\nThe applicants are also seeking support to receive Electronic Health Record (EHR) data, which is also held by PHE. This was queried with the applicants to clarify the data flows. PHE are able to collect electronic health records from hospitals who have an automatic feed in to PHE. Any relevant EHR data is already included into the NCRAS data which applicants receive back from PHE, so support for EHR data is already included in the flow of NCRAS data from PHE back to the SEARCH study team. It was further clarified that this is the same arrangement for HES data, which applicants are receiving, but it is included in the NCRAS data from PHE and applicants do not receive this from NHS Digital. "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Public Health and Primary Care, Department of Oncology"]
[null,"Strangeways Research Laboratory"]
[null,"Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone","01223 761 926"]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","3,800 Cases of primary malignant bladder, kidney, oesophagus, pancreas, brain cancers, malignant melanoma and lymphomas diagnosed between ages 18 - 69 years, who had already consented to take part in SEARCH Multi."]
["Description of confidential patient information used","Data sources\n1. Public Health England:\n   • National Cancer Registration and Analysis Service (NCRAS) data \n   • National SARS-CoV2 testing data \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Cancer Registration identifier\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis purposes.\n\nAdditional information\nPotentially sensitive data items required by applicants for analysis include:\n\n•\tTumour site \n•\tTumour morphology, grade and receptor status \n•\tTumour size Number of positive nodes \n•\tStage Treatment data \n•\tVital status \n•\tCause of death \n•\tSARS-CoV-2 testing data, \n•\tElectronic Health Record (EHR) for   long term morbidity and mortality\n\nIn order to track participants’ health over the long-term and enable investigations into the determinants of health outcomes of cancer survivors in relation to the 2019 Covid19 pandemic multiple requests for morbidity data will be required:  Applicants estimate that requests for National SARS-COV testing data would be made quarterly and additional health outcomes data (through NCRAS) annually for a minimum of 5 years."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-20"]
["Next Review Date","2024-10-20"]
["Notes","Amendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n15\tDecember 2022 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), (including National SARS-CoV2 testing data (Hospital Episode Statistics (HES) and Electronic Health Record (EHR) as part of NCRAS)\n\nSpecific conditions of support\n\n1. Applicants are required to provide to the CAG Sub-Committee updated information to go on the website, which makes it clear what information is being linked, why, and how to raise objections, within one month from the date of this letter.\n\nConfirmed - 17 November 2020: \nApplicant has responded to condition of support in application regarding updated website text. CAG content with response. \n\n2. Favourable opinion from a Research Ethics Committee \nConfirmed – 18 August 2020\n\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission. \n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331)  was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02542","index":585,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02542"]
["Reference","20/CAG/0133"]
["Other Refs","IRAS Project ID: 287792  REC Reference: 00/3/001"]
["Application Title","Yorkshire Specialist Register of Cancer in Children and Young People"]
["Application Summary","This application, from the University of Leeds, sets out the purpose of establishing a database for medical research purpose, which aims to undertake research on the area of cancer.\nCancer is a rare disease in children and young people and one that places a considerable burden not only upon the patients themselves but also on their families and the health care system. Little is known about the causes in this young age group. The Yorkshire Specialist Register of Cancer in Children and Young People is an established population-based register of tumours diagnosed in the childhood, adolescent and young adult age ranges. The Register currently contains information on 10,500 young people diagnosed with cancer while living within the former Yorkshire Regional Health Authority.\n\nThe primary aim of the Register is to investigate the causes of cancer through the application of epidemiological analyses. This includes monitoring time trends and investigating geographical patterns of disease across the region. Secondly, our aim is to investigate the delivery of care to young people with cancer in Yorkshire to ensure the best treatment is available and to minimise long-term health and social effects; for example by looking at pathways of care, factors that influence survival and minimise long-term complications.\n\nSupport is requested to enable sharing of confidential patient information between University of Leeds and Local NHS Trusts, EMIS, TPP, NHS Digital, Public Health England, Department of Education and Department of Work and Pensions in order to establish and maintain a research database. The database contains around 10,500 young people and linkages continue to be sought for these people. Linkages occur at monthly/quarterly intervals and each includes transfer of identifiers from the register to the organisation, with pseudonymised data returned (identified by study ID). For PHE, names are also returned to trace individuals’ records in medical record departments in order to fill in any missing clinical information. For Trusts, the register receives a regular feed from the electronic health record systems.\nIn addition, prospective patients continue to be included in the registry. New childhood cases are notified by the 2 Principal Treatment Centres in Yorkshire: Leeds Teaching Hospitals NHS Trust and Sheffield Children’s Hospital through nhs.net secure email and through NCRAS data from PHE for Teenage and Young Adult cases. Once these new cases are added, linkages with the above databases will continue.\n\nThe database is used for research purposes to which research teams can apply access to. Following approval by the advisory committee the researchers will be provided with an anonymised data extract. Note the protocol states that where the applicant requests identifiers (e.g. to contact the patient) this will require a separate application for support."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Richard Feltbower, Professor of Epidemiology"]
["Address","University of Leeds"]
[null,"Leeds Institute for Data Analytics"]
[null,"School of Medicine"]
["Postcode","LS2 9JT"]
["Telephone","01133 434 841"]
["Email","r.g.feltbower@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals between 0-29 diagnosed with a malignant (or benign central nervous system) tumour whilst resident in the area contiguous with the former Yorkshire and the Humber SHA region.\n\nRetrospectively data has been included in the registry since 1974. The data will also include prospective patients "]
["Description of confidential patient information used","Data sources\n1. Local NHS Trusts\n2. EMIS \n3. TPP \n4. NHS Digital (HES inpatient, outpatient, A&E and Mental Health datasets)\n5. Public Health England (National Cancer Registration Service, Radiotherapy Dataset, Chemotherapy treatment, Systemic Anti-Cancer therapy dataset).\n6. Department of Education \n7. Department of Work and Pensions\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of Birth\n3. Date of Death\n4. Postcode\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode\n4. Gender\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-10-22"]
["Next Review Date","2024-10-22"]
["Notes","Amendment supported 20 October 2023 to clarify that Patient Reported Outcome Measures (PROMs) as an additional data source, will also be collected from University of Leeds, and potentially from any other NHS Trust or University in the UK, and to extend the upper age range for inclusion of the first primary tumour from 29 years up to 39 years\n\nAmendment supported 12 May 2023 to include Patient Reported Outcome Measures (PROMs) as an additional data source, from Leeds Teaching Hospital NHS Trust (LTHT), and to change the research database hosting environment for YSRCCYP from University of Leeds-LASER, to AIMES, therefore include a new data processor for this application\n\n19 January 2023 - change in data processors from;\n•\tPublic Health England (PHE) to NHS England (previously NHS Digital), regarding data sources - National Cancer Registration and Analysis Service (NCRAS), Radiotherapy Dataset, Chemotherapy treatment, Systemic Anti-Cancer therapy dataset\n•\tNHS Digital, to NHS England regarding data sources – Hospital Episode Statistics (HES) (inpatient, outpatient, A&E) and Mental Health datasets\n\n\nAmendment supported 19 July to expand the inclusion criteria to include those with a benign tumour, and to clarify the age range should cover all those diagnosed under the age of 30 years from 1st January 1990\n\n16 June 2021 - Amendment supported\nSupport provided to obtain a bespoke download of data from the Leeds Teaching Hospitals Trust PPM platform, to conduct a data linkage to ChemoCare, an electronic chemotherapy prescribing system and to include data fields on Covid-19 diagnosis.\n\nSpecific conditions of support\n\n1. At the next annual review provide confirmation that the study website has been revised to make it easier for patients to access full information.\nCondition met 16 December 2021\n\n2. At the next annual review, provide an updated poster which details the mechanism for opting out of use of data.\nCondition met 16 December 2021\n\n3. At the next annual review, provide details on the make up of the Young Persons Advisory Group.\nCondition met 16 December 2021\n\n4. At the next annual review, provide confirmation that at least one lay person has been appointed to the Advisory Group that reviews requests for data. It is also suggested that there are formal links between the Young Persons Advisory Group and the Advisory Group that reviews requests for data.\nCondition met 16 December 2021\n\n5. At the next annual review, provide an update on the change of system architecture at the University of Leeds.\nCondition met 16 December 2021\n\n6. At the next annual review confirm that the opt out information provided to patients has been updated to clarify that opting out will not affect the care of the patient.\nCondition met 16 December 2021\n\n7. Support for this application has been provided for medical research purposes only. Where the data is to be used for non-research purposes in the management of health and social care a separate application for support should be submitted.\n\n8. Support is provided on the understanding that data provided to researchers is effectively anonymised. Where a researcher requests identifiable data, a separate, project specific application should be submitted for support.\n\n9. Favourable opinion from REC Received 15 May 2000 (updated through amendments since)\n\n10. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital DSPT submission for University of Leeds (18/19), NHS Digital (19/20), EMIS (19/20, and TPP (19/20) were confirmed as ‘Standards Met’ by NHS Digital (by check of DSPT tracker on 18 October 2020).\n\nThe NHS digital review for Department for Education (19/20) and Department for Work and Pensions (19/20) confirmed that equivalent standards have been met (by check of DSPT tracker on 18 October 2020).\n\nThe NHS Digital DSPT submission for Public Health England (18/19) was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked 18 October 2020). Please note the updated specific condition of support below.\n\nPublic Health England should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02543"]
["Reference","20/CAG/0104"]
["Other Refs","IRAS Project ID: 274147  REC Reference: 20/NW/0248"]
["Application Title","POST-BOX: Consensus-building a post-partum haemorrhage kit using citizen science (Workpackage 1)"]
["Application Summary","This application from the THIS Institute at the University of Cambridge set out the purpose of medical research that seeks to inform the design and use of post-partum haemorrhage (PPH) kits used in UK maternity units. \n\nPost-partum haemorrhage is a rare complication where a woman experiences heavy bleeding after the birth of their baby. PPH kits are kits used on maternity units which bring together the equipment needed to manage PPH effectively and rapidly. The content, form and packing of PPH kits varies widely across Trusts. The applicants intend to investigate how the design of PPH kits can be optimised in order to ensure that patients are offered the best care. \n\nThe applicants plan to visit 3-5 maternity units in England and Wales to observe practice and interview a sample of healthcare professionals who use or stock PPH kits, in order to develop understanding of current practice. Maidstone and Tunbridge Wells (MTW) NHS Trust has been identified as a participating trust. The applicants are in the process of recruiting the other sites and will submit amendments to include additional trusts as data processors. The applicants will also explore the practicalities of uploading photographs of PPH kits and their contents to the study platform to be used for following work packages, the Thiscovery platform. Patients will not be involved directly, but the applicants may be incidentally exposed to confidential patient information when carrying out the observations and interviews with staff, therefore support under s251 is sought. "]
["Applicant Organisation Name","THIS Institute, University of Cambridge"]
["Contact Name","Professor Mary Dixon-Woods"]
["Address","University of Cambridge"]
[null,"THIS Institute, Clifford Allbutt Building"]
[null,"Cambridge Biomedical Campus, Cambridge"]
["Postcode","CB2 0AH"]
["Telephone","01223 761 841"]
["Email","mary.dixon-woods@thisinstitute.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort involved are NHS staff working in clinical roles in maternity units or in a procurement function. No patients will be recruited into the study. "]
["Description of confidential patient information used","Data sources\nInterviews and observations carried out in participating Trusts. 3-5 trusts will be involved, but only one has been identified at this point:\n\n1. Maidstone and Tunbridge Wells (MTW) NHS Trust\n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be collected for linkage purposes\n\nIdentifiers required for analysis purposes\nNo items of confidential patient information will be collected for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-10-29"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, this research will look at how to optimise the design of PPH kits to ensure the best care to women experiencing a PPH. Work package 1 (which has been undertaken under Regulation 5 support) is the first stage of this research study. The public benefits derived from the research study (i.e. from optimised design of PPH kits to provide the best care to women experiencing this maternity emergency) are expected to arise when the whole study has been completed. \n\n\nConditions of support:\n\n1. The information sheet is to be revised to display the following statement more prominently, “There are researchers working in the maternity unit today. If you do not want to take part, please let a member of staff know. This will not affect your treatment.” \nCondition met as part of annual review, confirmed 24 January 2022\n\n2. Favourable opinion from a Research Ethics Committee Confirmed 18 June 2020. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n\n• Confirmed – University of Cambridge has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by check of the NHS Digital DSPT tracker on 09 September 2020.\n\n• Confirmed – Maidstone and Tunbridge Wells NHS Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2019/20 by email from NHS Digital DSPT tracker on 29 October 2020. "]

{"sheet":"A02544","index":587,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02544"]
["Reference","20/CAG/0120"]
["Other Refs","IRAS Project ID: 273665  REC Reference: 20/WM/0256"]
["Application Title","Incidence of Avoidant/Restrictive Food Intake Disorder (ARFID) in children and young people presenting to secondary care in the UK and Ireland"]
["Application Summary","This application from Imperial College London sets out the purpose of medical research that aims to determine the number of new cases of children and young people with Avoidance/Restrictive Food Intake Disorder (ARFID) and associated psychiatric symptoms in the UK and Republic of Ireland over one year. The study also aims to examine referral pathways, patterns of presentation, and clinical features of ARFID, including eating behaviours, medical complications and the types of medical or psychiatric presentations it is associated with. The applicants also plan to compare rates, presentation and management of ARFID with other countries, as well as generating new research questions on prognosis, long-term outcomes and treatment of ARFID.\n\nARFID is an umbrella term used to describe restrictive eating patterns which result in significant health problems, including weight loss, poor growth, nutritional deficits or poor emotional wellbeing. Unlike in anorexia nervosa, restrictive eating in ARFID is not associated with concerns about body image, weight or shape. To date very little is known about this disorder and its associated behaviours and outcomes in British and Irish children and adolescents.\nThe limited research data on ARFID means that it was excluded from the scope of the NICE (National Institute for Health and Care Excellence) guidelines on eating disorders (NG69) and therefore from commissioning guidance for children and young people with eating disorders (2015). The exclusion of ARFID from NICE guidelines has resulted in different referral pathways and availability of care depending on where in the UK patients live. The proposed research will help in improving the help that affected children and their families receive by ensuring standardised intervention, treatment paths and care.\n\nThis national active surveillance study will be established using the British Paediatric Surveillance Unit (BPSU) and Child and Adolescent Psychiatric Surveillance system (CAPSS) research methodology. Every children’s doctor in the UK, through the BPSU and CAPSS, will be asked whether they have seen a child that month with ARFID. The Imperial College ARFID research team will contact reporting clinicians to ask for service specific information, information about the case reported including clinical presentation, investigations and findings, impact of the disorder and management in the form of a questionnaire. A follow up questionnaire one year later will be conducted to understand the course of the disorder, impact and further management. The research will be taking place across England, Wales, Scotland, Northern Ireland and the Republic of Ireland, however support under the Regulations only covers England and Wales.\n\nThe research team will access questionnaire data through REDCap and store as a password protected Excel sheet. The research team will not have access to the full identifiable details (such as names, etc.) of the patients that clinicians report in the surveillance, instead, they will have access to partial identifiers such as date of birth, sex and ethnicity. Each record will have a separate unique code which the research team will assign to cases. The research team will separate the identifiable data and the clinical data and use the unique code to link the two. After the 12 month follow up questionnaire has been completed date of birth will be converted to age in months for analysis. Gender, ethnicity, and sector level postcode will be retained alongside age in months for analysis, and additionally for 10 years after the study has closed. These partial identifiers will therefore also be potentially shared with other countries outside the EEA. "]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Dr Dasha Nicholls, Reader in Child Psychiatry"]
["Address","Imperial College London"]
[null,"7th Floor, Commonwealth Building"]
[null,"Du Cane Road, London"]
["Postcode","W12 0NN"]
["Telephone","020 8383 4161"]
["Email","d.nicholls@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Estimated sample size: 180 \n\nReporting Instructions requested of all consultant paediatricians and child psychiatrists in the UK and Republic of Ireland on the BPSU and CAPSS mailing list:  Please report any child seen in the last month who meets the case definition in the UK or the Republic of Ireland.\n\nHowever support under the Regulations is given only for those patients seen in England and Wales.\n\nBPSU surveillance system: children and young people aged 5-15 years\nCAPSS surveillance system: children and young people aged 5-17 years\n\nAny child or adolescent aged 5 to 17 years with persistent restriction of quantity and/or range of food intake, associated with one or both of the following:\n•\tNutritional deficiency that requires additional clinical investigation or treatment (e.g. weight loss or poor growth, micronutrient deficiency, reliance on nutritional supplementation, anaemia) that is not fully accounted for by poverty or neglect, cultural practice or an existing medical condition or another mental disorder*\n•\tInterference with day-to-day functioning due to eating behaviour (e.g. unable to eat at school or with peers, needs to take preferred foods when out of home). \n\nNot explained by ANY of the following:\n•\tLack of available food (e.g. from poverty, famine or neglect)\n•\tCulturally sanctioned practice (e.g. endorsed religious and cultural practice)\n•\tOther known diagnosis\no\te.g. Allergy to specific food group (e.g. dairy)\no\tGastrointestinal disorder\no\tConstipation \no\tSwallowing difficulties\no\tOther eating disorder e.g. anorexia nervosa, bulimia nervosa\no\tOther medical or psychiatric disorder that fully explains food restriction (not requiring additional clinical attention) e.g. depression, anxiety, OCD, malignancy, diabetes mellitus, inflammatory bowel disease, thyroid disease\n \n*If eating disturbance occurs in the context of another condition/disorder, then in order to meet case definition for ARFID, the severity of eating disturbance should exceed that routinely associated with the particular condition/disorder - and warrant additional clinical attention.\n"]
["Description of confidential patient information used","Data sources:\n1. Reporting clinicians\n\nIdentifiers required for de-duplication and linkage with 1 year follow-up purposes:\n1. Sex\n2. Date of Birth\n3. Ethnicity\n4. Sector level postcode\n\nIdentifiers required for analysis purposes:\n1. Sex\n2. Ethnicity\n3. Sector level postcode \n\nAge – Date of Birth will be converted to age in months, after it has been used at 12 months for de-duplication. The full DOB is not required for analysis.\n\nAdditional information:\nReporting clinicians will not provide names and addresses to the study team."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-11-04"]
["Next Review Date","2024-11-04"]
["Notes","The application to allow the disclosure of confidential patient information from Clinicians in the UK to the ARFID research team at Imperial College London via the BPSU/CAPSS methodology to enable de-duplication and linking baseline and follow-up questionnaires, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nSpecific conditions of support\n\n1. Data sharing with other countries to pool estimates of the frequency of occurrence, is supported on the understanding that this is limited to anonymised data only.\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 7 October 2020\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed - The NHS Digital 2018/19 DSPT review for Imperial College London - School of Public Health Medical Trials and Research (EE133887-SPHTR) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 October 2020). The 2019/20 DSPT is currently under review by NHS Digital."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","A02545"]
["Reference","19/CAG/0188"]
["Other Refs","IRAS Project ID: 229257  REC Reference: 07/MRE05/17"]
["Application Title","A population based study of genetic predisposition and gene-environment interactions in prostate cancer in East Anglia, Trent and West Midlands: SEARCH Prostate"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that seeks to obtain epidemiological information and biological material on a population-based series of prostate cancer cases, for the purpose of Identifying novel cancer susceptibility genes\n\nThe SEARCH study began in 1996. Participants were identified by the local cancer registry, the Eastern Cancer Registration and Information Centre (ECRIC). Participants were asked to provide a blood sample, from which the research team extracted DNA for genetic analyses, to complete a comprehensive questionnaire on their lifestyle and family history of cancer and gave consent for the research team to access their medical records and to retrieve pathology material. The applicants ceased recruiting new participants to the prostate arm of SEARCH in March 2013, due to funding. The anonymised data already collected is still used for research. The applicants are now seeking support to link this data to National Cancer Registration and Analysis Service (NCRAS) data held by Public Health England in order to update the data. NCRAS also provided regular updates on vital status from routine death notification data. \n\nThe original consent form for the application contained a clause giving consent for this access. Due to recent developments, and in accordance with guidance from the Medical Research Council and the HRA on the preparation of participant information, the participant information sheets and consent forms for arms of SEARCH where new participants are still being recruited had been updated to fully explain the access to patient records and data linkages required, including specifying that patient’s electronic patient records would be accessed. The applicants had determined that it would be impracticable to recontact and consent the existing participants in the SEARCH prostate study, and were therefore seeking support under Section 251 to continue to receive confidential patient information from the Public Health England (PHE) Cancer Registry.  "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Public Health and Primary Care, Department of Oncology"]
[null,"Strangeways Research Laboratory"]
[null,"Worts Causeway, Cambridge"]
["Postcode","CB1 8RN"]
["Telephone","012 2376 1926"]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","4,700 patients diagnosed with prostate cancer, who had already consented to take part in SEARCH prostate. "]
["Description of confidential patient information used","Data sources:\n1. National Cancer Registration and Analysis Service, held by NHS Digital\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS Number\n3. Date of birth\n4. Cancer Registration identifier\n\nIdentifiers required for analysis purposes \nNo identifiers will be retained for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-11-05"]
["Next Review Date","2024-11-05"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), (including National SARS-CoV2 testing data (Hospital Episode Statistics (HES) and Electronic Health Record (EHR) as part of NCRAS)\n\nAmendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\n09 November 2020 - Amendment conditionally supported to allow:\n• The disclosure of confidential patient information from the study team at University of Cambridge to Public Health England (PHE), for additional linkage of the prostate SEARCH database to National SARS-CoV2 testing data, \n\n• and additionally to allow the data flow back to the study team at University of Cambridge from PHE (as although pseudonymised with the cancer registration number, there are sensitive data items including Covid-19 status and date of death, and the research team at University of Cambridge will be able to re-identify these patients).\n\nSpecific conditions of support:\n1. Applicants are required to provide to the CAG Sub-committee updated information to go on the website, which makes it clear what information is being linked, why, and how to raise objections, within one month from the date of this letter.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support.\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. \nConfirmed 18 August 2020\n\n\nThe application to allow the disclosure of confidential patient information from the study team at the University of Cambridge to Public Health England, for linkage to the National Cancer Registration and Analysis Service database is conditionally supported,\n\nSpecific conditions of support:\n\n1. Further patient and public involvement is to be carried out with feedback to be provided at the time of first annual review. This activity should explore different methods of notifying patients that the study is being undertaken and ways of facilitating study specific dissent. \nCondition met as part of annual review, confirmed 10 February 2022\n\nConfirmed - 17 November 2020: \nApplicant has responded to condition of support in application regarding updated website text. CAG content with response. \n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 18 August 2020\n\n3. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission \n\nConfirmed:-\nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331)  was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02546"]
["Reference","19/CAG/0171"]
["Other Refs","IRAS Project ID: 228340  REC Reference: 02/5/042"]
["Application Title","A population based study of genetic predisposition and gene-environment interactions in breast cancer: SEARCH breast"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research which seeks to determine the role of inherited genetic variation in cancer risk and clinical outcomes.\n\nThe SEARCH study has been running since 1996 and was set up to investigate how normal, common genetic variation affects cancer risk. Support under Section 251 has not been required previously, however the study team are now seeking to change the recruitment process. In this application, support is being sought for the National Cancer Registration and Analysis Service (NCRAS) to identify patients suitable for the study. NCRAS disclosed the patient list to NHS Digital, who then removed patients who were deceased, had moved away from the UK or who had registered a dissent. The revised list was then disclosed to the NHS Digital Personal Demographics Service (PDS), who attached patients’ addresses and the name and address of patients’ GP. This list was then sent to the SEARCH study co-ordinator to facilitate the invitation process. \n\nThe SEARCH study co-ordinator then contacted the GPs of eligible patients, asking them to invite patients to take in the study. The GPs were then provided with the study information leaflet, a letter of introduction from the study team and a reply slip for the patients to return to the SEARCH team if they wished to take part. Patients participation in the project then proceeded on a consented basis. Patients were not approached if the G.P. indicated that the patient was under the age of 18 or unfit to participate for any reason. "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Valerie Rhenius, Research Assistant"]
["Address","Department of Public Health and Primary Care, Department of Oncology"]
[null,"University of Cambridge, Strangeways Research Laboratory, Worts Causeway"]
[null,"Cambridge"]
["Postcode","CB1 8RN"]
["Telephone","01223 761 926"]
["Email","vr264@medschl.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged between 18 and 70 years. It is anticipated that 40,400 patients will be recruited to the SEARCH Breast study. "]
["Description of confidential patient information used","Data sources\n1. The National Cancer Registration and Analysis Service held by Public Health England (PHE)\n2. Patient Demographics Service - NHS Digital \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. GP registration\n4. Date of birth\n5. Date of death\n6. Postcode\n7. GP name and address\n\nIdentifiers required for analysis purposes\nNo identifiers are retained for analysis purposes.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-11-11"]
["Next Review Date","2024-11-11"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer Registration and Analysis Service (NCRAS), and a change in data processor from NHS Digital to NHS England regarding demographics information\n\nAmendment supported 12 January 2023 \nTo change the Chief Investigator from Professor Paul Pharoah, to Professor Antonis Antoniou \n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. (Confirmed 28 January 2019).\n\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission \n\nConfirmed: \nThe 2018/19 NHS Digital DSPT review for - University of Cambridge (School of Clinical Medicine) (8F331)  was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020). (DSPT 2019/20 published but not yet reviewed).\n\nThe 2019/20 DSPT equivalent for NHS Digital was confirmed as standards met on the NHS Digital DSPT Tracker (checked 12 October 2020).\n\nThe NHS Digital 2018/19 DSPT review for National Cancer Registration and Analytical Services (Public Health England) (X25) was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking data security awareness training’ on the NHS Digital DSPT Tracker (checked 12 October 2020). Please note the updated specific condition of support below. (DSPT 2019/20 not yet published)\n\nAll staff at National Cancer Registration and Analytical Services (Public Health England) (X25)  that are involved in processing information under this application reference should have successfully completed local data security awareness training before processing any information under support."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02547"]
["Reference","18/CAG/0188"]
["Other Refs","IRAS Project ID: 245127  REC Reference: 20/WS/0162"]
["Application Title","Road Traffic Injury – Analytics for Integrated Data (RTI-AID)"]
["Application Summary","This application from Imperial College London set out the purpose of medical research which aimed to investigate the patterns of physical trauma caused amongst individuals suffering road traffic accidents in order to identify risk factors for injury severity. The project will use Greater London as a representative population of the UK. The project will link datasets from the London police, transport and health systems in order to create a database which follows individuals involved in road traffic accidents from the point of impact to indefinite care in order to facilitate analysis of patterns of risk and injury behaviour. \n\nThe study will link information from the following sources:\n• STATS19 accident data – police accident reporting form (out of scope for CAG),\n• Trauma Audit Research Network (TARN) – which operates with support under the Regulations under reference ECC 7-05(g)/2011,\n• London Ambulance Service (LAS) – no confidential patient information (out of scope for CAG)\n• Hospital Episode Statistics (HES).\n\nTo limit access to confidential patient information, data will be disclosed from TARN direct to NHS Digital, which will act as trusted party for the project, facilitating linkage with the HES dataset, prior to disclosing a pseudonymised dataset to the applicants at Imperial College London to be utilised for analysis. This is with the exception of data items from LAS, who will send to NHS Digital via Imperial College London, as the dataset does not contain any confidential patient information, and STATS19 accident data which will also be sent to NHS Digital via Imperial College London.\n\nThe project will also link the data from these established data sources with novel datasets including Transport for London Public API, Waze traffic app, news feeds, Twitter posts. This supplementary information is available within the public domain and is out of scope for CAG consideration. "]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Ara Darzi"]
["Address","Academic Surgical Unit"]
[null,"10th Floor, QEQM Building"]
[null,"St Mary's Hospital, Praed Street"]
["Postcode","W2 1NY"]
["Telephone","02033 121 310"]
["Email","a.darzi@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals who were involved in a road traffic collision and road traffic collision in the Greater London area between 2013 and 2017 featured in the datasets prescribed (STATS 19, LAS, HES, TARN). It is estimated that there will be 5,000 patients within the cohort. "]
["Description of confidential patient information used","The following items of confidential patient information have been requested for the purposes as specified below:\n\n• Name – sample validation and linkage,\n• NHS Number – sample validation and linkage,\n• Hospital ID No – sample validation and linkage,\n• Date of birth – sample validation and linkage,\n• Date of death – sample validation, linkage and analysis,\n• Postcode – sample validation and linkage, \n• Sex – analysis,\n• Ethnicity – linkage and analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-11-13"]
["Next Review Date","2021-11-13"]
["Notes","The application to allow the disclosure of confidential patient information from the Trauma Audit Research Network (TARN – at the University of Manchester) to NHS Digital to facilitate linkage with Hospital Episode Statistics (HES) data, is conditionally supported,\n\n(STATS19 information will also be disclosed by the Police/Department for Transport to NHS Digital for linkage with the wider health information; however, this data source is out of scope for support, and London Ambulance Service (LAS) information will be disclosed via Imperial College London to NHS Digital, however this data contains no confidential patient information and does not require support) \n\nSpecific conditions of support\n\n1. Ways to widen the dissemination of the research findings should be explored to ensure the benefits of the project are maximised and the appropriate agencies are aware of the outcomes. Feedback should be provided at the time of annual review of progress made with the dissemination plan. \n\n2. Favourable opinion from REC: Confirmed 11 November 2020\n\n3. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \nConfirmed -  NHS Digital 2019/20 DSPT equivalent to ‘standards met’ (by check of DSPT tracker 2 November 2020) "]

{"sheet":"A02548","index":591,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02548"]
["Reference","20/CAG/0148 (previously 18/CAG/0007)"]
["Other Refs","IRAS Project ID: 214219  REC Reference: 17/EM/0209"]
["Application Title","Evaluating alternative protocols for identifying and managing patients with familial hypercholesterolaemia: cost-effectiveness analysis with qualitative study"]
["Application Summary","This application from the University of Nottingham and University of York sets out the purpose of medical research with a focus on Familial Hypercholesterolaemia, which is the most common autosomal dominant disorder with at least 1 in 500 individuals (0.2%) affected by the more common heterozygote form. This is a multi-centre mixed methods study which includes database analysis, cost-effectiveness analysis, and qualitative interviews. The setting is UK Primary (general practice) and Secondary Care.\n\nThe study involves the extraction of routine secondary care NHS data and data from other databases of FH patients to inform the development of economic models for alternative protocols of FH identification and management. The study will compare current practice for cascade testing using differing criteria/thresholds, methods of testing [genetic, low density lipoprotein (LDL)], direct or indirect contacting of relatives, how far to test family (1st, 2nd, 3rd degree relatives etc.) and how this could be extended beyond specific health regions.\n\nThe applicants are seeking support to allow confidential patient information to be released from the Simon-Broome Registry, held by University College London, to NHS Digital to facilitate linkage with HES data. The following information will be provided back to the applicants on a pseudonymised, patient-level dataset: HES admitted patient-care, HES A&E and HES outpatient information. The applicants will supplement this pseudonymised dataset with anonymised data extracts from the Clinical Practice Research Datalink (CPRD) and the National Institute of Cardiovascular Outcomes Research (NICOR), which are out of scope for consideration of the CAG. \n\nThere is separate qualitative study which will involve interviewing patients; however, this is operated on a consented basis and is out of scope of the application for CAG consideration."]
["Applicant Organisation Name","University of Nottingham & University of York"]
["Contact Name","Professor Nadeem Qureshi"]
["Address","The University of Nottingham"]
[null,"Research and Graduate Services"]
[null,"King's Meadow Campus"]
["Postcode","NG7 2NR"]
["Telephone","01158 466 917"]
["Email","nadeem.qureshi@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients, aged 18 years and over, who are listed on the Simon-Broome Registry. The sample size for this Simon Broome Registry-HES linkage will be the 3382 participants with the clinical diagnosis of FH (1650 men, 1732 women)."]
["Description of confidential patient information used","The following items of confidential patient information will be released by UCL to NHS Digital and processed for the purposes detailed below:\n\n• Name – linkage,  \n• NHS Number – linkage,  \n• GP Registration – linkage,  \n• Date of birth – linkage and converted to age for analysis,  \n• Postcode (District Level) – linkage,  \n• Gender – analysis, \n• Ethnicity – analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2018-01-26"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as the activity was never able to commence.\n\n08 February 2021 - Amendment supported\nThe amendment, to extend the duration of support until 30 June 2021, is supported, subject to compliance with the standard conditions of support.\n\n18 November 2020 - New application reference established\nThis replaces 18/CAG/0007 following change in controllership from solely University of Nottingham to joint controllership between University of Nottingham and University of York\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 13 November 2020 \n\n2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. \n\nConfirmed:\n2019/20 DSPT NHS Digital have achieved the equivalent to ‘standards met’ \n2018/19 DSPT UCL School of Life and Medical Sciences (EE133902-SLMS) achieved ‘standards met’ (by check of DSPT tracker 28 October 2020)."]

{"sheet":"A02549","index":592,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02549"]
["Reference","20/CAG/0123"]
["Other Refs","IRAS Project ID: 234587  REC Reference: 20/WA/0312"]
["Application Title","REadmission And Cardiovascular ouTcomes following Acute Myocardial Infarction in England and Wales (REACT-AMI)"]
["Application Summary","This application from Keele University Clinical Trials Unit sets out the purpose of medical research that aims to determine the type, incidence, prevalence, secular trends and prognostic impact of post-discharge complications and unplanned readmission on long term clinical outcomes in patients admitted with a heart attack. Applicants also hope to develop risk scores to predict future events and risk stratify patients presenting with heart attacks, which would allow clinicians managing these patients to tailor treatment according to the patient baseline risk and risk of future events.   \n\nAcute myocardial infarction (heart attack) remains a leading cardiovascular cause of morbidity and mortality worldwide and is the commonest manifestation of coronary heart disease. It is estimated that almost half of the cardiovascular disease-related deaths are due to heart attacks in the UK. The acute survival of patients following a heart attack has improved significantly over the past decade. However, the UKs ageing population is resulting in an increasingly multimorbid population at greater risk of complications, readmissions and mortality. There is limited information around the incidence and type of post discharge complications of heart attacks, readmission and their association with long term outcomes. \n\nThe team plans to use data from a large observational cohort of all recorded heart attack cases in England and Wales, initially from 1st January 2005 to 31st March 2020; The Myocardial Ischaemia National Audit Project (MINAP) dataset. MINAP is a dataset within the national cardiac audit programme (NCAP) which contains information about the care provided to patients who are admitted to hospital with acute coronary syndromes (heart attack). This dataset is held at The National Institute for Cardiovascular Outcomes Research (NICOR) which is hosted at Barts Health NHS Trust. The legal basis for the NCAP datasets is support under Regulation 5, CAG ref: ECC 1-06(d)/2011 which was replaced by 17/CAG/0071.\nApplicants plan to link the MINAP dataset with Hospital Episode Statistics (HES) data and Office of National Statistics (ONS) mortality data which are held by NHS Digital. They outline the process, of NICOR disclosing identifiers of patients in the MINAP dataset to NHS Digital for the purposes of linkage with HES and ONS data. This dataset is then sent back from NHS Digital to NICOR, for the purposes of linking the HES and ONS data to the MINAP clinical dataset. The dataset will be pseudonymised before being sent to researchers at The University of Keele Clinical Trials Unit, however it can be considered anonymous to the research team as they will not have access to any re-identification key. Analysis will be performed by Keele Cardiovascular Research Group. \n\nThis study is planned for four years from the date of data access from NICOR. During this time, annual updates of newly recorded patients will be requested from NICOR. The applicant expects that this will be approximately 90,000 patients per year, and will include any new patients recorded in the MINAP dataset."]
["Applicant Organisation Name","Keele University Clinical Trials Unit"]
["Contact Name","Professor Mamas Mamas, Professor in Cardiology"]
["Address","Arthritis Research UK Primary Care Centre"]
[null,"Primary Care & Health Sciences"]
[null,"Keele University"]
["Postcode","ST5 5BG"]
["Telephone","01782 671 621"]
["Email","m.mamas@keele.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximate Total UK sample size: 700,000 initially, with an additional 90,000 per yearly update (4 yearly updates in total)\n\nPatients admitted with a diagnosis of a heart attack from 1st January 2005 to 31st March 2020, presenting to one of the 235 acute NHS hospitals in England or Wales. \nLower age limit:  18 Years \nUpper age limit: 105 Years\n\n(This is all patients in the Myocardial Ischaemia National Audit Project (MINAP) dataset)."]
["Description of confidential patient information used","Data sources\n1. Myocardial Ischaemia National Audit Project (MINAP) dataset held at The National Institute for Cardiovascular Outcomes Research (NICOR), hosted by Barts health NHS Trust.\n2. Hospital Episode Statistics (HES) & \nOffice of National Statistics (ONS) Civil Registration and Death Register held at NHS Digital\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Hospital ID\n3. Date of Birth\n4. Postcode\n5. Gender \n6. Date and time of admission\n\nIdentifiers required for analysis purposes\n1. Date of death (not sent to applicant as full date of death, it is modified by NICOR to ‘survival time to censored time’ in number of days)\n2. Postcode (not sent to applicant but modified to deprivation score by NICOR)\n3. Gender\n4. Ethnicity\n\nAdditional information\nThis study is planned for four years from the data of data access from NICOR. During this time, annual updates will be requested from NICOR. These annual updates will be requesting the same data for all additional patients added into MINAP each year."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-11-27"]
["Next Review Date","2024-11-27"]
["Notes","29 January 2024 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil Registration – deaths\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, Myocardial Ischaemia National Audit Project (MINAP) cardiac audit.\n\n\n29 January 2024 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil Registration – deaths\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, Myocardial Ischaemia National Audit Project (MINAP) cardiac audit.\n\n\nThe application to allow the disclosure of confidential patient information from;\n• Barts health NHS Trust (on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR) to NHS Digital for the purposes of linkage with HES and ONS data, \n• NHS Digital back to Barts health NHS Trust (on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR) for the purposes of linkage with the MINAP clinical dataset\n\nConditions of support:\n\n1. Support is given on the understanding that full date of death is not received by researchers at Keele University.\n\n2. Further Patient and Public Involvement (PPI) is required to be undertaken to explore the views of patients regarding the use of confidential patient information to perform the proposed linkages without prior consent. Please provide evidence of the outcomes of the Patient and Public Involvement (PPI), at annual review.\nCAG confirmed condition met 16 February 2022\n\n3. Favourable opinion from REC \nConfirmed 25 November 2020\n\n4. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \n\nConfirmed:\nThe NHS Digital 2019/20 DSPT equivalent review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (17 November 2020)\n\nThe NHS Digital 2018/19 DSPT review for Barts health NHS Trust (On behalf of NICOR) was confirmed as ‘Standards Not Fully Met (Plan Agreed)’ on the NHS Digital DSPT Tracker (checked 17 November 2020). Please note the updated specific condition of support below. The 2019/20 DSPT was published but not yet reviewed.\n\nBarts health NHS Trust (On behalf of NICOR) should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02550","index":593,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02550"]
["Reference","20/CAG/0106"]
["Other Refs","IRAS Project ID: 283418  REC Reference: 20/HRA/3828"]
["Application Title","The SUFFICE CoV-Study"]
["Application Summary","This application from the Oxford University Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to develop understanding and identify the clinical success factors contributing to Covid-19 negative and positive patients being detected as deteriorating and rescued within the clinical ward area. \n\nUp to 40,000 hospital patients yearly suffer a preventable death due to staff failing to recognise patient illness or delays in medical review, leading to a delay in the escalation of care. This problem has been identified in NHS care reviews and current research is focused on the reasons why escalation of care does not always happen. Further reduction in patient death may be possible by examining the care of unwell hospital patients who are successful managed and identifying success factors in the escalation of care. The applicants noted that the Covid-19 pandemic presented an opportunity to examine care escalation in two distinct patient groups, those who are Covid-19 positive and those who are Covid-19 negative, as the NHS has had to modify care delivery models meaning that success factors may now be evident. \n\nThe application is formed of 4 Stages:\n\nStage 1 – Staff observations during escalation events. 200-400 care escalation events will be observed, detailing staff interactions for Covid-19 positive and negative patients. \n\nStage 2 – Care record reviews. 200-400 records of Covid-19 positive and negative patients who deteriorated, improved and were not admitted to ICU.\n\nStage 3 – Staff interviews. The applicant will interview 30 doctors and nurses to identify escalation success factors, how these could be applied effectively and the impact of pandemic care models.\n\nStage 4 – Data integration phase. The study will use a 'coding buddy' who will ensure confirmability in qualitative data findings. The advice of a qualified statistician will be sought for the quantitative data analysis.\n\nThe applicants are seeking support for Stage 2 of the study, to extract and anonymise data from patients who are unable to consent or for whom an approach to seek consent is impracticable. Records for 200 – 350 patients who deteriorated to the point where an intensive care review was triggered but did not require admission to ICU. Up to 50 notes will be reviewed for patients who became unwell while on the ward, were admitted to ICU and then died. The purpose of the notes review is to develop understanding of the care of patients with Covid-19, such as the recognition and presentation of their deterioration, how current care processes support or hinder their deterioration events, their illness patterns, care delivered and management. "]
["Applicant Organisation Name","Oxford University Hospitals NHS Foundation Trust"]
["Contact Name","Mrs Jody Ede"]
["Address","Oxford University Hospitals NHS Foundation Trust"]
[null,"Adult Intensive Care Unit, Level 3"]
[null,"John Radcliffe Hospital"]
["Postcode","OX3 9DU"]
["Telephone","01865 857 625"]
["Email","jody.ede@ouh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over, both Covid-19 positive and negative. \n\n830 patients in total will be included, however the records of up to 400 patients will be examined for Stage 2, for which support is sought. \n\n2 - 400 escalation events will also be observed."]
["Description of confidential patient information used","Data sources\n1. Hospital electronic and paper patient records, held at Oxford University Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Hospital ID number\n4. Date of birth\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Ward location and movement throughout the admission episode if relevant to escalation of care episode\n4. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-11-17"]
["Next Review Date"]
["Notes","Applicant confirmed in March 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the applicant has developed a framework of escalation success factors from this work which will underpin process improvements and refinements which will ultimately improve patient care and outcomes.  \n\n\n13 April 2021 - Amendment supported:\nAmendment supported to include the Royal Berkshire Hospital NHS Trust as a secondary research trust and to extend the inclusion criteria to those with an Early Warning Score of 3 or above.\n\nSpecific conditions of support:\n\n1. Further patient and public involvement will need to be conducted around the acceptability of the use of confidential patient information in relation to this specific COVID-related research and feedback provided at the first annual review. \n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 12 October 2020. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n(Confirmed – Oxford University Hospital NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by  NHS Digital email dated 17 September 2019). "]

{"sheet":"A02551","index":594,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02551"]
["Reference","20/CAG/0080"]
["Other Refs","IRAS Project ID: 275557  REC Reference: 20/NS/0119"]
["Application Title","Investigating whether elevated C-reactive protein is associated with probable depression in paediatric Chronic Fatigue"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research which aims to evaluate whether raised C-reactive protein (CRP) is associated with probable depression, as measured on the Revised Childhood Anxiety and Depression Scale.\n\nPaediatric chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is relatively common (prevalence 0.1–2%), with significant morbidity for children and their families. Co-morbid mental health disorders are common in children and young people with CFS/ME. Up to approximately 30% of children diagnosed with CFS/ME have co-morbid depression. In these children, depression is not thought to be the primary cause of the fatigue or disability. Whilst we assume the depression is secondary to the disability, loss of function and subsequent loss of social life/school and friendships, it is possible that the depression describes a phenotype of CFS/ME. Several pro-inflammatory markers have been associated with depression, most notably CRP. Adult population-based studies have demonstrated an association between elevated CRP and both increased risk of depression and increased severity of depression. This study aims to understand more about the association of high CRP and probable depression; it thereby addresses an unmet need by attempting to better understand, diagnose and treat co-morbid depression in children and adolescents with CFS/ME. Establishing whether neuroinflammation could contribute to the manifestation of depression in young people with CFS/ME may help us to both phenotype the different forms of CFS/ME and also give insights into the aetiology of depression in this population.\n\nThe research team have previously undertaken two studies (FITNET-NHS and DDS/Wellbeing) in a cohort of children with CFS/ME. The Wellbeing study was completed about a year ago, whilst FITNET-NHS is still ongoing. Whilst a consented activity, the research team now wish to link the data from these studies with CRP data, held by Royal United Hospital Bath NHS Trust. The research team have discussed this with their sponsor (and data controller for the data), who believe that the original consent take was not adequate (specific enough) to provide a legal basis for the proposed activities in this retrospective part of the present study.\n\nFrom the original study datasets, the applicants will create two new databases (one for each previous study) which will hold name, date of birth, respective study identifier (Participant Id/Research Id) and this study's Participant Code. Each will then be populated with questionnaire data from the original study and then pseudonymised (removing names, dates of birth and study identifiers leaving just the clinical data and the participant codes in each database). These two pseudonymised databases will then be merged into one pseudonymised dataset (minus the questionnaire data) that is then transferred to Royal United Hospital Bath NHS Trust. The Trust is then able to reidentify participants from the study keys that they already hold and populate the database with the CRP data. The returned pseudonymised CRP data is then merged with the questionnaire data to create the final dataset for the study for analysis."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Esther M Crawley"]
["Address","University of Bristol"]
[null,"Centre of Academic Child Health"]
[null,"1-5 Whiteladies Road, Bristol"]
["Postcode","BS8 1NU"]
["Telephone","01174 283 073"]
["Email","esther.crawley@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Participants in the Wellbeing study who have completed RCADS questionnaires (approximately 90).\n\nParticipants in the FITNET-NHS study that have CRP blood results available in the Royal United Hospital Bath NHS Trust medical records at the RUH site and will be included in the current study (approximately 170)."]
["Description of confidential patient information used","Data sources\n1. University of Bristol\n2. Royal United Hospital Bath NHS Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. Date of Birth\n3. Study ID\n\nIdentifiers required for analysis purposes\nNone"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-11-20"]
["Next Review Date","2024-11-20"]
["Notes","Specific conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 22 October 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: Royal United Hospital Bath NHS Trust and the University of Bristol have confirmed ‘Standards Met’ grade on DSPT 2019/20 (by check of the NHS Digital DSPT tracker on 20 November 2020). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02552","index":595,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02552"]
["Reference","20/CAG/0099"]
["Other Refs","IRAS Project ID: 255525  REC Reference: 20/LO/1045"]
["Application Title","Promoting vision-related quality of life (QoL): first stage development of a model for intervention from the evidence of what matters most to visually impaired children and their families"]
["Application Summary","This application from the University College London Great Ormond Street Institute of Child Health set out the purpose of medical research that seeks to identify the key ‘risk’ and ‘protective’ factors associated with self-perceived quality of life, identify the time points when specific factors exert the greatest influence and propose which factors can be used in an intervention model to improve quality of life for children and young people with visual impairment and their families. \n\nThe applicants aim to inform intervention development by identifying risk and protective factors that promote better quality of life by investigating the views and experiences of children and young people with visual impairment and their families, as well as their personal and environmental characteristics. The applicants have developed a suite of validated age-appropriate patient-reported outcome measures (PROMs), which will be used to enable children to self-report their views on the impact of their visual impairment on their everyday lives and the health care they receive. These PROMs will be used in a large-scale survey of children and young people with visual impairment and their parents, in combination with other questionnaires measuring the family environment, levels of support, social-emotional well-being, personal and psychological factors, health and clinical and socio-economic characteristics of the child. In-depth qualitative interviews will also be undertaken with a subset of these participants. \n\nThe applicants seek support to allow a research assistant, who is not part of the clinical care team, to access confidential patient records at Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust in order to identify eligible patients. Patients will then be contacted about the study and to seek consent to participate. The applicants also noted that, should it become necessary, patients may also be identified from Moorfields Eye Hospital. An amendment to the CAG will be submitted should this be necessary. "]
["Applicant Organisation Name","University College London Great Ormond Street Institute of Child Health"]
["Contact Name","Professor Jugnoo S Rahi"]
["Address","UCL Great Ormond Street Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone","02079 052 250"]
["Email","j.rahi@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 8 and 18 years of age who attend Paediatric Ophthalmology services at Great Ormond Street Hospital (GOSH) who are sight impaired/severely sight impaired (defined as corrected visual acuity LogMAR > 0.50 ) due to any disorder and are able to assent (aged 8-15 years) or consent (aged 16-18 years), but are without significant motor, intellectual, learning/cognitive and other sensory impairments. \n\nAlso the parents or primary carers of children or young people with visual impairment selected as eligible and able to\nconsent to take part will also be invited to participate.\n\n150 family units will be recruited."]
["Description of confidential patient information used","Data sources\n1. Patient records held at Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. GP Registration\n5. Date of birth\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Postcode – unit level\n3. Ethnicity\n4. Visual acuity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-11-23"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the study has provided the necessary evidence to inform the development of multimodal intervention that may be tested in future research. \n\nParticipants also reported that they highly valued the opportunity to discuss their experiences of living with visual impairment and felt that insights from their participation would enable clinicians and other health professionals involved in their care to enhance the services they deliver. On multiple occasions parents/carers (especially of young children) mentioned the study helped them to have an open conversation with their child about the impact visual impairment has on their life.\n\n\n04 October 2021 - amendment supported  to increase the sample size to 200 family units, and to add Moorfields eye hospital as a data processor, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 20 November 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold \n(Confirmed – Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by check of the NHS Digital DSPT Tracker on 09 September 2020). "]

{"sheet":"A02553","index":596,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02553"]
["Reference","20/CAG/0095"]
["Other Refs","IRAS Project ID: 283163  REC Reference: 20/YH/0242"]
["Application Title","Gender-specific outcomes post transcatheter aortic valve implantation"]
["Application Summary","This application from Imperial College Healthcare NHS Trust set out the purpose of medical research that seeks to compare the mid-long-term survival of men versus women in patients with aortic stenosis treated with current versus older transcatheter aortic valve implantation (TAVI) technologies.\n\nSevere AS is the commonest form of valvular abnormality in the developed world and accounts for more than 40% of patients with native valvular disease with an approximately equal prevalence in men and women. TAVI is now widely practiced with treatment of over 300,000 patients worldwide. Many centres now regularly implant devices in patients for whom conventional aortic valve replacement (AVR) is deemed high or intermediate risk. Several studies have shown that women have an apparent better outcome with TAVI than men. There are many potential reasons why there may be an apparent favourable benefit of TAVI in women. Newer devices had reduced the introducer French size and have been associated with reduced rates of vascular and bleeding complications. This may lead to a higher survival benefit in women. \n\nThe applicants will investigate gender temporal survival trends and complications, such as stroke and heart attack, in patients with AS treated with current transcatheter valves versus older generation transcatheter valves. The applicants have already successfully obtained the required periprocedural data from the National Institute for Cardiovascular Outcomes Research (NICOR), which is pseudonymised. In this application, the applicants are seeking support for the disclosure of confidential patient information from NICOR to NHS Digital for linkage to ONS mortality data before returning the data to NICOR. NICOR will then link this information to the applicants’ NICOR data and will then return a pseudonymised dataset to the applicants."]
["Applicant Organisation Name","Imperial College Healthcare NHS Trust"]
["Contact Name","Dr Ghada Mikhail, Consultant Cardiologist"]
["Address","Imperial College Healthcare NHS Trust"]
[null,"Hammersmith Hospital"]
[null,"Du Cane Road"]
["Postcode","W12 0HS"]
["Telephone","020 3313 1000"]
["Email","g.mikhail@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","14086 patients who underwent transfemoral TAVI for the\ntreatment of severe aortic stenosis in the UK (between 2007 and 2017) will be included."]
["Description of confidential patient information used","Data sources\n1. NICOR national dataset\n2. ONS mortality data held by NHS Digital \n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Name\n3. Date of birth\n4. Post code\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Gender\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-12-03"]
["Next Review Date","2024-12-02"]
["Notes","09 October 2023 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data source Civil registration – deaths.\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits, including Transcatheter Aortic Valve Implementation (TAVI).\n\n\nSpecific conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\n(Confirmed: Imperial College Healthcare NHS Trust, Barts Health NHS Trust and NHS Digital have confirmed ‘Standards Met’ grade on DSPT 2018/19, by check of the NHS Digital DSPT tracker on 26 August 2020). "]

{"sheet":"A02554","index":597,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02554"]
["Reference","20/CAG/0121"]
["Other Refs","IRAS Project ID: 262197  REC Reference: 20/LO/1152"]
["Application Title","Strengthening the Implementation and Operationalisation of ‘Open Disclosure’ with Women and Families After Unexpected Harm in NHS Maternity Care: DISCERN study"]
["Application Summary","This application from King’s College London sets out the purpose of medical research that aims to explore the critical factors that can improve the incidence and quality of disclosure and discussion of harm  or ‘Open Disclosure’ (OD) in NHS maternity services, and what the actual or anticipated consequences of these improvements are likely to be for different stakeholders and in what contexts. The applicants aim to generate actionable evidence and produce tailored outputs to inform maternity providers how to strengthen OD practice and processes in NHS maternity services, to improve the quality and safety of maternity care for the benefit of women, families and clinical teams.\n\nOpen disclosure (OD) – the disclosure and discussion of harm that has happened to a patient during healthcare – has been identified as important in health services. OD is now publicly recognised as an entitlement of harmed patients and families, and research has identified multiple potential benefits. However, OD is often not routinely practiced and, when it is, it often falls short of both patient and family expectations and of professional or organisational guidelines.  Research shows that the issue of Open Disclosure is often problematic in maternity care, where incidents tend to have high stakes in terms of emotional, professional, and economic costs\n\nWhile the barriers to improving the incidence and quality of OD have been extensively documented, how some maternity services are managing to negotiate these barriers to improve OD policies, procedures and practices has yet to be answered. A central aspect of maternity review and investigation improvement identified by the Secretary of State is communication with families, including explanation of events of harm and assurance that lessons have been learned. There is therefore a need to understand how this difficult work can be best encouraged and supported within services.\n\nThis study is being undertaken in 3 phases. Phase 1 and 3 are outside of scope of this support. Phase 2 is in scope and applicants will undertake in-depth case studies in 3 NHS maternity services. The case studies will comprise of observations of OD work routines and effects, staff interviews, patient interviews and analysis of paperwork. The case studies will be undertaken by a series of virtual visits to staff and patients, completed over 8 months. All visits will be remote/virtual due to the Covid-19 pandemic, until or unless otherwise agreed with clinical leads, however it is possible that the applicants will occasionally be observing or meeting people face-to-face rather than virtually.  All staff observations and staff and patient interviews will be undertaken where possible with written informed consent, however it is likely that most observations of individual staff will indirectly involve others (for example, in meetings, training events). Support under the regulations is required in case of accidental disclosure of confidential patient information regarding a non-consented patient during either observations or interviews with staff and consented patients. The researchers have put in a number of safeguards to protect patient confidentiality including consent where possible, avoiding meetings where patient details may be disclosed, and reminding all staff and patient participants to respect patient confidentiality during interviews and observations."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Professor Jane Sandall, Professor of Social Sciences and Women's Health"]
["Address","King's College London"]
[null,"10th Floor, North Wing, St Thomas' Hospital"]
[null,"Westminster Bridge Road, London"]
["Postcode","SE1 7HE"]
["Telephone","02071 888 149"]
["Email","jane.sandall@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Support is only given regarding patients of maternity services, not for NHS staff or family members of patients.\n\nThe cohort are patients treated on maternity wards who are not consented into this study, whose information may be incidentally disclosed. "]
["Description of confidential patient information used","Data sources\nInterviews and observations carried out in 3 participating NHS Trusts:\n• West Sussex Trust \n• Guys and St Thomas NHS Foundation trust \n• Chelsea & Westminster Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be collected for linkage purposes\n\nIdentifiers required for analysis purposes\nNo items of confidential patient information will be collected for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-11-30"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, it is not yet possible to evaluate this. \n\n\nSpecific conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee \nConfirmed – REC Favourable opinion issued 23 November 2020\n\n2.\tConfirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission\n\nConfirmed:\nThe 2018/19 NHS Digital DSPT reviews for Chelsea and Westminster Hospital NHS Foundation Trust RQM (2019/20 not yet published), Brighton and Sussex University and Western Sussex Hospitals Trusts RXH (covers West Sussex trust) (2019/20 not yet published), and Guys and St Thomas' NHS Foundation Trust RJ1 (2019/20 submitted but not reviewed) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2020)."]

{"sheet":"A02555","index":598,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02555"]
["Reference","20/CAG/0147"]
["Other Refs","IRAS Project ID: 287455  REC Reference: 20/SC/0408"]
["Application Title","Global Consortium Study of Neurological Dysfunction in COVID 19 - paediatric substudy "]
["Application Summary","This application from Birmingham Women's and Children's NHS Foundation Trust sets out the purpose of medical research that aims to quantify neurological symptoms and diagnoses in paediatric patients with confirmed or presumed COVID-19 who are admitted to hospital. This study has three planned tiers, but this application is only for tier one, which aims to use routinely collected observational data. \n\nAs the COVID-19 pandemic evolves worldwide, reports of a spectrum of mild to severe neurological syndromes among patients infected with SARS-CoV-2 are emerging. Early reports indicate that adults experience a variety of neurological symptoms and diagnoses in approximately 36% of patients. In children, recent evidence highlights acute and long-term neurological manifestations due to other viral illnesses, however, COVID-19 reports in children lack detailed information on the frequency and outcomes of neurological findings. Identifying neurological manifestations of SARS-CoV-2 may identify an important fraction of COVID-19 patients who have non-classical presentation with neurological symptoms. Understanding neurophenotypes is particularly important in the paediatric population. Identifying post-infectious neurological events that can occur subsequent to the diagnosis and may impact long-term outcomes (e.g., cognitive, emotional, physical health) is equally critical.\n\nThis study aims to collect routinely collected data from children admitted to hospitals in England and Wales with confirmed or suspected COVID-19, from 01 January 2020 to 31 December 2021. Patient identifiers are only required to link to a pseudonymous study ID. The extraction of the data will be both retrospective and prospective. Consent is not planned to be taken due to the importance of studying the entire cohort, and also due to minimising infection risk between patients and researchers, and the importance of preserving personal protective equipment (PPE) for necessary clinical use. The extraction of data will in some cases be done by the clinical team which would not require support under Regulation 5, however in some cases this will be performed by researchers, due to the clinical team not having the resource to perform this extraction, and it is these cases where support under regulation 5 is requested. \n\nThe identifiers will be modified and removed to create a pseudonymous dataset. The key will be retained by individual trusts, however in some cases this will be retained by researchers who are not part of the direct care team, and in these cases support is required to retain the key linking the pseudonymous study ID to confidential patient identifiers until 31 December 2032. The pseudonymous clinical data will be securely sent to Birmingham Women's and Children's NHS Foundation Trust, quarterly, and to the central team at Birmingham. The data will not be able to be re-identified and so can be considered anonymous. The anonymous dataset will be securely sent to the UPMC Children's Hospital of Pittsburgh, USA, for central analysis, and this will be co-ordinated by the team at Birmingham. "]
["Applicant Organisation Name","Birmingham Women's and Children's NHS Foundation Trust"]
["Contact Name","Dr Hari Krishnan, Consultant Paediatric Intensivist"]
["Address","Birmingham Women's and Children's NHS Foundation Trust"]
[null,"Steelhouse Lane"]
[null,"Paediatric Intensive Care Unit, Birmingham Children's Hospital, Birmingham"]
["Postcode","B4 6NH"]
["Telephone","01213 338 754"]
["Email","hari.krishnan2@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any child aged 0-17, admitted to a hospital in England and Wales, with confirmed or presumed COVID-19 infection (including COVID-19 associated hyperinflammatory syndrome)\n\nFrom January 1, 2020 to December 31, 2021.\n\nTotal UK sample size: 200 \nTotal international sample size (including UK): 1000\n\nThis is a pragmatic estimate based on early data. It is likely that the numbers of patients could be significantly higher if there are further waves of COVID-19 infection"]
["Description of confidential patient information used","Data sources\nParticipating Trusts across England and Wales who treat paediatric Covid-19 cases (hospital electronic databases and medical records or physical medical records where appropriate)\n\nConfirmed:\n• Birmingham Women's and Children's NHS Foundation Trust \n• Guy's and St Thomas' NHS Foundation Trust (Evelina London Children's)\n• Barts Health NHS Trust (Royal London Hospital)\n• Alder Hey Children's NHS Foundation Trust\n• Nottingham University Hospitals NHS Trust (QMC)\n• King's College Hospital NHS Foundation Trust\n• University Hospitals of Leicester NHS Foundation Trust \n• Cardiff and Vale University Health Board (University Hospitals Wales)\n\nDiscussions ongoing, support also requested for:\n• Great Ormond Street Hospital NHS Foundation trust\n• Imperial College Healthcare NHS Trust\n• Leeds teaching Hospitals NHS Trust\n• University Hospitals Birmingham NHS Foundation Trust\n• Manchester University NHS Foundation Trust\n• University Hospitals Southampton NHS foundation trust\n• University Hospitals Bristol NHS Foundation Trust \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Hospital ID\n4. Date of birth \n5. Date of Death\n\n(Required to link to pseudonymous study ID)\n\nIdentifiers required for analysis purposes\n1. Date of birth modified to age in months/years\n2. Pseudonymous study ID\n3. Date of admission\n4. Date of discharge\n5. Gender\n6. Ethnicity\n7. Covid-19 status\n\nAdditional information\nKey linking pseudonymous study ID to identifiers held at each hospital\n\nData will be submitted by trusts to Birmingham children hospital quarterly\n\nDataset sent to USA for analysis; this dataset can be defined as anonymous.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-12-04"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as all processing of identifiable patient information without consent under this support is now complete.\n\nIn terms of public benefit, higher lymphocytes and lower fibrinogen levels were observed to be associated with a severe neurological manifestation after adjustment for several other variables. 5% of children with severe neurological manifestations died compared with 0.5% for those without.  \n\n\n23 March 2021 - Amendment supported\nThe amendment, to add a number of new NHS Trusts as additional data processors;\n• Great Ormond Street Hospital NHS Trust\n• Royal Brompton and Harefield Hospitals Trust\n• Imperial College Healthcare NHS Trust\n• Oxford University Hospital\n• Cambridge University Hospital\n• Leeds Teaching Hospitals NHS Trust\n• Sheffield Children's NHS Trust\n• University Hospitals Bristol and Weston NHS trust\nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\n1. Support is provided for occasions where confidential patient information is processed by a researcher who is not a member of the direct care team. Support under Regulation 5 is not required if this is performed by a member of the direct care team. This condition will remain for the duration of the study.\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \nThe Trusts where patients are identified will be required to have security assurances in place. However, as there are more than five organisations, the CAT team will not check each one individually; it is the responsibility of the applicant to ensure these are in place.\n\n3. Confirmation of a favourable opinion from a Research Ethics Committee. Confirmed 10 March 2021\n\n04 December 2020 - Application Supported\nThe application, \n• to allow the identification of the patient cohort from medical records at NHS Trusts in England and Wales in order to link confidential patient information to a pseudonymous study ID, by researchers who are not members of the direct care team, \n• and for the key linking the pseudonymous study ID to confidential patient identifiers to be held by individual trusts until 31 December 2023 (in the cases where the research team holding the key are not members of the direct care team), \nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nSpecific conditions of support\n\n1. Support is provided for occasions where confidential patient information is processed by a researcher who is not a member of the direct care team. Support under Regulation 5 is not required if this is performed by a member of the direct care team. This condition will remain for the duration of the study.\n\n2. Please provide the patient notification text that will be used on the website, which is linked to the QR code on the study poster provided, within 3 months of the date of this letter.\n\nConfirmed 06 April 2021 - Applicant provided an updated of version which the CAG confirmed met the condition of support by email on 06 April\n\n3. Please clarify if the National Data Opt Out will be applied to the cohort and provide this information to the CAG within 3 months from the date of this letter.\n\nConfirmed 06 April 2021 - Applicant confirmed that the national data opt would apply in each participating centre by the time it was mandatory and the CAG confirmed this met the condition of support by email on 6 April 2021\n\n4. Please provide feedback on the outcomes of the planned patient and public involvement, surrounding the use of confidential patient information without consent, and report back within 3 months from the date of this letter.\n\nConfirmed 06 April 2021 - The applicant provided the requested information and the CAG confirmed this met the condition of support by email on 6 April 2021\n\n5. Favourable opinion from REC \nFavourable Opinion Received 12th November 2020\n\n6. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \n\nThe Trusts where patients are identified will be required to have security assurances in place. However, as there are more than five organisations, the CAT team will not check each one individually; it is the responsibility of the applicant to ensure these are in place."]

{"sheet":"A02556","index":599,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02556"]
["Reference","20/CAG/0137"]
["Other Refs","IRAS Project ID: 282238  REC Reference: 20/SC/0156"]
["Application Title","Best Care for Abdominal Emergencies - The BCAE Study.  A retrospective single, centre cohort study of patients with intestinal emergencies"]
["Application Summary","This application from Portsmouth Hospitals NHS Trust sets out the purpose of medical research that aims to improve the quality of care for all patients with an abdominal emergency, irrespective of whether they have a laparotomy or not. The study aims to provide mortality rates for different treatment options, and analysis of short and long term outcomes. The study is a single-centre retrospective cohort study, and will use data from electronic patient records collected at Portsmouth Hospitals Trust NHS as part of routine patient care. \nAbdominal emergencies are common, and patients often need life-saving emergency surgery; laparotomy. This procedure is high risk with 10% mortality rate. However, patients who do not have a laparotomy are not well characterised and do not receive the prioritised care patients having surgery do, even though their condition is no less severe. There are two additional groups of patients admitted with abdominal emergencies: patients having keyhole surgery (laparoscopy) and patients for whom any treatment would be futile and would benefit most from an end of life care pathway. Further research is needed to investigate the management of all patients with intestinal emergency, to optimise care for each group of patients. \n\nThis study will use electronic hospital records from Portsmouth Hospitals NHS Trust to retrospectively identify all patients admitted with an abdominal emergency over a six year period, using ICD-10 diagnosis, OPCS-4 procedure codes from the Patient Administration System (PAS) and TheatreManTM and National Emergency Laparotomy Audit (NELA) data, all of which is held locally at Portsmouth Hospitals NHS Trust. The cohort will be extracted from records that are collected as part of routine clinical care, by a member of staff who is not part of the direct care team. The applicant plans to identify patient and admission characteristics of 4 groups of patients (laparotomy, laparoscopy, nonsurgical treatments, and end of life care). The confidential patient information of patients who don’t meet the criteria will not be seen or extracted. The patients identified will be screened to remove those who have registered with the NHS national data opt-out. The resulting dataset will form the final study cohort. The main data extraction phase will then take place using patients’ NHS numbers to extract patient demographics, (age, gender, date of death), their primary (and subsequent admissions) with diagnoses and procedures, and their vital signs, blood tests and surgery specific data for their intervention episode into linked datasets. The linked datasets will then be pseudonymised and identifying characteristics (name, address, date of birth) replaced by a study identification number (ID), by the Portsmouth Hospitals NHS Trust research data manager before it leaves the hospital’s systems. Age at first intervention will be recorded as it is required for the analysis, as will date of death. The key to the pseudonymisation will be deleted once the data has been extracted.\nThe pseudonymised datasets will be transferred with a Trust issued encrypted device from the Portsmouth Hospital NHS Trust research server onto the University of Portsmouth research server via a University of Portsmouth encrypted laptop. \n\nAs part of the response to provisional, the applicant will modify date of death after analysis to less identifiable formats, and at this point the study will no longer require support under Regulation 5."]
["Applicant Organisation Name","Portsmouth Hospitals NHS Trust"]
["Contact Name","Mr Simon K C Toh, Consultant Surgeon"]
["Address","Portsmouth Hospital NHS Trust"]
[null,"Queen Alexandra Hospital"]
[null,"Cosham, Portsmouth"]
["Postcode","PO6 3LY"]
["Telephone","02392 286 885"]
["Email","simon.toh@porthosp.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All adult patients admitted to Portsmouth Hospital NHS Trust with acute abdominal intestinal conditions over the study period (6.5 years: 01 December 2013 – 28 February 2020)\n\nLowest age 16, no upper age limit. \n\nAn approximate total of <5,800 patients with an intestinal emergency and <3,400 patients undergoing surgery. \n\nInclusion criteria: \n- Must have an acute intestinal condition, based on their ICD-10 codes and OPCS-4 codes \n- Must be >= 16 years of age at the time of admission \n- Have at least one full set of vital signs recorded on the day of admission \n- Have at least one full set of routine blood tests recorded on the day of admission \n\nExclusion criteria: \n- Maternity admissions during/after pregnancy \n- Patients admitted or undergoing intestinal surgery for a second time or more"]
["Description of confidential patient information used","Data sources\n1. Portsmouth Hospitals NHS Trust - electronic patient records collected as part of routine patient care (will be screening all general adult wards, excluding maternity)\n\nIdentifiers required to extract electronic data and create study ID\n1. Name\n2. NHS Number\n3. Hospital ID\n4. GP registration\n5. Date of Birth\n6. Date of Death \n7. Postcode\n\n(These identifiers are extracted and used to link to clinical datasets within Portsmouth Hospital)\n\nIdentifiers required for analysis purposes\n1. Date of Death\n\nAdditional information\nAnalysis will be undertaken by University of Portsmouth.\n\nAll data will be pseudonymised at the point of extraction and the national opt-out will be applied. Identifying characteristics (name, address, date of birth) will be replaced by a study identification number (ID)"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-12-08"]
["Next Review Date","2024-12-08"]
["Notes","08 December 2020 - Support issued\nThe application to allow named members of staff, who are not part of direct clinical care team, to extract the patient cohort from electronic patient records at Portsmouth Hospitals NHS Trust is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nPlease note that the legal basis to allow access to the specified confidential patient information without consent is now in effect for activities at Portsmouth Hospitals NHS Trust.\n\nSupport to additionally transfer confidential patient information from Portsmouth Hospitals NHS Trust to University of Portsmouth for the purposes of analysis, is not supported.\n\nSupport to transfer confidential patient information from Portsmouth Hospitals NHS Trust to University of Portsmouth is not in effect until a separate outcome letter is issued\n\nConditions of support:\n\n1. Support is in place to allow named members of staff, who are not part of direct clinical care team, to extract the patient cohort from electronic patient records at Portsmouth Hospitals NHS Trust. Support for the transfer of confidential patient information from Portsmouth Hospitals NHS Trust to University of Portsmouth for the purposes of analysis is not supported, and is dependent upon NHS Digital review of the Data Security and Protection Toolkit (DSPT) for University of Portsmouth being confirmed as ‘standards met’.\n\nCondition met 09 July 2021\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 12 November 2020\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:\n\n• The NHS Digital 2019/20 DSPT review for Portsmouth Hospitals NHS Trust (RHU) was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 22 October 2020).\n\n• The NHS Digital DSPT review for University of Portsmouth is pending, and will be required to be provided in order to support the transfer of the dataset for analysis to University of Portsmouth. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02557","index":600,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02557"]
["Reference","20/CAG/0136"]
["Other Refs","IRAS Project ID: 280452  REC Reference: 20/WM/0275"]
["Application Title","A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus standard care using a mixed methods approach: NightLife"]
["Application Summary","This application from University of Leicester sets out the purpose of medical research that aims to test the clinical and cost effectiveness of thrice weekly, extended hours nocturnal dialysis compared to standard dialysis care thrice weekly during the day. The study is a pragmatic, multi-centre, consented, randomised controlled trial with a health economic analysis.  \n\nKidney dialysis is a lifesaving treatment for around 24,000 patients in the UK. However haemodialysis (HD) can have extensive physiological, psychological and sociological impacts on patients. This is due to the side effects of haemodialysis and also the scheduling of treatment times, which results in patients ‘losing’ three days a week. Unsurprisingly, patient-reported quality of life is low, with many patients unable to continue paid employment. Studies suggest that people who have their dialysis overnight may feel better and may be able to live a life which is closer to normal. There is, however, a need for further evidence to establish the effectiveness and cost-effectiveness of nocturnal extended dialysis compared with daytime dialysis.\n\nThis study is being undertaken in 3 workstreams. Workstream 1 and 3 are outside of scope of this support. Workstream 2 is in scope and applicants will undertake observations and interviews in 9 NHS haemodialysis units over the course of the NightLife study. Applicants will use a mixed methods approach to provide an evaluation of the study processes. This will include an assessment of whether the implementation is given per protocol and identification of contextual factors that influence its implementation and adoption. Collection and monitoring of quantitative data collected as part of the main study and a mixture of ethnographic methods which are the subject of this application (observations, interviews and document collation) will be used to generate qualitative data. \n\nIt is expected that 2-3 visits per dialysis unit at different time-points will take place (e.g. pre-intervention, during the training period and during nocturnal haemodialysis delivery). Each observation period will last approximately 6-8 hours, to include a nightshift and handovers. The observations and interviews will comprise of observing both standard and nocturnal haemodialysis practice in different dialysis units, exploring staff and patient engagement and experiences, and identifying barriers and facilitators to nocturnal haemodialysis. Copies of relevant documentation may be collected. Observations and interviews will be undertaken by study researchers from University of Leicester over the course of 42 months. All staff and patient interviews will be undertaken with written informed consent, and all staff and patient observations will be undertaken with verbal consent. However it is possible that observations of individuals may indirectly involve others. Support under the regulations is required in case of accidental disclosure of confidential patient information regarding a non-consented patient during either observations or interviews with staff and consented patients. The researchers have put in a number of safeguards to protect patient confidentiality including consenting where possible, and avoiding making any records of confidential patient information. Eligible participants will be approached by a member of the clinical team.  \n\nApplicants are mindful of the impact of the post COVID-19 on undertaking observations in dialysis units and interviews with staff and patients. They will comply with local Trust requirements. It may be possible to undertake observations as planned, however for periods when restrictions do not allow observations on a unit, applicants will rely more heavily on interview data, which may be conducted remotely (via telephone or approved video-conferencing software, e.g. Microsoft Teams or Google Hangouts)."]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Professor James Burton, Professor of Renal Medicine"]
["Address","University of Leicester, Department of Cadiovascular Sciences"]
[null,"College of Life Sciences, Maurice Shock Building"]
[null,"University Road, Leicester"]
["Postcode","LE1 7RH"]
["Telephone","01162 588 043"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","For CAG purposes support is only given regarding patients in haemodialysis units, not for NHS staff or family members of patients.\n\nThe cohort requiring support are: patients treated on haemodialysis units who are not consented into this study, whose information may be incidentally disclosed.\n\nDuring observations and interviews carried out by researchers of:\n• 20-40 Patients established on haemodialysis for >3 months (i.e. prevalent dialysis patients) \n• Relatives or visitors accompanying patients (that fulfil RCT eligibility criteria) to haemodialysis sessions \n• 20-40 Clinical and non-clinical staff working at haemodialysis units participating in the Nightlife study"]
["Description of confidential patient information used","Data sources\nInterviews and observations carried out in 9 participating dialysis units around the UK who are participating in the NightLife RCT:\n\n- University Hospitals Leicester NHS Trust\n- Northamptonshire Healthcare NHS Foundation Trust\n- University Hospitals of North Midlands NHS Trust (Stoke)\n- University Hospitals Birmingham NHS Foundation Trust (Heartlands Hospital)\n- University Hospitals Birmingham NHS Foundation Trust (Queen Elizabeth Hospital)\n- Sheffield Teaching Hospitals NHS Foundation Trust \n- King's College Hospital NHS Foundation Trust\n- Cambridgeshire and Peterborough NHS Foundation Trust\n- Cardiff and Vale University Health Board\n\nIdentifiers required for linkage purposes\n1. No items of confidential patient information will be collected for linkage purposes\n\nIdentifiers required for analysis purposes\n1. No items of confidential patient information will be collected for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-12-11"]
["Next Review Date","2024-12-11"]
["Notes","Amendment supported 17 January 2024 to include Barts Health NHS Trust, Manchester University NHS Foundation Trust and University of Coventry & Warwickshire NHS Trust as participating sites and data processors for the CAG application\n\nAmendment supported 13 October 2023 to include Liverpool University Hospitals NHS Foundation Trust and Norfolk & Norwich University Hospitals NHS Foundation Trust as participating sites and data processors for the CAG application\n\nAmendment supported 17 November 2022 to remove Cardiff and Vale University Health Board as a data processor, and include Betsi Cadwaladr University Health Board as a participating site and data processor for the CAG application\n\n14 July 2021 - amendment supported to remove the Northamptonshire Healthcare NHS Foundation Trust and Cambridge and Peterborough NHS Foundation Trust as data processors \n\n26 April 2021 - Amendment supported:\nThe amendment, to include virtual interviews and virtual photovoice methods of undertaking interviews and observations with patients and staff at participating Trusts, is supported, subject to compliance with the standard conditions of support.\n\n11 December 2020 - Support issued\nThe application, to allow potential incidental disclosure of confidential patient information when researchers from the University of Leicester, who are not members of the direct care team, carry out consented interviews with haemodialysis unit staff, consented interviews with patients, and observations on haemodialysis units at nine named NHS Trusts, is supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 10 December 2020\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nSecurity assurances are required for the 9 sites where the observations take place. Support will be based on confirmation that the DSPT at the site will be complied with and that no identifiable information will be kept onsite or removed from the site. However, as this is more than 5 organisations, these will not be individually checked by the Confidentiality Advice Team, and it is the responsibility of the applicant to ensure that appropriate security assurances are in place."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02559","index":601,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02559"]
["Reference","20/CAG/0143"]
["Other Refs","IRAS Project ID: 261085  REC Reference: 19/SC/0590"]
["Application Title","CTSU clinical trial follow-up service with NHS Digital to provide de-identified follow-up data for use in the EBCTCG breast cancer meta-analyses"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to use data collected by the CTSU clinical trial follow-up service for Early Breast Cancer Trialists' Collaborative Group (EBCTCG) to support the conduct of meta-analyses of the comparative effects of different treatments for women with early breast cancer on death from breast cancer.\n\nThe Clinical Trial Service Unit clinical trial follow-up service (CTSU-ctfs) undertakes linkages of the identities of participants in clinical trials for early breast cancer with NHS Digital, in order to provide follow-up information to the Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Since the 1940s, several hundred randomised trials of women with early breast cancer have been conducted, involving hundreds of thousands of women. The need to identify effective treatments is ongoing and requires long-term follow-up of women recruited into trials. To aid in developing understanding of the results of these trials, every few years since 1985, the EBCTCG has brought together evidence on the major questions for central meta-analyses of the anonymised individual participant data. The CTSU-ctfs was set up in the 1980s to assist clinical researchers in designing, conducting and analysing clinical trials. One service offered by the CTSU-ctfs was assistance in obtaining long-term follow-up of patients in UK clinical trials via the Office of National Statistics (ONS). The CTSU-ctfs has been used by researchers for their own analyses and to contribute data to the EBCTCG meta-analyses of clinical trials. \n\nIn this application, the applicants are seeking support to follow-up 1385 patients who took part in seven trials conducted between 1948 and 1987. The applicants are also seeking support to continue to hold the confidential patient information already obtained for the 1385 patients. Confidential patient information will be transferred from CTSU-ctfs to NHS Digital, to be linked to the HES and MRIS (Medical Research Information Service) datasets at NHS Digital. A dataset containing confidential patient information will then be returned to CTSU-ctfs, who will create a copy of the dataset. This copy will be de-identified and provided to EBCTCG, who will use this dataset to conduct meta-analysis. A copy of the dataset created by NHS Digital, containing confidential patient information, will be retained by CTSU-ctfs until the project is complete. It will then be deleted according to procedures approved by NHS Digital. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Robert Hills, Professor of Medical Statistics, NDPH"]
["Address","University of Oxford"]
[null,"Clinical Trial Service Unit & Epidemiological Studies Unit"]
[null,"Richard Doll Building, Old Road Campus, Roosevelt Drive"]
["Postcode","OX3 7LF"]
["Telephone","01865 743 604"]
["Email","robert.hills@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1385 patients recruited to 7 UK clinical trials into treatment of early breast cancer between 1948 and 1987. "]
["Description of confidential patient information used","Data sources\n1. HES and MRIS datasets held by NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n6. Postcode – District Level\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-12-03"]
["Next Review Date","2022-12-03"]
["Notes","10 August 2021 - Amendment supported to include 8 further trials in the meta-analysis, and to support the disclosure of confidential patient information from participating trialists to University of Oxford, and then onwards to NHS Digital, in order to link to Hospital Episode Statistics (HES), Demographics, Office for National Statistics (ONS) Civil Registration -Deaths and Cancer Registration datasets at NHS Digital and provide the applicant with a pseudonymised dataset (containing study ID).\n\n03 December 2020 - Support issued\nConditions of support:\n\n1. Support is not given for the retrospective holding of confidential patient information collected in the seven trials conducted between 1948 and 1987. Support is given for the continued holding and processing of confidential patient information collected in the seven trials conducted between 1948 and 1987. \n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 19 December 2019. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed – University of Oxford – Medical Sciences Division – Nuffield Department of Population Health (by check of the NHS Digital DSPT tracker on 17 November 2020) and NHS Digital (by check of the NHS Digital DSPT tracker on 17 November 2020) have confirmed ‘Standards Met’ grade on DSPT submission 2019/20. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02560","index":602,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02560"]
["Reference","14/CAG/1012"]
["Other Refs","IRAS Project ID: 148894  Previous CAG Reference: 14/CAG/1001"]
["Application Title","Critical Care Health Informatics Collaborative"]
["Application Summary","This application detailed the establishment of a research database including clinical, laboratory and demographic data in relation to all patients admitted to Adult Critical Care Units across 5 NHS Trusts. "]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Mervyn Singer"]
["Address","Wolfson Institute of Biomedical Research"]
[null,"University College London"]
[null,"Gower Street"]
["Postcode","WC1E 6BT"]
["Telephone","0207 679 6714"]
["Email","m.singer@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data will be collected automatically from all patients on the participating critical care units. The data will be extracted from existing databases"]
["Description of confidential patient information used","NHS number, date of birth, postcode and gender were requested in order to carry out linkages to HES data."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2015-11-25"]
["Next Review Date","2024-11-25"]
["Notes","21 November 2023 - change in data processor from NHS Digital to NHS England, regarding data source   Hospital episode Statistics (HES)\n\n12 May 2022 - Amendment supported\nAmendment supported to restructure the framework of the research database.\n\n05 January 2021 - Amendment supported\nThe amendment, to include Manchester University NHS Foundation Trust as an additional data processor, and to extend the data items collected for the patients admitted to the critical care units to include their entire hospital stay, is supported, subject to compliance with the standard conditions of support.\n\n01 November 2019 - Amendment supported \nAmendment supported to add the following two new data sources into the scope of the application activity: Royal Marsden NHS Foundation Trust and University Hospitals Bristol NHS Foundation Trust. These sites would disclose the same dataset, including items of confidential patient information, into the research database as was currently supported for the wider five named sites providing data. \n\nApplication was initial considered at CAG meeting on 19/06/2014.\nThis application was considered again on 28 August 2014.\n\nConditions of support:\nCAG agreed that the minimum criteria under the Regulations appeared to have been met, and therefore advised recommending support to the Secretary of State for Health, subject to compliance with the specific and standard conditions of support as set out below.\n\n1. Confirmation of a favourable Research Ethics Committee opinion\nReceived 04/11/2015\n\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission.  \nReceived 04/11/2015"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02561"]
["Reference","20/CAG/0138"]
["Other Refs","IRAS Project ID: 283899  REC Reference: 20/EE/0157"]
["Application Title","Avon Community Acquired Pneumonia Study (Avon CAP): A Pan-Pandemic Acute Lower Respiratory Tract Disease Surveillance Study"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research which aims to determine population-based incidence rates of hospitalized adults ≥18 of age with community-acquired lower respiratory tract infection (LRTI - including Community Acquired Pneumonia) in Bristol.\n\nAcute lower respiratory tract disease (LRTD) encompasses pneumonia, lower respiratory tract infection (LRTI), acute bronchitis, exacerbation of underlying respiratory disease including asthma and chronic obstructive pulmonary disease (COPD). The healthcare costs of pneumonia throughout Europe before the COVID-19 pandemic was in excess of €10 billion per annum. In the UK, pneumonia affects 0.5 to 1% of adults each year, and the incidence of LRTI is considerably higher in patients ≥ 65 years of age. \n\nAccurate incidence rates of acute LRTD and its disease subsets, such as pneumonia and LRTI, remain elusive and the impact of COVID-19 on respiratory disease burden is unclear. Accurate incidence rates of vaccine-preventable infection are required to assess the potential population-level impact of vaccination recommendations. On this basis, the applicants seek to conduct a study to measure the true burden of acute respiratory disease due to these pathogens during and after the COVID-19 pandemic within the limitations of currently available diagnostic testing. \n\nThis is a hospital based prospective surveillance study undertaken across two hospitals in Bristol. It is primarily a consented study, with the study team making every effort to consent patients into the study. However, there will be some patients who die or who are discharged before consent is attempted. For these patients the applicants seek support to collect confidential patient information at transfer these to the University of Bristol. The clinical data will be sent using a pseudonym to the University of Bristol, with the identifiers in a separate dataset. The identifiers will be used to prevent any ‘double counting’ of patients if seen at both hospitals within a short period of time. Those patients that are approached for consent and decline will not be included in the data sharing between Trusts under support."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Adam Finn, Professor of Paediatrics"]
["Address","Bristol Vaccine Centre, University of Bristol"]
[null,"39-41 St Michael’s Hill"]
[null,"Bristol"]
["Postcode","BS8 1TD"]
["Telephone","n/a"]
["Email","adam.finn@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 or over presenting at one of the participating NHS Trust with acute illness (i.e., present for 28 days or less) and evidence of acute Lower Respiratory Tract Disease from 01 August 2020.\n\nThe applicants estimate that approximately 12,000 patients over 3 years will require processing of confidential patient information under support but will as far as possible seek consent and the true number may be less than this."]
["Description of confidential patient information used","Data sources\n1. North Bristol NHS Trust\n2. University Hospitals Bristol and Weston NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Admission date\n3. Date of birth\n4. Postcode (sector level)\n\nIdentifiers required for analysis purposes\n1. Postcode (sector level)\n2. Gender\n3. Ethnicity\n4. Date of admission\n\nAdditional information\nDate of birth will be recorded in the NHS database and will be used to calculate age at admission/death, etc. The patient age will be transferred to the University of Bristol IT domain. However, the date of birth will also be transferred to act as a second identifier within the dataset.\n\nDate of death will not be moved beyond the NHS IT domain. It will be used within this IT domain to calculate survival (days), age at death (etc.), and these values will be transferred to the University of Bristol domain"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-12-01"]
["Next Review Date","2024-12-01"]
["Notes","Amendment supported 26 October 2023 to extend the duration of ‘s251’ support until end of June 2025\n\nAmendment supported 11 August 2022 \n\nTo widen the cohort supported under ‘s251’ to include patients presenting to the emergency department who are then not admitted to hospital\n\nAmendment supported 19 July to include GP practice details as part of the data items collected for all study participants covered by ‘s251’ (not consented patients), and for the use of an encrypted USB key to transfer data into an encapsulated virtual machine (EVM)\n\n11 April 2022 - Amendment supported:\nAmendment supported to extend the retention period of NHS number, date of birth and admission date for all study participants covered by ‘s251’ (not consented patients), for a period of 5 years from the end of patient enrolment to the Avon CAP study, to enable future potential linkages.\n\n29 October 2021  - amendment supported to allow the applicants to record the details of any serious/significant adverse events resulting from administration of the BNT162b2 Pfizer vaccine against Covid19, in the Avon-CAP database and report the event to Pfizer.\n\nSupported outcome 01 December 2020 - Specific conditions of support:\n\n1.\tFavourable opinion from REC 05 June 2020 (with the non-consented arm given favourable ethical opinion through an amendment on 08 October 2020).\n\n2.\tContinual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The NHS Digital 2018/19 DSPT review for University of Bristol (Bristol Medical School) and North Bristol NHS Trust was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 21 October 2020).\n\nThe NHS Digital 2018/19 DSPT review for University Hospitals Bristol and Weston NHS Foundation Trust was confirmed as ‘Qualified Assurance – Trust has not achieved 95% staff undertaking security awareness training’ on the NHS Digital DSPT Tracker (checked 21 October 2020). Please note the specific condition of support. All staff at organisation that are involved in processing information under this application reference should have successfully completed local security awareness training before processing any information under support."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02562","index":604,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02562"]
["Reference","20/CAG/0149"]
["Other Refs","IRAS Project ID: 289074  REC Reference: 04/Q1205/69"]
["Application Title","Yorkshire & Humberside Haematology Network Register"]
["Application Summary","This application from the University of York set out a refreshed application for the Yorkshire & Humberside Haematology Network Register (YHHN Register). This Register was created to provide a comprehensive population-based patient cohort (“registry”) of patients newly diagnosed with haematological malignancies in the regions covered by the West Yorkshire & Harrogate and Humber, Coast & Vale Cancer Alliances.\n\nHaematological malignancies are comprised of a heterogenous group of cancers, with differing treatments and prognoses. Haematological cancers comprise a comparatively neglected cancer group, largely because of the complexities associated with their diagnoses and treatment. The YHHN Register was set up to monitor patient care by collating clinical and demographic real-world data, combined with accurate and complete follow-up information. The Register covers a population of around 4 million. In addition to the provision of real-world descriptive data for commissioning purposes and national guidelines, the YHHN Register also provides the infrastructure to facilitate studies in other research areas, which includes; examining the potential causes of haematological cancers and investigating factors associated with a delay in diagnosis, gaining a greater understanding of the biology of these tumours to potentially improve disease management and outcome, and investigating health inequalities, summarizing health resource utilization and costing the treatment pathways, and examining end-of-life of care and place of death.\n\nThe patient population is comprised of adults and children who were newly diagnosed with a haematological malignancy on or after 1 September 2004, who are resident in West Yorkshire & Harrogate and the Humber, and Coast & Vale Cancer Alliances. Informed consent is sought from patients whenever possible, however, due to the nature of haematological cancers, it may not always be possible to obtain consent. This may be due to aggressive disease and/or co-morbidities, meaning patients are too unwell to be consented, or have died before consent could be sought. Patients may also have died before a formal diagnosis of haematological malignancy was diagnosed. In 2007, the applicants sought exemption under Section 60 of the Health and Social Care Act 2001 (PIAG 1-05(h)/2007). A refreshed application has now been submitted to update the application and to add Hull University Teaching Hospitals NHS Trust as a joint data controller, alongside the University of York. \n\nAs part of the routine diagnostic process, samples from patients across the Network are sent to the Haematological Malignancy Diagnostic Service (HMDS) based at Leeds Teaching Hospitals NHS Trust. Patients’ name, date birth and NHS number are sent with the sample and entered onto MHDS’s web-based sample tracking and reporting system, HMDS Information Laboratory Integrated System (HILIS). The applicants have support under s251 to allow research nurses, employed by the University of York, to access confidential patient information within HILIS to identify suitable patients and seek their consent for inclusion in the study. Support is also requested to allow patients who were too unwell to be approached for consent or died before they could be approached. The research nurses will liaise with the patient’s clinical team to determine whether they are too unwell to be approached for consent. Where patients are too unwell, the research team will check with the clinical care team at a later date to ascertain whether patients are well enough to be consented. Approximately 6 months after the diagnosis, the applicants will begin the data collection process. A cancer-specific data collection form is generated from the patient’s HILIS record at LTHT. This form is sent to the patient’s treating hospital for prognostic, treatment and outcome data to be abstracted from the medical records. Data abstraction is then undertaken for consented and non-consented patients by University of York research nurses. For all patients, a pseudonymised dataset is download from HILIS containing demographic, diagnostic, prognostics, treatment and outcome data. No identifiable data will be included, and this file is securely exported to the University of York where data are analysed. Confidential patient information will be disclosed from the University of York to NHS Digital to HES, Death notification and cancer registration datasets held by NHS Digital. Data received from NHS Digital does not contain any personal identifiers, just the study identifier; and these data are stored in their own separate database. "]
["Applicant Organisation Name","University of York"]
["Contact Name","Professor Eve Roman"]
["Address","Professor/Director of the Epidemiology & Cancer Statistics Group"]
[null,"Department of Health Sciences"]
[null,"University of York"]
["Postcode","YO10 5DD"]
["Telephone","01904 321 881"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adults and children (from age 0 upwards) newly diagnosed with a haematological malignancy whilst resident in the regions covered by the West Yorkshire & Harrogate and Humber, Coast & Vale Cancer Alliances.\n\nSince the inception of the study in 2004 to date, approximately 36,000 patients have been ascertained. 2,500 are added each year. The applicants estimate that 45,000 patients will have been recruited by the current planned end date of September 2024 and that approximately 27,500 of this number will not have given consent. "]
["Description of confidential patient information used","Data sources\n1. Electronic diagnostic and pathology records held on the Haematological Malignancy Diagnostic Service’s (HMDS) Integrated Laboratory Information System (HILIS)\n2. HES, Death notification and cancer registration data held by NHS Digital\n3. Hospital medical records at participating trusts:\na. Airedale NHS Foundation Trust\nb. Bradford Teaching Hospitals NHS Foundation Trust\nc. Calderdale and Huddersfield NHS Foundation Trust\nd. Harrogate and District NHS Foundation Trust\ne. Hull University Teaching Hospitals NHS Trust\nf. Leeds Teaching Hospitals NHS Trust\ng. Mid Yorkshire Hospitals NHS Trust\nh. Northern Lincolnshire and Goole NHS Foundation Trust\ni. York Teaching Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Hospital ID number\n4. GP Registration\n5. Date of birth\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – unit level\n4. Gender\n5. Occupation\n6. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-12-17"]
["Next Review Date","2024-12-17"]
["Notes","1 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Civil Registration – deaths, and Cancer registrations.\n\nSpecific conditions of support\n1. Further clarification on the consent process and the scope of the s251 sought is required: a. Provide further clarification on the consent process and how non-responders have been dealt with so far. \n\tb. Clarify if a legal basis under the Mental Capacity Act could be used for adults lacking capacity. \n\t\n\n2. The patient notification material needs to be revised and updated, in collaboration with the patient and public involvement group, and the role of the University of York fully explained. \n\n3. Favourable opinion from a Research Ethics Committee. Confirmed 03 September 2004. \n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n• University of York – Department of Health Sciences – DSPT pending for 2019/20 \n• Hull University Teaching Hospitals NHS Trust – DSPT pending for 2019/20 \n• Leeds Teaching Hospitals NHS Trust - DSPT pending for 2019/20 \n• Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations. \nAs the above conditions have been accepted, this letter provides confirmation of final support. I will arrange for the register of approved applications on the HRA website to be updated with this information."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02563"]
["Reference","19/CAG/0127"]
["Other Refs","IRAS Project ID: 266580  REC Reference: 18/SC/0372"]
["Application Title","CRIS Linkage with the HIV and AIDS Reporting System"]
["Application Summary","This application from South London and Maudsley NHS Foundation Trust set out the purpose of medical research which aims to link patient mental health records from the Trust with the HIV and AIDS reporting system (HARS) maintained by Public Health England. The linked data will be made available within the CRIS database (Clinical Records Interactive System) for the purposes of research. \n\nThe proposed linkage will be the first between an NHS mental health electronic health records and the HIV and AIDS reporting system (HARS). By making this linkage the applicants will be able to answer questions of fundamental importance to patients, clinicians, and policy makers. These include estimating the prevalence of HIV in people with serious mental illness (SMI) in the UK, identifying groups of people with SMI who are potentially at higher risk of contracting HIV, and identifying potential suboptimal treatment in specific groups."]
["Applicant Organisation Name","South London and Maudsley NHS Foundation Trust"]
["Contact Name","Dr Margaret Heslin"]
["Address","Box 024, The David Goldberg Centre"]
[null,"DeCrespigny Park"]
[null,"London"]
["Postcode","SE5 8AF"]
["Telephone","020 7848 0198"]
["Email","margaret.heslin@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A historical cohort of 450,000 adults, aged 16 and over, who presented for the first time for treatment by South London and Maudsley NHS Foundation Trust between 01 January 2007 and 31 December 2018."]
["Description of confidential patient information used","Data sources\n1. South London and Maudsley NHS Foundation Trust Biomedical Research Centre’s CRIS System,\n2. HIV and AIDS reporting system (HARS) – Public Health England. \n\nIdentifiers required for linkage purposes\n1. Date of birth,\n2. Surname (scrambled – soundex)\n3. First initial\n4. Gender \n5. Ethnicity,\n6. Country of birth\n7. Lower Super Output Area of residence\n8. BRCID pseudonym\n\nIdentifiers required for analysis purposes\n1.\tDate of birth – month and year only\n2.\tDate of death – month and year only\n3.\tPostcode (sector level) \n4.\tGender\n5.\tEthnicity\n\nAdditional information\nA control cohort will also be extracted and retained by Public Health England. This will contain patients registered within the HARS dataset who are also registered as living within in a borough covered by the South London and Maudsley NHS Foundation Trust but are not registered within the CRIS database. The Trust covers Lambeth, Lewisham, Southwark and Croydon. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-01-17"]
["Next Review Date"]
["Notes","Applicant confirmed in February 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised.\n\nIn terms of public benefit, applicants have published an open access study which examines the prevalence of HIV in the SLaM cohort. Applicants continue to develop results from the linked data. Anticipated public benefits include identification of at-risk groups, assessment of parity in treatment and testing compared to the general population, and identification of clinical challenges and solutions to these challenges. This work is ongoing.\n\n19 January 2023 - change in data processor from Public Health England (PHE) to UK Health Security Agency (UKHSA) regarding the data source - HIV and AIDS reporting system (HARS)\n\n17 January 2020 - Application Approved\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 12 July 2019.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\nConfirmed: South London and Maudsley NHS Foundation Trust (by NHS Digital email 06 December 2019) and Public Health England (by NHS Digital email 06 September 2019) have confirmed ‘Standards Met’ grade on DSPT 2018/19."]

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[]
[]
["Application Number","A02564"]
["Reference","20/CAG/0157"]
["Other Refs","IRAS Project ID: 164361  REC Reference: 15/SC/0545"]
["Application Title","The Oxford Risk Factors And Non-invasive imaging Study: ORFAN"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to develop and validate novel imaging biomarkers to predict future heart attacks and other cardiovascular complications. This is a multi-arm study, with arm 4 only relevant to this application. Following the COVID-19 pandemic, the ORFAN study will additionally ascertain COVID-19 status (suspected or confirmed). The influence of COVID-19 infection on the outcome measures of the study will be explored.\n\nObesity is a known risk factor for cardiovascular disease (CVD). Body fat accumulation is associated with increased metabolic risk and it is now recognised that not only body fat quantity but also adipose tissue (AT) quality determines increased CVD risk. CT scans provide a reliable, accurate and non-invasive way to assess body adiposity. Increased volume of AT as measured by CT is independently associated with increased CVD risk in large clinical cohorts; similarly, increased epicardial AT volume is an independent predictor of cardiovascular event in subjects undergoing coronary CTA. Developing imaging biomarkers for assessing body adiposity could potentially provide a useful screening tool for the primary or secondary prevention of CVD.\n\nA substantial proportion of Covid-19 patients have suffered adverse cardiovascular outcomes. If applicants can identify patients at risk for rapid deterioration during acute Covid-19 infection by quantifying the background vascular inflammation and the tendency of micro-thromboses, this will enable deployment of appropriate therapeutic measures (e.g. anticoagulation) and guide allocation of NHS resources. \n\nNHS Trust direct care teams will identify retrospective patients with eligible scans. They are assigned a unique study ID, and the minimum required identifiers extracted alongside this ID are sent to;\n\n• NHS Digital, for the purposes of linkage with HES, ONS, and other datasets as detailed below, including the emergency care dataset, medicines dispensed in primary care, and covid-19 hospitalisations, \n\n• Barts Health NHS Trust, on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), for the purposes of linkage with clinical outcomes, such as heart attack\n\n• Kings College London, on behalf of the Sentinel Stroke National Audit Programme (SSNAP), for the purposes of linkage with clinical outcomes, such as stroke, \n\n• Participating NIHR Biomedical Research Centres (BRC’s) for the purposes of linking with baseline clinical data extracted from the Electronic Patient record (EPR) of associated participating trust. \n\nThe above parties will perform the data linkage, will modify date of birth and date of death and will delete identifiable data, with only the unique study ID remaining. The linked datasets will be sent to the ORFAN study team, at University of Oxford. The third parties that performed the data linkage will keep the linkage file for 10 years to update the relevant outcomes on an annual basis, to avoid individual NHS Trusts having to send identifiers to the third parties multiple times. \n\nThe scans are pseudonymised with the unique study ID by the direct care team and securely sent to University of Oxford. The direct care team will also screen electronic health records for health outcomes. Participating trusts also send health outcomes alongside the unique study ID to the ORFAN study team, at university of Oxford. The ORFAN team will link the datasets received from NHS Digital, NICOR, SSNAP and the NIHR BRCs, with the clinical data including the scans from the participating Trusts. \n\n75,000 retrospective patients data will be collected over a 2 year period from when CAG support is provided. The data collected will span different time points as each participating Trust, as they commenced CT services at different times. However no patient with a scan prior to 2010 will be included. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Charalambos Antoniades, Professor of Cardiovascular Medicine"]
["Address","Oxford University Hospitals NHS Foundation Trust"]
[null,"Level 6, West Wing"]
[null,"John Radcliffe Hospital, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865 228 340"]
["Email","antoniad@well.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","75,000 retrospective patients in the UK (England and wales only for the purposes of CAG) who have undergone clinical CTA’s or unenhanced CT chest, abdomen and pelvis scans at participating NHS Trusts. \n\nThe timescale for inclusion in the ORFAN study Arm 4 is different for each collaborating NHS Trust, however no patient with a scan before 2010 will be included in the study.\n\nInclusion criteria detailed in the application"]
["Description of confidential patient information used","Data sources\n1. NHS Digital; (HES, ONS, Medicines dispensed in primary care, Emergency care dataset, Covid-19 hospitalisations – datasets as detailed below)\n\na. Hospital Episode Statistics (HES) – Accident and Emergency dataset\nb. HES – Admitted patient care dataset\nc. HES - Outpatients\nd. HES – Critical care\ne. Emergency Care Data Set (ECDS)\t\nf. Medicines dispensed in Primary Care (NHSBSA data)\ng. Civil Registration (Deaths) - Secondary Care Cut\t\nh. COVID-19 Hospitalization in England Surveillance Syste\t\ni. HES:Civil Registration (Deaths) bridge \n\nHQIP is the data controller for the below datasets, however the legal entity where identifiers are sent are;\n\n2. Barts health NHS Trust (on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR) \n\n3. Kings College London, on behalf of the Sentinel Stroke National Audit Programme (SSNAP)\n\n4. NHS Trusts participating – PACS radiology systems and electronic patient records at;\n• Oxford University Hospitals \n• Royal United Hospitals Bath \n• Milton Keynes University Hospital \n• University Hospitals of Leicester \n• Barts Health\n• Royal Brompton and Harefield \n• Leeds Teaching Hospitals\n• Royal Papworth Hospital\n• Cambridge University Hospitals\n• Guy's and St Thomas' NHS Foundation Trust \n• New Cross Hospital \n• Royal Wolverhampton NHS Trust \n• Sandwell & West Birmingham Hospitals \n• Queen Elizabeth Hospital Birmingham\n• University Hospitals Birmingham NHS Foundation Trust \n• University Hospital of Manchester Foundation Trust\n\n5. NIHR Biomedical Research Centres (BRCs) that operate at Trusts with collaborating clinical teams – data extracted from electronic patient record (EPR) of the associated local trust\n• Oxford\n• Royal Brompton and Harefield\n• Leicester\n• Leeds\n• Cambridge\n• Barts\n\nIdentifiers required for linkage purposes (minimum required as confirmed with each data processor)\n\nNHS Digital \n1) NHS Number\n2) Date of birth\n3) Postcode (if NHS Number is not available)\n4) Name (if NHS Number is not available)\n\nNICOR \n1) NHS Number\n2) Date of birth\n3) Postcode\n\nSSNAP \n1) NHS Number\n2) Date of birth\n3) Postcode (if NHS Number is not available)\n4) Name (if NHS Number is not available)\n\nNIHR BRCs \n1) NHS Number\n2) Date of birth\n3) Local hospital number (MRN)\n4) Date of relevant CT scan\n\nIdentifiers required for analysis purposes\n1. Ethnicity\n2. Unique study ID\n3. Covid-19 status\n4. Gender\n5. Date of death in the following format MM/YYYY.\n6. Date of birth in the following format MM/YYYY\n\nThis dataset can be considered anonymous as the applicants will not be able to re-identify any patient.\n\nAdditional information\nThe third party that performed the data linkage will keep linkage files to enable yearly outcome updates for 10 years"]
["S251 Class(es)"," ","Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-01-07"]
["Next Review Date","2025-01-07"]
["Notes","19 July 2023 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) (Accident and Emergency, Admitted patient care, Outpatients & Critical care), Emergency Care Data Set (ECDS), Medicines dispensed in Primary Care (NHSBSA data), Civil Registration (Deaths) - Secondary Care Cut, COVID-19 Hospitalization in England Surveillance System, & HES:Civil Registration (Deaths) bridge, and\n•\tBarts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data sources - National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits.\n\nAmendment supported 19 July 2023 to include The Newcastle upon Tyne Hospitals NHS Foundation Trust as an additional data processor, as a newly participating site.\n\nAmendment supported 10 August 2022 \n\nTo include The Liverpool Heart and Chest Hospital NHS Foundation Trust as an additional data processor, as a newly participating site, and to collect post mortem CT scans\n\n01 February 2022 - Amendment supported:\nAmendment supported to increase the size of the cohort from 75,000 to 200,000 patients.\n\n07 January 2021 - Application Approved\nThe application, to allow the disclosure of confidential patient information from participating NHS Trusts to NHS Digital, Barts health NHS Trust (on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), Kings College London (on behalf of the Sentinel Stroke National Audit Programme (SSNAP), and local NHS Trust NIHR Biomedical Research Centres (BRC’s) for the purposes of time limited linkage with clinical datasets as listed in the application, in order for anonymised linked datasets to be disclosed to the applicants at the University of Oxford, and to allow these third parties to hold the linkage file throughout the life of the ORFAN Study to facilitate annual follow up for 10 years, is fully supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from REC. This application is relevant to substantial amendment 6 - Favourable Opinion Confirmed 05 January 2021\n\n2. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \nAll organisations processing confidential patient information, including the Trusts where patients are identified will be required to have security assurances in place. However, as there are more than five organisations, the CAT team will not check each one individually; it is the responsibility of the applicant to ensure these are in place."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02565","index":607,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02565"]
["Reference","20/CAG/0113"]
["Other Refs","IRAS Project ID: 262231  REC Reference: 19/SC/0262"]
["Application Title","Heart Protection Study Long-term Follow-up: A randomised study of the effects on mortality and morbidity of HMG CoA reductase inhibitors and of antioxidant vitamins in a wide range of people at high risk of coronary heart disease"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to assess the very long-term effects of around 5 years statin treatment and the very long-term effects of around 5 years use of antioxidant vitamin supplements.\nThe Heart Protection Study (HPS) was a large randomised controlled trial, which ran between 1994 and 1997. 20,536 individuals at increased risk of coronary heart disease were randomised to receive 40mg simvastatin daily versus a matching placebo, and to an anti-oxidant vitamin supplementation with vitamins E, C and beta-carotene versus placebo. Participants took trial medications for an average 5 years scheduled treatment period and the main trial closed in 2001. The aim was to study the overall effects on survival by preventing heart attacks, strokes and other major vascular events. The results of this trial showed that allocation to cholesterol-lowering therapy with simvastatin was associated with a 20% reduction in the risk of heart attack and stroke, and a reduction in all-cause mortality. Statins are now commonly prescribed to patients. \n\nAnnual questionnaires were sent to participants between 2001-2007. This follow-up was supplemented with cause-specific mortality data from HES and ONS, and incident cancers via the national cancer registries. Post-trial follow-up showed that the reductions seen in heart attacks, strokes and vascular death associated with allocation to simvastatin were maintained during this 5-year period. This suggests that longer statin use would result in greater absolute benefits and supports the early initiation and long-term continuation of lipid-lowering therapy in those at increased vascular risk. Concerns about the long-term safety of use of lipid-lowering therapy persist amongst the public. The applicants are now seeking to conduct a long-term follow-up of surviving patients from HPS via central registries and routine health records in order to gather evidence of the long-term safety of lipid-lowering therapy. \n\nData from participants in HPS will be linked to their electronic health records and other routinely collected health data from NHS Digital and NHS Wales Informatics Service. This will include HES data, mental health data, cancer and mortality data. Data requested will also include fact and cause of death. Other data requested may include deceased participants due to data lag with some datasets e.g. cancers. Data previously collected from deceased participants will be retained. NHS Digital and NHS Wales Informatics Service will return the data in a pseudonymised format, using trial ID number, and all datasets will be linked within Nuffield Department of Population Health (NDPH), University of Oxford."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Rory Collins"]
["Address","Nuffield Department of Population Health"]
[null,"University of Oxford"]
[null,"Oxford"]
["Postcode","OX3 7LF"]
["Telephone","01865 743 734"]
["Email","rory.collins@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","20,536 patients enrolled in the HPS main trial. The last NHS Digital linkage in 2016 linked 18,715 records."]
["Description of confidential patient information used","Data sources\n1. HPS records held by the University of Oxford\n2. HES, Admitted Patient Care (APC), Emergency Care Dataset (ECDS), Critical Care (CC), Outpatients (OP), cancer registrations, mental health and death statistics, held by NHS Digital\n3. Patient Episode Database for Wales (PEDW) held by NHS Wales Informatics Service (NWIS)\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Date of death\n5. Postcode – district level\n6. Gender\n7. Cancer Type\n8. Cancer Behaviour\n9. ICD code\n10. Place of death\n11. Place of birth\n12. Occupation\n13. Event data\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-01-06"]
["Next Review Date","2025-01-06"]
["Notes","09 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Admitted Patient Care (APC), Emergency Care Dataset (ECDS), Critical Care (CC), Outpatients (OP), cancer registrations, mental health data, and civil registrations deaths.\n\n06 January 2021 - Application Approved\n\nSpecific conditions of support\n\n1. A separate application for support should be submitted if the applicants will use this data to set up a research database.\n\n2. Where the confidential patient information collected under this legal support (as outlined in the application) is used for a different purpose , the applicants should consider whether an amendment or new application is necessary.\n\n3. Favourable opinion from REC \nConfirmed 19 July 2019\n\n4. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \n\nThe NHS Digital 19/20 DSPT review for NHS Digital and University of Oxford - Medical Sciences Division - Nuffield Department of Population Health was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 22 October 2020).\n\nThe CPiP for NHS Wales Informatics Service was received and is satisfactory."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02566","index":608,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02566"]
["Reference","20/CAG/0127"]
["Other Refs","IRAS Project ID: 288589  REC Reference: 20/WM/0265"]
["Application Title","Admissions far away from home or to adult wards - understanding the impact of current practices for accessing inpatient care for adolescents with mental health difficulties: a surveillance study"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research that seeks to determine the extent that young people aged between 13 and 17  are admitted to units far away from their home, defined as over 50 miles from their postcode or to a different NHS region, or to an adult ward.\n\nYoung people with mental health disorders of a severity that requires inpatient admission are at risk of poor long-term outcomes, including persistent mental health problems, poor physical health and academic under-achievement. These long-term outcomes are often associated with long-term health and societal costs. National policy specifies that young people who require inpatient admission should be cared for in units appropriate to their age-group. Unfortunately there are few units that serve children with poor mental health and places are limited, and many young people are admitted to adult units or units far away from their home. This means that inpatients may be separated from family or friends, or receive care not specifically tailored for their age. This may worsen the distress experienced by the young people and their families, and impact on the care they receive after discharge. Limited information is available at a national level regarding the number of admissions of young people to units away from home or to adult units and the applicants are seeking to collect information on this, in order to inform clinical practice, guidelines and service organisation and commissioning. \n\nData collection will be undertaken via questionnaires completed by reporting consultant psychiatrists, utilising the Child Adolescent Psychiatry Surveillance System (CAPSS). CAPSS uses an active surveillance approach to facilitate epidemiological studies which are looking at either rare mental health disorders or events amongst children and adolescents in the United Kingdom and Ireland. CAPSS maintains a database of consultant child and adolescent psychiatrists in the United Kingdom and Ireland. Using these contact details, administrative staff from CAPSS send out a CAPSS report card or a weblink on a monthly basis to this centrally held mailing list of child and adolescent psychiatrists. This will contain a list of conditions being surveyed, together with reporting instructions. Reporting psychiatrists will be asked to check boxes against the reportable conditions they have seen during the preceding month or indicate that they have seen no eligible cases, and then return the card/weblink to CAPSS. This report will not contain any patient identifiable data. \n\nCAPSS then contact the research team with the contact details of the reporting consultant. The research team will send an email or letter to the consultant with the questionnaire for them to complete with the patient details, including confidential patient information, and return to the research team. Data will also be extracted from patient medical records by the same clinician. A follow-up questionnaire will also be sent to the reporting clinician after 6 months. Data will be entered into a computerised database and patient identifiable data will be stored on a separate database to the rest of the questionnaire data. These will only be linked by a unique study ID number for each case."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Dr Kapil Sayal"]
["Address","Professor of Child & Adolescent Psychiatry, Faculty of Medicine & Health"]
[null,"Institute of Mental Health"]
[null,"Triumph Road, Nottingham"]
["Postcode","NG7 2TU"]
["Telephone","0115 823 0264"]
["Email","Kapil.Sayal@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 13-17 years who require admission to an inpatient psychiatric unit and who were admitted to a unit over 50 miles from home, out of commissioning area or to an adult ward, during the 12-month data collection period. \n\nThe aim of the application is to establish how often this occurs, therefore a total sample size could not be provided. "]
["Description of confidential patient information used","Data sources\n1. Questionnaires completed by reporting consultant psychiatrists\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n3. Postcode – unit level\n4. Gender\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Postcode – unit level\n3. Gender\n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-01-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed March 2023 that ‘s251’ support could be expired because data containing potentially identifiable patient information have been cleared from the database and are now irretrievable. \n\nIn terms of public benefit, these findings about different types of admission will be used to make recommendations for clinical practice, guidelines and policy to improve the care provided by both CAMHS and adult services in relation to this vulnerable group of young people.\n\n\n15 November 2022 – amendment supported to \nExtend the duration of support until 31 December 2022.  \n\nConditions of support:\n\n1. The patient facing information is to be revised to direct patients to the National Data Opt-Out website to register any objections to the use of their data. \n\n2. Report to be provided at the first annual review about the further patient and public involvement that have been undertaken, particularly around the level of potentially identifiable data that will be processed. \n\n3. Favourable opinion from a Research Ethics Committee. \nConfirmed 26 October 2020\n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital DSPT review for University of Nottingham organisation was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 15 October 2020) "]

{"sheet":"A02567","index":609,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02567"]
["Reference","21/CAG/0010"]
["Other Refs","IRAS Project ID: 268205  REC Reference: 20/LO/1038"]
["Application Title","Peritoneal Mesothelioma Retrospective Sample Collection \n(Short title: Peritoneal Mesothelioma TMA)"]
["Application Summary","This application from the Royal Papworth Hospital NHS Trust (MesobanK database) set out the purpose of medical research which aims to prepare tissue microarrays (TMAs) of retrospective peritoneal mesothelioma samples, which will be initially be used to determine if expression of the transcription factor CHOP predicts survival in peritoneal mesothelioma. The remainder of the TMAs will remain in the MesobanK database to be used in subsequent mesothelioma research. The tissue specimens were taken for diagnostic purposes and retained for many years in case of legal claims due to the occupational nature of asbestos-related diseases. Consent for the use of these samples in research may not be in place, however, as the vast majority of the tissue samples will belong to subjects who are deceased it will not be possible to obtain their consent, and applicants feel that contacting relatives to seek their consent would cause unnecessary distress. Applicants have previously used this approach during assembly of similar mesothelioma TMAs, and this is fully compliant with the Human Tissue Act 2006.\n\nPeritoneal Mesothelioma is a form of cancer that affects the membrane that surrounds the abdominal cavity - the peritoneum, often following exposure to asbestos. It is widely accepted that progress in the treatment of mesothelioma requires a better understanding of its biology.  As with many rare cancers, the fundamental mechanisms regulating mesothelioma cell growth and death are poorly understood. Peritoneal mesothelioma has previously not been collected by MesobanK, there is therefore an unmet need for peritoneal mesothelioma tissue samples.\n\nPathologists at collaborating pathology departments will identify suitable retrospective diagnostic specimens of patients with proven peritoneal mesothelioma stored in the form of paraffin blocks. The study aims to identify as many eligible samples as possible, and support is requested for samples of up to 100 individuals. The local pathologist will assign a unique code to the blocks, and these will then be submitted pseudonymously to the Pathologist at Royal Papworth Hospital in Cambridge where they will be checked for quality and suitability for inclusion in the TMA. Upon being accepted for use in the TMA, the pseudonymised block will be linked to a unique MesobanK identifier, fully catalogued and sent to Cancer Research UK Cambridge Research Institute (CRUK). TMAs will be constructed at the CRUK from these tissue samples, and the paraffin blocks from which the TMA samples are taken, will then be returned to their provider using the unique code assigned by original pathology unit. MesobanK will then store and control access to the remaining TMA sections.\n\nIn addition, a minimal clinical dataset will be collected for each patient whose tissue is used in the TMA, including the original pathology report, which will be sent from collaborating pathology departments. A member of staff from the direct care team at the pathology department will enter identifiers for each eligible patient onto the MesobanK database, linked to the unique code assigned by the pathology department, which is also linked to the MesobanK ID. MesobanK staff will then transfer the minimum identifiers required to PHE, for the purposes of linkage with The Cancer Registration and Analysis Service (NCRAS). Linked data will be transferred back to MesobanK, including the MesobanK ID, and date of death and other clinical details as listed in the application. National data opt out will be respected. Data transfer to and from PHE will be by PHE Secure File Transfer Service. The data will be collated and stored on the MesobanK electronic data capture/tissue tracking database. All identifiers will be modified and removed from the database, with the exception of NHS number which will be retained indefinitely.  MesobanK will store and manage the release of the TMA blocks, along with linked clinical data, to other researchers, who will not receive any confidential patient information."]
["Applicant Organisation Name","Royal Papworth Hospital NHS Trust (MesobanK database)"]
["Contact Name","Professor Stefan Marciniak, Consultant Physician, Professor of Respiratory Science"]
["Address","Cambridge University, Cambridge Institute for Medical Research (CIMR)"]
[null,"The Keith Peters Building, Hills Road"]
[null,"CB2 0XY"]
["Postcode"]
["Telephone","0122 376 2660"]
["Email","sjm20@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Up to 100 adult patients with a pathological diagnosis of Peritoneal Mesothelioma. (Aged 18-100)\n\nSome of the FFPE blocks may have been in the archives prior to 2006 and some post-2006, however no sample that has been stored for over 20 years will be used due to likely degradation of material."]
["Description of confidential patient information used","Data sources\n1. Collaborating Pathology departments that hold diagnostic specimens of peritoneal mesothelioma:\n\na. Basingstoke and North Hampshire Hospital (Hampshire Hospitals NHS Foundation Trust)\nb. The Royal Marsden NHS Foundation Trust \nc. Other pathology labs (Royal Liverpool University Hospital in set up, but names of other Trusts not yet confirmed)\n\n2. The Cancer Registration and Analysis Service (NCRAS), held at Public health England (PHE)\n\nIdentifiers required for linkage purposes\n1. Date of birth\n2. NHS number\n3. Date of diagnosis \n4. MesobanK identifier\n\nIdentifiers required for analysis purposes\n1. Date of death (modified to MM/YYY)\n2. Date of birth (modified to MM/YYY)\n3. Age\n4. Age at diagnosis (calculated from DoB and date of diagnosis)\n5. MesobanK identifier\n6. Gender\n7. Ethnicity\n\nNHS number is only identifier retained in the research database indefinitely, it is stored alongside the MesobanK ID, which is separated from the clinical data, and not required for analysis.\n\nAdditional information\nThe applicants expect only one data request from PHE, however depending on the samples included a second data request could be required, and this will be confirmed with PHE once the samples have been sourced."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-01-29"]
["Next Review Date","2025-01-29"]
["Notes","19 January 2023 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source National Cancer Registration and Analysis Service (NCRAS)\n\n29 January 2021 - Application approved\nThe application, \n\n• to allow the disclosure of confidential patient information about patients with proven peritoneal mesothelioma from collaborating pathology departments to MesobanK at Royal Papworth Hospital NHS Trust, for MesobanK at Royal Papworth Hospital NHS Trust to share identifiers with PHE for the purposes of linkage, and for the flow of data returned from PHE to MesobanK at Royal Papworth Hospital NHS Trust, as the return flow includes full date of death,\n\n• and to allow MesobanK at Royal Papworth Hospital NHS Trust to retain the NHS number for the duration of time that the TMAs are included in MesobanK, which is estimated at 15 years,\n\nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. Please provide a report on further patient and public involvement, surrounding the use of confidential patient information without consent, at annual review. Condition met at first annual review\n\n2. Please consider whether it is necessary to retain month and year of death, and provide either a justification for the retention, or confirmation that it will be further modified or deleted, at annual review. Condition met at first annual review\n\n3. Please consider whether it is necessary to retain NHS number, and provide either a justification for the retention, and confirmation that this will be restricted to Chief Investigator only, or confirmation that this will be deleted after the linkage has been performed, at annual review. Condition met at first annual review\n\n4. Favourable opinion from REC \n Favourable Opinion Received 17th September 2020\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \n\nThe Trusts where samples are identified will be required to have security assurances in place, alongside Public Health England (PHE) and Royal Papworth Hospital NHS Foundation Trust. However, as there are five or more organisations in total, the CAT team will not check each one individually; it is the responsibility of the applicant to ensure these are in place."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02568","index":610,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02568"]
["Reference","20/CAG/0107"]
["Other Refs","IRAS Project ID: 280738  REC Reference: 20/LO/1023"]
["Application Title","Childhood outcomes after perinatal brain injury: a population-based linkage study  "]
["Application Summary","This application from University College London Great Ormond Street Institute of Child Health (UCL GOS ICH) set out the purpose of medical research that aims to conduct a population-based matched cohort study of children born in England 2008-2020, to investigate differences in long-term health, mortality and educational outcomes in children with perinatal brain injury compared to those without brain injury. The primary outcome for the study is neurodisability at 2, 5 and 12 years, and secondary outcomes include all-cause mortality, mental health and behavioural conditions, chronic conditions, academic attainment, and special-educational needs.\nOver 3400 babies born in England suffer a brain injury every year. Neonatal brain injuries around the time of birth can have devastating lifelong consequences for children, parents and society as a whole. There have been major advances in healthcare that mean more babies with brain injuries survive, but the long-term effects of these injuries are not well-known. Currently, it is not known which infants suffering perinatal brain injury should be followed up, how long they should be followed up for, what conditions they are likely to develop or what additional support they may need from the NHS, social care, or schools in terms of their health, development and education. This study has been created with the aim of gathering information on the prognosis and quality of life after a neonatal brain injury in order to assist staff in conducting family-centred discussions about what the future may hold and help shape health and educational services.\n\nThree cohorts will be included in the study. Cohort 1 will include all newborns with a perinatal brain injury who were born in England between 2008 and 2020. Cohort 2 will be a per-term control group and will contain a 1:1 propensity score matched comparator group for babies born before 34 weeks gestation. NHS Digital will match the cohort using Office of National Statistics (ONS) data in order to create Cohort 3, a full-term control group. \n\nThe National Neonatal Research Data (NNRD) captures data items, including date of birth, postcode, and infant NHS number, but does not reliably hold children’s’ registered names. Additionally, the NNRD contains the infants’ postcodes at birth, but does not capture postcode changes throughout childhood. Therefore, the NNRD cohorts 1&2 will be linked to the NHS Digital Personal Demographics Service (PDS), using NHS number, date of birth, gender and postcode at birth: to identify registered forename and surname, and postcodes changes. \n\nNHS Digital will then link all 3 cohorts to 3 datasets held at NHS Digital; Hospital Episode Statistics (HES), ONS mortality data, Mental Health Services Dataset (MHSD). NHS Digital will send identifiers to the Department for Education (DfE) for linkage with the National Pupil Database (NPD). The Neonatal Data Analysis Unit will create a pseudonymous file containing the neonatal care data for cohort 1 & 2. Cohort 3 will be identified by NHS Digital. Cohorts 1, 2 & 3 will be linked at NHS Digital and the Department for Education, and a pseudonymous file will be created for each linked dataset. The 5 pseudonymised datasets will then be securely transferred to ONS Secure Research Service (SRS), where they will be cleaned and merged. Data within the SRS will retain only an anonymous unique identifier - they key to which will only be held at the Department for Education and NHS Digital for their respective linkages. The data generated by the study will be analysed in the ONS secure research service. It will either be accessed through one of the ONS safe rooms of via a UCL SRS remote connectivity site."]
["Applicant Organisation Name","University College London Great Ormond Street Institute of Child Health (UCL GOS ICH)"]
["Contact Name","Dr Philippa Rees"]
["Address","1st floor Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone","07794 669 436"]
["Email","p.rees@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","• Cohort 1: All newborns with perinatal brain injury, born in England between 1 January 2008 to 31 December 2020 (approximately 43,582)\n\n• Cohort 2: Pre-term control group: Propensity score matched comparator group for those born <34 weeks gestation (1:1) to control infants using propensity score matching to account for confounders, born in England between 2008-2020 (approximately 16, 175) \n\n• Cohort 3: term control group: matched term population for the infants ≥34 weeks gestation in cohort 1, identified by NHS Digital using the covariates below, born in England between 2008-2020 (using a 1:3 algorithm; approximately 82, 221)."]
["Description of confidential patient information used","Data sources\n1. National Neonatal Research Database controlled by the Neonatal Data Analysis Unit (NDAU)\n\n2. ONS, PDS, HES and MHSD datasets, held by NHS Digital \n\n3. National Pupil Database, held by the Department for Education\n\nIdentifiers required for linkage purposes\nFor linkage of cohort 1&2 with NHS Digital (PDS) data:\n1. NHS number\n2. Date of birth\n3. Postcode at birth\n4. Gender\nFrom these provided identifiers NHS Digital PDS will identify infant forename, surname and postcodes over time, which will validate linkages and be sent to DfE.\n\nFor linkage of cohort 1,2 & 3 with NHS Digital: HES, ONS, MHSD data:\n1. NHS number\n2. Infant Forename\n3. Infant Surname\n4. Date of birth\n5. Gender\n\nFor linkage of cohort 1, 2 & 3 with National Pupil Database NHS Digital will send the following identifiers to the DfE: \n1. Infant Forename\n2. Infant Surname\n3. Date of birth\n4. Gender\n5. Postcode at birth, \n6. Most recent postcode\nAny additional childhood postcodes\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis\n\nAdditional information\nFor NHS Digital to identify cohort 3 the following non identifiable data from the infants ≥34 weeks gestation in cohort 1 is required:\n\n1.\tBirthweight\n2.\tYear of birth\n3.\tMultiplicity\n4.\tGender\n5.\tLower layer Super Output Areas (LSOA)\n\nThe ONS SRS will receive 5 pseudonymised files: file 1 from the NNRD containing neonatal care data for cohorts 1 and 2; files 2-4 containing survival, health and mental health data for cohorts 1-3; and file 5 containing educational outcomes data for cohorts 1-3. None of these will contain personal identifiers. \n\nThe data generated by the study will be analysed in the ONS secure research service. It will either be access through one of the ONS safe rooms of via a UCL SRS remote connectivity site"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-01-28"]
["Next Review Date","N/A"]
["Notes","08 April 2022 - Support expired, application superseded by 22/CAG/0068 as amendment for joint data controllership.\n\nThis submitted information represented a new application in relation to an existing activity under application reference 20/CAG/0107. As a result of the original application not providing clarity on the joint controllership, the sole change is that of an addition of a controller, from solely University College London to joint controllership between University College London and Imperial College London. The intention is to replace 20/CAG/0107 with this new application (22/CAG/0068) once support is in place\n\n28 January 2021 - Application approved\n\nConditions of support:\n\n1. Feedback from the planned continuing engagement is to be provided when submitting annual reviews to the CAG. \n\n2. The patient information leaflet needs to be revised to include telephone and postal contact details, as well as email. \n\n3. Favourable opinion from a Research Ethics Committee. \nConfirmed 25 September 2020. \n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nThe NHS Digital DSPT review for the following organisations were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 18 September 2020) \n\n• University College London – School of Life and Medical Sciences (standards met for DSPT 2018/19) \n• Office for National Statistics (standards met for DSPT 2019/20) \n• Department for Education (standards met for DSPT 2019/20) \n• NHS Digital (standards met for DSPT 2018/19) \n• Chelsea & Westminster Hospital NHS Foundation Trust (standards met for DSPT 2018/19) \n\n24 August 2021 - Amendment supported to include gestation as an additional variable to match cohort 3."]

{"sheet":"A02569","index":611,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02569"]
["Reference","21/CAG/0008"]
["Other Refs","IRAS Project ID: 286947  REC Reference: 05/MRE04/87"]
["Application Title","Clinical Practice Research Datalink (CPRD)"]
["Application Summary","This application from the MHRA sets out the purpose of medical research to link data from numerous sources in order to establish a research database. The Clinical Practice Research Datalink (CPRD) has been operating for about 30 years and has established support under Regulation 5 for NHS Digital to act as a trusted third party in order to link data from numerous sources. This is a resubmission of ECC 5-05(a)/2012 following a request by CAG as part of the 2020 annual review.\n\nThe CPRD is a government research service, jointly supported by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health Research (NIHR) CPRD collects de-identified data from participating GP practices to establish the research database and to date includes over 50 million patient lives. Deidentified data is shared with research teams whose applications are reviewed by the CPRD’s data governance review process. CPRD also provides other services to researchers, such as patient recruitment, support with interventional research and study planning/feasibility. Note that the activities undertaken by the CPRD do not require Regulation 5 support as the data that CPRD process is not identifiable.\n\nHowever, about 75% of approved research protocols use linked data to provide more depth to the analysis. External data custodians (the organisations holding the data) provide NHS Digital with NHS number, gender, date of birth and postcode and a pseudonym. NHS Digital matches the identifiers to those provided by the GP system suppliers to generate a linker file (links GP system pseudonym with external dataset pseudonym). Deidentified data is then sent by the external data custodians to CPRD who link the data with the primary care data on pseudonyms alone.\n\nSome linkages are undertaken on a routine basis, where there is sufficient demand for them, whilst others may be undertaken on a study specific basis."]
["Applicant Organisation Name","MHRA"]
["Contact Name","Dr Puja Myles, Director of Clinical Practice Research Datalink "]
["Address","Medicines and Healthcare products Regulatory Agency"]
[null,"10 South Colonnade"]
[null,"London"]
["Postcode","E14 4PU "]
["Telephone","0203 080 6884"]
["Email","puja.myles@mhra.gov.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients within practices that have signed up to provide data to the CPRD (except for those patients that opt out)."]
["Description of confidential patient information used","Data sources\n1.\tVision\n2.\tEMIS\n3.\tTPP\n4.\tNHS Digital (HES, PROMs, Mental health Dataset,, mortality data, emergency care)\n5.\tIQVIA (IMS Health Hospital)\n6.\tNational Confidential Enquiry into Patient Outcome and Death\n7.\tNational Bowel Cancer Audit Programme (NBOCAP)\n8.\tHead and Neck Cancer Audit\n9.\tNational Lung Cancer Audi\n10.\tOesophago-Gastric Cancer Audit\n11.\tNational Neonatal Audit Programme\n12.\tPaediatric Intensive Care Audit Network\n13.\tHeavy Menstrual Bleeding Audit\n14.\tEpilepsy 12 Audit (Childhood Epilepsy)\n15.\tChild Health\n16.\tNational Maternity and Perinatal Audit\n17.\tNational Cardiac Audit Programme\n18.\tNational Diabetes Audit (Adult)\n19.\tNational Diabetes Audit (Paediatrics)\n20.\tNational Joint Registry (NJR) – not currently processed or held, but available to obtain if a specific study requests this\n21.\tInflammatory Bowel Disease Audit (IBD)\n22.\tNational Pain Database Audit\n23.\tNational Audit of Dementia\n24.\tNational Audit of Psychological Therapies (NAPT)\n25.\tNational Audit of Schizophrenia\n26.\tSuicide and homicide\n27.\tSentinel Stroke National Audit Programme \n28.\tCarotid Interventions Audit\n29.\tFalls and Bone Health Audit\n30.\tContinence Care Audit\n31.\tFalls and Fragility Fracture Audit (includes the Hip Fracture Database)\n32.\tNational Asthma and COPD Audit Programme\n33.\tTranscatheter Aortic Valve Implantation (TAVI)\n34.\tNational Cancer Data Repository \n35.\tBINOCAR\n36.\tPHE Surveillance (Flu virology)\n37.\tUK Renal Registry\n38.\tBritish Society of Rheumatology\n39.\tAbdominal Aortic Aneurysm Screening Programme\n40.\tBowel Cancer Screening Programme\n41.\tNHS Blood and Transplant (Organ Transplant)\n42.\tTrauma Audit and Research Network\n43.\tIntensive Care National Audit and Research Centre (ICNARC)\n44.\tUniversity Hospitals Birmingham NHS Foundation Trust (UHB) (Supported for a specific study which did not get funded, but being explored for use in further study)\n\nIdentifiers required for linkage purposes\n1.\tNHS number\n2.\tDate of Birth\n3.\tPostcode\n4.\tGender\n\nIdentifiers required for analysis purposes\n1.\tYear of Birth\n2.\tDate of Death\n3.\tGender\n4.\tOccupation\n5.\tEthnicity\n6.\tGP Practice Postcode and SHA region\n\nAdditional information\nNote that month of birth is additionally provided for under 16s to support research into children and infants."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-02-08"]
["Next Review Date","2025-02-08"]
["Notes","Annual review supported 16 February 2024 and additional specific conditions of support applied:\n\n1.\tThe CAG requested that the website should clearly describe the study specific Opt-Out process and make it easily accessible to patients. Feedback should be provided in 6 months.\n\n2.\tPatient and public involvement needs to be carried out, and feedback provided to CAG within 6 months. The feedback should include:\n1.\tA routine inclusion of lay members in all levels of patient and public involvement. \n2.\tincrease the number of representative individuals in the patient and public involvement group, and ensure the use of confidential patient information without consent, and outside the direct care team is discussed. \n3.\tExplain what ad-hoc reviewers mean. \n4.\tThere needs to be a better inclusion of practice participation groups. \n\n3.\tProvide assurance that research in response to ministerial requests, such as research in support of security, intelligence, prosecution and international relations, has a medical purpose. Feedback should be provided in 6 months.\n\n4.\tProvide an update on the progress towards the Trusted research environment. Feedback should be provided in 6 months.\n\n\n12 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - HES, PROMs, Mental health Dataset, Civil Registrations mortality data, emergency care, including Uncurated Low Latency Hospital Data Sets for Admitted Patient Care, Outpatient, and Critical Care. NHS England also acts as a trusted third part processor for CPRD, and therefore this also covers all datasets listed in the CPRD application. \n\nAmendment supported 12 January 2024 to remove Dr Tim Williams as joint Director of CPRD, and name Dr Puja Myles as sole Director of CPRD, and to receive ‘Uncurated Low Latency Hospital Data Sets for Admitted Patient Care, Outpatient, and Critical Care’ from NHS England.\n\nAnnual review supported 23 February 2023, and additional specific conditions of support applied:\n\n1. The following conditions need to be reported on within 3 months of the issuing of this outcome letter:\na. The criteria for determining whether a study is high-risk need to be re-examined and more precise criteria produced and provided to the CAG.\nb. Examples of studies that were potentially high-risk and went through the CPRD escalation process, without advice being sought from the CAG, were provided, so the CAG could see the type of activity that was being flagged as potentially high-risk.\nc. Provide details of any lay involvement in the decisions making and escalation processes within CPRD. If no lay input is currently sought, this needs to be considered in future.\nd. A detailed plan on the further patient and public involvement to be conducted needs to be provided.\ne. Clarify whether CPRD request that applicants seeking to use CPRD data conduct patient and public involvement before granting access to CPRD data.\n\nThe above conditions were confirmed as met on 09 June 2023\n\n2.\tA report of the further patient and public involvement activity conducted needed to be provided at the next annual review.\n\nThe above condition was confirmed as met as part of the 2024 annual review submission\n\n12 May 2022 - Amendment supported\nAmendment supported to remove Dr Janet Valentine as Director of CPRD and add Drs Puja Myles and Tim Williams as interim Joint Directors and to make revisions to the poster, as recommended by the REC.\n\n06 May 2021 - Amendment supported\nAmendment supported to allow the following datasets to be added to the CPRD master dataset and list to be linked with by NHS Digital:\n• SGSS – Second Generation Surveillance System – from PHE\n• CHESS – COVID-19 Hospitalisation in England Surveillance System – from PHE\n• NPEx – National Pathology Exchange COVID-19 Pillar 2 test data – from NHS Digital\n• HES-MSDS – Maternity Services Data Set – from NHS Digital\n• NHSBSA – Medicines dispensed in primary care – from NHS Digital\n• NCARDRS – National Congenital Anomaly and Rare Disease Registration Service – from PHE (CAG 10-02(d)/2015)\n• NAAASP – NHS Abdominal Aortic Aneurysm Screening Programme data – from PHE\n\n1. Within one month of the date of this letter, provide evidence that the public landing page of the CPRD website contains details about the use of confidential patient information without consent, and a mechanism to opt out, linking to a secondary page for further details.\nConfirmed 06 May 2021\n\n2. Within one month of the date of this letter, provide an updated poster that adequately refers to the use of confidential patient information without consent.\nConfirmed 06 May 2021\n\n3. Within one month of the date of this letter, provide an updated protocol which reflects the current actions of the CPRD.\nConfirmed 06 May 2021\n\n4. Within one month of the date of this letter, provide a detailed protocol for both initial and ongoing meaningful patient and public involvement on the use of confidential patient information without consent for the purposes of linking datasets for CPRD.\nConfirmed 06 May 2021\n\n5. Within three months of the date of this letter, provide a report on the resulting initial patient and public involvement that has been undertaken.\nConfirmed 06 May 2021\n\n6. Following submission of the initial patient and public involvement, a meeting will be arranged between members of the CAG and CPRD.\n\n7. Regulation 5 support for the specific datasets to be added to the master dataset list for linkage by NHS Digital, as detailed in the amendment form, is not supported until satisfactory resolution of the above points. However, it is noted that the SGSS SARS-CoV-2 virology testing and CHESS data will continue to flow with the COPI notice as the legal basis.\n\n8. Favourable opinion from REC\nConfirmed\n\n9. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. \nConfirmed - The 19/20 DPST submission NHS Digital has been confirmed as ‘standards met’."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","A02570"]
["Reference","20/CAG/0144"]
["Other Refs","IRAS Project ID: 274495  REC Reference: 20/LO/0625"]
["Application Title","Follow-up of the QUEST Cohort - Wave 3 Additions"]
["Application Summary","This application from King’s College London set out the purpose of medical research that aims to identify the early childhood personal, family, genetic and wider environmental factors for significant mental health and/or behavioural problems in adolescents with Autism Spectrum Disorder (ASD). \n\nASD is a severe and lifelong developmental disability, affecting about 1% of children and characterized by pervasive impairments in social communication, and also stereotyped and restricted interests. The application related to the follow-up of participants who were involved in the original QUEST study, which was operated on a fully consented basis. QUEST began in 2008 and 277 families with children aged 4-8 years and diagnosed with ASD were recruited. In 2015-16, the applicants followed up the original cohort, who were then aged 11-15 (QUEST Wave 2), to examine the personal, family and wider environmental risk/protective factors that may predict severe mental health/behavioural problems in adolescence. The same sample was allowed followed up at age 13-17 (wave 3) in 2017-18, to determine which young people had persistent mental health/behavioural problems and which factors were predictive. 214 of the original QUEST families were followed-up in Wave 3. \n\nIn the third \"wave\" of the QUEST study (time 3), the applicants wish to follow up the children again, now that they are aged 12-16, years old, to determine which young people have persistent severe maladaptive behaviour or mental health problems, and to determine which factors were predictive.\n\nThe QUEST study team are seeking to add DNA samples and family history information, which would provide them with valuable information on additional potential additional risk factors. During the course of the study, 14 families were lost to follow up. Following the previous s251 application, which was deferred, the applicants are now applying again to use the confidential patient information they have to use the NHS Personal Demographics Service (run by NHS Digital and accessed through South London and Maudsley NHS Foundation Trust) to obtain up to date contact details for patients, including their GP details. Patients’ GPs will then be contacted and asked to forward the cover letter to the participants. The team plan to then consent those that make contact. For those who do not make contact the team would delete the details gained from the Personal Demographics Service."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Professor Emily Simonoff, Professor & Head of Department of Child & Adolescent Psychiatry"]
["Address","IoPPN, King's College London"]
[null,"Child & Adolescent Psychiatry Building"]
[null,"De Crespigny Park, London"]
["Postcode","SE5 8AF"]
["Telephone","0207 848 5312"]
["Email","emily.simonoff@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","QUEST participants for whom the study team have lost contact with (n=14)"]
["Description of confidential patient information used","Data sources\n1. NHS Personal Demographics Service (accessed via South London and Maudsley NHS Foundation Trust)\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n\nIdentifiers required for analysis purposes\n1. Name\n2. NHS Number\n3. Date of Birth\n4. Gender\n5. Unit level postcode\n6. Last known address\n7. Date of Death\n\nAdditional information\nNote that the identified for analysis are those obtained from the PDS for trying to re-establish contact in order to consent. Date of death to ensure no inappropriate contact."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-02-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, CAG support allowed applicants to trace and attempt to re-contact some families that participated in the first wave of the\nresearch (age 4-7), and offer them the opportunity to re-join the study and participate in the adolescent follow-up.\nThe study has produced a number of well-cited scientific papers on factors associated with mental health and other outcomes in autistic children and young people.\n\n\n03 February 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 01 June 2020\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n• Confirmed: NHS Digital and South London and Maudsley NHS Foundation Trust (by check of the NHS Digital DSPT tracker on 04 December 2020) have confirmed ‘Standards Met’ grade on DSPT 2018/19). \n• King’s College London (The Institute of Psychiatry) – DSPT for 2019/20 confirmed 26 January 2021."]

{"sheet":"A02571","index":613,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02571"]
["Reference","21/CAG/0017"]
["Other Refs","IRAS Project ID: 291887  REC Reference: 21/SC/0021"]
["Application Title","Outcomes of Patients who survived Treatment on an Intensive Care unit for COVID-19 in England and Wales: a retrospective cohort study "]
["Application Summary","This application from University of Oxford set out the purpose of medical research which aims to characterise mortality and other adverse outcomes for patients treated on an Intensive Care Unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. The study will use retrospective existing national audit data from The Intensive Care National Audit and Research Centre (ICNARC) linked to other healthcare datasets.\n\nAcross England and Wales, over 10,000 patients have been treated for severe COVID-19 on an intensive care unit. Around 60% survived to leave hospital. Research shows that patients who survive ICU treatment are at greater risk of death, and report lower health-related quality of life. Evidence also suggests that patients admitted with COVID-19 receive higher intensity organ support and suffer more complications than observed in other viral respiratory infections. The long-term consequences of severe COVID-19 on the health of survivors are unknown. Understanding the risks faced by patients treated in an ICU has the potential to help healthcare professionals mitigate those risks.\n\nParticipants will be identified from the existing Case Mix Programme (CMP) dataset held by ICNARC, by staff at ICNARC (the CMP data controller). The primary cohort will include patients admitted to ICU with confirmed COVID-19 between 1st January 2020 and 1st July 2020, who were discharged alive from hospital. ICNARC staff will then identify comparator groups of emergency ICU admissions between 1st January 2016 to 1st July 2020 as listed in the application, from the CMP dataset. Eligible participants identified from the ICNARC CMP audit will be assigned a pseudonymous Study ID. The Study ID will be sent alongside Date of Birth, NHS number, Postcode, and gender to;\n\n• NHS Digital, \n• NWIS, \n• Barts health NHS Trust (on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), \n• Kings College London (on behalf of the Sentinel Stroke National Audit Programme (SSNAP), \n• The Renal Association (on behalf of the UKRR)\n\nLinkage will be performed by these trusted third parties to clinical datasets as listed below, to obtain information on subsequent hospitalisations, and longer-term mortality, cardiovascular and renal outcomes.  The linkages will be requested twice; in March 2021 and October 2021, to allow 6 month and 1 year follow up of the entire cohort, however identifiers are sent by ICNARC once only, and the third parties hold the pseudonymous study ID linked to confidential patient information for the 6 months in-between. Third parties performing the linkage will then remove identifiers from the datasets, including modifying postcode to deprivation score or LSOA, and transfer pseudonymised linked datasets to the University of Oxford. The University of oxford will receive the pseudonymous Study ID, and the datasets from NICOR, SSNAP and UKRR can be considered anonymous as the co-ordinating centre will not be able to re-identify any participant. The datasets received from NHS Digital and NWIS will contain full date of death, and as such this data flow will require support. The applicants will modify this date to ‘time from hospital discharge to death’ and delete the date of death prior to analysis.\n\nThe study will also link data from the UK Obstetric Surveillance System (UKOSS) to identify patients who were pregnant at the time of ICU admission using probabilistic matching. All data will be combined into a final study dataset containing no confidential patient information, by researchers at the University of Oxford for analysis. Analysis of the study dataset will be conducted by researchers at the University of Oxford and ICNARC. Pseudonymised data will also be securely transferred to ICNARC and accessed via secure servers managed by ICNARC. The ledger linking pseudonymous Study ID to direct identifiers will only be accessed by ICNARC for GDPR privacy enquiries and in the event of data quality concerns, and will be kept until the end of the study – 1st November 2021."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Peter Watkinson, Associate Professor of Intensive Care Medicine"]
["Address","University of Oxford"]
[null,"Kadoorie Centre"]
[null,"John Radcliffe, Level 3, Oxford"]
["Postcode","OC3 9DU"]
["Telephone","01865 231 448"]
["Email","ccrg.research@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","319,600 Patients over 16 admitted to an intensive care unit in England or Wales and discharged alive from hospital. \n\nAdmitted between 1st January 2016 to 1st July 2020\n"]
["Description of confidential patient information used","Data sources\n1. The Case Mix Programme (CMP), (The Intensive Care National Audit and Research Centre (ICNARC))\n2. NHS Digital; \n    a) Hospital Episode Statistics (HES), \n    b) ONS Civil Registration data, \n    c) GPES Data for Pandemic Planning and Research COVID-19 (GPES)\n3. Patient Episode Database for Wales (PEDW), (NHS Wales Informatics Service (NWIS)\n4. National Institute for Cardiovascular Outcomes Research (NICOR), (Barts Health NHS Trust,  HQIP)\n5. Sentinel Stroke National Audit Programme (SSNAP), (Kings College London, HQIP)\n6. UK Renal Registry (UKRR), (The Renal Association)\n7. UK Obstetric Surveillance System (UKOSS) (University of Oxford)\n\nAll datasets have a legal basis to process confidential patient information.\n\nIdentifiers required for linkage purposes\n1. Date of Birth, \n2. NHS number\n3. Postcode\n4. Gender\n5. Pseudonymous Study ID\n\nIdentifiers required for analysis purposes\n1. Postcode (modified to deprivation score or LSOA by third parties)\n2. Date of death (modified to time from hospital discharge to death by applicants)\n3. Pseudonymous ‘study ID’\n\n(This can be considered anonymous)\n\nAdditional information\nFollow up period: 1 year after discharge from an intensive care unit. 2 linkages will be performed, one at 180 days (March 2021) and one at 365 days (October 2021)."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-02-25"]
["Next Review Date","2025-02-25"]
["Notes","Amendment supported 24 July 2023 to increase the size of the initial cohort to include participants admitted to ICU from January 2016 to 30 June 2022, to extend the duration of support until 31 August 2024, and to additionally collect COVID-19 vaccination status as a data item, and include selected causes of death as secondary outcome measures\n\n30 January 2023 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), ONS Civil Registration data, & GPES Data for Pandemic Planning and Research COVID-19 (GPES). \n•\tBarts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits.\n\n15 December 2021 - Amendment supported\nAmendment supported to extend the duration of support until 31 July 2022.\n\n28 October 2021 – Amendment supported \nto clarify that confidential patient information will be obtained from NHS Digital for patients admitted to ICU for 5 years prior to the admission, and that the Maternity Services Data Set (MSDS) the Emergency Care Data Set (ECDS) and Hospital Episode Statistics: Accident and Emergency will be linked.\n\n15 June 2021 - Amendment supported\nThe amendment, to link the cohort of patients with the Maternity Services Data set (MSDS) product via NHS Digital, is supported, subject to compliance with the standard conditions of support.\n\n25 February 2021 - Application supported\nThe application, to allow the disclosure of confidential patient information from The Intensive Care National Audit and Research Centre (ICNARC) to;\n\n• NHS Digital, \n• NHS Wales Informatics Service (NWIS), \n• Barts health NHS Trust (on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), \n• Kings College London (on behalf of the Sentinel Stroke National Audit Programme (SSNAP), and\n• The Renal Association (on behalf of the UKRR) \n\nfor the purposes of time limited linkage with clinical datasets in order for pseudonymised linked datasets to be disclosed to the applicants at the University of Oxford, and for the return of full date of death from NHS Digital and NWIS to the University of Oxford, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. Applicants should conduct a small survey with patients from an appropriate patient forum. Applicants should outline their approach, explore the use of confidential patient information without consent in this specific context, and provide a report back to the CAG within three months from the date of this letter.\n\nConfirmed:- Applicant has provided a response to the Sub-Committee on 26 April 2021. Further Patient and public involvement has been undertaken which has adequately explored the acceptability of the use of confidential patient information without consent. The CAG were content that the condition had been met, and this was confirmed by email to the applicant on 28 April 2021. \n\n2. Favourable opinion from a Research Ethics Committee \nConfirmed 22 February 2021\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:- As there are more than 5 organisations processing confidential patient data these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for the following organisations have been assessed as ‘standards met’ by NHS Digital;\n\n• University of Oxford \n• ICNARC 8HN44 \n• NHS Digital \n• NICOR (Barts Health NHS Trust) \n• SSNAP King's College London - Sentinel Stroke National Audit Programme  EE133874-SSNAP \n• UKRR (The Renal association) 8HQ50 \n\n• A CPiP assessment is in place for NWIS.\n\nAmendment supported 05 August 2022 \n\nTo extend the duration of support until 31 July 2023"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","A02572"]
["Reference","21/CAG/0029"]
["Other Refs","IRAS Project ID: 240420  REC Reference: 19/SC/0373"]
["Application Title","BOSU Study on Newly Presenting Visual Loss Secondary to myopic maculopathy"]
["Application Summary","This application from South Tyneside and Sunderland NHS Foundation Trust set out the purpose of medical research which aims to describe the incidence of patients newly presenting with visual loss secondary to myopic maculopathy in the UK, over a one-year surveillance programme operating via the British Ophthalmological Surveillance Unit (BOSU) methodology, using the monthly reporting card amongst UK ophthalmologists. This is a replacement of a previous application (19/CAG/0133), which was given a provisional outcome in 2019. There are no changes to the study design, however the applicant was required to resubmit as the application had been withdrawn due to the time elapsed. \n\nPathological myopia describes a series of degenerative disease processes that can result in severe loss of visual function. A recent Biobank study showed 4% of the population are highly myopic and that this is increasing, being more common amongst younger people. Previous studies that have estimated the UK incidence of sight loss secondary to pathological myopia has been extrapolated from large scale epidemiological studies performed in other countries, however little is known of the UK data.\n\nThe BOSU methodology is established and has received support in principle from the CAG. Ophthalmologists will indicate that they have seen a new patient who has experienced visual loss from myopic maculopathy through the BOSU reporting system. The BOSU collects no patient identifying information but will notify the study investigator of all ophthalmologists who report new cases. The researcher will then contact the reporting ophthalmologist directly and will send a questionnaire requesting information to determine the incidence. Follow-up will be conducted at six-months following initial reporting. \n\nEach case will be given a unique study number by the BOSU study centre. Hospital number, year of birth, gender, and ethnicity will be recorded alongside clinical data on paper questionnaires. These will be sent to the Sunderland Eye Infirmary, and all paper forms will be stored in a locked cabinet. All identifying data will be stored electronically and separated from the clinical dataset, linked only by the unique study number. All identifies will be deleted once the follow-up is completed and duplicates identified. "]
["Applicant Organisation Name","South Tyneside and Sunderland NHS Foundation Trust"]
["Contact Name","Mr Ajay Kotagiri, Consultant Opththalmologist"]
["Address","South Tyneside and Sunderland NHS Foundation Trust"]
[null,"Sunderland Eye Infirmary"]
[null,"Queen Alexandra Road, Sunderland"]
["Postcode","SR2 9HP"]
["Telephone","0191 569 9954"]
["Email","ajay.kotagiri@chsft.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 254 patients who have experienced visual loss from myopic maculopathy\n\nPatients with high myopia (-6.00DS or worse) presenting with new vision loss to a level of 6/18 (logMAR 0.50, 60 ETDRS letters) or worse in their better eye, secondary to myopic maculopathy who report to a treating ophthalmologist across the 12 months reporting period, expected to be between June 2021 to June 2022.  "]
["Description of confidential patient information used","Data sources\n1. Clinical records at the Trusts of BOSU reporting ophthalmologists\n\nIdentifiers required for linkage purposes\n1. Hospital number (identify duplicates and identify same patient for follow up)\n2. Unique study number\n\nIdentifiers required for analysis purposes\n1. Year of birth\n2. Gender\n3. Ethnicity \n4. Unique study number\n\nAdditional information\n1 year of baseline collection (June 2021 to June 2022) and then additional 6 month follow up until December 2022."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-02-26"]
["Next Review Date","2022-02-26"]
["Notes","26 February 2022 - Application supported\nThe application, to allow the disclosure of confidential patient information from treating ophthalmologists to the research team at South Tyneside and Sunderland NHS Foundation Trust via the BOSU methodology to enable de-duplication and linking baseline and follow-up questionnaires, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 30 September 2019 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:\nThe NHS Digital 19/20 DSPT review for South Tyneside and Sunderland NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 25 February 2021).\n\nThe study includes 5+ reporting ophthalmologists – security assurances will not be checked by the Confidentiality Advice Team (CAT) team for all participating sites. Support is recommended on the basis that the applicant is responsible for seeking assurance that the appropriate security arrangements are in place\n"]

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[]
[]
["Application Number","A02573"]
["Reference","21/CAG/0030"]
["Other Refs","IRAS Project ID: 292131  REC Reference: 21/WM/0018"]
["Application Title","Experiences of gestational trophoblastic disease: reconciling cancer, pregnancy and loss"]
["Application Summary","This application from The University of Sheffield set out the purpose of medical research which aims to undertake observations of Multi-Disciplinary Team meetings (MDTs) and pathology laboratories, and interviews with staff and patients in order to understand their experiences of gestational trophoblastic disease (GTD). The study is funded by the Wellcome Trust. This study will primarily be based at the GTD specialist centre at Weston Park Hospital, Sheffield, and will also involve participation from the GTD screening centre in Dundee, which is out of scope for CAG support. \n\nGestational trophoblastic disease (GTD) is a rare condition that can arise following conception, causing abnormal cells to develop within the womb. Some forms of GTD can become cancerous, with these termed gestational trophoblastic neoplasia (GTN). GTD and GTN are umbrella terms for a number of individual diseases, which together have an incidence in the UK of approximately 1 in 714 live births. GTD can mean that though a woman may receive a positive test and experience pregnancy symptoms, she might not be carrying a baby. Some women require chemotherapy, and all must have their hormone levels monitored for a specific amount of time. Research has shown evidence of impacts on health-related quality of life, including physical effects of chemotherapy, fear and anxiety surrounding recurrence, death, and future fertility. However, experiences of GTD are poorly understood. Qualitative sociological perspectives on GTD/GTN are important, as they help to make sense of the wider factors shaping women’s experiences of the condition, and clinical approaches to managing the disease. Improved understanding of these factors can inform patient support, and interactions between health professionals and patents, ensuring these are sensitive to patient experience of this rare and complex condition. This study will improve understanding of patients experiences of GTD, raise awareness of the condition, and it is hoped that the research will feed into GTD practice and care.\n\nObservations will be made of staff, both in pathology laboratories and MDTs in the GTD specialist centre, which is part of Sheffield Teaching Hospitals NHS Foundation Trust. Interviews will be undertaken with staff and consented patients. The MDT and lab observations will not be audio recorded, and the researcher will not record any confidential patient information in field notes. The researcher will observe by encrypted video link, if it is not possible to attend in person due to the pandemic. Interviews are planned to take place face-to-face, at a time and location convenient to participants. However, should ‘lockdown’ COVID-19 restrictions be in force, these interviews will take place via telephone or via encrypted video. The interviews will be audio-recorded and then transcribed and anonymised, however if incidental disclosure takes place, this will be ‘bleeped out’, to ensure no confidential patient information without consent is sent to the transcription company. The study is expected to consist of approximately 20 MDT observation sessions, 10 observations in pathology settings, 20 staff interviews and 20 patient interviews over a period of thirty-one months, and a total of around 60 participants are expected to be observed and interviewed.\n\nAll observations of MDTs and pathology settings, and interviews with patients and staff will be undertaken with informed consent, however it is possible that the researcher may be incidentally exposed to confidential patient information. Support under the regulations is required in case of accidental disclosure of confidential patient information regarding a non-consented patient during either observations or interviews with staff and consented patients. The researchers have put in a number of safeguards to protect patient confidentiality including consent where possible, ceasing observations when requested, and reminding all staff participants to respect patient confidentiality during interviews. However the potential incidental disclosure that is likely during MDT and pathology laboratory observations are regarding patients other than those who have been consented, and so Regulation 5 support is required as it is not possible for the researcher to predict these disclosures in advance of observations."]
["Applicant Organisation Name","The University of Sheffield"]
["Contact Name","Dr Emily Ross, Research Fellow"]
["Address","The University of Sheffield"]
[null,"Department of Sociological Studies, Elmfield Building"]
[null,"Northumberland Road, Sheffield"]
["Postcode","S10 2TU"]
["Telephone","07956 173 514"]
["Email","e.ross@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Applicants will observe and interview approximately 60 participants, made up of patients over the age of 18 diagnosed with gestational trophoblastic disease (GTD), and staff involved in diagnosis, treatment and care of GTD. However these will be consented observations/interviews, and are out of scope for CAG support.\n\nSupport for CAG purposes is provided regarding any patient whose confidential patient information may be incidentally disclosed without consent whilst these observations and interviews are taking place."]
["Description of confidential patient information used","Data sources\nInterviews and observations carried out in the participating NHS Trust:\n1. Sheffield Teaching Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be collected for linkage purposes\n\nIdentifiers required for analysis purposes\nNo items of confidential patient information will be collected for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-03-02"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit the applicant now has a dataset on experiences of this rare condition. Arising from the data, the applicant has data due to be published on the hormone hCG which is key to monitoring GTD. The applicant is also writing an article about patient experiences of hCG monitoring for a sociological journal, and has two further publications planned.  In March 2023 the applicant led a creative workshop with patients to capture their experiences and raise awareness of GTD.\n\n\n02 March 2021 - Application supported\nThe application, for potential incidental disclosure of confidential patient information when the applicants, who are not members of the direct care team, carry out interviews with consented staff and patients and observations of MDT meetings and pathology laboratories in Sheffield Teaching Hospitals NHS Foundation Trust, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 16 February 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed: \nThe NHS Digital 19/20 DSPT review for Sheffield Teaching Hospitals NHS Foundation Trust was confirmed as ‘Standards met’ by email from NHS Digital to the CAG inbox (on 26 February 2021)"]

{"sheet":"A02574","index":616,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02574"]
["Reference","21/CAG/0012"]
["Other Refs","IRAS Project ID: 275959  REC Reference: 20/LO/0566"]
["Application Title","Expression and Reception of Gratitude in Healthcare: Analytical Ethnography"]
["Application Summary","This application from King’s College London set out the purpose of medical research which aims to observe and describe the various ways in which gratitude is expressed, received and displayed in a healthcare setting, in the Royal Brompton Hospital. This study is an exploratory study that will inform subsequent phases of a wider project investigating gratitude in healthcare, and how it can enhance the wellbeing of those who give and receive it. \n\nGratitude is an emotion essential to supporting communicative human relationships. Expressions of gratitude form a significant source of patient feedback, but few healthcare providers use the data to implement change; however, when positive patient feedback is used effectively, increased staff morale brings quantifiable benefits.  Analysis of staff and patient surveys shows an association between staff experience and patient experience, from which has in turn been linked to patient safety and clinical effectiveness. A positive organisational climate and supportive peer relationships enhance staff wellbeing, and this is an antecedent for improved patient care. The King’s Fund has highlighted low morale as a significant problem in the NHS, with a major contributing factor being that staff feel undervalued. The study explores gratitude as a factor that feeds into a supportive climate that has the potential to significantly enhance morale. The project overall will generate advice and guidance for healthcare institutions who wish to better recognise and facilitate gratitude for the morale and subjective well-being of their staff and patients, and therefore improve the quality of care and patient safety.\n\nObservations will be made of exchanges of gratitude between patients and visitors with members of staff, and between staff members on six identified wards at the Royal Brompton Hospital. Observations may be followed up with informal conversations or arranged interviews. Displays of gratitude that are visible in the Hospital (e.g. noticeboards displaying thank-you cards) will also be recorded. Photographs may be taken (with permission) of objects related to gratitude, but no identifiable information will be photographed. No confidential patient information will be recorded. The study is expected to consist of approximately 30 half-day observation sessions over a period of nine months, and a total of around 450 participants are expected to be observed.\n\nAll observations and interviews with patients, staff or visitors will be undertaken where possible with informed consent, however it is possible that the researcher may be incidentally exposed to confidential patient information. Support under the regulations is required in case of accidental disclosure of confidential patient information regarding a non-consented patient during either observations or interviews with staff and consented patients. The researchers have put in a number of safeguards to protect patient confidentiality including consent where possible, observing from a distance to try to avoid overhearing where appropriate, ceasing observations when requested, and reminding all staff and patient participants to respect patient confidentiality during interviews and observations."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Professor Anne Marie Rafferty"]
["Address","The Florence Nightingale"]
[null,"Faculty of Nursing, Midwifery & Palliative Care"]
[null,"James Clerk Maxwell Building, 57 Waterloo Road"]
["Postcode","SE1 8WA"]
["Telephone","020 7848 4698"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Applicants will observe approximately 450 participants, made up of patients over the age of 16, staff and visitors on specified wards. However these will be consented observations/interviews.\n\nSupport for CAG purposes is provided regarding any patient whose confidential patient information may be incidentally disclosed without consent whilst these observations and interviews are taking place. "]
["Description of confidential patient information used","Data sources\nInterviews and observations carried out in the participating NHS Trust:\n1. The Royal Brompton and Harefield NHS Foundation Trust \n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be collected for linkage purposes\n\nIdentifiers required for analysis purposes\nNo items of confidential patient information will be collected for linkage purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-03-04"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as the activity was never able to commence.\n\n04 March 2021 - Application supported\nThe application to allow potential incidental disclosure of confidential patient information when the applicants, who are not members of the direct care team, carry out interviews with consented staff and patients and undertake observations surrounding expressions of gratitude in The Royal Brompton and Harefield NHS Foundation Trust, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee \nConfirmed 4 March 2021 \n\n2. Confirmation from the IGT Team at the Health and Social Care Information Centre of suitable security arrangements via Information Governance Toolkit (IGT) submission\n\nConfirmed:\nThe 2019/20 NHS Digital DSPT reviews for The Royal Brompton and Harefield NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26 January 2021)."]

{"sheet":"A02575","index":617,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02575"]
["Reference","20/CAG/0017"]
["Other Refs","IRAS Project ID: 273884  REC Reference: 19/NW/0753"]
["Application Title","Effectiveness of Differing Psychotherapies Offered in a Specialist Psychotherapy Service – a benchmarking study"]
["Application Summary","This application from the University of Sheffield set out the purpose of medical research that seeks to determine how effective and durable psychotherapy is for patients presenting for specialist tertiary care psychotherapy. \n\nTertiary level psychotherapy services, often regional centres, cater for particularly complex and enduring presentations. This is because patients using these services have been non-responsive to interventions offered in Primary and Secondary care. Little research evidence is available regarding the effectiveness of tertiary care psychotherapy services and is therefore under-represented with regards to evidence compared to primary and secondary services. The applicants will carry out an in-depth statistical analysis of a pre-existing routine outcome data-set collected by a Specialist Psychotherapy Service (SPS) at Sheffield Health and Social Care NHS Foundation Trust, to collect evidence for local tertiary care services to establish how tertiary care services compare to existing benchmarks set by randomised controlled trials.\n\nPatients accessing the SPS are invited to complete an outcome measure, the OQ-45, at the start of treatment, monthly, at the end of treatment and as follow-up from psychotherapy at the SPS. The changes in the questionnaire score will be used as an indicator of the effectiveness of an intervention. Patient outcomes data, along with other relevant demographic information, age, gender, employment status, is routinely recorded within an electronic database. Patients who indicate they do not wish to share their clinical records for health purposes, or decline questionnaire participation, are omitted from this process. The applicants will use this dataset for analysis. They will also request individual electronic patient records in order to extract additional information on medication use, previous psychological therapy input, diagnosis, carecluster. The dataset will be imported into the service outcomes database. Support is sought as the student investigator, who is not part of the direct care team, will carry out the anonymisation of the dataset, before it is exported to the University of Sheffield through the data-gatekeeper identified for this study. Following verification that data is fully anonymised, data will be forwarded to the research team for data analysis."]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Dr Stephen Kellett"]
["Address","Clinical Psychology Unit"]
[null,"Cathedral Court"]
[null,"1 Vicar Lane"]
["Postcode","S1 2LT"]
["Telephone","01142 226 610"]
["Email","s.kellett@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 18 and 80, who have attended a specialist psychotherapy service.\n\nThe applicants anticipate that 1000 patients will be included."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records at Sheffield Health and Social Care NHS Foundation Trust\n2. The outcomes evaluation database at Sheffield Health and Social Care NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-03-10"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support can be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, ‘s251’ support allowed the applicant to publish important details regarding study findings in British Journal of Clinical Psychology. \n\n10 March 2021 - Application supported\n\nThe application, to allow the applicant, who is not a member of the direct care team, to access confidential patient information from the Specialist Psychotherapy within Sheffield Health and Social Care NHS Foundation Trust in order to extract an anonymised dataset for analysis at the University of Sheffield, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. The dataflow diagram needs to be revised to describe the dataset as ‘de-identified.’\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 17 January 2020.\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed: 2019/20 DSPT for Sheffield Health and Social Care NHS Foundation Trust has been reviewed as ‘Standards Met’ (confirmed by email to CAG inbox on 8 March 2021).  "]

{"sheet":"A02576","index":618,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02576"]
["Reference","19/CAG/0047"]
["Other Refs","IRAS Project ID: 239795  REC Reference: 20/WA/0038"]
["Application Title","Development and validation of a risk assessment tool for self-harm in prisoners"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to develop a tool that will identify the risk of repeat self-harm amongst prisoners within three months post ACCT closure. Assessment, Care in Custody and Teamwork (ACCT), is a risk management plan, which is used to collect important information for prisoners considered at risk of self-harm and suicide, to assist in reducing self-harm and suicide in prisons.\n\nThe proposed study has three elements, for the CAG is only being asked to consider the initial part in relation to the development of the tool for which routinely collected data from prison healthcare records and ACCT documentation will be used to create a statistical model to predict repeat self-harm. The second phase of the study will be a qualitative phase working with staff and prisoners on a consented basis and the third phase will involve testing the tool in a cohort of prisoners at the end of their ACCTs. \n\nThe cohort to be included within the first phase of the study will be identified from a dataset which was created in an historical study. This original dataset contains 14,111 ACCT reviews opened between 2004 and 2017 in four prisons at the North of England [HMP NewHall (females), HMP Wealstun, HMP Hull and HMP Leeds]. The dataset contains pseudonymised prison number, date the ACCT was opened and closed, the location where it was opened, reason for opening and closing the ACCT, and post-closure review date. The applicant is seeking support under the Regulations to access the wider clinical records of a sub-cohort of 1,000 patients enrolled in this previous study. The applicant will reverse the pseudonymisation process in order to access the individual prison ID numbers of patients, to enable access to the wider patient records held within the medical record system, SystmOne, which is a known clinical records system. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Seena Fazel, Professor of Forensic Psychiatry"]
["Address","Department of Psychiatry"]
[null,"University of Oxford"]
[null,"Warneford Hospital"]
["Postcode","OX37 JX"]
["Telephone","01865 614 831"]
["Email","seena.fazel@psych.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female adult prisoners (age 18 years old and above) that were on an ACCT following a self-harm episode (including threats of self-harm) between 2004 and 2017 in four prisons at the North of England [HMP NewHall (females), HMP Wealstun, HMP Hull and HMP Leeds, Prison categories (A to C)]. 1000 patient records would be accessed in order to establish the cohort of 750 to be included in phase one of the study."]
["Description of confidential patient information used","The only item of confidential patient information required is Prison ID – the applicant has clarified that this identifier is used within the clinical records system, SystmOne, to identify individual patients. Gender and ethnicity would also be utilised in analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-03-10"]
["Next Review Date","2025-03-10"]
["Notes","Amendment supported 20 December 2022 to allow the applicant to undertake stage 3 of the study with ‘s251’ support instead of consent, (the aim of which is to evaluate and validate the developed RAT and test the tool’s predictive ability in a new cohort of prisoners)\n\n05 May 2022 - Amendment supported to extract one further data item from SystmOne records; ‘Are details of the ACCT recorded in SystmOne’\n\n10 August 2021 - Amendment supported to disclose confidential patient information (Assessment, Care in Custody and Teamwork (ACCT) records,) from participating prisons to HMP Manchester or HMP Styal, and for the researcher to access prison health records remotely\n \n10 March 2021 - Application Supported\nThe application to allow access to prisoner health records by a research assistant to extract wider clinical information necessary for analysis is supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 02 April 2020\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.  \n\nConfirmed: The NHS Digital 19/20 DSPT review for Greater Manchester West Mental Health NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 10 March 2021)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02577","index":619,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02577"]
["Reference","21/CAG/0033"]
["Other Refs","IRAS Project ID: 276144  REC Reference: 21/SC/0064"]
["Application Title","Risk of Aneurysm Rupture Study (ROAR)"]
["Application Summary","This application from University Hospitals Southampton NHS Foundation Trust set out the purpose of medical research which aims to explore whether the PHASES (Population, Hypertension, Age, Size, Earlier subarachnoid haemorrhage, and Site) rupture risk tool provides accurate estimates of rupture risk over 5 years for unruptured intra-cranial aneurysms in a UK population. There are further additional aims including an aim to develop a new future rupture risk prediction model including all described predictors of risk, and to report long-term risk of aneurysm rupture. The applicants propose a multi-centre retrospective observational study of people found to have an unruptured intra-cranial aneurysm between 2006-2020, using clinical data collected from medical notes, and linking to centrally held data on hospital admissions and deaths to identify which patients had a subsequent aneurysm rupture.\n\nBrain aneurysms are found in approximately 3% of people at the age of 55 in the UK. While most cause no symptoms, about 1.4% per year will burst (rupture) and cause a type of brain haemorrhage called subarachnoid haemorrhage (SAH). 30% of people with an SAH will die, while others are left disabled. Aneurysms can be treated prophylactically to prevent rupture, however, these treatments risk serious complications, including stroke and death, at a rate of approximately 5-20%. Because relatively few aneurysms actually rupture, it is difficult to decide if these treatments should be undertaken. Currently the best way to estimate what risk an aneurysm poses is to use the PHASES risk prediction tool. It is however based on data from other countries, that are believed to have a different risk of aneurysm rupture to the UK. It is therefore not clear regarding the validity and applicability of this tool in British patients. It is likely that patients are regularly either being treated unnecessarily or not receiving treatment they would benefit from. This application aims to influence neurosurgical practice and improve patient outcomes by generating an improved risk prediction model more applicable to the UK; it is crucial that patients are provided with most accurate information possible for their treatment decisions.\n\nThe direct care team in participating neurosurgical units around the UK will identify 22,781 patients aged over 18 with an unruptured intra-cranial aneurysm retrospectively from the medical notes. The maximum search period will be 1st January 2006 to 31st December 2020, although units may choose to search only a portion of this period if their systems do not extend back to 2006. Patients who have registered with the national Data Opt Out will be deleted from the list of eligible patients by the clinical team at each individual Trust before onwards disclosure. The clinical teams in each Trust allocate a pseudonymised study number to each individual, and will maintain two separate lists of patient data – one containing identifiers alongside the pseudonymised study number including patient name, postcode, date of birth and NHS number, and once containing clinical information including the pseudonymised study number alongside baseline characteristics. This element does not require support, as this is performed by the direct care team and there is no breach in patient confidentiality. \n\nBoth lists will be securely transferred from participating trusts to the co-ordinating centre at University Hospitals Southampton NHS Foundation Trust, and support under Regulation 5 is required for this disclosure. The co-ordinating centre will combine the lists of identifiable patient information in order to disclose full name, date of birth, NHS number, post code, and pseudonymised study number to NHS Digital and NWIS for the purposes of linkage with HES, ONS and PEDW data. NHS Digital and NWIS will provide the applicant with a dataset containing information on hospital admissions that match these patients with ICD10 diagnostic codes for aneurysmal subarachnoid haemorrhage, traumatic subarachnoid haemorrhage or stroke, and deaths, alongside the pseudonymised study number. Support is required for this flow, as it contains full date of death, however, all other identifiable information is removed. The HES/ONS/PEDW linked datasets will be linked to the clinical datasets by the co-ordinating centre using the pseudonymised study number. Full date of death will be modified to age at death by the applicants, and full date of death deleted within 60 days of data return. Date of birth will be modified to age at diagnosis, and postcode will be modified to deprivation score by the applicant. Once patient identifiable data has been disclosed for linkage purposes the patient identifiable lists will be deleted at the co-ordinating centre and the patient identifier datasets only maintained by individual participating Trusts.\n\nTo ensure the data received is accurate and meaningful, all patients with admissions or death related to subarachnoid haemorrhage will have their pseudonymised study number sent from the co-ordinating centre to the participating neurosurgical units where they were identified, in order to confirm with their medical records that the diagnosis is truly aneurysmal subarachnoid haemorrhage. This is anticipated to be 1% of the dataset. Other codes for traumatic subarachnoid haemorrhage or stroke will be additionally queried to assess rates of misdiagnosis in the overall cohort. The participating trusts will then confirm the diagnosis with the co-ordinating centre via the pseudonymised study number. Final analysis will then occur at the coordinating centre using only pseudonymised data. The University of Southampton and Oxford University will be providing statistical support for data analysis. Neither will have access to the pseudonymisation lists and will not be able to access any identifiable data. Fully anonymised data may be shared with collaborators in the UK or abroad for purposes such as metanalysis of studies of unruptured aneurysms."]
["Applicant Organisation Name","University Hospitals Southampton NHS Foundation Trust"]
["Contact Name","Mr Diederik Bulters, Consultant Neurosurgeon"]
["Address","University Hospitals Southampton NHS Foundation Trust"]
[null,"Department of Neurosurgery, MP 101"]
[null,"Southampton General Hospital, Tremona Road, Southampton"]
["Postcode","SO16 6YD"]
["Telephone","02381 204 803"]
["Email","dbulters@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","22,781 patients aged over 18 with an unruptured intra-cranial aneurysm identified retrospectively.\n\nThe maximum search period will be 1st January 2006 to 31st December 2020 (although units may choose to search only a portion of this period if their systems do not extend back to 2006)"]
["Description of confidential patient information used","Data sources\n1. Up to 25 participating Trusts (Examples of documents from which patients can be identified include medical notes, clinic letters, discharge summaries, multi-disciplinary meeting reports and radiology reports.)\n2. NHS Digital (HES & ONS)\n3. NWIS (PEDW) \n\nIdentifiers required for linkage purposes\n1. Full Name\n2. Date of birth \n3. NHS number\n4. Post code\n5. Pseudonymised study number\n\nIdentifiers required for analysis purposes\n1. Date of birth (modified to age at diagnosis)\n2. Gender\n3. Ethnicity\n4. Date of death (modified to age at death)\n5. Post code (modified to deprivation score)\n\n(Can be considered anonymous as co-ordinating centre will not retain any identifiers) \n\nAdditional information\nThe applicant will request these linkages up to 3 times within the support for this application; one as a pilot, one in October 2021, and one final one in 2022. Any patients who are part of the first 2 linkages will have their CPI retained by the co-ordinating centre until the final linkage is requested, to avoid 25 trusts re-sending identifiers for the same patients."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-03-17"]
["Next Review Date","2024-03-17"]
["Notes","Amendment supported 03 January 2024 to confirm that ‘s251’ support is in place until the final data linkage to NHS England data, regardless of the date this occurs\n\nAmendment supported 03 January 2024 to include the Maternity Services Data Set retained by NHS England, as an additional data source\n\nAmendment supported 03 January 2024 to include the Personal Demographics Service (PDS) Dataset retained by NHS England, as an additional data source\n\n30 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital episode Statistics (HES) & Office for National Statistics (ONS) mortality data\n\nAmendment supported 19 July 2022 to include renal units as additional data sources\n\n17 March 2021 - Application Approved\n\nSpecific conditions of support \n\n1. Support under Regulation 5 only extends to England and Wales.\n\n2. Please amend the sentence in the notification poster: ‘The study has therefore been approved by the national research ethics service and confidentiality advisory groups to proceed without consent.’ to read; \n‘ROAR has received favourable opinion from a Research Ethics Committee (REC) (IRAS number/REC reference number XXX) and has support from the Health Research Authority following advice by the Confidentiality Advisory Group (England and Wales) under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 to conduct the study without study-specific consent) (CAG reference number: XX/CAG/XXXX)’\nAnd provide an updated version to the CAG for consideration within one month from the date of this letter. \n\nConfirmed - The applicant responded to the Sub-committee on 7 April with an amended poster. The CAG were content with this response.\n\n3. Please provide feedback to the CAG with the outcome of the Wessex subarachnoid haemorrhage support group review of the patient notification materials (poster and website), within one month from the date of this letter.\n\nConfirmed - The applicant responded to the Sub-committee with feedback from a PPI group regarding the poster only. The CAG felt that the feedback from the PPI group is sufficient to support the use of the updated poster, however the CAG were not content that the PPI covered the current text on the website. They would therefore prefer if the current website text For patients | ROAR (roarstudy.co.uk)  could be replaced by the wording from the new poster which has been supported by the PPI feedback. It was felt that there is not much difference in the length or content of the text and therefore condition 3 would be met if this was possible. \n\nThe applicant confirmed that this had been updated on 21 April 2021 and the Conditions of support have now been met.\n\n4. Favourable opinion from a Research Ethics Committee. \nConfirmed 17 March 2021\n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:\nThe NHS Digital 19/20 DSPT review for University Hospitals Southampton NHS Foundation Trust and the DSPT equivalent for NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 10 March 2021).\n\nNWIS has a Caldicott Principles into Practice (CPiP) outturn report of 97.5% provided 15th June 2020. \n\nAs there are more than 5 organisations processing confidential patient information without consent, the CAT team has not individually checked the DSPTs; this is the responsibility of the applicant to ensure these are in place."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02578","index":620,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02578"]
["Reference","21/CAG/0044"]
["Other Refs","IRAS Project ID: 290946  REC Reference: 20/NW/0446"]
["Application Title","UK Longitudinal Linkage Collaboration (Study to NHS identifier flow v1)"]
["Application Summary","This application from University of Bristol (UoB) set out the purpose of medical research which aims to create a pseudonymised research database - The UK Longitudinal Linkage Collaboration (UK LLC) - which will bring together data from UK longitudinal population studies (LPS), linked to data from national central datasets, into one secure 'Trusted Research Environment' (TRE), initially with a focus on COVID-19 research. Sir Patrick Vallance, Chief Scientific Advisor to UK Government, established the National Core Studies (NCS), covering key aspects of the pandemic such as surveillance, transmission, trials and vaccines. The Longitudinal Health and Wealth (LH&W) NCS forms part of this initiative. The UK LLC will form a crucial data infrastructure to support scientists working on the LH&W NCS in terms of immediate response and the long-term considerations of the impact of the virus and the pandemic. Support is only requested regarding participating studies which have current support under Regulation 5. Studies using a consented model do not require support. The LLC research database is UK wide but Regulation 5 support does not extend to Scotland or Northern Ireland.\n\nThe LLC will be a co-ordinated research resource, to be used for the ongoing assessment of the impact of Covid-19 in the UK.  The design of the research database is more responsive to changing circumstances and therefore better suited to informing evidence-based policy decisions. Some research questions of LLC include understanding patterns and predictors of infection, (including re-infection) and disease outcomes, including outcomes such as Long-COVID, general health and wellbeing resulting from the pandemic and behavioural restrictions and changes in health help seeking behaviour. Further research areas will be identified as required.\n\nParticipant LPS which currently operate under Regulation 5 support will create 2 files containing data about their cohorts. One file contains identifiers alongside a link ID, and the other file contains pseudonymous attribute data alongside the link ID, which will include date of birth and date of death in modified format (month and year of birth). Identifiable datasets containing name, address, date of birth, date of death, gender and NHS number are disclosed to NWIS as a trusted third party on behalf of LLC. Support is requested for this flow. NWIS will combine all identifiers into one file and remove any duplications, and assign a key ID. The files containing pseudonymous data alongside link ID are sent from LPS to UKSeRP Gateway (University of Swansea) as a trusted third party on behalf of LLC. Support is not required for this flow as it does not contain identifiers. UKSeRP will combine these data into a single file, and will assign the same key ID to the dataset, as the key between link ID and key ID will be disclosed from NWIS to UKSeRP. \n\nNWIS will disclose the file containing identifying information alongside key ID to NHS Digital to facilitate linkage with English Covid-19 related data sets as detailed in the application. This flow requires Regulation 5 support. NHS Digital will apply an LLC flag against each of these individuals on the NHS Patient Demographic Service (PDS). If date of death is available, NHS Digital will modify this to month and year of death. The identifiers will then be removed, and pseudonymous data alongside the key ID will be returned to UKSeRP (acting on behalf of LLC); this flow does not require support as it does not contain any confidential patient information. This data will then be linked to the pseudonymous data files supplied by LPS using the key ID, and transferred into the UK LLC TRE, with University of Swansea as processor for UoB. The LLC research database operates pseudonymously, and therefore the retention of the LLC database does not require support under Regulation 5. Welsh covid-19 related data is obtained through SAIL, however support is not required for this element as no identifiers are disclosed to them in order for SAIL to provide LLC with pseudonymised information.  \n\nNWIS retains identifiers, to enable ongoing de-duplication, and also retains the key between key ID and link ID. The participating LPS retain the key between link ID and identifiers. Each new LPS operating under Regulation 5 that participates in LLC is expected to be added to LLC application with a CAG amendment.\n\nEach LPS will perform this data transfer quarterly, in order to reflect the dynamic nature of LPS membership where participants enter studies (through recruitment or birth) and leave studies (through registering an LLC opt-out or withdrawing from the study). NHS Digital will provide repeated monthly extracts of linked pseudonymised data to the LLC, in order to refresh the UK LLC with timely flows of Covid-19 records.\n\nThe UK LLC resource will be added to the HDRUK Gateway catalogue. The data access approvals mechanism is described in the application, and applicants aim to recruit lay members (ideally study participants) to the Data Access Committee which will process applications to use the UK LLC.  The UK LLC is intended to be a resource for UK based researchers investigating Covid-19. All use must be for the purpose of delivering public benefits through improvements to the Health and Social Care system. For profit purposes are not permitted, although private sector organisations conducting research aiming to improve the public good (with a commitment for prompt public domain publication) may be permitted. Only aggregated data are permitted to leave the UK LLC TRE, and can be considered anonymous to the researchers receiving it. "]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Mr Andy Boyd"]
["Address","Director, UK Longitudinal Linkage Collaboration (UK LLC) \n"]
[null,"University of Bristol"]
[null,"Canynge Hall, 39 Whatley Road, Bristol"]
["Postcode","BS8 2PS"]
["Telephone","07792 954 024"]
["Email","a.w.boyd@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","More than 1 million UK longitudinal population studies (LPS) participants, however those requiring support are likely to number around 100,000"]
["Description of confidential patient information used","Data sources\n1. The National Survey of Health and Development (NSHD) (UCL) CAG REF: 15/CAG/0139\n\n2. The Southall and Brent Revisited (SABRE) study (UCL)  CAG REF: ECC 8_02(FT5)/2010 (extension to PIAG 2_05(FT1)/2008\n\n3. TwinsUK (KCL) CAG REF: 19/CAG/0223\n\n4. ALSPAC (University of Bristol) CAG REF: ECC 1-05(b)/2012 \n\n5. NHS Digital; the full Covid-19 relevant dataset for the above cohort - this will include primary care data (the COVID-19 GPES dataset), Covid-19 testing and vaccination records, HES records, mortality records and specialist datasets covering mental health community care (MHSDS, IAPT) and disease registers. The full list can be found in the application. \n\nIdentifiers required for linkage purposes\n1. Full Name (current and historic name)\n2. Address and postcode (current and historic)\n3. Date of Birth\n4. Date of death \n5. NHS number\n\nIdentifiers required for analysis purposes and retained in LLC database\n1. Deprivation indices (modified from postcode by University of Leicester and sent in a file 2 format as per flow diagram)\n2. Sex\n3. Occupation \n4. Ethnicity\n5. Date of birth (modified to month and year by LPS and sent in file 2)\n6. Date of death (modified to month and year by LPS or NHS Digital and sent in file 2)\n7. Encrypted person ID\n\n(Can be considered as effectively anonymous to LLC)\n\nAdditional information\nPatients will be flagged as LLC by NHS Digital on their records.\n\nNWIS will retain identifiers and the key between the link ID and the Key ID.\n \nLPS will update NWIS with new file 1’s quarterly, and NHS Digital will provide monthly updates of pseudonymised linked data to LLC.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-03-29"]
["Next Review Date","2024-07-01"]
["Notes","Amendment outcome 20 December 2023;\n\n1.\tThe amendment, to add EPIC Norfolk (The European Prospective Investigation into Cancer Norfolk Study) as a participating LPS, is supported, subject to compliance with the standard and specific conditions of support.\n\n2.\tThe amendment, to extend the duration of support until June 2028, is supported, subject to compliance with the standard and specific conditions of support.\n\n3.\tThe amendment, to widen the purposes of support from COVID-19 research to all research is provisionally supported, subject to Requests for further information for Change 3 (and compliance with the standard and specific conditions of support). Support is not in effect until a response to the following request for further information is received and a final outcome letter is issued. \n\nAdditional specific conditions of support:\n\n1.\tThe CAG requested that any additional longitudinal data set that is going to be added, where consent is not sufficient, should be submitted as an amendment to CAG. This should provide clear detail on how these participants will be informed of the new use.\n\n2.\tThe CAG requested that more details to be provided on the types of research that the data access panel has considered and supported/rejected within six months from the date of approval of this amendment.\n\n3.\tSection 251 can only be provided where there is a medical purpose. The applicants should ensure that any request to use the data should be for a medical purpose\n\n4.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold Confirmed: \n\nThe applicant must ensure that NHS England confirmation of ‘standards met’ for organisations processing confidential patient information is in place. As there are more than 5 organisations, the DSPTs will not been individually checked by the Confidentiality Advice Team (CAT). This will be the responsibility of the applicant.\n\n5.\tConfirmation of a favourable opinion from a Research Ethics Committee. Confirmed 16 October 2023\n\n\n\nAmendment supported 05 September 2023 \nTo remove SABRE (Southall and Brent Revisited) as a participating longitudinal population study (LPS), and to include TEDS (Twins’ Early Development Study) data into the UK Longitudinal Linkage Collaboration (LLC), as a participating LPS\n\n06 June 2023 - change in data processor from NHS Digital to NHS England regarding the full Covid-19 relevant dataset, including primary care data (the COVID-19 GPES dataset), Covid-19 testing and vaccination records, HES records, mortality records and specialist datasets covering mental health community care (MHSDS, IAPT) and disease registers. The full list can be found in the application.\n\n29 March 2021 - Application supported\n\nSpecific conditions of support\n\n1.\tSeek legal opinion on whether the application will fall within scope of the COPI notice and confirm this in writing as soon as known. \na.\tWhere it does fall in scope Regulation 5 support, through this letter, will only come into effect on expiry of the COPI notice.\nb.\tWhere it does not fall in scope, this letter confirms Regulation 5 support for the application.\n\nAccepted, and the outcome letter provided will come into effect at the expiry of the COPI notice. Condition met 22 September 2021.\n\n2.\tSupport is provided for the purposes of Covid-19 research only, any further purposes of the research database would require an amendment, with the medical purpose clearly described.\n\nApplicant confirmed understanding September 2021. \n\n3.\tSupport is provided for two years from the date of this letter. A duration amendment will be required if the applicant wishes to extend this support.\n\nApplicant confirmed understanding September 2021. \n\n4.\tPlease justify the requirement for NWIS to retain confidential patient information after the initial linkage and flagging has occurred, or confirm that NHS number and date of birth will be sufficient for de-duplication and the remaining data items will be deleted. Please confirm within four months from the date of this letter. \n\nThe members considered that the justification provided for DHCW (NWIS) retaining identifiers seems to be future linkage. This is acceptable to the Members. However they wish to state that they disagree with the statement that this CPI 'arguably would not be reasonably considered as socially sensitive within this context.' This CPI deserves to be treated as CPI in any context. Condition met 22 September 2021.\n\n5.\tPlease develop a shorter patient notification for the LLC website which leads on to the more lengthy privacy notice, and provide an updated version to the CAG, within four months from the date of this letter.\n\nCondition met 22 September 2021.\n\n6.\tPlease ensure that the involvement of any commercial partners is made clear in patient facing LLC documents, within four months from the date of this letter.\n\nCondition met 22 September 2021.\n\n7.\tPlease provide copies of the LPS patient notification materials used, at annual review.\n\nCondition met 06 June 2023.\n\nApplicant accepted, however as they are now operating under the COPI notice, annual review will be 1 year after the COPI notice expires.\n\n8.\tPlease confirm that individuals were able to opt out of LLC with their individual LPS without withdrawing from the participating LPS as a whole, within four months from the date of this letter.\n\nCondition met 22 September 2021.\n\n9.\tPlease provide clarity on what Patient and Public Involvement and Engagement activities are planned for feedback surrounding the acceptability of the use of confidential patient information without consent for the purposes of LLC, and the anticipated timescales for achieving this, within four months from the date of this letter. \n\nCondition met 22 September 2021.\n\n10.\tPlease explain in more detail how the LLC Data Access Committee interacts with the LPS providing the individual data sets, when deciding whether or not to release data to applying researchers, within four months from the date of this letter.\n\nCondition met 22 September 2021, however the CAG wish to emphasise that the applicant should make every effort to ensure lay representation at all meetings of DAC which, given the frequency of the meetings, might require more lay members. \n\n11.\tFavourable opinion from a Research Ethics Committee. Confirmed 13 November 2020\n\n12.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nAs there are more than 5 organisations, the DSPTs have not been individually checked by the Confidentiality Advice team (CAT). This is the responsibility of the applicant to ensure that security assurances are in place for any organisation processing confidential patient information without consent. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02579","index":621,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02579"]
["Reference","20/CAG/0100"]
["Other Refs","IRAS Project ID: 280873  REC Reference: 20/LO/1006"]
["Application Title","Study of lung transplant in cystic fibrosis through linkage between the UK Cystic Fibrosis Registry and the UK Cardiothoracic Transplant Registry"]
["Application Summary","This application, from London School of Hygiene & Tropical Medicine, sets out the medical purpose to undertake data linkage and research into lung transplants in Cystic Fibrosis.\n\nCystic fibrosis (CF) is one of the most common inherited diseases and affects around 10,500 people in the UK. The most seriously affected organ in CF is the lung and people with CF experience long-term deterioration in lung function. Lung transplantation is a treatment option for people with CF who have end-stage lung disease, with the aim being to improve both quality and quantity of life.\n\nThe applicants wish to link data held within the Cystic Fibrosis Registry and NHS Blood and Transplant (Cardiothoracic Transplant Registry). Identifiers, without clinical data, from each registry will be sent to NHS Digital to enable common pseudonyms to be generated. The pseudonymised IDs will be transferred to London School of Hygiene & Tropical Medicine from NHS Digital, as will the clinical data from each registry, where the data from each registry will be linked. The actions of Cystic Fibrosis Registry is undertaken through participant consent, whereas section 251 support will be required for the actions of NHS Blood and Transplant.\n\nThe resultant data will be used for research purposes by the team to investigate how people with CF progress along the transplant pathway from joining the waiting list to transplant and to death on the waiting list or post-transplant, the impact of lung transplantation on life expectancy for people with CF, how patient characteristics are associated with the risks and benefits of lung transplant and how patient and donor characteristics affect post-transplant outcomes."]
["Applicant Organisation Name","London School of Hygiene & Tropical Medicine"]
["Contact Name","Professor Ruth Keogh"]
["Address","London School of Hygiene & Tropical Medicine"]
[null,"Keppel Street"]
[null,"London"]
["Postcode","WC1E 7HT"]
["Telephone","020 7927 2570"]
["Email","Ruth.Keogh@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","People with CF in the UK who have data recorded in the UK Cardiothoracic Transplant Registry up to and including 2019.\n\nPeople without CF and lung transplant donor who have data recorded in the UK Cardiothoracic Transplant Registry, up\nto and including 2019."]
["Description of confidential patient information used","Data sources\n1. NHS Blood and Transplant\n2. NHS Digital\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of Birth\n3. Gender\n\nIdentifiers required for analyis purposes\n1. Date of Death\n\nAdditional information\nThe applicants state that The Cystic Fibrosis Registry data is collected under consent, and so is not part of this support."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-03-31"]
["Next Review Date","2022-03-31"]
["Notes","31 March 2021 - Application Supported\n\nSpecific conditions of support\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 16 September 2020\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \nThe NHS Digital 19/20 DSPT review for London School of Hygiene and Tropical Medicine, NHS Digital and NHS Blood and Transport was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 30 March 2021)"]

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[]
[]
["Application Number","A02580"]
["Reference","21/CAG/0003"]
["Other Refs","IRAS Project ID: 266579  REC Reference: 20/EM/0186"]
["Application Title","Transforming research with routinely collected linked clinical data using an umbrella ethics and governance approach at Newcastle Hospitals"]
["Application Summary","This application from Newcastle upon Tyne Hospitals NHS Foundation Trust set out the purpose of medical research which aims to link data from datasets held within Newcastle upon Tyne Hospitals NHS Foundation Trust for use in research projects under this ‘umbrella’ application.\n\nThe Newcastle-upon-Tyne Hospitals NHS Foundation Trust is moving to the use of electronic patient records and allows for these to be used for a wide range of research that has the potential to improve patient care. For example; a better understanding of disease patterns and risk factors for disease, as well as new information on how effective treatments are in the real world, how to make diagnoses more efficiently, and a better understanding of how healthcare services are used by patients.\n\nResearchers wishing to access the data will apply through the Newcastle-upon-Tyne Hospitals NHS Foundation Trust. The application will be considered by the Data Access Committee, which includes lay representation. On approval through this committee the required data will be linked from the datasets, held by Newcastle-upon-Tyne Hospitals NHS Foundation Trust. This involves access to identifiable data by a member of staff who does not have a legal basis under common law to do so. A deidentified dataset will then be created and shared with the researcher, who will need to access the data through Trust systems.\n\nThe applicants are seeking ‘umbrella’ support to use this methodology for any applicants that apply for data from Newcastle upon Tyne Hospitals NHS Foundation Trust. A separate, permanent database is not being created. Instead, bespoke datasets will be created from Newcastle upon Tyne Hospitals NHS Foundation Trust medical records upon request. "]
["Applicant Organisation Name","Newcastle upon Tyne Hospitals NHS Foundation Trust"]
["Contact Name","Professor Miles Witham"]
["Address","NIHR Newcastle Biomedical Research Centre"]
[null,"Campus for Ageing and Vitality"]
[null,"Newcastle"]
["Postcode","NE4 5PL"]
["Telephone","0191 282 5959"]
["Email","Miles.Witham@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients accessing Newcastle upon Tyne Hospitals NHS Foundation Trust service since 2009 and have a Trust record."]
["Description of confidential patient information used","Data sources\n1. Newcastle upon Tyne Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID\n4. Date of Birth\n5. Postcode (unit level)\n\nIdentifiers required for analysis purposes\n1. Postcode (District level)\n\nAdditional information\nNote that whilst the Trust electronic record went live in 2009 some patients with an electronic record may have scanned information from contacts prior to 2009, and these will be included in the research."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-03-25"]
["Next Review Date","2024-03-25"]
["Notes","25 March 2021 - Application Supported\n\nSpecific conditions of support \n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 10 August 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed 25 March 2021 - DSPT for 2019/20 confirmed for Newcastle Upon Tyne Hospitals NHS Foundation Trust (by check of the NHS Digital DSPT tracker on 25 March 2021). "]

{"sheet":"A02581","index":623,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02581"]
["Reference","19/CAG/0215"]
["Other Refs","IRAS Project ID: 64396  REC Reference: 11/S0703/6"]
["Application Title","Fractional Flow Reserve versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary Syndromes: a developmental clinical study of management guided by coronary angiography combined with fractional flow reserve (FFR) measurement versus management guided by coronary angiography alone(standard care) in patients with non-ST elevation MI"]
["Application Summary","This application from the University of Glasgow set out the purpose of medical research that seeks to obtain information on how coronary fractional flow reserve (FFR) data relate to clinical decisions based on visual assessment of the coronary angiogram in order to guide the design of a future clinical trial of FFR-guided decisions in non-ST elevated myocardial infarction (NSTEMI).\n\nNSTEMI is the commonest type of acute myocardial infarction (MI) / acute coronary syndrome and MI is a leading cause of premature ill health and death in the community. The morbidity and mortality rate in patients with NSTEMI is high and 5-10% of patients had die or experience a recurrent NSTEMI within 12 months of the original NSTEMI. Coronary fractional flow reserve is the pressure drop across a narrowed coronary artery. FFR is measured using a coronary ‘pressure wire’, similar to that used in coronary angiography and angioplasty. The pressure wire is commonly used in angina patients but not in patients who have had a recent heart attack, due to a lack of evidence of its effectiveness in this patient group. The applicants sought to gather information on whether use of the pressure wire in patients who have had a recent heart attack can alter and improve treatment decisions made in the catheter lab\n\nA pilot study ran between October 2011 to May 2014, to collect information about the potential usefulness of the pressure wire and inform whether a larger scale trial was feasible. A two-centre study was run and recruited 350 patients who received coronary angiography and angioplasty following a heart attack. The pressure wire was used in all patients, however the FFR value would be disclosed in half of the patients (FFR group) but not in the 'usual care' group. Doctors in the FFR group were given an FFR result which they may or may not choose to guide decision-making. Clinical decisions were made in the normal way in the 'usual care' patients. Patients were recruited into the pilot study on a consented basis and followed-up for at least 6 months. Enrolment completed in 2013. NHS Digital have reviewed the patient information and consent materials used at the time and determined that it was not explicitly stated that data would be held and analysed at the University of Glasgow. Section 251 support was therefore sought for the continued holding of this data and linkage to HES data held by NHS Digital."]
["Applicant Organisation Name","University of Glasgow"]
["Contact Name","Dr Colin Berry"]
["Address","BHF Glasgow Cardiovascular Research Centre"]
[null,"126 University Place"]
[null,"Glasgow"]
["Postcode","G12 8TA"]
["Telephone","0141 330 1671"]
["Email","colin.berry@clinmed.gla.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","167 patients aged 18 and over who had experienced a myocardial infarction and were recruited into the pilot study."]
["Description of confidential patient information used","Data sources\n1. Study data collected for the pilot study and held at the University of Glasgow\n2. HES and ONS data held by NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Postcode – unit level\n5. FAMOUS study ID\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Gender\n4. FAMOUS study ID"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-04-01"]
["Next Review Date","2025-04-01"]
["Notes","30 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital episode Statistics (HES) and Office for National Statistics (ONS) mortality data\n\n01 April 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 10 August 2020. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Pending for University of Glasgow. \n\nConfirmed:-\n- NHS Digital has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 10 June 2019. \n\n- NHS Digital confirmed that ISO 27001 is acceptable security assurance for the Robertson Centre for Biostatistics at the University of Glasgow. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02582","index":624,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02582"]
["Reference","21/CAG/0021"]
["Other Refs","IRAS Project ID: 268639  REC Reference: 21/NE/0033"]
["Application Title","Increasing cervical cancer screening uptake in Yorkshire: Testing the effectiveness of a behaviour change intervention in deprived and non-deprived populations"]
["Application Summary","This application from University of Leeds set out the purpose of medical research which aims to pilot and test the effectiveness of a new low-cost behaviour change intervention to increase uptake of cervical screening in Yorkshire. This randomised controlled trial will test two interventions individually and combined; (a) Implementation intention-based intervention, (b) a motivational based intervention, (c) both these interventions combined, and (d) usual care control. The study will investigate if the intervention reduces inequality by increasing screening in low uptake groups. \n\nEarly identification of cervical cancer risk could prevent a large number of deaths. The NHS Cervical Screening Programme is the central strategy for reducing cervical cancer mortality. However, screening uptake rates are falling, particularly in women aged 25-49 years and remain low in deprived groups. The behaviour change techniques included in this intervention have been shown to effectively encourage a wide range of positive health behaviours, including medical screening. By applying these techniques to encourage cervical cancer screening uptake, this low cost intervention has three potential benefits; Increased early detection and therefore increased patient survival, Reduced inequalities – screening uptake is particularly low in areas of socioeconomic deprivation, and it is hoped that this study will help reduce these inequalities by encouraging screening in low uptake groups, and substantial cost savings for the NHS.\n\nThe cohort is 16,000 individuals living in North East and Yorkshire region, who will be sent an invitation to take part in cervical cancer screening from the National Cervical Cancer Screening programme within the next 48 hours. NHS Digital will extract a list of individuals who are due to be sent an invitation to take part in cervical cancer screening in the following 48 hours from the Cervical Screening Administration Service (CSAS) database, using the National Health Application and Infrastructure Services (NHAIS) database. NHS Digital will remove any individuals who have registered with the National Data Opt Out, along with anyone who has requested not to be invited to take part in the study (Information will be available on certain websites providing an opt out option prior to the intervention date). The remaining women will be randomised to one of the four conditions of the randomised controlled trial. A document with randomisation order will be provided by the research team to NHS Digital. NHS Digital will then provide the list of eligible participants in the format; Name, NHS number, Address including postcode, and randomised study condition, to Capita Intelligent Communications (CIC), the mailing service used by the Leeds Cervical Screening Administration Service mailing centre. The study information sheet along with the intervention materials, as described in the application will be sent by CIC to the participants, approximately 48 hours after the initial screening letter is sent from the cervical screening service. \n\nParticipants are free to decide not to take part (i.e., not to use the intervention materials) should they wish. Participants will also be able to opt out from having their uptake data used in the study, by contacting NHS Digital. Screening uptake data will be extracted on a one-off basis at the end of the trial (16 weeks post-screening invitation) by NHS Digital, by linking the list of patients who were sent the intervention with data on cervical cancer screening uptake (using the NHAIS database, or replacement, both held at NHS Digital) using NHS number, date of birth and address. Date of birth will be modified to age group, and postcode will be modified to deprivation score by NHS Digital. All identifiers will be removed from the dataset, and NHS Digital will send the anonymised dataset to the researchers at the University of Leeds. At no stage of the research will the University of Leeds research team have access to confidential patient identifiable information. NHS Digital are acting as data processor on behalf of Public Health England, the data controller for all cervical screening data in England. "]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Prof Daryl O'Connor"]
["Address","University of Leeds"]
[null,"School of Psychology"]
[null,"Leeds"]
["Postcode","LS2 9JT"]
["Telephone","0113 343 5727"]
["Email","d.b.oconnor@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","At the timepoint of data extraction to create the cohort;\n16,000 Individuals aged 24.5-64 who are eligible for cervical cancer screening and who are due to receive a screening invitation in the following 48 hours from the National cervical cancer screening programme, located within North East and Yorkshire region.\n\nAt the timepoint of receiving study information;\nthe cohort will have received their cervical cancer screening invitation in the previous 48 hours.\n\nThis data extraction is planned to take place in February or March 2021."]
["Description of confidential patient information used","Data sources\nAt the timepoint of data extraction to create the cohort;\n16,000 Individuals aged 24.5-64 who are eligible for cervical cancer screening and who are due to receive a screening invitation in the following 48 hours from the National cervical cancer screening programme, located within North East and Yorkshire region.\n\nAt the timepoint of receiving study information;\nthe cohort will have received their cervical cancer screening invitation in the previous 48 hours.\n\nThis data extraction is planned to take place in February or March 2021.\n\nIdentifiers required to extract and disclose to Capita\n1. Name\n2. NHS number\n3. Address including postcode\n4. Study intervention condition\n\nIdentifiers required for linkage purposes\n1. NHS number \n2. Date of birth \n3. Address including postcode  \n4. Study intervention condition\n\nIdentifiers required for analysis purposes\n1.\tStudy intervention condition\n2.\tAge group (modified from date of birth)\n3.\tDeprivation score (modified from postcode)\n\nThis data will be extracted on a one-off basis, 16 weeks post screening invitation by NHS Digital, and can be considered anonymous.\n\nAdditional information\nThe research team at the University of Leeds will not receive any identifiable information."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-03-30"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised\n\nIn terms of public benefit, the findings of this large randomised control trial (N=14,536) did not find support that a volitional or a motivational intervention improved uptake of cervical cancer screening in the North of England. However, it did find that only 40% of participants attended for cervical cancer screening 16 weeks after receiving their invitation. These levels of uptake are below the national average. Future research ought to investigate and understand the barriers to uptake following on from the COVID-19 pandemic.\n\n\n30 March 2021 - Application Supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 25 March 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:\n• The NHS Digital 19/20 DSPT equivalent review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 05 February 2021).\n• The 19/20 DSPT submission for Capita Business Services was confirmed as ‘Standards Met’ by NHS Digital email to CAG inbox (received 26 February 2021).\n• University of Leeds 8E218 – SEED does not require a DSPT for this application, as no identifiers are processed at this organisation."]

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[]
[]
["Application Number","02583"]
["Reference","20/CAG/0141"]
["Other Refs","IRAS Project ID: 276367  REC Reference: 20/LO/1168"]
["Application Title","Conversation analytic (CA) study of prognostic decision-making within palliative multi-disciplinary team (MDT) meetings"]
["Application Summary","This application from University College London, Division of Psychiatry, Marie Curie Palliative Care Research Department sets out the purpose of medical research that aims to explore how health care professionals with different backgrounds make decisions regarding prognosis for terminally ill patients during MDT meetings in a hospice. The analyses will use Conversation analytic (CA) methodology to give an insight in to how MDT prognostic decisions are initiated, structured, potentially challenged and negotiated, and finally closed. This application is a qualitative study of recorded interactions between healthcare professionals in MDT meetings in the Marie Curie Hospice, Hampstead, as part of a PhD project. \n\nStudies show that there is value for patients and families in accurate prognostic information. Clinicians’ predictions about length of survival are inaccurate and over-optimistic, and no clear guidance exists on how clinicians can be taught to perform this task better. Nonetheless, clinical predictions of survival remain the most common method of arriving at a prognostic estimate. This inaccuracy and inconsistency is maintained when the timeframe of the prognosis is reduced to days. One potential method to improve prognostication has been to look at decisions made by an MDT, however the manner in which different estimates are combined to arrive at an MDT estimate is not well understood.\n\nApplicants plan to collect video recordings of 20-30 hospice-based MDT meetings. The collaborating hospice has two wards that each holds a weekly MDT meeting, during which staff members with different professional backgrounds discuss palliative patients' care planning. Before MDT meetings, a researcher will set up equipment (cameras, microphones) in the meeting room, and immediately before the meeting begins, the equipment will be turned on. The researcher will stay outside the meeting room, to avoid interfering in the processes of the meeting. All staff and visitors taking part in the MDT will have been approached by the researcher with an information sheet and asked to provide signed informed consent. If the staff member declines consent, their data will be excluded from analysis. A note on the door will also inform staff and visitors that the meeting is being recorded.\n\nData will be collected using encrypted recorders. Recordings will be uploaded electronically to a UCL encrypted laptop at the hospice site as soon as possible after the meeting, and then then deleted from the recorders.  If the recordings are not immediately uploaded, they will be safely stored in a locked cabinet with restricted access at the hospice for a maximum of 72 hours. The laptop will be physically transferred back to UCL, where all patient identifiable information will be deleted or anonymised from the video recordings before transferring to the UCL s:drive for storage, and deletion from the laptop. \n\nThe researcher will make detailed transcriptions of the recordings, and information that might lead to identification of the patients being discussed or of the participants in the meetings will be anonymized and pseudonymised. This will be done by (1) using pseudonyms instead of participants’ and patients’ names, location etc. in transcripts etc. and by (2) beeping out”/audibly masking the identifiable information in the video recording. A list of pseudonyms will not be maintained so patients will not be able to be re-identified. No patient-identifiers will be retained because this information is not required for the study purposes. The method of CA closely investigates the sequential organisation and the interactional functions of naturally occurring talk as well as non-verbal behaviour. Therefore the applicants plan to use the transcription system CLAN (Computerized Language Analysis), to enable them to link the transcripts to media. "]
["Applicant Organisation Name","University College London"]
["Contact Name","Prof Patrick Stone, Chair in Palliative Medicine"]
["Address","Marie Curie Palliative Care, Research Department, Division of Psychiatry"]
[null,"PI Office 6, UCL, 6th Floor, Wing B"]
[null,"Maple House, 149 Tottenham Court Road, London"]
["Postcode","W1T 7NF"]
["Telephone","020 7679 9623"]
["Email","p.stone@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","For CAG purposes support is only given regarding patients at the Hospice, not for staff members or official visitors.\n\nThe cohort is: patients treated Marie Curie Hospice, Hampstead who are being discussed during MDT meetings, whose information may be incidentally disclosed."]
["Description of confidential patient information used","Data sources\n1. Video recordings of MDT meetings at Marie Curie Hospice, Hampstead\n\nIdentifiers required for linkage purposes\n1. No items of confidential patient information will be collected for linkage purposes\n\nIdentifiers required for analysis purposes\n1. No items of confidential patient information will be collected for analysis purposes\n\nAdditional information\nVideo recordings will be anonymised by \n• Using pseudonyms instead of participants’ and patients’ names, location etc. in written transcripts. Applicant has confirmed that a list of patient names and their identifiers will not be kept.\n• Audibly masking the identifiable information in the video recording by ‘beeping out’"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-04-06"]
["Next Review Date","N/A"]
["Notes","April 2022 - Support Expired\nApplicant confirmed April 2022 that ‘s251’ support is no longer required and the application can be expired. \n\nApplicant confirmed that they completed data collection in December 2021. All video recordings have now been anonymised. \n\nIn terms of public benefits, the evidence suggest that both professionals, carers and patients all value accurate prognostic information. This study is taking the first steps in how hospice MDT members discuss prognoses and the findings can be used to inform recommendations for clinical practice. Findings may also guide future research. Moreover, preliminary findings have received interest from the Marie Curie head office. Marie Curie is working on ensuring earlier access to palliative care where prognostication plays an important role. Prognostication research has been particularly relevant with the recent change in the current Special Rules for Terminal Illness which fast-track benefit applications for those with a terminal diagnosis of six months are being replaced with a new 12-month, end of life definition. The study team has been invited to participate in ongoing work on the impact of prognostic decisions with the Marie Curie Policy and Research team.\n\n06 April 2021 - Application Supported\n\nConditions of support:\n\n1. Wider patient and public involvement and engagement activity should be carried out to test the acceptability of the project and its methodology with a wider group. Feedback about the activity undertaken and the views expressed is required at the time of first annual review. If the views provided were negative, the CAG would take this into account when considering whether support can continue or whether further work is required.\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 4 December 2020\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed –\nThe 2019/20 NHS Digital DSPT review for UCL School of Life and Medical Sciences (EE133902-SLMS) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 06 November 2020).\nThe 2019/20 NHS Digital DSPT review for Marie Curie London (8GK24) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 06 April 2021)."]

{"sheet":"A02584","index":626,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02584"]
["Reference","21/CAG/0025"]
["Other Refs","IRAS Project ID: 285241  REC Reference: 21/WA/0028"]
["Application Title","Retrospective Review of the Use of Simplex High Viscosity Bone Cement for Joint Arthroplasty\n(Short title: Simplex Cement)"]
["Application Summary","This application from Royal Devon & Exeter NHS Foundation Trust set out the purpose of medical research which aims to evaluate the success rate of cemented Triathlon Total Knee Replacement surgery with fixation of components implanted using Simplex high viscosity bone cement (Simplex HV). Success is defined as absence of revision due to aseptic loosening in cemented Triathlon Total Knee components implanted with Simplex HV, at two years post initial surgery. This application is only for a retrospective, consecutive series, evaluation of medical records of patients who have undergone total knee replacement (TKR) at Royal Devon & Exeter NHS Foundation Trust. The study is sponsored by Stryker, and the anonymised dataset will be sent to Stryker for analysis, however this flow of data, and any other participating sites are not in scope for this application.  \n\nNearly 100,000 primary TKR surgeries are performed per year in the UK. There has been concern that high viscosity (HV) cement could cause early loosening of the components in some patients. However, HV cement has advantages over low viscosity cement, including allowing more time to work with the cement during the handling and setting phases of surgery, which has potential to allow for greater operational/surgical efficiency. There is therefore a need to demonstrate the safety of HV cement used in TKR, as measured by the absence of loosening at two years after surgery.\n\nAs a part of routine care, Royal Devon & Exeter NHS Foundation Trust already keeps a clinical database of patients who have undergone TKR. The Chief Investigator (CI), who is part of the direct care team, will identify potential study cases from this database, therefore this element does not require support. The CI will then inform medical student researchers of eligible patients by disclosing confidential patient information. The subsequent extraction of the data for those meeting the inclusion criteria will be undertaken by medical student researchers; this element requires support under Regulation 5, as data extraction will be performed by members of staff who are not part of the direct care team, by searching the patient administration system, paper and electronic medical records and radiology systems. Name, date of birth, and hospital number will be used to ensure the information extracted is for the correct patient. The researchers will complete the paper case report forms, which are then pseudonymised by the CI with patient code (randomly allocated starting AA etc – this is not related to the patients initials), centre number and subject number. These paper based forms are then disclosed to Stryker by entering into an electronic database, and then Stryker send to their statistician in the US for analysis. This disclosure can be considered anonymous and does not require support. A log linking the study number, and patient code attributed to each patient to their confidential patient information will be kept by the CI only until 6-12 months after the results are published (estimated date February 2023). The CI is a member of the direct care team, and therefore support not required for this. "]
["Applicant Organisation Name","Royal Devon & Exeter NHS Foundation Trust"]
["Contact Name","Prof Andrew Toms, Consultant Orthopaedic Surgeon"]
["Address","Royal Devon Exeter NHS Foundation Trust"]
[null,"Barrack Road"]
[null,"Exeter"]
["Postcode","EX2 5DW"]
["Telephone","0139 240 3562"]
["Email","andrewtoms@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 Patients aged 18-100 years who have undergone total knee replacement as the treatment for end stage osteoarthritis of the knee in 2014-15. All will have had had anti-biotic loaded HV cement"]
["Description of confidential patient information used","Data sources\nThe hospital patient administration, paper and electronic medical records and radiology systems at Royal Devon & Exeter NHS Foundation Trust. Data collected as part of routine care \n\nIdentifiers required for the purposes of data extraction\n1. Name\n2. Date of Birth\n3. Hospital number\n\nIdentifiers required for analysis purposes\n1. Patient code (randomly allocated AA etc as described in application)\n2. Centre #\n3. Subject #\n4. Age\n5. Gender \n6. Diagnosis\n\n(This can be considered anonymous as Stryker will not be able to re-identify)\n\nAdditional information\nThe CI retains the key between the patient code, centre #, subject # and the identifiers, until after publication of results, in case the study team find unexpected and unreported adverse events. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-04-06"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised\n\nIn terms of public benefit, the information from this study has been used to write a report for the cement manufacturers documenting the safety and efficacy of the bone cement that was being studied. A research paper for presentation to the surgical community is being prepared.\n\n\n06 April 2021 - Application Supported\n\nConditions of support:\n\n1. It is a condition of support that the applicant comply with the national data opt out once this is mandated for NHS Trusts.\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 09 February 2021\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \nThe NHS Digital 19/20 DSPT review for Royal Devon & Exeter NHS Foundation Trust was confirmed as ‘Standards Met’ (by email to the CAG inbox on 24th March 2021) "]

{"sheet":"A02585","index":627,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02585"]
["Reference","21/CAG/0036"]
["Other Refs","IRAS Project ID: 286034  REC Reference: 21/LO/0219"]
["Application Title","Identification of Specific Low-Uptake Population Segments in Breast Cancer Screening"]
["Application Summary","This application from Imperial College London set out the purpose of medical research that aims to confirm the extent to which socio-demographic and co-morbidity factors predict breast screening adherence. It also aims to establish whether combinations of these factors are more strongly associated than single demographics. The applicant therefore aims to characterise a non-compliant phenotype, and this will later inform targeted measures to increase breast cancer screening adherence. This is a retrospective analysis of two linked datasets; the NHS Breast Screening Programme (NHSBSP) and Hospital Episode Statistics (HES). Linkage will be performed by NHS Digital as a trusted third party, and applicants will only have access to a dataset which is effectively anonymised.\n\nBreast cancer is the most common cancer amongst women in the UK, and incidence rates are increasing. The NHSBSP was introduced in 1988, and it has been estimated that breast screening saves 1300 lives annually. Despite this, the number of people taking up the invitation to screen is falling, and uptake has dramatically declined over the past 5 years in some regions. Such trends can be a public health concern, and as such significant work has been undertaken to counteract this decline. Demographic and cognitive factors have been associated with poorer uptake of screening, however much of this previous research does not acknowledge geographical variability. Understanding the common and disparate characteristics of the non-compliant populations in differing regions where uptake is poor, would potentially allow for the development of more effective interventions. The applicants aim to more accurately characterise which patients do not undertake screening, and better inform a tailored intervention to increase screening compliance amongst low uptake subgroups. \n\nPublic Health England (PHE) will identify, from the NHSBSP database, a dataset containing all people who were invited to attend breast screening in England between 31st March 2012 to 1st April 2020. The dataset will contain NHS number, date of birth, postcode alongside type of invitation and whether or not the person attended. PHE will then securely transfer the dataset to NHS Digital, who will be responsible for linking with socio-demographic and medical information from the Hospital Episode Statistics (HES) database. NHS Digital will modify date of birth to age, modify postcode to LSOA, and then remove NHS number, date of birth and postcode. No other identifiers remain in the dataset. A pseudonym in the form of encrypted HESID is added for transfer to the applicant, however this flow of data can be considered anonymous and does not require support. NHS Digital transfer the data to the applicant at the Imperial College London Big Data and Analytical Unit (BDAU).  NHS Digital will retain the key that links the encrypted HESID to identifiers for 3-6 months after the linkage is performed, and then this will be deleted."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Ara Darzi, Co-Director of Institute of Global Health Innovation, Professor of Surgery"]
["Address","Division of Surgery and Cancer"]
[null,"10th Floor, QEQM Building, St Mary's Hospital"]
[null,"Paddington, London"]
["Postcode","W2 1NY"]
["Telephone","020 3312 1310"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Females aged between 49y and 8months to 70 years and 11 months who were invited for breast screening in England between 31st March 2012 to 1st April 2020 \n\nThe cohort includes both people who did not attend and people who did attend, and the applicants estimate this to be approximately 5.6million people."]
["Description of confidential patient information used","Data sources\n1. PHE; National Breast Screening Programme (NHSBSP)\n2. NHS Digital; Hospital Episode Statistics (HES) \n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Ethnicity\n3. Age\n4. LSOA \n5. Comorbidities\n\n(can be considered anonymous to the researchers)\n\nAdditional information\nNHS number, date of birth, and postcode are removed by NHS Digital before sending to researchers at Imperial college London, and a pseudonym in the form of encrypted HESID is added.\n\nThe key between the HESID and identifiers are retained by NHS Digital for a short time period and then deleted. "]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-04-23"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as the activity was never able to commence.\n\nThe application, to allow the disclosure of confidential patient information about women invited for breast screening from the National Breast Screening Programme (NHSBSP) data held by PHE to NHS Digital, for the purposes of linkage with HES data, in order for NHS Digital to then remove identifiers and provide a pseudonymised data set for analysis to the applicants at Imperial College London (Big Data Analytical Unit (BDAU), is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 12 April 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \n\nThe NHS Digital 2019/20 DSPT review for Public Health England (PHE) and the equivalent for NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 11 March 2021). \n\nA DSPT for Imperial College London (Big Data Analytical Unit (BDAU) is not required as no confidential patient information is processed at this organisation for the purposes of this study."]

{"sheet":"A02586","index":628,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02586"]
["Reference","21/CAG/0022"]
["Other Refs","IRAS Project ID: 287529  REC Reference: 21/LO/0184"]
["Application Title","The use of telephone based digital triage in urgent care provision and the associated patient service use and health outcomes: A routine data analysis study before and during the Covid-19 pandemic"]
["Application Summary","This application from the University of Warwick set out the purpose of medical research that seeks to determine how telephone based digital triage in the provision of urgent care affects patient use of care services and health outcomes.\n\nDigital triage offers the potential to improve the consistency of care, patient safety and efficient use of the health system. Whilst telephone based digital triage is widely used in urgent care, evidence of its impact on patient health outcomes and health care service use is very limited and mixed. The main knowledge gaps relate to the accuracy, patient compliance, service use and health outcomes following telephone based digital triage. This project will analyse large datasets, together with appropriate sample size calculations, to generate new information and knowledge in terms of these outcomes, to address this gap.\n\nThe project will use two datasets; triage data, provided by telephone triage services, and patient outcome data, provided by NHS Digital, which will include HES Admitted Patient Care (HES APC) and the Emergency Care Data Set (ECDS). Advanced Health and Care Ltd will provide the Data Access Request Service (DARS) at NHS Digital with patients’ NHS number and date of birth, as well as the patients’ study ID, to facilitate linkage to the HES APC and ECDS datasets. NHS Digital will undertake the linkage and de-identify the data, before sending the dataset to the research team at the University of Warwick for analysis. The data linkage will be undertaken on a one-off basis."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Dr H Atherton, Associate Professor"]
["Address","Unit of Academic Primary Care, Warwick Medical School"]
[null,"University of Warwick"]
[null,"Gibbet Hill, Coventry"]
["Postcode","CV7 4AL"]
["Telephone","02476 151 405"]
["Email","h.atherton@warwick.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100,000 patients who attended A&E following telephone triage between 01 April 2019 and 30 September 2020."]
["Description of confidential patient information used","Data sources\n1. HES Admitted Patient Care (HES APC) and the Emergency Care Data Set (ECDS), provided by NHS Digital\n2. Triage data provided by Advanced Health and Care Ltd\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-04-12"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as all processing of identifiable patient information without consent under this support is now complete.\n\nIn terms of public benefit, the research has allowed applicants to generate insight on the safety of telephone based digital triage in England’s two-step model of urgent care delivery. \nDigital triage plays a central role in urgent care and the healthcare system overall, by managing patient demand and ensuring patients are referred to appropriate services for care. There has been limited research conducted on patients’ health and service use outcomes following digital triage within the urgent care setting. This research provides new analysis on both primary and secondary triage outcome urgency in relation to patients’ subsequent use of emergency department and in-patient care.\n\n12 April 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 01 March 2021. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \nThe NHS Digital 2019/20 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker 09 February 2021\n\nThe NHS Digital 2019/20 DSPT review for Advanced Computer Software Group Ltd was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker 09 April 2021."]

{"sheet":"A02587","index":629,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02587"]
["Reference","21/CAG/0026"]
["Other Refs","IRAS Project ID: 290143  REC Reference: 21/NW/0009"]
["Application Title","High intensity treatment at the end of life in children with cancer: retrospective, national,data linkage study"]
["Application Summary","This application from the University of York set out the purpose of medical research that seeks to determine whether the use of high intensity treatment at the end of life for children, teenagers and young adults with cancer, varies depending on the model of end of life care available.\n\nApproximately 4,500 babies, children and teenagers in England and Wales require end of life care each year. The provision of this care varies across the country and little is currently known about how this variation impacts on children and their families. This project in comprised of three studies. The first study is a survey, conducted with relevant cancer services and other wards to provide specialist care to children, to identify the different models of providing care to patients aged 0-18 within England and Wales. The second study will involve interviews with bereaved parents about their experience of their child’s end of life care. These two studies are outside the scope of support sought.\n\nThe third study will investigate the impacts of the different models of end of life care on children and their families. The findings from study 2 will help the applicants to decide which outcomes to measure, but they are likely to include quality of care at the end of life, place of death, whether care is planned and the treatments given at the end of life. Information will be collected from the medical records of approximately 4000 children treated in cancer services. Information from around 800 bereaved parents, whose child received care in neonatal or paediatric units, will also be collected. \n\nThe applicants are seeking support for the transfer of confidential patient information from PICANet and ICNARC to Public Health England. Public Health England will link the individual level data with cancer registry, death certificate data, treatment information and hospital episodes data. Public Health England will then transfer a pseudonymised dataset to the research team at the University of York."]
["Applicant Organisation Name","University of York"]
["Contact Name","Professor Lorna K Fraser"]
["Address","Director of the Martin House Research Centre"]
[null,"University of York, Area 2 Seebohm Rowntree Building"]
[null,"Heslington, York"]
["Postcode","YO10 5DD"]
["Telephone","01904 321 889"]
["Email","lorna.fraser@york.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any child, teenager of young adult (0-24 years) with a diagnoses of cancer who died between 01/01/2012 and 31/12/2020 in England and Wales.\n\n4000 patients will be included. "]
["Description of confidential patient information used","Data sources\n1. PICANet (held by the University of Leeds)\n2. ICNARC\n3. National Cancer and Registration System (NCRAS), ONS death certificate data, treatment information and hospital episodes datasets held by Public Health England\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Date of death\n5. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Lower super output area\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-04-16"]
["Next Review Date","2025-04-16"]
["Notes","Amendment supported 14 July 2023 to remove the study specific opt out mechanism from this application, as NHS England have confirmed they do not have the capacity to apply any opt out to the NCRAS dataset\n\n15 December 2022 - change in data processor from Public Health England (PHE) to NHS England (previously NHS Digital), regarding data source - National Cancer and Registration System (NCRAS), (which also contains ONS death certificate data, treatment information and hospital episode statistics (HES) datasets).\n\n16 April 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 18 January 2021 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- The NHS Digital 2019/20 DSPT reviews for ICNARC (by check of the NHS Digital DSPT Tracker on 23 February 2021), Public Health England (by check of the NHS Digital DSPT Tracker on 23 February 2021), University of Leeds – SEED (by check of the NHS Digital DSPT Tracker on 14 April 2021) and the University of York (Department of Health Sciences) (by check of the NHS Digital DSPT Tracker on 14 April 2021) were confirmed as ‘Standards Met’."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02588","index":630,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02588"]
["Reference","21/CAG/0042"]
["Other Refs","IRAS Project ID: 252548  REC Reference: 21/SW/0031"]
["Application Title","The Wynn Database - Metabolic Risk Factors and Mortality v1.0"]
["Application Summary","This application from Imperial College London (ICL) set out the purpose of medical research of creating ‘the Wynn Database’, which will hold metabolic data concerning cholesterol and glucose levels. This information has already been collected between 1965 and 2000 by Professor Victor Wynn’s group, for clinical and research purposes, from 14,615 individuals who attended various clinics run by Professor Victor Wynn. The database has been retained in the public interest up until this point, as the database is a valuable research resource. As part of this application the applicant is requesting support under Regulation 5 for the ongoing retention of the Wynn Database until the point it is pseudonymised, to ensure a legal basis under common law. The applicants plan to link the database to age at death and cause of death, as this will enable extensive retrospective and prospective analyses of relationships between metabolic risk factors, mortality and cause of death. The applicants will then delete all identifiable information from their database, however support is still required for NHS Digital to undertake annual linkages with mortality data which will then be provided to the applicant in pseudonymised format. \n\nThe applicants propose to use this resource as a research database to enable future research to be undertaken using pseudonymised data, as the Wynn Database will provide a more comprehensive understanding of metabolic risk factors, their inter-relationships and how those inter-relationships might contribute to cardiovascular disease, diabetes and cancer. Establishing a long-term future for the Wynn Database will enable a range of further investigations relating to risk factor inter-relationships and the relationships of risk factors to cause of death.\n\nCurrently, the Wynn Database is contained in two electronic files at ICL: \n• One containing non-identifiable clinical information, alongside a unique database number, including age, year of birth, gender and ethnicity. \n• The second contains identifiable information and is securely stored separately from the clinical dataset, alongside the unique database number. \n\nThe identifiers held are forename, surname, initial, date of birth and gender and last known postcode. ICL will add an additional unique ID - member number to each individual. ICL will then disclose the file containing identifiable information to NHS Digital. NHS Digital link the Wynn database identifiers with the Personal Demographics Service (PDS) In order to find the NHS number, and then link with ONS mortality data. Age of death, cause of death, and member number will be returned to the applicants, who will then link the mortality data to the clinical dataset using the member number. Once linkage has been undertaken, applicants will delete all identifiable information, including their copy of the Wynn Database identifiable information file and any paper records. The database will be retained in pseudonymised format. The original Wynn Database record database number will be replaced by the member number, and the original database number will be eliminated from the Database, however a key that links member number to original database number will be retained by the applicants, separated from the other information, should the need arise to cross-reference future Wynn Database analyses with previous analyses of data included in the Wynn Database, for the duration of the database being in existence. NHS Digital will retain a key linking member number to identifying information, in order to provide the applicant annual mortality updates, in principle until all participants have died.\n\nAs the database will be pseudonymised it will not be possible for any investigators, including the applicants, to link either member number or database number to personal identifiers. Access to the database will be via research proposals and protocols developed by or in consultation with the Head of the Section of Metabolic Medicine, with review by and discussion with other members of the Management Group. As the database is relevant to the research specialities of the Section of Metabolic Medicine, it is expected that the great majority of proposals will be generated within the Section of Metabolic Medicine at Imperial College London."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Nick Oliver"]
["Address","Wynn Chair in Human Metabolism, Imperial College London"]
[null,"7S7a, 7th Floor, The Commonwealth Building"]
[null,"Hammersmith Hospital, DuCane Road"]
["Postcode","W12 0NN"]
["Telephone","020 3313 1593"]
["Email","nick.oliver@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","14,615 individuals;\n\nThis encompasses everybody who attended the Department of Metabolic Medicine and the Wynn Institute to provide a blood sample, with data collected between 1965 and 2000."]
["Description of confidential patient information used","Data sources\n1. The Wynn database (Held by Imperial College London)\n2. NHS Digital; \n    • Office for National Statistics (ONS) Mortality dataset\n    • Personal Demographics Service (PDS)\n\nIdentifiers required for linkage purposes\nIn order to facilitate first linkage with PDS:\n\n1. Unique ID - member number, \n2. Name, \n3. Date of birth, \n4. Gender, \n5. Postcode\n\nIn order to facilitate linkage with ONS mortality outcomes:\n\n1. NHS number derived by NHS Digital from PDS, also used to link to mortality data by NHS Digital, but will not be accessible to the applicants\n2. Unique ID - member number\n\nIdentifiers required for analysis purposes\n1. Age\n2. Year of birth\n3. Gender\n4. Ethnicity\n5. Unique ID - member number \n\nUnique ID – original database number retained separately from the database.\n\nThis can be considered pseudonymous.\n\nAdditional information\nNHS Digital will hold the key linking member number to\npersonal identity in order to provide annual mortality updates to the applicant, in principle until all participants have died.\n\nICL hold a key for member number to database number for the duration of the existence of the database."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-04-26"]
["Next Review Date","2024-04-26"]
["Notes","30 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Personal Demographics Service (PDS), and Office of National Statistics (ONS) mortality data.\n\n26 April 2021 - Application supported\n\nConditions of support:\n1. Support is provided for five years in the first instance, and at this point an amendment should be submitted to extend the duration of support.\n\n2. Please provide updated patient notification within three months from the date of this letter, which is; \n    • layered into a shorter notification, and then a longer privacy notice,\n    • clearer with more specific content regarding the Wynn database, and with any irrelevant sections removed.\n\nCondition met 10 August 2021\n\n3. Please undertake further patient and public involvement, specifically discussing the acceptability of the proposed use of confidential patient information without consent, within three months from the date of this letter.\n\nCondition met 09 September 2021\n\n4. Favourable opinion from a Research Ethics Committee. Confirmed 12 April 2021 \n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 19/20 DSPT review for Imperial College London - School of Public Health Medical Trials and Research (EE133887-SPHTR) and the DSPT equivalent for NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 19 April 2021)."]

{"sheet":"A02589","index":631,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":true,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number"]
["Reference"]
["Other Refs"]
["Application Title"]
["Application Summary"]
["Applicant Organisation Name"]
["Contact Name"]
["Address"]
[]
[]
["Postcode"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status"]
[]
["Outcome Date"]
["Next Review Date"]
["Notes"]

{"sheet":"A02590","index":632,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02590"]
["Reference","21/CAG/0040"]
["Other Refs","IRAS Project ID: 252548  REC Reference: 21/SW/0031"]
["Application Title","Welsh Study of Mothers and Babies. Examining the association between cardiac echogenic foci at the 18-20 week antenatal fetal anomaly scan and cardiac disease in early childhood: An electronic record-linked cohort study. Sub-study 1: Obtaining scan images for further classification of the cardiac echogenic foci"]
["Application Summary","This application from Cardiff University set out the purpose of medical research that aims to examine whether babies with cardiac echogenic foci (CEF) have more adverse outcomes during childhood compared to babies without the marker and whether specific marker characteristics are predictive of these outcomes. The application describes an un-consented sub-study of a larger consented project; The Welsh study of mothers and babies. When first recruited, women gave their consent for the study team to record the presence of markers on the anomaly scan, and to use their NHS number to link these with data on health outcomes from the routinely-collected population-based child health datasets available in Wales. Information on the presence or absence of CEF at the anomaly scan was therefore collected during the original study. The cohort for this sub-study are 616 mother-fetus pairs who had a fetal anomaly ultrasound scan between 2008 and 2011, where CEF were recorded as present. The applicants are requesting support under Regulation 5 to process confidential patient information about these mother-fetus pairs without consent, as the original consent did not cover the identification of certain characteristics of the CEF (multiple versus single; in the right or bilateral ventricles versus the left ventricle; larger versus smaller foci), and applicants will be transferring identifiable information without consent to study clinicians in Cardiff and Vale Health Board and the research radiographer at Betsi Cadwaladr Health Board to identify and code the appropriate scan images. The study did not collect information on the features of the CEF originally, because this was not known to be important when the data were collected in 2008-2011. The applicant has provided justification for why gaining consent for the sub-study is not practicable, and therefore is requesting support for this disclosure. All other elements of the study are undertaken with consent.\n\nCEF are non-structural markers identified at routine 18–20 week fetal anomaly ultrasound scans. Evidence on the clinical significance of CEF is limited, as it is not clear whether CEF is predictive of adverse health outcomes in childhood. Recent studies have suggested that the number, size or location of foci may be important to predict the presence of congenital heart disease and to distinguish between benign and pathological lesions, although these studies had small sample sizes and focused on high-risk populations (pregnant women who had clinical factors that increased the risk of adverse outcomes). Further large population-based studies, which include data on the characteristics of the foci, are therefore needed to fully evaluate outcomes in early childhood. The Welsh Study of Mothers and Babies provides a unique opportunity to address this research gap, by following a large population-based sample of consented mothers and babies to examine whether babies with CEF detected at the 18-20 week scan have more adverse health outcomes during childhood compared to children without this marker. The results of this application will facilitate the development of clinical guidelines and care pathways during pregnancy and after birth, and provide more accurate information to counsel women and their families.\n\nThe applicants, at Cardiff University, already hold identifiable information about 616 mother-fetus pairs who had a fetal anomaly ultrasound scan between 2008 and 2011, where CEF were recorded as present. However, the study does not have the actual images of the ultrasound scan on record. In order to identify additional features of the foci, the applicants will need to obtain the images from the anomaly scans where cardiac echogenic foci were identified. NHS number, name, date of birth, scan date, and woman’s study identification number of the eligible cohort will be extracted from the Welsh Study of Mothers and Babies database of identifiable information. 586 images can be accessed from the Synapse system at Cardiff and Vale Health Board, however 30 images are required to be transferred to Cardiff and Vale from Betsi Cadwaladr Health Board. Applicants will disclose the mentioned identifiers regarding the 30 women who were scanned at Betsi Cadwaladr Health Board to the research radiographer at Betsi Cadwaladr, via the secure NHS file sharing portal. The 30 images will be retrieved by the research radiographer, and sent to Cardiff and Vale. Identifiable information will then be deleted by the research radiographer at Betsi Cadwaladr. Applicants will also disclose the mentioned identifiers regarding the remaining 586 women who were scanned at other health boards, and also the 30 scanned at Betsi Cadwaladr, to two named clinicians based at University Hospital Wales, which is part of Cardiff and Vale Health Board, via the secure NHS file sharing portal. The clinicians will code around half of the scans each. They will both code the first 10% of scans and their results will be compared to ensure consistency. Each clinician will therefore have access to the information of 370 women.\n\nThe disclosed identifiable information will be used to identify the correct ultrasound scans. The clinicians will then review all 616 images to identify and record the pre-defined foci characteristics. The clinicians will then remove NHS number, name, date of birth, and date of scan from the dataset, and return the data containing foci characteristics alongside woman’s study identification number to the applicant at Cardiff University via the NHS secure file sharing portal. The pseudonymised information will then be uploaded by the applicant into the Secure Anonymised Information Linkage (SAIL) databank, linked to the Welsh Study of Mothers and Babies information already held within the databank using the encrypted study identification number, and analysis will be undertaken to examine whether certain foci characteristics are more likely to be associated with adverse outcomes. This application will no longer require support under Regulation 5 at the point the identifiers are removed from the dataset and deleted by the clinicians at Cardiff and Vale health bard, and the applicants estimate that this process could take up to three months."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Lisa Hurt, Senior Lecturer"]
["Address","Division of Population Medicine, Cardiff University"]
[null,"3rd Floor, Neuadd Meirionnydd"]
[null,"Heath Park, Cardiff"]
["Postcode","CF14 6NE"]
["Telephone","02920 687 807"]
["Email","hurtl@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","616 mother-fetus pairs who had a fetal anomaly ultrasound scan between 2008 and 2011, where a specific cardiac finding (“cardiac echogenic foci”) was seen in the baby’s heart at the 20 weeks scan \n\nAll women were recruited into a previous study (the Welsh Study of Mothers and Babies) with consent"]
["Description of confidential patient information used","Data sources\n1. Cardiff university database of Welsh Study of Mothers and Babies.\n2. Cardiff and Vale Health Board (Synapse imaging system - fetal anomaly ultrasound scans)\n3. Betsi Cadwaladr Health Board (local imaging system - fetal anomaly ultrasound scans)\n\nIdentifiers required for identification of correct scan purposes\n1. NHS number\n2. Name\n3. Date of birth\n4. Date of fetal anomaly scan\n5. Woman’s study identification number \n\nIdentifiers required for analysis purposes\nNone"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-05-13"]
["Next Review Date"]
["Notes","The applicant confirmed in June 2023 that this activity can be expired as the activity did not commence. \n\nThere will be no public benefit from this sub-study because the work could not be completed.\n\n\n13 May 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed (Favourable opinion with conditions) 21 April 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed: \n\n• Betsi Cadwaladr University Health Board completed their most recent Caldicott Principles in Practice (CPiP) assessment on the 31st of July 2020. They achieved a score of 95.6%.\n• Cardiff and Vale University Health Board completed their most recent Caldicott Principles in Practice (CPiP) assessment on the 17th of March 2021. They achieved a score of 83.8%. An improvement plan has also been provided, as the threshold score for CAG purposes is 93%."]

{"sheet":"A02591","index":633,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02591"]
["Reference","21/CAG/0001"]
["Other Refs","IRAS Project ID: 231048  REC Reference: 20/EM/0148"]
["Application Title","Optimum Patient Care Research Database (OPCRD)"]
["Application Summary","This application from Optimum Patient Care (OPC) Ltd set out the purpose of creating a real-world, longitudinal research database that provides anonymised data to support scientific, medical, public health and exploratory research.\n\nThe OPC database holds de-identified data provided from participating GP practices. Data collection for OPCRD is conducted by Optimum Patient Care Limited (OPC), a not-for-profit social enterprise that provides quality improvement programmes for chronic conditions and research support services to GP practices across the UK. OPC quality improvement programmes and research support services are provided at no cost to participating GP practices under a service agreement. \n\nAs part of the service agreement, GP practices agree to contribute de-identified patient data to OPCRD for quality improvement and for research purposes. This includes de-identified longitudinal primary care patient data (derived from both electronic health records (EHR) data and from patient questionnaires delivered as part of quality improvement) and data linked from other health-related datasets e.g. secondary care data. The population base for OPCRD is all patients at contributing GP practices, excluding patients who have opted-out or refused consent for data sharing for care planning (quality improvement) or for research purposes. Data recorded or coded as “Confidential” in patient EHR and sensitive special category data which are not relevant for quality improvement or research, such as sexually transmitted diseases (STDs), termination of pregnancy, fertility treatment, marital status, convictions/imprisonments, physical/psychological/sexual abuse, etc. are not collected by OPC or for OPCRD.\n\nData contributed to OPCRD enables research into all chronic conditions in primary care. OPCRD has received data contributions from over 750 GP practices and currently holds de-identified data for approximately 9.6 million patients or data subjects. Over the last calendar year of 2019, the OPCRD has received data contributions from over 320 GP practices, accounting for over 3.6 million non-identifiable patient records. Anonymised data only is supplied to researchers for use in ethically approved scientific and public health research. All research conducted using the OPC database must also be approved by the Anonymised Data Ethics and Protocols Transparency committee (ADEPT). Proceeds from OPCRD data access fees and detailed feasibility assessments are re-invested into OPC services for the continued free provision of patient quality improvement programmes and research support services for contributing GP practices.\n\nOPCRD receives pseudonymised de-identified electronic health records data and questionnaire data of patients from participating GP practices. This may include de-identified questionnaire data for any condition or disease. OPCRD may also receive anonymised linked data from other health-related datasets and registries for patients from consented contributing GP practices. This may include Hospital Episode Statistics (HES), Scottish Morbidity Record (SMR), Patient Episode Database for Wales (PEDW), Northern Ireland Hospital Statistics (NIHS). \n\nThe applicants are seeking support under s251 for the disclosure of confidential patient information from participating GP practices to the Harvey Walsh Secure Portal. Harvey Walsh will then collect all patient identifiers and Study IDs received from the participating GP practices and combine them into one file. Harvey Walsh will then transfer the patient identifiers and Study ID to NHS Digital via the Health and Social Care Network (HSCN). NHS Digital will match the dataset to HES and return de-identified HES data, with Study IDs, to Harvey Walsh via the secure HSCN.  Harvey Walsh will use the Study IDs to link the de-identified GP electronic health records data, received from OPCRD, with the de-identified HES data to create the linked OPCRD-HES dataset, which is stored securely on OPCRD-NEXUS. No patient identifiable data will be held in OPCRD or OPCRD-NEXUS. The applicants will request linkages from NHS Digital on a quarterly or six-monthly basis.\n\nThe applicants acknowledged that linkages to SMR and NIHS are outside the remit of Regulation 5 (‘s251’ support). Support for linkage to PEDW data was not sought within this application. "]
["Applicant Organisation Name","Optimum Patient Care Research Database (OPCRD)"]
["Contact Name","Professor David Price"]
["Address","5 Coles Lane"]
[null,"Oakington"]
[null,"Cambridge"]
["Postcode","CB24 3BA"]
["Telephone","01223 967 855"]
["Email","professordavidprice@optimumpatientcare.org"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients registered at contributing GP practices, unless patients have objected to sharing of their data for use in research or care planning."]
["Description of confidential patient information used","Data sources\n1. Electronic patient information provided by participating GP practices\n2. HES datasets (HES Admitted Patient Care, HES Outpatient Care, HES Critical Care, HES Accident and Emergency (A&E), HES Emergency Care Data Set (ECDS) and HES Civil Registry (Deaths)) held at NHS Digital\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Postcode – unit level\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-05-20"]
["Next Review Date","2022-05-20"]
["Notes","20 May 2021 - Application Supported\n\nSpecific conditions of support:\n\n1. Support is given for the processing of redacted free text. Any failures of the redaction process which result in identifiable data being shared should be reported to CAG immediately for consideration of proposed remedial action.\n\n2. The potential change to the data flow, so that GPs can send confidential patient information to NHS Digital directly, needs to be explored by the applicants and reported to the CAG at the first annual review. If the data flow cannot be revised, a justification for why this could not be given will need to be provided. \n\n3. Favourable opinion from a Research Ethics Committee. Confirmed 06 July 2020\n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n• Confirmed: NHS Digital and Harvey Walsh Ltd (by check of the NHS Digital DSPT spreadsheet on 25 January 2021) have confirmed ‘Standards Met’ grade on DSPT 2019/20.\n\n• Participant GP practices – Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations."]

{"sheet":"A02592","index":634,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02592"]
["Reference","21/CAG/0061"]
["Other Refs","IRAS Project ID: 291069  REC Reference: 21/EM/0110"]
["Application Title","British Paediatric Surveillance Study of Neonatal Stroke in the United Kingdom and the Republic of Ireland presenting/diagnosed in babies in the first 90 days of life"]
["Application Summary","This application from University of Nottingham sets out the purpose of medical research that aims to determine the number of new cases of Neonatal stroke in the UK and Republic of Ireland over 13 months, as well as determining the proportion of neonatal stroke subtypes. This study will also provide a current description of neonatal stroke including the associated factors, management and outcomes at two years. The research will be taking place across England, Wales, Scotland, Northern Ireland and the Republic of Ireland, however support under the Regulations only covers England and Wales.\n\nNeonatal stroke is a devastating condition that causes brain injury in babies and often leads to lifelong impairment. Children with this condition may have problems walking, moving their arms or expressing themselves. Some may develop fits throughout childhood. Presently, there is insufficient information about the number of babies with neonatal stroke, which babies are most at risk and what problems they will likely face. There is also no agreed guidance for investigations and treatment. By exploring neonatal stroke in this study, future studies looking at prevention and new treatment options can be better designed, with an eventual aim of preventing neonatal stroke and improving care.\n\nThis national active surveillance study will be established using the British Paediatric Surveillance Unit (BPSU) research methodology. Every children’s doctor in the UK, through the BPSU, will be asked whether they have seen a child that month with neonatal stroke, via the BPSU orange e-card system. The BPSU will inform the University of Nottingham study team of the names and contact details of the notifying clinicians each month. The study team will then send an online questionnaire to the notifying clinicians, asking information about the presentation of neonatal stroke, demographic details, investigation (including neuroimages) and management. The online questionnaire has been developed by the BPSU - Health Informatics Centre (HIC) data platform, run through University of Dundee (UoD). De-identified neuroimages will also be uploaded onto the UoD - HIC safe haven server. This can alternatively be undertaken by email, or paper, and images sent by CD if required. These will then be uploaded to the data platform by the University of Nottingham study team. A follow up two years later will be conducted.\n\nThe questionnaire contains minimal patient identifiable information necessary to allow for case verification, matching and removing duplicate notifications and provide essential clinical research data – NHS number, date of birth, date of death, sex, ethnicity, and district level postcode. Data collection cannot be completely anonymous as it would not be possible to determine if two clinicians had reported the same case. Each case will be pseudonymised through a unique computer generated BPSU identifier number. The University of Nottingham research team will have access to the questionnaire data on the BPSU Health Informatics Centre (HIC) data platform server. The research team will however separate the identifiable data and the clinical data within the database and use the BPSU identifier number to link the two. After the two year follow up questionnaire has been completed, date of birth and date of death will be converted to age for analysis before deletion, partial postcode will be modified to region of care before deletion, and NHS number will also be deleted. Only data which can be considered anonymous will be downloaded on to a University of Nottingham computer."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Dr Don Sharkey"]
["Address","Academic Division of Child's Health, Obstetrics and Gynaecology,"]
[null,"E floor, East block, Queen's Medical Centre"]
[null,"Derby Road, Nottingham"]
["Postcode","NG7 2UH"]
["Telephone","01158 230 602"]
["Email","don.sharkey@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any child below 90 days of age, of any gestation, with neonatal stroke (arterial ischaemic, venous thrombosis or haemorrhagic in origin) seen in the last month before orange card received. \n\n(125 expected across the UK)"]
["Description of confidential patient information used","Data sources\n1. Reporting clinicians will access local medical records\n\nIdentifiers required for de-duplication and linkage with 1 year follow-up purposes\n1. NHS number\n2. Date of birth \n3. Date of death\n4. Sex \n5. District level postcode\n6. Ethnicity\n\nIdentifiers required for analysis purposes\n1. Sex\n2. Ethnicity\n3. Region of care – is calculated from district level postcode\n4. Age at presentation– Date of Birth will be converted to age at presentation in days\n5. Age at death – date of death will be converted to age at death in weeks \n\nAdditional information\nBaseline questionnaire will be sent over 13 months.\n\nFollow up questionnaire sent at 2 years of age. \n\nReporting clinicians will not provide names and addresses to the study team."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-05-27"]
["Next Review Date","2024-05-27"]
["Notes","Amendment support 17 November 2023 to include Amazon Web Services as an additional data processor, and to clarify that where data collection via other agreed pathways is not possible, the University of Nottingham study team will liaise with the reporting clinician directly to obtain the clinical information which will be entered by the research team directly onto the University of Dundee, HIC Safe haven\n\nAmendment supported 19 July to extend the duration of ‘s251’ support until 03 November 2025\n\n27 May 2021 - Application supported\n\nConditions of support:\n1. Please note that CAG support applies to England and Wales only.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 17 May 2021\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 19/20 DSPT review for University of Nottingham E133856-RGD was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 25 May 2021)\n\nSecurity assurances are required for the submitting clinicians. Support will be based on confirmation that the DSPT at the site will be complied with. However, as this is 5 or more organisations, these will not be individually checked by the Confidentiality Advice Team, and it is the responsibility of the applicant to ensure that appropriate security assurances are in place."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02593","index":635,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02593"]
["Reference","21/CAG/0054"]
["Other Refs","IRAS Project ID: 277060  REC Reference: 20/NE/0020"]
["Application Title","A cluster randomised controlled trial to assess the effectiveness and cost-effectiveness of the ‘Your Care Needs You’ intervention to improve safety and experience of care transitions"]
["Application Summary","This application from Bradford Institute for Health Research (based at Bradford Teaching Hospitals NHS Foundation Trust) set out the purpose of medical research which aims to examine the impact of the ‘Your Care Needs You’ (YCNY) intervention on unplanned hospital readmissions for patients aged 75 years and over who are discharged to their own homes. \n\nTransitions of care from hospital to home can be risky, especially for older people with multiple health conditions, with up to 1 in 5 people experiencing an adverse event within the first three weeks after leaving hospital. Previous research has suggested that the post-discharge period may be improved by better involving patients and families in their care. This study forms part of a programme of research which aims to develop an intervention to improve the safety and experience of transitions from hospital to home for people aged 75 years and over. \n\nA feasibility study 19/CAG/0105 has already been conducted, which identified that hospital coding did not accurately distinguish people who are admitted from and discharged to their own homes compared to those who are admitted from and discharged to a nursing /care home or other. Applicants only require data on those discharged to their own home, and therefore will resolve this issue by involving a trust employed research nurse to manually check the discharge destination, as this was confirmed to be feasible as part of the previous study. This application is for an RCT of the intervention at 11 acute hospital NHS Trusts, and support is requested for routine clinical data regarding hospital readmissions at 30, 60 and 90 days after discharge of 4,400 patients who have not consented to be extracted and anonymised by Trust staff who are not part of the direct care team, and does not include 1,000 consented patients. Approximately 40 participating wards will be recruited from across 11 acute NHS Trusts in England. Using ward level randomisation, wards will be randomly allocated to one of two trial arms: delivery of the YCNY, or care as usual. \n\nInformation Services within each Trust will create a list of patients from participating wards aged over 75 years and who were discharged to 'usual place of residence' as per standard hospital coding. The file will contain NHS number, date of birth, gender, and admission and discharge details, dates of subsequent planned and unplanned admissions and discharges up to 90 days post discharge, and details of whether or not a patient has died. They will calculate age at first index admission. The file will be internally transferred to the Trust employed Research Nurse who will manually check the actual discharge destination after the index stay from the medical records, and record ‘yes’ or ‘no’ for discharged back to own home rather than the actual location. As the research nurses may be defined as outside the direct care team, an application to CAG has been made. The applicants have commented that clinical staff are unable to undertake the data extraction as manual checking of actual discharge location is quite labour intensive, and direct care team staff already face considerable workload pressures. The PACT research team will notify the individual trust research nurses of patient opt outs and ask for those patients to be removed. The research nurse will then delete dates of birth and NHS numbers and remove all data for patients who were not discharged to their own homes. The file can be considered anonymous, as the recipients will not be able to re-identify any patient. The file will be transferred to the PACT research team at Bradford Teaching Hospitals NHS Foundation Trust. This will then be onwardly disclosed to the York Trials Unit at the University of York for analysis. "]
["Applicant Organisation Name","Bradford Institute for Health Research (based at Bradford Teaching Hospitals NHS Foundation Trust)"]
["Contact Name","Professor Rebecca Lawton, Professor in Psychology of Healthcare"]
["Address","School of Psychology, University of Leeds"]
[null,"University Road, Woodhouse"]
[null,"Leeds"]
["Postcode","LS2 9JT"]
["Telephone","0113 343 5715"]
["Email","r.j.lawton@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","4,440 patients who were discharged to own/carer’s home and aged 75 years or older at the index admission"]
["Description of confidential patient information used","Data sources\nPatients records (electronic or paper as appropriate) from approximately 40 participating wards across 11 acute NHS Trusts;\n• Bradford Teaching Hospitals NHS Foundation Trust\n• Calderdale & Huddersfield NHS Trust\n• Doncaster & Bassetlaw Hospital\n• Harrogate and District NHS Trust\n• Hull University Teaching Hospital \n• Sheffield Teaching Hospital\n• York Teaching Hospital\n• Royal Blackburn Teaching Hospital\n• Lancashire Teaching Hospital\n• South Tyneside and Sunderland NHS Trust\n• Newcastle upon Tyne Hospital Trust\n\nIdentifiers required to extract an anonymised dataset\n1. NHS Number\n2. Hospital ID Number\n3. Date of birth\n4. Date of death\n5. Gender\n6. Postcode (unit level)\n7. Address of patients’ usual residence\n8. Date of admission to hospital\n9. Ward admitted to\n10. Date of discharge\n11. Dates of re-admission\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Age\n3. Date of admission to hospital\n4. Ward admitted to\n5. Date of discharge\n6. Dates of re-admission\n\nThis can be considered anonymous for analysis purposes, as the researchers will not have any way to re-identify the patients."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-05-28"]
["Next Review Date","2024-05-28"]
["Notes","15 December 2021 - Amendment supported\nAmendment supported to include Leeds Teaching Hospitals NHS Trust and South Tees Hospitals NHS Foundation Trust as participating sites.\n\n28 May 2021 - Application supported\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed: Favourable opinion regarding related amendment 21 May 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nSecurity assurances are required for the 11 sites where the data extraction take place. Support will be based on confirmation that the DSPT at the site will be complied with. However, as this is more than 5 organisations, these will not be individually checked by the Confidentiality Advice Team, and it is the responsibility of the applicant to ensure that appropriate security assurances are in place."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02594","index":636,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02594"]
["Reference","21/CAG/0060"]
["Other Refs","IRAS Project ID: 294661  REC Reference: 21/WA/0089"]
["Application Title","A pan cancer programme of tumour typing (version 1)"]
["Application Summary","This application from Leeds Teaching Hospitals NHS Trust set out the purpose of medical research that seeks to provide specimens to their commercial partner, TriStar, who will house the samples to be used in a range of analyses as part of drug development programmes undertaken by pharmaceutical companies.\n\nThe applicants have previously undertaken a pilot study, which sought to gain further understanding around the genetic blueprint defects and pathways leading to abnormal protein expressions in patients with ovarian cancer, supported by the CAG under reference 19/CAG/0008. The applicants are now seeking to expand this model to include 200 other cancer types, including breast, lung, skin, reproductive, blood and gastrointestinal cancers. The outlook for patients diagnosed with the 200 cancer types is poor. Lung cancer alone is responsible for 35,300 deaths each year, with only 9.5% of patients surviving 10 years or more after diagnosis. Low cancer survival rates occur for a number of reasons, such as late diagnosis, meaning that a diagnosis is made after the cancer has spread and the cancer is at a more advanced stage, where therapeutic intervention is less effective. A better understanding of the genetic blueprint defects and the pathways leading to abnormal protein expression may help to develop more effective targeted therapies. \n\nIn this project, the applicants will provide surplus archival cancer tissue samples and electronically scanned tissue slides, alongside anonymised case-specific demographic annotations to a commercial partner, TriStar, who are also funding the project. In turn, TriStar will then distribute these materials and images to pharmaceutical companies, who will use these materials in cancer drug development programmes. Staff within Leeds Teaching Hospitals NHS Trust, but who are not considered to be members of the direct care team, will identify suitable patients from electronic patient records within the same Trust. Tissue blocks will be retrieved and, if the samples are deemed suitable following review by the Chief Investigator, the blocks will be transferred to TriStar alongside anonymised information. This means that only anonymised information will be disclosed outside the Trust. "]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Trust"]
["Contact Name","Dr Nicolas Orsi"]
["Address","University of Leeds/Leeds Teaching Hospitals Trust"]
[null,"Department of Histopathology, Level 5, Bexley Wing"]
[null,"St James' University Hospital, Beckett Street, Leeds"]
["Postcode","LS9 7TF"]
["Telephone","0113 3438 625"]
["Email","n.m.orsi@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over, treated for cancer at Leeds Teaching Hospitals NHS Foundation Trust. 12,000 cases, offering a cross-representation of different cancer types and sub-types, will be selected. \n\nThe study is expected to last for five years and cases between 1991 and 2021 may be selected, however the applicant expected that cases between 2005 and 2025 were most likely to be selected. "]
["Description of confidential patient information used","Data sources\n1. Electronic patient records at Leeds Teaching Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Date of death\n\nIdentifiers required for analysis purposes\n1. Ethnicity\n2. Gender\n3. Age in years\n\nAdditional information\nAnonymised information only will be disclosed outside Leeds Teaching Hospitals NHS Foundation Trust"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-05-28"]
["Next Review Date","2024-05-28"]
["Notes","28 May 2021 - Application supported\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed: 19 March 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \nThe NHS Digital 2019/20 DSPT review for Leeds Teaching Hospitals NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 06 May 2021)."]

{"sheet":"A02595","index":637,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02595"]
["Reference","21/CAG/0070"]
["Other Refs","IRAS Project ID: 299277  REC Reference: 21/WA/0180"]
["Application Title","The DAMPen-D study: Improving the Detection, Assessment, Management, and Prevention of Delirium in Hospices - Co-design and feasibility study of a flexible and scalable implementation strategy to deliver guideline-adherent delirium care"]
["Application Summary","This application from the University of Hull set out the purpose of medical research that seeks to establish whether it is feasible to collect sufficient outcome data, explanatory process data, and cost data, in a future effectiveness evaluative study in palliative care settings. \n\nIt is common for people to suffer from acute confusion, or delirium, towards the end of their life, which can be distressing for those with delirium, and their friends, family and carers. Treating delirium can also cause anxiety and stress for the health professionals who are trying to manage the delirium effectively. The applicants noted the importance of improving how delirium is assessed, prevented and managed within hospices. Guidelines for improving delirium care have been issued by the National Institute for Health & Care Excellence, the Scottish Intercollegiate Guidelines Network, and the Australian Commission on Safety & Quality in Health Care, however research shows that less than half of palliative care doctors use delirium guidelines. Delirium screening tools are infrequently used, yet there is no research about how to improve the implementation of delirium guidelines and tools in day-to-day practice. The applicants seek to address this by conducting a feasibility study to assess the usefulness of the CLECC-Pal implementation plan in day-to-day use of guideline-recommended clinical care, and whether, under these circumstances, the number of delirium days suffered by patients is reduced in a cost-effective manner. The applicants will also be assessing whether a larger-scale study can be run. The study is comprised of 3 work packages. Work Package 1 involves engagement with stakeholders. Work Package 3 is a process evaluation, where staff and volunteers will take part in surveys. Work Packages 1 and 3 are outside the scope of REC review and the support sought under Regulation 5.\n\nThe study will be conducted in three non-NHS inpatient hospice units in Yorkshire. The hospices will be supported by the study team in using the CLECC-Pal plan to implement guideline recommended delirium care over a minimum of 12 weeks. At sites 1 and 2, paper case records will be accessed by the research team. The hospice staff will identify 50 consecutive patients who were admitted to the hospice before the CLECC-Pal was used in the hospice. The researcher will then access the patient records to extract anonymised data. Each documented case of delirium will be assigned a unique identifier number by the researcher (the study ID), which will be used internally by the research team to identify individual episodes of delirium. This unique identifier will not be used to link the extracted data back to the clinical records, as no key is retained. The same process will be repeated for 12 weeks after the implementation of the CLECC-Pal at the site. Site 3 has electronic patient records only. This computer will be located in a GP practice in Hull. As at sites 1 and 2, hospice staff will identify 50 consecutive patient records preceding the date CLECC-Pal (the intervention) was introduced to the hospice. Hospice staff will email the patients NHS number to the researcher via secure NHS email, in order for the researcher to be able to identify the patient on SystmOne. The researcher will then access the patient records on SystmOne remotely via a secure NHS GP surgery computer located at a GP surgery in Hull and extract an anonymised dataset. Only pseudonymised data will be uploaded to the study records, on the University of Hull laptop, and this can be considered anonymous to the applicants. "]
["Applicant Organisation Name","University of Hull"]
["Contact Name","Dr Mark Pearson, Senior Lecturer in Implementation Science"]
["Address","University of Hull, Wolfson Palliative Care Research Centre,"]
[null,"Hull York Medical School, Allam Medical Building"]
[null,"Cottingham Road, Hull"]
["Postcode","HU6 7RX"]
["Telephone","0148 2463 335"]
["Email","mark.pearson@hyms.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who are receiving inpatient palliative care at the three participating hospices\n\n(50 consecutive patients from each hospice, over 2 time periods, so 100 total per site.)\n"]
["Description of confidential patient information used","Data sources\n1. Paper records held at 2 participating hospices \n    • Dove House Hospice, Hull\n    • St Leonards Hospice, York\n\n2. Electronic records held at the third participating hospice:\n    • Marie Cure, Bradford, which will be accessed on University of Hull encrypted laptop at James    \n      Alexander Family practice, Hull\n\nIdentifiers required for data extraction for paper records at 2 participating hospices\n1. Age\n2. Sex\n3. Ethnicity\n4. Unit level Postcode (converted to multiple deprivation index at extraction)\n5. Unique study ID – allocated by the researcher at point of extraction \n6. Patients medical records will be viewed\n\nIdentifiers required for data extraction from SystmOne at 1 partcipating hospices\n1. NHS number (in order to identify patient on SystmOne)\n2. Age\n3. Sex\n4. Ethnicity\n5. Unit level Postcode (converted to multiple deprivation index at extraction)\n6. Unique study ID – allocated by the researcher at point of extraction \n7. Patients medical records will be viewed\n\nIdentifiers required for analysis purposes\n1. Age \n2. Sex\n3. Ethnicity\n4. Unique study ID\n\nThis can be considered anonymous to the researchers."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-06-14"]
["Next Review Date"]
["Notes","Applicant confirmed April 2023 that ‘s251’ support can be expired, as only anonymised data was extracted/received. Access to source data containing identifiable patient information without consent is now complete. \n\nIn terms of public interest, Regulation 5 support enabled this data to be collected with no burden on, or risk of distress to, patients and their carers. Therefore, applicants were able to obtain a truly consecutive, and therefore representative, sample including all those who were vital to include, but most likely to be poorly represented by using consent. Without this ability to collect data from everybody, applicants would have disproportionately “missed” many of those who had delirium, and missed the signal of benefit which now confirms the need for a definitive study after the completion of this pilot.\n\n26 May 2022 - Amendment supported:\nAmendment supported to extend the duration of ‘s251’ support until 15 February 2023.\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January to add a new data processor, in the form of a fourth study site - St Catherine’s Hospice, Scarborough.\n\n14 June 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 28 May 2021.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nSecurity assurances are required for the 5 sites where processing of confidential patient information will take place. Support will be based on confirmation that the DSPT at the site will be complied with. However, as this is 5 or more organisations, these will not be individually checked by the Confidentiality Advice Team, and it is the responsibility of the applicant to ensure that appropriate security assurances are in place.\n\nThe organisations involved are:\n• University of Hull - Hull Health Trials Unit (EE133824-HHTU) \n• Dove House Hospice, Hull\n• St Leonards Hospice, York\n• Marie Cure, Bradford\n• James Alexander Family practice, Hull"]

{"sheet":"A02596","index":638,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02596"]
["Reference","18/CAG/0187"]
["Other Refs","IRAS Project ID: 54370  REC Reference: 10/H1070/70"]
["Application Title","Project to Enhance ALSPAC through Record Linkage (PEARL): Phenotypic enrichment of the ALSPAC original parent/carer (G0) cohort through linkage to primary care electronic patient records and other databases."]
["Application Summary","This application from ALSPAC at the University of Bristol set out the purpose of medical research which aims to follow-up the parents and carer cohort (referenced as Generation 0 within the application) of the Avon Longitudinal Study of Parents and Children (ALSPAC) study via NHS administrative datasets held by NHS Digital, together with records held at local Trusts and primary care data from GP practices. \n\nThe Avon Longitudinal Study of Parents and Children (ALSPAC) is a three-generation cohort study with >15,000 enrolled participant families. Comprising the G0 generation cohort of pregnant women who lived in Bristol in 1991/92 and the fathers/partners; the G1 generation of children born in 1991/92 cohort; and the G2 generation of G1 offspring. All generations have provided information in questionnaires, study clinic assessments, through gifting biological samples and linkage to routine records. To obtain ALSPACs full value further follow–up is needed to explore research questions relating to the G0’s health and wellbeing as they age and to investigate how exposures to G0 parent/carers interactions with the long-term outcomes in G1. Extending linkage to health records provides a cost-effective means of data collection with low participant burden. "]
["Applicant Organisation Name","ALSPAC, University of Bristol"]
["Contact Name","Professor John Macleod, Professor in Clinical Epidemiology and Primary Care"]
["Address","University of Bristol,"]
[null,"Canynge Hall, 39 Whatley Road"]
[null,"Bristol"]
["Postcode","BS8 2PS"]
["Telephone","0117 3313 935"]
["Email","John.MacLeod@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All enrolled parents and carers recruited to the ALSPAC study, known as ‘Generation 0’ (G0).\n\nThis includes approximately 15,500 G0 mothers and ~3,500 G0 fathers/partners."]
["Description of confidential patient information used","Data sources\n1. ALSPAC administrative database\n2. NHS Digital datasets:\n    a. Personal Demographics Service (PDS)  \n    b. Hospital Episode Statistics (HES), \n    c. Office for National Statistics (ONS) Mortality dataset \n    d. Mental Health Minimum Dataset (MHMD)\n    e. Mental Health and Learning Disabilities Data Set (MHLDDS)\n    f. Mental Health Services Data Set (MHSDS)\n    g. Emergency Care Data Set (ECDS)\n3. North Bristol NHS Trust, local records\n4. Royal United Hospitals Bath NHS Foundation Trust, local records\n5. Primary Care information is received from GP practice providers via the SAIL databank, (which only handles pseudonymised data and applicant confirms does not require a recommendation of support)\n6. University Hospitals Bristol and Weston NHS Foundation Trust, local records (currently provisionally supported only due to an outstanding DSPT – an updated support letter will be provided once security assurances are in place)\n\n\nIdentifiers required for linkage purposes\n1. Name – sample validation and linkage\n2. NHS Number – sample validation and linkage \n3. Hospital ID Number – sample validation and linkage\n4. GP registration – sample validation and linkage \n5. Date of birth – sample validation and linkage and analysis \n6. Postcode – sample validation and linkage and analysis\n\n\nIdentifiers required for analysis purposes\n1. Date of birth – analysis \n2. Postcode – analysis \n3. Date of death – analysis\n4. Sex – analysis\n5. Ethnicity – analysis\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-06-17"]
["Next Review Date","2024-06-17"]
["Notes","13 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Personal Demographics Service (PDS), Hospital Episode Statistics (HES), Office for National Statistics (ONS) Mortality dataset, Mental Health Minimum Dataset (MHMD), Mental Health and Learning Disabilities Data Set (MHLDDS), Mental Health Services Data Set (MHSDS) & Emergency Care Data Set (ECDS).\n\n10 August 2021 - Amendment supported to allow; the disclosure of confidential patient information from the Avon Longitudinal Study of Parents and Children (ALSPAC) to PHE in order to link to COVID-19 test records and COVID-19 hospitalisation records, and for the flow of data back to ALSPAC, the addition of COVID-19 related data items received from NHS Digital, and the disclosure of confidential patient information from ALSPAC to PHE in order to identify missing NHS numbers from the G0 cohort, and for the flow of data back to ALSPAC\n\n17 June 2021 - Application supported\n\nConditions of support:\n\n1. Support extends to the linkage and access to confidential patient information held within the registry datasets and personal demographics information cited in the application. Support does not extend to those items/data sources that are not clearly confidential patient information. It is the responsibility of the applicant, together with NHS Digital, to determine which of the specific data items requested would fall within the legal definition set out in the NHS Act 2006. An alternative legal basis would need to be established for information which does not fall within the legal definition set out in the NHS Act 2006.\n\n2. Favourable opinion from a Research Ethics Committee (Confirmed – 31 August 2018).\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:- \nThe NHS Digital 20/21 DSPT review for ALSPAC, NHS Digital, UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST, Royal United Hospital Bath, and North Bristol NHS Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker, (checked 29 April 2021), and by email to the CAG inbox (11 October 2021)"]

{"sheet":"A02597","index":639,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02597"]
["Reference","21/CAG/0035"]
["Other Refs","IRAS Project ID: 259312  REC Reference: 21/WA/0073"]
["Application Title","ABC Discover (Molecular Phenotyping of Breast Cancer)"]
["Application Summary","This application from the University of Southampton sets out the purpose of medical research that seeks to determine how diet and environmental factors influence breast cancer patient outcomes. \nThe follow-up of cancer patients previously involved in research is undertaken in order to detect any recurrence of cancer as early as possible, with the aim of enabling rapid treatment provision. Due to improvements in treatment of cancer, many patients live longer. Extended follow-ups are undertaken to detect what may influence cancer recurrence, what causes progression and the eventual time to death. \n\nThe applicants are seeking support to use confidential patient information collected for the DietCompLyf study to investigate how diet and environmental factors influence breast cancer patients’ outcomes and to compare disease-free long-survival patients with those showing cancer progression. The DietCompLfy study was a prospective observational study, which recruited patients between 1997 and 2010 and closed in 2015, and examined the relationship between diet and lifestyle and breast cancer recurrence and survival rates in the UK. \n\nThe DietCompLfy was originally sponsored by University of Westminster, but the CI and sponsorship subsequently moved to University College London. However all data remained with University of Westminster and never moved.\n\nThis separate, subsequent study seeks to transfer the data to University of Southampton to assimilate the data and link with HES data at NHS Digital. Participants consented to linkage with the predecessor of NHS Digital, but the applicants consider this not to be sufficient for linkage as consent to do so was for a separate study. Following completion of linkages all identifiers will be deleted and anonymised, at which point support will no longer be required."]
["Applicant Organisation Name","University of Southampton"]
["Contact Name","Dr Paul Skipp"]
["Address","Centre for Proteomic Research, B85, Life Sciences Building"]
[null,"University of Southampton, University Road"]
[null,"Highfield, Southampton"]
["Postcode","SO17 1BJ"]
["Telephone","0238 059 4204"]
["Email","pjss@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female patients aged 16 years and over who were recruited into the DietCompLyf study. 3390 will be included. "]
["Description of confidential patient information used","Data sources\n1. Patient records from the DietCompLyf study, held at University of Westminster\n2. Paper study diaries and questionnaires, held by University of Westminster (note these do not contain identifiable data but may be sent with the identifiers)\n3. HES 10-year mortality/morbidity data is held by NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Date of death\n2. Postcode – district level\n3. Gender \n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-06-21"]
["Next Review Date","2022-06-21"]
["Notes","21 June 2021 - Application Supported\n\nSpecific conditions of support:\n1. Favourable opinion from a Research Ethics Committee. \nConfirmed 04 March 2021 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed - The NHS Digital 2019/20 DSPT reviews for the University of Southampton Clinical Trials Unit, University College London – School of Life and Medical Sciences, and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 19 March 2021)."]

{"sheet":"A02598","index":640,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02598"]
["Reference","21/CAG/0077"]
["Other Refs","IRAS Project ID: 294918  REC Reference: 21/NE/0104"]
["Application Title","Classification of breast cancer for personalised therapy"]
["Application Summary","This application, from University of Nottingham sets out the purpose of medical research that aims to determine key mechanisms, roles and drives controlling breast cancer behaviour and prognosis.\n\nOver 56,000 women are diagnosed with breast cancer in the UK each year. About a third of patients develop an aggressive form of breast cancer and can die earlier. Some forms of breast cancer do not respond well to drugs.\n\nThe applicants wish to build upon a current study (19/CAG/0084) by using 6000 cases from Sherwood Forest Hospitals NHS Foundation Trust. Members of staff from University of Nottingham and Sherwood Forest Hospitals NHS Foundation Trust, who are not considered part of the direct care team, will access confidential patient information at Sherwood Forest Hospitals NHS Foundation Trust to identify the patient cohort and collect information from the medical records. These will be sent to University of Nottingham in a pseudonymised manner to allow further research alongside tissue samples from the patients.\n\nThe applicants will use the tissue and associated clinical and outcome data to refine the criteria of breast cancer diagnosis and grading in the era of digital pathology, to use computational pathology and machine learning and artificial intelligence to evaluate various morphological features in breast cancer and to interrogate publicly available molecular datasets to utilise gene expression microarrays and next generation sequencing which provide data on tens of thousands of genes. The applicants intend to identify novel targets for further investigation and validation using tissue microarray technology and different analytical techniques."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Emad A Rakha"]
["Address","Department of Histopathology"]
[null,"City Hospital Campus, Hucknall Road, Nottingham"]
[null,"The University of Nottingham and Nottingham University Hospitals Trust"]
["Postcode","NG5 1PB"]
["Telephone","0115 969 1169 ext 56875"]
["Email","emad.rakha@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","6000 consecutive male and female patients, presenting at Sherwood Forest Hospitals NHS Foundation Trust between 1st January 2000 and 31st December 2015 with breast lesions who had surgery for diagnostic purposes."]
["Description of confidential patient information used","Data sources\n1. Sherwood Forest Hospitals NHS Trust\n\nIdentifiers required for linkage purposes\n1. Date of birth\n2. Hospital Number\n3. Gender\n\nIdentifiers required for analysis purposes\n1. None\n\nAdditional information\nGender will be retained for analysis purposes, and date of diagnosis will be converted to age at diagnosis."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-06-21"]
["Next Review Date"]
["Notes","Applicant confirmed in September 2023 that ‘s251’ support could be expired as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, this is not applicable, as the Main Phase project delivery did not commence due to difficulties in gathering associated tissue samples.\n\n\n21 June 2021 - Application supported\n\nConditions of support:\n\n1. Please clarify which individuals are actually undertaking the data extraction, to be clear on the scope of support required under Regulation 5, and provide a response to CAG within one month from the date of this letter. \n\n2. Please clarify whether the dataset collected under this application would be combined with the dataset from the previous application, 19/CAG/0084, and provide a response to CAG within one month from the date of this letter. \n\n3. A study specific patient notification leaflet should be developed, and all references to Google should be removed. Please provide an updated version of this notification to the CAG within one month from the date of this letter.\n\n4. Please undertake further patient and public involvement activity, specifically around the acceptability of the use of confidential patient information without consent for the purposes of this specific application, and report back to the CAG within six months from the date of this letter.\n\nConditions met 05 July 2021;\nApplicant response received by CAG. New condition applied 16 December 2021:-\nPlease explicitly demonstrate that the lack of consent/ opt out processes have been discussed with a patient and public involvement group (e.g. the next planned support group meeting), which could inform how to present information about use of data and opt out in study materials, and to report back to CAG at the first annual review.\nCondition met 30 May 2022 as part of first annual review\n\n5. Favourable opinion from a Research Ethics Committee. Confirmed 27 May 2021\n\n6. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:-\nThe NHS Digital 19/20 DSPT reviews for University of Nottingham and Sherwood Forest Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 16 June 2021)"]

{"sheet":"A02599","index":641,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02599"]
["Reference","21/CAG/0063"]
["Other Refs","IRAS Project ID: 295868  REC Reference: 21/WA/0145"]
["Application Title","The Impact of introducing real time feedback on ventilation rate and volume by ambulance clinicians in out of hospital cardiac arrest"]
["Application Summary","This application from the North East Ambulance Service NHS Foundation Trust set out the purpose of medical research that seeks to determine whether introducing real time ventilation feedback improves clinician compliance with recommended rate and volume of ventilation in clinical practice during out of hospital cardiac arrest. \nCardiac arrest is a life-threatening emergency and occurs when the heart suddenly stops beating. When the heart stops beating it cannot pump blood to the brain, lungs and other organs. When a cardiac arrest occurs in the community, outside of a hospital setting, it is called an out of hospital cardiac arrest (OHCA). When attending a patient suffering an OCHA, paramedics are required to deliver chest compressions and to assist breathing, by inserting a tube into patients mouths and squeezing a bag inflated with oxygen. It is important that the right amount of oxygen is delivered. Recommendations exist on how much oxygen should be delivered; however many paramedics administer too much or too little. Until recently, there has been no method to measure how much oxygen patients receive. A new feedback device has been developed. This device attaches to the tube which is inserted into the patient’s mouth. The other end of the device is connected to the defibrillator screen used by paramedics. When a paramedic squeezes the bag to deliver oxygen, the amount of oxygen delivered will appear on screen. Paramedics can then respond to any under or over delivery of oxygen. A five second counter is also included, which tells the paramedics when to squeeze the bag. \nThe applicants plan to undertake a clinical trial to determine whether use of this device improves paramedic compliance with ventilation recommendations during OCHA and if this improves patient outcomes. The trial will take place at three ambulance stations, Blucher, Redcar and Middlesbrough, which are all part of the North East Ambulance Service NHS Foundation Trust. Patients will not be randomised, instead the treating stations will be randomised. Clinicians based at each ambulance station will form a cluster. Initially no cluster will be exposed to real time ventilation feedback and all will be control clusters. All control clusters will use the real time ventilation feedback device but will receive no feedback. Each month one cluster will be randomised to ‘switch on’ the device and will move from control to intervention, until all clusters are exposed to real time ventilation feedback and are using the feedback during OHCA. Following all clinical assessments and confirmation of OHCA, the paramedic will confirm the patient meets the eligibility criteria. If the patient is eligible the paramedic will enrol the patient in the study and use the ventilation feedback device when providing ventilations. At the end of the study there will be a period when all clusters are exposed. Data collection will continue throughout the study, so that each cluster contributes observations under both control and intervention observation periods. The applicants explained that all patients will receive full standard care, however those treated while the feedback device is ‘turned on’ will receive additional care, in the form of the device being used. It is very likely that patients will be unconscious when receiving treatment and prior consent cannot be sought due to the emergency nature of the situation.\n\nWhen a patient has been enrolled in the study and the resuscitation has been completed, the study paramedic will send a unique incident number via text to a secure study mobile telephone held by the research paramedic. All recruited patients will be allocated a unique study identification number by the research paramedic, who will access the patients’ electronic patient records to determine if they have been conveyed to the emergency department.  Patients who have been conveyed to the emergency department will be tracked remotely by the research team. The research paramedics will screen NEAS OHCA audit reports for missed recruitment opportunities and to check for patient enrolment that has not been reported to the research team. Patients who are conveyed to hospital will be followed-up remotely by the research team. Patients who have died during the index visit will have their study data collected and input into the study database, and then their data will be anonymised. Patients who have been declared deceased on scene and have not been conveyed will remain in the study and the research paramedic will collect their study data from the electronic patient record and enter it onto the study database. This data will be anonymised immediately. Support is needed for the processing of confidential patient information for deceased patients. "]
["Applicant Organisation Name","North East Ambulance Service NHS Foundation Trust"]
["Contact Name","Mr Karl Charlton"]
["Address","North East Ambulance Service NHS Foundation Trust"]
[null,"Bernicia House, Goldcrest Way"]
[null,"Newburn, Riverside, Newcastle upon Tyne"]
["Postcode","NE15 8NY"]
["Telephone","0191 430 2000"]
["Email","karl.charlton@neas.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 18 years and over who are treated for out of hospital cardiac arrest by North East Ambulance Service NHS Foundation Trust.\n\nThe target for recruitment is 48 patients. The applicant noted that recruitment will take place over a four-month period and that recruitment will continue if the target is reached before the conclusion of the study period. "]
["Description of confidential patient information used","Data sources\n1. Electronic ambulance care records at North East Ambulance Service NHS Foundation Trust\n2. Electronic patient records at South Tees Hospitals NHS Foundation Trust, Newcastle Hospitals NHS Foundation Trust and Northumbria Healthcare NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Date of death\n4. Postcode – district level\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – district level\n4. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-06-22"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised.\n\nIn terms of public benefit, the aim of this research was to explore the effectiveness of a real time ventilation feedback device, which provides paramedics delivering ventilations, feedback on how much oxygen they are delivering each time they squeeze the bag. The evolving scientific evidence suggests too much oxygen during assisted breathing is detrimental to survival.  There is a need to determine how devices such as the ventilation device used in this study guide oxygen delivery and the impact this may have on survival from OHCA.    \n\n\n22 June 2021 - Application supported\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 07 June 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:-\nThe NHS Digital 19/20 DSPT review for Newcastle Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 06 May 2021)\n\nThe NHS Digital 19/20 DSPT reviews for South Tees Hospitals NHS Foundation Trust and Northumbria Healthcare NHS Foundation Trust were confirmed as ‘Standards Met’ (by email to the CAG inbox on 28 May 2021)\n\nThe NHS Digital 19/20 DSPT review for North East Ambulance Service NHS Foundation Trust was confirmed as ‘Standards Met’ (by email to the CAG inbox on 22 June 2021)"]

{"sheet":"A02600","index":642,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02600"]
["Reference","21/CAG/0081"]
["Other Refs","IRAS Project ID: 295868  REC Reference: 21/WA/0145"]
["Application Title","neoWONDER: Neonatal Whole Population Data linkage to improving long-term health and wellbeing of preterm and sick babies"]
["Application Summary","This application from the Neonatal Data Analysis Unit (NDAU) at Imperial College London sets out the purpose of medical research that aims to improve the lifelong health and wellbeing of babies born preterm and/or with surgical conditions by linking existing data from the National Neonatal Research Database (NNRD) with routine health, educational and environmental datasets in England and Wales to evaluate the long-term impact of neonatal interventions. A pseudonymous linked dataset will be crated for analysis, and the applicant is specifically researching long-term health and educational outcomes, the effect of air pollution or other environmental and socio-economic factors, and the impact of neonatal interventions, for example donor breast milk, on health and educational outcomes. \n\nMedical and surgical interventions in babies born preterm and/or with surgical conditions influence health and educational outcomes. Survivors are at risk of long-term neurological impairment and ongoing health, educational and social care needs, however due to the cost and complexity of obtaining long-term outcome data mean that longer term outcomes for the 90,000 babies born very preterm in the UK over the last decade is not yet known. This research will benefit children born preterm and/or with surgical conditions by identifying modifiable factors that influence long-term health and developmental outcomes, with the aim of improving outcomes for this patient group. Information on long-term outcomes will support counselling of families, decision-making, and inform future research and public policies to benefit patients and families. \n\nSupport is requested to use confidential patient information held in the NNRD for the purpose of linkage, by three trusted third parties – NHS Digital, Digital Health & Care Wales (DHCW) (Formerly known as NHS Wales Informatics Service, NWIS) and Office for National Statistics secure research service (ONS-SRS). These third parties will remove identifying information, and disclose only outcome data alongside an anonymised unique ID. The researchers will not have access to any confidential patient information and no individual patient will be able to be identified. A split file process will be used which will ensure that no organisation will hold identifiers along with clinical data together. \n\nFour cohorts of babies born between 2007 and 2020 who are either preterm, and/or have a surgical condition, will be created from the NNRD. The NNRD is an established national database retaining confidential patient information which is collected with support under the Regulations as the legal basis (CAG ref: ECC 8-05(f) / 2010). These cohorts will be linked to other health and education databases. A unique ID will be applied by the NDAU. \n\nRegarding Welsh data, NDAU will disclose identifiers from NNRD to DHCW (formerly NWIS) in a ‘File 1’, as Trusted third party for purposes of linkage with Welsh data in SAIL databank. Linkage with SAIL data is undertaken by DHCW without identifiers and this therefore does not require Regulation 5 support. ‘File 2’ of NNRD clinical data only, alongside the unique ID is disclosed to SAIL from the NDAU, and will be linked to Welsh health and education outcome data using only the anonymised unique ID. \n\nFor English data, PICANet, South London and Maudsley Clinical Record Interactive Search (SLaM-CRIS), and NDAU will send the identifiers (file 1 - NHS number, sex, postcode, date of birth, unique ID) for babies born in the study years to NHS digital as the trusted third party. Note that not all the NNRD records will have a match in the PICANet and CRIS datasets, and multiple PICANet or CRIS records may match with same record in the NNRD. NHS Digital will only retain PICANet and CRIS records that match with NNRD, non-matching identifiers will be discarded. (Note that NDAU will not be sending identifiers directly to PICANet / CRIS as a large proportion of these identifiers will not have matches). \n\nNHS Digital will undertake linkage between the NNRD cohorts, PICANet, CRIS, HES, ONS mortality data, and MHSDS. Identifying information is then removed, except the unique ID, and the pseudonymous dataset is transferred back to the NDAU. File 2 from each source (clinical data, unique ID, no identifiers) is then linked back to the outcome dataset from NHS Digital using the unique ID only by the NDAU.\n\nRegarding English education data, the Department for Education (DfE) holds the National Pupil Database (NPD) in the ONS-SRS and data from the NPD cannot leave the ONS SRS. The NNRD reliably captures data items such as date of birth, postcode, and infant NHS number, but it does not reliably hold the child’s registered name. Additionally, the NNRD contains the infants’ postcodes at birth, but does not capture postcode changes throughout childhood. Therefore NHS Digital will also link the identifiers from the NNRD cohorts to the Personal Demographics Service (PDS) to identify registered forename and surname and postcode changes, in order to undertake linkage with the NPD which does not contain NHS number. Forename, surname, date of birth, and postcodes alongside unique ID will be securely transferred to the ONS SRS to be used to link to educational data within the NPD. Identifying information is then removed. The NDAU send the clinical NNRD-HES/ONS/MSDS-PICANet-CRIS data and unique ID to ONS SRS and this is then linked to NPD using unique ID. The final de-identified NNRD-HES/ONS/MSDS-PICANet-CRIS-NPD linked dataset (without identifiers) will be accessed via researchers in the ONS-SRS safehaven, and the de-identified linked Welsh data will be accessed within the SAIL databank."]
["Applicant Organisation Name","Neonatal Data Analysis Unit (NDAU), Imperial College London"]
["Contact Name","Dr Cheryl Battersby, Clinical Senior Lecturer and Honorary Consultant Neonatologist"]
["Address","Chelsea and Westminster Hospital"]
[null,"369 Fulham Road"]
[null,"Chelsea and Westminster Gospital Imperial College Campus"]
["Postcode","SW10 9NH"]
["Telephone","02033 153 047"]
["Email"," c.battersby@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 120,000 babies born and received care in neonatal units in England and Wales between 1st Jan 2007 and 31st December 2020; recorded gestational age of less than 32 weeks OR Any gestational age AND recorded to have received surgery and diagnosis of one of 6 conditions: necrotising enterocolitis, Hirschsprung’s disease, gastroschisis, oesophageal atresia, congenital diaphragmatic hernia and posterior urethral valves.\n\n1. Cohort 1 Born 2007-2020 in England: link to health data (HES,ONS, PICANet, MHSDS) \nPreterm babies born less than 32 weeks and surgical babies (all gestations) \n2. Cohort 2 Born 2007-2016 in England: link to school age outcomes (NPD and CRIS) \nPreterm babies born less than 32 weeks gestation \n3. Cohort 3 Born 2012-2016 in England: link to school-age outcomes (NPD and CRIS) \nSurgical babies (all gestations) \n4. Cohort 4 Born 2012-2020 in Wales: link to SAIL databank (contains health, education, social data) \nPreterm babies born less than 32 weeks (Inclusion criteria: Preterm babies born <32 weeks in neonatal units in Wales 2012-2019 (11 neonatal units in the Wales Neonatal Network))\n"]
["Description of confidential patient information used","Data sources\n1. National Neonatal Research Database controlled by the Neonatal Data Analysis Unit (NDAU) (Chelsea and Westminster NHS Foundation Trust campus of Imperial College London)\n\n2. NHS Digital \n•\tNHS Digital Personal Demographics Service (PDS) \n•\tHospital Episode Statistics (HES)  \n•\tOffice for National Statistics (ONS) mortality data Identifiers include NHS number, date of birth, gender.\n•\tMental Health Services Dataset (MHSDS) (The MHSDS also contains its predecessor, the Mental Health and Learning Disabilities Data Set and the Mental Health Minimum Data Set)\n\n3. National Pupil Database (controlled by Department for Education DfE), retained in the ONS-SRS\n\n4. Paediatric Intensive Care and Audit network, (PICANet) controlled by Healthcare Quality Improvement Partnership (HQIP) and is retained at the Universities of Leeds and Leicester\n\n5. South London and Maudsley Clinical Record Interactive Search (SLaM-CRIS); held and controlled by South London and Maudsley NHS Foundation Trust (SLaM) at King’s College London. \n\n6. (SAIL) databank, also holds education data for Wales. (linkage is undertaken by using DHCW (formerly NWIS) as a trusted third party without using confidential patient information and support not required). \n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth \n3. Sex\n4. Postcode\n5. Unique ID\n\nIdentifiers required for analysis purposes\nN/A - no identifiable information for analysis.\n\nAdditional information\n1. Date of death: Note that date of death is modified to postnatal age at death by NHS Digital\n\n2. Data access: The de-identified linked dataset set containing education data will be accessed through the Office for National Statistics (ONS) Secure Research Service (SRS). A de-identified dataset without the education data will also be held on the Imperial College server. A de-identified linked Welsh dataset will be retained in SAIL databank. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-06-22"]
["Next Review Date","2024-06-22"]
["Notes","22 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Personal Demographics Service (PDS), Hospital Episode Statistics (HES), Office for National Statistics (ONS) mortality data, Mental Health Services Dataset (MHSDS) (The MHSDS also contains its predecessor, the Mental Health and Learning Disabilities Data Set and the Mental Health Minimum Data Set).\n\nAmendment supported 23 August 2022 to clarify the linkage process regarding NPD data (NHS Digital to disclose confidential patient information to Department for Education, who disclose pseudonymous information on to the ONS-SRS)\n\n18 January 2022 - Amendment supported:\nAmendment supported to clarify the linkage process regarding PICANet and CRIS datasets (NHS Digital to disclose dummy PICANet/CRIS study ID to NDAU, who disclose on to PICANet and CRIS)\n\n22 June 2021 - Application supported\nThe application, to allow;\n\n1. Disclosure of confidential patient information (from NNRD) from The Neonatal Data Analysis Unit (NDAU) at Chelsea & Westminster Hospital NHS Foundation trust to Digital Health & Care Wales (DHCW) (Formerly known as NHS Wales Informatics Service, NWIS) in File 1 (as Trusted third party for purposes of linkage with Welsh data in SAIL databank),\n\n2. Disclosure of confidential patient information (from NNRD) from The Neonatal Data Analysis Unit (NDAU) at Chelsea & Westminster Hospital NHS Foundation trust, Universities of Leeds and Leicester (PICAnet), and Kings College London (SLaM-CRIS) to NHS Digital (in file 1) as trusted third party for purposes of linkage together, and to link to Hospital Episode Statistics (HES), Office for National Statistics (ONS) mortality data, and the Mental Health Services Dataset (MHSDS) (The MHSDS also contains its predecessor, the Mental Health and Learning Disabilities Data Set and the Mental Health Minimum Data Set), in order to disclose a pseudonymised dataset back to the NDAU,\n\n3. NHS Digital to link confidential patient information (from NNRD) with the personal demographics service (PDS), and for NHS Digital to disclose confidential patient information alongside unique ID to ONS SRS in order to link to National Pupil Database (NPD),\n\n4. NHS Digital and Department for Education (DfE) to retain linkage keys for possible future applications,\n\nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. Please provide further justification for the inclusion of SLaM-CRIS data, within one month from the date of this letter.\nApplicant response provided 16 July 2021, and CAG confirmed condition met (email confirmation 22/07/2021)\n\n2. Please provide an updated patient notification document for CAG review, within one month from the date of this letter. This should incorporate the following changes;\na.\tIncorporate a layered approach\nb.\tRemove inaccuracies, and ensure clarity, using the feedback in the advice form and the letter \nc.\tEnsure neoWONDER specific opt out is clearly provided\nApplicant response provided 16 July 2021, and CAG confirmed condition met (email confirmation 22/07/2021)\n\n3. The patient notification should be displayed for at least 6 weeks prior to data extraction.\nApplicant response provided 16 July 2021, and CAG confirmed condition met (email confirmation 22/07/2021)\n\n4. Please provide an update as to whether any individual units have opted out of neoWONDER at annual review. Condition met as part of first annual review\n\n5. Please undertake ongoing patient and public involvement with teenagers, to explore the acceptability of the use of confidential patient information without consent, and provide feedback to CAG within six months from the date of this letter. Condition met 17 January 2022\n\n6. Please provide justification as to why multiple datasets for analysis are required to be held in two different locations, within one month from the date of this letter.\nApplicant response provided 16 July 2021, and CAG confirmed condition met (email confirmation 22/07/2021)\n\n7. Favourable opinion from a Research Ethics Committee. Confirmed 02 June 2021\n\n8. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- As there are more than 5 organisations processing confidential patient data these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for these organisations have been assessed as ‘standards met’ by NHS Digital"]

{"sheet":"A02601","index":643,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02601"]
["Reference","21/CAG/0062"]
["Other Refs","IRAS Project ID: 283103  REC Reference: 21/EE/0123"]
["Application Title","Barts Haemato-Oncology Research Tissue Bank (HOTB)"]
["Application Summary","This application from Barts Cancer Institute, Queen Mary University of London set out the purpose of medical research that aims to provide support for Barts Haemato-Oncology Research Tissue Bank (HOTB) team staff, who are not members of the direct care team to identify and screen patients attending Haemato-Oncology clinics and wards at Barts Health for eligibility, in order to subsequently seek their consent into the Barts HOTB. The aim of the HOTB is to recruit patients and healthy volunteers, to collect, store and share high quality tissue and bodily fluids and associated clinical data for translational research into haematological malignancies; however all other processes of the HOTB do not require Regulation 5 support, as all participants are consented. The current HOTB model is for the direct care team to identify and consent eligible patients, but the applicants have identified that this model is not practicable as the process is very inefficient. The direct care team is not able to spend time identifying and introducing the patients to the HOTB team during very busy clinic hours and consequently the number of identified patients is currently very low.\n\nHaematological malignancies comprise a variety of different tumour types affecting the bone marrow, blood and lymph glands. Collectively, they remain the third biggest cause of cancer deaths, and the incidence and age of patients with haematological malignancies are rising. The treatments available are frequently toxic and often cannot be given to older or unfit patients. There is therefore a continued need to better understand these malignancies, and the HOTB will help a number of local, national and international researchers to investigate the causes of haematological cancers, in order to improve diagnosis, early detection, preventative strategies and treatment for haematological cancer patients in the future.\n\nMembers of the HOTB team, who are not members of the direct care team, will use Barts Health patient records such as Cerner Millennium Powerchart, NHS.net calendars and EPR to identify and screen patients that may be appropriate to approach for consent. Any patient who has opted out via the national data opt out will be removed from the screening process. This process is still in development but will be implemented by September 2021.  All patients that may be eligible for HOTB (with a suspected or diagnosed haematopoietic malignancy) will be recorded on the shared calendar of the BCI (Barts Cancer Institute) Tissue Bank shared NHS.net email address (within the Barts health NHS Trusts servers). In order to undertake screening, HOTB staff will view confidential patient information (Full name, NHS Number, Hospital number, Date of birth). HOTB staff will record if a patient is eligible or not on a shared calendar of an NHS.net email address on the Barts NHS Trust servers, using the stated items of confidential patient information. This will show whether a patient needs to be approached to request consent. \n\nThe HOTB team member will use the shared calendar entries to approach the direct care team and ask whether it is appropriate to approach the identified patient for consent. Providing the direct care team are happy that it is appropriate to consent the patient for research purposes the HOTB team member will approach potential patients in order to gain consent. Patient consent or dissent to the Tissue Bank will continue to be recorded on the patient’s record on Millennium Powerchart to prevent a dissented patient being inadvertently re-approached. However, the identifiable details of any patient that dissents will not be recorded or stored in the HOTB systems. Any hard copies of screening will be destroyed through confidential waste or shredded, although the applicant has confirmed there should not be any paper copies."]
["Applicant Organisation Name","Barts Cancer Institute, Queen Mary University of London"]
["Contact Name","Coleen Colechin, Senior Operations Manager"]
["Address","Queen Mary Innovation Centre"]
[null,"Lower Ground Floor, 5 Walden Street"]
[null,"London"]
["Postcode","E1 2EF"]
["Telephone",2078827252]
["Email","c.g.colechin@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients attending Haemato-Oncology clinics and wards at Barts Health NHS Trust with a suspected or diagnosed haematological malignancy \n\nApproximately 160 patients a week will be screened, to identify approximately 20 eligible patients. "]
["Description of confidential patient information used","Data sources\nBarts Health NHS trust: Electronic Patients Record (EPR) and Care Record Service (CRS)/Millennium Powerchart, WinPath, CyberLab and Varian prescribing system. \n\nThis includes lists of patients attending day-unit, clinics or wards, which could be provided by direct care team, as well as the physical procedure diary on the day-unit, and NHS.net calendars.\n\nIdentifiers required for identification of cohort\n1. Full name\n2. NHS Number\n3. Hospital number \n4. Date of birth\n\nIdentifiers required for analysis purposes\nN/A - undertaken with consent."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-06-23"]
["Next Review Date","2024-06-23"]
["Notes","23 June 2021 - Application supported\nThe application, to allow Barts Haemato-Oncology Research Tissue Bank (HOTB) team staff, who are not members of the direct care team, to identify and screen patients attending Haemato-Oncology clinics and wards at Barts Health NHS Trust for eligibility, in order to subsequently seek their consent into the Barts HOTB, and also for the retention of confidential patient information regarding any samples collected prior to 2006, where consent has not been provided, and the donor is now deceased, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. Support provided for 5 years in line with REC favourable opinion. A duration amendment will be required at this time to extend support.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 11 June 2021.\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:- \nThe NHS Digital 19/20 DSPT review for Barts NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 25 May 2021)"]

{"sheet":"A02602","index":644,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02602"]
["Reference","21/CAG/0056"]
["Other Refs","IRAS Project ID: 293034  REC Reference: 21/WA/0141"]
["Application Title","A randomized, controlled trial to assess the clinical utility of a multi-cancer early detection (MCED) test for population screening in the United Kingdom (UK) when added to standard of care"]
["Application Summary","This application from Grail Bio UK Ltd and Kings College London (KCL) set out the purpose of a randomised controlled trial (RCT) that aims to understand whether the Galleri™ test (a Multi-cancer early detection (MCED) test) is a better way of detecting cancer early than the existing NHS pathway in people who do not have any symptoms of cancer. \n\nThe Galleri™ test is a new blood test that can detect signs of many different types of cancer in a single blood sample. If the Galleri™ test can find these signs earlier than other tests and before people have symptoms of cancer, it may mean cancer treatments that are less serious, less invasive and more successful can be utilised. NHS England has set an ambition to achieve a significant shift in the proportion of cancers diagnosed at an early stage by 2028. An intent of this study is to understand if the Galleri™ test can contribute to this aim. The RCT is consented and outside the scope for support. \n\nRegulation 5 support is required solely for the activity of identifying potential patients by the processor(s) of this activity. This will be undertaken by NHS Digital (under the brand of NHS DigiTrials https://digital.nhs.uk/services/nhs-digitrials) and a sub-contracted third party mail-out company (APS) to send out invitation letters to seek consent. Potential participants will be identified via three methods, however Regulation 5 support has been requested for NHS Digital and APS, as a sub-processor, to undertake the invitation approach only.\n\nIdentification of the cohort will be undertaken by NHS Digital using the Personal Demographic Service (PDS) dataset to extract a cohort of eligible patients, and link to the National Cancer Registration and Analysis Service (NCRAS) to exclude certain cancer diagnoses. NHS Digital will apply the national data opt out, and PHE-specific opt out for the NCRAS data. Date of death will be checked in order to exclude any participants who have died. A pseudonymised invitation code for each individual is added to the dataset by the NHS Digital team. \n\nNHS Digital will disclose name, full postal address, month and year of birth, and invitation code to APS in order to send the invitation letters to identified participants. Invitation letters will be sent out once only. Invitees will be invited to contact a study contact centre via a study website or phone if they are interested in participating, after which consent will be provided if participating. The central study team at KCL and Grail Bio UK Ltd will only learn about the invitee when they contact the central study team to express interest in participating.\n\nThe recruitment process is expected to take 10-12 months after June 2021, but could take up to 18 months, and potential participants will be identified in monthly data extracts by NHS Digital. Identifying information is deleted by APS two weeks after each mailout."]
["Applicant Organisation Name","Grail Bio UK Ltd & King's College London (KCL)"]
["Contact Name","Graham Cheetham, Senior Director Clinical Operations"]
["Address","Evergreen House North"]
[null,"Grafton Place"]
[null,"London"]
["Postcode","NW1 2DX"]
["Telephone","07746 159 986"]
["Email","gcheetham@grailbio.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 2.8 Million people in the general population, not currently diagnosed with cancer (or within the last three years) aged 50-77 to be contacted by letter in order to obtain consent from 140,000 participants."]
["Description of confidential patient information used","Data sources\n1. The Personal Demographic Service (PDS) dataset (held by NHS Digital)\n\n2. The National Cancer Registration and Analysis Service (NCRAS). (PHE is the controller for NCRAS but data is held within NHS Digital currently for other COVID-19 purposes. PHE have provided permission for NHS Digital to use NCRAS data for this purpose if support is in place)\n\nIdentifiers required for identification and invitation purposes\nData items required for identification of cohort by NHS Digital:\n• Age\n• Sex\n• Postcode\n• Ethnicity\n• Date of death\n• History of invasive cancer diagnosis or treatment within the three years prior to the query\n• Current investigation for suspected cancer via the two-week wait pathway\n• Receiving hospice and end of life care through a Gold Standards Framework (GSF) Centre\n\nIn order to send out patient letters the following identifiers are disclosed to APS:\n• Name\n• Address including full postcode\n• Month and year of birth (as mentioned on letter)\n• Invitation code (as mentioned on letter)\n\nAdditional information\nNHS DigiTrials will extract lists of eligible participants approximately monthly for up to 18 months. However, if recruitment is slow or there are key groups under-represented then the number of extracts may be increased to weekly. \n\nAreas out of scope\nThe applicant has stated that the following are outside \nthe scope of this application and do not require support \nunder Regulation 5 of the Health Service (Control of \nPatient Information) Regulations 2002:\n\n1. Identification of participants via query of GP practice records and invitation by GP.\n2. Participant self-identification via an interested individual who presents after learning about the study from family member or friends, or from seeing the study recruiting in their area.\n3. ‘Phase 2’ screening using the GP dataset held by NHS Digital is not yet ready to be supported and an amendment will be submitted in due course.\n4. All flows of data after the time point participants consent to participate."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"x","Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-06-23"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in August 2022 that ‘s251’ support is no longer required, as the activity covered by application, to allow NHS Digital (DigiTrials) to extract a cohort of eligible participants for the purposes of mailing invitation letters in order to seek consent to the NHS-Galleri trial, has now completed. \n\nIn terms of public benefits, the scale and the speed with which participants have been enrolled to the trial is important, and if the trial is successful, it is hoped that the NHS will adopt the test and could impact the lives of millions of individuals within the NHS in the future.\n\n23 June 2021 - Application supported\nThe application, to allow NHS Digital to extract a cohort of eligible patients from the Personal Demographic Service (PDS) dataset, link to information held in the National Cancer Registration and Analysis Service (NCRAS) (controlled by PHE and held by NHS Digital), and for NHS Digital to disclose confidential patient information to APS (Allied Publicity Services (Manchester) Limited) for the purposes of mailing invitation letters to eligible participants in order to seek consent, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 08 June 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\n• The NHS Digital 19/20 DSPT review for APS (Allied Publicity Services (Manchester) Limited and the 19/20 DSPT equivalent for NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 20 April 2021).\n• NCRAS data is controlled by PHE, however NHS Digital currently hold this and therefore this data is subject to NHS Digital’s governance."]

{"sheet":"A02603","index":645,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02603"]
["Reference","21/CAG/0093"]
["Other Refs","IRAS Project ID: 289425  REC Reference: 21/NE/0079"]
["Application Title","Facilitating access to online NHS primary care services - current experience and future potential (Di-Facto)"]
["Application Summary","This application from the university of Exeter sets out the purpose of medical research that aims to explore patient access to digital services provided by primary care.\n\nThe COVID-19 pandemic has led to an increase in digital routes of contact offered by general practices (for example online triage platforms) and therefore an increased need for patients to be capable of using digital routes to access care. During the early stages of the COVID-19 pandemic, NHS England encouraged all general practices to move to a ‘total triage’ model which requires all patients to make an initial contact with their general practice via an online platform (those patients who cannot use online services must use the telephone) so that the information can be used to decide which type of appointment a patient requires. However, recently published data has shown that even during the pandemic, telephone was the most commonly used alternative to a face-to-face consultation, shown to comprise around 90% of all consultations, indicating that digital routes of contact are still far from routinely used by patients even though they are more available.\n\nIt is therefore important to understand how barriers to uptake might be overcome and patients best supported in the move to online services of all kinds. One way to address this is with digital facilitation; supporting NHS patients and carers in their use of online services. ‘Digital facilitation’ is defined as ‘that range of processes, procedures, and personnel which seeks to support NHS patients in their uptake and use of online services.’ There is, however, no existing evidence as to the nature and scope of applying digital facilitation. This is compounded by the fact that the nature and extent of innovative approaches offered by practices are unknown. It is important to understand the extent to which digital facilitators or other approaches to digital facilitation are being used, how they are  used, how they may be impacting patient health and access to healthcare information and services, GP practices, and the wider NHS.\n\nThis study is one which primarily operates using consent as the legal basis (and therefore outside the scope of support). However, as part of the study researchers, not part of the direct care team, will be observing 8 GP practices (to be identified). These observations are interested in the interactions between patients and staff, and between staff, and are not interested in patient information. However, during the observations, confidential patient information may be incidentally disclosed (e.g. overhearing staff talk about a patient). No audio recordings are made and no notes are take relating to confidential patient information."]
["Applicant Organisation Name","University of Exeter"]
["Contact Name","Professor John Campbell"]
["Address","Professor of General Practice and Primary Care"]
[null,"College of Medicine and Health - University of Exeter, Medical School"]
[null,"Smeall Building, Magdalen Road"]
["Postcode","EX1 2LU"]
["Telephone",1392722741]
["Email","john.campbell@exeter.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients at 8 GP practices whose confidential patient information may be incidentally disclosed during observations"]
["Description of confidential patient information used","Data sources\n\n\t1.\t8 GP practices to be identified\n\nIdentifiers required for linkage purposes\n\n1.\tNo items of confidential patient information will be collected for analysis purposes\n\nIdentifiers required for analysis purposes\n\n1.\tNo items of confidential patient information will be collected for analysis purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-07-01"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in November 2022 that the application can be expired, as all activities for the Di-Facto ethnographic study are now complete, and the incidental disclosure of confidential patient information without consent is now complete. \n\n01 July 2021 - application supported\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 April 2021\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed. \n\nDue to the number of organisations involved it is the responsibility of University of Exeter, as controller, to ensure that practices hosting researchers meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a practice."]

{"sheet":"A02604","index":646,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02604"]
["Reference","21/CAG/0067"]
["Other Refs","IRAS Project ID: 291682  REC Reference: 21/EM/0103"]
["Application Title","Derivation and narrow validation of a clinical decision rule for paramedics to triage older adults with a traumatic brain injury \nShort title: Clinical Decision Rule for TBI in Older adults (CEREBRAL)"]
["Application Summary","This application from South East Coast Ambulance Service NHS Foundation Trust set out the purpose of medical research that aims to develop and test a clinical decision rule (CDR) that paramedics could use to aid triage of patients aged 60 years or older who could be at risk of a traumatic brain injury (TBI), to a hospital with neurosurgical services onsite.\n\nIt is now considered that older adults are a large proportion of the TBI patient population, with the majority presenting to the emergency department (ED) via emergency services. Therefore the responsibility of the initial assessment, triage, and transportation of these patients falls to the paramedic. However clinical presentation following a TBI may not correlate with the severity of injury, and as a result, the triage of older adults suffering a TBI can be inaccurate, increasing the risk of poor patient outcomes. When older adults with traumatic injuries are transported to an appropriate hospital, they are more likely to have a good outcome. Understanding which older TBI patients should be transported to a hospital with onsite neurosurgery and the variables that may predict this could help paramedics in the acute triage and management of older adults with suspected TBI.\n\nCurrently, it is difficult to accurately identify patients with a TBI until they have had a scan of the head which can only occur in a hospital. Therefore, to identify patients presenting to the ambulance service with a clinically significant TBI, the applicants plan to work backwards from the hospital records. Retrospective patient records will be identified from two different hospital sources; \n\n1. Hospital records of patients meeting the inclusion criteria referred to neurosurgeons will be screened via the online neurosurgical referral service. These records will be screened and extracted by the applicant, who is not a member of the direct care team. The direct care team do not have capacity to undertake this screening and extraction. He has explained that the access to the online Neurosurgical referral platform will be through Kings College London NHS Foundation Trust (KCL), as they are the central Trust in SELKaM Trauma Network, who operate a hub and spoke model, and all neurosurgical referrals go through KCL, and  for Sussex trauma network data will be extracted from Brighton and Sussex University Hospital. He will extract CAD incident number if available, alongside date of transport, NHS number, date of birth, date and ED admission time, Gender, ethnicity, and other clinical information. He will securely send this dataset to the Business Intelligence department at South East Coast Ambulance Service NHS Foundation Trust (SECAmb). \n\n2. Hospital records of patients meeting the inclusion criteria who attended the ED but were not referred to neurosurgeons will be screened via the ED hospital registry. Intelligent information specialists at hospitals within East Kent Foundation Hospitals Trust for SELKaM Trauma Network, and University Hospitals Sussex NHS Foundation Trust for Sussex Trama network+ will identify and extract a dataset regarding eligible patients. Support is requested for this, as the Trusts may not consider these staff to be the direct care team. They will and extract CAD incident number if available, alongside date of transport, NHS number, date of birth, date and ED admission time, Gender, ethnicity, and other clinical information. They will securely send this dataset to the Business Intelligence department at South East Coast Ambulance Service NHS Foundation Trust (SECAmb). \n\nThe patient’s hospital records regarding neurosurgical referrals and ED data will be linked together by SECAmb Business Intelligence (BI) department, and also linked to SECAmb ambulance patient record using CAD numbers, NHS numbers and dates of birth. Once linkage is complete, The BI team will assign a pseudonymous study ID, and the CAD number, NHS number and date of birth are removed and destroyed. No key between the pseudonymous ID and identifiable information is retained. The dataset is sent to the study team at University of Surrey. and it can be considered anonymous to the research team, as they will be unable to re-identify the patients. The study team will not have access to patient identifiable information.\n \nThe final dataset will also include SECAmb patients who were not transported to the hospital over the same period, however this element does not require CAG support."]
["Applicant Organisation Name","South East Coast Ambulance Service NHS Foundation Trust"]
["Contact Name","Mr Jack Barrett, Research Paramedic"]
["Address","Nexus House"]
[null,"4 Gatwick Road"]
[null,"Crawley"]
["Postcode","RH10 9BG"]
["Telephone","07789 650 548"]
["Email","jack.barrett@secamb.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Older adults (60+) who have a TBI or suspected TBI or head injury, and present to South East Coast Ambulance Service (SECAmb) between the 1st of January 2020 and the 31st of December 2020 and transported to hospitals within the trauma networks of South East London, Medway, and Kent (SELKaM) Trauma Network or Sussex Trauma Network.\n\nApproximately 1080 patients expected."]
["Description of confidential patient information used","Data sources\n• Hospital online Neurosurgical referral platform: For SELKaM Trauma Network, accessed only at King’s College Hospital, and for Sussex trauma network this is accessed at Brighton and Sussex University Hospital\n\n• Participating Emergency Department hospital records, in SELKaM Trauma Network;\n1. King’s College Hospital\n2. William Harvey Hospital \n3. Queen Elizabeth Queen Mary Hospital \n4. Canterbury Hospital \n\nand Sussex trauma network;\n1. Brighton and Sussex University Hospital \n2. Worthing Hospital\n3. St Richards Hospital  \n4. Princess Royal Hospital \n5. Conquest Hospital \n6. Eastbourne Hospital \n\n\n• SECAmb ePCR database (South East Coast Ambulance patient electronic records)\n\nIdentifiers required for linkage purposes\n1. CAD number\n2. NHS number\n3. Date of birth\n4. Date and time of ED admission\n5. Pseudonymous ID\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Ethnicity\n3. Pseudonymous ID\n4. Age\n\n(Effectively anonymous for analysis)"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-07-20"]
["Next Review Date"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, these are currently in progress, but the benefits arising from this work should provide further evidence and support for ambulance clinicians to make informed decisions regarding which patients presenting with a head injury should be transported to the hospital.\n\n\n19 April 2022 - Amendment supported, to extend the duration of support for the collection of confidential patient information from 30 April 2022 to 30 June 2022.\n\nAmendment supported 09 November 2021 - to allow data extraction from emergency departments patient records to be undertaken by a researcher (who is not part of the direct care team) at participating hospitals (in cases where Intelligent information specialists do not have the capacity to do so), and to include Medway Maritime Hospital NHS Foundation Trust as a new data processor\n\n20 July 2021 - Application Supported\nThe application, to allow;\n\n• data extraction regarding neurosurgical referrals to be undertaken by the applicant (who is not part of the direct care team) at Kings College Hospital NHS Trust, and Brighton and Sussex University Hospital, and for the onwards disclosure of confidential patient information to SECAmb,\n• data extraction from emergency departments patient records undertaken by Intelligent information specialists (who are not part of the direct care team) at participating hospitals (part of East Kent Foundation Hospitals Trust for SELKaM Trauma network and part of University Hospitals Sussex NHS Foundation Trust for Sussex Trauma network), and for the onwards disclosure of confidential patient information to SECAmb,\n• and for SECAmb to link the hospital datasets with the SECAmb ambulance patient data, and provide the research team with a pseudonymous dataset for analysis,\n\nis fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 10 June 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. \n\nConfirmed:- As there are more than 5 organisations processing confidential patient data these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for the following organisations have been assessed as ‘standards met’ by NHS Digital;\n\n•\tSouth East Coast Ambulance Service NHS Foundation Trust\n•\tKing’s College Hospital \n•\tEast Kent Foundation Hospitals Trust \n•\tUniversity Hospitals Sussex NHS Foundation Trust (new merged Trust, should currently be covered by the below;\n•\tBrighton & Sussex university Hospital NHS Trust and \n•\tWestern Sussex Hospitals NHS Trust"]

{"sheet":"A02605","index":647,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02605"]
["Reference","21/CAG/0089"]
["Other Refs","IRAS Project ID: 299464  REC Reference: 21/LO/0455"]
["Application Title","Evaluating the integration of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) into primary care and its impact on patient treatment and care\nShort title: ReSPECT in primary care"]
["Application Summary","This application from the University of Warwick sets out the purpose of medical research to evaluate the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) process for adults in primary care, to determine how, when and why it is used, and what effect it has on patient treatment and care. \n\nThe ReSPECT plan is a type of emergency care treatment plan, used in hospitals and intended to help patients (or their families) and doctors or senior nurses talk about and record advice about emergency treatments that they may need or want, should they become seriously ill and unable to be involved in decisions about their care. The applicants have recently completed an evaluation of ReSPECT in NHS Acute Trusts, but the ReSPECT process may be more effective if discussed in primary care. The applicants noted the important of evaluating how this process works in primary care, and what impact it has for patients and their families. GPs were encouraged to use ReSPECT prior to COVID, and this has accelerated during the pandemic. However, rapid implementation under pressure of the pandemic risks inappropriate use, which may have implications for future implementation. There is therefore a pressing need to explore how the ReSPECT plan currently does or does not work in primary care, the impact of the pandemic on its implementation, and implications for patients, their families and health care professionals. If the plan is effective, then patient care should be improved and NHS resources used more effectively. \n\nThe project involves a number of work packages; however, only work packages WP1 and WP3 are within the scope of support sought under s251. Support is required as members of the research team, who are not part of the direct care team, may be required to view patients medical records, as it will not always be possible for GP staff to undertake these tasks. \n\nIn Work Package 1, the applicants will undertake consented interviews with patients with a ReSPECT form, their families and GPs or senior nurses involved in the ReSPECT process, and staff in care homes. GP staff will identify eligible patients, and contact them via letter in order to consent for interview, however it may be necessary for researchers who are not part of the direct care team to view confidential patient information when extracting a pseudonymised dataset for analysis regarding all patients in participating GP practices who have had a ReSPECT form completed in the last 12 months. They will record basic demographic data, eFrailty index, and type of residence (residential care or own home). These data will not contain any items of identifiable information, but researchers may be required to access medical records to extract this dataset, which therefore requires support under ‘s251’. Patient contact details are required in order to invite participants for interview, however this is undertaken via the GP practice.\n\nWork Package 3 involves a review of ReSPECT forms and patient GP records to map ReSPECT recommendations to subsequent treatment decisions. Researchers at the Univresity of Warwick will review the anonymised records of patients who have a ReSPECT form completed in the last 12 months. Support under ‘s251’ is requested in order to allow the research team to access the patients’ medical records to extract a pseudonymised dataset for analysis, and collect pseudonymised copies of the ReSPECT form, and discharge summaries or appointment letters.\n\nA pseudonymised dataset is disclosed to the University of Warwick for analysis, however this will be effectively anonymous to researchers as the key will be retained at GP practices. 24 care homes will also be taking part in this research study, however support is not required for this element as only care home staff, who are providing direct care, will be processing confidential patient information in order to extract a pseudonymised dataset. "]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Professor Anne Slowther, Professor of Clinical Ethics"]
["Address","University of Warwick"]
[null,"Warwick Medical School"]
[null,"Gibbet Hill Campus, Coventry"]
["Postcode","CV4 7AL"]
["Telephone","0247 657 4513"]
["Email","a-m.slowther@warwick.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","WP1: all adults (18 and over) in the practice with a ReSPECT form completed in the previous 6 months - will have data accessed in order to screen for eligibility. Up to 100 patient records per practice will be accessed and 48 will be invited for interview. \n\nWP3: all adults (18 and over) in the practice with a ReSPECT form completed in the previous 12 months - will have data accessed in order to screen for eligibility and extract an anonymised dataset for analysis (not required if direct care team). 40 patient records per practice will be accessed in order to achieve the estimated sample size for analysis. \n"]
["Description of confidential patient information used","Data source\n1. 12 GP practices from across three Clinical Commissioning Groups (CCGs)\n2. 24 Care homes (outside the scope of support)\n\nIdentifiers required for extracting a pseudonymised dataset\nFor WP1;\nClinical patient records will be viewed in order to extract the pseudonymous dataset for analysis\n\nFor WP3;\nClinical patient records will be viewed in order to extract the pseudonymous dataset for analysis\n\nCopies of ResPECT form and entire GP record (hospital discharge letters) for 6 months following form completion. These records will be copied, but pseudonymised before being disclosed to the research team. \n\nIdentifiers required for analysis purposes\nPseudonymous participant identification number\nAge\nSex\nEthnicity\neFRailty index\n\nThis can be considered anonymous to researchers.\n\nAdditional information\nThe participant identification number will be assigned by practice staff at the original identification of patients who have had a ReSPECT form completed. \n\nPatient NHS number only will be retained with participant identification number as the key at GP practices.\n\nThe pseudonymisation key will be retained until the end of data collection and analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-07-21"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in July 2023 that ‘s251’ support can be expired as all identifiable patient information held without consent under this support has been pseudonymised, and the University of Warwick has no technical means of accessing the linkage key. \n\nIn terms of public benefit, the project has provided  insights into how ReSPECT is used  in primary and community care and  how it can be improved to ensure that health care professionals are supported to make treatment decisions for patients in an emergency that reflect their wishes and preferences.\n\n\nAmendment supported 25 May 2023 to extend the duration of ‘s251’ support until 31 July 2023\n\nAmendment supported 02 March 2023 \nTo extend ‘s251’ support to include 3 care homes as additional data processors, to allow members of the research team to view confidential patient information whilst accessing care home residents’ ReSPECT forms and care records, and for the research team to use care home records (rather than GP records) to identify acute clinical events for the care homes recruited to the feasibility study\n\n21 July 2021 - Application supported\nThe application,\n\nto allow (as part of Work package 1) the research team, who are not considered members of the direct care team, to view confidential patient information while extracting a pseudonymised set of demographic data (applicants anticipate that this will often be done by members of the direct care team, however support is sought should this not be possible), \n\nand to allow (as part of Work package 3) the research team, who are not considered members of the direct care team, to view confidential patient information while extracting a pseudonymised dataset for analysis from the GP medical records (applicants anticipate that this will often be done by members of the direct care team, however support is sought should this not be possible), \n\nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1. The poster and corresponding website text for GP practices should be updated to explain what ReSPECT is, provide a telephone number and postal address alongside the email address, and provide a clear opt out option. Updated versions should be provided to the CAT for review, within one month from the date of this letter.\n\nCondition met 10 August 2021\n\n2. Favourable opinion from a Research Ethics Committee. \nConfirmed 17 June 2021\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. \n\nConfirmed:-\nDue to the number of participating care providers involved it is the responsibility of the applicant, as controller, to ensure that all organisations processing confidential patient information meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a care provider. These will not be individually checked by the CAT team due to the number of organisations involved."]

{"sheet":"A02606","index":648,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02606"]
["Reference","21/CAG/0009"]
["Other Refs","IRAS Project ID: 282429  REC Reference: 20/LO/1189"]
["Application Title","Motor Neuron Disease Register for England, Wales and Northern Ireland"]
["Application Summary","This application from Kings College London (KCL) set out the purpose of medical research which aims to create a research database that will act as a central resource of information about all people with a diagnosis of Motor Neuron Disease (MND) as confirmed by a consultant neurologist in England, Wales and Northern Ireland, to enable the calculation of incidence and prevalence of MND in England, Wales and Northern Ireland. Confidential patient information will also be linked with clinical data from national datasets. There is also a separate non-research application (21/CAG/0028).\n\nMotor neuron disease (MND, ALS) is a terminal disease resulting in progressive paralysis and leading to respiratory failure around 2–5 years after symptom onset. Research shows that the overall number of people diagnosed with MND in the UK is expected to increase significantly. Across the UK there are five regional population registers for MND. Current estimates suggest there are 5,000 people living with MND in the UK at any one time, but whether this is the true figure and how people with MND are geographically distributed is not known. Having a national MND Register for patients living in England, Wales and Northern Ireland will enable calculation of the incidence and prevalence of the disease across these three regions, improve care provision, examine regional differences in survival, and reveal clusters. A national register will also allow the correct modelling of epidemiological variables, for example, the development of a mathematical model of MND. Such models can inform future studies, drug discovery and knowledge of pathogenesis of the disease. \n\nThe MND Register for England, Wales and Northern Ireland has been established to provide the international research community with a resource to understand the epidemiology of MND in the UK, and to further knowledge of causative and disease modifying factors in the disease. It has been funded through a healthcare research grant provided by the MND Association. The MND Register received REC approval in 2015, and has been recruiting patients from England, Wales and Northern Ireland for 5 years using a consented model. Applicants have recruited 1,802 patients across 32 centres in England and Wales which includes complete data capture from six recruiting centres only, and a rate of 38% ascertainment. \n\nApplicants have found it difficult to meet the primary objective of obtaining the incidence and prevalence of MND across England, Wales and Northern Ireland as data has been incomplete. Applicants are therefore proposing to change to an opt-out registry to ensure complete ascertainment, and are seeking support under Regulation 5 to enable the prospective recording of all patients with MND across England and Wales. Northern Ireland Is not covered by regulation 5 support. Support is also being sought to collect data retrospectively for patients dating back to June 2015, however, the applicant has confirmed that anyone who previously declined will not be added, and their dissent will be respected. \n\nApplicants will collect confidential patient information regarding every person with MND in England and Wales, in order to prevent double counting, and send to NHS Digital and NWIS annually for the purposes of linkage with data from Hospital Episode Statistics (HES), and Office of National Statistics (ONS) mortality data (held at NHS Digital), and also to Patient Episode Database for Wales (PEDW) data held at NHS Wales Informatics Service (NWIS). The register is currently consented, however, the consent taken does not cover the proposed linkages with HES and ONS data. Therefore Regulation 5 support is requested to link identifiers from the previously consented patients to these datasets, and also to link data about every patient added to the register under Regulation 5 support, either prospectively or retrospectively. Clinical and identifiable data will be sent to the study team at KCL every 6 months from clinicians and other providers. Each participant will be assigned a unique study identifier by the direct care team, at the time of data collection and this will be used throughout the involvement of the project. \n\nIdentifiers will be held in a separate database to clinical information and this will be linked through the unique study identifier. The Applicants describe the Data Access Committee (DAC) for the MND register as consisting of the Principal Investigators Professor A Al-Chalabi and Professor K Talbot, the Project managers, computer scientist, a representative of the MND Association, a patient representative (for example a patient with MND or a carer) and two annually elected representatives of the local registers that contribute to the database. The DAC will grant access to data to researchers according to the DAC terms of reference, which have been provided as part of the application. No identifiable data will be made available to external researchers. The following fields will never be shared: Full name, date of birth, NHS number, full postcode, exact dates for example date of birth or date of death. If the researcher requires the year of birth (for risk factor analysis) then this will be provided. Data will be sent directly to researchers securely, via a secure encrypted spreadsheet."]
["Applicant Organisation Name","Kings College London"]
["Contact Name","Professor Ammar Al-Chalabi, Consultant Neurologist & Head of Basic and Clinical Neuroscience at KCL"]
["Address","Maurice Wohl Clinical Neuroscience Institute"]
[null,"Kings College London, Department of Basic and Clinical Neuroscience"]
[null,"5 Cutcombe Road, Camberwell, London"]
["Postcode","SE5 9RX"]
["Telephone","0207 848 5192"]
["Email","ammar.al-chalabi@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Data will be collected from patients living in England, Wales, and Northern Ireland over the age of sixteen with a diagnosis of Motor Neuron Disease (MND) as confirmed by a consultant neurologist.\n\nThis collection will be retrospective dating back to June 2015, and prospective.\n\nNote: CAG support only extends to patients in England and Wales, and will not override the dissent of anybody who previously declined."]
["Description of confidential patient information used","Data sources\n1. NHS Digital - HES Admitted Patient Care, Outpatients, and ONS Mortality datasets\n2. NHS Wales Informatics Service, Patient Episode Database for Wales (PEDW).\n3. Clinical notes of MND patients in England and Wales held at various:\n• NHS Providers\n• Independent Sector Providers \n• Voluntary & Third Sector Providers\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Name, \n3. DOB, \n4. Gender \n5. Full Postcode\n6. Unique study identifier\n\nIdentifiers retained in KCL research database\n1. Date of Birth\n2. Gender\n3. Postcode\n4. NHS number\n5. Name (First name and surname)\n6. Full date of death \n7. Ethnicity \n8. Date of diagnosis \n9. Unique Study identifier\n\nPatient identifiable information will be held in a separate database to clinical information and this will be linked through a unique study identifer\n\nThese identifiers will be held within the research database but not released to applying researchers; any dates required will be modified before releasing\n\nIdentifiers required for analysis purposes\n1. Date of birth (modified for release to year of birth)\n2. Date of death (modified for release)\n3. Gender\n4. Ethnicity\n5. Date of diagnosis (modified for release)\n6. Unique study identifier \n\nOther clinical data as described in the application\n\nData released for analysis can be considered anonymous\n\nAdditional information\nAnnual extracts from HES – identifiers are sent each time to NHS Digital/NWIS from KCL, and not retained by NHS Digital/NWIS"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-02-23"]
["Next Review Date","2025-04-14"]
["Notes","Amendment supported 12 January 2024 to include data from Motor Neuron Disease (MND) clinical trials (AMBROSIA and the ALS Biomarker studies) into the MND register, and inform CAG about an internal change of location of data storage at King’s College London, from a secure server to a trusted research environment (TRE) - the KCL CREATE TRE, (which is also at King’s College London)\n\n20 July 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), and Office of National Statistics (ONS) mortality data.\n\nAmendment supported 20 July 2023 to inform CAG about an internal change of location of data storage at King’s College London, from SharePoint to a secure server (still at King’s College London)\n\n23 February 2021 - Application supported\nThe application to allow;\n\n• The disclosure of confidential patient information prospectively for every Motor Neurone Disease (MND) patient over 16 in England and Wales, and retrospectively dating back to June 2015, from various healthcare providers to Kings College London (KCL), for the purposes of building a research database, (However, support is not in place to override any patient who has previously dissented from the MND Register),\n\n• Disclosure of confidential patient information from the MND register at KCL to NHS Digital and NHS Wales Informatics Service (NWIS) for the purposes of linkage with Hospital Episode Statistics (HES), and Office of National Statistics (ONS) mortality data (held at NHS Digital), and also to Patient Episode Database for Wales (PEDW) outcomes; This support is regarding approximately 1,802 consented patients who have previously consented to be on the register, but not specifically consented for their data to be linked, and also for any patients who are added to the MND register under Regulation 5 support, and for the flow of data from NHS Digital and NWIS back to KCL, as date of death is part of this dataset and can be considered identifiable, \n\n• KCL to hold identifiers in this research database indefinitely, \n\nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n1. As applicants are planning to consult with patients on an ongoing basis, any feedback regarding these ongoing conversations with patients should be provided to the CAG at the time of the first annual review.\n\n2. Support is in place for five years from the date of this letter. Further support is to be sought after this time.\n\n3. Support is not in place for those people who previously dissented to be part of the MND register when the consented model was in place.\n\n4. Support is only in place for England and Wales, and does not extend to Northern Ireland.\n\n5. Favourable opinion from a Research Ethics Committee. Confirmed 25 November 2020\n\n6. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold.\n\nConfirmed:-\nThe NHS Digital 19/20 DSPT review for Kings College London (HQ) EE133874 was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 08 February 2021).\n\nThe NHS Digital 2019/20 DSPT equivalent was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 08 February 2021).\n\nA CPiP has been received for NHS Wales Informatics Service (NWIS). \n\nAs there are additionally 5 or more organisations who will be processing confidential patient information without consent as part of this application, the Confidentiality Advice Team (CAT) team will not check these individually. It is the responsibility of the applicant to ensure these are in place.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02607","index":649,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02607"]
["Reference","21/CAG/0066"]
["Other Refs","IRAS Project ID: 275198  REC Reference: 21/PR/0077"]
["Application Title","Improving outcomes in Advanced Colorectal Tumours: The IMPACT I Project. Assessing multidisciplinary team management and referral patterns of patients with locally advanced and recurrent rectal cancer in the UK \nShort title:(IMPACT I)"]
["Application Summary","This application from Newcastle University set out the purpose of medical research that aims to identify and assess multidisciplinary team (MDT) referral and management patterns, decision-making and treatment strategies in all patients with locally advanced rectal cancer (LARC) and locally recurrent rectal cancer (LRCC) in the UK. \n\nIn the United Kingdom (UK), around 14,000 new cases of rectal cancer are diagnosed every year. It is estimated between 5% and 10% of rectal cancer will be locally advanced at presentation (LARC), and approximately 10% of patients will develop a local recurrence following previous curative resection of rectal cancer (LRRC). There is significant disparity in the management of patients with LARC and LRRC, with inconsistent referral practices and variable access to specialist centres. There are also differences in clinical decision making with regards to patient selection and treatment strategies at an MDT level. The Association of Coloproctologists of Great Britain and Ireland (ACPGBI) has identified the mapping out of clinical pathways in LARC and LRRC as a key area for improvement.  This project should identify whether local units are complying with current guidance on the management of patients with LARC and LRRC, and identify regional and national patterns of decision-making. The results will help build standardised regional and national referral strategies for patients with LARC and LRRC, to increase the number of patients referred to specialist centres and provided with appropriate treatment, with an end aim to improve patient-reported, clinical and oncological outcomes. \n\nApplicants plan to link to routinely collected clinical datasets to measure short and long term clinical and oncological outcomes. This study is planned in three phases. Phase one does not require CAG support.  Phase two will assess the current MDT decision-making for patients with LARC and LRRC across all colorectal cancer MDTS. Phase three will assess clinical decision-making within specialist MDTs for the management of patients with LARC and LRRC.\n\nConsecutive patients will be identified prospectively by members of the direct care team, through records of MDT meetings across the UK, across a 6-month time period for each phase. This will include approximately 1000 patients from all colorectal cancer MDTs for phase two, and for phase three only specialist MDTs for the management of patients with LARC and LRRC will participate, and around 100 patients are expected to be recruited. Clinical data from patients who are eligible will be disclosed to the University of Newcastle, via uploaded to the IMPACT I database by the direct care team. All items of confidential patient information are removed, apart from the NHS number and patients date of death (if applicable) which is required for linkage, both between different MDTs, and to outcome data. REDCap will generate a unique patient identification number. Local MDTs will send information sheets to patients, however this is not designed as a consent document. The research team at University of Newcastle will receive opt out requests, and feed back to the local MDTs to ensure removal. The flow of identifiable information regarding opt out does not require CAG support, as the patient is providing this information for the purposes of opt out.\n\nA 12 month follow up is undertaken at local participating sites. At two years and five years, linkage with COLoRECTal Repository (CORECT-R), a research database containing linked national clinical datasets held at University of Oxford is undertaken. CORECT-R links the English National Cancer Registration Dataset (COSD), Hospital Episodes Statistics (HES), Cancer Waiting Times (CWT), National Radiotherapy (RTDS), National Bowel Cancer Screening Programme (BCSP) records and Systemic Anti-cancer Therapy (SACT) data.  Data from IMPACT will be linked with CORECT-R using NHS numbers only. CORECT-R will retain a flag for IMPACT I patients between two and five years, meaning applicants will not have to disclose NHS number again. Following data linkage the NHS number will be deleted, and date of death will be modified to overall survival from date of diagnosis and/or date of MDT; the dataset will therefore be effectively anonymous for analysis. "]
["Applicant Organisation Name","University of Newcastle"]
["Contact Name","Miss Deena Harji"]
["Address","Population Health Sciences"]
[null,"Baddiley-Clark Building"]
[null,"University of Newcastle, Newcastle-Upon-Tyne"]
["Postcode","NE2 4AX"]
["Telephone",7973187348]
["Email","deena.harji@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Phase two:\n\nApproximately 1000 Patients with a new diagnosis of locally advanced rectal cancer (LARC) or locally recurrent rectal cancer (LRRC) discussed within a colorectal surgery MDT meeting during the study period \n\n6-month prospective recruitment period:\n\nPhase 2 Data Collection Period: September 2021 – Feb 2022. (6 Months).\n\nPhase three:\n\nPatients with a new diagnosis of locally advanced rectal cancer (LARC) or locally recurrent rectal cancer (LRRC) discussed within a specialist MDT for the management of patients with LARC and LRRC during the study period. The applicants anticipate that approximately 20 specialist centres will participate. The sample size for this phase will be approximately 250 patients. \n\n\n6-month prospective recruitment period:\n\nPhase 3 Data Collection Period: Sep-2021 to Feb-2022 (6 Months)"]
["Description of confidential patient information used","Data Sources:\n\n1.\tParticipating Colorectal units with a dedicated colorectal cancer MDT, 65 sites in England and 7 in Wales for phase two. (Phase three will have approximately 20 or 30 participating centres)\n\n2.\tCOLoRECTal Repository (CORECT-R) research database (REC 18/SW/0134) at the University of Oxford. The CORECT-R dataset consists of data linked across the following datasets:\n-\tEnglish National Cancer Registration Dataset (COSD)\n-\tHospital Episodes Statistics (HES)\n-\tCancer Waiting Times (CWT)\n-\tNational Radiotherapy (RTDS)\n-\tNational Bowel Cancer Screening Programme (BCSP)\n-\tSystemic Anti-cancer Therapy (SACT)\n\nIdentifiers required for linkage purposes\n\n1.\tNHS number\n2.\tUnique Patient identification number\n3.\tDate of death\n\nIdentifiers required for analysis purposes\n\n1.\tAge\n2.\tGender\n3.\tDate of death – will be modified to overall survival from date of diagnosis/date of MDT for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-06-26"]
["Next Review Date","2022-06-26"]
["Notes","Specific conditions of support \n\n1.\tPlease provide an updated patient notification leaflet, which has a more patient friendly diagram, does not state that CORECT-R is anonymised, and contains a telephone number and postal address in order to opt out, to the CAT, within three months form the date of this letter.\nCondition met 13 December 2021\n\n2.\tPlease truncate the full date of death after survival times have been calculated, or provide a justification why this is not feasible, and provide a response to the CAT, within three months form the date of this letter.\nCondition met 13 December 2021\n\n3.\tSupport provided for English and Welsh data only.\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 23 April 2021\n\n5.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 19/20 DSPT reviews for University of Newcastle - Health and Social Care Data (EE133852-HSCD) and University of Oxford - Medical Sciences Division - Nuffield Department of Population Health (EE133863-MSD-NDOPH-NDPH) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 21 July 2021)\n\nAs the study will be carried out across 80 participating Trusts, individual security assurance will not be checked by the Confidentiality Advice Team (CAT). Support will be recommended on the basis that the applicant is responsible for seeking assurance that the appropriate security arrangements are in place.  "]

{"sheet":"A02608","index":650,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02608"]
["Reference","21/CAG/0078"]
["Other Refs","IRAS Project ID: 274569  REC Reference: 21/LO/0133"]
["Application Title","Cancer Survivorship Studies"]
["Application Summary","This application, from University of Birmingham, sets out the purpose of medical research that aims to establish a research database by combining two research databases, The British Childhood Cancer Survivor Study and The Teenage and Young Adult Cancer Survivor Study.\n\nBy 2030 it is estimated that there will be 4 million individuals living with the long-term consequences of cancer and its treatment. Recently there have been three UK-wide research priority setting initiatives involving detailed consultations with cancer patients/survivors, their families and friends, and health care professionals who treat or follow-up individuals who are living with or beyond cancer. Half of the final top 10 research priorities ultimately identified related to an issue concerning “cancer survivorship”, that is concerns which relate to problems encountered after cancer treatment is completed and the survivor returns to ‘normal’ life. The linkage of large-scale population-based cancer survivors cohorts to electronic health care databases provides a unique opportunity to investigate the risks of a wide spectrum of long-term adverse health outcomes following treatment for cancer on a national level.\n\nThe applicants request to combine two research databases currently operating under Regulation 5 support; The British Childhood Cancer Survivor Study (BCCSS - ECC 2-02(f)/2011) and The Teenage and Young Adult Cancer Survivor Study (TYACSS - ECC 3-04(c)/2010). Confidential patient information will flow from the University of Birmingham to link to a number of datasets detailed in the data sources section. These are a combination of national datasets, those operating under consent or others operating under CAG support. Linkage will be undertaken on an annual basis. Clinical data will be flowed back to University of Birmingham to create the database. \n\nResearchers requesting access to the database will submit a research proposal that will be reviewed by the chief investigator and Senior Researchers who may consult with patient representatives to assess whether the research is relevant and important to cancer survivors. \n\nFollowing support for this application the British Childhood Cancer Survivor Study (BCCSS - ECC 2-02(f)/2011) and The Teenage and Young Adult Cancer Survivor Study (TYACSS - ECC 3-04(c)/2010) will be expired."]
["Applicant Organisation Name","Institute of Applied Health Research - the University of Birmingham"]
["Contact Name","Professor Michael M Hawkins"]
["Address","Institute of Applied Health Research"]
[null,"Baddiley-Clark Building"]
[null,"The University of Birmingham"]
["Postcode","B15 2TT"]
["Telephone","0121 414 7924"]
["Email","m.m.hawkins@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The British Childhood Cancer Survivor Study (BCCSS) -  35,000 individuals who were diagnosed with cancer under the age of 15 years, between 1940 and 2006, in England, Wales or Scotland, and who survived at least 5 years from diagnosis. \n\nThe Teenage and Young Adult Cancer Survivor Study (TYACSS) - 200,945 individuals diagnosed with cancer when aged 15 to 39 years inclusive, between 1971 and 2006, in England or Wales and who survived at least 5 years from diagnosis."]
["Description of confidential patient information used","Data Sources:\n\n1.\tUniversity of Birmingham:\na.\tBritish Childhood Cancer Survivor Study (BCCSS - ECC 2-02(f)/2011) \nb.\tThe Teenage and Young Adult Cancer Survivor Study (TYACSS - ECC 3-04(c)/2010)\n2.\tNHS Digital\na.\tNational death registries (ONS Mortality datasets)\nb.\tNational cancer registries\nc.\tHospital Episode Statistics (HES)\nd.\tThe National Mental Health Services Dataset \ne. \tDemographics data (to ensure data regarding embarkation)\n3.\tPublic Health England\na.\tNational NHS GP prescription database\nb.\tNational Systemic Anti-Cancer Therapy Dataset\nc.\tNational Radiotherapy Dataset \nd.\tNational Diagnostic Imaging Dataset\ne.\tNational Congenital Anomalies and Rare Disease Registry (CAG 10-02(d)/2015)\n4.\tDigital Health & Care Wales (DHCW) (Formerly known as NHS Wales Informatics Service, (NWIS)\na.\tPatient Episode Database for Wales (PEDW)\n5.\tBarts Health NHS Trust\na.\tNational Institute for Cardiovascular Outcomes Research (NICOR) - Various Cardiovascular outcomes datasets (17/CAG/0078)\n6.\tBirmingham Women's and Children's NHS Foundation Trust\na.\tWest Midlands Regional Children’s Tumour Registry (17/CAG/0103)\n7.\tBritish Society of Blood and Marrow Transplantation and Cellular Therapy\na.\tBSBMTCT Data Register (held under consent) \n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tGender\n3.\tDate of Birth\n4.\tNHS number\n5.\tPost Code\n6.\t(Random Key)\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth (month and year only)\n2.\tDate of death (month and year only)\n3.\tPostcode (unit level)\n4.\tGender\n5.\tEthnicity \n6.\tDate of cancer diagnosis (month and year only)"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-07-28"]
["Next Review Date","2024-07-28"]
["Notes","18 December 2023 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Civil Registration – Deaths, Cancer registration, Hospital Episode Statistics (HES), The National Mental Health Services Dataset MHSDS), and Demographics data\n•\tAnd from Public Health England (PHE) to NHS England regarding data sources - National NHS GP prescription database, National Systemic Anti-Cancer Therapy Dataset, National Radiotherapy Dataset, National Diagnostic Imaging Dataset, National Congenital Anomalies and Rare Disease Registry (CAG 10-02(d)/2015).\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits.\n\n\nSpecific conditions of support \n\n1.\tPrevious applications, The British Childhood Cancer Survivor Study (BCCSS) – ECC 2-02(f)/2011 and The Teenage and Young Adult Cancer Survivor Study (TYACSS) - ECC 3-04(c)/2010, will be expired from the date of the final outcome letter, and replaced by 21/CAG/0078.\n\n2.\tSupport is in place for five years from the date of the final outcome letter, in line with the REC. Further support is to be sought after this time, via a duration amendment.\n\n3.\tSupport only extends to England and Wales.\n\n4.\tContinuing patient and public involvement should be undertaken, to specifically explore the purposes and data flows involved in this specific application, and a report should be provided to the CAG within six months from the date of the final outcome letter. Condition met June 2022\n\n5.\tFavourable opinion from a Research Ethics Committee. Confirmed 23 February 2021.\n\n6.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: As there are more than 5 organisations processing confidential patient data these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for the following organisations have been assessed as ‘standards met’ by NHS Digital;\n\n•\tUniversity of Birmingham\n•\tPublic Health England\n•\tNHS Digital\n•\tBirmingham Women's and Children's NHS Foundation Trust (WM cancer registry)\n•\tBritish Society of Blood and Marrow Transplantation and Cellular Therapy \n•\tBarts Health NHS Trust \n\n•\tA CPiP assessment is in place for NWIS."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02609","index":651,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02609"]
["Reference","21/CAG/0076"]
["Other Refs","IRAS Project ID: 298407  REC Reference: 21/WA/0178"]
["Application Title","Configuration and utilisation of clinical pathways by patients who attend A&E in suicidal crisis"]
["Application Summary","This application from Liverpool John Moores University sets out the purpose of medical research that aims to gain an understanding of how visits to A&E for self-harm, suicidal ideation and crisis are coded, and whether the pathways of care are consistent at each A&E site. This study will explore suicidal crisis data at A&E level and will test feasibility across two trusts with the aim of developing a national data collection tool for A&E departments to record people who attend in suicidal crisis. This study requires CAG support for phase one only, phase two is out of scope for CAG support.\n\nSuicide is a major public health issue. Although national data is available for individuals who attend A&E for self-harm and suicidal injury, there is no national data for those individuals who attend A&E in suicidal crisis. The clinical pathways available for service users after presentation in suicidal crisis are complex and have not been examined systematically. Gaining a greater insight into the configuration and utilisation of clinical pathways for service users in suicidal crisis will better inform modelling of service provision for these patients. \n\nThe initial identification of potential participants medical notes, using the electronic databases at each of nine A&E sites, will be undertaken by the direct care team who will inform the researcher. The named researcher, who is not a member of the direct care team, will have on-site access to patient medical records, which include confidential patient information. Retrieving information will be a time-consuming activity, and the direct care team have indicated that they do not have the time and resources to complete this work. Therefore CAG support is required. Potential participants will be screened by the named researcher, and if eligible, pseudonymised data will be recorded. Although a key is retained between the NHS number and the unique anonymised study ID, this is retained by the direct care team only. Therefore support is not required for this retention, and the collected dataset can be considered anonymous to the named researcher. No confidential patient information will be recorded or retained by the researcher. Data will subsequently be analysed at Liverpool John Moores University. "]
["Applicant Organisation Name","Liverpool John Moores University"]
["Contact Name","Dr Pooja Saini "]
["Address","Liverpool John Moores University"]
[null,"School of Psychology"]
[null,"317 Tom Reilly Building, Byrom Street, Liverpool"]
["Postcode","L3 3AF"]
["Telephone",7946169335]
["Email","P.Saini@ljmu.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individuals aged 16 and over who have attended A&E in suicidal crisis between January 2019- December 2020.\n(people who may have presented in suicidal crisis, for self-harm or following suicide attempts)\n\nsample size of 1200 (approximately 133 per site)"]
["Description of confidential patient information used","Data Sources:\n\n•\tElectronic databases at 9 A&E departments, and associated Trust medical records\n\nCheshire and Wirral A&E sites are: \n1.\tArrowe Park, \n2.\tCountess of Chester Hospital, \n3.\tMacclesfield District General Hospital, \n4.\tLeighton Hospital. \n\nMersey Care A&E sites are: \n5.\tRoyal Liverpool University Hospital, \n6.\tAintree University Hospital, \n7.\tSouthport and Formby District Hospital, \n8.\tWhiston Hospital, \n9.\tWarrington Hospital\n\nIdentifiers required for linkage purposes\n\n1.\tResearcher will view medical notes to extract a pseudonymised dataset\n2.\tHospital ID\n3.\tNHS number\n4.\tUnique anonymised study number\n\nIdentifiers required for analysis purposes\n\n1.\tAge\n2.\tGender\n3.\tEthnicity\n4.\tEducation\n5.\tEmployment status\n6.\tHas the patient had COVID-19 \n7.\tUnique anonymised study number\n\nIt is not possible for the researcher to re-identify a patient from this data extract."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-07-29"]
["Next Review Date","N/A"]
["Notes","05 November 2021 - The applicant advised that support was no longer required. \n\nSpecific conditions of support \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 May 2021\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 19/20 DSPT review for Mersey Care NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 16 June 2021)\n\nThe NHS Digital 20/21 DSPT review for Cheshire & Wirral Partnership NHS Trust was confirmed as ‘Standards Met’ (by email to the CAG inbox 29 July 2021)"]

{"sheet":"A02610","index":652,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","02610"]
["Reference","21/CAG/0049"]
["Other Refs","IRAS Project ID: 280995  REC Reference: 21/WM/0050"]
["Application Title","Do Safe and Well Visits delivered by the Fire and Rescue service reduce falls and improve quality of life among older people?  A randomised controlled trial (FIREFLI)"]
["Application Summary","This application from the University of York set out the purpose of medical research that seeks to determine whether the Safe and Well Visits delivered by the Fire and Rescue Service reduce the number of falls and improve the quality of life of people over 70 years of age. \n\nThe Fire and Rescue Service (FRS) routinely carry out approximately 670,000 Safe and Well Visits (SWV) each year. These visits take place in people’s home and are aimed to reduce the risk of fire, as well as addressing wider issues related to health and wellbeing. This includes falls prevention, smoking cessation, winter warmth advice and social isolation. Falls can be a serious issue for older people. Around 1 in 10 people who have a fall suffer a serious injury as a result, costing the NHS £2.3 billion per year to treat. Some evidence exists that interventions to improve home safety are effective at reducing falls, however it is not known whether SWV delivered by the FRS reduce falls, improve quality of life or are good value for money. \n\nThe applicants will recruit 1156 people aged 70 years and over from lists held on FRS databases. All participants will receive a falls prevention leaflet from Age UK and usual care from their GP and/or other healthcare professionals. Participants will be randomised into two groups. Half will receive a SWV at the start of the study and half will receive a SWV after 12 months. All participants will complete a falls calendar and four postal questionnaires sent out over the 12-month period of the study. The applicants will also conduct interviews participants and members of the FRS to find out if the visits were acceptable to older people and the FRS.\n\nThe Humberside Fire and Rescue Service will submit an application to the NHS Primary Care Registration Management (PCRM) at NHS Digital to request a new ‘cleansed’ set of Exeter data, which is held by NHS England and Improvement, specifically for the study. The PCRM will then disclose a list of people aged 70 years and over, living in the catchment areas for Humberside FRS, to the Humberside FRS. The Fire Service will use this information to create a list of eligible patients. Confidential patient information from the Exeter dataset is routinely shared with Fire and Rescue Services in England to allow the Services to prioritise which households to target with their SWV, however the current data sharing agreement does not allow use of this data for research purposes; therefore the applicants are seeking support to use data from Exeter to identify and invite eligible people to take part in the study. FRS staff will then remove those who have already received an SWV and send potential trial participants an invitation pack in the post, asking if they would like to take part in the study. The invitation pack will contain an invitation letter from Humberside Fire and Rescue Service (FRS), addressed to a named individual in the household. Participants who wish to take part in the study, will complete the consent and screening forms and return them to the York Trials Unit. Their participation will then be on a consented basis. The applicants advised that members of the research team based at the University of York, York Trials Unit (YTU) will not know which households have been mailed out to until the study documentation is returned to the University. However, the FRS may require help from the research team when undertaking the mailout of invitation packs and the researchers may be exposed to confidential patient information when assisting."]
["Applicant Organisation Name","Department of Health Sciences, University of York"]
["Contact Name","Mrs Sarah Cockayne"]
["Address","Department of Health Sciences"]
[null,"York Trials Unit, ARRC Building, Lower Ground Floor"]
[null,"York  "]
["Postcode","YO10 5DD"]
["Telephone","01904 321736"]
["Email","sarah.cockayne@york.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Those aged 70 years and over, living in the catchment areas for Humberside Fire and Rescue Service who have not previous received an SWV. 1156 patients will be included. "]
["Description of confidential patient information used","Data Sources:\n\n1.\tExeter database at NHS England and Improvement\n2.\tPrimary Care Registration Management at NHS Digital\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tDate of birth\n3.\tPostcode – unit level\n4.\tGender\n\nIdentifiers required for analysis purposes\n\nAnalysis will be undertaken after participants have consented to the research. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-07-20"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed March 2023 that ‘s251’ support could be expired because the activity was never undertaken under ‘s251’ support, as Kent and Humberside Fire and Rescue Service were unable to obtain the requested data. \n\nIn terms of public benefit, there has therefore been no benefit to the public under Regulation 5 support. Had the study team been able to obtain the data, then it would have allowed a more targeted mailout to potential participants, asking them to take part in the FIREFLI study.\n\n17 February 2022 - Amendment supported:\nThe amendment, to include an additional interim recruitment method regarding Experian data is noted and accepted by the CAG, however ‘s251’ support is not required for this additional flow, as there is no breach in the common law duty of confidentiality. The original recruitment method using confidential patient information remains supported, and will be implemented when possible.\n\nAmendment supported 11 November 2021 - to include disclosure of confidential patient information from the Exeter database to NHS E&I to the Kent Fire and Rescue Service, via NHS Digital’s PCRM so that suitable patients can be approached for consent to take part in the study\n\nAmendment supported 11 November 2021 - to extend the study duration until March 2024. All other elements of this amendment which relate to confidential patient information arrangements, have previously been supported.\n\nSpecific conditions of support \n\n1.\tConfirmation on whether the new data flow, suggested by the CAG, will be implemented needs to be provided within three months of the issuing of the outcome letter. If the data flow had not been implemented within this timeframe or NHS England and Improvement did not agree to the change, then reasons for this need to be provided to the CAG. \n\nCAG confirmed condition met 10 November 2021\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 April 2021\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: The NHS Digital 2019/20 DSPT review for the University of York and the Humberside Fire and Rescue Service was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (26 July 2021)"]

{"sheet":"A02611","index":653,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02611"]
["Reference","21/CAG/0102"]
["Other Refs","IRAS Project ID: 297411  REC Reference: 21/WM/0171"]
["Application Title","Barts Myocardial Infarction with Non-Obstructed Coronary Arteries Registry"]
["Application Summary","This application from the Queen Mary University of London set out the purpose of medical research that seeks to assess the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease. \nThe introduction of primary angioplasty over the last 15 years has radically improved patient outcomes for those suffering an acute myocardial infarction (AMI). However, the system wide availability of prompt investigation has reviewed an important group of patients where progress has stalled, their diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with non-obstructive coronary arteries (MINOCA) is found in 1 – 13% of all patients with a clinical diagnosis of AMI. MINOCA represents a diagnostic challenge with limited current guidance on how to investigate and treat the condition. Cardiac Magnetic Resonance Imaging (CMR) plays a pivotal role in cardiac morphological, functional assessment and tissue characterisation, and therefore has the potential to identify underlying aetiologies and aid a final diagnosis in MINOCA. Small, retrospective case series have suggested that CMR can provide a definitive diagnosis in 63-72% of patients. These previous studies also suggested that only 5-15% of patients with MINCOA had had an MI. \n\nThe applicants seek to create the Barts-MINOCA registry, a single-centre, retrospective observational registry based at Barts Health NHS Trust. The aim is to develop understanding of the characteristics and outcomes of patients with MINOCA and troponin rise without diagnosis. All patients aged>16 years old with MINOCA or an unknown cause of troponin rise, regardless of severity, referred to Barts Health NHS Trust will be included in this study. Confidential patient information will be prospectively collected from clinical database and systems (such as PACS for imaging data, CRS for blood results). The data is stored at Barts Health NHS Trust on secure NHS clinical servers and will be accessed only by named members of the clinical team. Data is entered onto the database by clinical team members and is used directly for patient care. Patients will not be contacted at any point to obtain data specifically for research purposes. As the majority of information on patient outcomes will not be available locally, the applicants will disclose confidential patient information to NHS Digital for linkage of HES and ONS datasets. "]
["Applicant Organisation Name","Queen Mary, University of London"]
["Contact Name","Dr. Daniel A Jones"]
["Address","Charterhouse Square"]
[null,"Queen Mary, University of London"]
[null,"London"]
["Postcode","EC1M 6BQ"]
["Telephone",7809677655]
["Email","dan.jones8@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and over who either have a diagnosis of MINOCA or patients who do not have a clear cause of troponin rise.\n\n2500 patients will be included. "]
["Description of confidential patient information used","Data Sources:\n\n1.\tElectronic and paper records held at Barts Health NHS Trust\n2.\tHES and ONS datasets at NHS Digital \n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID number\n4.\tDate of birth\n5.\tPostcode – District level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death\n3.\tPostcode – district level\n4.\tGender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-07-30"]
["Next Review Date","2024-07-30"]
["Notes","18 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources – Hospital Episode Statistics (HES) and ONS mortality data\n\nSpecific conditions of support \n\n1.\tThe date that the confidential patient information collected for the project will be deleted by the research team needed to be confirmed. Condition met 07 September 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 July 2021.\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 2019/20 DSPT review for Barts Health NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (by check of the NHS Digital DSPT tracker on 28 July 2021)."]

{"sheet":"A02612","index":654,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02612"]
["Reference","21/CAG/0020"]
["Other Refs","IRAS Project ID: 280231  REC Reference: 21/EM/0035"]
["Application Title","The effect of age at first invitation for breast screening in the NHS Breast Screening Programme in England and Wales (AFBSS)"]
["Application Summary","This application from University of Oxford set out the purpose of medical research which aims to establish whether the age at women are first invited for routine mammogram affects mortality from breast cancer. NHS Digital will link further death records and cancer registrations to flagged Age at first breast screening (ABFSS) patients originally flagged on the NHS Central Register (NHSCR), and supply the outcomes to the applicants who will link these data to the dataset they already hold on 1.4 million women born in 1945-1948 in England and Wales.\n\nThis was previously supported as a non-research application in 2007; PIAG 3-05(l)/2007, however in 2018, the NHS Breast Screening Programme changed their definition of age, meaning PIAG 3-05(l)/2007 can no longer be classed as an audit of its routine practices. Therefore applicants are seeking support for this new research application to complete data analyses and to extend follow up period to include data from between 31st December 2012 and 31st December 2019 for research purposes, and replace the previous PIAG application. \n\nIn England and Wales, the NHS routinely offers breast screening every three years to all women aged 50-70 and this screening has been shown to reduce mortality from breast cancer. Although women are eligible for breast screening at the age of 50 years, in practice they are first invited for screening between the ages of 50 years and 52 years. It is not known whether this three-year range in age makes a difference to breast cancer mortality. The study aims to address this, and findings will inform screening policy and practice regarding the age at first routine mammogram.\n\nA part of PIAG 3-05(l)/2007, data routinely collected by the NHS Breast Screening Programme on women’s first invitation to routine screening were extracted from the NHAIS system in England for women born in 1945-1948. These women were flagged on the NHSCR, which enabled follow up for cause-specific mortality and cancer diagnosis up to 31st December 2012, through record linkage to death records and cancer registrations. Details of individuals in the study population have already been collected and are held securely at the University of Oxford. This database contains identifiers: name, NHS number, date of birth, postcode and a unique participant study number only.  \n\nThe study population of AFBSS patients are already flagged on the NHSCR, held by NHS Digital. The same function is now carried out by the Personal Demographics Service (PDS), but as the women in the study were flagged on the NHSCR, NHS Digital will be able to trace their details using the unique participant number. Support is requested for NHS Digital to link the flagged patients to further death records and cancer registrations from the ONS Civil Registration Mortality dataset, and Cancer Registrations Data dataset controlled by Public Health England, until 31st December 2019. These datasets are also held by NHS Digital. Deaths, cause of death and cancer incidence will be provided from NHS Digital to the applicants at University of Oxford alongside a unique study number. This data flow also requires support as date of death can be considered an identifier. The applicants will then link the provided outcome information to their existing dataset using the unique participant study number. The data will be pseudonymised for analysis, except full date of death which is required. Name, NHS number, date of birth, postcode will be deleted before linkage takes place, as soon as the applicants can access the historical database. Once the study is published all identifiable data will be destroyed, and the applicants estimate that support will be required until 31st December 2024"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Isobel Barnes"]
["Address","Cancer Epidemiology Unit, NDPH"]
[null,"University of Oxford, Old Road Campus"]
[null,"Oxford"]
["Postcode","OX3 7LF"]
["Telephone",1865289680]
["Email","isobel.barnes@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1.4 million women born in 1945-1948 in England and Wales who were alive, on the NHAIS system; and age 50 in 1995-1998\nThis application is only concerned with linkages to death and cancer outcomes between 31sT December 2012 and 31st December 2019"]
["Description of confidential patient information used","Data sources\n\n1. PIAG 3-05(l)/2007 dataset, held at the University of Oxford. Data collected under Regulation 5 support.\n2. NHS Digital - ONS Civil Registration Mortality dataset, and Cancer Registrations Data dataset (controlled by Public Health England, but held by NHS Digital), and details of previously flagged ABFSS patients on the NHS Central Register (NHSCR).\n\nIdentifiers required for linkage purposes\n\n1. Unique participant study number only\n\nIdentifiers required for analysis purposes\n\n1. Full date of death\n2. date of birth modified to month and year of birth"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-08-10"]
["Next Review Date","2024-08-10"]
["Notes","24 October 2023 - change in data processors from NHS Digital to NHS England, regarding data sources Civil Registration Mortality and Cancer Registrations Data\n\nAmendment supported 24 October 2023 to extend follow-up dates for linked Civil registration mortality and cancer registration data, to the latest available data held by NHS England (instead of up until 31 December 2019)\n\nConditions of support:\n\n1.\tSupport under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 for PIAG 3-05(l)/2007 will be expired from the date of this letter, and replaced by 21/CAG/0020.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 12 February 2021\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 20/21 DSPT reviews for University of Oxford - Medical Sciences Division - Nuffield Department of Population Health (EE133863-MSD-NDOPH-NDPH), and the 20/21 DSPT equivalent for NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 10 August  2021)"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02613","index":655,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02613"]
["Reference","21/CAG/0098"]
["Other Refs","IRAS Project ID: 238693   REC Reference: 18/EM/0267"]
["Application Title","Paediatric Intensive Care Audit Network (research application)"]
["Application Summary","This application from University of Leeds and University of Leicester, set out the purpose of creating a research database collecting data on all infants, children and young people accepted for referral, transported or admitted to designated PICUs providing paediatric Level 3 Critical Care.\nThe University of Leeds and the University of Leicester are joint data controllers for this research application and the database is held at the University of Leeds. In addition to the two universities, Healthcare Quality Improvement Partnership (HQIP) & NHS England & Improvement are also joint data controllers for English NHS PICUs and transport teams only. PICANet is a collaboration between the Universities of Leeds and Leicester who are both also data processors and considered part of the Research Database Team.\nPICANet currently has ‘s251’ support under application reference PIAG 4-07 (c)/ 2002. This research application has been submitted alongside a non-research application (21/CAG/0090), in order to split out the research and non-research functions of PICANet into separate applications, and to refresh the support required, as the original application was supported in 2002. ‘s251’ support for PIAG 4-07 (c)/ 2002 will be expired and replaced with 21/CAG/0090 and 21/CAG/0098.\nThe aim of the research database is to support high quality research into: paediatric intensive care; specific conditions affecting children and young people accessing paediatric intensive care services; public health, including the impact of Covid-19; and other research areas listed in the application. Data collection started in 2002 and is ongoing under PIAG 4-07 (c)/ 2002. Data is collected from PICUs and Specialist Paediatric Critical Care Transport Services throughout the UK and Republic of Ireland via a secure web-based application, however, this application only covers English and Welsh data. Confidential patient information is collected to allow identification of multiple admissions, referrals, and transports for the same individual. Data is also collected regarding demographics, referral, transport and admission details, diagnosis, interventions received and outcomes. Customised data collections are occasionally undertaken, which collect additional clinical data items specific to an area of care or in response to local or national policy requirements.\nIdentifiable patient data collected as part of PICANet dataset is stored at the University of Leeds on the Secure Electronic Environment for Data (SEED) system. Identifiers are retained in the same database as clinical data but are stored in a separate table using column-level AES-256 encryption. During Summer 2021, the SEED architecture is being replaced by a new system called LASER. Patient identifiable data will be stored in a secured project area on the LASER platform.\nThe REC Favourable Opinion allows research to be carried out by the PICANet Database Research Team or by sharing de-identified data with other researchers. Data may also be shared for the purposes of research if the recipient has their own project specific-research ethics approval in place and an appropriate legal basis for data sharing. PICANet has a Clinical Advisory Group (CAG), whose members review requests for access to PICANet data to ensure feasibility, prevent duplication of research activity and to encourage collaboration. Requests are also reviewed by the PICANet team and, where requests involve data from English providers, will be subject to approval by the HQIP Data Access Review Group (DARG). Only anonymous data is released to external third parties, or pseudonymous data which cannot be re-identified by the third party."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Richard Feltbower"]
["Address","Level 11 LIDA Reception"]
[null,"Worsley Building"]
[null,"Clarendon Way, University of Leeds"]
["Postcode","LS2 9JT"]
["Telephone","0113 343 4841"]
["Email"," r.g.feltbower@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All infants, children and young people accepted for referral, transported or admitted to designated PICUs providing paediatric Level 3 Critical Care (as defined by the Royal College of Paediatrics and Child Health) in the UK and Republic of Ireland. (‘s251’ support covers England and Wales only).\nThere are on average around 20,000 new admissions per year in total, approximating 16,500 for England and Wales. (relevant to ‘s251’ support)\nData collection started in 2002 and is ongoing."]
["Description of confidential patient information used","Data sources\n\nMedical records from the below sources;\n\n1. English NHS PICUs\n2. English private/non-NHS PICU\n3. Welsh NHS PICU\n4. English NHS Transport teams\n5. Welsh NHS Transport teams\n\nIdentifiers collected in PICANet database\n\nName\nAddress\nPostcode (unit level)\nNHS number\nCase note number/Hospital number\nGP registration\nDate of birth\nDate and time of death\nPage 4 of 15\nSex\nEthnicity\n\nIdentifiers required for linkage purposes within PICANet database\n\nNHS number\nCase note number/Hospital number\nPostcode (with address used to validate postcode)\nName\nDate of Birth\nSex\n\nIdentifiers required for analysis purposes\n\n1. Date of birth\n2. Postcode\n3. Date of death\n4. Sex\n5. Ethnicity\n\nNo identifiers released to external third parties for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-08-10"]
["Next Review Date","2024-08-10"]
["Notes","Conditions of support:\n\n1.\tSupport for PIAG 4-07 (c)/ 2002 is expired from the date of this letter.\n\n2.\tSupport extends to data collected in England and Wales only.\n\n3.\tSupport is provided for five years, at which time point a duration amendment is required.\n\n4.\tPlease provide evidence of how PICANet reach conclusions about the appropriateness of research which is undertaken both internally and externally. The Group would like clarity on what the process is in deciding which research projects will be undertaken, and this should be evidenced by a ‘terms of reference’ document for a data access committee, and any other relevant evidence. Please feed back to the Confidentiality Advisory Group within three months from the date of this letter.\nCAG confirmed condition met 10 December 2021\n\n5.\tThe website should be edited in order to clearly define the research function of the database. There should be clear information regarding the previous and current activities, and benefits should be presented in order to help evidence that the PICANet research database is in the public interest. Please provide feedback to the Confidentiality Advisory Group within three months from the date of this letter.\nCAG confirmed condition met 10 December 2021\n\n6.\tPlease provide justification as to why GP registration is required, and feedback to the Confidentiality Advisory Group within three months from the date of this letter. \nCAG confirmed condition met 10 December 2021\n\n7.\tPlease review the privacy notice, and other patient notification materials in line with the advice given in the text of this letter, ensuring the research database purposes are clearly described, and provide updated versions to the Confidentiality Advisory Group within three months from the date of this letter.\nCondition met 15 December 2021\n\n8.\tObjections should be available to remove all data fields for research purposes, not just identifiable fields. Please confirm if this can be implemented, within three months from the date of this letter.\nCondition met 15 December 2021\n\n9.\tPlease provide a Patient and Public Involvement plan, which includes discussions surrounding research activity to the Confidentiality Advisory Group within three months from the date of this letter.\nCAG confirmed condition met 10 December 2021\n\n10.\tPlease consider lay representation on the PICANet Clinical Advisory Group, and report back to the Confidentiality Advisory Group within three months from the date of this letter.\nCAG confirmed condition met 10 December 2021\n\n11.\tPlease confirm your understanding that this application does not support direct contact with patients for the purposes of research.\nCAG confirmed condition met 10 December 2021\n\n12.\tFavourable opinion from a Research Ethics Committee. Confirmed 18 October 2018, originally approved 2005 (05/MRE04/17)\n\n13.\tConfirmation provided from the IG Delivery Team at NHS Digital to the Confidentiality Advisory Group that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 19/20 DSPT reviews for University of Leeds - Secure Electronic Environment for Data (SEED) (8E218 – SEED) and University of Leicester College of Life Sciences (EE133832-CMBSP) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26 July 2021)\n\nThe NHS Digital 20/21 DSPT review for University of Leeds - LASER (8KM29) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26 July 2021) - will be required once migration from SEED to LASER is complete later this year.\n\nDue to the number of participating PICUs/transport providers involved it is the responsibility of the applicant, as controller, to ensure that all organisations processing confidential patient information meet the minimum required standard in complying with DSPTs (or CPiPs for Wales), and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a care provider. These will not be individually checked by the CAT team due to the number of organisations involved."]

{"sheet":"A02614","index":656,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02614"]
["Reference","21/CAG/0043"]
["Other Refs","IRAS Project ID: 274918  REC Reference: 21/EE/0071"]
["Application Title","Barts Cancer Institute Breast BioBank"]
["Application Summary","This application from Barts Cancer Institute, Queen Mary University of London set out the purpose of medical research that aims to provide support for Barts Cancer Institute Breast Biobank (BCIBB) staff, who are not members of the direct care team to identify and screen patients attending Barts Health NHS Trust for a breast procedure (which covers patients from Barts, Whipps Cross, Homerton and Newham Hospitals) for eligibility, in order to subsequently seek their consent into the Barts Cancer Institute Breast BioBank. The aim of the Biobank is to recruit patients and healthy volunteers, and to collect, store and share high quality tissue and biological samples with associated data for translational research into breast cancer; however all other processes of the Barts Cancer Institute Breast BioBank do not require Regulation 5 support, as all participants are consented. The BioBank is co-funded by Breast Cancer Now and Barts Cancer Institute, and has been recruiting patients since 2015. The Barts Cancer Institute Breast Biobank (BCIBB) is also the parent site of the Breast Cancer Now Tissue Bank (BCNTB) and will donate equal samples into the BCNTB. The current model is for the direct care team to identify and consent eligible patients, but the applicants have identified that this model is not practicable as the process is very inefficient. The direct care team is not able to spend time identifying and introducing the patients to the BCIBB team during very busy clinic hours and consequently the number of identified patients is currently very low.\n\nBreast cancer is the second most common cancer in women in the Western world. A woman in the UK born after 1960 has a 1 in 7 lifetime risk of developing breast cancer, and whilst overall survival has significantly improved, there are still ~10,700 annual deaths from breast cancer. There is therefore a continued need to better understand the disease, the mechanisms underlying it and its response and resistance to treatment. Understanding normal breast cell biology is also critical to understanding the development of breast cancer as well as improving approaches to prevention, and therefore applicants also will approach healthy controls for consent. \n\nMembers of the BCIBB team will use records of planned surgeries provided by the Direct Care team (e.g. surgical calendar, Surginet, Multi-Disciplinary Meetings (MDTs), Pre-assessment clinic lists, all of which can be accessed via Electronic patient records (EPR)) to identify patients that may be appropriate to approach for consent. The BCIBB staff already have access to the Barts Health NHS Trust clinical systems in order to collect information about consented biobank patients, via a designated Barts Health NHS Trust PC installed in Barts Cancer Institute, Queen Mary University of London. The BCIBB staff will access this Barts Heath NHS Trust PC in order to access EPR and retrieve the clinical lists of anybody attending for a breast related procedure. The list of eligible patients will be checked weekly to remove any patient who has opted out via the national data opt out. This process is still in development but will be implemented by September 2021.  The clinical lists will be saved on this computer (within the Barts health NHS Trusts servers) and BCIBB staff will then use various electronic patient records in order to screen any patients who have not opted out via national data opt out for eligibility, including EPR, Care Record Service (CRS)/Millennium Powerchart. In order to undertake this task they will view confidential patient information (Full name, NHS Number, Hospital number, Date of birth) of all patients that are attending for a breast related procedure within Barts Health NHS Trust, and this is why support is requested. BCIBB staff will record if a patient is eligible or not on the clinic lists, and also on the shared calendar of the BCIBB shared NHS.net email address on the Barts NHS Trust servers. This will enable the members of the BioBank to know whether a patient needs to be approached prior to surgery to request consent. \n\nThe BCIBB team member will use the shared calendar entries, and the screened electronic clinical list to approach the direct care team and ask whether it is appropriate to approach the identified patient for BCIBB consent. Providing the direct care team are happy that it is appropriate to consent the patient for research purposes the BCIBB team member will approach potential patients in order to gain consent. Patient consent or dissent to the Tissue Bank will continue to be recorded on the patient’s record on Millennium Powerchart to prevent a dissented patient being inadvertently re-approached. However, the identifiable details of any patient that dissents will not be recorded or stored in the BioBank systems. The electronic version of the screening list containing identifiers will be kept on Barts Health NHS Trust server, and will be deleted once the patients have consented (or dissented). Any hard copies will be destroyed through confidential waste or shredded, although the applicant has confirmed there should not be any paper copies."]
["Applicant Organisation Name","Barts Cancer Institute"]
["Contact Name","Coleen Colechin, Senior Operations Manager "]
["Address","Research Services, Department W, c/o Mile End Post Room"]
[null,"Queen Mary University of London"]
[null,"327 Mile End Road, London"]
["Postcode","E1 4NS "]
["Telephone","020 7882 7252 "]
["Email","c.g.colechin@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients that are attending for a breast related procedure within Barts Health NHS Trust\n\nApproximately 5000 patients per year."]
["Description of confidential patient information used","Data sources\n\nBarts Health NHS trust: Electronic Patients Record (EPR) and Care Record Service (CRS)/Millennium Powerchart\n\n(this includes records of planned procedures produced by the Direct Care Team (e.g. surgical calendar, Surginet, Multi-Disciplinary Meetings (MDTs), Pre-assessment clinic lists) \n\nData sources\n\nBarts Health NHS trust: Electronic Patients Record (EPR) and Care Record Service (CRS)/Millennium Powerchart\n\n(this includes records of planned procedures produced by the Direct Care Team (e.g. surgical calendar, Surginet, Multi-Disciplinary Meetings (MDTs), Pre-assessment clinic lists) \n\nIdentifiers required for identification of cohort\n\n\n1.\tFull name\n2.\tNHS Number\n3.\tHospital number\n4.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tN/A – undertaken with consent"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-08-11"]
["Next Review Date","2024-08-11"]
["Notes","Conditions of support:\n\n1.\tSupport provided for 5 years, to be in line with the REC – at this point a duration amendment should be submitted for continued support.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 April 2021.\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 2019/20 DSPT review for Barts Health NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (11 August 2021)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02615","index":657,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02615"]
["Reference","21/CAG/0108"]
["Other Refs","IRAS Project ID: 296932  REC Reference: 21/SW/0076"]
["Application Title","What clinical outcomes are associated with the ‘joint care’ for teenagers and young adults with cancer?\nShort title: BRIGHTLIGHT_2021"]
["Application Summary","This application from University College London Hospital NHS Foundation Trust (UCLH) set out the purpose of medical research, of administering patient surveys to help determine if there are clinically significant differences in outcomes in 2021 for teenagers and young adults (TYA) with cancer receiving ‘joint care’ compared to all or no care in a teenagers and young adults Principal Treatment Centre (TYA-PTC).\n\nIn England, approximately 2,100 new cancers occur in TYA aged 16-24 annually. Cancer is the most common cause of non-accidental death in TYA with around 300 young people each year dying from their cancer. Five-year survival for young people with cancer varies from 50-98%, with improvements in the last 20 years lagging those observed for adults. TYA treatment-related morbidity is considerable, as are interruptions to social development, education, and employment, highlighting the importance of considering non-clinical outcomes, such as quality of life (QoL), alongside clinical outcomes, such as survival, in young people with cancer. \n\nSpecialist services provide care in thirteen TYA-PTCs. BRIGHTLIGHT (CAG reference: ECC 8-05(d)/2011) was a national evaluation of these TYA cancer services between 2013-2014, which included a cohort study examining differences in QoL, survival and costs of specialist care based on exposure to the TYA-PTC (all, some, or none). Results suggested young people whose care is divided between PTCs and other hospitals (joint care) have lower quality of life than those having all their care in a PTC or no care in a PTC. New NHS commissioning guidance recommends ‘joint care’. It is therefore important to assess whether the findings of BRIGHTLIGHT still hold in 2021, or whether ‘joint care’ can now be as good as all-TYA-PTC and no-TYA-PTC care. This application, BRIGHTLIGHT-2021 will provide the evidence to inform TYA cancer care policy, which will in turn maximise better outcomes for young people with cancer.\n\nThe eligible cohort is all people aged 16-24, 4-6 months after a cancer diagnosis, screened by the direct care team over a 10 month time period, which the applicants estimate to number approximately 1000 people. Support is required in this application to allow members of the direct care team at the 13 TYA-PTCs to disclose a password protected Excel file containing patient forename, surname, date of birth, NHS number, gender, address, and details of any potential challenges to participation, i.e., non-English speaking, visual impairment to Quality Health. The methodology is the same as that used for the National Cancer Patient Experience Survey (CAG reference 21/CAG/0084) and also similar to the methodology trialled in BRIGHTLIGHT (CAG reference: ECC 8-05(d)/2011). Quality health will then send a postal invitation letter including a patient information sheet to the cohort, containing a survey about QoL, other factors including social support, and their experience of their cancer journey and care. Two reminders will be sent to non-responders. Before each correspondence is sent, Quality Health will run a deceased check. Survey responses will be taken as implied consent to take part in the survey. However, further linkage will be undertaken with ‘s251’ support as the legal basis.\n\nSurvey responses, in addition to NHS Number, postcode and date of birth, (but not name and address) will be disclosed from Quality Health to NHS Digital. The survey responses will then be linked to clinical data from National Cancer Registration and Analysis Service (NCRAS) including cancer (type, staging), treatment (systemic anti-cancer therapy, radiotherapy, surgery), survival at 1 year after diagnosis, and hospital inpatient and outpatient activity in the first six months after diagnosis. Identifiable data will be modified from full dates to current age, age at diagnosis, survival time (based on date of death derived from the registry data) and postcode will be modified to Lower Layer Super Output Area (LLSOA) and Index of Multiple Deprivation (IMD) score. All items of confidential patient information will then be deleted prior to analysis. Analysis will be undertaken by a member of the UCLH research team who will be seconded to NCRAS. Anonymous data will be disclosed to UCLH for further analysis, and this does not require CAG support.\n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Rachel Taylor"]
["Address","University College London Hospitals NHS Foundation Trust"]
[null,"1st Floor East, 250 Euston Road"]
[null,"London"]
["Postcode","NW1 2PG"]
["Telephone",7967012909]
["Email","rtaylor13@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All (Approximately 1000) young people in England aged 16-24 years, between 4-6 months of a new cancer diagnosis.\n\nScreening will take place over a 10 month time period, which will start once all approvals are in place. "]
["Description of confidential patient information used","Data Sources:\n\n1.\t13 TYA treatment centre MDTs \n2.\tNational Cancer Registration and Analysis Service (NCRAS) – (Hospital Episode Statistics – (HES) data is already incorporated into NCRAS dataset as standard). Controlled currently by PHE, but this is being transferred to NHS Digital, and NCRAS is currently held at NHS Digital. \n\nIdentifers required to send out questionnaire (including DBS check):\n\n1.\tName\n2.\tDate of birth, \n3.\tNHS number, \n4.\tgender, \n5.\tFull address including postcode\n\nIdentifers required for linkage purposes:\n\n1.\tNHS Number\n2.\tPostcode \n3.\tDate of birth\n\nIdentifiers required for analysis purposes:\n\n1.\tGender\n2.\tEthnicity\n3.\tPostcode modified to LLSOA and IMD\n\nCan be considered anonymous to those undertaking analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-08-24"]
["Next Review Date","2024-08-24"]
["Notes","Amendment supported 19 February 2024;\n•\tTo change the data flows in order for analysis to be undertaken at University College London Hospital NHS Trust, instead of National Cancer Registration and analysis Service (NCRAS),\n•\tTo allow Quality Health to disclose confidential patient information (date of birth and date of death) to UCLH alongside IMD quintile and pseudo-ID,\n•\tTo allow Quality Health to disclose confidential patient information (name, address, date of birth and NHS number) to NHS England to undertake linkage with National Cancer Registration and analysis Service (NCRAS) to identify date of diagnosis, and for NHS England to flow pseudo-ID alongside date of diagnosis from to UCLH,\n•\tTo extend the duration of ‘s251’ support until June 2025\n\nAmendment supported 17 November 2022 to extend the recruitment period to include young people diagnosed from August 2022 to December 2022, meaning participating sites will be screening and uploading patient details until June 2023\n\n26 January 2022 - Amendment supported:\nAmendment supported 26 January for Quality Health to additionally apply the National Data Opt-Out, and to include the University Hospital of Wales Cardiff as an additional participating site, (and therefore additionally allow the disclosure of confidential patient information from Quality Health to Welsh Cancer Intelligence and Surveillance (WCIS), for the purposes of linkage with Cancer registration data, already linked to PEDW).\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 18 August 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nDue to the number of organisations involved it is the responsibility of University College London Hospitals NHS Foundation Trust as controller, to ensure that all organisations processing confidential patient information without consent meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a practice. This will not be individually checked by the Confidentiality Advice Team (CAT), as there are more than 5 organisations involved."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02616","index":658,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02616"]
["Reference","21/CAG/0137"]
["Other Refs","IRAS Project ID: 258590   REC Reference: 19/LO/0984"]
["Application Title","IBIS-II-O: Long term observational follow up of previous participants of the IBIS-II studies: DCIS and Prevention"]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research which aims to undertake the long-term observational follow-up of patients who were previously enrolled on a fully consented basis to the IBIS-II Prevention and DCIS clinical trials. \n\nThe IBIS studies have investigated preventative agents for breast cancer since 1992. IBIS-II Prevention compared tamoxifen to placebo in women with increased risk of breast cancer. IBIS-II DCIS compared anastrozole to tamoxifen in women with excised ductal carcinoma in situ (DCIS). Active treatment in the trials stopped in 2017; however, follow-up continues to determine the benefit and risk involved in preventative treatments. The current scope of the follow-up, which was described in the initial study protocols, proceeds with support under the Regulations as it was determined that the consent taken from women did not sufficiently describe the follow-up which would be carried out. In this application, the applicants are seeking support to carry out further longer-term follow-up of the patient cohorts beyond the scope of the initial protocols, which were planned to come to an end in 2022. The follow-up process will require data collected from registries only, as this provides sufficient and accurate information to enable annual patient questionnaires to be terminated. \n\nThe follow-up within this protocol will involve flagging the patient cohorts within cited NHS administrative datasets to enable longer-term follow-up to be undertaken in line with the scientific objectives set-out within the initial clinical trials. Further follow-up data may also be requested from the patient’s GP where necessary. The purpose of the follow-up is to enable longer monitoring of the longer-term safety profile of the preventative treatments and gain an understanding of potentially related events, including other cancers, bone fractures and cardiovascular events. "]
["Applicant Organisation Name","Wolfson Institute for Cancer Prevention"]
["Contact Name","Nadia Haidar"]
["Address","Centre for Evaluation and Methods"]
[null,"Wolfson Institute of Population Health, Charterhouse Square"]
[null,"London"]
["Postcode","EC1M 6BQ"]
["Telephone",2078822930]
["Email","n.haidar@qmul.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who were previously enrolled on the IBIS-II Prevention trial (3864 women) and IBIS-II DCIS trial (2980 women). This covers 2,867 patients in England and Wales."]
["Description of confidential patient information used","Data sources:\n\n1.\tExisting IBIS-II trial databases held at Queen Mary of London University\n\n2.\tNHS Digital;\na.\tHospital Episodes Statistics (HES)\nb.\tNational Cancer registry data, (NCRAS) (originally planned to acquire from Public Health England (PHE) also, however it is understood that this dataset will be transferred to NHS Digital).\nc.\tONS Mortality data\n \n3.\tDigital Health & Care Wales (DHCW) (Formerly known as NHS Wales Informatics Service, (NWIS)\na.\tPatient Episode Database for Wales (PEDW)\n\n4.\tNational Cancer Registration and Analysis Service, Public Health Wales\n\n5.\tGP surgeries\n\nIdentifiers required for linkage purposes:\n\n1.\tName\n2.\tNHS Number \n3.\tDate of birth\n4.\tPostcode \n5.\tStudy ID\n\nIdentifiers required for analysis purposes:\n\n1.\tDate of birth\n2.\tDate of death\n3.\tGender\n"]
["S251 Class(es)","Identifiers required for linkage purposes","Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-08-25"]
["Next Review Date","2024-08-25"]
["Notes","31 October 2023 - change in data processors from NHS Digital to NHS England, regarding data sources Hospital Episodes Statistics (HES), National Cancer Registration Analysis Service data, (NCRAS) and Civil registration mortality data\n\nConditions of support:\n\n1.\tThis application supersedes 20/CAG/0134 and 20/CAG/0135, which in turn superseded 19/CAG/0126.  \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 06 July 2021\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 20/21 DSPT review for Barts CR-UK Cancer centre was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 25 August 2021).\n\nRegarding other data processors including GP practices, due to the number of organisations involved it is the responsibility of Queen Mary University of London as controller, to ensure that all organisations processing confidential patient information without consent meet the minimum required standard in complying with DSPTs, or CPiPs in Wales, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a practice. As there are 5+ organisations these will not be individually checked by the Confidentiality Advice Team (CAT)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02617","index":659,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02617"]
["Reference","21/CAG/0071"]
["Other Refs","IRAS Project ID: 258819   REC Reference: 20/LO/1216"]
["Application Title","Congenital Hypothyroidism with Gland in Situ: establishing risk factors and outcomes using population-based data linkage methods"]
["Application Summary","This application from UCL Great Ormond Street Institute of Child Health sets out the purpose of medical research that aims to determine why more babies are being diagnosed with congenital hypothyroidism with gland in situ (CH-GIS), and what health and development is like for children living with this condition. Applicants propose to link routine clinical and education data, and compare between children with CH-GIS, children with other forms of congenital hypothyroidism (CH), and unaffected children. Once linkage is complete, only pseudonymised data will be stored and analysed.\nPage 3 of 11\nAll children in the UK are offered screening for rare conditions at five days of age, one of which is CH, which without early detection and treatment can result in severe learning disability. Since the introduction of newborn screening 40 years ago, there has been an increase in the proportion of babies born with CH, particularly a type called CH-GIS. It is not clear why CH-GIS is becoming more common, or how it affects health, development and learning as children grow up. Study results will help inform parents and children about the health and education consequences of congenital CH-GIS, and clinicians about which treatment regimen is best for children’s health and development. The results will also advise public health professionals about CH-GIS, and how it can be prevented.\nThe applicants are proposing two study designs within this application. A cohort study to investigate a change in the birth prevalence of CH and CH-GIS, which will link data for all children screened for a number of inborn conditions at the GOSH newborn screening laboratory between 1 January 2000 and 31 December 2020 (approximately 2.2 million children) (the GOSH NBS database) to the GOSH clinical database of diagnostic and treatment information for all children who screen positive for CH (the GOSH CH database). The applicants also plan to link the mothers to their children to indicate which babies are siblings in order to examine familial clustering of newborn TSH screening results. This dataset will be linked by NHS Digital to the Office for National Statistics (ONS) birth and deaths registration data.\nThe second study design is a case-control design which will link approximately 1800 children diagnosed with CH-GIS (from the GOSH CH database), will be linked by NHS Digital to Hospital Episode Statistics (HES), National Child Measurement Programme (NCMP), NHS Business Services Authority (NHSBSA) community dispensing data, and the National Pupil Database (NPD). Applicants will compare children's height and weight distribution as well as patterns of medicine dispensing in children with CH or CH-GIS compared to all children using aggregate data from NCMP and the NHSBSA dispensing database. Applicants will request these aggregate datasets from NHS Digital, for which support is not required. 15 controls per case will be selected from the HES part of the pseudonymous ECHILD database, matched on sex, month and year of birth and local authority, for which support is not required.\nHES and NPD data are already linked for the ECHILD study and a pseudonymised version is held in the UCL Data Safe Haven (DSH), which applicants will be able to access with the pseudonymous HES-NPD linkage key provided by NHS Digital. NHS Digital will also provide the applicant with linked ONS data (to the whole NBS cohort), which will have all identifying information removed apart from the date of death, and the NBS identifier. NHS Digital will provide the applicant will a pseudonymous linked CH dataset, linked to NCMP and NHSBSA data.\nGOSH link the datasets received from NHS Digital back to the NBS and CH linked dataset, modify the postcode to LSOA, and send the dataset to UCL Data Safe Haven for analysis. This flow also requires support as the date of birth and date of death will be contained in this file. UCL staff extract HES records (from the HES part of the linked-NPD-HES data) for children in CH database using the pseudonymised HES-NPD linkage key provided.\nAll the datasets will be pseudonymised for analysis. This will involve date of birth and date of death being modified to be less disclosive, and this will be performed within the UCL DSH by the named researcher. Full date of birth and full date of death will then be deleted.\nPage 4 of 11\nThe linked health data will be held in UCL's Data Safe Haven. Selected pseudonymous clinical variables from the linked health data will be securely transferred to the ONS SRS. The cohort will then be linked to the NPD part of the linked HES-NPD ECHILD data. The education outcomes will be analysed in the ONS SRS, according to DfE regulations.\nThe linkages are also below;\n1. GOSH link two internal databases (NBS & CH) which will contain NBS cohort identifier\n2. GOSH send identifiers, plus NBS cohort identifier to NHSD\n3. NHSD link NBS data to ONS births and deaths registration data\n4. NHSD link CH data only to NCMP data and NHSBSA data, and provide a HES-NPD ECHILD linkage key\n5. Linked data sent back to GOSH, support required due to date of death, and GSH link to NBS-CH linked database using NBS cohort identifier\n6. GOSH send linked dataset containing clinical information and date of birth and date of death, alongside NBS Cohort ID to UCL safehaven\n7. UCL safehaven undertakes linkage from CH dataset to HES part of the linked NPD-HES data, using HES-NPD ECHILD linkage key.\n8. Identifiers removed from dataset and deleted once in UCL DSH\n9. Selected variables sent from UCL DSH to ONS SRS for analysis, and dataset linked to NPD part of the linked NPD-HES ECHILD data, using HES-NPD ECHILD linkage key.\n10. Analysis undertaken in both ONS-SRS and UCL-DSH"]
["Applicant Organisation Name","UCL Great Ormond Street -Institute of Child Health"]
["Contact Name","Dr Pia Hardelid"]
["Address","UCL Great Ormond Street -Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone",2079052979]
["Email","p.hardelid@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All babies born in the North Thames region (including North London, Bedfordshire, Hertfordshire and Essex), whose newborn screening blood spot sample was tested at the Great Ormond Street Hospital (GOSH) newborn screening laboratory between 1 January 2000 and 31 December 2020 (approximately 2.2 million children)\nThis will include approximately 1800 children with congenital hypothyroidism in the GOSH CH database.\nage limit: 0 - 20 Years\nThe childrens mothers will also be included, however this will be less than 2.2 million mothers as some children will have the same mother\nPopulation based study: all 2.2 million\nCase-control study: 1800"]
["Description of confidential patient information used","Data sources:\n\n1. Great Ormond Street Hospital for Children NHS Foundation Trust:\na. North Thames Newborn blood spot screening database– held at GOSH (GOSH NBS database). (legal basis =Clinical database)\nb. GOSH Congenital Hypothyroidism (CH) Database – held at GOSH (GOSH CH database). (legal basis = Clinical database)\n2. NHS Digital:\na. Hospital Episode Statistics (HES), Admitted Patient Care (HES-APC), Accident & Emergency/Emergency Care Dataset (HES A&E), Outpatient Data (HES-OPD): Note, HES records for both mother and baby will be linked and analysed for this study. linkage key for NPD-HES data obtained via NHS Digital, (the data controller), however the pseudonymous HES ECHILD database is retained in the UCL DSH\nb. Office of National Statistics Birth and Deaths registration data (ONS) (held by NHS Digital)\nc. National Child Measurement Programme (NCMP, held by NHS Digital; height and weight of primary school children at 4-5yr and 10-11yr) (legal basis = nationally mandated)\nd. NHS Business Service Authority (NHSBSA) community dispensing data (held by NHS Digital)\n3. Department for Education (DfE):\na. National Pupil Database (NPD), information on school performance and special educational needs) (has alternate legal basis – not defined as confidential patient information) – linkage key for NPD-HES data obtained via NHS Digital, DfE is the data controller for this dataset, however the pseudonymous NPD ECHILD database is retained in the ONS SRS\n\nIdentifiers required for linkage purposes:\n\n1. Name\n2. NHS number (of child)\n3. Mothers NHS number\n4. Hospital ID\n5. Date of Birth\n6. Date of Death\n7. Postcode (Unit level)\n8. Postcode histories\n9. NBS Cohort identifier\n\nIdentifiers required for analysis purposes:\n\nNo identifiers which have not been modified are required for analysis: identifiers will be deleted once they are modified.\n1. Date of Birth - modified to analysis variable such as week of birth. This will be done by named researcher at UCL DSH\n2. Date of Death - modified to month and year of death. Follow-up time from birth in days will also be calculated.\nPage 6 of 11\nThis will be done by named researcher at UCL DSH\n3. Post code (unit level) - used to map to Lower Super Output Areas. This will be done by the GOSH DRE team. ‘Researchers’ will not have access to full postcodes.\n4. Gender\n5. Ethnicity\n6. Parent's country of birth,\n7. Parent's occupation\n8. NBS Cohort identifier\n9. HES-NPD linkage key"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-07"]
["Next Review Date","2024-09-07"]
["Notes","12 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Civil registrations Birth and Deaths, Child Measurement Programme (NCMP), NHS Business Service Authority (NHSBSA) community dispensing data (held by NHS Digital), and the linkage key for NPD-HES dataUpdate to original conditions\n\n1. Please provide feedback at the time of the first annual review around the planned communication activities undertaken. \n\nCondition met 22 November 2022\n\n3. Please provide feedback surrounding further patient and public involvement undertaken with healthy mothers, to ensure the acceptability of using their confidential patient information without consent, within six months from the date of this letter.\n\nCondition met 22 November 2022\n\n\nSpecific conditions of support\n\n1. Please provide feedback at the time of the first annual review around the planned communication activities undertaken.\n2. Please provide a lay explanation of hypothyroidism at the start of the notification materials, and provide an updated version to CAG, within one month from the date of this letter.\nCondition met 24 September 2021\n3. Please provide feedback surrounding further patient and public involvement undertaken with healthy mothers, to ensure the acceptability of using their confidential patient information without consent, within six months from the date of this letter.\n4. Favourable opinion from a Research Ethics Committee Confirmed 24 June 2021\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\nThe NHS Digital 20/21 DSPT reviews for University College London – School of Life and Medical Sciences (EE133902-SLMS), Office for National Statistics (ONS SRS) (XDC), Great Ormond Street Hospital for Children NHS Foundation Trust (RP4) and NHS Digital (X26) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 07 September 2021)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02618","index":660,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02618"]
["Reference","21/CAG/0088"]
["Other Refs","IRAS Project ID: 296325   REC Reference: 21/NW/0182"]
["Application Title","Barts Structural Interventional Registry (BSIR)"]
["Application Summary","This application, from Barts Health NHS Trust, aims to undertake medical research to understand the characteristics and outcomes in patients with valvular heart disease (VHD).\nVHD is defined as any alteration to the normal structure and/or function of the heart valves and is often caused by a combination of cardiac and often non-cardiac factors. It is often caused by a number of diseases rather than a single one and often several valve diseases coexist in the same patient. Much research has been undertaken within strict conditions, but the real-world efficacy is not known for some sub-populations. The database will be used to test several hypothesis including but not limited to investigating characteristics of patients treated, complications of interventional and medical treatment, outcomes of patients and highlight structural and fluid-dynamics performance. This research will add substantially to the literature by providing real-world data from a leading valvular interventional centre.\nBarts will send NHS Digital identifiers of the eligible cohort, in order to link to central datasets. This data, including date of death, will be returned to Barts and linked back to clinical information. Data that is subsequently required for research purposes under the terms of this support will be extracted by the clinical team, pseudonymised and provided to the research team for research purposes. Pseudonymisation will be achieved by assigning each patient with a study ID. A file will be created linking the study ID to the identifiable data. This file will be held by the CI on a Barts Health NHS server under password protection. Any data that is used for research purposes will only contain the study ID. This data will not have patient name, date of birth, postcode or NHS number. The application also explains how a data access committee will approve all uses of data required from NHS Digital, however after clarification from the REC, this application is for a specific study only, rather than a research database, and as such, any further uses of this data will require a further application."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Dr Michael Mullen"]
["Address","Barts Health NHS Trust"]
[null,"St Bartholomew's Hospital,"]
[null,"West Smithfield, London"]
["Postcode","EC1A 7BE"]
["Telephone",7905697170]
["Email","mmullen@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any patient >16 years old with VHD referred to Barts Health NHS Trust from 01/01/2015 until present (Retrospective\nPage 3 of 10\npatients only included)"]
["Description of confidential patient information used","Data sources:\n\n1. Barts Health NHS Trust clinical data;\n(PACS, CRS, patient notes)\n2. NHS digital;\na. The office for national statistics (ONS) Mortality dataset\nb. Health episodes statistics (HES)\nc. Electronic Prescription Service\nd. Patient Related Outcome Measures (PROMS)\n\nIdentifiers required for linkage purposes:\n\n1. Name\n2. Date of birth\n3. Postcode\n4. NHS number\n5. Study ID\n\nIdentifiers required for analysis purposes:\n\n1. Study ID\n2. Age\n3. Date of admission\n4. Date of intervention\n5. Date of discharge\n6. Date of death (this will be modified for analysis)\n7. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-07"]
["Next Review Date","2024-09-07"]
["Notes","18 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), civil registrations – Deaths, Electronic prescription service, and Patient related Outcome measures (PROMs)\n\nConditions of support:\n\n1.\tAn updated patient notification poster should be provided at the time of first annual review, which contains more information about the research questions being addressed and the datasets that will be accessed.\n\nCondition met 06 October 2022\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 17 June 2021\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT review for Barts Health NHS Trust and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 07 September 2021). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02619","index":661,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02619"]
["Reference","21/CAG/0106"]
["Other Refs","IRAS Project ID:  285902 REC Reference: 20/NW/0402"]
["Application Title","TRIM: What Triage model is safest and most effective for the management of 999 callers with suspected COVID-19? A linked outcome study"]
["Application Summary","This application from Swansea University set out the purpose of medical research that seeks to determine which ambulance service triage model is safest and most effective for the management of 999 calls with suspected Covid-19.\nThe COVID-19 epidemic in the UK has caused surges in 999 calls from people concerned about possible coronavirus symptoms including fever and shortness of breath. As an example, the London Ambulance Service has recorded receiving three times its usual number of 999 calls each day for a sustained period. Ambulance Services need to triage calls to determine whether to dispatch a vehicle to conduct a face to face assessment and, if attended, whether the patient needs to be treated in hospital. The triage is key to identifying patients who need to be treated in hospital. Under-triaging may result in patient harm, while over-triaging may result in the unnecessary conveyance of patients to hospital. Different models of triage are used across the UK and there is a lack of evidence on which model of triage works best for patients and the NHS in a pandemic situation.\nThe applicants have already undertaken a survey of all ambulance services and now seek to use linked-anonymised data to evaluate models used to triage and manage emergency ambulance service care for patients with Covid-19 who call 999 in England. Four ambulance services will be identified, alongside one large general hospital in each services catchment area, apart from the Yorkshire Ambulance Trust, which will be working with two trusts in order to ensure coverage of all age groups.\nTwo cohorts will be involved, a forwards cohort and a backwards cohort:\nFor the forwards cohort, the participating hospital trusts will disclose confidential patient information to their linked ambulance service, so that linkage of the hospital and ambulance data can be undertaken. The ambulance trusts will then disclose confidential patient information to NHS Digital for linkage to the Covid-19 Hospitalisation in England Surveillance System (CHESS), ECDS, Civil Registration – Deaths, and HES datasets. A pseudonymised dataset will then be disclosed to the research team at the University of Swansea. Separately, the participating ambulance trusts will transfer pseudonymised data to the research team at the University of Swansea.\nFor the backwards cohort, participating ambulance service trusts will identify suitable patients and their confidential patient information is disclosed directly to NHS Digital, with no linkage to hospital trust data. A pseudonymised dataset will then be disclosed to the research team at the University of Swansea. Separately, the participating ambulance trusts will transfer pseudonymised data to the research team at the University of Swansea."]
["Applicant Organisation Name","Swansea University"]
["Contact Name","Professor Alan Watkins"]
["Address","Swansea University"]
[null,"Health Services Research Team"]
[null,"Swansea University"]
["Postcode","SA2 8PP"]
["Telephone",1792513410]
["Email","a.watkins@swansea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Forwards cohort: Patients who made a 999 call classified as suspected COVID-19 by a selected ambulance service, between 01 March 1 2020 and 31 August 2020\nBackwards cohort: Patients who were diagnosed with COVID-19 in specified hospitals within the catchment areas of study ambulance services, again between 08 March 2020 and 7 September 2020.\nThe applicants estimate that 80,000 patients will be included."]
["Description of confidential patient information used","Data sources:\n\n1. Electronic patient records at the 4 participating Ambulance Service Trusts and their partnered Hospital Trust:\na. East Midlands Ambulance Service Trust, working with Queen's Medical Centre, Nottingham University Hospital Trust;\nb. East of England Ambulance Service Trust, working with Norfolk and Norwich University Hospitals NHS Foundation Trust;\nc. West Midlands Ambulance Service Trust, working with Sandwell and West Birmingham Hospitals NHS Trust\nd. Yorkshire Ambulance Service Trust, working with Sheffield Teaching Hospitals NHS Foundation Trust and Sheffield Children's NHS Foundation Trust. (Two trusts and needed to ensure coverage across all age groups)\n2. The following datasets held by NHS Digital:\na. Covid-19 Hospitalisation in England Surveillance System (CHESS)\nb. Emergency Care Dataset (ECDS)\nc. Hospital Episode Statistics (HES)\nd. Civil Registration - Deaths\n\nIdentifiers required for linkage purposes\n\n1. Name\n2. NHS number\n3. Date of birth\n4. Postcode – unit level\n\nIdentifiers required for analysis purposes\n\n1. Date of birth\nPage 4 of 11\nfor analysis purposes\n2. Date of death\n3. Postcode – unit level\n4. Gender\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-02"]
["Next Review Date","2024-09-02"]
["Notes","12 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Covid-19 Hospitalisation in England Surveillance System (CHESS), Emergency Care Dataset (ECDS), Hospital Episode Statistics (HES) & Civil Registration – Deaths\n\nAmendment supported 17 January 2024 to extend the duration of ‘s251’ support until 07 June 2025\n\n1.\tConfirmation needs to be provided that the mechanism of backwards linkage is undertaken by members of the direct care team.  Condition met 01 October 2021.\n\n2.\tA separate Privacy Notice and Patient Notification Leaflet need to be provided. The Patient Notification needs to contain a lay description of the research, including the use of confidential patient information without consent and how patients can dissent, and a link to the Privacy Notice. \nCondition met 01 October 2021.\n\n3.\tConfirm that the use of confidential patient information without consent as proposed in this application had been discussed during patient and public involvement. Feedback from the patient and public involvement confirming this discussion needs to be provided.\nCondition met 01 October 2021.\n\n4.\tResponses to the above three conditions need to be provided within three months of the issuing of this outcome letter. \n\n5.\tFavourable opinion from a Research Ethics Committee. Confirmed 04 November 2020. \n\n6.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02620","index":662,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02620"]
["Reference","21/CAG/0104"]
["Other Refs","IRAS Project ID:   277778 REC Reference: 21/NW/0123"]
["Application Title","Enhancing Pre-hospital Chest Pain Telephone-triage Using a Prediction Model"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to investigate whether the use of a prediction model in telephone triage can reduce the over-triage of chest pain patients. \n\nChest pain is one of the main symptoms of Acute Coronary Syndrome (ACS). It is also one of the most common reasons for use of ambulance services and admission to emergency departments. ACS patients typically present with chest pain, while the majority of chest pain patients transported by ambulance and admitted to emergency departments are diagnosed with non-cardiac disease. Approximately 20% of those admitted with suspected ACS go on to be diagnosed with ACS. In this application, the applicants are aiming to create and validate a prediction model for use in the pre-hospital setting. \n\nA retrospective, observational cohort study will be conducted to collect data from the North West Ambulance Services (NWAS) EMS dispatch system for patients who called 999 with a chief complaint of chest pain. NWAS will transfer confidential patient information to the research team at the University of Manchester via nhs.net email. The consolidated dataset will then be transferred to the Manchester University NHS Foundation Trust for linkage to data held by the Trust. The linkage and pseudonymisation process will be carried out by a research nurse within the Trust. Each patient will be given a key number, containing no identifiable information, and transferred to the University of Manchester by nhs.net email. The minimum dataset required for data linkage will be shared securely by the research team with MRI NHS Trust, in order to verify the outcomes of patients. From this audit database, a pseudonymised research data set will be extracted, this will be stored at the University of Manchester. This dataset will then be stored in the Data Safe Haven at the University of Manchester and only the assigned research team will have access to those data."]
["Applicant Organisation Name","Manchester University NHS foundation Trust"]
["Contact Name","Professor Richard Body"]
["Address","Manchester Royal Infirmary"]
[null,"Manchester University NHS foundation Trust"]
[]
["Postcode","M13 9WL"]
["Telephone","01612765072"]
["Email","richard.body@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","5,500 patients who contacted 999 with a chief complaint of chest pain, who were transported to Manchester University NHS Foundation Trust by ambulance for further care. \n\n"]
["Description of confidential patient information used","Data Sources:\n\n1.\tElectronic patient data held by North West Ambulance Services (NWAS) NHS Trust\n2.\tElectronic patient data held by the University of Manchester NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID Number\n4.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-15"]
["Next Review Date","2024-09-15"]
["Notes","Amendment supported 24 July 2023 to extend the duration of ‘s251’ support until 30 January 2024\n\nSpecific conditions of support\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 April 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nThe NHS Digital 2020/21 DSPT reviews are:\n\n•\tUniversity of Manchester – confirmed 17 June 2021\n•\tManchester University NHS Foundation Trust – confirmed 08 July 2021\n•\tNorth West Ambulance Services NHS Trust – confirmed 13 August 2021"]

{"sheet":"A02621","index":663,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02621"]
["Reference","21/CAG/0099"]
["Other Refs","IRAS Project ID: 279078  REC Reference: 21/NS/0029"]
["Application Title","Governing parental opioid use: a relational ethnography\nShort title: The Relations Study_v1.0"]
["Application Summary","This application from University of Stirling sets out the purpose of medical research that aims to better understand the treatment and care of parents who use drugs and their families, including from the perspective of professionals and service providers.\n\nThere are 4 workstreams in this study, and CAG support is only relevant regarding workstream 3, as other activities are being undertaken with consent. In workstream 3, researchers will attend, observe and listen to professional meetings at which patients are not present and where it is not possible to know in advance who is going to be discussed. Researchers will not record any confidential patient information and will make anonymised notes concerning 'Patient or Family X' and the type of issues being discussed. There is likely to be incidental disclosure of confidential patient information during these observations, and it is for these incidental disclosures that ‘s251’ support is required. \n\nThere is a growing consensus that in order to fully understand, and respond to, parental opioid and other drug use, research must take into account the wider context, rather than simply focus on drug use in isolation. Observation of professional meetings will help understand professional decision-making and how staff discuss and manage risk, make decisions together, work together, and plan care and services together. The in-depth information and learning from these observations will inform recommendations for changes to policy and practice in the future, or may inform the development of future interventions, which in turn, may lead to better treatment and better outcomes for parents who use drugs and their families.\n\nApplicants will undertake observations of clinical practice in 3 NHS Trusts in London, and additionally in 3 other types of service provider and the equivalents in Scotland which are out of scope for support. The observations will include staff meetings, shadowing staff, discussing policies and guidelines, and additional observations described in the protocol, via several different methods depending on how the service functions. Patients are not the focus of the staff/service observations. Observations will be undertaken by a researcher from Kings College London, who will situate themselves within participating sites for a consecutive time period of between 3-6 months either full or part time. The observations will be completed over 21 months altogether. All staff observations and staff and patient interviews, and ethnographic observations of parents and families will be undertaken with written informed consent, however it is likely that most observations of clinical practice will indirectly involve other patients (for example, in meetings). Support under the regulations is required in case of accidental disclosure of confidential patient information regarding a non-consented patient during ethnographic observations of practitioners and services. The researchers have put in a number of safeguards to protect patient confidentiality including consent where possible, not recording any confidential patient information in the written field notes, and removing themselves from the area if requested. At all times, the researchers will wear their University staff badge on a lanyard whilst on site.\n\nA recommendation for class 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Stirling "]
["Contact Name","Professor Anne Whittaker"]
["Address","University of Stirling (seconded from NHS Lothian)"]
[null,"NMAHP Research Unit,"]
[null,"Pathfoot Building, University of Stirling, Stirling"]
["Postcode","FK9 4LA"]
["Telephone","01786 466341"]
["Email","anne.whittaker@stir.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","For CAG purposes support is only given regarding patients of services, not for NHS staff or family members of patients (unless they themselves are patients of the service).\n\nThe cohort is: Parents who are in treatment for opioid use who are not consented into this study, whose information may be incidentally disclosed.\n\nThe applicants have estimated this to approximate 144 families, however, it is not possible to predict incidental disclosures, and this could be more or less. "]
["Description of confidential patient information used","Data Sources\nObservations carried out in 3 participating NHS Trusts:\n•\tHomerton University Hospital NHS Foundation Trust \n•\tSouth London and Maudsley NHS Foundation Trust \n•\tLewisham and Greenwich NHS Trust\n\nIdentifiers required for linkage purposes - None\nIdentifiers required for analysis purposes - None"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-15"]
["Next Review Date","2022-09-15"]
["Notes","Applicant confirmed in October 2022 that ‘s251’ support could be expired as the ethnographic observations have completed. \n\nWith regards to public benefit, data from these observations are being analysed for a paper to be delivered at the European Society for the Social Study of Drugs. In addition, the insights that will be delivered from these observations will contribute to practice focused recommendations in preparation for social services and health care staff to improve the care and support of parents who use drugs and their families.\n\n\nConditions of support:\n\n1.\tSupport only extends to England and does not cover sites in Scotland.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 30 March 2021\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \nThe NHS Digital 20/21 DSPT reviews for South London and Maudsley NHS Foundation Trust (RV5), Homerton University Hospital NHS Foundation Trust (RQX) and Lewisham and Greenwich NHS Trust (RJ2) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 September 2021). "]

{"sheet":"A02622","index":664,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02622"]
["Reference","19/CAG/0200"]
["Other Refs","IRAS Project ID: 132999  REC Reference: 13/LO/1787"]
["Application Title","The PROFILE Study- Germline genetic profiling: correlation with targeted prostate cancer screening and treatment."]
["Application Summary","This application from the Institute of Cancer Research set out the purpose of medical research that seeks to determine the role of targeted prostate cancer screening in men at a higher genetic risk and its association with specific genetic profiles and biomarkers.\n\nProstate cancer is the most common cancer in men in the western world with over 40,000 men diagnosed each year and a lifetime risk of 1 in 11 in the United Kingdom. Prostate cancer can run in some families and research studies have identified several genetic changes that are thought to increase the risk of developing prostate cancer. Additionally, men from Afro-Caribbean ancestry are thought to have an increased risk of prostate cancer when compared to Caucasian men. This study aims to look at the potential risk of these changes in targeted screening in men at a higher genetic risk. The applicants will invite Caucasian men with a family history of prostate cancer and men of African/Afro-Caribbean origin, irrespective of family history, for targeted prostate screening. Living participants will be recruited and their participation will be on a consented basis.\n\nThe applicants also wish to access the records of relatives of participants in the study, if they had a diagnosis of prostate cancer. Living relatives will be given information and a consent form, requesting permission to access the records. If the relatives have died, participants are asked whether the applicants can write to the hospital that treated their relative to request copies of their medical records. Participants are also asked to provide the death certificate for their relative, if they have access to it, in order to verify their relative’s diagnosis. \n\nIn this application, the applicants are seeking support under Section 251 to access data from the National Cancer Registration and Analysis Service (NCRAS) in order to confirm the relative’s diagnosis. The relative’s diagnosis needs to be verified to confirm the participants eligibility for the trial prior to any invasive procedures being undertaken, as the eligibility of the Caucasian cohort relies of a family history of prostate cancer. \n\nA recommendation for class 1, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","The Institute of Cancer Research"]
["Contact Name","Professor Rosalind Eeles"]
["Address","The Institute of Cancer Research"]
[null,"15 Cotswold Road"]
[null,"Sutton"]
["Postcode","SM2 5NG"]
["Telephone","0208 722 4094"]
["Email","rosalind.eeles@icr.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The deceased relatives of Caucasian participants in the PROFILE study, who had a diagnosis of prostate cancer. \n\n350 Caucasian patients would be recruited into the study. "]
["Description of confidential patient information used","Data sources:\n1.\tNational Cancer Registration and Analysis Service (NCRAS), at Public Health England\n\nIdentifiers required for linkage purposes:\n1.\tName\n2.\tDate of birth\n3.\tDate of death\n4.\tPostcode – District Level\n5.\tPlace of death (hospital, hospice or residence)\n\nIdentifiers required for analysis purposes:\nNo identifiers will be retained for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2020-06-25"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed August 2023 that ‘s251’ support can be expired as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, the activity enabled patients to access research by confirming their eligibility (based on a confirmed history of prostate cancer in a deceased close relative).\n\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 28 November 2019.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed – Public Health England has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 02 September 2019. \n\n•\tConfirmed - The Institute of Cancer Research, the Royal Marsden NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2018/19 by NHS Digital email dated 28 February 2020."]

{"sheet":"A02623","index":665,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02623"]
["Reference","21/CAG/0111"]
["Other Refs","IRAS Project ID: 270690  REC Reference: 19/L0/1700"]
["Application Title","Barts Cancer Research Tissue Bank (CTB)"]
["Application Summary","This application from Barts Cancer Institute, Queen Mary University of London set out the purpose of medical research that aims to provide support for Barts Cancer Research Tissue Bank (CTB) team staff, who are not members of the direct care team to identify and screen patients attending clinics and wards at Barts Health for eligibility, in order to subsequently seek their consent into the Barts CTB. The aim of the CTB is to recruit patients and healthy volunteers, to collect, store and share high quality tissue and bodily fluids and associated clinical data for research into distinct types of cancer; however, all other processes of the CTB do not require Regulation 5 support, as all participants are consented. The current CTB model is for the direct care team to identify and consent eligible patients, but the applicants have identified that this model is not practicable as the process is very inefficient. The direct care team is not able to spend time identifying and introducing the patients to the CTB team during very busy clinic hours and consequently the number of identified patients is currently very low.\n\nCurrently, there is no reliable biomarker for cancer spread in general or for organ-specific identification. The search for a reliable biomarker requires access to uniformly collected, reliably stored, and clinically annotated samples to develop a diagnostic test. This bio-bank will therefore be critical to develop and validate novel cancer metastases biomarkers. These biomarkers will help to reduce the overall health burden by early diagnosis, thus prolonging life through more timely interventions to control disease progression.\n\nMembers of the CTB team, who are not members of the direct care team, will use Barts Health patient records such as Cerner Millennium Powerchart, NHS.net calendars and EPR to identify and screen patients that may be appropriate to approach for consent. Any patient who has opted out via the national data opt out will be removed from the screening process. This process is still in development but will be implemented by September 2021.  All patients that may be eligible for CTB (e.g. with a suspected or diagnosed gastro-intestinal or other cancer) will be recorded on the shared calendar of the BCI (Barts Cancer Institute) Tissue Bank shared NHS.net email address (within the Barts health NHS Trusts servers). In order to undertake screening, CTB staff will view confidential patient information (Full name, NHS Number, Hospital number, Date of birth). CTB staff will record if a patient is eligible or not on a shared calendar of an NHS.net email address on the Barts NHS Trust servers, using the stated items of confidential patient information. This will show whether a patient needs to be approached to request consent. \n\nThe CTB team member will use the shared calendar entries to approach the direct care team and ask whether it is appropriate to approach the identified patient for consent. Providing the direct care team are happy that it is appropriate to consent the patient for research purposes the CTB team member will approach potential patients in order to gain consent. Patient consent or dissent to the Tissue Bank will continue to be recorded on the patient’s record on Millennium Powerchart to prevent a dissented patient being inadvertently re-approached. However, the identifiable details of any patient that dissents will not be recorded or stored in the CTB systems. Any hard copies of screening will be destroyed through confidential waste or shredded, although the applicant has confirmed there should not be any paper copies.\n\nA recommendation for class 1, 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Barts Cancer Institute, Queen Mary University of London"]
["Contact Name","Coleen Colechin, Senior Operations Manager "]
["Address","Queen Mary Innovation Centre\n"]
[null,"Lower Ground Floor"]
[null,"5 Walden Street, London"]
["Postcode","E1 2EF "]
["Telephone",2078827252]
["Email","c.g.colechin@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients attending the surgical, gastroenterology and oncology clinics and wards at Barts Health NHS Trust with a suspected or confirmed malignancy.\n\nApproximately 200 patients a week will be screened, to identify approximately 30-40 eligible patients. "]
["Description of confidential patient information used","Data sources:\nBarts Health NHS trust: Electronic Patients Record (EPR) and Care Record Service (CRS)/Millennium Powerchart, WinPath, CyberLab and Varian prescribing system, Surginet and surgical diaries.\n\nThis includes lists of patients attending day-unit, clinics or wards, or theatre lists, which could be provided by direct care team, as well as the physical procedure diary on the day-unit, and NHS.net calendars. \n\nIdentifiers required for identification of cohort\n1.\tFull name\n2.\tNHS Number\n3.\tHospital number \n4.\tDate of birth\n\nIdentifiers required for analysis purposes\n1.\tN/A – undertaken with consent"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-24"]
["Next Review Date","2024-09-24"]
["Notes","Conditions of support:\n\n1.\tSupport provided for 5 years in the first instance. A duration amendment will be required at this time to extend support. \n\n2.\tPlease confirm if the clinical appointment letter makes clear that not everybody invited to clinic will turn out to have cancer, within one month from the date of this letter.\n\nCondition met 25 October 2021\n\n3.\tPlease amend the order and description of the opt out options as described above, and provide an updated version to CAG, within one month from the date of this letter.\n\nCondition met 25 October 2021\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 09 December 2019\n\n5.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT review for Barts Health NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 21 September 2021)\n"]

{"sheet":"A02624","index":666,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02624"]
["Reference","21/CAG/0048"]
["Other Refs","IRAS Project ID: 243856  REC Reference: 04/MRE07/35"]
["Application Title","Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy"]
["Application Summary","This application from the Institute of Cancer Research, University of London set out the purpose of medical research that seeks to improve the way in which prostate cancer is managed. \n\nProstate cancer is a major health problem world-wide and accounts for nearly one fifth of all newly diagnosed male cancers. In the UK, approximately 57,192 people were diagnosed with prostate cancer in 2018 and over 11,500 people died from the disease. Because of the shortage of research in prostate cancer, the National Cancer Research Institute (NCRI) has identified prostate cancer as high priority for research in the UK. Prostate cancers depend upon the male hormone testosterone for their growth. Lowering testosterone levels, such as by removing all or the functioning part of both testes, or by having hormone therapy, slows the growth of prostate cancers. Hormone therapy is given in the long−term as standard treatment to patients whose prostate cancer has spread outside the prostate gland. Although hormone therapy is usually successful at stopping the cancer growing for a period of time, it is does not cure the cancer and most tumours will usually begin to grow again within 18−24 months.  The increasing and widespread use of hormone therapy in prostate cancer management has led to growing awareness of the adverse effects of this treatment. An alternative approach for improving long-term outcomes in patients is therefore to reduce some of these side-effects. Many of these side-effects can affect quality-of-life as well, as result in significant and potentially life-threatening consequences, particularly with prolonged treatment and in patients with pre-existing medical conditions. The applicants created the STAMPEDE trial to examine the use of metformin as a treatment, as this may prevent some of the effects of long-term hormone therapy. Transdermal oestradiol patches would also be looked at as an alternative form of hormone therapy, which may be as effective or more effective than some other forms of hormone therapy in treating prostate cancer, but with fewer side-effects.\n\nThe trial was created as a multi-centre, randomised controlled trial for patients with locally advanced or metastatic prostate cancer who are initiating long-term hormone therapy. The trial uses a multi-arm multi-stage (MAMS) platform design to efficiently test a number of treatment options. The trial opened to recruitment and 2005. Initially, the effects of adding a bisphosphonate (zoledronic acid), a cytotoxic chemotherapeutic agent (docetaxel) and a cyclooxygenase (Cox-2) inhibitor (celecoxib), as single agents or combinations (arms A-F) were assessed. These were referred to as the “original comparisons”. These comparisons are now closed to recruitment and STAMPEDE is no longer collecting any further follow-up data from hospital sites. However, for the secondary aims of the trial, the applicants will obtain demographics, Civil Registration (deaths), cancer registrations, and HES data from NHS Digital. These will be used to determine the effects of trial treatments on quality-of-life, health economics, adverse effects and skeletal-related events as well as long-term overall survival, and to do associated methodological work on estimating cancer progression and the utility of routinely collected health data. \n\nThe majority of trial participants explicitly consented to the proposed data linkage. A small number explicitly dissented. The applicants have identified that there are 1585 participants, recruited between October 2005 and January 2013, for whom it is not known whether they consented to the linkages. IGARD had also agreed that the consent given at the time did not extend to these proposed data linkages. The applicants are therefore seeking support to undertake the linkages to datasets held by NHS Digital for the patients for whom consent is unknown. \n\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Institute for Cancer Research"]
["Contact Name","Professor Nicholas James"]
["Address","237 Fulham Road\nLondon\n"]
[null,"London"]
[]
["Postcode","SW3 6JB"]
["Telephone","020 7153 5130"]
["Email","nick.james@icr.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1585 participants in the STAMPEDE trial, who were recruited into the trial prior between 17 October 2005 and 01 February 2013, when consent for the linkages to routine data was not mandatory."]
["Description of confidential patient information used","Data sources\n1.\tDemographics, Civil Registration (deaths), cancer registrations, and HES data held by NHS Digital for patients in England\n2.\tThe Civil Death Registration Dataset at NHS Digital for Welsh patients\n3.\tSTAMPEDE trial data, held by University College London in the Data Safe Haven\n\nIdentifiers required for linkage:\n1.\tNHS Number\n2.\tDate of birth\n3.\tPostcode\n\nIdentifires requied for analysis:\n1.\tDate of death"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-09-28"]
["Next Review Date","2024-09-28"]
["Notes","As of 01 February 2023, NHS England replaced NHS Digital as data processor for the Personal Demographics Service (PDS), Civil Registrations (deaths), Civil Death Registration Dataset for Welsh patients, cancer registrations and HES datasets.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 28 July 2021\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2020/21 DSPT reviews for University College London – School of Life and Medical Sciences and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 28 September 2021)"]

{"sheet":"A02625","index":667,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02625"]
["Reference","21/CAG/0064"]
["Other Refs","IRAS Project ID: 280103  REC Reference: 21/WM/0121"]
["Application Title","How are assessment tools and chronologies used by health and social care professionals in England to identify child neglect?"]
["Application Summary","This application from Oxford Brookes University set out the purpose of medical research that seeks to establish how the assessment tools and chronologies undertaken by health visitors and social workers in England are used to identify child neglect. \n\nNeglect is the most prevalent form of child maltreatment in England and its identification and assessment pose significant challenges to practitioners. Tools and standardised approaches have been found to aid professionals in conducting robust and systemic analyses in cases featuring neglect, however, they are not consistently used. The study will explore the factors that influence the use of child neglect assessment tools and chronologies by health visitors and social workers in England. The extent to which these tools may mediate the quality of analysis and planning, and outcomes for children who have suffered neglect, will also be examined. \n\nThe project is comprised of two phases. Phase 2 involves semi-structured consented interviews, and is outside the scope of support sought. The first phase will explore the extent to which use of the child neglect assessment tools and chronologies impact on the quality of social work analysis and planning. The applicants will undertake a retrospective case file review of 60 case files for children and the appraisal of their health visiting case records via data linkage. The data collection will take place in Oxfordshire County Council local authority. A list will be made of all the children who were made subject to child protection plans for neglect between April 2018 and March 2019 and whose ages were 0 to 11 years (inclusive) at the time the plan was implemented. The Performance and Information Manager at the Local Authority will produce a report (R1) containing identifiable data for children meeting the inclusion criteria. This consists of Liquidlogic Children’s social care System (LCS) number, NHS number, LCS status, Name and Date of birth for the 60 children whose case files will be included in the study sample. This will be sent to the NHS direct care team at Oxford Health NHS Foundation Trust, who will undertake a check against the Carenotes system to establish which of the 60 children also have a Carenote record. A new data file is produced (R2), containing only the LCS and corresponding NHS numbers for the study sample. If any of the children do not have a Carenote record, their NHS number will be removed from R2, and it will contain their LCS number only. \n\nThe NHS Direct care team will send the datafile containing only LCS and NHS number to the CI at the University. The CI will add a unique study reference number to each patient to create R3. Data linkage between R3 and Liquidlogic, the electronic Local Authority Children’s social care database, will be undertaken by the CI at home using the LCS number, via an Oxford Brookes University laptop. She will only record pseudonymous information into a separate file for analysis. Data linkage between R3 and Carenotes, the electronic database for health visitor records, will be undertaken by the CI at the NHS Trust on a Trust PC, using the NHS number. She will only record pseudonymous information into a separate file for analysis."]
["Applicant Organisation Name","Oxford Brookes University"]
["Contact Name","Mrs Monica Duman"]
["Address","Oxford Brookes University"]
[null,"Jack Straw's Lane"]
[null,"Oxford"]
["Postcode","OX3 0FL"]
["Telephone","07879132726"]
["Email","19043359@brookes.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","60 children aged 0 - 11 who were made subject to child protection plans for neglect between 01/04/2018 and 31/03/2019\n\n24 health and social care professionals, who are outside the scope of support"]
["Description of confidential patient information used","Data sources\n\n1.\tChildren's Social Care (LA) case files (Liquidlogic electronic database for social work records- Oxfordshire County Council Local Authority Children’s Services)\n\n2.\tNHS health visiting care notes (Carenotes electronic database for health visitor records- Oxford Health NHS Foundation Trust).\n\nIdentifiers required for identification of the cohort\n\n1.\tLiquidlogic Children’s social care System (LCS) number \n2.\tNHS number\n3.\tLCS status \n4.\tName \n5.\tDate of birth\n\nIdentifiers required for linkage purposes\n\nTo link to Children's Social Care (LA) case files;\n1.\tLiquidlogic Children’s social care System (LCS) number \n2.\tunique study reference number\n\nTo link to NHS health visiting care notes;\n1.\tNHS number\n2.\tunique study reference number\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tEthnicity\n3.\tAge\n4.\tDisability status"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-10-05"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as the activity did not commence. \n\n21 December 2021 - Study temporarily paused:\nApplicant has informed CAG that the study is temporarily paused\n\nConditions of support:\n\n1.\tPlease undertake continued patient and public involvement, and present feedback to CAG at annual review. The CAG strongly recommend that this should include further opinions from children who have experienced neglect. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 July 2021\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT reviews for Oxford Health NHS Foundation Trust (RNU) and Oxfordshire County Council, Local Authority Children’s Services (608) and The Faculty of Health and Life Sciences, Oxford Brookes University (EE133864-FHLS) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 30 September 2021)"]

{"sheet":"A02626","index":668,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02626"]
["Reference","21/CAG/0131"]
["Other Refs","IRAS Project ID: 277329  REC Reference: 21/LO/0124"]
["Application Title","Confirming ongoing nasogastric tube position – an analysis of practice and outcomes between the UK and Australia "]
["Application Summary","This application from the University College London Hospital NHS Foundation Trust (UCLH), in partnership with Queensland University of Technology (QUT), set out the purpose of medical research that seeks to conduct a prospective observational chart review on hospitalised adults with Naso-Gastric Tubes (NGTs) from one Trust in the UK, to measure outcomes associated with ongoing confirmation of NGT position using pH testing. Anonymous results will then be compared with an Australian cohort to determine the difference between outcomes.\n\nThe literature to support any method of ongoing testing of NGT position is limited and of poor quality. Primary evidence is required to assess the risks and benefits of any of the available options. However, Trusts and national policies set standards for safe practice in this area, despite the lack of available evidence. Therefore, this research aims to contribute to the evidence in the field to guide policy and practice to improve patient outcomes. \n\nA feasibility study was successfully completed in May 2021. This demonstrated it was possible to extract meaningful data from patients' electronic medical records (without patient contact or consent) to address the study objectives. The method of data extraction has proven valuable during COVID as patients and clinicians do not have any additional patient contact for research purposes. As the study protocol now includes more patients and wards required to perform a fully powered study, the data collection will not all be conducted by a dietitian already involved in the patients care. Therefore the applicant requires ‘s251’ support to cover the extraction of a pseudonymised dataset for analysis by somebody who is not considered direct care team. \n\nThe ward dietitians (direct care team) will send a list of new NGT patients, to the data collector and primary researcher via secure chat in the UCLH electronic notes system. Once the patient has been included in the study, UCLH requires that patients are marked as enrolled in the study, within EPIC. Support is not required for this marker as it is within the Trust systems. Initials and identifying information regarding ward and bed number are deleted from the collected dataset post data collection. The final dataset which can be considered anonymous to the recipients, is transferred to Queensland University of Technology for analysis."]
["Applicant Organisation Name","University College London Hospital NHS Foundation Trust "]
["Contact Name","Dr Christine Elizabeth Weekes"]
["Address","University College London Hospital"]
[null,"250 Euston Road"]
[null,"London"]
["Postcode","NW1 2PG"]
["Telephone","02034479755"]
["Email","elizabeth.weekes@gstt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","120 adult inpatients requiring nasogastric tube feeding (in UCLH only)"]
["Description of confidential patient information used","Data sources\n\n1.\tUniversity College London Hospital NHS Foundation Trust; EPIC electronic patient records \n\nIdentifiers required for data collection/extraction purposes\n\n1.\tPatient initials\n2.\tPatient location (Ward)\n3.\tPatient bed number\n4.\tPatient ID (made up of the above 3 data items)\n5.\tElectronic Medical records viewed in order to extract dataset\n\nIdentifiers required for analysis purposes\n\n1.\tPatient location (Ward)\n2.\tAge in years\n3.\tGender\n\nCan be considered anonymous for disclosure to Australia"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-10-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in August 2023 that ‘s251’ support can be expired as this study is now complete and analysis is being conducted on fully de-identified data.\n\nIn terms of public benefit, the results found during this research are new to the literature.  They highlight potential patient safety concerns which have previously not been well reported in the literature.  It is a recommendation from this study that further qualitative research with consumers be conducted to determine their opinions on the outcomes identified during this study. \n\n\n1.\tThe applicant should display the patient notification poster, and this should be altered as per the descriptions above, to include updated references to CAG, and contact details for the Chief Investigator, and remove references to contacting CAG. The updated poster should be provided to CAG within one month from the date of this letter.\n\nCondition met 15 October 2021\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 July 2021 (for amendment relating to CAG application)\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT review for University College London Hospital NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 06 October 2021)"]

{"sheet":"A02627","index":669,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02627"]
["Reference","21/CAG/0126"]
["Other Refs","IRAS Project ID: 297665  REC Reference: 21/SC/0213"]
["Application Title","A retrospective cohort study to investigate body composition and survival in metastatic breast cancer"]
["Application Summary","This application from University of Southampton set out the purpose of medical research that aims to use computerised tomography (CT) scans from deceased patients with metastatic breast cancer from University Hospital Southampton NHS Foundation Trust to describe how body composition (fat and muscle distribution) changes over the course of disease and investigate the value of body composition measurements as prognostic factors for survival and response to chemotherapy.\n\nIn women diagnosed with early breast cancer, those who are obese are more likely to die earlier and have more side-effects from their cancer treatment than those who are not obese. However obesity is determined by raised body mass index (BMI) which does not take body composition, meaning the proportions of muscle, fat and bone in the body, into account. Studies in other countries have suggested that poor muscle quality is linked to shorter survival and lower muscle quantity is related to the amount of severe chemotherapy side-effects women experienced. This suggests that it may be possible to use body composition measurements to help predict how long women with metastatic breast cancer will live and how likely they are to suffer from severe treatment side effects. Few studies have looked at how body composition changes during the course of metastatic breast cancer disease. This research may help design prospective studies in metastatic breast cancer patients, including interventional studies to optimise nutritional support and chemotherapy dosing to improve oncological outcome.\n\nIdentification of potential cases for inclusion in this study will be undertaken by researchers, using University Hospital Southampton NHS Foundation Trust electronic clinical records, including the Southampton Breast Cancer Database. This database allows filtering of patients by diagnosis and disease/alive. Therefore only the filtered deceased patients' clinical data will be screened by researchers using hospital electronic records to clarify if patients meet the study inclusion and exclusion criteria. A pseudonymous identifier will be applied to each individual, and a key linking the pseudo ID to hospital number and initials will be retained by the direct care team at the Trust. A researcher will have access to the key until it is deleted after 2 years. Routine CT images will be viewed in anonymised format at an NHS radiology workstation within University Hospital Southampton and the images will be analysed using \"SliceOMatic\" software. All patient identifiable data will remain within the University Hospital Southampton electronic systems and server and only pseudonymous data will be transferred to the University of Southampton"]
["Applicant Organisation Name","University of Southampton"]
["Contact Name","Dr Ellen Copson "]
["Address","University of Southampton and University Hospital Southampton,"]
[null,"Cancer Research UK Clinical Centre"]
[null,"Somers Cancer Research Building, MP 824 Southampton General Hospital, Southamton"]
["Postcode","SO16 6YD "]
["Telephone","07967187272"]
["Email","E.Copson@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","300 women diagnosed with metastatic breast cancer at Southampton University Hospital between 2012 and 2021 who have subsequently died 1st September 2021."]
["Description of confidential patient information used","Data sources\n\n1.\tUniversity Hospital Southampton NHS Foundation Trust clinical records including;\n\n•\tSouthampton Breast Cancer Database\n•\tE-docs (clinic letters)\n•\tElectronic medical records\n•\tPACS (electronic radiology system) CT scans\n•\tARIA chemotherapy prescribing system records of chemotherapy prescriptions\n\nIdentifiers required for patient identification and to extract a pseudonymous dataset\n\n1.\tHospital ID\n2.\tDate of death\n\nMedical records will be viewed in order to extract a pseudonymous dataset\n\nIdentifiers required for analysis purposes\n\nNo identifiers required for analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-10-11"]
["Next Review Date","2024-10-11"]
["Notes","Amendment supported 25 May 2023 to extend the duration of ‘251’ support until October 2024\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 12 July 2021\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT review for University Hospitals Southampton NHS Foundation Trust was confirmed as ‘Standards Not Fully Met, Plan Agreed’ on the NHS Digital DSPT Tracker (checked 28 September 2021). Please note the updated specific condition of support below.\n\nUniversity Hospitals Southampton NHS Foundation Trust should achieve the security assurance action plan as agreed with NHS Digital.  All staff involved in processing information under this application reference should be aware of the precise scope of support and its boundaries and have successfully completed local security awareness training before processing any information under support."]

{"sheet":"A02628","index":670,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02628"]
["Reference","20/CAG/0112"]
["Other Refs","IRAS Project ID:  277114 REC Reference: 20/LO/1279"]
["Application Title","Ethnic Density and Psychosis in a British Pakistani Population: an investigation using data from the East Lancashire Early Intervention Service"]
["Application Summary","This application from the University of Liverpool set out the purpose of medical research that seeks to determine whether living in areas with a higher proportion of one’s own ethnic group protects against the risk of developing psychosis in British Pakistani groups in a region of Northern England. \n\nEthnic minority groups have an elevated risk of developing psychosis. However, it has been found that living in areas with a higher proportion of one's own ethnic minority group (ethnic density) protects against this risk, described as the ethnic density effect. Contrary to other ethnic groups, survey studies have indicated an absence, or potentially a reversed effect, of increased ethnic density on risk of psychosis for Pakistani groups in the UK. These findings are currently preliminary, and past studies have been limited by unreliable, self-report questionnaire measures of clinical diagnosis. The applicants aim to test the ethnic density effect in British Pakistani populations, using more clinically reliable data collected by the East Lancashire Early Intervention Service (ELEIS). The service accepts referrals for those experiencing psychosis for the first time (or are within their first three years of treatment).\n\nSecondary data, collected by the NHS trust as part of routine practice, will be used. Full postcodes for patients are required in order to accurately estimate geographical variables consisting of area ethnic density and neighbourhood social deprivation. These variables will be generated by matching postcodes to both Census Area Statistic (CAS) Wards and also the more detailed Lower Super Output Area (LSOA), using 2001 and 2011 UK census data."]
["Applicant Organisation Name","University of Liverpool "]
["Contact Name","Dr Ross White"]
["Address","University of Liverpool"]
[null,"Liverpool"]
[]
["Postcode","L69 7ZA"]
["Telephone","0151 794 5532"]
["Email","rgwhite@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 14 and 65 years of age, referred to ELEIS with psychosis, or at high risk of psychosis, residing or registered with a GP in the selected districts, presenting with psychotic symptoms for the first time (or are in their first three years of treatment). \n\nData for referrals between 2005 and 2020 will be analysed.\n\nThe applicants anticipate that 1500 patients will be involved. "]
["Description of confidential patient information used","Data sources\n\n1.\tEast Lancashire Early Intervention Service (ELEIS) at Lancashire & South Cumbria NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tPostcode – unit level\n2.\tGender \n3.\tEthnicity\n4.\tAge at time of referral"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-09-24"]
["Next Review Date"]
["Notes","Applicant confirmed April 2023 that ‘s251’ support can be expired, as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the findings from the study have demonstrated that Pakistani people in East Lancashire have elevated incidence rates of first episode psychosis in comparison to the white majority population. It was also found that, for Pakistani people, living in areas of low ethnic density (where the local neighbourhood has a low proportion of Pakistani residents) increases this risk of developing psychosis. These findings have highlighted the importance of social context in the development of psychotic disorders, which are highly disabling and are associated with high burden as well as financial costs. It is hoped that dissemination of the findings will inform policy and clinical practice, with the goal of improving mental health outcomes for Pakistani people. \n\n17 February 2022 - Amendment supported:\nAmendment supported to change the Chief Investigator from Dr Ross White to Dr Victoria Vass, and to extend the duration of support until 30 September 2022.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 07 January 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tConfirmed:\n\n•\tUniversity of Liverpool has a confirmed ‘Standards Met’ grade on DSPT submission 2020/21 by NHS Digital. \n\n•\tEast Lancashire Early Intervention Service (ELEIS) at Lancashire & South Cumbria NHS Foundation Trust has a confirmed ‘Standards Met’ grade on DSPT submission 2020/21 by NHS Digital."]

{"sheet":"A02629","index":671,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02629"]
["Reference","21/CAG/0120"]
["Other Refs","IRAS Project ID: 281705  REC Reference: 21/WA/0282"]
["Application Title","NHS England Hepatitis C Virus Case Finding in Primary Care Pilot (HepCAPP)"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research that seeks to establish the acceptability of wide-scale HCV screening of general public through primary care.\n\nApproximately 100,000 people in England have chronic Hepatitis C Virus (HCV) infection. Over 85% of these infections were acquired via intravenous drug use. Due to the recent development of Direct Acting Antivirals (DAA), chronic HCV can now be cured in over 95% of patients. Targeted case-find using risk markers for HCV has recently shown to be effective. However, people infected with HCV but who have no history of intravenous drug use recorded on their history, may have been missed. The applicants will test the acceptability of wide-scale HCV screening of the general public, conducted via primary care services, to inform whether the intervention should be rolled-out nationwide. The applicants will invite patients aged 40-64 years of age who are registered at participating GP practices to have a HCV test using an Oral Fluid swab home testing kit. Patients will be informed of their result and will be followed up accordingly if they have a positive result. \n\nApproximately 30 practices across Bristol, South-West London and Leeds will be invited to take part in the study. The participating GP practices will run a search on their Electronic Medical Records to create a list of eligible patients. This list will be sent to Public Health England Laboratories. PHE will then send potential participants a study invitation letter via post. If patients would like to participate, they are directed to a web link and a QR code. This will take them to the study participant information leaflet and e-consent form. One reminder letter will be sent. 2-3 weeks after completing the study E-consent form, participants will receive the Oral Swab home testing kit via post. "]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Matthew Hickman"]
["Address","Population Health Sciences"]
[null,"Bristol Medical School"]
[null,"Canynge Hall, 39 Whatley Rd, Bristol"]
["Postcode","BS8 2PS"]
["Telephone","00 44 117 428 4012"]
["Email","matthew.hickman@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 40 and 64 years of age who are registered at one of the participating GP practices. \n\n100,000 patients will be contacted. The applicants anticipate that 1 in 10 will consent and that 10,000 patients will be included in the final cohort. "]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic medical records at participating GP surgeries\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tGP registration\n4.\tDate of birth\n5.\tUnit level postcode and full postal address\n\nIdentifiers required for analysis purposes\n\n1.\tName\n2.\tDate of birth\n3.\tPostcode – unit level"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-10-08"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed march 2023 that application can be expired as all confidential patient information has been deleted. \n\nIn terms of public benefit, the study used the unconsented identifiable patient data in order to invite patients at registered GP practices the opportunity to take part in a Pilot Oral Swab Hepatitis C screening study. The results will inform whether the screening program can or should be rolled out nationally by NHS England and if it is cost effective. \n\n20 January 2023 - change in data processor from Public Health England (PHE) to the UK Health Security Agency (UKHSA) (for the purposes of contacting eligible patients to seek consent).\n\nAmendment supported 24 October 2022 \nTo remove the sending of the reminder letter from the application, and include changes to the associated patient notification materials\n\n08 June 2022 - Amendment supported\nAmendment supported to include the West Yorkshire and Humber Clinical Research Network as a data processor.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 September 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2020/21 DSPT review for the University of Bristol and Public Health England were confirmed (tracker checked 08 October 2021)."]

{"sheet":"A02630","index":672,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02630"]
["Reference","21/CAG/0135"]
["Other Refs","IRAS Project ID: 291686   REC Reference: 21/EM/0217"]
["Application Title","Clinical management of Patients with Malignant Bowel Obstruction: A Multi-centre retrospective Cohort Study"]
["Application Summary","This application from the University of Hull set out the purpose of medical research that seeks to describe the presentation, management and outcomes of those admitted to hospital with Malignant Bowel Obstruction and identify predictors of better outcomes.\n\nMalignant Bowel Obstruction (MBO) is a common, distressing complication of bowel, gynaecological and other cancers. It causes severe pain, intractable nausea and vomiting, anorexia and death. It has a profound effect on patients’ quality of life and involves repeated and prolonged hospitalisation for persistent and unresolved symptoms. Numerous management options are possible, from surgery or stenting to less invasive approaches such as medication or tube-drainage of intestinal contents. Each patient’s situation is unique, making clinical decision-making difficult. Surgery gives the best option for longer-term survival in the “right” patients, but there are currently no nationally agreed guidelines and practice varies widely nationally. Non-surgical palliative approaches for inoperable MBO (IMBO) usually involve administration of a combination of parenteral antiemetics and anti-secretory agents, yet the evidence is inconclusive regarding their effectiveness. Tailored treatments may benefit individuals, but there is little guidance to support clinicians and patients in decision-making. Two other therapeutic options for the management of MBO are available; venting gastrostomy (VG) and parenteral (intravenous) nutrition (PN). Limited evidence is available regarding their use or to inform clinical decision making. \n\nThe applicants will undertake a historical cohort study of patients who were admitted to two hospitals, Hull University Teaching Hospital NHS Trust and Leeds Teaching Hospitals NHS Trust. Patients with a diagnosis of malignant bowel obstruction will be identified via hospital coding by business intelligence teams at the two trusts. Patients will then be followed from the time of those records to the present day or the patient’s death. The research team will then access patient records in order to extract an anonymised dataset. "]
["Applicant Organisation Name","University of Hull"]
["Contact Name","Mr Michael Patterson"]
["Address","Hull York Medical School"]
[null,"Allam Medical Building"]
[null,"University of Hull"]
["Postcode","HU7 6RX"]
["Telephone","07872302504"]
["Email","michael.patterson@hyms.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over, diagnosed with cancer and bowel obstruction, who were admitted to Hull University Teaching Hospital NHS Trust and Leeds Teaching Hospitals NHS Trust between 01 January 2019 to 31 December 2020. \n\nThe applicants anticipate that 350 patients will be recruited. "]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic and paper patient records at Hull University Teaching Hospital NHS Trust and Leeds Teaching Hospitals NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tHospital ID number\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tEthnicity\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-10-15"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete. \n\nIn terms of public benefit, the expansion of knowledge regarding an under-researched topic would not have been possible with ‘s251’ support.\n\n\nSpecific conditions of support \n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 October 2021\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2020/21 DSPT review for Hull University Teaching Hospitals NHS Trist and Leeds Teaching Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 08 October 2021)."]

{"sheet":"A02631","index":673,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02631"]
["Reference","21/CAG/0127"]
["Other Refs","IRAS Project ID: 292632   REC Reference: 05/Q1604/70"]
["Application Title","The Oxford Vascular Study: a population-based study of the incidence and outcome of stroke, transient ischaemic attack, acute coronary syndromes and peripheral vascular events\nShort title: OxVasc"]
["Application Summary","This application from University of Oxford sets out the purpose of medical research that seeks to determine the incidence and case-fatality of stroke, transient ischaemic attack (TIA), acute coronary syndromes (ACS) and acute peripheral vascular events (PVE) in the same population at the same time. The Oxford Vascular Study (OxVasc) is a single centre, population based consented study which has been recruiting since 2002. \n\nThe applicants had been receiving long term health outcome data from HSCIC for some of the cohort, however they have not received any since 2016. In 2020, NHS Digital determined that the consent materials used by the study were not valid for the requested processing, and therefore the legal basis to supply the relevant information is no longer clear, under common law. NHS Digital recommended that ‘s251’ support be obtained to process data for participants that are either deceased, no longer in regular contact with the study, lacking capacity to understand new information about the study, or otherwise unable to consent. However, as the applicants are not planning to re-consent every participant from prior to June 2020, ‘s251 support is required to provide a legal basis for linkage under common law, for the entire cohort, with the exception of those who are fully re-consented. Since June 2020, all OxVasc participants now receive the study Privacy Notice, and the linkage is undertaken with consent as the legal basis for processing.  \n\nIt is an important part of the OxVasc study design to receive comprehensive follow-up of long term health outcomes and all-cause mortality, and therefore data linkage with NHS central health records (NHS Digital) is essential. By developing a high-quality epidemiological evidence-base the applicants hope to better target preventive treatment.\n"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Peter Rothwell"]
["Address","NDCN, University of Oxford\n"]
[null,"Wolfson Centre for Prevention of Stroke and Dementia"]
[null,"Wolfson Building, John Radcliffe Hospital, Headley Way, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865611260"]
["Email","peter.rothwell@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Previously consented OxVasc patients, prior to June 2020: Any adult over 18 years of age diagnosed with stroke, transient ischaemic attack, acute coronary symptoms or a peripheral vascular event registered with a collaborating GP within the catchment of the John Radcliffe Hospital, at the time of their first acute vascular event\n\nApril 1st 2002 – 2016 (cohort already flagged with NHS Digital) – 9000 patients\n\n2016 – June 2020 (cohort not yet flagged with NHS Digital) around 400 patients annually \n\nCAG support would not extend to those who have been fully reconsented."]
["Description of confidential patient information used","Data Sources: \n1. University of Oxford OxVasc database \n2. NHS Digital – \n•\tHospital Episode Statistics (HES) \n•\tONS Mortality data \n•\tCancer registration data \n\nIdentifiers required for linkage:\n1.\tFirst and last name, \n2.\tDate of birth, \n3.\tNHS number \n4.\tUnique Oxvasc participant number\n\nIdentifiers required for analysis:\n1.\tDate of death \n2.\tUnique Oxvasc participant number\n\nOther data items are retained for analysis with consent as the legal basis\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-10-21"]
["Next Review Date","2024-10-21"]
["Notes","31 October 2023 - change in data processors from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES), Civil Registration Mortality data, and Cancer registration data\n\nAmendment supported 23 August 2022 - an administrative change to remove University of Oxford - Medical Sciences Division - Nuffield Department of Population Health (ODS EE133863-MSD-NDOPH-NDPH) as a data processor, and replace with University of Oxford –Medical Sciences Division (ODS 8HM11)\n\nSupported 21 October 2021:\nConditions of support:\n\n1.\tSupport is provided for five year in the first instance, and this should be extended with a duration amendment when required.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: Favourable Opinion of substantial amendment relating to the CAG application (IRAS ID 292632) 02 September 2021.\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT reviews for University of Oxford - Medical Sciences Division - Nuffield Department of Population Health and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 05 October 2021)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02632","index":674,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02632"]
["Reference","21/CAG/0058"]
["Other Refs","IRAS Project ID: 291149  REC Reference: 21/SW/0068"]
["Application Title","Evaluation of Homeless Health Peer Advocacy: an analysis of secondary data\nShort title: HHPA evaluation: Secondary analyses of Hospital Episodes Statistics"]
["Application Summary","This application from the London School of Hygiene & Tropical Medicine & University \nCollege London (as joint data controllers) sets out the purpose of medical research that \nseeks to explore how the homeless health peer advocacy (HHPA) intervention affects\nhomeless peoples’ use of health services. The applicants are proposing using a \nretrospective cohort of homeless adults who used an NHS hospital in London, and \ncomparing the frequency of hospital use over 12 months between HHPA clients and \ncontrols. The research team has an ongoing mixed-methods consented research project \n(IRAS 271312) to evaluate the effect of HHPA, however Covid-19 related restrictions \nhave caused the consented study to be halted. Applicants therefore propose this\nalternative design in order to meet the evaluations objectives.\n\nPeople experiencing homelessness suffer extreme health inequalities. The health care \ncosts of people who are homeless are estimated to be 8 times higher than the general \npopulation. Groundswell, a third sector organisation, have pioneered HHPA among \nhomeless populations in London, a model that is being adapted by others. Peer \nadvocates who themselves have experience of homelessness provide one-to-one\nsupport to attend health care appointments, which could be an acceptable, effective and \ncost-efficient intervention. However there is limited evidence showing the impact of \nHHPA on health service utilisation and other health and social outcomes. Further \nevidence would facilitate development and scale-up of the intervention among homeless \nand other vulnerable populations in London and elsewhere.\n\nGroundswell’s HHPA data manager will identify the last 150 new clients who received \nsupport from a peer advocate to attend an outpatient appointment prior to 1st March \n2019 as intervention participants. Their confidential patient information will be collected \n(Name, NHS number, hospital ID, Date of birth, postcode (district level), sex, Nationality and ethnicity), alongside their HHPA start date. A Unique ID number is assigned by \nGroundswell’s HHPA data manager, and the identifiable dataset is disclosed to NHS \nDigital in order for NHS Digital to link the details with the Personal Demographic Service \n(PDS) to locate any outstanding NHS numbers. NHS Digital will then undertake linkage \nof the intervention cohort to Hospital Episode Statistics (HES) records for the 12 months \nprior to and after their HHPA start date. NHS Digital then removes identifiers and \ndiscloses the linked dataset alongside the Unique ID back to applicants at UCL Data \nSafe Haven (DSH). Groundswell will also disclose a pseudonymised dataset linked to \nUnique ID to the UCL DSH in order for the applicants to be able to link this to the \npseudonymised HES-linked dataset that is returned by NHS Digital, using the Unique ID.\nFor comparison participants, applicants will request NHS Digital to identify from the HES \ndatabase 1000 adults aged 25 or more who had hospital-based care in London between \nMarch 2018 and March 2019 and who are likely to be homeless. People who have opted \nout or those who are HPPA clients are excluded, and other exclusions are listed in the \napplication. The comparison participants HES records are requested for the 12 months \nprior to their first hospital visit in this time span, and for 12 months after. Identifiers are \nremoved from this dataset by NHS Digital, and disclosed to the applicants at UCL. "]
["Applicant Organisation Name","London School of Hygiene & Tropical Medicine"]
["Contact Name","Professor Lucy Platt, Professor of Public Health Epidemiology"]
["Address","London School of Hygiene & Tropical Medicine\n"]
[null,"15-17 Tavistock Place, London\n"]
[]
["Postcode","WC1E 7SH"]
["Telephone","07811375123"]
["Email","lucy.platt@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All participants will be:\n• aged 25 years or older, and\n• Homeless, per UK government definition\n• Had hospital-based health care in London between March \n2018 to March\n2019.\n150 intervention participants;\nThe last 150 newly-enrolled HHPA clients who received \nsupport from a peer advocate to attend an outpatient \nappointment prior to 1st March 2019. (HES records linked 12 \nmonths prior and 12 months after start of HHPA enrolment)\n1000 control participants identified by NHS Digital \n(HES records linked 12 months prior and 12 months after first \nhospital visit)"]
["Description of confidential patient information used","Data Sources:\n1. Groundswells HHPA database\n2. Personal Demographics Service (PDS) (to find any \nmissing NHS numbers) - NHS Digital\n3. Hospital Episode Statistics (HES) - NHS Digital \n\nIdentifiers required for linkage:\nData items sent by Groundswell to facilitate linkage with PDS:\n1. Name (first name, surname, aliases)\n2. NHS number \n3. Hospital admission date\nPage 4 of 10\n4. Hospital of admission\n5. Date of birth, \n6. postcode (district level), current and previous\n7. Nationality, \n8. Ethnicity\n9. Sex\n10. Unique ID number\n(HHPA start date additionally sent)\nNHS Digital will then use the NHS number to link with the \nHES database\n\nIdentifirs required for analysis:\n1. Ethnicity\n2. Nationality (converted to WHO region of birth)\n3. Gender\n4. Postcode (district level)\n5. Age\nThis dataset can be considered anonymous to the applicant"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-10-25"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as the activity was never able to commence.\n\nAmendment supported 16 January:\nTo amend the inclusion criteria for the intervention group as follows;\n•\tto include \"significant interactions\" with HHPA\n•\tspecify a recruitment period of 1st April 2018 - 31st March 2019 and removing the upper limit of 150 individuals\n•\tExpanding the age range to 18 years and above (rather than 25 years and above)\n\nAnd to amend the inclusion criteria for the comparator group as follows;\n•\tExpanding the age range to 18 years and above (rather than 25 years and above)\n•\tTo include individuals whose postcodes are a known, residential homelessness hostel during the recruitment period (March 2018 to 2019)\n•\tTo include people with an appointment recorded irrespective of attendance\n\n\nsupported 25 October 2021 - Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 3 June 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT equivalent review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 05 October 2021)\n\nThe NHS Digital 20/21 DSPT review for Groundswell (8J114) was confirmed as ‘Standards Met’ (by email to the CAG inbox 25 October 2021)"]

{"sheet":"A02633","index":675,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02633"]
["Reference","20/CAG/0056"]
["Other Refs","IRAS Project ID: 268410  REC Reference: 10/H1010/70"]
["Application Title","PEARL s251 Sensitive Health Records Template (Maternal smoking during pregnancy and intellectual disability)"]
["Application Summary","This application from University of Bristol set out the purpose of medical research that seeks to investigate whether maternal smoking during pregnancy is associated with intellectual disability in children.\n\nTobacco use during pregnancy has been shown to influence foetal brain development and has also been associated with intellectual disability. It is unclear whether this link is causal or not. The applicants will use a variety of statistical techniques with the aim of improving understanding of linkage between tobacco use in pregnancy and intellectual disability in children. The smoking behaviour of mothers and fathers will be compared, and genetic methods used to determine causality. These analyses will be undertaken in several large population-based birth cohorts, including the Avon Longitudinal Study of Parents and Children (ALSPAC) and sibling designs in other cohorts, to seek better understanding of the non-genetic causes of intellectual disability.\n\nThe applicants seek support to process confidential patient information from GP records, NHS Digital (HES data, the Mental Health Services Data Set) and data from the Avon and Wiltshire Mental Health Partnership, in line with ALSPAC’s existing approval.\n\nALSPAC wish to:\n\n•\tIf the required sensitive data has already been collected through a previous project specific s251 support, repurpose the data for this purpose, in order to reduce flow of confidential information.\n•\tFor data not already collected though a previous project specific s251 support, request data from GP providers, NHS Digital and Avon and Wiltshire Mental Health Partnership using existing processes.\n\nThe data will then combined/anonymised by the ALSPAC team within UKSeRP (hosted by the University of Swansea but managed by ALSPAC staff). ALSPAC staff will then make the anonymised combined data available to the research team for this project.\n\nA recommendation for class 1 and 4 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Mark Mumme (ALSPAC Data Linkage Manager)"]
["Address","ALSPAC, Oakfield House, Oakfield Grove, Bristol, "]
[]
[]
["Postcode","BS8 2BN"]
["Telephone","0117 3310033"]
["Email","mark.mumme@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All people enrolled in ALSPAC, excluding those who have explicitly withdrawn from the study, declined consent to linkage to their health record, have not received ALSPAC fair processing information or have consented to data linkage.\n\nOf the 15,000 ALSPAC participants, around 5500 have consented to data linkage and are not part of this request for support."]
["Description of confidential patient information used","Data sources:\n1.\tNHS Digital (HES and MHSDS data)\n2.\tGP software providers \n3.\tAvon and Wiltshire Mental Health Partnership NHS Trust \n\nIdentifiers for linkage:\n1.\tNHS Number\n2.\tDate of birth\n3.\tDate of death\n\nIdentifers for analysis:\n1.\tGender\n2.\tDate of Birth will be used (by ALSPAC) to derive 'Age at Event' (expressed in days, minutes, seconds) and time intervals. This allows ALSPAC to provide information to researchers in event sequence order without disclosing Date of Birth or event date."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2020-09-17"]
["Next Review Date","2024-09-17"]
["Notes","Application supported 17 September 2020. Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed February 2011\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital DSPT review for University of Bristol, The Phoenix Partnership and the EMIS Group was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 10 May 2020). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02634","index":676,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02634"]
["Reference","21/CAG/0095 "]
["Other Refs","IRAS Project ID: 289144  REC Reference: 21/WM/0150"]
["Application Title","IMplementation of the Preterm Birth Surveillance PAthway: a RealisT evaluation (including a realist literature scope)"]
["Application Summary","This application from King’s College London set out the purpose of medical research that seeks to identify and understand the features of successful and unsuccessful implementation of the Preterm Birth Surveillance Pathway (PBP). \n\nIn the UK, 1 in 13 babies are born pre-term, defined as before 37 weeks of pregnancy. Currently, women at risk of preterm birth receive different care depending on the hospital they’re treated at. Some women are offered specialist care in a preterm birth prevention clinic, however many do not receive any specialist care. NHS England has published some guidance on how to standardise care across the UK and this new guidance has developed a pathway called the Preterm Birth Surveillance Pathway (PBP). This pathway states that midwives should assess every pregnant woman for the risk of having a preterm birth by asking questions about her medical history and determining whether she is at high, intermediate or low risk of a preterm birth. If a woman is assessed as being at high or intermediate risk that she should be referred to a special preterm birth prevention clinic. These clinics can offer additional tests and, depending on the results, decide which women may need further help, such as admission to hospital to help prevent the preterm birth. \nThe applicants will investigate to what extent and in what contexts the PBP is implemented through a realist evaluation, including a realist literature scope (a theory-driven and interpretive type of literature review). The guidance recommending the PBP was published in March 2019 and maternity providers should have implemented this by April 2020. The applicants seek to undertake this research as hospitals begin implementation in order to track the intended and unintended outcomes of pathway implementation, explore implementation facilitators and barriers so sustainability of the pathway is likely, and develop theories on how to improve implementation at different hospitals. A set of recommendations for improving the implementation of the PBP can then be provided. \n\nHospital staff at participating trusts will access confidential patient information within their IT system and remove patient names and all records for patients who have opted-out. Members of the research team from King’s College London, who are not members of the direct care team, will then access the data onsite, under the supervision of a member of the sites’ local team in order to pseudonymise the data. The hospital staff will be provided with a record that links the personal information to study participant information number, used to identify duplicated entries and allow data checking/validation. This will be kept locally only on secure NHS servers. Pseudonymised data will be sent securely centrally to King's College London through an established NHS electronic network. Linkage of different datasets will be done centrally based in the study participant information number. \n\nThe applicants will also conduct interviews with staff members and patients at each site. Patients will be identified and approached by the clinical care team. Observations of patient care will also be undertaken by the direct care team. The researchers will only have access to confidential patient information for patients who have consented to the sharing of their information.  This is outside the scope of the support sought. \n\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application.\n"]
["Applicant Organisation Name","King’s College London "]
["Contact Name","Professor Jane Sandall, Professor of Social Science and Women's Health"]
["Address","Dpt Women and Children's Health, 10th Floor, North Wing, St Thomas' Hospital, "]
[null,"Westminster Bridge Road\n\n"]
[null,"London"]
["Postcode","SE1 7EH"]
["Telephone","07713743150"]
["Email","jane.sandall@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women who booked their pregnancy between 1st March 2018 – 31st October 2021 at the three participating trusts. 60,900 patients will be included in the data collection. \n60 participants in total, half staff and half patients, will be included in the interview arm, which is outside the scope of support. "]
["Description of confidential patient information used","Data sources:\n1.Patient records at:\na.\tLeeds Teaching Hospitals NHS Trust\nb.\tHomerton University Hospital NHS Foundation Trust \nc.\tYeovil District Hospital NHS Foundation Trust\n\nIdentifiers requried for linkage:\n1.\tNHS Number\n2.\tHospital ID number\n3.\tDate of birth\n\nIdentifiers requried for analysis:\nNo identifiers will be retained for analysis.  "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-11-08"]
["Next Review Date","N/A"]
["Notes","The applicant confirmed in October 2022 that ‘s25’1 support could be expired as the aspect of the study that required CAG is no longer feasible to undertake. Therefore, this data will not be collected or analysed. \n\nSupported 08 November 2021. Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 30 June 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information Confirmed: \n\nThe NHS Digital 2020/21 DSPT reviews for Leeds Teaching Hospitals NHS Trust and Homerton University Hospital NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (27 July 2021).\n\nThe NHS Digital 2020/21 DSPT review for Yeovil District Hospital NHS Foundation Trust was confirmed as ‘Standards Met’ by email to the CAG inbox (05 November 2021)."]

{"sheet":"A02635","index":677,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02635"]
["Reference","21/CAG/0097 "]
["Other Refs","IRAS Project ID: 296508  REC Reference: 21/EE/0166"]
["Application Title","PARADISE: Predicting AF after Cardiac Surgery - A Clinical Prediction Rule for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to develop and validate two prognostic models to predict post-operative atrial fibrillation after cardiac surgery.\n\nAtrial Fibrillation (AF) after cardiac surgery (AFACS) is the most common complication following cardiac surgery, with an incidence between 30% and 50%. Around 35,000 patients undergoing cardiac surgery in the UK every year. AFACS is strongly associated with adverse patient outcomes, longer hospital and ICU stays, increased risk of stroke, increased risk of developing long-term AF, with associated complications and need for anticoagulation, and increased all-cause 30-day and 6-month mortality. Interventions that reduce the incidence of AFACS would have a substantial impact both on patient outcomes and cost. Current evidence therefore indicates that AFACS itself contributes to poor patient outcomes following cardiac surgery, and that tools to predict, prevent and guide treatment of AFACS are needed. There is no widely accepted prediction model currently, that reliably allows clinicians to determine the risk of a patient developing AFACS, despite multiple efforts over the past 15 years to develop one. The lack of effective pre and immediate post-operative prediction models for estimating AFACS risk has prevented the implementation of AF prophylaxis protocols. Interventions to prevent AFACS lead to decreased hospital length of stay, lower costs of hospital treatment, and decreased risk of postoperative stroke.\n\nThis is an international, multi-centre retrospective cohort study of patients who have undergone cardiac surgery. Two prognostic models will be developed, PARADISE-1 and PARADISE-2. PARADISE-1 will be conducted in the pre-operative assessment clinic and PARADISE-2 in the post-operative care unit. Both models will then be externally validated on prospectively collected data from two large UK centres and one UK clinical trial. The predictive models will be developed using data from the CALIBER and PARTNERS research databases, for which existing ethical approvals are in place. The models will be externally validated on data collected as part of the Tight-K study and the Brigham and Women’s CABG Genomics Database in the United States. Consent from participants in the Tight-K study has already been sought to use their data for related research. The applicants will apply for separate ethical approvals to use Brigham and Women’s CABG (Coronary Artery Bypass Grafting) Genomics Database. The applicants will also use prospective data collected at The Liverpool Heart & Chest Hospital (LHCH) and Barts Heart Centre (BHC) to carry out validation. Data from all study databases/sites will be de-identified prior to secure transfer to Oxford. \n\nThe applicants are seeking support to allow staff outside the direct care teams at LHCH and Barts Health NHS Trust to process confidential patient information in order to identify the study cohort and to compile a dataset containing information from multiple routinely-collected data sources. Confidential patient information will also be disclosed from LHCH and Barts Health NHS Trust to NHS Digital in order for the National Data Opt-Out to be applied. Pseudonymised data only will be disclosed from LHCH and Barts Health to the research team at the Nuffield Department of Clinical Neurosciences. Pseudonymised information will also be shared from the Tight-K trial, and the Brigham and Women’s CABG Genomics Database and PARTNERS study in the United States to the Nuffield Department of Clinical Neurosciences. \n\nA recommendation for class 1, 2, 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Peter Watkinson"]
["Address","Kadoorie Centre for Critical Care Research and Education, \n"]
[null,"Nuffield Department of Clinical Neurosciences,\n"]
[null,"Oxford \n"]
["Postcode","OX3 9DU"]
["Telephone","01865231448"]
["Email","ccrg.research@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 18 years and over who were admitted to hospital for any cardiac surgery. \n\nThe scope of support extends to 12,000 patients treated at LHCH and BHC, treated between 1st January 1998 to 31st December 2020, for the retrospective cohort and the 1st July 2021 to 31st July 2023 for the prospective cohort. "]
["Description of confidential patient information used","Data sources:\n1.Electronic patient records held at the Liverpool Heart and Chest NHS Foundation Trust\n2.Electronic patient records at Barts Health Centre at Barts Heath NHS Trust. \n3.Pseudonymised data from:\na.\tThe Tight-K study at Barts Health NHS Trust,\nb.\tThe CALIBER study at University College London,\nc.\tThe Brigham and Women’s CABG Genomics Database, Brigham and Women’s Hospital, USA,\nd.\tThe Partners Research Database (PRD), USA.\n\nIdentifiers required for linkage:\n1.\tName\n2.\tNHS Number\n3.\tHospital ID number\n4.\tDate of birth\n5.\tPostcode – unit level\n\nIdentifers requreid for analysis:\n1.\tPostcode – district level\n2.\tAge\n3.\tGender \n4.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-11-09"]
["Next Review Date","2024-11-09"]
["Notes","16 May 2022 - Amendment supported\nAmendment supported to include Oxford University Hospitals NHS Trust as an additional site.\n\nApplication supported 09 November 2021. Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 25 August 2021. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n•\tThe NHS Digital DSPT review for Nuffield Department of Clinical Neurosciences, University of Oxford for 2020/21 was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 05 November 2021).\n\n•\tThe NHS Digital DSPT review for Barts NHS Trust for 2019/20 was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 05 November 2021).\n\n•\tThe NHS Digital DSPT review for Liverpool Heart and Chest NHS Foundation Trust for 2020/21 was confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 05 November 2021).\n"]

{"sheet":"A02636","index":678,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02636"]
["Reference","21/CAG/0160"]
["Other Refs","IRAS Project ID:   REC Reference: "]
["Application Title","Secondary/additional findings in the 100,000 Genomes Project: disease manifestation, impacts on recipients and healthcare utilisation "]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to develop understanding of the correlation of specific additional findings (AF) with clinical and family history relevant to health condition associated with AF, and clinical follow up and clinical outcomes relating to specific AF following disclosure.\n\nWhole genome sequencing (WGS) is a powerful, recently developed technology that allows the simultaneous analysis of vast amounts of genetic information, with the potential to define and understand the genetic changes that have lead to disease development. In the Genomics England 100,000 Genomes Project, the primary use of WGS was to identify the precise genetic changes associated with currently manifested disease. It is also possible that WGS could be used to identify genetic changes that may be associated with risk of future disease development or unexpected disease. Such variants have been termed “secondary” or “additional” findings, and it is currently unclear how such information should be managed. Analysis of the benefit and harms of WGS needed to be carried out in order to information discussions on whether genome variants that may identify pre-disposure to future or asymptomatic disease should be disclosed to patients and/or participants. \n\nNHS England has established several Genomic Medicine Service Alliances (GMSA) to deliver genomic medicine in the NHS, including legacy activities of the 100,000 Genome Project, such as reporting of AF to the patient participants. This study will focus on patients in the South Central GMSA, which covers the West Midlands, Oxford and Wessex, and represents around one fifth of participants recruited. The trusts included in the South Central GMSA are Oxford University Hospitals NHS Foundation Trust, Birmingham Women’s and Children’s Hospitals NHS Foundation Trust, University Hospitals Birmingham, University Hospitals Southampton Hospitals NHS Foundation Trust. Confidential patient information is collected by clinical personnel and stored in patient records as part of clinical care. The SAFE study team, up to 3 researchers who are not members of the direct care team, will access this information for 12 months after disclosure. The information will be collected either remotely or by visiting trusts, if remote access is not possible. The researchers will enter the required information onto a CRF. Patients will be identified by a study code only, so that the information will be pseudonymised for research storage and processing. The pseudonymised information will be stored on a database held securely by the University of Oxford. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Elizabeth Ormondroyd, Senior Researcher"]
["Address","University of Oxford"]
[null,"RDM, Level 6, West Wing"]
[null,"John Radcliffe Hospital, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","07812391582"]
["Email","liz.ormondroyd@cardiov.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","400 patients recruited to the 100,000 Genome Project within the South-Central Genomic Medicine Service Alliances (GMSA) and who were informed by the NHS that they have an AF in their sample."]
["Description of confidential patient information used","Data sources:\n1. South Central Genomic Medicine Service Alliances, which is comprised of the following NHS Trusts:\na. Oxford University Hospitals NHS Foundation Trust\nb. Birmingham Women’s and Children’s Hospitals NHS Foundation Trust \nc. University Hospitals Birmingham NHS Foundation Trust\nd. University Hospitals Southampton Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n6. Postcode – district level\n\nIdentifiers required for analysis purposes:\n1. Postcode – sector level\n2. Gender \n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-11-18"]
["Next Review Date","2024-11-18"]
["Notes","Conditions of support:\n1. Further patient and public involvement is to be undertaken and reported back to the CAG at the first annual review. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 19 August 2021.\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for Oxford University Hospitals NHS Foundation Trust, Birmingham Women’s and Children’s Hospitals NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust and University Hospitals Southampton Hospitals NHS Foundation Trust, were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 04 November 2021)"]

{"sheet":"A02637","index":679,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02637"]
["Reference","21/CAG/0114"]
["Other Refs","IRAS Project ID: 300939  REC Reference: 21/LO/0567"]
["Application Title","Trends in the Prevalence and Complexity of Children with a Life-limiting or Life-threatening condition in Wales"]
["Application Summary","This application from University of York set out the purpose of medical research that aims to estimate the number of children in Wales who are living with a Life-limiting or Life-threatening condition (LLC) and to assess the complexity and severity of this population to aid service planning and delivery. The applicant proposes to use Digital Health & Care Wales (DHCW) (Formerly known as NHS Wales Informatics Service NWIS) as a trusted third party to undertake linkage with Welsh clinical data from Secure Anonymised Information Linkage (SAIL) databank, Paediatric Intensive CareAudit Network (PICANet) data, and data from NHS Digital. \n\nLife-limiting conditions (LLC) are serious health conditions in which the child's life may be shortened. Children living with an LLC usually have repeated admissions to hospitals and require healthcare including palliative care for many years. A challenge in LLC research is lack of information on the severity or complexity of the child’s condition. This application will link data from different sources which will be pivotal for service planning and provision.\n\nIdentifiable data from NHS Digital and PICANet from all Wales residents ageing 0 to 25 years old is sent to DHCW to be linked and for cohort identification. The data linkage will be undertaken by the SAIL Databank team and DHCW. Data for any individuals who do not meet the cohort inclusion criteria will be deleted once the cohort has been made. After linkage, data will be pseudonymised using a unique identifier that matches with SAIL datasets. This dataset will be disclosed to SAIL, alongside full date of death for those who have passed away. SAIL will then link to clinical data and modify date of death to month and year of death 6-8 weeks after receiving the dataset. ‘s251’ support will then no longer be required. Researchers from the University of York will have access to the pseudonymised dataset via secure remote access provided by SAIL."]
["Applicant Organisation Name","University of York"]
["Contact Name","Professor Lorna Fraser"]
["Address","University of York"]
[null,"Area 2 Seebohm Rowntree Building"]
[null,"Heslington, York"]
["Postcode","YO10 5DD"]
["Telephone","0190 432 1889"]
["Email","lorna.fraser@york.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All children and young adults aged 0-25 years old with a life-limiting condition (LLC), resident in Wales from 2003-2020.\n\n~63,000 cases"]
["Description of confidential patient information used","Data sources:\n1. SAIL databank (linked via Digital Health & Care Wales (DHCW) (Formerly known as NHS Wales Informatics Service, (NWIS);\n• Primary Care GP (2000-2020)\n• Patient Episode Database for Wales (PEDW) (1997-2020)\n• Critical Care Dataset (2006-2020)\n• Emergency Department Data Set (EDDS) (2009-Present)\n• Outpatient (2004-2020)\n• Annual District Death Extract (2003-Present)\n• Congenital Anomaly Register and Information Service (CARIS) (1998-2019)\n• Welsh Cancer Intelligence and Surveillance Unit (WCISU) (1972-Present)\n\n2. The Paediatric Intensive Care Audit Network (PICANet) data from the University of Leeds \n\n3. NHS Digital;\n• Hospital Episode Statistics (HES) (A/E; Admission; Outpatient) \n• Emergency Care Data Set (ECDS)\n\nIdentifiers required for linkage purposes:\n• NHS Digital linkage:\n1. NHS Number\n2. Postcode\n3. Date of birth\n4. Sex\n\nPICANet linkage:\n1. PICANetidentifier\n2. Name\n3. NHS number\n4. Postcode\n5. Date of birth\n6. Sex\n\nIdentifiers required for analysis purposes:\n1. Date of death (modified to month and year)\n2. Ethnicity\n\nAdditional information:\nData linkage undertaken by Digital Health & Care Wales (DHCW) \n\nThe pseudonymised dataset will be hosted by the Secure Anonymised Information Linkage (SAIL) databank at Swansea University. The researchers at the University will access and analyse the dataset via secure remote access provided by SAIL."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-11-25"]
["Next Review Date","2025-01-02"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 11 August 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:  \n• The NHS Digital 20/21 DSPT reviews for NHS Digital and PICANet – University of Leeds LASER were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 September 2021), and Secure Anonymised Information Linkage (SAIL databank) 8WG95 was confirmed as ‘Standards Met’ (by email to the CAG inbox on 1 October 2021) \n• Digital Health & Care Wales (DHCW) has a confirmed Caldicott Principles into Practice (CPiP) Outturn report. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02638","index":680,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02638"]
["Reference","21/CAG/0164"]
["Other Refs","IRAS Project ID: 300595  REC Reference: 21/NW/0267"]
["Application Title","Recovery, Renewal and Reset of Services to Disabled Children"]
["Application Summary","This application from Newcastle University set out the purpose of medical research that seeks to establish which reconfiguration of services, practices and strategies for disabled children made during the coronavirus pandemic worked well.\n\nEight percent of children living in the UK are disabled. Half of these children have neuro disability conditions, affecting their brain and central nervous system. Many have complex physical and mental health needs, which are generally met through multiple services. In response to the coronavirus pandemic, disabled children who are at increased risk due to poor respiratory function were advised to shield. The duty to deliver care as specified in children’s individual Education, Health and Care Plans (EHCPs) was relaxed and most community services for children were de-prioritised as efforts centred on those most at risk from the virus. Services were stopped and re-organised, with some resuming via video link and others face-to-face, but the practice varied and has continued to flex and change in response to policy changes. Many parents reported their children’s mental health as deteriorating, and parents’ own isolation and distress. Impacts on physical health are currently unclear, however virtual consultations may not suit physical examination, diagnosis or interventions requiring touch or instrumentation. There is emerging evidence of delays to diagnosis and treatment of children, increases in abuse, and in regional and socio-economic inequity in the impacts of coronavirus. The applicants seek to conduct research into changes to service provision and their consequences for children’s physical mental health, as well as the impact on their families’ wellbeing. The research will be used to inform practical policy solutions for integrated service recovery. \n\nThis study is comprised of six work packages. The applicants are seeking support under Regulation 5 for Work Package 2, as this involves analysis of routinely collected data and consent will not be sought for access to this confidential patient information. Children aged 0-19 years with a confirmed or suspected diagnosis of a neuro disability condition, and living in one of five local authority areas in England, will be included in the study. Areas have been selected so that findings will be generalisable and representative UK-wide and internationally relevant. The NHS Trusts in the five areas will provide the pseudonymised NHS number of each child who meets the inclusion criteria to the North of England Commissioning Support Unit (NECS). NHS medical, community and learning disability services, as well as non-medical services, in participating areas will transfer data on contacts with services to NECS. This data will be individual level data and individuals will be identified by their pseudonymised NHS number and diagnostic category. NHS Digital will also disclose pseudonymised HES and MHSDS data relating to identified children’s use of services to NECS. NECS will create unique identifiers for all participating children and will apply a second pseudonymisation code to the datasets. NECS will then send datasets in which children are identified by second pseudonymisation code to the research team. Each process will involve data being shared once, e.g. one list of identified children will be shared once with NECS by a lead NHS Trust; NECS will provide NHS Digital pseudonymised data on children from an area once to the research team.\n\nThe applicants are seeking support as, while the data disclosed between individual NHS organisations, NECs and NHS Digital will be pseudonymised, NHS Digital will retain the pseudonymisation key and will be required to identify patients before sharing the relevant datasets."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Professor Lindsay Pennington"]
["Address","Newcastle University"]
[null,"Population Health Sciences Institute, FMS"]
[null,"Sir James Spence Institute, Royal Victoria Infirmary"]
["Postcode","NE1 4LP"]
["Telephone","0191 282 1360"]
["Email","lindsay.pennington@ncl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children aged between 0 and 19 years of age, diagnosed with a neuro disability (disability arising from maldevelopment or damage to the brain in early development)"]
["Description of confidential patient information used","Data sources:\n1. HES and MHSDS datasets at NHS Digital\n\nIdentifiers required for linkage purposes:\n1. Pseudonymised NHS Number\n\nNHS Digital will hold the re-identification key and will be able to re-identify patients to conduct the linkage.\n\nNHS Digital will link datasets using;\n1. NHS Number\n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes:\n1. Date of birth (this is modified to month and year of birth for analysis)\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-03"]
["Next Review Date","2024-12-03"]
["Notes","18 December 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), civil registrations – Deaths, and the mental health Services data set (MHSDS)\n\nAmendment supported 15 December 2023 to extend the duration of ‘s251’ support until 31 May 2024, and to clarify that Civil Registrations – Deaths is a data source\n\n13 April 2022 - Amendment supported, to clarify that month and year of birth would be included in dataflow B.\n\n03 December 2021 - Application supported\n\nSpecific conditions of support \n1. A response to the two first two conditions below need to be provided within one month of the issuing of this letter. Conditions met 10 December 2021.\n\n2. Please clarify where NHS Digital will obtain patients dates of birth and postcodes from. Clarification also needs to be provided on why NHS Digital require these identifiers. Conditions met 10 December 2021.\n\n3. Please revise the notices to be displayed in waiting rooms and newsletters to include further details on how data would be processed. Conditions met 10 December 2021.\n\n4. Favourable opinion from a Research Ethics Committee. Confirmed 23 November 2021. \n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for North of England Commissioning Support Unit (NECS) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 23 November 2021)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02639","index":681,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02639"]
["Reference","21/CAG/0123"]
["Other Refs","IRAS Project ID: 292593  REC Reference: 21/SC/0290"]
["Application Title","RE-BLEED: A digital platform for identifying bleeding patients – a feasibility study"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to test whether a digital platform can efficiently identify patients who have suffered a bleeding event, so that identified patients can be approached for consent to participate in trials of new treatments and blood tests. \n\nBleeding affects up to 40% of all trauma patients, up to 30% of all surgery patients, and is one of the commonest causes of death for women giving birth. The presentation and features of bleeding vary between patients. In some cases, bleeding is easily recognised but, in other cases, bleeding is harder to diagnose. Bleeding must be stopped promptly in order to prevent severe illness or death. Many studies have shown differences in how patients who bleed are treated. Some treatments are also more effective on some patients than others. Understanding how practice and patient characteristics affect outcome can aid in the design and testing of potential improvements in care. Patients in hospital have regular tests that measure levels of the different types of cells and clotting in their blood. For example, a drop in red blood cells can indicate that patients have suffered bleeding. More advanced blood tests are available that can provide more detailed information on why patients are bleeding and what treatments might be most effective, although these tests are not routinely performed in hospital.\n\nThe applicants will develop and test a real-time hospital-wide digital system to identify patients in hospital who have suffered from bleeding and whether this system could be used in future to identify patients suitable to take part into trials of new tests or treatments. Both retrospective and prospectively collected data will be used to identify patients in hospital with acquired bleeding. Retrospective data collected from patients admitted to one hospital over a ten-year period will be used to develop the algorithm. The algorithm will be refined using prospective data collected over a three-month period.\n\nParticipants who experienced bleeding will be identified from electronic patient records at Oxford University Hospitals NHS Trust. For the retrospective cohort, suitable patients will be identified from electronic patient records at Oxford University Hospitals NHS Trust as being admitted to, or attending the emergency department at, Oxford University Hospitals NHS Foundation Trust between 1/3/2011 and 1/3/2021. Approximately 1,750,000 patients will be included. These records will be used to construct a research database of patients who have likely experienced bleeding. Data for those who are screened but who are not identified as having experienced bleeding during their hospital admission will be deleted. A dataset, pseudonymised by applying the study idea, will be transferred to the University of Oxford and used to develop the algorithm. \n\nIn the final three months of the study, the algorithm will be tested with a prospective cohort. Patients currently in hospital will be identified by the real time digital platform created using the data collected in the retrospective cohort. During the period the algorithm is running, it will digitally screen all new admissions to the hospital.  It will retain all the data fields that were identified in the retrospective stage and listed in the protocol for the duration of that hospital admission.  This is because bleeding can occur at any point during an admission and the aim is to capture bleeding in all its clinical manifestations.  If bleeding has not occurred by the point of discharge or death, the records will be deleted.  Only those that are identified as bleeding will be retained.  \n\nIf a patient is identified as meeting the study criteria, members of the research team will liaise with the clinical care team. A member of the clinical care team will approach the patient and introduce a member of the research team, who will explain the study and seek consent. Should the patient consent, the Trust laboratory will be notified and advised that the patients blood sample needs to be retained until the end of the study. If a patient lacks capacity to consent, then a consultee opinion will be sought in line with the Mental Capacity Act. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Peter Watkinson, Chief Investigator"]
["Address","Kadoorie Centre"]
[null,"John Radcliffe Hospital, Headley Way"]
[null,"Headington"]
["Postcode","OX3 9DU"]
["Telephone","01865 223 101"]
["Email","ccrg.research@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Retrospective cohort: Adults aged 16 – 110 years of age who were admitted to, or attended the emergency department at, Oxford University Hospitals NHS Foundation Trust between 1/3/2011 and 1/3/2021. Approximately 1,750,000 patients will be included. \n\nProspective cohort: Adults aged 16-110 years of age who were admitted to, or attended the emergency department at, Oxford University Hospitals NHS Trust between 01/10/2021 – 01/02/2022. The data for 87,500 patients will be screened in order to gain consent from 200 patients."]
["Description of confidential patient information used","Data sources:\n1. Electronic patient records at Oxford University Hospitals NHS Trust\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes:\n1.\tGender\n2.\tOccupation\n3.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-09"]
["Next Review Date","2024-12-09"]
["Notes","Amendment supported 12 March 2024 to extend the duration of ‘s251’ support until 28 February 2025\n\nAmendment supported 16 August 2023 to change the dates of the screening for the prospective cohort to between 01 October 2021 and 29 February 2024.\n\nAmendment supported - 03 October 2022 \n\nTo change the dates of the screening for the prospective cohort to between 01 October 2021 and 31 August 2023\n\n21 March 2022 - Amendment supported\nAmendment supported to change the dates of the screening for the prospective cohort to between 01 October 2021 and 31 August 2022.\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 15 November 2021. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for Oxford University Hospitals NHS Foundation Trust is confirmed (by check of the NHS Digital DSPT tracker on 15 September 2021). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02640","index":682,"n_rows":37,"n_cols":3,"rows_kept":37,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02640"]
["Reference","21/CAG/0128"]
["Other Refs","IRAS Project ID: 292593  REC Reference: 21/SC/0290"]
["Application Title","Investigating the role of play experiences in paediatric hospital settings"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that seeks to investigate the play provisions available in hospital settings, and explore the experiences and opinions of staff, children and families engaging in hospital play. \n\nPaediatric patients with chronic or severe illness may spend significant portions of their children in hospital. The European Association for Children in Hospital (EACH) Charter stipulates that children have a full opportunity for recreation and play, suitable to their age and in an environment suitable to their needs. Access to provisions for play can vary widely between hospitals. In certain circumstances various healthcare professionals, including play or child life staff, nurses, physicians, surgeons, therapists, etc, may utilise play in their delivery of care, whether for children’s physical, mental, or emotional health. Paediatric patients can partake in these more structured or designed playful opportunities, but will also engage in free, spontaneous play in the hospital. Previous research has shown that free, child-directed play, is positively associated with the physical, mental and emotional health of children. The applicants note the need to better understand the play provisions that exist in paediatric settings, including experiences and opinions on the role and value of hospital play. \n\nThe applicants will undertake ethnographic observations followed by semi-structed interviews with staff and patients, to explore perceptions and experiences of hospital play. A preparatory phase will be undertaken, in which the research team will meet with hospital stakeholders to determine the appropriate location and population for the study, and learn the hospital safety and safeguarding protocols. Phase 1 of the study will consist of a 3-4 week ethnographic period, focusing on the observation of play experience and opportunities within the culture of the hospital ward. The researchers will tale detailed field notes around existing play provisions and the parameters by which play occurs. The study will be conducted on 1-2 paediatric wards. Appropriate wards will be determined in consultation with the hospital’s clinical stakeholders. \n\nIn Phase 2, semi-structured interviews will be conducted with healthcare professionals to collect their experiences of engaging in and utilising play in their delivery of paediatric medical care. Interviews will also be held with young patients and their families. "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Paul Ramchandani"]
["Address","Professor of Play in Education, Development and Learning & Honorary Consultant Child and Adolescent Psychiatrist"]
[null,"Faculty of Education, University of Cambridge"]
[null,"184 Hills Road, Cambridge"]
["Postcode","CB2 8PQ"]
["Telephone","01223 767 600"]
["Email","pr441@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 3 – 12 years of age who are inpatients in participating hospitals. "]
["Description of confidential patient information used","Data sources:\n1. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust\n\nThe observations will take place at the above Trust, but no confidential patient information will be recorded. \n\nIdentifiers required for linkage purposes:\nNo patient identifiers will be collected for linkage purposes.\n\nIdentifiers required for analysis purposes:\nNo patient identifiers will be collected for analysis purposes.\n "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-12-10"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, this data is contributing to a wider research initiative around understanding the role and value of play in paediatric health care. Furthermore, these data are contributing to the development of an educational programme for healthcare professionals around integrating play into multidisciplinary paediatric care, as well as informing ongoing discussions with those involved with building new paediatric hospitals about what play can be like during children’s hospitalisations and how it might influence their overall wellbeing.\n\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 24 November 2021. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (21 September 2021)."]
["This is a duplicate entry - hidden"]

{"sheet":"A02641","index":683,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02641"]
["Reference","21/CAG/0177"]
["Other Refs","IRAS Project ID: 291853  REC Reference: 21/WA/0175"]
["Application Title","Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency hip fracture care Delivery"]
["Application Summary","This application from Swansea University set out the purpose of medical research that seeks to test the safety, clinical effectiveness and cost-effectiveness of paramedics providing Fascia Iliaca Compartment Block (FICB) as pain relief to patients with suspected hip fracture in the pre-hospital environment. \n\nHip fractures are a common injury for elderly people. Pain relief given before the patient reaches hospital is often inadequate and causes side effects which may slow down recovery. The applicants have conducted a small study to test whether a local anaesthetic injection into the hip area, a treatment called Fascia Iliaca Compartment Block (FICB), given by paramedics at the scene of injury is safe and acceptable. The results concluded that a full trial is feasible.\n\nThe applicants will conduct a randomised controlled trial to assess whether FICB is a safe, effective and cost-effective treatment. The research will take place at four research sites in England and Wales. Each site will be comprised of two NHS organisations; an ambulance service and a receiving hospital. Patients will be allocated to receive either FICB or a usual treatment (often morphine) at a ratio of 1:1. Patients in both arms of the trial will still receive Entonox, paracetamol and anti-sickness tablets, as needed. Patients will be initially recruited into the study under the emergency provisions of the Mental Capacity Act. An NHS researcher (paramedic or nurse) will approach the patient within ten days of their attendance by paramedics to discuss the trial. All patients will be included in anonymised follow up using routinely collected data, unless they dissent from this. Patients will be asked whether they would be willing to take part in questionnaires for the study. If so, they will complete a consent form and be sent two questionnaires - one at one month after the 999 call, and one at four months after the 999 call. Confidential patient information will be uploaded by the participating trusts to the researchers at Swansea University via REDCap. Confidential patient information will then be disclosed from the University of Swansea to NHS Digital and Digital Health and Care Wales for linkage to routine health datasets. A pseudonymised dataset will then be disclosed from NHS Digital to the SAIL Gateway. A pseudonymised dataset will be disclosed from Digital Health and Care Wales to the SAIL Databank for linkage to routine healthcare data and then to the SAIL Gateway. \n\nPatients will be initially recruited into the study under the emergency provisions of the Mental Capacity Act. Support is sought as, while the applicants anticipate that the majority of patients will be consented, some may be discharged from hospital before consent can be obtained. Therefore, the applicants are seeking support to include these patients and to conduct the data linkages to NHS Digital and Digital Health and Care Wales. "]
["Applicant Organisation Name","Swansea University"]
["Contact Name","Professor Helen Snooks"]
["Address","Professor of Health Services Research"]
[null,"ILS2 Singleton Campus"]
[null,"Swansea University"]
["Postcode","SA2 8PP"]
["Telephone","01792 513 418"]
["Email","h.a.snooks@swansea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who are treated for a suspected hip fracture in a pre-hospital setting. \n\nThe applicants anticipate that 1404 patients will be recruited, 702 in the control arm and 702 in the intervention arm."]
["Description of confidential patient information used","Data sources:\n1.\tConfidential patient information from patient records in the following trusts, health boards and ambulance services:\na.\tEast of England Ambulance Service,\nb.\tSouth East Coast Ambulance Service, \nc.\tSouth Western Ambulance Service,\nd.\tWelsh Ambulance Service NHS Trust,\ne.\tPrincess Royal Hospital, University Hospitals Sussex NHS Foundation Trust,\nf.\tRoyal Surrey NHS Foundation Trust,\ng.\tAshford and St Peter’s Hospitals NHS Foundation Trust,\nh.\tRoyal Devon and Exeter NHS Foundation Trust\ni.\tSwansea Bay University Health Boards,\nj.\tJames Paget University Hospitals NHS Foundation Trust \n\n2.\tPatient-reported data: \na.\tpain scores (taken by paramedic before randomisation and at by nurse at arrival at ED); \nb.\tOne month questionnaire, \nc.\tFour month questionnaire.\n\n3.\tLinked routine data provided by NHS Digital from the following datasets:\na.\tCivil Registrations – Deaths\nb.\tEmergency Care Dataset\nc.\tHES: Civil Registration (Deaths) Bridge\nd.\tHospital Episode Statistics Admitted Patient Care\ne.\tHospital Episode Statistics Critical Care\n\n4.\t Linked routine data provided by the SAIL Databank from the following datasets:\na.\tAnnual District Death Extract\nb.\tCritical Care Dataset\nc.\tEmergency Department Dataset\nd.\tPatient Episode Database for Wales\ne.\tWelsh Demographics Service\n\nIdentifiers required for linkage purposes:\n1.\tName\n2.\tNHS number\n3.\tDate of birth\n4.\tPostcode – unit level\n\nIdentifiers required for analysis purposes:\n1.\tDate of birth\n2.\tDate of death\n3.\tDeprivation scoring\n4.\tGender\n5.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-10"]
["Next Review Date","2024-11-22"]
["Notes","Specific conditions of support \n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 August 2021.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- \nThe NHS Digital 2020/21 DSPT review for SAIL Databank (within University of Swansea) and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 08 December 2021).\n\nThe Caldicott: Principles into Practice (CPiP) for Digital Health and Care Wales was confirmed on 05 October 2021."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02643","index":684,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02642"]
["Reference","21/CAG/0123"]
["Other Refs","IRAS Project ID: 292593  REC Reference: 21/SC/0290"]
["Application Title","RE-BLEED: A digital platform for identifying bleeding patients – a feasibility study"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to test whether a digital platform can efficiently identify patients who have suffered a bleeding event, so that identified patients can be approached for consent to participate in trials of new treatments and blood tests. \n\nBleeding affects up to 40% of all trauma patients, up to 30% of all surgery patients, and is one of the commonest causes of death for women giving birth. The presentation and features of bleeding vary between patients. In some cases, bleeding is easily recognised but, in other cases, bleeding is harder to diagnose. Bleeding must be stopped promptly in order to prevent severe illness or death. Many studies have shown differences in how patients who bleed are treated. Some treatments are also more effective on some patients than others. Understanding how practice and patient characteristics affect outcome can aid in the design and testing of potential improvements in care. Patients in hospital have regular tests that measure levels of the different types of cells and clotting in their blood. For example, a drop in red blood cells can indicate that patients have suffered bleeding. More advanced blood tests are available that can provide more detailed information on why patients are bleeding and what treatments might be most effective, although these tests are not routinely performed in hospital.\n\nThe applicants will develop and test a real-time hospital-wide digital system to identify patients in hospital who have suffered from bleeding and whether this system could be used in future to identify patients suitable to take part into trials of new tests or treatments. Both retrospective and prospectively collected data will be used to identify patients in hospital with acquired bleeding. Retrospective data collected from patients admitted to one hospital over a ten-year period will be used to develop the algorithm. The algorithm will be refined using prospective data collected over a three-month period.\n\nParticipants who experienced bleeding will be identified from electronic patient records at Oxford University Hospitals NHS Trust. For the retrospective cohort, suitable patients will be identified from electronic patient records at Oxford University Hospitals NHS Trust as being admitted to, or attending the emergency department at, Oxford University Hospitals NHS Foundation Trust between 1/3/2011 and 1/3/2021. Approximately 1,750,000 patients will be included. These records will be used to construct a research database of patients who have likely experienced bleeding. Data for those who are screened but who are not identified as having experienced bleeding during their hospital admission will be deleted. A dataset, pseudonymised by applying the study idea, will be transferred to the University of Oxford and used to develop the algorithm. \n\nIn the final three months of the study, the algorithm will be tested with a prospective cohort. Patients currently in hospital will be identified by the real time digital platform created using the data collected in the retrospective cohort. During the period the algorithm is running, it will digitally screen all new admissions to the hospital.  It will retain all the data fields that were identified in the retrospective stage and listed in the protocol for the duration of that hospital admission.  This is because bleeding can occur at any point during an admission and the aim is to capture bleeding in all its clinical manifestations.  If bleeding has not occurred by the point of discharge or death, the records will be deleted.  Only those that are identified as bleeding will be retained.  \n\nIf a patient is identified as meeting the study criteria, members of the research team will liaise with the clinical care team. A member of the clinical care team will approach the patient and introduce a member of the research team, who will explain the study and seek consent. Should the patient consent, the Trust laboratory will be notified and advised that the patients blood sample needs to be retained until the end of the study. If a patient lacks capacity to consent, then a consultee opinion will be sought in line with the Mental Capacity Act. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Peter Watkinson, Chief Investigator"]
["Address","Kadoorie Centre"]
[null,"John Radcliffe Hospital, Headley Way"]
[null,"Headington"]
["Postcode","OX3 9DU"]
["Telephone","01865 223 101"]
["Email","ccrg.research@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Retrospective cohort: Adults aged 16 – 110 years of age who were admitted to, or attended the emergency department at, Oxford University Hospitals NHS Foundation Trust between 1/3/2011 and 1/3/2021. Approximately 1,750,000 patients will be included. \n\nProspective cohort: Adults aged 16-110 years of age who were admitted to, or attended the emergency department at, Oxford University Hospitals NHS Trust between 01/10/2021 – 01/02/2022. The data for 87,500 patients will be screened in order to gain consent from 200 patients."]
["Description of confidential patient information used","Data sources:\n1. Electronic patient records at Oxford University Hospitals NHS Trust\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Date of death\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Gender\n2. Occupation\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-09"]
["Next Review Date","2022-12-09"]
["Notes","Specific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed 15 November 2021. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for Oxford University Hospitals NHS Foundation Trust is confirmed (by check of the NHS Digital DSPT tracker on 15 September 2021). "]

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[]
[]
["Application Number","A02644"]
["Reference","21/CAG/0128"]
["Other Refs","IRAS Project ID: 300180  REC Reference: 21/YH/0232"]
["Application Title","Investigating the role of play experiences in paediatric hospital settings"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that seeks to investigate the play provisions available in hospital settings, and explore the experiences and opinions of staff, children and families engaging in hospital play. \n\nPaediatric patients with chronic or severe illness may spend significant portions of their children in hospital. The European Association for Children in Hospital (EACH) Charter stipulates that children have a full opportunity for recreation and play, suitable to their age and in an environment suitable to their needs. Access to provisions for play can vary widely between hospitals. In certain circumstances various healthcare professionals, including play or child life staff, nurses, physicians, surgeons, therapists, etc, may utilise play in their delivery of care, whether for children’s physical, mental, or emotional health. Paediatric patients can partake in these more structured or designed playful opportunities, but will also engage in free, spontaneous play in the hospital. Previous research has shown that free, child-directed play, is positively associated with the physical, mental and emotional health of children. The applicants note the need to better understand the play provisions that exist in paediatric settings, including experiences and opinions on the role and value of hospital play. \n\nThe applicants will undertake ethnographic observations followed by semi-structed interviews with staff and patients, to explore perceptions and experiences of hospital play. A preparatory phase will be undertaken, in which the research team will meet with hospital stakeholders to determine the appropriate location and population for the study, and learn the hospital safety and safeguarding protocols. Phase 1 of the study will consist of a 3-4 week ethnographic period, focusing on the observation of play experience and opportunities within the culture of the hospital ward. The researchers will tale detailed field notes around existing play provisions and the parameters by which play occurs. The study will be conducted on 1-2 paediatric wards. Appropriate wards will be determined in consultation with the hospital’s clinical stakeholders. \n\nIn Phase 2, semi-structured interviews will be conducted with healthcare professionals to collect their experiences of engaging in and utilising play in their delivery of paediatric medical care. Interviews will also be held with young patients and their families. "]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Professor Paul Ramchandani, Professor of Play in Education, Development and Learning & Honorary Consultant Child and Adolescent Psychiatrist"]
["Address","Faculty of Education"]
[null,"University of Cambridge"]
[null,"184 Hills Road, Cambridge"]
["Postcode","CB2 8PQ"]
["Telephone","01223 767 600"]
["Email","pr441@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 3 – 12 years of age who are inpatients in participating hospitals."]
["Description of confidential patient information used","Data sources:\n1. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust\n\nThe observations will take place at the above Trust, but no confidential patient information will be recorded. \n\nIdentifiers required for linkage purposes:\nNo patient identifiers will be collected for linkage purposes.\n\nIdentifiers required for analysis purposes:\nNo patient identifiers will be collected for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-10"]
["Next Review Date","2022-12-10"]
["Notes","Conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 24 November 2021. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (21 September 2021)."]

{"sheet":"A02645","index":686,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02645"]
["Reference","21/CAG/0177"]
["Other Refs","IRAS Project ID: 291853  REC Reference: 21/WA/0175"]
["Application Title","Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency hip fracture care Delivery"]
["Application Summary","This application from Swansea University set out the purpose of medical research that seeks to test the safety, clinical effectiveness and cost-effectiveness of paramedics providing Fascia Iliaca Compartment Block (FICB) as pain relief to patients with suspected hip fracture in the pre-hospital environment. \n\nHip fractures are a common injury for elderly people. Pain relief given before the patient reaches hospital is often inadequate and causes side effects which may slow down recovery. The applicants have conducted a small study to test whether a local anaesthetic injection into the hip area, a treatment called Fascia Iliaca Compartment Block (FICB), given by paramedics at the scene of injury is safe and acceptable. The results concluded that a full trial is feasible.\n\nThe applicants will conduct a randomised controlled trial to assess whether FICB is a safe, effective and cost-effective treatment. The research will take place at four research sites in England and Wales. Each site will be comprised of two NHS organisations; an ambulance service and a receiving hospital. Patients will be allocated to receive either FICB or a usual treatment (often morphine) at a ratio of 1:1. Patients in both arms of the trial will still receive Entonox, paracetamol and anti-sickness tablets, as needed. Patients will be initially recruited into the study under the emergency provisions of the Mental Capacity Act. An NHS researcher (paramedic or nurse) will approach the patient within ten days of their attendance by paramedics to discuss the trial. All patients will be included in anonymised follow up using routinely collected data, unless they dissent from this. Patients will be asked whether they would be willing to take part in questionnaires for the study. If so, they will complete a consent form and be sent two questionnaires - one at one month after the 999 call, and one at four months after the 999 call. Confidential patient information will be uploaded by the participating trusts to the researchers at Swansea University via REDCap. Confidential patient information will then be disclosed from the University of Swansea to NHS Digital and Digital Health and Care Wales for linkage to routine health datasets. A pseudonymised dataset will then be disclosed from NHS Digital to the SAIL Gateway. A pseudonymised dataset will be disclosed from Digital Health and Care Wales to the SAIL Databank for linkage to routine healthcare data and then to the SAIL Gateway. \n\nPatients will be initially recruited into the study under the emergency provisions of the Mental Capacity Act. Support is sought as, while the applicants anticipate that the majority of patients will be consented, some may be discharged from hospital before consent can be obtained. Therefore, the applicants are seeking support to include these patients and to conduct the data linkages to NHS Digital and Digital Health and Care Wales. "]
["Applicant Organisation Name","Swansea University"]
["Contact Name","Professor Helen Snooks, Professor of Health Services Research"]
["Address","ILS2 Singleton Campus"]
[null,"Swansea University"]
[]
["Postcode","SA2 8PP"]
["Telephone","01792 513 418"]
["Email","h.a.snooks@swansea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who are treated for a suspected hip fracture in a pre-hospital setting. \n\nThe applicants anticipate that 1404 patients will be recruited, 702 in the control arm and 702 in the intervention arm."]
["Description of confidential patient information used","Data sources:\n1. Confidential patient information from patient records in the following trusts, health boards and ambulance services:\na. East of England Ambulance Service,\nb. South East Coast Ambulance Service, \nc. South Western Ambulance Service,\nd. Welsh Ambulance Service NHS Trust,\ne. Princess Royal Hospital, University Hospitals Sussex NHS Foundation Trust,\nf. Royal Surrey NHS Foundation Trust,\ng. Ashford and St Peter’s Hospitals NHS Foundation Trust,\nh. Royal Devon and Exeter NHS Foundation Trust\ni. Swansea Bay University Health Boards,\nj. James Paget University Hospitals NHS Foundation Trust \n\n2. Patient-reported data: \na. pain scores (taken by paramedic before randomisation and at by nurse at arrival at ED); \nb. One month questionnaire, \nc. Four month questionnaire.\n\n3. Linked routine data provided by NHS Digital from the following datasets:\na. Civil Registrations – Deaths\nb. Emergency Care Dataset\nc. HES: Civil Registration (Deaths) Bridge\nd. Hospital Episode Statistics Admitted Patient Care\ne. Hospital Episode Statistics Critical Care\n\n4. Linked routine data provided by the SAIL Databank from the following datasets:\na. Annual District Death Extract\nb. Critical Care Dataset\nc. Emergency Department Dataset\nd. Patient Episode Database for Wales\ne. Welsh Demographics Service\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS number\n3. Date of birth\n4. Postcode – unit level\n\nIdentifiers required for analysis purposes:\n1. Date of birth\n2. Date of death\n3. Deprivation scoring\n4. Gender\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-10"]
["Next Review Date","2022-12-10"]
["Notes","Specific conditions of support \n1. Favourable opinion from a Research Ethics Committee. Confirmed 05 August 2021.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- \n\nThe NHS Digital 2020/21 DSPT review for SAIL Databank (within University of Swansea) and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 08 December 2021).\n\nThe Caldicott: Principles into Practice (CPiP) for Digital Health and Care Wales was confirmed on 05 October 2021."]

{"sheet":"A02646","index":687,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02646"]
["Reference","21/CAG/0173"]
["Other Refs","IRAS Project ID: 305956  REC Reference: 21/YH/0271"]
["Application Title","Establishing the burden of vaccine preventable acute lower respiratory tract infections in primary care, UK: Avon-CAP GP2"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research to describe the incidence of acute lower-respiratory tract infection (aLRTI) in adults who present to primary care, and to estimate the proportion caused by vaccine preventable infections, including Streptococcus pneumoniae, Respiratory Syncytial Virus (RSV) and SARS-CoV-2.\n\nCurrently, accurate incidence rates of acute lower-respiratory tract disease (aLRTD) and its disease subsets, such as pneumonia and aLTRI in individuals presenting to primary care are unknown. The applicants seek to measure the true burden of acute respiratory disease due to these pathogens. The applicants will also undertake quality of life measurements to assess the cost-effectiveness of recommending vaccinations. This study will run alongside a sister study, Avon-CAP (Avon Community Acquired Pneumonia study), which is investigating incidence rates of adults hospitalised with community-acquired lower respiratory tract infection in Bristol. This new application will investigate the incidence rates of adults who present to primary care with chest infections. GP practices in Bristol have been selected in order to capture information for patients with different backgrounds, ethnicities and circumstances. \n\nThe study is comprised of two parts. A surveillance study will be undertaken in which routinely collected clinical data will be extracted from participating GP practices for patients who meet the eligibility criteria, and a sampling study, in which patients will be asked to complete an enrolment survey and symptom diaries, and provide naso-pharyngeal/oropharyngeal, saliva and urine samples. Participants will be consented into both parts of the study where possible, and the applicants anticipate that most study activities will be undertaken by the direct care team or with patient consent. If a health professional diagnoses an adult patient with an aLRTD, a prompt will appear advising that the patient is eligible for the study. The health professional will be prompted to outline the study, and seek consent for the patient to be sent a text message about the study. The research team will also follow-up with a phone call to explain more about the study. ‘s251’ support is not required for this process. \n\nAdditionally, some patients will be offered an initial screening appointment with a research nurse or research practitioner, however they will have consented to this appointment offered by the direct care team in additional to usual clinical care, and ‘s251’ support is not required for this method of identification.\n\nA research nurse or research practitioner, who is not part of the direct care team, will additionally access patient records to screen patients for eligibility and approach for consent, in order to ensure all eligible patients are approached. ‘s251 support is required for this element’. An out of hours provider, Brisdoc, does not have capacity to screen for eligibility, and therefore the research staff at GP practices will also screen clinical out of hours letters each day at the GP practices, in order to identify eligible patients who were seen by Brisdoc. \n\nAny patient who has passed away, or who the research team is unable to contact by phone, will not be offered the chance to consent, as it has not been possible. These patients will be included in the surveillance study using ‘s251’. These patients are not defined as non-responders, as they will not have been supplied information in the post regarding being asked for consent. \n\nData for the surveillance study will be processed and transferred to the University of Bristol central database on a monthly basis. Identifiable data fields will be removed from the database and transferred to a separate database with restricted access. Senior research staff will use this database to undertake any necessary analysis or processing, for example identifying individuals occurring more than once in the database. Pseudonymised data will then be transferred to a central University of Bristol database, which will therefore combine the pseudonymised data from each participating NHS Trust (AVON CAP). This pseudonymised data will be processed and analysed."]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Adam Finn, Professor of Paediatrics"]
["Address","University of Bristol"]
[null,"University Hospital Bristol (UHB) Education Centre"]
[null,"Upper Maudlin Street, Bristol"]
["Postcode","BS2 8AE"]
["Telephone","0117 331 3903"]
["Email","adam.finn@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adults presenting to participating GP practices in Bristol (including out of hours provider Brisdoc) with acute lower respiratory tract disease, including pneumonia, lower respiratory tract infection and heart failure\n\nMaximum of 4000 patients, however ‘s251’ support will not extend to those instances where the direct care team have screened and approached the patient. "]
["Description of confidential patient information used","Data sources\n1. Electronic records, including out of hours discharge letters from participating GP practices, \na. Courtside Surgery \nb. Tyntesfield Medical Group \nc. Concord Medical Centre \nd. Wellspring Surgery \ne. Montpellier Health Centre \nf. Pioneer Medical Group \n\nIdentifiers required for identifying eligibility, and approaching for consent purposes\n1. Name\n2. NHS number \n3. GP registration\n4. Date of birth\n5. Date of death\n6. Postcode – sector level\n7. Phone number\n\nIdentifiers required for analysis purposes\n1. pseudo ID \n2. date of birth – modified for analysis (by University)\n3. Date of death – modified for analysis (in NHS IT domain prior to University)\n4. gender\n5. Ethnicity\n6. Sector level postcode – modified to deprivation score\n\nTherefore pseudonymous for analysis\n\nAdditional information\nConfidential patient information will be retained in a surveillance database at University of Bristol, held separately from the pseudonymised database for analysis, linked to the pseudo ID. This includes NHS number, sector level postcode, and date of birth. Therefore ‘s251’ support required for this element.\n\nConfidential patient information regarding the surveillance study will be sent monthly to University of Bristol from research nurses at participating GP practices"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-21"]
["Next Review Date","2024-12-21"]
["Notes","Amendment supported 11 October 2023 to extend the duration of ‘s251’ support until end of October 2024\n\nAmendment supported 12 June 2023 to include non English speaking patients into the anonymised descriptive dataset, to clarify further sub-groups of eligible patients who cannot be approached for consent to be included in the surveillance arm, collection of additional data from electronic GP records for patients included in the non-consented surveillance arm, and for research practitioners to send a text message to potential participants prior to phoning them.\n\n13 April 2022 - Amendment supported\nAmendment supported to widen the cohort supported under ‘s251’ to include patients presenting to the emergency department who are then not admitted to hospital, and extend ‘s251’ support to the wider research team rather than just research nurses/practitioners.\n\n21 December 2021 - Application Supported:\nConditions of support:\n\n1. Please provide clarification regarding what being ‘logged and counted’ means regarding patients who opted out. Is any confidential patient information recorded without consent, outside of the direct care team? Please provide a response within one month from the date of this letter.\nApplicant has confirmed that no confidential patient information is processed regarding patients who opted out and are logged. CAG confirmed condition met 16 February 2022.\n\n2. Please provide a list of data items disclosed to Pfizer, within one month from the date of this letter.\nApplicant provided the requested information. CAG confirmed condition met 16 February 2022.\n\n3. Please provide updated posters, as per the guidance above, including the addition of ‘GP’, the Pfizer logo if appropriate, make the opt out option more prominent, and include the legal basis under common law to access the data. Please provide within one month from the date of this letter.\nApplicant provided an updated poster. CAG confirmed condition met 16 February 2022.\n\n4. Favourable opinion from a Research Ethics Committee. Confirmed 01 December 2021\n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information \n\nConfirmed:- \nThe NHS Digital 20/21 DSPT review for University of Bristol - Bristol Medical School (EE133799-BRMS) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 December 2021).\n\nThe NHS Digital 20/21 DSPT review for NHS Bristol, North Somerset & South Gloucestershire CCG (to cover the 6 participating GPs) was confirmed as ‘Standards Met’ by email to the CAG inbox (on 21 December 2021)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","02647"]
["Reference","22/CAG/0004"]
["Other Refs","IRAS Project ID: 306710  REC Reference: 21/HRA/4858"]
["Application Title","Mass evaluation of lateral flow immunoassays for the detection of SARS-CoV-2 antibody responses in immunosuppressed people"]
["Application Summary","This application, from Imperial College London, sets out the purpose of medical research which aims to evaluate the detection of SARS-CoV-2 antibodies at a population level in immunosuppressed individuals.\n\nImmunosuppressed patient populations have a poor prognosis to infection with SARS-CoV-2. The immune response to SARS-CoV-2 vaccines have been shown to be suboptimal in immunocompromised individuals; and data suggests they have continued risk of breakthrough severe infections. Immune responses and protection from infection following third doses are likely to be influenced by clinical factors as well as behaviour. Such information could help provide stratified advice to specific patient groups and could help estimate and/or identify the number of patients who may benefit from additional or alternative methods of prophylaxis, such as monoclonal antibody therapy.\n\nSupport under regulation 5 is requested for NHS Digital to disclose name, address, telephone number and date of birth to Ipsos Mori for the purpose of inviting individuals to the study. An initial letter will be sent, followed up with a text message and a further letter in the event of no response. If no response is received after these attempts (over approximately a two-week period) no further contact with the individual will be made. Where an individual responds to the invite all study activities and further data linkages will be undertaken on the basis of consent."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Dr Michelle Willicombe, Senior Clinical Lecturer"]
["Address","Imperial College London, Centre for Inflammatory Disease"]
[null,"9th Floor, Commonwealth Building, Hammersmith Hospital,"]
[null,"Du Cane Road, London"]
["Postcode","W12 0NN"]
["Telephone"]
["Email","m.willicombe08@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adults ≥18 years of age, and are classified as being part of one of the following patient groups:\n\n1. Patients with a rare autoimmune disease (n=12,000)\n2. Patients with lymphoid malignancies (n=12,000)\n\nParticipants need to undertake a self-administered lateral flow assay within 21 - 90 days of completion of their primary COVID-19 vaccination course (3 vaccines of which may include a mix of vaccine types; 3 vaccines may include a booster dose).\n\nIt is estimated up to 40,000 people will be invited into the groups  above, to gain the 24,000 patients."]
["Description of confidential patient information used","Data sources:\n1. National Disease Registration Service (NDRS). The NDRS is made up of two disease registers called the:\na. National Cancer Registration and Analysis Service (NCRAS) \nb. National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) \n\nFrom 01 October 2021 the NDRS is managed by NHS Digital under the National Disease Registries Directions 2021\n\nIdentifiers required for sending invites:\n1. Full Name\n2. Address (including postcode)\n3. Mobile Phone Number\n4. Date of birth\n\nIdentifiers required for analysis/linkage purposes:\nNone\n\nAdditional information:\nDate of birth is transferred in order to confirm the identity of individuals that sign up and to enable linkages with NHS Digital. It is not used on the invite letter.\n\nFurther data processing, including linkages, will be undertaken on the basis of consent.\n\nNote that a third cohort is included in this study (those that have had a solid organ transplant recipient, n=12,000). These groups are being recruited outside the scope of this support."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-12-10"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in March 2023 that ‘s251’ support could be expired, as all confidential patient information has been destroyed.\n\nIn terms of public benefit, the MELODY study demonstrates that immunocompromised individuals may be identified and reached via national disease registration services and the linkage of unique data sets. 23,000 people participated in the study.\n\nThe study shows it is possible to find, identify, invite and test whole cohorts of people who are immunosuppressed. \n\nApproximately one in five individuals with Solid Organ Transplants, Rare Autoimmune Rheumatic Disease and Lymphoid malignancies have no detectable IgG spike-protein antibodies despite three or more vaccines, but this proportion reduces with sequential booster doses. Choice of immunosuppressant and disease-type is strongly associated with serological response.\n\nAmendment supported 19 July to extend the duration of support until 30 September 2022\n\n06 January 2022 - Amendment supported:\nAmendment supported to allow NHS Blood and Transplant to disclose confidential patient information (NHS number) of 40,000 transplant recipients to NHS Digital, and to allow NHS Digital to disclose confidential patient information to Ipsos Mori for the purpose of inviting transplant recipients to the study.\n\n10 December 2021 - Application supported:\n\nConditions of support\n1. Add the statement provided in the “Patient Notification’ and mechanism for managing dissent” section above to the “How did you get my name and address?” section of the patient invitation letter. CAG confirmed condition met 23 February 2022\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 26 November 2021\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 20/21 DSPT review for Ipsos Mori was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 06 December 2021)."]

{"sheet":"A02648","index":689,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02648"]
["Reference","21/CAG/0182"]
["Other Refs","IRAS Project ID: 294881  REC Reference: 21/WA/0267"]
["Application Title","PriDem: Best Practice in Primary Care Led Dementia Support"]
["Application Summary","This application from University College London set out the purpose of medical research to test the feasibility and implementation of the best practice care model developed by the PriDem programme. \n\nThere is a need for good quality, accessible and equitable post-diagnostic dementia care and support in England. This need has been exacerbated by the coronavirus pandemic. Updated national guidance summarises evidence-based practice for post diagnostic dementia support but lacks practical advice on implementation. The Alzheimer’s Society funded the PriDem programme, which aims to develop and deliver accessible, feasible and sustainable primary care-based, post-diagnostic dementia care, and to support patients and their families. The findings from these programmes have been used to develop the PriDem intervention. \n\nIn order to test the intervention, participating Primary Care Networks (PCN) will be provided with a Clinical Dementia Expert, who will be employed by UCL in the southeast and by a participating PCN in the northeast. The Experts will work with the local team to formalise care-led systems to support post diagnostic support care for patients with dementia and their carers. The intervention is designed to deliver tailored care through ongoing holistic review and care planning, and to provide a tiered system of support. Work will also be undertaken to build capacity and capability to ensure that non-specialist staff also have the skills and knowledge to provide the best practice post-diagnostic support. A range of health care professionals and commissioners will be invited to participate in two audio-recorded interviews to explore their views and experience of the intervention. Patients with dementia and their carers will be invited to give their views on the feasibility and implementation of the intervention. The patient and their carers will be asked to complete baseline questionnaires at the start of the study. Interviews will also be held. \n\nSupport is required for two aspects of the application. In order to identify patients suitable to take part in the intervention and the interviews, members of the research team will review case notes of patients with dementia at participating GP practices. The applicants confirmed that the researchers will not collect any items of confidential patient information for patients deemed ineligible. The names, addresses, email address, phone number of patients deemed eligible, and the name and contact details of a main carer, will be collected and transferred to the UCL Data Safe Haven. An interim unique study ID number will be recorded alongside the patients’ name. A separate document, which will contain no confidential patient information, will be created and will contain the interim ID and information regarding eligibility decisions and any recruitment activity. Contact will be made by post from the research team within 7 working days of obtaining patients contact details. If a response is not received within 10 working days, the research team will telephone the patients. A second phone call will be made within the next 3 working days and a final phone call made within a further 3 working days. If the call is not answered at this point, no further contact attempts will be made, and the GP practice will be informed that contact could not be made. Patient data will be retained for a maximum of 3 working days after the final contact attempt. If a patient expresses dissent via phone call or post, their data will be deleted immediately. \n\nThe applicants also seek support to review the records of patients on the dementia register at participating GP surgeries to conduct a care plan audit. An anonymised dataset will be collected.  "]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Sarah Griffiths, PriDem Study Manager         "]
["Address","Centre for Ageing Population Studies, Research Department of Primary Care and Population Health,"]
[null,"Upper third floor - Royal Free Campus"]
[null,"London"]
["Postcode","NW3 2PF"]
["Telephone","020 3108 6699"]
["Email","s.a.griffiths@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 18 years and over who have a diagnosis of dementia and are registered with participating GP practices, also carers for patients with dementia. \n\n401 patients will be included, comprised of 80 patients with dementia, 66 carers, 40 HCPs and 215 patients in the care plan audit."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records held at participating GP practices in the participating Primary Care Networks (PCN).\n\nIdentifiers required for linkage purposes\n1. Name\n2. Postcode – Unit Level\n3. Full address\n4. Email\n5. Telephone number\n\nIdentifiers required for analysis purposes\nIntervention and interview: Identifiers will be retained under consent.\nCare plan audit: No identifiers will be recorded, other than ethnicity. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2021-12-23"]
["Next Review Date","N/A"]
["Notes","Applicant has confirmed June 2023 that ‘s251’ support can be expired, as recruitment is completed, and applicants no longer retain any personal data relating to non-consented patients.\n\nWith regards to public benefit, People living with dementia (PLWD) are typically under-represented in dementia research. ‘s251’ support has contributed to inclusion of PLWD in research; crucial for understanding the impact of new interventions on their quality of life and wellbeing. \nCAG support has allowed a pre- and post-intervention audit of the quantity and quality of personalised care plans across 7 general practices in the southeast and northeast of England. Findings will inform the future implementation of care and support services for PLWD and their carers, including improved systems and resources for personalised care planning. The data is currently being analysed. \n\n21 March 2022 - Amendment supported\nAmendment supported to include 3 further participating GP surgeries as additional data processors.\n\n23 December 2021 - Application supported\n\nSpecific conditions of support:\n\n1. The patient notification documents need to be reviewed by the PPI group and their views sought on how the documents can be made more accessible. The CAG need to be notified of the changes made. Condition met 08 July 2022\n\n2. The poster also needs to contain a clear statement about the legal basis under which the activity will take place, including a reference to the CAG. Condition met 08 July 2022\n\n3. Further patient and public involvement needs to be undertaken with patients living with dementia around the care plan audit and feedback from the discussions and details of any changes made as a result of the discussion provided to the CAG. Condition met 08 July 2022\n\n4. Favourable opinion from a Research Ethics Committee. Confirmed 05 November 2021.\n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\nConfirmed – DSPTs in place for 2020/21 confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 December 2021)\nUniversity College London\nEast Barnet Health Centre\nOakleigh Road Health Centre\nThrockley Primary Care Centre\nThe Grove Medical Practice\nSaville Medical Group\nBrunswick Park Medical Practice\n"]

{"sheet":"A02649","index":690,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02649"]
["Reference","21/CAG/0133"]
["Other Refs","IRAS Project ID: 294022  REC Reference: 21/LO/0680"]
["Application Title","Mortality and morbidity outcomes after aorto-vascular surgery in patients with Marfan Syndrome: A UK experience "]
["Application Summary","This application from Barts Health NHS Trust sets out the purpose of medical research that seeks to investigate the UK incidence of aorto-vascular surgery in patients with Marfan Syndrome and patients’ mortality outcome one-year after surgery. \n\nMarfan Syndrome (MFS) is a genetic disease which affects the eyes, skeleton, heart and arteries. Although MFS affects multiple organ systems, cardiovascular manifestations are the most serious and life-threatening. Approximately 80% of adults MFS patients will have a dilated aortic root by 40 years, with aortic aneurysm and dissection the leading causes of morbidity and mortality. Improvements in diagnostics and medical and surgical interventions have increased life expectancy. However, the natural history and the influence of medical or surgical interventions in the UK population are not fully described. Further, the incidence of aorto-vascular surgery in this patient group is unknown, as MFS is not routinely documented in the National Institute of Cardiovascular Outcome Research (NICOR) national cardiac surgery dataset and, therefore, there is currently no mechanism for exploring the aorto-vascular outcomes for this patient group.\n\nThe applicants will undertake a 10-year secondary analysis of linked national data, provided from the National Institute of Cardiovascular Outcome Research (NICOR), the Office of National Statistics (ONS) and HES data from NHS Digital, in order to identify the UK incidence and outcome of aorto-vascular surgery in patients with MFS. This includes associated hospital length of stay, mortality and morbidity rates, to provide information on the burdens that the aorto-vascular manifestations may place on the MFS population. \n\nNHS Digital will be asked to identify patients with MFS within the HES database between January 2010 and December 2019. NHS Digital will then undertake linkage to HES and ONS datasets, and transfer the dataset to Barts Heart Centre (BHC) using secure electronic transfer. Research staff at BHC will then identify MFS patients who have aorto-vascular diseases from the data received from NHS Digital. Patients’ NHS number, date of birth and date of surgery will then be transferred to NICOR to be linked to surgery specific data. NICOR is hosted by Barts Health NHS Trust and support is required for the transfer of confidential patient information between departments within the same organisation. NICOR will then transfer the linked dataset back to Barts Heart Centre and linked to the mortality and morbidity data, previously supplied by NHS Digital. Confidential patient information will be deleted from the dataset once the linkage is complete.  "]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Prof Julie Sanders - Director Clinical Research (Barts), Clinical Professor (QMUL) "]
["Address","Director of Clinical Research"]
[null,"St Bartholomew’s Hospital "]
[null,"West Smithfield, London"]
["Postcode","EC1A 7DN "]
["Telephone"]
["Email","j.sanders@qmul.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over, diagnosed with Marfan Syndrome and who had aorto-vascular surgery in England and Wales between 01 January 2010 and 31 December 2019.\n\nThe applicants advised that a sample size could not be estimated, as it was unknown how many patients with MFS underwent aorto-vascular surgery. "]
["Description of confidential patient information used","Data sources\n1. HES and ONS data, held by NHS Digital\n2. The National Adult Cardiac Surgery Audit within NICOR, held by Barts Health NHS Trust \n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Date of surgery\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained in the dataset used for analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-12-23"]
["Next Review Date","2024-12-23"]
["Notes","12 February 2024 - change in data processors from;\n•\tNHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Civil Registration mortality data\n•\tAnd from Barts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, (NICOR) National Adult Cardiac Surgery Audit.\n\n\n23 December 2021 - Application supported\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 17 September 2021. \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the  relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the  ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: The NHS Digital 2020/21 DSPT review for Barts Health NHS Trust was confirmed as  ‘Standards Met’ on the NHS Digital DSPT Tracker (23 September 2021)\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02650","index":691,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","02650"]
["Reference","21/CAG/0175"]
["Other Refs","IRAS Project ID: 304779  REC Reference: 21/CAG/0174"]
["Application Title","Peer support Observational Ethnography – Theory in Context (POETIC) Study"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research to explore how mental health support workers integrate and work with the wider mental health team, and whether institutional logics support, compete with or conflict with peer support worker role implementation. \n\nPeer support worker (PSW) roles are increasingly becoming an integral part of mental health systems in the United Kingdom. However, evaluations of peer support role implementation consistently identify that organisational culture is the largest influence on the successful implementation of peer support worker roles. The study will focus on peer support workers who are employed at Nottinghamshire Healthcare NHS Foundation Trust. The co-investigator will undertake non-participant observation of peer support workers daily activities by concentrating on their interactions, behaviours, language, and dynamics with each other, other team members, and non-team members, e.g., non-NHS staff, service users, and family members, with a specific focus on understanding the peer support worker role in its context. Following this, the co-investigator will also interview a range of team members and elicit their perspectives about working alongside peer support workers and their role. In parallel, the co-investigator will also collect documents relating to the peer support worker role.\n\nThe applicants will use a qualitative and ethnographic approach to investigate how institutional logics may influence the implementation of peer support worker roles in a mental health organisation. The study will take place at two services within Nottinghamshire Healthcare NHS Foundation Trust. The applicants will observe peer support workers undertaking their daily activities, concentrating on their interactions, behaviours, language and dynamics with each other and with other team members and non-team members. The observations will be conducted for two to three days per week, with each period of observation lasting up to 6 hours. Those observed have been divided into two Groups; Group A – comprised of other NHS staff members from the same team, and Group B – comprised of anyone else, including other NHS staff not in the peer support worker's team, service users, informal carers, who may be present. The co-investigator will also conduct up to forty semi-structured interviews with participants, comprising of peer support workers and other Group A members. The applicants will also collect documents relating to the peer support worker role.\n\nSupport is sought as the observations will include observation of peer support workers encounters with each other, Group A members, and Group B members, e.g. at multi-disciplinary team meetings where all team members meet to discuss team issues, and/or PSWs discussing their day-to-day tasks with other staff members in the team office space, and/or PSWs delivering one-to-one sessions with service users. The types of conversations in the team office may include work-based discussions e.g. queries about tasks, duties, information technology-based questions, and upcoming meetings with service users. The observers may be exposed to confidential patient information during these observations. "]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Mike Slade, Professor of Mental Health Recovery and Social Inclusion"]
["Address","School of Health Sciences, University of Nottingham"]
[null,"Institute of Mental Health, Innovation Park, "]
[null,"Nottingham"]
["Postcode","NG7 2TU"]
["Telephone","0115 823 1294"]
["Email","m.slade@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort under investigation is peer support workers and other members of staff in the same NHS team as the peer support worker. 40 members of staff will be involved. \n\nThe confidential patient information potentially disclosed during observations will relate to service users of the two services at Nottinghamshire Healthcare NHS Foundation Trust."]
["Description of confidential patient information used","Data sources\nIncidental disclosures of confidential patient information may be made when the applicant observes multi-disciplinary team meetings and peer support workers undertaking their usual activities. \n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be retained for linkage. \n\nIdentifiers required for analysis purposes\nNo items of confidential patient information will be retained for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-01-07"]
["Next Review Date","N/A"]
["Notes","07 January 2022 - Application supported\n\nSpecific conditions of support:\n\n1. The notification needs to be revised to specify the patient group that will be observed and that support under Regulation 5 of the Control of Patient Information (COPI) Regulations (also known as ‘s251 support’) has been granted. The revised notification is to be submitted within one month of the issuing of this outcome letter. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 13 December 2021. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\n\nThe NHS Digital 2020/21 DSPT review for the University of Nottingham was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (06 December 2021).\n\nThe NHS Digital 2020/21 DSPT review for Nottinghamshire Healthcare NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (16 December 2021). \n\nThe applicant confirmed in August 2022 that ‘s251’ support is no longer required because no personal data was collected for the study. The study was regarding incidental exposure as part of observations undertaken and these have now finished as the study itself has finished. Therefore, there will be no ongoing exposure to personal data without consent. \n\nRegarding public benefits, findings of this study are likely to generate new insights into peer support worker role implementation. This research will be beneficial in informing the implementation strategy of new peer support worker roles in the mental health trust in which the study was undertaken and will highlight some of the barriers and facilitators which may support best use of this new emerging workforce. In addition, the findings will also be applicable and transferable to other mental health services implementing peer support worker roles. \n"]

{"sheet":"A02651","index":692,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02651"]
["Reference","20/CAG/0101"]
["Other Refs","IRAS Project ID: 285996  REC Reference: 20/NW/0430"]
["Application Title","FFRCT In Stable Heart disease & CTA Helps Improve Patient care and Societal costs"]
["Application Summary","This application from Liverpool Heart and Chest Hospital NHS Foundation Trust sets out the medical purpose to undertake medical research to determine which of two diagnostic pathways are superior in the chest pain pathway.\n\nChest pain may be a symptom that is related to a narrowing of the heart blood vessels (coronary artery disease [CAD]). This chest pain, known as angina, can result in a reduced quality of life and, if not diagnosed and managed appropriately, could result in a heart attack. Guidelines recommend the use of tests to help diagnose and manage chest pain ‘angina’ patients. Coronary computed tomography angiography (CCTA) is a test that takes images of the heart blood vessels. It is the main test for patients presenting with angina. A new technology, CT-derived fractional flow reserve (FFRCT) uses the CCTA images to make a 3D model of the heart blood vessels that shows whether there is a limitation in the blood flow to the heart which is causing the symptoms. The National Institute for Health and Care Excellence (NICE) recommends the use of FFRCT in a chest pain pathway. However, use of this new technology remains limited due to funding restrictions and uncertainty as to its benefit in the NHS. \n\nThis study will collate the data of approximately 120,000 patients from participating NHS Trusts. Confidential patient information from participating Trusts will be linked with data from the Hospital Episode Statistics (HES) database, diagnostic imaging data (DID) set and the emergency care dataset (ECDS).. In addition, Trusts will also provide patient referral to treatment time (RTT) data, including NHS number. Further, a commercial entity, Heartflow (who receive patient data for clinical purposes related to FFRCT) will provide FFRCT data. The exact data flows were unclear, and the CAG requested that further clarifications, detailed below, were provided. "]
["Applicant Organisation Name","Liverpool Heart and Chest Hospital NHS Foundation Trust"]
["Contact Name","Dr Timothy Fairbairn, Consultant Cardiologist, Honorary Lecturer,"]
["Address","University of Liverpool"]
[null,"Liverpool Heart and Chest Hospital,"]
[null,"Thomas Drive, Liverpool"]
["Postcode","L14 3PE"]
["Telephone","0151 600 1477"]
["Email","timothy.fairbairn@lhch.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals at participating NHS Trusts that received a CTCA during the 2-year period of the national FFRCT programme (2018-2020) and a year prior to the programme (2017-2018)"]
["Description of confidential patient information used","Data sources:\n1. Participating NHS Trusts\n2. Heartflow\n\nIdentifiers required for linkage purposes:\n1. NHS Number\n2. Hospital ID number\n3. Postcode – district level\n\nIdentifiers required for analysis purposes:\n1. Gender\n2. Postcode\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-01-28"]
["Next Review Date","2025-01-28"]
["Notes","21 February 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Medicines Dispensed in Primary Care Data Set (from NHS Business Services Authority (BSA)), Hospital Episode Statistics (HES), (including Admitted Patient Care (APC), Critical Care (CC), Outpatients (OPC), & Accident and Emergency (AE)), Diagnostic imaging data (DID), the emergency care dataset (ECDS) and Civil Registration Deaths.\n\nAmendment supported 21 February 2023 to include full date of death as a data item, received from Civil Registration Deaths dataset, (retained by NHS England, previously NHS Digital)\n\nAmendment supported 20 December 2022 to include NHS Business Services Authority (BSA) dataset as a data source, (retained by NHS England, previously NHS Digital)\n\n28 January 2021 - Application Supported:\n\nSpecific conditions of support\n1. Favourable opinion from a Research Ethics Committee. Confirmed – 12 January 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- Liverpool Heart and Chest Hospital NHS Foundation Trust - NHS Digital have confirmed qualified assurance against the organisation’s 2018/19 DSPT submission on the basis that the Trust has not met the 95% standard relating to staff security awareness training. \n\nAs a result, the following specific condition of support has been added: all staff involved in processing data under this section 251 support must have successfully completed local security awareness training before processing any data."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02652","index":693,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02652"]
["Reference","21/CAG/0176"]
["Other Refs","IRAS Project ID: 306395  REC Reference: 21/WM/0281"]
["Application Title","What Are the Organisational And Cultural Issues That Affect the Maintenance of Safety During The Management Of High Security Forensic Patients Outside of the High Secure Setting"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research that seeks to explore the organisational and cultural factors that contribute to effective safety management when a high secure patient is managed outside of the secure setting.\n\nSecurity plays a primary role within a forensic environment, as it maintains the safety of patients, staff and the general public and allows the patient to experience the most beneficial therapeutic environment because of the reduction in risk of harm. The primary risk of security breaking down is when systems interact. System interactions includes movement between departments, from hospital to community, from prison to hospital and between hospitals. This application has been created to look at how safety is maintained when high secure patients are managed outside of the secure setting during leaves of absence, which happen to enable patients to access healthcare such as treatment at hospital, to attend court or to attend a leave trial at a medium secure hospital, to be transferred to prison, or for leave on compassionate grounds. Leave of absences (LOAs) are classed as a high-risk activity because of the absence of structural aspects of security, that is, the locks, the fences, the CCTV, the alarms and the additional staff. In addition to this, the act itself exposes or potentially exposes these patients to the public, which can present opportunities for psychological and physical harm towards the patient, general public and staff. This also risk damaging the reputation of the hospital and the confidence from the public that the hospital has ability to contain these risks. The LOAs of high-risk patients are meticulously planned, looking at both historical and dynamic risks. This activity involves multidisciplinary team planning and also working in partnership with other organisations such as Ministry of Justice, courts, police, general hospital staff and their security staff, etc. Thus, there are also different staff with roles involved in the activity, for example, the actual LOA itself is often led by a nurse with several healthcare assistants with the numbers determined by the risks that the individual patient is deemed to pose. Thus, in order for this activity to be carried out smoothly several organisational and cultural aspects need to be considered to understand how the aspects interact in order to maintain safety. Although these activities rarely go wrong, it is important to consider this activity from a safety perspective, in order to understand how to learn from the aspects that contribute to the maintenance of safety during such activities when they work well.\n\nThe applicants will conduct interviews with staff and management from different wards and departments that are involved in the maintenance of safety during the planning and implementation of LOAs from high secure forensic hospitals. Ethnographic observations will be completed in person in the setting, this will be opportunistic in the respect of LOAs, briefings, debriefings and serious incident feedback meetings involving LOAs that take place in the data collection time frame from January 2022 to the end of December 2022. The applicants will also review current policies, protocols and procedures relating to LOAs. Reviews of incident reports will also be undertaken by the researchers. Support is sought as the applicants may be exposed to confidential patient information when undertaking ethnographic observations. No patient information will be recorded by the researchers, as the study is exploring safety management processes only. "]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Stephen Timmons, Professor of Health Services Management"]
["Address","University of Nottingham, Nottingham University Business School (NUBS)"]
[null,"Jubilee Campus"]
[null,"Nottingham"]
["Postcode","NG8 1BB"]
["Telephone","0115 846 6635"]
["Email","stephen.timmons@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort involved are staff at Broadmoor Hospital, West London NHS Trust"]
["Description of confidential patient information used","Data sources:\n1. Interviews and observations conducted with staff at Broadmoor Hospital.\n\nIdentifiers required for linkage purposes:\nNo patient information is required for linkage purposes. \n\nIdentifiers required for analysis purposes:\nNo patient information is required for analysis purposes. \n\nAdditional information:\nThe applicants have ticked “Name” in Q37, however have clarified that this is not be required for the study. Patient names will not be documented in field notes and will be redacted from interview data.  "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-01-25"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as the activity was never able to commence.\n\n25 January 2022 - Application Supported:\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 25 January 2022 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for University of Nottingham and West London NHS Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 07 December 2021)"]

{"sheet":"A02653","index":694,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02653"]
["Reference","21/CAG/0113"]
["Other Refs","IRAS Project ID: 287117  REC Reference: 21/WA/0177"]
["Application Title","A comprehensive assessment of peri-prosthetic fractures associated with the CPT® stem in a large teaching hospital over 16 years"]
["Application Summary","This application from Nottingham University Hospitals NHS Trust set out the purpose of medical research that aims to define the incidence of Peri-prosthetic fractures (PPF) related to cemented collarless polished tapered stem (CPT®) design, by linking a retrospective consecutive series of patients who received the CPT® stem for primary THR at Nottingham University Hospitals NHS Trust to Hospital Episode Statistics (HES) data to identify all hospital admissions within the cohort with a femoral fracture. Applicants will also investigate if any particular risk factors can be identified.\n\nPPF are a serious complication of total hip replacement (THR). Recent publications have suggested a higher prevalence of PPF with the CPT® stem compared to other polished taper stem designs and a higher revision rate for PPF in the UK National Joint Registry (NJR). Nottingham began using this stem design in 2009 and have not identified a significant cohort of patients suffering PPF, however, the true incidence may be unknown, as some patients may undergo fixation that is not recorded in the NJR. \n\nApplicants will disclose confidential patient information alongside a pseudonymous ID to NHS Digital in order to link to HES to identify all A&E visits with coding related to femoral fracture during the lifetime of each implant. NHS Digital will return a pseudonymous dataset to the applicant, however this flow will still require support as the applicant will be able to re-identify the data. The applicant will link back to their clinical dataset using the pseudonymous ID. Once identified, the clinical team will review admission xrays and subsequent treatment xrays from Nottingham University Hospitals NHS Trust. After linkage, the dataset will be anonymised for analysis. "]
["Applicant Organisation Name","Nottingham University Hospitals NHS Trust"]
["Contact Name","Mr Andrew Manktelow, Orthopaedic Consultant "]
["Address","Nottingham University Hospitals NHS Trust "]
[null,"Nottingham City Hospital "]
[null,"Nottingham"]
["Postcode","NG5 1PB"]
["Telephone","0115 924 9924"]
["Email","andrew.manktelow@nuh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who have received the CPT stem for primary THR in Nottingham University Hospitals NHS Trust\n\nBetween April 2009 and April 2020, n=2852"]
["Description of confidential patient information used","Data sources:\n1. Nottingham University Hospitals NHS Trust: \n• Existing arthroplasty audit database (clinical database)\n• Local imaging data\n\n2. Hospital Episode Statistics (HES) – NHS Digital\n\nIdentifiers required for linkage purposes:\nTo link to HES:\n1. NHS number\n2. Date of Birth\n3. Postcode\n4. Pseudonymous ID\n\nIdentifiers required for analysis purposes:\nN/A – no confidential patient information required for analysis\n\nAdditional information:\nPseudonymous ID will be added by the Trust. \n\nLinkage key of pseudonymous ID numbers linked to NHS numbers will be kept on hospital intranet in secure folder this file will be password protected and accessible only by CI.  direct care team only - no support required. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-01-24"]
["Next Review Date","2024-01-24"]
["Notes","24 January 2022 - Application Supported:\n\nConditions of support:\n1. Please provide a report on the study specific patient and public involvement undertaken at the time of the first annual review.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 09 June 2021.\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- \nThe NHS Digital 20/21 DSPT equivalent review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 28 October 2021). The NHS Digital 20/21 DSPT review for Nottingham University Hospitals NHS Trust was confirmed as ‘Standards Met’ by email to the CAG inbox (21 January 2022)"]

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[]
[]
["Application Number","A02654"]
["Reference","22/CAG/0017"]
["Other Refs","IRAS Project ID: 261218  REC Reference: 19/WM/0155"]
["Application Title","Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe): a multi-centre randomised controlled trial"]
["Application Summary","This application from the University of Warwick set out the purpose of medical research of a multi-centre randomised controlled trial (RCT) to test if supervised pulmonary hypertension exercise rehabilitation (Sphere), a programme of online remotely supervised, home-based exercise rehabilitation, with psychosocial and motivational support, can improve walking distance and quality of life (QoL), more than best-practice usual care, in people with all forms of pulmonary hypertension (PH) (particularly groups 2 & 3). This application to CAG is only for the screening and inviting of eligible patients to consent to the trial, by a researcher who is not considered part of the direct care team, in Patient Identification Centres (PIC) where the direct care team has indicated they do not have capacity to do so. This trial has been running since 2019 using only the direct care team to screen and invite eligible patients, however participating sites have identified that the direct care team have low or no capacity to undertake this activity.\n\nPH is a debilitating long-term condition characterised by severe exercise intolerance. Pulmonary and cardiovascular function are progressively compromised, often during minimal physical exertion. Consequently, exertional breathlessness, fatigue and dizziness are common, impacting on QoL, morbidity and mortality. For people with PH secondary to cardiac or pulmonary disease (groups 2 & 3), there are no specific treatments of proven benefit. Supervised exercise rehabilitation is a common treatment for many heart and lung conditions, however, exercise rehabilitation has not yet been adequately tested in PH groups 2 & 3, or in an out-patient setting in the UK. This RCT will examine if exercise rehabilitation for PH delivered in an NHS out-patient setting is effective or cost effective, or if there are any long-term health benefits or harms. \n\nAll patients are consented in to the trial, and the main trial therefore does not require ‘s251’ support. Potential participants will be invited to participate by clinical teams involved in their care, which does not require ‘s251’ support, or by the SPHERe Clinical Research Fellow (CRF) based at Warwick Clinical Trials Unit (WCTU) at some PIC sites, which does require ‘s251’ support. The SPHERe CRF will support PIC sites in their screening and mail out work. To do so, this person will require access to medical records to screen for eligibility, and name and address in order to send out invitation letters. In doing so, they will therefore be processing confidential patient information without consent. No confidential patient information will be disclosed to the University of Warwick without the consent of the patient to do so."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Dr Gordon McGregor, Chief Investigator "]
["Address","Warwick Clinical Trials Unit"]
[null,"University of Warwick"]
[null,"Coventry"]
["Postcode","CV4 7AL "]
["Telephone","07772 462 255 "]
["Email","sphere@warwick.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","352 Adults with pulmonary hypertension (groups 1-5) from at least 10 centres will be consented and randomised. \n\nHowever CAG support is required for all those screened and invited. Applicants estimate that approximately 1000 patients will be screened per PIC site by the Warwick CRF. Applicants further estimate that approximately 25-35% of those screened will be eligible to invite.\n\n32 participants have been recruited to the trial to date, and ‘s251’ support does not extend to these individuals. \n"]
["Description of confidential patient information used","Data sources\nParticipating Patient Identification Centres (PIC); \nHospital medical records, (both paper notes and electronic medical records) including clinic letters, discharge records, operation notes and scan reports e.g. echocardiogram reports. Screening may also include local secondary care disease registers.\n\nIdentifiers required for screening/identification purposes, and for inviting patients to consent\n1. Access to full medical record to determine diagnosis of PH\n2. Date of Birth (to check eligibility)\n3. Patients full name (to send invitation letter)\n4. Patients address including full postcode (to send invitation letter)\n\nIdentifiers required for analysis purposes\nN/A - all data for analysis is collected with consent\n\nAdditional information\nIn all instances, an appropriately qualified clinician will be asked to confirm diagnosis prior to any patient contact.\n\nConfidential patient information will not be disclosed from the NHS Trust to the University of Warwick until the patient has consented into the trial.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-01-31"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as the study has finished recruiting and is no longer engaging in screening activities for which section 251 was granted. Identifiable patient information is no longer being processed as no study staff are accessing NHS Trust records. Recruitment ended on 31Aug2023.\n\nAmendment supported 16 August 2023 to extend the end of recruitment to 31 August 2023, which will therefore extend the duration of ‘s251’ support.\n\nAmendment supported 13 February 2023 \nTo extend the end of recruitment from 30 November 2022 to 31 March 2023, which will therefore extend the duration of ‘s251’ support\n\n31 January 2022 - Application Supported\n\n1. Please confirm if someone receives an invitation letter but does not respond to it, will further invites be sent? If so, then how many? Please provide a response to CAG within three months from the date of this letter. Condition met 22 April 2022\n\n2. Please undertake further patient and public involvement with some additional patient representatives, in order to explore the acceptability of this use of confidential patient information without consent, and provide feedback to the CAG within three months from the date of this letter. Condition met 27 October 2022\n\n3. Please confirm whether the CRF will have enough information about whether the patient has capacity to consent, or if the CRF will be able to discuss this with the clinical care team in order to ensure every person who has capacity to consent is offered the opportunity to take part. Please provide a response to CAG within three months from the date of this letter.\nCondition met 22 April 2022\n\n4. Favourable opinion from a Research Ethics Committee. \nConfirmed: Amendment 4 10 January 2022\n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- As there are more than 5 organisations processing confidential patient data these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for these organisations have been assessed as ‘standards met’ by NHS Digital"]

{"sheet":"A02655","index":696,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02655"]
["Reference","21/CAG/0149"]
["Other Refs","IRAS Project ID: 264198  REC Reference: 21/LO/0551"]
["Application Title","Legacies and Futures: Gestational Parents' Experiences with Vulnerability and Resilience as it Influences Parent and Neonatal Health"]
["Application Summary","This application from University College London sets out the purpose of medical research that aims to research what roles resilience and vulnerability play in the health and wellbeing of LGBTQ+ gestational parents, as compared to their cis-heterosexual peers, during their antenatal care and their neonates.\n\nThere is an assumption that those using pregnancy-related health services are cisgender and heterosexual. The patient population also includes those of different genders and sexual orientations. Structural cis-genderism and hetero-sexism in reproductive healthcare may cause stressors of stigma and discrimination, including social and medical exclusion, during critical windows of foetal development. Stress and discrimination are linked to higher rates of miscarriage, preterm birth, macrosomia, and other undesirable birth outcomes. These stressors affect more than 525,000 lesbian, gay, bisexual, queer, and/or transgender (LGBTQ+) potential gestational parents in the UK, resulting in preventable higher risk for prenatal complications. The applicants intend to assess the impact of vulnerability as a measure of minority stress and systemic exclusion, alongside multi-level resilience factors.\n\nFour sites, University College London Hospitals NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, Imperial College Healthcare NHS Trust and King’s College Hospital NHS Foundation Trust, have been selected as recruitment sites, based on higher rates of LGBTQ+ residents in their catchment area. A monthly report will be run by the Principal Investigator or a supporting IT midwife at each site. This report will include active antenatal patients with a gestational age lower than 36 weeks. This list will be transferred to the Data Safe Haven at University College London, where the researcher will access the information. A selection of participants from this list will be emailed by the researchers and invited to take part in the study. LGBTQIA+ participants will be matched with cis-heterosexual parents accessing antenatal services at the same care site. Matching cases across the groups controls for potential confounders, including geographic and temporal differences that would otherwise not key to the overall analysis as individual variables. If interested, participants will follow a link in the email to a screener questionnaire that will be used to assess eligibility.  If eligible, patients will be emailed with an invitation to participate in the study and sent a link to provide consent and complete the study surveys. Their participation will then proceed on a consented basis. Support is needed for the research team to receive the list of patients from the participating sites and to email eligible patients. "]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr. David Frost, Associate Professor of Social Psychology"]
["Address","University College London"]
[null,"Thomas Coram Research Unit"]
[null,"27-28 Woburn Square, London"]
["Postcode","WC1H 6403"]
["Telephone","020 7612 6403"]
["Email","d.frost@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18-49 years who identify as lesbian, gay, bisexual, queer and/or transgender, or cisgender and heterosexual, and who are currently pregnant and receiving antenatal care at one of the 4 study sites. \n\nThe applicants anticipate that 800 patients will be included. "]
["Description of confidential patient information used","Data sources:\n1. Electronic and paper records held at 4 participating sites:\n• University College London Hospitals NHS Foundation Trust\n• Brighton and Sussex University Hospitals NHS Trust \n• Imperial College Healthcare NHS Trust\n• King’s College Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes:\n1. Name\n2. Hospital ID number\n3. Date of birth\n4. Date of death\n5. Postcode – district level\n\nIdentifiers disclosed to the Data Save Haven at UCL for contact purposes:\n1. Name\n2. Email address\n3. Gestational due date\n\nIdentifiers required for analysis purposes:\n1. Date of birth\n2. Date of death\n3. Postcode – district level\n4. Gender\n5. Ethnicity\n6. Sexual orientation\n\nAdditional information:\nThe scope of support only extends to the sharing of contact details with the researchers. Once consent has been given, patients will complete online surveys and an at-home journal. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-01-31"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in April 2024 that ‘s251’ support could be expired, as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, being able to reach the population of interest within the participating sites would not have been possible without the CAG-supported recruitment efforts. This includes consideration for alternative methods for reaching these patient populations, such as social media and community groups. The level of participation that has been facilitated by CAG approach will allow for the research outcomes to provide a better understanding of the roles of stressors and resilience resources within the context of ante- and perinatal care, including providing considerations for improving outcomes and providing healthcare services in a way that should help to reduce the rates of minority stress in reproductive health services.\n\n\n15 November 2022 – amendment supported to \nInclude two additional sites Epsom and St Helier University Hospitals NHS Trust and Lewisham and Greenwich NHS Trust, and to make changes to the materials sent to patients.\n\n21 July 2022 – amendment supported to add St George’s University Hospitals NHS Foundation Trust as a data processor.\n\n22 April 2022 - Amendment supported\nAmendment supported to include additional participating Trusts as new data processors.\n\nConditions of support:\n1. Provide a report on the progress of recruitment within 3 months of the Fully Supported Outcome being issued.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 10 September 2021. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for University College London, University College London Hospitals NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust and King’s College Hospital NHS Foundation trust are confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked date 14 October 2021).\n\nThe NHS Digital 2020/21 DSPT review for Imperial College Healthcare NHS Trust is pending. "]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02656","index":697,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02656"]
["Reference","21/CAG/0132"]
["Other Refs","IRAS Project ID: 300674  REC Reference: 21/LO/0565"]
["Application Title","Evaluating the health inequality effects of the Best Practice Tariff for hip fracture"]
["Application Summary","This application from the University of York (UoY) set out the purpose of medical research that seeks to explore whether the introduction of the best practice tariff (BPT) for fragility hip fracture in 2010 and subsequent changes to its components in 2017 led to changes in health inequalities across the population of England. This is a retrospective, observational study, which proposes to link clinical information which is already collected as part of the National Hip Fracture Audit database (NHFD) with Hospital Episode Statistics (HES) data and Office for National Statistics (ONS) Mortality data, using NHS Digital as a trusted third party to create the bridging file. ‘s251’ support is required to undertake linkage between the datasets. \n\nA hip fracture is a serious injury that carries a risk of death and long-term pain. It is possible that the introduction of the hip fracture BPT might lead to improvements in care delivery that benefit predominantly those with higher socioeconomic status, thereby widening inequalities. Applicants will compare how care changed in Wales over time to how care changed in England over time to tell us what difference BPTs made to each socioeconomic group of people. Applicants will then be able to describe the impact of BPTs on quality and length of life across the whole population.\n\nIn order to undertake this linkage, Crown Informatics, who process the NHFD data on behalf of Royal College of Physicians (RCP), will transfer confidential patient information to NHS Digital, (as the data controller for HES and ONS mortality data) to generate a bridging file containing NHFD ID and HES ID which is then disclosed to the applicants at UoY. Crown informatics will also disclose a clinical dataset containing NHFD ID to the applicant at UoY. The Centre for Health Economics at UoY already holds linked HES+ONS data that are used for a number of research projects, which contains HES ID, and also contains full date of death. NHFD and HES+ONS data will be linked by a member of the research team, using the bridging file, after which, the bridging file and the HES ID / NHFD ID in the resulting dataset will be deleted. Dates of events will be used to calculate time interval in days between events, so that the final analysis dataset will not include any dates. This will be effectively anonymous for analysis. "]
["Applicant Organisation Name","University of York"]
["Contact Name","Professor Susan Griffin"]
["Address","Centre for Health Economics"]
[null,"University of York"]
[null,"Heslington"]
["Postcode","YO10 5DD"]
["Telephone","0190 432 1401"]
["Email","susan.griffin@york.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 600,000 hip fracture patients in England\nand Wales during the period 01 April 2008 to 31 March 2020\n\nAll individuals included in the National Hip Fracture Database will be included. "]
["Description of confidential patient information used","Data sources:\n1. Crown Informatics (on behalf of the Royal College of Physicians, commissioned by HQIP); National hip fracture audit database. \n\n2. NHS Digital – controller for Hospital Episode Statistics (HES) data and Office for National Statistics (ONS) mortality datasets, however the Centre for Health Economics at University of York already holds HES+ONS data, and outcomes will be sourced from this dataset (provided to UoY under DARS-NIC-84254-J2G1Q). \n\nIdentifiers required for linkage purposes:\nDisclosed from NHFD to NHS Digital:\n\n1. NHS number\n2. Date of Birth\n3. Postcode\n4. Sex\n5. NHFD ID\n\nBridging file disclosed from NHS Digital to University of York:\n1. NHFD ID \n2. HES ID\n\n(not possible for applicants to re-identify patients)\n\nIdentifiers required for analysis purposes:\n1. LSOA (provided by Crown informatics)\n2. Sex\n3. Date of death – modified to survival time from admission (in days).\n\nEffectively anonymous to applicants\n\nAdditional information:\nHES & ONS outcome data will be extracted for all included patients up until up to 31st March 2020."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-02-10"]
["Next Review Date","2024-02-10"]
["Notes","28 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Office for National Statistics (ONS) mortality\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 29 July 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- The NHS Digital 20/21 DSPT reviews for Crown informatics, NHS Digital and University of York EE133913-CHE were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 October 2021)\n"]

{"sheet":"A02657","index":698,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02657"]
["Reference","22/CAG/0021"]
["Other Refs","IRAS Project ID: 300247  REC Reference: 22/WA/0027"]
["Application Title","The South London Stroke Register: Improving the lives of stroke survivors with data. (SLSR)"]
["Application Summary","This application from King's College London set out the purpose of medical research which aims to develop the South London Stroke Register (SLSR) to estimate the incidence of stroke and its outcomes in South London (Lambeth and Southwark) to address key questions in stroke epidemiology, particularly around the health of newly classified mild stroke patients and long term stroke survivors.\nThe SLSR is a consented observational study which has been recruiting patients since 1995, and at present there are over 7,000 people on the register. Data from the SLSR have underpinned improvements in acute stroke care and rehabilitation in the UK, which have led to reduced stroke death and disability, better long-term health outcomes, and cost savings for the NHS. Stroke is the fourth leading cause of death in the UK and the single largest cause of complex disability in adults. Definitions of stroke are changing, and therefore updated data is required to describe survivors' needs and outcomes adequately. The updated SLSR will address the challenges posed by the changing nature of stroke leading to future improvements in stroke care and patient outcomes. Since 1995, the SLSR team have been screening and consenting patients at the Trusts, however due to evolution in Trust policy, the clinical researchers are no longer considered direct care team, and ‘s251’ support is now requested. \n\nAs a consented register, ‘s251’ support is not required for the majority of study processes. However ‘s251’ support is sought for members of the SLSR research team from King's College London, who are not considered direct care team, to screen medical records at participating Trusts in order to identify eligible participants for the purposes of seeking consent. The applicants reason that this would be too onerous for the direct care team to undertake. If a patient does not consent within 6 months, their confidential patient information is deleted. No identifiable data items will leave the Trusts without the consent of a patient or their consultee. ‘s251’ support is also required for members of the SLSR research team from King's College London, to view confidential patient information regarding eligible patients who are deceased, in order to collect a pseudonymous dataset for analysis. No identifiable data will be disclosed outside of the Trusts. The applicants reason that it is important that data can be collected about people who have died from stroke. These people are more likely to have experienced severe stroke, adverse health or socioeconomic circumstances, or in some cases possibly poor quality care."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Iain Marshall, Chief Investigator"]
["Address","School of Life Course and Population Sciences\nKing’s College London\n"]
[null,"3rd Floor, Addison House, Guy's Campus"]
[null,"LONDON "]
["Postcode","SE1 1UL"]
["Telephone"]
["Email","iain.marshall@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with a confirmed first stroke (WHO ICD-11 clinical definition)¬  since 1st October 2021 who live in the Lambeth and North Southwark areas of South London\n\nApproximately 400 patients will be recruited prospectively per year. (2000 total over 5 years)\n\nApplicants estimate approximately 4000 records would need to be viewed per year to identify 400 potential participants annually. Therefore ‘s251’ support required for approximately 20,000 individuals records to be screened."]
["Description of confidential patient information used","Data sources:\n1. Guy's and St Thomas' NHS Foundation Trust and\n2. King's College Hospital NHS Foundation Trust \n\nPatient medical records (paper and electronic notes), and hospital ward lists, including stroke clinic lists, radiology reports, Electronic patient records (EPR)\n\nIdentifiers required for screening and inviting patients to consent:\nScreening:\n1. Access to medical records [Screening for eligibility]\n2. Postcode [Screening for eligibility]\n3. NHS number [Screening for eligibility]\n4. Hospital ID [Screening for eligibility]\n\nInvitation:\n5. Name\n6. Hospital number\n7. Ward location [inpatients] \n8. Telephone number [discharged patients] \n\nIdentifiers required for analysis purposes (relevant for deceased patients only, as the rest of the cohort is consented):\n1. Date of Birth (modified to age in years at time of stroke)\n2. Date of death (modified to days from stroke until death)\n3. Postcode (modified to area-based socioeconomic score)\n4. Ethnicity recorded as ONS broad category\n5. Sex\n\nTherefore this can be considered anonymous for analysis as the register staff will not have access to CPI regarding deceased patients at KCL. \n\nAdditional information:\nNo confidential patient information will be disclosed outside of participating trusts without consent."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-02-16"]
["Next Review Date","2025-02-16"]
["Notes","Amendment support 15 November 2023 to allow linkage with NHS England data on mortality (date and cause of death) and Hospital Episode Statistics (HES) for all SLSR patients who are either deceased or who had their last follow-up contact with the study team more than 5 years ago\n\nAmendment supported 25 May 2023 for Dr Iain Marshall to replace Professor Charles Wolfe as Chief Investigator\n\nConditions of support:\n1. Support provided for 5 years in the first instance to match the current funding. A duration amendment will be required at this timepoint to extend the duration of ‘s251’ support.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 9 February 2022\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 20/21 DSPT reviews for Guy's and St Thomas' NHS Foundation Trust (RJ1) and King's College Hospital NHS Foundation Trust (RJZ) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 01 February 2022)"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02658","index":699,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02658"]
["Reference","21/CAG/0155"]
["Other Refs","IRAS Project ID: 275649  REC Reference: 20/EM/0025"]
["Application Title","Using patient records to identify potential participants for the fourth National Survey of Sexual Attitudes and Lifestyles (Natsal-4)"]
["Application Summary","This application from the University College London set out the purpose of medical research that seeks to use confidential patient information held by NHS Digital, to create a sampling frame in order to invite English participants to consent into the fourth National Survey of Sexual Attitudes and Lifestyles (Natsal-4). Natsal is the world’s largest, most detailed study of sexual behaviour, and has taken place every 10 years (1990, 2000, 2010). Previous iterations have used an address-based sample frame (Postcode Address File - PAF), and conducting eligibility screening and selection on the doorstep. However this has been found to be inefficient, especially regarding young person and ethnic minority boost samples, who experience a disproportionate burden of adverse sexual and reproductive health outcomes. The applicants plan to use name based sampling for the ‘dress rehearsal and mainstage’ of Natsal-4, but will also include the address based sampling into their ethics application as a back-up in case they cannot implement the names based method in time. However they do not consider this to be a practicable alternative to CAG support, due to the huge inefficiencies found in implementation, and the lack of ability to include boost samples.\n\nNatsal-4 will provide updated nationally representative data on sexual and reproductive health. Past equivalent data has been extensively used to guide policy and practice, including to improve sexual health education, design interventions (e.g. chlamydia screening, teenage pregnancy strategy, HPV vaccination) and deliver health services.\n\nThe Natsal research team at NatCen provide NHS Digital with a specification of the sample file requirements. This will provide the number of records required, the geographical areas to be included, and the stratification requirements (e.g. by age, ethnicity, and potentially other demographic stratifiers). NHS Digital will create a named sampling frame from Demographics and HES datasets, and provide this information to NatCen. NatCen will disclose this information on to Formara, and also to individual interviewers in order for them to consent patients as part of fieldwork. Natsal-4 aims to achieve a consented sample of 10,000 participants aged 16-59 who will be randomly selected from across Britain. Applicants plan to include young person (16-29 year olds) and ethnic minority boost samples to ensure robust subgroup analyses in these groups. Prior to the letters being sent, the applicants plan to have a notification on the study website, so people can opt out of this if they wish.\n\nFormara send out invitation letters to patients, which also have an opt out option included on the letter. Approximately a week later, an interviewer will visit the address of the selected individual and will explain the study further. This is the same approach used in a number of other social surveys (including the Mental Health of Children and Young People 16/CAG/0016). The patient is then consented into the study, and asked to complete a computer-assisted questionnaire, provide a biological sample (urine or vaginal swabs) and consent to data linkage, and these elements are therefore out of scope for support as they are undertaken with consent as the legal basis under common law. "]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Pam Sonnenberg"]
["Address","University College London"]
[null,"UCL Institute for Global Health Mortimer Market Centre"]
[null,"off Capper Street, London "]
["Postcode","WC1E 6JB"]
["Telephone","020 3108 2077"]
["Email","p.sonnenburg@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Participants aged 16-59 resident in private households in England. \n\nUp to 80,000 will be approached via letter in order to consent 10,000.\n\nBoost samples of young people (16-29) and ethnic minorities will also be recruited, this is included in the above figures."]
["Description of confidential patient information used","Data sources:\n1. NHS Digital:\n   a. Demographics\n   b. Hospital Episode Statistics (HES) \n\nIdentifiers required for linkage purposes:\n1. Full name\n2. Address including postcode\n3. Gender\n4. Date of birth\n5. Ethnicity\n\nIdentifiers required for analysis purposes:\nN/A - any data for analysis is retained with consent"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-02-16"]
["Next Review Date","2025-02-16"]
["Notes","01 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources Demographics & Hospital Episode Statistics (HES).\n\nAmendment supported 13 September 2022\nTo allow a 3rd option for sending invitations out – using an ‘enhanced address-based sample’\n\n17 March 2022 - Amendment supported\nAmendment supported to to allow the disclosure of confidential patient information from the Welsh Demographics dataset, held by Digital Health and Care Wales, to NatCen, who will then send the mail merge files to Formara, a sub-processor who will carry out print and dispatch, in order for Formara to send out invitation letters to eligible patients, and to allow onwards disclosure of confidential patient information to interviewers.\n\n16 February 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 20 January 2022 (amendment)\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\n\nThe NHS Digital 20/21 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 23 November 2021).\n\nThe NHS Digital 20/21 DSPT reviews for NatCen social research (8HW76) and Formara Limited (8JK40) were confirmed as ‘Standards Met’ via email to the CAG inbox (07 December 2021)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02659","index":700,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02659"]
["Reference","21/CAG/0121"]
["Other Refs","IRAS Project ID:   REC Reference: "]
["Application Title","Long-term risk of cancer and general health outcomes in women who underwent assisted reproductive technology in Great Britain, 1991-2010: a data linkage study "]
["Application Summary","This application from UCL Institute of Child Health set out the purpose of medical research that seeks to investigate the long-term risk of cancer and general health outcomes in women who underwent assisted reproductive technology treatment. \n\nInfertility, defined as the inability of a sexually active couple to achieve pregnancy within one year, is associated with significant medical, social, economic and demographic consequences and, as such, is considered a major public health problem by the World Health Organization with approximately 50 million couples experiencing it worldwide in 2010. There has been a global increase in the number of women who have undergone assisted reproductive techniques (ART). ART cycles typically require 2-4 weeks of ovarian stimulation and endometrial support with gonadotrophins and sex steroid hormones. Most women undergo multiple rounds of treatment, which results in abnormally elevated exposure to endogenous steroid hormones. This endocrine assault is a continuing source of concern for patients and the medical profession, primarily because of the potential carcinogenic effects on hormone responsive tissues, such as the breast, endometrium and ovary. Other short and long-term health outcomes observed in women who have undergone ART include ovarian hyperstimulation syndrome, multiple pregnancy, and increased pregnancy morbidity and obstetric complications, Side-effects of medications are also well known and poor mental health has also been reported. However, much of the evidence examining cancer and long-term general health outcomes in women who have undergone ART remains largely inconsistent.\n\nThe applicants have conducted a previous study which found increased risk of in-situ breast cancer and invasive and borderline ovarian tumours in a cohort of 255,786 women who underwent ART in the UK. In this previous study, the HFEA records of women who had undergone ART in the UK between 1991 and 2009 were linked to the NHS Service Central Registers of England, Wales and Scotland as a one-off data linkage. The applicants seek to use this previously established cohort to compare hospital admission rates and general health outcomes of women who have previously undergone fertility treatment to population controls. The applicants will also investigate whether the risk of cancer has changed with the increased follow-up period. \n\nThe archived dataset from the previous study (the ART cohort) is currently held by NHS Digital. NHS Digital will identify an unexposed comparison cohort, consisting of women who conceived spontaneously, from the Personal Demographics Service dataset. Two unexposed women for each member of the ART cohort will be included, matched on month and year of birth, sex and parity. NHS Digital will link the ART and Population comparison cohorts to the NHS Digital Cancer Registration Dataset and HES. The linked datasets will then be pseudonymised. For the ART cohort, the unique ID number assigned during the previous study will be used. The Population comparison cohort will be assigned unique ID numbers. The pseudonymised datasets will then be disclosed to UCL. The datasets will be linked to pseudonymised fertility data from the previous study and held in UCL archives. The data analysis will be carried out in the UCL Data Safe Haven."]
["Applicant Organisation Name","UCL Institute of Child Health"]
["Contact Name","Professor Alastair Sutcliffe, Professor of General Paediatrics"]
["Address","UCL Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone","020 7905 2367"]
["Email","a.sutcliffe@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","255,786 women who underwent fertility treatment in England and Wales between 1991 and 2009 and were included in the ART study.\n\nPopulation comparison cohort consisting of women who conceived naturally, matched for age, sex and parity, identified in a 1:2 ratio. Approximately 534,000 patients will be included as a population comparison cohort.\n\n\nThe applicants note that the archived cohort held by NHS Digital includes patients who underwent fertility treatment in the UK between 1991 and 2009. Additionally, 5,762 women recorded as having had their first assisted reproduction cycle in the period 1st January 2010 to 31st December 2010 and as having given consent for their data to be used for research were also included in this cohort; the latter are out of scope for approval."]
["Description of confidential patient information used","Data sources\n1. The ART Cohort dataset, archived at NHS Digital\n2. The NHS Digital Cancer Registration Dataset, held by NHS Digital\n3. HES dataset, held by NHS Digital\n4. The Personal Demographics Service dataset at NHS Digital\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Date of birth\n4. Postcode – district level\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-02-18"]
["Next Review Date","2024-02-18"]
["Notes","Amendment supported 14 November 2023 to remove the control cohort of two population controls per each patient who received ART and to include a cohort of naturally conceived children collected under ECC 4-03(g)/2012 which will be linked to the National Cancer Registration and Analysis Service database at NHS England.\n\n18 February 2022 - Application Supported\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 08 October 2021.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- \nThe NHS Digital 2020/21 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02660","index":701,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02660"]
["Reference","22/CAG/0010"]
["Other Refs","IRAS Project ID: 301420  REC Reference: 21/WM/0278"]
["Application Title","The Integration and Analysis of Data Using ARtificial InTelligence to Improve Patient Outcomes with Thoracic Diseases"]
["Application Summary","This application from Oxford University sets out the purpose of medical research that seeks to develop an Artificial Intelligence model to aid in the diagnosis of lung cancer in pulmonary nodules identified on CT scans performed as part of the NHSE Lung Cancer Screening Programme. \n\nLung cancer is the most lethal and second commonest cancer in the UK. Lung cancer is also the commonest cancer worldwide, with 1.8 million cases diagnosed each year. Early diagnosis can reduce mortality, however early diagnosis is dependent on both the detection of a lung nodule and the determination of whether this is malignant. CT scanning has been shown to be a useful method of detecting lung nodules as part of a lung cancer screening programme, determining whether a nodule is benign or malignant is challenging. Lung nodules are detected in around 25% of scans carried as part of routine care or in lung cancer screening trials for smokers. Approximately 98% of these nodules are benign, meaning that large numbers of patients have pulmonary nodules detected on their scans which are not of significance but result in significant patient anxiety, and also places a substantial burden on scanning facilities and staff. The applicants seek to create a CT AI model which will produce a percentage likelihood of malignancy and a follow up algorithm, calculating how many CT scans are required and the interval needed. CT scan images will be overlaid with images gained from digital pathology scanning, to aid in interpretation of the CT image. The applicants hypothesise that further characterisation of pulmonary nodules on chest CT scans and histology specimens will improve the accuracy of stratifying lung nodules as benign or malignant and help guide their management. \n\nParticipating NHS trusts will transfer clinical data, including patient NHS numbers, CT images and data, NHS England Lung Health Check Screening spreadsheets and pathology data on a quarterly basis to an NHS DART email account at Oxford University Hospitals NHS Foundation Trust (OUH NHS FT). The data will then be pseudonymised and transferred to the Trust Hermes Research server. Histology slides, from biopsies and lung resections, will be transferred after the patients’ care has been completed. The patient identifier will be taped over, and a pseudonymisation number given to the slides. The slides will then be posted to the Tissue Histopathology Laboratory (THL) in Oxford, where they will be digitised and then posted back to the originating laboratory. The digital images from the THL will then be transferred to the Radiology Research Laboratory in the OUH NHS FT, and the pseudonymised slide will then be linked to the code from the originating laboratory, and the images then pseudonymised and transferred to the research server at OUH NHS FT. The data can then be transferred to researchers for the Dart project at the University of Oxford, Roche, GE and Optellum. The dataset will be effectively anonymised at this point, as the researchers will not be able to link the dataset to the patients NHS numbers. "]
["Applicant Organisation Name","Oxford University"]
["Contact Name","Professor Fergus Gleeson, Consultant Radiologist"]
["Address","Oxford University, Department of Oncology"]
[null,"Old Road Campus Research Building"]
[null,"Roosevelt Drive"]
["Postcode","OX3 7DQ"]
["Telephone","01865 235 746"]
["Email","fergus.gleeson@oncology.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients invited for a Lung Health Check within England from 01 January 2019 onwards. Those aged between 55 and 80 years are invited for Lung Health Checks. \n\nIt is estimated that 300,000 patients will be included. "]
["Description of confidential patient information used","Data sources:\n1. Patient records at the Lung Health Check centres\n2. Patient records from the referral hospitals\n3. Pathology data\n4. Radiology data\n\nIdentifiers required for linkage purposes:\n1. NHS number\n\nIdentifiers required for analysis purposes:\nNo items of confidential patient information will be retained for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-02-23"]
["Next Review Date","2025-02-23"]
["Notes","Amendment supported 21 March 2024 to extend the duration of ‘s251’ support until 31 March 2025\n\nAmendment supported 16 August 2023 for the disclosure of confidential patient information from the Yorkshire Lung Screening Trial (18/CAG/0038), at University of Leeds, to the Oxford University Hospitals NHS Foundation Trust, to be included as a new data source for DART\n\nAmendment supported 20 June 2023 to disclose confidential patient information from OUH to NHS England for linkage to NHS England datasets, including Hospital Episode Statistics (HES), ONS Mortality data, Cancer Registration, and the Emergency Care Data Set (ECDS), and for the flow of data back from NHS England to OUH to allow DART to correctly link the HES and DART data\n\n22 December 2022 – amendment supported \nTo include updated patient  notification  materials  and protocol, which had  been  revised  following review  by  a  Patient  and  Public Involvement Group.\n\n08 June 2022 - Amendment supported:\nAmendment supported to amend the names of participating Trusts, and to include linkage with SCOOT data as a new purpose for processing.\n\n23 February 2022 - Application Supported\n\n1. Clarify who outside the direct care team will have access to confidential patient information. Condition met 17 June 2022.\n\n2. Consider whether consent could be sought from patients in the prospective cohort. If it was determined that consent could not be sought from the prospective cohort, further justification on why not needs to be provided. Condition met 17 June 2022\n\n3. The following changes to the patient notification materials are required:\n\na. Clarification on the role and nature of the relationship with the commercial partners in the project needs to be included.\n\nb. The Information Sheet and Privacy Notice need to be restructured to be more patient friendly.\n\nc. An explanation on who would apply the National Data Opt-Out and the project specific opt-out needs to be provided.\n\nCondition met 17 June 2022\n\n4. Further patient and public involvement needs to be carried out, including discussion of the specific issue of use of confidential patient information without consent as proposed in the application and the involvement of commercial partners.\n\n5. The above conditions need to be responded to within 3 months of the issuing of this outcome letter.\n\n6. Favourable opinion from a Research Ethics Committee. Confirmed 07 December 2021.\n\n7. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 2020/21 DSPT review for Oxford University Hospitals NHS Foundation Trust – and Oxford University were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 20 February 2022)\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02661","index":702,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02661"]
["Reference","22/CAG/0012"]
["Other Refs","IRAS Project ID: 290133  REC Reference: 22/WM/0006"]
["Application Title","Using linked secondary and primary care electronic health records to evaluate opioid utilisation and safety"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to evaluate the prescribing patterns of opioids started in secondary care and continued between intermediate and primary care, in order to provide a better understanding of prescribing factors and patient subgroups at a high risk of opioid related harms. \n\nOpioids are commonly prescribed to patients for the first time for a number of reasons, including following surgery. Patients undergoing orthopaedic surgery for musculoskeletal conditions, such as osteoarthritis, are a particularly vulnerable population for opioid-related harms due to older age, multi-morbidity and polypharmacy. Clear postsurgical opioid prescribing is not currently available, partially due to limited evidence about current prescribing patterns in hospital and post-discharge, and the subsequent effect of longer schedules of post-discharge opioids. \n\nPatients will be identified from the EHR records for all adult patients registered with Salford Royal NHS Foundation Trust (SRFT). Prescription and other electronic data will be used to identify all those who have been given opioids during an in-patient stay since 2009. This will be done by the Salford Business Intelligence Team, who have experience with performing and extracting such information for similar studies. Only the Salford Business Intelligence team will have access to the NHS numbers required to link the data sources. No items of confidential patient information will leave the Trust or be accessible to the researchers. Support is needed as, while the Business Intelligence Team at the Northern Care Alliance (NCA) access secondary care data routinely for planning and research, they do not usually access the primary care (SIR) dataset. CAG support is requested to provide a legal basis for access to the SIR dataset and for the BI team to retain the hashed algorithm until the end of the study. The de-identified dataset which is then made available to UoM researchers in a project-specific space in NCA datalake."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Dr Meghna Jani, NIHR Clinician Scientist and Honorary Consultant Rheumatologist"]
["Address","Stopford Building"]
[null,"Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9PT"]
["Telephone","07808 765 126"]
["Email","meghna.jani@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over admitted to Salford Royal NHS Foundation Trust between 01 January 2010 and 31 August 2021, who were receiving an administered opioid medication. \n\nThe applicants estimate that 50,000 patients will be included. "]
["Description of confidential patient information used","Data sources:\n1. Salford Integrated Record (SIR), primary care data\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS number\n3. Hospital ID number\n4. Date of birth\n\nIdentifiers required for analysis purposes:\n1. Postcode – district level\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-03-01"]
["Next Review Date","2025-03-01"]
["Notes","01 March 2022 - Application supported\n\nConditions of support:\n\n1. Further patient and public involvement, including engagement with patients who have been prescribed opioids, needs to be carried out and feedback provided to the CAG within 3 months of the issuing of this outcome letter. Condition met 03 May 2022\n\n2. The patient notification poster needs to be provided for review within 3 months of the issuing of this outcome letter. Condition met 03 May 2022\n\n3. Confirmation needs to be provided that all patient notification documents will include postal and telephone contact details, as well as email, for patients to register dissent. This confirmation needs to be provided within 3 months of the issuing of this outcome letter. Condition met 03 May 2022\n\n4. Favourable opinion from a Research Ethics Committee. Confirmed 17 January 2022. \n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for the University of Manchester and the Northern Care Alliance were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 February 2022)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02662","index":703,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02662"]
["Reference","21/CAG/0148"]
["Other Refs","IRAS Project ID: 279114  REC Reference: 21/WA/0276"]
["Application Title","Postoperative vasopressor usage: a prospective observational study. Relation to Perioperative Atrial Fibrillation (AF)"]
["Application Summary","This application from the University of Liverpool set out the purpose of medical research that seeks to identify the proportion of patients who develop post-operative atrial fibrillation. \n\nSome patients develop a syndrome called vasoplegia while undergoing surgery. Vasoplegia occurs when the function of blood vessels become impaired, blood pressure falls to abnormally low levels and additional medications (vasopressors) are required to maintain blood pressure. If vasoplegia persists after surgery, it often necessitates admission to the intensive care unit for management of vasopressors, which results in prolonged hospital stays and a greater risk of complications, including the development of atrial fibrillation (AF), an irregular heart rhythm that increases the risk of stroke and death. \nThe applicants seek to investigate the prevalence of post-operative AF in a non-cardiac surgical population. The study will be conducted in two parts and two cohorts will be involved. The SQUEEZE UK study will be conducted in at least 40 UK centres and the data collected in this study will be analysed as part of a worldwide study to understand the impact of vasoplegia on outcomes. \n\nIn the first part, cohort A, data will be collected from all patients who undergo surgery as hospital inpatients in order to determine the proportion who develop vasoplegia and AF, and to identify any risk factors. Suitable patients in cohort A will be identified by members of the direct care team (the perioperative anaesthetist). The clinical research team will then access confidential patient information in patient records to extract a pseudonymised dataset onto CRF 1. Additional information for patients will receive a Post-operative Vasopressor Infusion (PVI) will be collected and entered onto CRF 2. Information for patients who develop AF will be collected and entered onto CRF 3. \n\nIn phase two, cohort B, 30 patients recruited into cohort A from each participating centre who develop vasoplegia will be followed up in detail. Patients in cohort B will be identified by the clinical research team, who will then access confidential patient information in patient records to extract a pseudonymised dataset.\n\nSupport is required as, while the applicants expect that members of the direct care team will undertake processing of confidential patient information to identify patients for cohort A within some of the participating trusts, this would not be the case in all trusts. The applicants noted that one week of heavy workload would be involved, meaning that research nurses may need to process confidential patient information to recruit cohort A. A pseudonymised dataset will be extracted and entered onto the Clinical Report Forms (CRFs). The pseudonymisation key will be held by the participating trusts and Health Boards. Any re-identification of patients required will be undertaken by the Trust had submitted the information, who will retain the pseudonymisation key. The information uploaded to the ESAIC will be effectively anonymised. The anonymised dataset will be sent to University College London for analysis. "]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor Ingeborg Welters"]
["Address","Reader, Institute of Life Course and Medical Sciences"]
[null,"University of Liverpool"]
[null,"Liverpool"]
["Postcode","L7 8TX"]
["Telephone","0151 706 4210"]
["Email","I.welters@liverpool.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort A: Patients aged 18 years and over at the time of surgery, who have undergone surgery and were not discharged on the day of surgery.\n\nCohort B: Patients aged 18 years and over at the time of surgery, who have undergone surgery and were not discharged on the day of surgery, and who received an infusion of vasopressors which continues after the patient has left the operating room. \n\n5000 patients will be included in England and Wales."]
["Description of confidential patient information used","Data sources:\n1. Electronic patient records at 51 participating NHS Trusts and Health Boards in England and Wales.  \n\nIdentifiers required for linkage purposes:\n1. NHS number\n2. Date of birth\n\nIdentifiers required for analysis purposes:\n1. Date of birth\n2. Date of death\n3. Gender\n4. Study number (patient identification number)"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-03-15"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in March 2024 that ‘s251’ support could be expired as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, SQUEEZE UK will provide a unique insight into post operative vasoplegia and peri-operative AF (Atrial Fibrillation) in the UK. Whilst these complications occur in a small proportion of patients, due to the large number of patients undergoing surgery, this potentially affects thousands of patients in the UK alone. Understanding of these complications is vital to developing new ways to improve the patients journey through surgery to recovery.\n\n\n15 March 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed: Favourable Opinion issued 16 September 2021.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Not checked due to the number of sites involved in the study. Support is recommended on the basis that it is the applicant’s responsibility to ensure that the required security assurance standards have been met at each site prior to processing any confidential patient information with support under the Regulations."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02663","index":704,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02663"]
["Reference","22/CAG/0040"]
["Other Refs","IRAS Project ID: 277788  REC Reference: 22/SW/0040"]
["Application Title","A Surveillance Study of Congenital and Hospitalized Neonatal Varicella in the United Kingdom & Portugal (NEOPOX)"]
["Application Summary","This application from the UK Health Security Agency (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to collect data on the number of cases, severity, and treatment of FVS and babies hospitalised with neonatal varicella infections. This information will be collected over a 13-month surveillance period by asking paediatricians from across the UK to provide information about any cases they treat. This crucial information will help inform public health interventions, guide decisions about the benefits and cost effectiveness of introducing the vaccine to the routine immunisation schedule and describe short term outcomes and treatments for these conditions in the UK.\n\nSupport is requested to allow the disclosure of confidential patient information from the treating physician (NHS number, date of birth and full postcode) to the UKHSA, in order for them to identify duplicate reports.  \n\nThe data from questionnaires will be collated into two databases by UKHSA staff.   Database one will contain NHS number, date of birth and postcode to enable deduplication, and will be stored for 13 months (throughout the surveillance period) before being destroyed.   \n\nFollowing deduplication, the data will be inputted into database 2 by UKHSA staff.   This will contain anonymised data.   Age will replace date of birth,   NHS number will be replaced by a study number, and postcode will be reduced to a partial postcode.   \n\nWhen a paediatrician reports a case to the BPSU, their contact details will be shared between the BPSU and the UKHSA.    The UKHSA has an existing legal basis to conduct surveillance of infectious diseases for public health purposes and thus this data sharing falls outside of the scope of CAG support.  \n\nAny data collected from sites in Northern Ireland will need separate authorisation from the CAG equivalent in Northern Ireland.   "]
["Applicant Organisation Name","UK Health Security Agency"]
["Contact Name","Dr Kate Jordan"]
["Address","UK Health Security Agency"]
[null,"Immunization and Vaccine Preventable Diseases Division"]
[null,"61 Colindale Road, London"]
["Postcode","NW9 5EQ"]
["Telephone","07540 518 460"]
["Email","kate.jordan2@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children in the UK who develop chicken pox infection in the first month of life (neonatal varicella) and children who are diagnosed with fetal varicella syndrome (FVS)."]
["Description of confidential patient information used","Data sources\n1. Reporting clinicians via a questionnaire from every NHS site in England and Wales that receives an orange card from BPSU.\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of Birth\n3. Full postcode \n\nIdentifiers required for analysis purposes\n1. Partial postcode for deprivation scoring\n2. Date of death "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-03-21"]
["Next Review Date","2024-03-21"]
["Notes","Amendment supported on 12 December 2023 for the University of Dundee Health Informatics Centre to migrate its servers to a cloud service named AWS by Amazon.\n\nAmendment supported 09 December 2022 \nTo remove UKHSA as a data processor, and replace with University of Dundee (UofD) Health Informatics Centre (HIC) (as per new standardised BPSU methodology)\n\n21 March 2022 - Application supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Pending. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Pending. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02664","index":705,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02664"]
["Reference","22/CAG/0042"]
["Other Refs","IRAS Project ID: 257510  REC Reference: "]
["Application Title","A long-term prospective cohort study on the effects of smoking and prophylactic aspirin on all-cause mortality in male British doctors"]
["Application Summary","This application from University of Oxford sets out the purpose of medical research that seeks to determine the effects of smoking and aspirin use on a cohort of British doctors started in 1951. The British Doctors study (BDS) started in response an increase in deaths from lung cancer in the British population between 1922 and 1947, to investigate the link to tobacco consumption. This application to CAG is for a final linkage to mortality data and cancer registrations for the cohort.\n\nThe applicant retains a database of 35,000 male doctors, from 1951. They originally were included in a questionnaire study on the basis of implied consent (return of questionnaire). Further questionnaires about changes in smoking habits were sent in 1957, 1966, 1971, 1978, 1991, 1998 and 2001. In 1978, some participants were additionally consented (by paper consent) to a randomised trial of prophylactic daily aspirin to prevent death from stroke, heart attack or other vascular conditions (British Doctors Aspirin Trial-BDAT). Previous linkages of the cohort to ONS mortality data and cancer registration data have been undertaken under references PIAG 3-06(i)/2004 and ONS ref MR181, however any data received from HSCIC/NHS Digital has confirmed to have been deleted, and analysis complete. Analysis of data to date has shown the extent of the reduction in risk when cigarette smoking is stopped at different ages and the effects of long term use of aspirin on the incidence of cancers. This new application for final long-term follow-up through data linkage with NHS Digital will complete the study as the majority of BDS participants are now deceased, and applicants plan to analyse the time to death, cause of death and any incidence of cancer during follow up.\n\nBDS did not receive ethical approval prior to recruiting patient in 1951 because no relevant ethics committees existed at the time. Additionally, the legal basis under common law for the retention of confidential patient information regarding the BDS cohort at university of Oxford has been implied consent (due to return of questionnaires), and is now unclear. It has been held in the public interest until the present day. The applicant is therefore now requesting ‘s251’ support for the continued retention of this confidential patient information, in order to allow a final linkage with ONS mortality data, HES, and Cancer registration data from NHS Digital, before removing and separating the confidential patient information, and analysing a dataset contains date of death, but no other direct identifiers. Once analysis is complete, all confidential patient information will be deleted, which will be by March 2024. "]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Peter Rothwell, Action Research Professor of Neurology/Consultant Neurologist"]
["Address","Nuffield Department of Clinical Neurology"]
[null,"Level 6, West Wing,"]
[null,"University of Oxford, Oxford"]
["Postcode","OX3 9DU"]
["Telephone","01865 611 260"]
["Email","peter.rothwell@ndcn.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All registered medical doctors practising in the United Kingdom in October 1951 were invited to be included in the cohort.\n\nThis application is specifically for 34,439 Male British doctors, which make up the British Doctors Study database."]
["Description of confidential patient information used","Data sources\n1. The University of Oxford, Nuffield Dept of Population Health (NDPH) - The British Doctors Study (BDS) database \n\n2. NHS Digital (for England and Wales)\no National Cancer Registration and Analysis Service (NCRAS) \no ONS Mortality data\no Hospital Episode Statistics (HES)\n\nIdentifiers currently retained in BDS database\n1. BDS Study ID\n2. NHS Number\n3. Date of Birth\n4. Name\n5. Postcode\n6. Gender\n\nIdentifiers required for linkage purposes\n1. BDS Study ID\n2. NHS Number\n3. Date of Birth\n4. Name\n5. Postcode\n6. Gender\n\nIdentifiers required for analysis purposes\nData received back from NHS Digital;\n1. Cause of death - Primary outcome for the study \n2. Date of death \n3. Diagnosis of cancer (cancer registration) \n4. Date of registration of cancer (cancer registration) \n5. Date of embarkation or other loss to follow-up\n6. BDS ID\n7. Date of birth – to ensure perfect match\n\nIdentifiers required for analysis;\n• Date of birth – modified to month and year, in order to age at death/cancer and other disease diagnosis\n• Date of death – retained in full, in order to calculate age at death/cancer and other disease diagnosis\n\nOther identifiable information is retained in a separate location and is not required for analysis. \n\nAdditional information\nOne single extract requested"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-03-21"]
["Next Review Date","2025-03-21"]
["Notes","Amendment supported 27 February 2024 to extend the duration of ‘s251’ support until 31 December 2025\n\n27 February 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES) & ONS Mortality Data and Cancer registration data.\n\n21 March 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 15 September 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:- \nThe NHS Digital 2020/21 DSPT reviews for University of Oxford – Medical Sciences Division – Nuffield Department of Population Health and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 March 2022)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02665"]
["Reference","22/CAG/0031"]
["Other Refs","IRAS Project ID: 303489  REC Reference: 22/NW/0050"]
["Application Title","Magnetic Foreign Body Ingestion in Children (MAGNETIC): a prospective surveillance study"]
["Application Summary","This application from the University Hospital Southampton NHS Foundation Trust set out the purpose of medical research that seeks to establish the incidence of ingestion of magnetic foreign body by children aged 16 years and under within the UK and Ireland. \n\nMagnetic objects are known to be dangerous when swallowed by children, particularly when multiple magnets are ingested. Ingestion can lead to significant morbidity, including bowel obstruction, fistulation and perforation, which require emergency surgery to treat. Recent published research has shown that rates of magnetic foreign body ingestions are increasing globally. Studies from the UK have highlighted a significant burden of morbidity, but the exact scale of the problem in terms of actual incidence, burden of morbidity, risk factors and outcomes is currently unknown in the UK and Ireland. The applicants seek to conduct a prospective surveillance study across the UK and Ireland to collect data to establish the incidence rate of magnet ingestion, which investigations are best at diagnosing magnet ingestion and its complications, the treatment modality that is most effective, and the complications that may occur as a result of magnet ingestion.\n\nClinicians in participating trusts will be made aware of the study and inclusion criteria through relevant research networks and organizations. Children swallowing magnetic foreign bodies will be identified on initial presentation in emergency departments, or on presentation to paediatric medical or surgical teams. Clinicians will then complete a case report form on RedCap. At this point the patient's NHS number will be collected, along with other relevant routinely collected clinical data from the patient's health record. The NHS number will be held until the end of the study and used to check for duplicate entries, as patients may move between trusts when receiving treatment. At the end of the study, duplicate entries will be removed using NHS numbers within RedCap. This anonymised dataset will then be used for analysis.  "]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust"]
["Contact Name","Professor Nigel J Hall, Associate Professor of Paediatric Surgery"]
["Address","Department of Paediatric Surgery"]
[null,"University Hospital Southampton"]
[null,"Tremona Road, Southampton"]
["Postcode","SO16 6YD"]
["Telephone","023 8077 7222"]
["Email","n.j.hall@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and under who attended hospital in England or Wales having ingested at least one magnetic foreign body - confirmed on radiology or by clinical features."]
["Description of confidential patient information used","Data sources\n1. Electronic and paper patient records at participating trusts. \n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Postcode – unit level\n\nAdditional information\nPatient sex, ethnicity, postcode and age in months at presentation will also be recorded to meet the study objectives.\n\nData will also be collected for patients treated for ingestion of a magnetic foreign body in Scotland and Northern Ireland. The applicants will ensure that the appropriate support is in place for this data collection."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-03-23"]
["Next Review Date"]
["Notes","Applicant confirmed January 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, the research has contributed to greater awareness of this public health issue, improved clinician understanding on how to manage the problem (reducing morbidity) and ongoing public health activity to reduce exposure to high-power magnets.\n\n23 March 2022 - Application Supported\nConditions of support:\n\n1. Consultations with relevant organisations and patient groups are to be undertaken as the study continues and feedback from these discussions provided when submitting annual reviews. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed: 18 February 2022\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT review for University Hospital Southampton NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (28 February 2022)."]

{"sheet":"A02666","index":707,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02666"]
["Reference","22/CAG/0003"]
["Other Refs","IRAS Project ID: 302216  REC Reference: 21/LO/0912"]
["Application Title","Emergency Medical Services Streaming Enabled Evaluation In Trauma"]
["Application Summary","This application from the University of Surrey sets out the purpose of medical research to explore the feasibility of conducting a future randomised controlled trial to assess the clinical and cost effectiveness of using GoodSAM live video streaming to improve targeting of emergency medical resources. \n\nMajor trauma (MT) is any injury with the potential to cause death or prolonged disability. MT is a leading cause of serious morbidity and mortality. Advanced emergency medical care provided at the scene of an accident can prevent death and improve patient outcomes. Currently, UK emergency services rely on verbal telephone information from incidents to prioritise dispatch. Previous studies have shown at up to 50% of air ambulance deployments and 25% of land ambulance dispatches are inappropriate, highlighting the limitations of decisions based on audio information only. The applicants seek to explore the use of video to improve triage and dispatch decisions. The benefits of using video in other healthcare settings is growing, e.g. for remote healthcare consultation, but evidence is sparse in relation to use in emergency response. GoodSAM uses callers’ smartphone cameras to stream live footage directly to the dispatchers, offering unique opportunities to improve precision in dispatch. \n\nThis study is comprised of a feasibility trial, with embedded process evaluation and two sub-studies. In the feasibility trial, each eligible call received will be observed by research paramedics, who will collect data on the incident. They will also record the resource/dispatch decision making, noting whether any dispatch decisions are changed once the live stream is shared for calls on the intervention arm. The study research fellow will be present for some of the intervention arm shifts and may observe incidents in order to examine barriers and facilitators to the use of GoodSAM. Following the incident, the research paramedic or research nurse will approach the casualties or their representative to seek consent for access to their medical data. If consent is given, then patient records will be accessed for up to three months after the incident. \n\nSupport is required for the main study to undertake the live streaming without patient consent. Support is also needed for the Research Paramedic to use the CAD number to locate surviving casualties and seek consent or a consultee opinion. For deceased patients, support is needed for data collection from patient records, as consent cannot be sought. The Research Paramedic will undertake observation of shifts at the London Ambulance Service, where live streaming of trauma incidents is used routinely, and will be exposed to confidential patient information when undertaking the observations. A Process Evaluation sub-study will also take place, collecting data on fidelity, acceptability and use of GoodSAM and experiences of its use. Although confidential patient information is not required for this, the research fellow may be exposed to confidential patient information incidentally. "]
["Applicant Organisation Name","University of Surrey"]
["Contact Name","Professor Cath Taylor, Professor of Healthcare Workforce Organisation and Wellbeing"]
["Address","School of Health Sciences"]
[null,"Kate Granger Building"]
[null,"University of Surrey"]
["Postcode","GU2 7YH"]
["Telephone","01483 688 862"]
["Email","cath.taylor@surrey.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 0 and up who are casualties involved in a category 1 or 2 trauma incident. \n\n834 is the total sample size, approximately 250/300 will be included under support. \n\n999 callers who reported the incident (general public or friends/family of the casualty) – outside the scope of support, unless they are also casualties. \n\nNHS staff – outside the scope of support."]
["Description of confidential patient information used","Data sources\n1. Computer Aided Despatch (CAD) system at the South East Coast Ambulance Service NHS Foundation Trust and London Ambulance Service NHS Trust Ambulance Trust; and live collection of data whilst observing eligible calls.\n\n2. Patient records at 12 hospitals trusts:\na. Frimley Health NHS Foundation Trust\nb. Ashford and St Peter's Hospitals NHS Foundation Trust \nc. Surrey and Sussex Healthcare NHS Trust \nd. Royal Surrey NHS foundation Trust \ne. East Kent Hospitals University NHS Foundation Trust \nf. University hospitals Sussex NHS foundation trust (Brighton, St Richards, Worthing, conquest) \ng. Maidstone and Tunbridge Wells NHS Trust  \nh. Medway NHS Foundation Trust \ni. Dartford and Gravesham NHS Trust\nj. St Georges University Hospitals NHS Foundation Trust\nk. Kings College Hospital NHS Foundation Trust\nl. University Hospital Southampton NHS Foundation Trust\n\nEast of England Ambulance Trust – only involved in the sub-study of staff wellbeing, which is outside the scope of support. \n\nIdentifiers required for linkage purposes\n1. Hospital ID number\n2. CAD number\n3. Age\n4. Sex\n\nIdentifiers required for analysis purposes\n1. Age\n2. Sex"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-03-22"]
["Next Review Date"]
["Notes","Applicant confirmed October 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been removed (and is irretrievable), and any information that continues to be held is anonymised.\n\nIn terms of public benefit, this study would not have been possible without the collection of information without the patients consent due to the pre-hospital setting of the study and the focus on major trauma.  Live streaming is an intervention that is being used by ambulance services despite the currently limited evidence base, and this study was the first Randomised Controlled Trial of its use.  The findings from this feasibility study do support a further study to gain evidence of this and inform future use and policies for use in the pre-hospital emergency service setting.  \n\nAmendment supported 27 September 2022\n\nTo include name in the data items collected by the Research paramedic at the time of the incident, for the purposes of providing name alongside CAD number to participating hospitals in order to identify the individuals and seek consent, is supported, subject to compliance with the standard conditions of support.\n\n22 March 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 24 January 2022\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for London Ambulance Service NHS Trust, University of Surrey and the South East Coast Ambulance Service NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 07 February 2022)."]

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[]
[]
["Application Number","A02667"]
["Reference","22/CAG/0051"]
["Other Refs","IRAS Project ID: 293316  REC Reference: 21/EE/0016"]
["Application Title","Our Future Health"]
["Application Summary","This application from Our Future Health Ltd set out the purpose of medical research to create a research tissue bank for use in research into early detection of disease. \n\nThe aim of Our Future Health Ltd research programme is to speed up the discovery of new methods of early disease detection, and the evaluation of new diagnostic tools, to help identify and treat diseases early, with the hope that this will lead to better patient outcomes. \n\nOur Future Health aim to recruit up to 5 million adults from across the UK to create a cohort of people who have consented to participate in the research. In addition to being asked for permission to link their personal health data to other health-relevant data, participants will be asked to: provide biological samples and complete questionnaires on recruitment; agree to re-contact for ongoing biological sampling and questionnaires and consider taking part in further research studies; and consider being offered personal health information arising from the research. Potential participants will be identified and contacted in various ways, including: identification by staff in primary and secondary care, by NHS blood donation, direct recruitment and survey based sampling. Participants in existing research studies will also be contacted about this study. These methods of recruitment are outside the scope of the support sought, as confidential patient information will be processed only by those with an existing legal basis. \n\nThe applicants will also identify and contact patients in England via DigiTrials. Approximately 3 million patients will be identified and contacted, with an assumed response rate of 5%, around 150,000 patients will be recruited. The processing of confidential patient information by NHS Digital employees to generate the cohort to be invited into the research programme is covered by Directions (specifically the Pilot NHS DigiTrials Recruitment Support Services Direction 2021). Support is required to allow the disclosure of confidential patient information from NHS Digital to a contracted mailing supplier, APS Group. APS Group will be provided patient names, full addresses and postcode and invitation code. Patients will be sent either; an invitation letter, an invitation letter plus a short leaflet, or an invitation letter plus the full participant information sheet. Differences in the response rates from these three methods will be evaluated to inform which will be used in the long term. Interested patients will be directed to the Our Future Health web-based system, where they can electronically consent to participate. Only at this point will Our Future Health receive patient information. "]
["Applicant Organisation Name","Our Future Health Ltd"]
["Contact Name","Jackie Shears, Lead for NHS and Data "]
["Address","Our Future Health Ltd"]
[null,"New Bailey, 4 Stanley Street"]
[null,"Manchester "]
["Postcode","M3 5GS"]
["Telephone","07717 225201"]
["Email","jackie.shears@ourfuturehealth.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 18 and  who meet other inclusion or exclusion criteria to enable representative shaping of the overall Our Future Health participant base. "]
["Description of confidential patient information used","Data sources\n1. Personal Demographics Service at NHS Digital\n\nIdentifiers required for linkage purposes\n1. First name\n2. Surname\n3. Full Address\n4. Postcode\n\nIdentifiers required for analysis purposes\nAny identifiers retained will be done so with patient consent. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-03-29"]
["Next Review Date","2025-03-29"]
["Notes","Amendment supported 14 November 2023 to allow an additional approximate 5 million patients to be contacted for consent to make a total of approximately 25 million people (increased from 20 million)\n\nAmendment supported 25 May 2023 to allow an additional approximate 4 million patients to be contacted for consent, over approximately 6 months, to make a total of approximately 20 million people (increased from 16 million)\n\nAmendment supported 30 March 2023 to allow approximately 16 million patients to be contacted for consent (increased from approximately 12 million)\n\nAmendment supported 17 November 2022 \nTo allow approximately 12 million patients to be contacted (increased from 3 million)\n\n29 March 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 29 March 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:- \nThe NHS Digital 2020/21 DSPT review for APS Group Ltd was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 24 March 2022)"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02668","index":709,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02668"]
["Reference","22/CAG/0068"]
["Other Refs","IRAS Project ID: 280738  REC Reference: 20/LO/1023"]
["Application Title","Childhood outcomes after perinatal brain injury: a population-based linkage study  "]
["Application Summary","This application from University College London and Imperial College London (joint controllership) set out the purpose of medical research that aims to conduct a population-based matched cohort study of children born in England 2008-2020, to investigate differences in long-term health, mortality and educational outcomes in children with perinatal brain injury compared to those without brain injury. The primary outcome for the study is neurodisability at 2, 5 and 12 years, and secondary outcomes include all-cause mortality, mental health and behavioural conditions, chronic conditions, academic attainment, and special-educational needs.\nOver 3400 babies born in England suffer a brain injury every year. Neonatal brain injuries around the time of birth can have devastating lifelong consequences for children, parents and society as a whole. There have been major advances in healthcare that mean more babies with brain injuries survive, but the long-term effects of these injuries are not well-known. Currently, it is not known which infants suffering perinatal brain injury should be followed up, how long they should be followed up for, what conditions they are likely to develop or what additional support they may need from the NHS, social care, or schools in terms of their health, development and education. This study has been created with the aim of gathering information on the prognosis and quality of life after a neonatal brain injury in order to assist staff in conducting family-centred discussions about what the future may hold and help shape health and educational services.\n\nThree cohorts will be included in the study. Cohort 1 will include all newborns with a perinatal brain injury who were born in England between 2008 and 2020. Cohort 2 will be a per-term control group and will contain a 1:1 propensity score matched comparator group for babies born before 34 weeks gestation. NHS Digital will match the cohort using Office of National Statistics (ONS) data in order to create Cohort 3, a full-term control group. \n\nThe National Neonatal Research Data (NNRD) captures data items, including date of birth, postcode, and infant NHS number, but does not reliably hold children’s’ registered names. Additionally, the NNRD contains the infants’ postcodes at birth, but does not capture postcode changes throughout childhood. Therefore, the NNRD cohorts 1&2 will be linked to the NHS Digital Personal Demographics Service (PDS), using NHS number, date of birth, gender and postcode at birth: to identify registered forename and surname, and postcodes changes. \n\nNHS Digital will then link all 3 cohorts to 3 datasets held at NHS Digital; Hospital Episode Statistics (HES), ONS mortality data, Mental Health Services Dataset (MHSD). NHS Digital will send identifiers to the Department for Education (DfE) for linkage with the National Pupil Database (NPD). The Neonatal Data Analysis Unit will create a pseudonymous file containing the neonatal care data for cohort 1 & 2. Cohort 3 will be identified by NHS Digital. Cohorts 1, 2 & 3 will be linked at NHS Digital and the Department for Education, and a pseudonymous file will be created for each linked dataset. The 5 pseudonymised datasets will then be securely transferred to ONS Secure Research Service (SRS), where they will be cleaned and merged. Data within the SRS will retain only an anonymous unique identifier - they key to which will only be held at the Department for Education and NHS Digital for their respective linkages. The data generated by the study will be analysed in the ONS secure research service. It will either be accessed through one of the ONS safe rooms of via a UCL SRS remote connectivity site."]
["Applicant Organisation Name","University College London & Imperial College London"]
["Contact Name","Dr Philippa Rees"]
["Address","1st Floor Institute of Child Health"]
[null,"30 Guilford Street"]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone","07794 669 436"]
["Email","p.rees@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","• Cohort 1: All newborns with perinatal brain injury, born in England between 1 January 2008 to 31 December 2020 (approximately 43,582)\n\n• Cohort 2: Pre-term control group: Propensity score matched comparator group for those born <34 weeks gestation (1:1) to control infants using propensity score matching to account for confounders, born in England between 2008-2020 (approximately 16, 175) \n\n• Cohort 3: term control group: matched term population for the infants ≥34 weeks gestation in cohort 1, identified by NHS Digital using the covariates below, born in England between 2008-2020 (using a 1:3 algorithm; approximately 82, 221)."]
["Description of confidential patient information used","Data sources\n1. National Neonatal Research Database controlled by the Neonatal Data Analysis Unit (NDAU)\n\n2. ONS, PDS, HES and MHSD datasets, held by NHS Digital \n\n3. National Pupil Database, held by the Department for Education\n\nIdentifiers required for linkage purposes\nFor linkage of cohort 1&2 with NHS Digital (PDS) data:\n1. NHS number\n2. Date of birth\n3. Postcode at birth\n4. Gender\nFrom these provided identifiers NHS Digital PDS will identify infant forename, surname and postcodes over time, which will validate linkages and be sent to DfE.\n\nFor linkage of cohort 1,2 & 3 with NHS Digital: HES, ONS, MHSD data:\n1. NHS number\n2. Infant Forename\n3. Infant Surname\n4. Date of birth\n5. Gender\n\nFor linkage of cohort 1, 2 & 3 with National Pupil Database NHS Digital will send the following identifiers to the DfE: \n1. Infant Forename\n2. Infant Surname\n3. Date of birth\n4. Gender\n5. Postcode at birth, \n6. Most recent postcode\nAny additional childhood postcodes\n\nIdentifiers required for analysis purposes\nNo identifiers will be retained for analysis\n\nAdditional information\nFor NHS Digital to identify cohort 3 the following non identifiable data from the infants ≥34 weeks gestation in cohort 1 is required:\n\n1.\tBirthweight\n2.\tYear of birth\n3.\tMultiplicity\n4.\tGender\n5.\tLower layer Super Output Areas (LSOA)\n\nThe ONS SRS will receive 5 pseudonymised files: file 1 from the NNRD containing neonatal care data for cohorts 1 and 2; files 2-4 containing survival, health and mental health data for cohorts 1-3; and file 5 containing educational outcomes data for cohorts 1-3. None of these will contain personal identifiers. \n\nThe data generated by the study will be analysed in the ONS secure research service. It will either be access through one of the ONS safe rooms of via a UCL SRS remote connectivity site"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-04-08"]
["Next Review Date","2025-01-28"]
["Notes","17 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources - ONS, PDS, HES and MHSD datasets.\n\nAmendment supported 18 October 2022\nTo clarify sample sizes as follows;\n\n•\tcohort 1 includes 54,733 infants with brain injury,\n•\tcomparator cohort 2 will be 24, 612 infants,\n•\tcomparator cohort 3 will be 90, 363 infants, \n•\tOverall sample size will be 169, 708 infants\n\n\n08 April 2022 - Application supported, superseding application 20/CAG/0107 as amendment for joint data controllership.\n\nThis submitted information represented a new application in relation to an existing activity under application reference 20/CAG/0107. As a result of the original application not providing clarity on the joint controllership, the sole change is that of an addition of a controller, from solely University College London to joint controllership between University College London and Imperial College London. The intention is to replace 20/CAG/0107 with this new application (22/CAG/0068) once support is in place\n\nConditions of support:\n1. Feedback from the planned continuing engagement is to be provided when submitting annual reviews to the CAG. \n\n2. The patient information leaflet needs to be revised to include telephone and postal contact details, as well as email. – This has been provided by the applicant on 31 March 2022, and this condition is now met.\n\n3. Favourable opinion from a Research Ethics Committee. Confirmed 10 February 2022.\n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. The NHS Digital DSPT review for the following organisations were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 31 March 2022)\n\n• University College London – School of Life and Medical Sciences (standards met for DSPT 2020/21)\n• Office for National Statistics (standards met for DSPT 2020/21)\n• Department for Education (standards met for DSPT 2021/22)\n• NHS Digital (standards met for DSPT 2020/21)\n• Chelsea & Westminster Hospital NHS Foundation Trust (standards met for DSPT 2020/21)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02669","index":710,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02669"]
["Reference","22/CAG/0009"]
["Other Refs","IRAS Project ID: 302276  REC Reference: 20/LO/0018"]
["Application Title","Early detection of bladder cancer in Yorkshire: Feasibility assessments for implementing a targeted study in populations with high disease specific mortality risk"]
["Application Summary","This application from the University of Sheffield sets out the purpose of medical research that seeks to assess the feasibility of urinary self-testing for non-visible blood (non-visible haematuria - NVH) as an early detection method for bladder cancer. \n\nYorkshire has some of the lowest survival rates from bladder cancer in Britain. Improvements in survival could be delivered through earlier diagnosis by screening individuals at high risk of dying from this cancer. The detection of NVH in urine could be a way of detecting bladder cancer early in people without symptoms. The applicants are seeking to understand the best method of identifying and testing before starting a larger early detection trial across Yorkshire. \n\nIn this feasibility study, the applicants will send urine self-testing kits to three cohorts. In Cohort 1, 2000 urine self-testing kits will be sent to screen-engaged participants of the Yorkshire Lung Screening Trial (YLST). In Cohort 2, 3000 urine self-testing kits will be sent to eligible men (65-80 years). Participants in these two cohorts will self-test their urine on up to six occasions. Those with NVH detected in the urine will undergo further urine testing (for cancerous cells) and an ultrasound scan at a study clinic. Those with suspected cancer will be referred to their local hospital. In Cohort 3, 1000 self-testing kits will be sent to 1000 NHS patients being investigated for potential bladder cancer in the 2 week wait (2WW) pathway.\n\nThe applicants require support to identify and contact two of the three cohorts involved in the study:\n\n• Cohort 2 will be identified through a database search of 8-10 selected GP practices located in the Sheffield, Rotherham, Doncaster, and Barnsley CCG areas in South Yorkshire and identified to be in a high-risk bladder cancer mortality region. The applicants also seek to retain confidential patient information from all participants in Cohort 2, whether they respond to the invitation for urine self-testing or not, so that follow-up data can be obtained from NCRAS for the whole cohort. \n\n• Cohort 3 participants will be identified through 2WW referral lists for the investigation of haematuria at participating NHS Trusts. Contact details for this cohort will be shared with King’s College London and Testcard Ltd, the mailing company. Processing of confidential patient information may also be undertaken by the local research nursing teams, who may be outside of the direct care team, depending on individual trusts. \nCohort 1 will be identified via the YLST. This cohort is outside the scope of support, as they will give consent to be contacted about research projects before they are sent information about the YORKSURE study.  "]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor James Catto, Professor in Urological Surgery"]
["Address","University of Sheffield, Department of Oncology and Metabolism"]
[null,"GU19, G Floor, The Medical School"]
[null,"Beech Hill Road, Sheffield"]
["Postcode","S10 2RX"]
["Telephone","+44 114 215 9002"]
["Email","j.catto@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"x","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort 1: Men and women aged 55-80 years within the YLST. 2000 patients. \nCohort 2: Men aged 65-79 years registered with a selected GP in a region with a high BCa mortality risk. 3000 patients.\nCohort 3: Men and women aged 65-79 years referred by GPs with visible haematuria (VH) or non-visible haematuria (NVH) to urological departments at participating NHS Trusts. 1000 patients. "]
["Description of confidential patient information used","Data sources\n1. National Cancer Registration and Analysis Service (NCRAS)\n2. Patient records at participating GP practices\n3. Patient records at participating NHS hospital trusts. \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. GP registration\n4. Date of birth\n5. Address\n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Address\n3. Postcode – unit level"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-03-31"]
["Next Review Date","2024-03-31"]
["Notes","Amendment supported 17 August 2023 to include an additional participating NHS Trust - South Tees Hospitals NHS Foundation Trust, participating in Cohort 3, as an additional data processor under ‘s251’ support\n\nAmendment supported 24 July 2023 to extend the duration of ‘s251’ support until 30 June 2024\n\n30 March 2023 - change in data processor from NHS Digital to NHS England, regarding data source National Cancer Registration and Analysis Service (NCRAS)\n\n16 May 2022 - Amendment supported\nAmendment supported to allow the University of Sheffield to retain confidential patient information for those who do not respond to the invitation to take part in the study until the end of active recruitment.\n\n31 March 2022 - Application supported\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 28 March 2022. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for Testcard Ltd, King’s College London and NCRAS (held by NHS Digital) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 28 January 2022)"]

{"sheet":"A02670","index":711,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[13,1,13,4],[14,1,14,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[31,1,31,4],[33,1,33,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02670"]
["Reference","22/CAG/0006"]
["Other Refs","IRAS Project ID: 301864  REC Reference: 22/EE/0001"]
["Application Title","Developing a digital handover application for paramedics to provide a personalized approach to pre-hospital stratification for OOHCA – the RAPID-MIRACLE study"]
["Application Summary","This application from King’s College London set out the purpose of medical research that seeks to determine whether accurate and early prediction of outcome after cardiac arrest in a pre-hospital setting is possible. \n\nOut of Hospital Cardiac Arrest (OOHCA) occurs in 60,000 patients per year in the United Kingdom and presents a major public health challenge. The mortality remains very poor with <10% survival to hospital discharge from the community and, as a result, the condition has been highlighted as a priority by NHS England and the British Heart Foundation. The applicants are seeking to conduct a prospective study to identify patients admitted with cardiac arrest who are most likely to survive with good outcome. The main aim is to understand which patients are at highest risk of severe brain damage after OOHCA and to validate a previously developed risk score, the MIRACLE2 risk score. \n\nPatients meeting the eligibility criteria will be identified by paramedics treating on scene. The research paramedic at London Ambulance Service NHS Trust will be made aware that a suitable patient has been identified and will access the pre-hospital medical records at this time. Researchers will take 2ml of venous blood for point of care testing at the time of recovery. Patients will then be followed up at 30 days and 6 months to evaluate their outcome. Hospital data will be collected by the clinical research fellow at King’s College Hospital NHS Foundation Trust (KCH). This data will be used to perform statistical analyses to understand how well the MIRACLE2 can predict poor outcome at 30 days. Initial recruitment will be under the emergency research provisions of the Mental Capacity Act. All participants at the time of discharge from ITU to a hospital ward confirmed to meet all inclusion criteria will be approached and invited to participate. Their involvement will proceed on a consented basis. The applicants seek support to collect confidential patient information for patients who die during conveyance by ambulance staff or who die at the continuing care site before consent can be sought. \n\nFor patients who die during conveyance, the applicants seek support to allow the London Ambulance Service (LAS) access to confidential patient information without consent for data collection and then de-identification prior to sharing with KCH. For patients who die in hospital, Patients NHS number, conveyance date and site of admission will be provided by LAS to KCH research fellow. The research fellow will then contact the local site Principle Investigator who will collect data with e-CRF on NHS computer. A pseudonymised dataset, identifiable by unique study ID number only, will be transferred to KCH. \n\nThe applicants seek to include as many people as possible, which may include those in police custody who have not yet been charged and prisoners. The applicants noted that they did not seek to recruit prisoners specifically but would regard them as NHS patients treated by the London Ambulance Service. Prisoners are expected to make up a small percentage of the sample size. "]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr. Nilesh Pareek"]
["Address","Department of Cardiology"]
[null,"King's College Hospital"]
[null,"London"]
["Postcode","SE5 9RS"]
["Telephone","020 3299 9000"]
["Email","nileshpareek@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who experience an out of hospital cardiac arrest and sustained return of circulation (sustained pulse after recovery for 20 minutes). \n\nThe total UK sample size is 500. "]
["Description of confidential patient information used","Data sources\n1. Medical records at the London Ambulance Service\n\nIdentifiers required for linkage purposes\n1. NHS number\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-03-31"]
["Next Review Date","2024-08-14"]
["Notes","Amendment supported 03 January 2024 to extend the duration of ‘s251’ support until 20 March 2025\n\n09 September 2022 – amendment supported \n\nTo include West Hertfordshire Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, The Hillingdon Hospitals NHS Foundation Trust, London North West University Healthcare NHS Trust (LNWH), North Middlesex University Hospital NHS Trust, University College London Hospitals NHS Foundation Trust, Whittington Health NHS Trust and Surrey and Sussex Healthcare NHS Trust, to clarify that the end date of support will be 07 September 2024, and to clarify the data flows and application of the National Data Opt-Out\n\n10 May 2022 - Amendment supported\nAmendment supported to remove Queen Elizabeth Hospital King's Lynn NHS Foundation Trust as a data processor and include Lewisham and Greenwich NHS Trust as a data processor.\n\n31 March 2022 - Application supported\n\nConditions of support:\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 02 March 2022.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nThe NHS Digital 2020/21 DSPT review for the below organisations were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (26 January 2022):\n\n• London Ambulance Service NHS Trust \n• King’s College Hospital NHS Foundation Trust \n• Barts Health NHS Trust \n• Guy’s and St Thomas’ NHS Foundation Trust (includes Royal Brompton and Harefield NHS Foundation Trust)\n• St George’s University Hospital NHS Foundation Trust \n• Royal Free London NHS Foundation Trust\n• Homerton University Hospital NHS Foundation Trust \n• Chelsea and Westminster Hospital NHS Foundation Trust \n• Dartford and Gravesham NHS Trust \n• Imperial College Healthcare NHS Trust \n• Kingston Hospital NHS Foundation Trust \n• Croydon Health Services NHS Trust \n• Epsom and St Helier University Hospitals NHS Foundation Trust \n• Central and Northwest London NHS Foundation Trust"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02671","index":712,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02671"]
["Reference","22/CAG/0002"]
["Other Refs","IRAS Project ID: 303178  REC Reference: 21/NW/0354"]
["Application Title","Assembling the Data Jigsaw in Greater Manchester: improving MSK research to advance patient care and inform patient policy using linked primary and secondary care data "]
["Application Summary","This application from the University of Manchester sets out the purpose of medical research that seeks to estimate the prevalence and incidence of musculoskeletal (MSK) conditions in Salford and the burden on medication and healthcare use, to identify the factors that predict patients with a secondary care diagnosis of axial spondyloarthritis (AxSpA) and to evaluate the comparative safety of hospital prescribed opioids. \n\nThe study will take place over 18 months. Primary and secondary care data will be collected for the patient population of Salford. Staff employed at NCA will extract, link and de-identify the data on behalf of the research team. Although the Business Intelligence Team at NCA access secondary care data routinely for planning and research, they do not usually access the Salford Integrated Record (SIR) primary care dataset. CAG support is requested to provide a legal basis for access to the SIR dataset.\n\nConfidential patient information is extracted from the SIR and hospital data sources via an automated process. The Business Intelligence Team at NCA will link the data from the SIR and hospital data using NHS numbers and will hash the NHS number to create a de-identified dataset. Support is required for this as, while the Business Intelligence Team at NCA access secondary care data routinely for planning and research, they do not usually access the primary care (SIR) dataset. CAG support is requested to provide a legal basis for access to the SIR dataset and for the BI team to retain the hashed algorithm until the end of the study. The de-identified dataset which is then made available to UoM researchers in a project-specific space in NCA datalake. "]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Will Dixon, Professor of Digital Epidemiology"]
["Address","Centre for Epidemiology versus Arthritis"]
[null,"Room 2900, Stopford Building"]
[null,"Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health"]
["Postcode","M13 9PT"]
["Telephone","0161 275 5436"]
["Email","Will.Dixon@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over with a diagnosis of rheumatoid arthritis and ankylosing spondylitis are the subject of the research. \n\nRecords for all patients registered with a GP in Salford between 2010 and 2020 will be screened and potentially included. The Salford Primary Care sample size is 250,000."]
["Description of confidential patient information used","Data sources\n1. Salford Integrated Record (SIR), primary care data\n2. Secondary care data – outside the scope of support\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n\nIdentifiers required for analysis purposes\n1. Postcode – district level\n2. Gender\n3. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-04-26"]
["Next Review Date","2024-04-26"]
["Notes","Amendment supported 19 January 2024 to extend the duration of support until March 2025, and to add an additional step of manual annotation to the data flow\n\n06 October 2022 – Amendment supported to provide revised patient notification materials for patients involved in answering research questions 1 and 2 specifically. \n\n26 April 2022 - Application Supported\nConditions of support:\n\n1. The patient notification materials need to be revised to include telephone, email and postal contacts, should patients wish to dissent. Please provide the revised notification materials within 30 days of the issuing of this letter. \n\nCondition met 20 September 2023\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 10 February 2022.\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for the University of Manchester and the Northern Care Alliance were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 27 January 2022)."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02672"]
["Reference","22/CAG/0032"]
["Other Refs","IRAS Project ID: 303995  REC Reference: 22/LO/0113"]
["Application Title","A Foucauldian discourse analysis of clinicians' language regarding standards of care in the current socio-political NHS context"]
["Application Summary","This application from Surrey and Borders Partnership NHS Foundation Trust set out the purpose of medical research that seeks to investigate the discourses that clinicians draw upon in relation to standards of care when speaking in routine NHS meetings and the implications of the different discourses used. \n\nResearch suggests that clinicians working in the NHS experience high pressures to meet service targets and provide 'cost-effective' treatment. Paradoxically, meeting these targets can sometimes feel in conflict with clinicians' person-centred values. Broader issues such as political climate and the government's management of the NHS may play a role in shaping these pressures. However, research exploring these broader issues appears to be absent. The applicants seek to explore how clinicians talk in routine meetings, and specifically, how they may refer to standards of care within the current NHS context. This will require collecting and analysing conversations from various organisational meetings to highlight different ways of talking clinicians may use.\n\n The study findings will be used to develop understanding of the different influences and pressures that NHS clinicians experience. \n\nThe applicants will undertake review of video recordings of NHS staff meetings held in the South London and Maudsley NHS Foundation Trust. Confidential patient information is not required to meet the aims of the study, however the researchers may be exposed to confidential patient information when reviewing the recordings. "]
["Applicant Organisation Name","Surrey and Borders Partnership NHS Foundation Trust"]
["Contact Name","Miss Kristina Argustaite"]
["Address","7a Queen's Road"]
[null,"Tunbridge Wells"]
[]
["Postcode","TN4 9LL"]
["Telephone","07763 260 843"]
["Email","ka354@canterbury.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 18 and 75 years whose care is discussed at Psychology & Psychotherapy Leads Meeting, Covid Meeting, Reflective Practice Meeting, Monthly Service User Involvement Group Meeting, Carers Group Meeting, Inpatient Managers Meeting, Performance and Quality Meeting, Referral Meeting. All meetings will take place within South London and Maudsley NHS Foundation Trust between 01/03/2022 – 01/04/2022.\n\nUp to 7 meetings would be recorded, but the applicants could not estimate how many patients may be discussed at these meetings. "]
["Description of confidential patient information used","Data sources\n1. Recordings of NHS staff meetings held at South London and Maudsley NHS Foundation Trust\n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be used for linkage purposes. \n\nIdentifiers required for analysis purposes\nNo items of confidential patient information will be used for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-05-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed march 2023 that application can be expired as all confidential patient information has been anonymised. \n\nIn terms of public benefit, study findings will contribute to a growing understanding of how commonly used ways of talking may have an influence in the day-to-day work of clinicians in the NHS. Becoming more aware of these ways of talking can potentially empower NHS staff to question some ideas that might be 'taken for granted' and to be able to make a more conscious decision about how and when these ways of talking can be helpful or less helpful.\n\n\n03 May 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 13 April 2022.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:- \nThe NHS Digital 2020/21 DSPT review for South London and Maudsley NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 March 2022)."]

{"sheet":"A02673","index":714,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02673"]
["Reference","22/CAG/0036"]
["Other Refs","IRAS Project ID: 262331  REC Reference: 20/WA/0030"]
["Application Title","Cardiovascular morbidity and mortality in Liothyronine-treated patients: a linked record cohort study "]
["Application Summary","This application from Cardiff University set out the purpose of medical research that seeks to determine whether patients treated with T3 (liothyronine) have a higher risk of death than those treated with T4 (levothyroxine). \n\nHypothyroidism or thyroid hormone deficiency affects 1-2 million people in the UK and untreated patients suffer significant ill-health. Levothyroxine (T4) is the conventional treatment for hypothyroidism and most patients who are treated with T4 respond well to treatment and enjoy a good quality of life. However, a small proportion of patients remain unwell with T4 and therefore some practitioners treat such patients with an alternative form of treatment called T3. Although many patients who receive T3 report significant improvement in well-being, the long-term safety of the drug has not been established and current UK and international guidelines do not recommend its routine use in practice.\n\nThe applicants seek support to use data collected for patients treated with T3 in an independent medical clinic between 1996 to 2013 in order to evaluate the long-term risk of death, heart disease and strokes. This data is held by the Vaccine Research Trust. The clinic dataset contains data for over 4000 patients. This data will be compared with data for patients treated conventionally for hypothyroidism with T4 and a control group of patients without hypothyroidism. The clinic data will be linked to NHS hospital admission and mortality records via NHS Digital and the Wales Secure Anonymised Information Linkage (SAIL) Databank. Administrators of the Vaccine Research Trust will identify eligible patients through a review of electronic clinic records held by the Trust. Patients treated with T3 will be identified and their demographic clinical and treatment details will be forwarded to NHS Digital and SAIL using a split-file approach in which patient identifiable data (NHS number, gender, date of birth) is sent to NHS Digital and clinical and treatment data is sent to SAIL. A final file comprising pseudonymised linked data with a new encrypted ID for the data groups (T3, T4 and controls) will be made available to Cardiff University researchers via the SAIL portal."]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Professor Colin Dayan, Professor of Clinical Diabetes and Metabolism"]
["Address","C2 Link Corridor"]
[null,"University Hospital Wales"]
[null,"Heath Park"]
["Postcode","CF14 4XN"]
["Telephone","+44 (0)29 2074 2182"]
["Email","DayanCM@Cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who were treated with T3 for at least 3 months at an independent medical clinic between 01 January 1996 to 31 December 2013\n\n3100 - patients treated with T3.\n3100 - patients treated with T4.\n24800 – control subjects, with no thyroid disease\n\nPatients in the control group will also have received treatment between 01 January 1996 to 31 December 2013, and will be age and sex matched to the T3 and T4 cohorts."]
["Description of confidential patient information used","Data sources\n1. Electronic patient records held by the Vaccine Research Trust\n2. HES and ONS data, held by NHS Digital\n3. Patient Episode Database for Wales (PEDW), ONS, and the Primary Care GP dataset, held by SAIL\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. Date of birth\n\nIdentifiers required for analysis purposes\n1. Gender\n\nAdditional information\nThe applicants advised that they would request the week of birth and week of death from SAIL. These will then be truncated to age of death once the survival calculation was completed."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-04"]
["Next Review Date","2024-05-04"]
["Notes","22 September 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital episode Statistics (HES) and ONS mortality data.\n\n04 May 2022 - Application Supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 03 April 2020.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:-\nThe NHS Digital 2020/21 DSPT reviews for Cardiff University, the Vaccine Research Trust, SAIL (Swansea University) and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 March 2022)."]

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[]
[]
["Application Number","A02674"]
["Reference","22/CAG/0065"]
["Other Refs","IRAS Project ID: 298131  REC Reference: 22/WA/0074"]
["Application Title","Comorbidities and outcomes of patients with chronic pancreatitis: a single centre cohort study"]
["Application Summary","This application from Nottingham University Hospitals NHS Trust set out the purpose of medical research which aims to predict the risk of death and developing pancreatic cancer in patients with chronic pancreatitis (CP). By identifying prevalent comorbidities and associated risk factors, recommendations for potential interventions can be made.\n\nCP is an inflammatory condition characterized by scarring and inflammation of the pancreas in individuals with genetic, environmental, and other risk factors such as excess alcohol intake or hypertriglyceridemia. Life expectancy is reduced, and survival affected by complications of CP, and adverse effects of alcoholism, smoking, and diabetes. Studies indicate an increased risk of pancreatic cancer, and an increased prevalence of osteoporosis, cardiovascular events and inflammatory bowel disease in patient with CP. However, up to date data is lacking for the UK population. In addition, little is known about the prevalence of other comorbidities.\n\nApplicants wish to link confidential patient information collected about a retrospective and a prospective cohort of CP patients from Nottingham University Hospitals NHS Trust, to routinely collected clinical outcome data, to establish long-term clinical outcome data and associated comorbidities for patients with CP. Applicants will link together outcome data from various local Trust datasets, and will also link with NHS Digital datasets; ONS Mortality data, and cancer registration data. Applicants will link back the received data from NHS digital to the local dataset using NHS number, and all identifying information will then be removed. Analysis will be undertaken on an anonymous dataset."]
["Applicant Organisation Name","Nottingham University Hospitals NHS Trust"]
["Contact Name","Dr Aloysious Aravinthan, Chief Investigator"]
["Address","University of Nottingham, Nottingham Digestive Diseases Centre,"]
[null,"Translational Medical Sciences, School of Medicine, "]
[null,"E Floor, West Block, QMC Campus, Derby Road, Nottingham "]
["Postcode","NG7 2UH"]
["Telephone","0115 823 1214"]
["Email","Aloysious.Aravinthan@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All adult patients (aged ≥18 years at the time of diagnosis) diagnosed with chronic pancreatitis at Nottingham University Hospitals NHS Trust between 01 January 2006 to 31 December 2025 (approximately 4000 total)\n\n• Retrospective: A derivation cohort will include approximately 2,500 patients diagnosed with chronic pancreatitis between 1 January 2006 and 31 December 2020 \n\n• Prospective: A validation cohort will include approximately 1,500 patients diagnosed with chronic pancreatitis between 1 January 2021 and 31 December 2025."]
["Description of confidential patient information used","Data sources\n1. The Nottingham University Hospitals NHS Trust local clinical records, including:\n• Medway,\n• Clinical Imaging from local PACS system, \n• Summary Care Records and \n• Local Hospital discharge summary data \n\n2. NHS Digital – \n• ONS Mortality data \n• Cancer registration data\n\nIdentifiers required for linkage purposes\nFor linkage with NHS Digital datasets:\n1. NHS number\n2. Date of Birth \n\nFor linkage to local sources:\n1. NHS number \n2. Hospital number \n\nIdentifiers required for analysis purposes\n1. Receiving date of death – not clear if this is modified or not. \n2. Subsector level postcode (modified to deprivation score)\n3. Gender\n4. Ethnicity\n5. Date of birth - will be converted to age at diagnosis, and time to outcome (e.g. death or cancer) will be calculated from the time of diagnosis rather than using date of birth\n\nApplicant states analysis will be on anonymous dataset.\n\nAdditional information\nAt least 5 years follow up data will be collected. \n\nNHS Digital data for the derivation cohort will be requested once in January 2026 and NHS Digital data for validation cohort will be requested once in January 2031.\n\nIn addition, NHS Digital data will be requested for part of the derivation cohort (for those diagnosed with chronic pancreatitis between 1 January 2006 and 31 December 2015) as soon as support is in place, for preliminary analysis. \n\nIdentifiers will not be held in the same database as the clinical data."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-09"]
["Next Review Date","2024-05-09"]
["Notes","06 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources ONS Mortality data and Cancer registration data.\n\n09 May 2022 - Application Supported\nConditions of support:\n\n1. Please clarify if the full date of death is received from NHS Digital, if it is, is it modified for analysis by the applicant before deletion, and, if not, please justify why it is required in full format, and at what time point it will be deleted, within one month from the date of this letter. Conditions met 14 July 2022\n\n2. Please update the poster with an email address for opt out, and consider the addition of a QR code linking to the Trust privacy notice. Please provide the updated poster within one month from the date of this letter. Conditions met 14 July 2022\n\n3. Please confirm the numbers of individuals in the ‘Patient Advisory Group’. If this is less than 5, please undertake further patient and public involvement surrounding the use of confidential patient information without consent, and provide feedback to CAG within three months from the date of this letter. Conditions met 14 July 2022\n\n4. Favourable opinion from a Research Ethics Committee. Confirmed 24 March 2022.\n\n5. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:- \nThe NHS Digital 20/21 DSPT reviews for Nottingham University Hospitals NHS Trust and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 04 May 2022)"]

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[]
[]
["Application Number","A02675"]
["Reference","22/CAG/0059 (Previously CR2/2014)"]
["Other Refs","IRAS Project ID: 158963  REC Reference: 85/0938"]
["Application Title","The Whitehall II Study"]
["Application Summary","This application from University College London set out the resubmission of the Stress and Health Study (Whitehall II), which was originally started in 1985 to advance knowledge of the effects of social circumstances on health and the biological pathways by which they operate, with a particular focus on cardiovascular disease.\n\nLife expectancy has doubled in the last century, which has led to increasing median age in the UK. Understanding the specific morbidities which are more common at higher ages is a key societal and scientific priority. Increasingly, research suggests that it is midlife levels of risk factors that are important for health outcomes in old age. The W-II research design, which involves repeat measures of both risk factors and functioning starting in midlife, is ideally suited to allow the identification of the best targets of preventing these age-related conditions. Measures included blood pressure, blood sugar, blood lipid levels, height, weight, cardiovascular tests, walking speed, lung function, questions about diet, and five tests of mental functioning. \n\nAll participants were initially recruited in 1985 and have been followed up with clinical screenings at 3-5 years intervals. Patients were consented at recruitment and re-consented at each of the 13 phases via questionnaires and clinical assessments. The study database is held at the University College London Data Safe Haven (UCL DSH). In 2014, support was given to allow the applicants to disclose confidential patient information to NHS Digital and SAIL to link to death certificates, cancer registrations, HES data and MHMDS data. In 2016 an amendment was supported to extend support to access of Diagnostic Imaging Data for this cohort, via NHS Digital. Support was required as NHS Digital had determined that the consent in place did not cover the proposed data linkages.\n\nThe application was originally supported in 2014, under reference CR2/2014. This study had previously accessed data under the NHS Central Register (ECC 2-04(c)/2010) application. When the applicants submitted their 2021 annual review, they were asked to submit a refreshed application as the previous application had been made on a bespoke application form and important information was missing. "]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Mika Kivimaki, Chair of Social Epidemiology, Whitehall II Study Director"]
["Address","Department of Epidemiology & Public Health"]
[null,"University College London"]
[null,"1-19 Torrington Place, London"]
["Postcode","WC1E 7HB"]
["Telephone","020 7679 8260"]
["Email","m.kivimaki@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","5253 participants who were recruited into the Whitehall II study in 1985. The applicants anticipate that around 4900 participants will take part in phase 13."]
["Description of confidential patient information used","Data sources\n1. The following datasets, provided by NHS Digital and SAIL:\na. HES APC (1989-2019)\nb. HES Outpatients (2003-2015)\nc. HES A&E (2009-2019)\nd. Mental Health Minimum Data Set (2006-2015)\ne. Mental Health and Learning Disabilities Data Set (2014-2016)\nf. Mental Health Services Data Set (2017-2018)\ng. Diagnostic Imaging Dataset with Bridge file (2012-2018)\nh. MRIS - Members and Postings Reports (2017-2018)\ni. MRIS - Cohort Event Notification Report (Historical 1987-2020)\nj. MRIS - Cause of Death Report (Historical 1987-2020)\nk. Demographics (latest available)\nl. Civil Registrations - Deaths (latest available)\nm. Cancer Registration Date (latest available)\nn. COVID-19 data sets CHESS(SARI-WATCH) and SGSS\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Date of death\n5. Postcode – unit level\n\nIdentifiers required for analysis purposes\n1. Name\n2. Date of birth\n3. Date of death\n4. Postcode – unit level\n5. Gender\n6. Occupation\n7. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-10"]
["Next Review Date","2024-05-10"]
["Notes","11 November 2022 – amendment supported to \nAllow ongoing data linkages of Whitehall II data to datasets held by NHS Digital and SAIL, and to add the Covid Vaccination Dataset to the data sets, and to revise the name of the “HES A&E” dataset to “Emergency Care dataset.”\n\n10 May 2022 - Application Supported\nConditions of support:\n\n1. Previous application CR2/2014 will be expired from the date of this letter, and replaced with 22/CAG/0059.\n\n2. Consent needs to be explicitly sought for the data linkages from patients who are still actively responding. Provide feedback to the CAG within one month from the date of this letter.\nCondition met 24 June 2022 - The CAG accepted the applicants’ suggestion that explicit consent is sought from all patients who are actively responding in January 2023, after the current Phase 13 data collection phase has ended. \n\nCondition revised 19 October 2023 – The CAG accepted the applicant’s suggestion that consent is sought from patients during future face to face data collection meetings.\n\n3. The invitation letter sent out to all participants needs to inform patients of the linkages to NHS Digital and how to opt-out, but should not specifically seek consent. Provide feedback to the CAG within one month from the date of this letter.\nCondition met 24 June 2022 – The CAG accepted the applicants’ suggestion to send a linkage-specific information letter to all participants who have not responded to the current phase 13 data collection wave.\n\n4. The participant notification and information materials need to explain the data linkages to NHS Digital and advise how participants can opt-out of the use of their data for this purpose specifically. Telephone, postal and email contacts need to be provided for patients to register an opt-out. Provide feedback to the CAG within one month from the date of this letter. Condition met 24 June 2022\n\n5. Patient and public involvement needs to be undertaken around the use of confidential patient information without consent as described in the application. Feedback needs to be provided to the CAG, within two months from the date of this letter. Condition met 24 June 2022\n\n6. Provide confirmation that the REC are aware of the data linkages to NHS Digital and have given a favourable opinion to this activity. Provide feedback to the CAG within one month from the date of this letter. Condition met 24 June 2022\n\n7. Favourable opinion from a Research Ethics Committee. Confirmed (Previous Whitehall II application was under REC 16/SS/0003, Scotland A REC, The home visit leaflet refers to IRAS 142374, which relates to REC 85/0938. The applicants advised that they had used IRAS project 158963 for this refreshed application to CAG due to the age of their original REC application, and Favourable Opinion for 158963 was provided 02 February 2016) \n\n8. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:-\nThe NHS Digital 2020/21 DSPT reviews for University College London – School of Life and Medical Sciences, SAIL Databank within Swansea University and Natcen Social Research were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 05 May 2022)."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02676","index":717,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02676"]
["Reference","18/CAG/0158"]
["Other Refs","IRAS Project ID: 160395  REC Reference: 18/NE/0298"]
["Application Title","The Northern Region Young Persons' Malignant Disease Registry"]
["Application Summary","This application from Newcastle University set out the purpose of medical research through the continued building of the Northern Region Young Persons’ Malignant Disease Registry. This Registry was first established in 1968 and is used to underpin a programme of epidemiological and applied health research investigating incidence, survival and aetiology of cancer occurring in children and young people. The registry aims for complete coverage and includes all individuals aged 25 or under who have been diagnosed with a malignant (or benign central nervous system) cancer whilst resident in the area formerly known as the Northern Health Region. This is the geographical area covered in 2006 by the North East Government office of England and North Cumbria (the area covered by the North East Strategic Health Authority in 2006). "]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Richard McNally"]
["Address","Institute of Health & Society, Newcastle University"]
[null,"SJSI, Level 4, RVI,"]
[null,"Queen Victoria Road, Newcastle upon Tyne"]
["Postcode","NE1 4LP"]
["Telephone","0191 282 1356"]
["Email","richard.mcnally@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged 25 and under who reside within the historic North East Government Office of England and North Cumbria area who are diagnosed with a malignant (or benign central nervous system). Patients living elsewhere in England are also eligible for inclusion if their cancer treatment has taken place in any of the hospitals operating within the Northern Health Region. The registry includes information on this patient cohort dating back to its establishment in 1968. Approximately 150 patients were added to the registry each year. "]
["Description of confidential patient information used","Data Sources:\nData is provided from GP practices, Hospitals and wider NHS Sources. The following items of confidential patient information are recorded within the registry for the purposes identified: \n\n• Database Registration number – unique identifier\n• NHS Number – sample validation and linkage,\n• Name – sample validation,\n• Date of birth – sample validation, linkage and analysis,\n• Sex – sample validation and analysis,\n• Gender – analysis,\n• Ethnicity – sample validation and analysis,\n• Full Address and postcode (at diagnosis) – sample validation and analysis,\n• Full Address and postcode (at birth) – sample validation and analysis,\n• Full Address and postcode (current address) – sample validation and analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-05"]
["Next Review Date","2024-05-05"]
["Notes","05 May 2022 - Application Supported\n\nSpecific conditions of support\n\n1. Provide further justification for the continued need to retain identifiable data after a patient has died at the first annual review.\n\nCondition met 23 June 2023\n\n2. Favourable opinion from a Research Ethics Committee (Confirmed 17 March 2020).\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed\n\nThe NHS Digital 20/21 DSPT review for Newcastle University, Health and Social Care Data was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (7 October 2021)"]

{"sheet":"A02677","index":718,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02677"]
["Reference","21/CAG/0050"]
["Other Refs","IRAS Project ID: 265286  REC Reference: 20/EM/0293"]
["Application Title","Suicide in former service personnel: rates, antecedents, and prevention"]
["Application Summary","This application from the University of Manchester set out the purpose of medical research that seeks to investigate suicide risk amongst those who have left the UK Armed Forces, and to make comparisons with serving personnel and the general population.\n\nSuicide accounts for almost 6,000 deaths per year in the UK and prevention is a health priority. Previous international studies have examined the incidence of suicide in former military service personnel, as well as risk factors associated with suicide. Studies in the United States have shown veterans to have a higher rate of suicide compared to the US general population. Increased risks have been found in men, those with depression or alcohol-related problems, as well as those subject to early discharge. A previous study conducted by the applicants had found that 224 veterans died by suicide within a cohort of 233,803 individuals who had left the UK Armed Forces between 1996 and 2005. Although the overall rate of suicide was not greater than that in the general population, the risk of suicide in men aged 24 years and younger who had left the Armed Forces was approximately 2 to 3 times higher than the risk for the same age groups in the general and serving populations. The risk of suicide for men aged 30-49 was lower than that in the general population.\n\nSince this study was carried out, there has been no systematic investigation of suicide in UK veterans. It has been suggested that these individuals may be a potentially vulnerable group because of prior adverse life events, the difficulties associated with the transition to civilian life and high rates of homelessness and alcohol and substance misuse. The UK Armed Forces is just ending a period of very intensive operations. A range of new services for veterans may have improved access to mental health care. There is potentially greater public awareness and reduced stigma associated with mental health problems. In the general population, men in mid-life are now the group at highest risk of suicide. The applicants seek to undertake a new study to examine suicide in those who have left the UK Armed Forces to provide information to be used to inform preventive efforts.\n\nThe study will consist of two phases;\nPhase 1 - the applicants will conduct a retrospective UK-wide cohort study. The data flow is:\n• The Ministry of Defence will transfer data from the Service Leaver’s Database (SLD), which does not contain patient information, to the NCISH research team.\n\n• The applicants will link the SLD data to the NCISH general population suicide database, in order to identify patients who died by suicide/undetermined death.\n\n• The data for those who could not be linked to the NCISH general population dataset, i.e. those who are still alive or who died by means other than suicide, will be deleted.\n\n• The linked dataset will be pseudonymised at this point and a unique identifier applied.\n\n• The unique MoD number and unique NCISH identifier will be transferred to the MoD so that the MoD can include additional data fields relating to demographics and military service from MoD SLD and healthcare from MoD data on this “suicide cohort”. The dataset will then be pseudonymised.\n\n• The MoD will also create a new dataset, using the SLD, where they will remove the “suicide cohort” from the SLD. This new, anonymised dataset will contain data on demographics, military service and healthcare from MoD data for living discharged personnel and discharged personnel who died by other causes. No identifiers will be included in this dataset. The MoD will also provide the NCISH with an extract from the MoD Deaths database for all in-service deaths from suicide or probable suicide in service personnel between 1998 and 2018.\n\n• The NCISH research team, using a mixture of identifiers, will link this data to NCISH’s general population suicide database. The general population suicide database includes a unique identifier that links NCISH general population suicide data to NCISH data on patient suicide deaths.\n\n• Once linkage is complete all identifiers will be removed from the linked data, and unlinked data will be deleted.\n\n• The pseudonymised dataset will be linked to NCISH’s database of suicide deaths in people in recent contact with mental health services (patient suicides) using an existing unique NCISH identifier.\n\nPhase 2 – the applicants will collect data on the factors related to suicide from other official source, such as coroner’s records, for veterans who died by suicide. The applicants will apply random sampling to identify 200 patients from the dataset of veterans who died by suicide between 2007 and 2018. The applicants will then contact the relevant coroner by letter, which will include the patients name, date of birth and date of death, to request any information they have on that individual. This request will include audio copies of the inquest recordings, which are usually on CD but other formats will be requested if possible, from the Senior Coroner of the jurisdiction where the death occurred. If audio recordings are not available, the applicants will request copy statements or depositions and other relevant reports, such as post-mortem and toxicology reports, submitted as evidence during the inquest."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Navneet Kapur, Head of Suicide Research"]
["Address","National Confidential Inquiry into Suicide and Safety in Mental Health, \nCentre for Mental Health and Safety,\nDivision of Psychology and Mental Health, Faculty of Biology, Medicine and Health"]
[null,"2nd Floor Jean McFarlane Building, The University of Manchester"]
[null,"Oxford Road, Manchester"]
["Postcode","M13 9PL"]
["Telephone","0161 275 0714"]
["Email","nav.kapur@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Phase 1: 415,000 patients aged 16 years and over who are former service personnel of the UK Armed Forces, who died by suicide or probable suicide between 01 January 1996 and 31 December 2018.\n\nPhase 2: 200 patients aged 16 years and over who are former service personnel of the UK Armed Forces, who died by suicide or probably suicide between 01 January 2007 and 31 December 2018."]
["Description of confidential patient information used","Data Sources\nPhase One\n1. From the Ministry of Defence:\na. The Service Leaver’s Database,\nb. Deaths Database,\nc. Additional MoD data on education status, medical deployability status at exit, history of unlawful activity, disciplinary actions including military prison, whether failed a compulsory drug test, tariff descriptor for AFCS claims, marker for whether treated in Department Community Mental Health (DCMH), and mental health diagnosis if treated in DCMH.\n\n2. From the National Confidential Inquiry into Suicide and Safety in Mental Health (NCISH), held by the University of Manchester:\na. General population suicide database,\nb. Patient suicide database\n\nPhase Two\n1. Coroner inquest records, obtained from the Senior Coroner of the jurisdiction where the death occurred\n\nIdentifiers required for linkage purposes\n1. Name\n2. Date of birth\n3. Date of death\n4. Postcode – unit level\n5. Place of death\n6. Gender\n\nIdentifiers required for analysis purposes\n1. Date of birth\n2. Date of death\n3. Postcode – district level\n4. Gender\n5. Ethnicity\n\nAdditional information\nThe Department Community Mental Health (DCMH) service are an outpatient mental health service for serving personnel of the Armed Forces. They are commissioned by the MoD and run by the NHS."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-06-17"]
["Next Review Date","2024-06-16"]
["Notes","17 June 2021 - Application Supported\n\nSpecific conditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 16 December 2020.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:- The NHS Digital 2019/20 DSPT review for The National Confidential Inquiry into Suicide and Safety in Mental Health (NCISH) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (16 April 2021)."]

{"sheet":"A02678","index":719,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02678"]
["Reference","22/CAG/0071"]
["Other Refs","IRAS Project ID: 312494  REC Reference: 22/WA/0087"]
["Application Title","CompreHensive GeriAtRician led MEdication Review (CHARMER) - Work Package 3 Feasibility Trial"]
["Application Summary","This application from the University of Leicester (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to develop and test a way to support geriatricians (doctors working on older people’s medicine wards) and hospital pharmacists to proactively deprescribe for older people whilst they are in hospital.\n\nResearch shows that almost half of older people in hospital are prescribed a medication with a risk of harm, but these medicines are rarely stopped.  The reasons why geriatricians and hospital pharmacists do not proactively deprescribe for older people have been ascertained in a previous study.   The research team has used this work to develop an intervention to support and encourage proactive deprescribing and will test this in this feasibility study.\n\nFour hospitals in England will take part – geriatricians and pharmacists at 3 hospitals will receive the intervention and those at the 4th will not - they will be the control hospital.  The intervention will be tested for 4 weeks.\n\nSupport is requested to allow the disclosure of confidential patient information from NHS medical records to Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH).   \n\nNNUH will transfer NHS number, date-of-birth, postcode, and a study ID to NHS Digital for linkage to NHS Digital-held datasets.   \n\nNHS Digital will use NHS number, date of birth and postcode to link to Hospital Episode Statistics, ONS Mortality data and NHS prescription data.   \n\nData will be collected for each patient up to 3 months post discharge from the baseline hospital admission. Data end point will be 4 months after active study window end date to ensure that complete data for the maximum number of patients can be collected.\n\nRoutine data from Trust medical records will be collected for all patients receiving care from a recruited geriatrician during the 4-week active study window.   This will be collected by a member of the direct care team and therefore, access to these identifiers in NHS medical records is out of scope of support. \n\nAfter NHS Digital has linked the data, it will be anonymised prior to transfer to the Norwich Clinical Trials Unit by removing all identifiers and replacing with a study ID.   Therefore, support is not required for transfer from NHS Digital to the Norwich Clinical Trials Unit, as there are no identifiers flowing.  \n\nSome of the patients under the care of a participating geriatrician will consent.   These patients will have their NHS number, date of birth and contact details transferred from NHS sites to their GP practices to collect GP data.   Consent is the legal basis for transfer of these identifiers, and this is therefore outside of the scope of support.\n\nWhere these patients consent to completing PROMS questionnaires,  their name and contact details will be transferred to the Norwich Clinical Trials Unit for onward transfer to the CHARMER study team, for the purposes of arranging follow-up questionnaires to be sent.   Consent is the legal basis for transfer of these identifiers, and this is therefore outside of the scope of support."]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Megan Pritchard"]
["Address","University of Leicester"]
[null,"University Road"]
[null,"Leicester"]
["Postcode","LE1 7RH"]
["Telephone"]
["Email","M.Pritchard@uea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients under the care of a participating geriatrician on a study ward during the active study window who do not consent to the study.   This will be approximately 29 people per site out of 100.  "]
["Description of confidential patient information used","Data sources\nNHS sites\n1) Medical records\n\nNHS Digital\n1)  Hospital Episode Statistics (June to October 2022)\n2)  ONS Mortality Data (June to October 2022)\n3)  NHS Prescription Dataset (June to October 2022)\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes\nNone"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-20"]
["Next Review Date","2024-05-20"]
["Notes","Amendment supported 19 October 2023 to extend the duration of ‘s251’ support to 30 September 2025\n\n02 February 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), ONS Mortality Data, and NHS Prescription Dataset\n\nAmendment supported 02 February 2023 to extend the duration of ‘s251’ support to 31 August 2023\n\nAmendment supported 17 November 2022 to remove London North West University Healthcare NHS Trust as a data processor\n\n24 October 2022 – amendment supported \nTo allow confidential patient information to be collected from Patient Administration System (PAS) at participating trusts\n\n24 October 2022 – amendment supported \nTo allow confidential patient information to be collected from Patient Administration System (PAS) at participating trusts\n\n20 May 2022 - Application supported\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 07 April 2022 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\n\nThe NHS Digital 20/21 DSPT review for Northern Care Alliance NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for London North West Healthcare NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Norfolk and Norwich University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for University of Leicester was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\n\n3. Please confirm that however someone dissents, this dissent will be respected. Condition met 26 May 2022"]
["National Data Opt-out Status","Exempt"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02679","index":720,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02679"]
["Reference","22/CAG/0034"]
["Other Refs","IRAS Project ID: 249297  REC Reference: "]
["Application Title","Artificial Intelligence Stress Echo (FINESSE) "]
["Application Summary","This application from the Milton Keynes University Hospital NHS Foundation Trust set out the purpose of creating a research database to be used to conduct a 15 year follow up of patients who underwent stress echocardiography using a pharmacological agent.\n\nStress echocardiography using a pharmacological agent, dobutamine, is a bedside test with good tolerability and accuracy, and which relies on the recognition of regional wall motion abnormalities at rest and during progressive stages of dobutamine administration. The FINESSE Stress Echocardiography (SE) database currently contains data from over 3000 patients who underwent SE for chest pain assessment at Milton Keynes University Hospital (MKUH) by a single Cardiologist over a 15-year period. The database was initially set up for audit purposes. In 2019, the applicants submitted a Research Ethics application to convert the database to a research database and to collect follow-up data for patients. The applicants are now applying for support under s251 in order to undertake linkages to NHS Digital in order to follow-up patients. \n\nThe applicants seek support for the disclosure of confidential patient information from the FINESSE Audit Database at Milton Keynes University Hospital NHS Foundation Trust to NHS Digital for linkages to NHS Digital held datasets. NHS Digital will apply a Unique Research ID to patient records before returning the now pseudonymised, linked dataset to Milton Keynes University Hospital NHS Foundation Trust. The dataset will then be anonymised prior to use in analysis. "]
["Applicant Organisation Name","Milton Keynes University Hospital NHS Foundation Trust"]
["Contact Name","Professor Attila Kardos"]
["Address","8H Standing Way"]
[null,"Eaglestone"]
[]
["Postcode","MK5 6LD"]
["Telephone","+44(0)1908 660 033"]
["Email","attila.kardos@cardiov.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who underwent SE for chest pain assessment at Milton Keynes University Hospital between 01/10/2002 - 01/12/2017."]
["Description of confidential patient information used","Data sources\n1. The FINESSE Audit Database, held by Milton Keynes University Hospital NHS Foundation Trust\n2. NHS Digital held datasets:\n- a. Hospital Episode Statistics (HES) database\n- b. Office for National Statistics (ONS) database\n- c. Hospital Admitted Patient Care (APC) database\n- d. A&E Attendances and Emergency Admissions (AE) database\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Hospital ID number\n4. Date of birth\n5. Year of birth\n6. Date of death\n7. Gender\n\nIdentifiers required for analysis purposes\n1. Full Name\n2. NHS Number\n3. Hospital ID number\n4. Date of birth\n5. Year of birth\n6. Date of death\n7. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-30"]
["Next Review Date","2024-05-30"]
["Notes","30 May 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital Episode Statistics (HES), Hospital Admitted Patient Care (APC) database, A&E Attendances and Emergency Admissions (AE) database, and Office for National Statistics (ONS) mortality data.\n\nAnnual review supported 30 May 2023 and new condition of support applied:\n\n1.\tPlease undertake further patient and public involvement, including diversifying and increasing the numbers of patients involved, and report on the further patient and public involvement undertaken at the next annual review\n\n\n30 May 2022 - Application supported\nThe application, to allow the disclosure of confidential patient information from the FINESSE Audit Database at Milton Keynes University Hospital NHS Foundation Trust to NHS Digital for linkage to datasets held by NHS Digital, and the return of a pseudonymised, linked dataset to Milton Keynes University Hospital NHS Foundation Trust, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n1. Please undertake further patient and public involvement, and report on the further patient and public involvement undertaken at annual review. \n\nCondition met 30 May 2023\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed: 08 February 2022\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.\n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for Milton Keynes University Hospital NHS Foundation Trust and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 March 2022)."]

{"sheet":"A02680","index":721,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02680"]
["Reference","21/CAG/0169"]
["Other Refs","IRAS Project ID: 302336  REC Reference: 21/WM/0263"]
["Application Title","DECLINE: Decisions against curative treatment for lung cancer in eligible patients"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical research that aims to identify perceived barriers to curative treatment for patients with early stage lung cancer in the East Midlands Cancer Care Network, and to identify reversible factors that can be used to improve treatment rates and hence outcomes for patients with lung cancer. \n\nOne fifth of people eligible for curative treatment of their lung cancer, don’t receive that treatment. In a third of these cases, it is patient choice to refuse surgery, however the reasons why are unknown. This study will investigate the barriers experienced by both patients and clinicians treating lung cancer patients. The study will examine how to ensure more people decide to have the best possible treatment. Applicants hope that information gleaned from this study can be used to improve local services in the future.\n\nApplicants will undertake consented interviews with both patients and clinicians. This element of the study does not require ‘s251’ support. Additionally, analysis will be undertaken on a database. Part of the creation of this database does require ‘s251’ support. The database will be generated from local records by the direct care team at 4 Trusts, and will include data for all people aged 18 or older and diagnosed with lung cancer between January 2016 and December 2019. This element does not require support. Each patient will be given a unique identifier, which is linked to the NHS number. The key will be retained by direct care team at each Trust. At this stage the database will contain demographics, information about the patients lung cancer, and will include date of birth and date of death as direct identifiers. Researchers from the University of Nottingham will go to each of the 4 Trusts, and will modify the date of birth, date of death, and date of diagnosis to; age at diagnosis, survival time in days, and months and year of diagnosis. This element requires support, as the researchers are not considered direct care team. The database is now pseudonymised for analysis, and this will be disclosed to the University of Nottingham. In cases where patients do not receive treatment but guidelines would have recommended it, and a reason cannot be identified from the information already collected, members of the research team will visit the local hospital to review the patients’ records, looking for a reason why treatment was not given. Applicants assume this may be around 150 records in total. The researcher would have access to clinical records pertaining to the diagnosis. Some of the Trusts have electronic medical records and one uses paper notes. No confidential patient information will leave the Trusts. "]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Dr Manpreet Bains"]
["Address","University of Nottingham"]
[null,"C118 Clinical Sciences Building"]
[null,"Nottingham City Hospital, Nottingham"]
["Postcode","NG5 1PB"]
["Telephone","0115 823 1360"]
["Email","manpreet.bains@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","For database: \nAll people aged 18 or older and diagnosed with lung cancer between January 2016 and December 2019, at participating trusts (approximately 5000 patients)\n\nFor case note review:\nAny patient (in the database) who did not have treatment, and researchers can’t find a reason for why this would be the case from the dataset collected (approximately 150 patients)"]
["Description of confidential patient information used","Data sources:\nHospital data from NHS trusts which refer to Nottingham University Hospitals: \n1. Nottingham University Hospitals (‘s251’ support not required, researcher is direct care team)\n2. United Lincolnshire Hospitals NHS Trust (comprising Lincoln County and Pilgrim Hospitals),\n3. University Hospitals of Derby and Burton NHS Foundation Trust, \n4. Sherwood Forest Hospitals NHS Foundation Trust (Kings Mill Hospital)\n\nIdentifiers required for purposes of creating the database:\nSupport not required for the identification of the cohort, and initial extraction of the dataset, as is undertaken by direct care team. \n\nHowever the following data items will be viewed by researchers whilst modifying the dataset for analysis:\n1. Date of birth \n2. Date of death \n3. Sector level postcode\n4. Gender\n5. Ethnicity\n6. Pseudo ID\n\nFor the casenote review (of around 150 patients) researchers will read relevant clinic letters to try and identify the reason for non-adherence to guidance, and will incidentally view confidential patient information whilst undertaking this review. Between the 4 Trusts, there are both electronic and paper records.\n\nIdentifiers required for analysis purposes:\n1. Date of birth modified to age at diagnosis\n2. Date of death – modified to survival time in days\n3. Sector level postcode\n4. Gender\n5. Ethnicity\n6. Pseudo ID\n\nThis will be effectively anonymous to the research team.\n\nAdditional information:\nOnly direct care team will have access to the key between pseudo ID and NHS number. No support required for the retention of the key. \n\n‘s251’ support not required in Nottingham University Hospitals NHS Trust, as the researcher is considered direct care team at this Trust."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-06-09"]
["Next Review Date","N/A"]
["Notes","Expire\n\nApplicant confirmed in September 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised. It is not possible to re-identify individuals. All possibly identifiable data has been pseudonymised and any identifiable research data destroyed by the university.\n\nIn terms of public benefit, the final analysis is ongoing. Initial data has been presented at relevant conference – the British Thoracic Oncology Group, and will be presented at the British Thoracic Society. Once analysis is complete, findings will be published in a lay person accessible format on the Roy Castle Lung Cancer Foundation Website.\n\n\n09 June 2022 - Application Supported\nThe application to allow;\n\n• a researcher (who is not considered part of the direct care team) to view confidential patient information of approximately 5000 patients at participating Trusts in order to modify full dates and pseudonymise the dataset for analysis,\n\n• and also for a researcher (who is not considered part of the direct care team) to view confidential patient information of approximately 150 patients from this dataset at participating Trusts, in order to undertake a review of clinical notes relating to the lung cancer diagnosis, in order to extract information about why treatment was not received. No confidential patient information will be recorded as part of this review,\n\nis fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 10 December 2021\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 20/21 DSPT reviews for University Hospitals of Derby and Burton NHS Foundation Trust, and Sherwood Forest Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 December 2021)\n\nThe NHS Digital 20/21 DSPT review for United Lincolnshire Hospitals NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (and by email to CAG inbox 08 June 2022)"]

{"sheet":"A02681","index":722,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,1,7,4],[8,1,8,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[12,1,12,4],[13,1,13,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[34,1,34,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4]]}
[]
[]
["Application Number","A02681"]
["Reference","22/CAG/0071"]
["Other Refs","IRAS Project ID: 312494  REC Reference: 22/WA/0087"]
["Application Title","CompreHensive GeriAtRician led MEdication Review (CHARMER) - Work Package 3 Feasibility Trial"]
["Application Summary","This application from the University of Leicester (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to develop and test a way to support geriatricians (doctors working on older people’s medicine wards) and hospital pharmacists to proactively deprescribe for older people whilst they are in hospital.\n\nResearch shows that almost half of older people in hospital are prescribed a medication with a risk of harm, but these medicines are rarely stopped.  The reasons why geriatricians and hospital pharmacists do not proactively deprescribe for older people have been ascertained in a previous study.   The research team has used this work to develop an intervention to support and encourage proactive deprescribing and will test this in this feasibility study.\n\nFour hospitals in England will take part – geriatricians and pharmacists at 3 hospitals will receive the intervention and those at the 4th will not - they will be the control hospital.  The intervention will be tested for 4 weeks.\n\nSupport is requested to allow the disclosure of confidential patient information from NHS medical records to Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH).   \n\nNNUH will transfer NHS number, date-of-birth, postcode, and a study ID to NHS Digital for linkage to NHS Digital-held datasets.   \n\nNHS Digital will use NHS number, date of birth and postcode to link to Hospital Episode Statistics, ONS Mortality data and NHS prescription data.   \n\nData will be collected for each patient up to 3 months post discharge from the baseline hospital admission. Data end point will be 4 months after active study window end date to ensure that complete data for the maximum number of patients can be collected.\n\nRoutine data from Trust medical records will be collected for all patients receiving care from a recruited geriatrician during the 4-week active study window.   This will be collected by a member of the direct care team and therefore, access to these identifiers in NHS medical records is out of scope of support. \n\nAfter NHS Digital has linked the data, it will be anonymised prior to transfer to the Norwich Clinical Trials Unit by removing all identifiers and replacing with a study ID.   Therefore, support is not required for transfer from NHS Digital to the Norwich Clinical Trials Unit, as there are no identifiers flowing.  \n\nSome of the patients under the care of a participating geriatrician will consent.   These patients will have their NHS number, date of birth and contact details transferred from NHS sites to their GP practices to collect GP data.   Consent is the legal basis for transfer of these identifiers, and this is therefore outside of the scope of support.\n\nWhere these patients consent to completing PROMS questionnaires,  their name and contact details will be transferred to the Norwich Clinical Trials Unit for onward transfer to the CHARMER study team, for the purposes of arranging follow-up questionnaires to be sent.   Consent is the legal basis for transfer of these identifiers, and this is therefore outside of the scope of support."]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Megan Pritchard"]
["Address","University of Leicester"]
[null,"University Road"]
[null,"Leicester"]
["Postcode","LE1 7RH"]
["Telephone"]
["Email","M.Pritchard@uea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients under the care of a participating geriatrician on a study ward during the active study window who do not consent to the study.   This will be approximately 29 people per site out of 100.  "]
["Description of confidential patient information used","Data sources\nNHS sites:\n1) Medical records\n\nNHS Digital:\n1)  Hospital Episode Statistics (June to October 2022)\n2)  ONS Mortality Data (June to October 2022)\n3)  NHS Prescription Dataset (June to October 2022)\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of birth\n3. Postcode\n\nIdentifiers required for analysis purposes\nNone"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-05-20"]
["Next Review Date","2023-05-20"]
["Notes","20 May 2022 - Application Supported\n\nConditions of support:\n1. Favourable opinion from a Research Ethics Committee. Confirmed 07 April 2022 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 20/21 DSPT review for Northern Care Alliance NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for London North West Healthcare NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Norfolk and Norwich University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for University of Leicester was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\n\n3. Please confirm that however someone dissents, this dissent will be respected   Condition met 26 May 2022"]

{"sheet":"A02682","index":723,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02682"]
["Reference","22/CAG/0066"]
["Other Refs","IRAS Project ID: 301143  REC Reference: 22/LO/0130"]
["Application Title","A pragmatic trial of an Artificial intelligence DRiven appOInTment maNagEment SyStem"]
["Application Summary","This application from London South Bank University set out the purpose of medical research that seeks to investigate whether use of the DrDoctor appointment managing system increases the efficiency of patient appointments without compromising patient outcomes. \n\nManaging out-patient appointments is a challenge to healthcare providers and patients, as missed appointments can lead to missed treatments and wasted capacity. Technology for improving attendance, such as DrDoctor, has been developed. This uses Artificial Intelligence to address the issues. The applicants are seeking to evaluate the efficiency of the DrDoctor technology. The technology has three main elements;  a Did-Not-Attend (DNA) system which predicts how likely it is that patients will attend, a linked appointments system, which monitors the impact of appointment changes in one care pathway on other pathways, and a decision support tool which recommends the appointment type and urgency of appointment to clinical staff, based on the patient provided information.\n\nPatients will be sampled from a single intervention site, Nottingham University Hospital Trust and a single comparator site, Imperial College Healthcare NHS Trust London. Participating NHS Trusts will disclose confidential patient information to London South Bank University (LSBU) and held within the UKFAST Secure Cloud Data Storage. Confidential patient information, containing hospital patient ID, will also be disclosed to LSBU from DrDoctor. The DrDoctor data and data from hospital trusts will be combined. LSBU will create a unique identifier and the dataset for analysis will be pseudonymised using this identifier. A separate dataset, containing confidential patient information, will be retained until the data linkages and cross references are complete. There will be three data disclosures, one pre-covid, one pre-deployment of DrDoctor and post-deployment. The two datasets will then be combined, and all items of confidential patient information removed. "]
["Applicant Organisation Name","London South Bank University"]
["Contact Name","Professor Nicola Thomas"]
["Address","London South Bank University"]
[null,"103 Borough Road"]
[null,"London"]
["Postcode","SE1 0AA"]
["Telephone","020 7815 8045"]
["Email","nicola.thomas@lsbu.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over attending renal, ophthalmology, oncology outpatient\nappointments at Nottingham University Hospital Trust (intervention site) and Imperial College Healthcare NHS Trust (the comparator site).\n\nPatients will be eligible for inclusion in the analysis if they enter the service within one of the sampling periods (pre-COVID, pre deployment and 3 months post final deployment).\n\n•\tPre-COVID = 1st May 2019\n\n•\tPre-deployment = 1st May 2022\n\n•\tPost-deployment = 1st April 2023\n\n\nThe applicants anticipate that 500,000 patients will be included in the cohort where confidential patient information will be processed without consent.\n"]
["Description of confidential patient information used","Data sources\n1. Patient data supplied by participating trusts\n2. Patient data provided by the DrDoctor Patient Engagement Platform,\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Hospital ID number\n3. Date of birth\n4. Postcode – District Level\n\nIdentifiers required for analysis purposes\n1. Postcode – District Level\n2. Gender\n3. Occupation\n4. Ethnicity\n\nAdditional information\nAfter data linkage, patients date of birth will be converted to age by year. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-06-15"]
["Next Review Date","2024-06-15"]
["Notes","Amendment supported 11 October 2023 to include Chelsea and Westminster Hospital NHS Foundation Trust as an additional participating site, and a data processor for this CAG application\n\n15 June 2022 - Application Supported\n\nConditions of support:\n\n1. The wording on the Opt-Out Advert needed further revision and asked that the below wording was included:\n\nThe application was reviewed by the Confidentiality Advisory Group (CAG). They are part of the NHS Health Research Authority. CAG recommended that the application to allow the applicants to process confidential patient information without consent is supported. The Department of Health gave their approval. A link to Regulation 5 of the Control of Patient Information Regulations should also be included. \n\nThe revised Opt-Out Advert needs to be provided within one month of the issuing of this outcome letter. Condition met 17 June 2022\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed: Favourable Opinion issued 01 April 2022. \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 2020/21 DSPT reviews for Nottingham University Hospitals NHS Trust, Imperial College Healthcare NHS Trust, ICNH Ltd (DrDoctor) and UFAST were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 June 2022)."]

{"sheet":"A02683","index":724,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02683"]
["Reference","22/CAG/0072"]
["Other Refs","IRAS Project ID: 134959  REC Reference: 13/SC/0361"]
["Application Title","Epidemiology and Outcome from Out of Hospital Cardiac Arrest (Research application)"]
["Application Summary","This application from the University of Warwick set out the purpose of medical research, under reference 22/CAG/0072, that seeks to collect and summarise data to be used to improve outcomes of Out of Hospital Cardiac Arrests. \n\nThe Out of Hospital Cardiac Arrest Outcomes Project was started in 2013 to establish a database of patients who had a OHCA and where resuscitation was attempted, under CAG reference ECC 8-04 (c)/2013. In November 2021, the applicants submitted an amendment seeking support to include an additional data linkage from NHS Digital, to collect long-term outcome data from NHS Digital, and to increase the frequency of data collection from ambulance services from annual to continuous. The applicants noted that, from May 2021, ambulance services had recorded a new outcome variable, 30-day survival, under the general COPI notice, issued under Regulation 3(4) of the COPI Regulations. The applicants sought to continue receiving this data after the COPI Notice expired. 30-day survival would replace survival to discharge as the main outcome variable. A new application was requested, due to the change in main outcome variable from survival to discharge to 30-day survival, the changes made with the COPI Notice as the legal basis, and the age of the application. As part of CAT review, it was identified that OCHAO also has substantial use for non-research purposes, something that was not originally supported. As such, CAT requested that a non-research application was submitted to provide a legal basis for non-research use. A non-research application, under reference 22/CAG/0087, also from the University of Warwick, was submitted, setting out the collection and use of confidential patient information about people who experienced Out of Hospital Cardiac Arrests to be used to produce summary data for quality improvement work with ambulance services, charities and NHS England.\n\nAn estimated 60,000 people have an out of hospital cardiac arrest (OHCA) each year in the UK. Resuscitation is not attempted in around 60% of cases and attempted resuscitation by ambulance services occurs in less than 50% of cases. Where resuscitation is attempted, there is significant variability between ambulance services in rates of the return of spontaneous circulation (ROSC) at hospital handover and survival to hospital discharge. The average survival rate is 7% and if this could be increased to the best reported survival rate of 12%, then it is estimated that an additional 1000 lives could be saved each year. Improving survival to levels seen in the best performing health systems, e.g. 21% as is seen in Seattle, US, could save an estimated 4800 lives annually.\n\nThe audit teams at participating ambulance services will collect data from patient report forms, ambulance 999 call records, ambulance clinical records and ambulance vehicle tracking systems. The ambulance services will also collect patient outcome data from other NHS providers or systems, such as the Summary Care Record (SCR) at NHS Digital, or directly from NSH Trusts. The OHCAO project has an additional agreement in place with NHS Digital to collect additional variables relating to long-term survival and cause of death. This includes date of death, place of death and cause of death.\n\nThe research database is used as a data source for a variety of research projects. External collaborators wishing to access OHCAO data must complete and send in a data sharing request application form outlining their research project and the OHCAO data variables they require. Following an initial informal review by the OHCAO project team the application is sent to the OHCAO Academic Committee for a formal peer review. Data released to external researchers will be anonymised (unless they have their own ‘s251’ support)."]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Professor Gavin Perkins, Director Warwick Clinical Trials Unit"]
["Address","Warwick Medical School"]
[null,"University of Warwick"]
[null,"Gibbet Hill Road, Coventry"]
["Postcode","CV4 7AL"]
["Telephone","0247 615 0479"]
["Email","G.D.Perkins@warwick.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who experienced an OHCA, who were attended by or on behalf of an NHS Ambulance Service and where resuscitation was attempted. \n\nPatients who experienced an OHCA during inter-hospital transfer or on acute NHS hospital trust premises, or where there is clear evidence of death defined by the Joint Royal College Ambulance Liaison Committee (JRCALC) Recognition of Life Extinct (ROLE) criteria, will be excluded. \n\nThe OHCAO registry receives data for approximately 30,000 cases each year.\nTo date the registry holds 255,877 cases.\nTotal cases by the end of the current funding period (2018 to 2023) will be approx. 300,000."]
["Description of confidential patient information used","Data sources\n1.\tParticipating NHS ambulance services will provide data obtained from patient report forms, ambulance 999 call records, ambulance clinical records and ambulance vehicle tracking systems, and patient outcome data obtained from the Summary Care Record (SCR) at NHS Digital or through direct contact with acute NHS Trusts (which is part of their usual clinical process).\n\n2.\tNHS Digital \na.\tdemographics data, \nb.\tCivil Registration Mortality data (ONS)\n\nAs part of additional queries, linkage with ICNARC mentioned, and linkage to antecedants to OHCA held by NHS D mentioned, but these studies are not yet in place, and we should expect an amendment about each. \n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS number\n3. Date of birth\n4. Date of death\n5. Postcode – unit level\n\nIdentifiers required to be retained in the OHCA database\n1. Name\n2. Date of birth\n3. Date of death\n4. Postcode – unit level\n5. Gender\n\nAdditional information\nTwo patient identifiers (date of birth and date of death) will be held in the same table as the clinical data. A secondary table will hold the remaining identifiers (surname, forename, NHS number and home postcode). \n "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-06-15"]
["Next Review Date","2024-06-15"]
["Notes","Amendment supported 27 February 2024 to update the exit strategy, and duration of ‘s251’ support, with regards to the length of time funding is in place; as funding is now confirmed as extended until 31 October 2028\n\nAmendment supported 27 October 2023 to update the exit strategy with regards to the length of time funding is in place; funding is now confirmed as extended from autumn 2023, to 31 March 2024, (with potential for further extension until 30 September 2028)\n\n22 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – demographics data and Civil Registration Mortality data (ONS)\n\n15 June 2022 - Application Supported\n\nConditions of support:\n\n1. This application supersedes the support in place under ECC 8-04 (c)/2013.\n\n2. Further efforts need to be made to publicise the study;\n\na. The website information needs to be provided for review. The information needs to explain the research and non-research activities taking place and include a link to the Privacy Notice.\n\nb. The Privacy Notice needs to be written using lay appropriate language. The explanation of the CAG and its role also needs to be revised as follows, “The Confidentiality Advisory Group have recommended that support under Regulation 5 of the Health Service (control of patient information) Regulations 2002 (‘section 251 support’) is given for the processing of confidential patient information.”\n\nThe above conditions were met, as of 17 May 2023\n\n3. Provide further details on why confidential patient information needs to be retained long term and whether an alternative, such as NHS Digital retaining confidential patient information and/or a data linkage key, so that the applicants hold anonymised data only, could be used.\n\nThe above condition was met, as of 17 May 2023\n\n4. Provide further information on how an anonymised dataset could be done and an anticipated time frame for the creation of this.\n\nThe above condition was met, as of 17 May 2023\n\n5. Details on how requests by other researchers to access the data will be handled needs to be provided. This needs to include information on the application process and how it would be determined whether a project was research or non-research.\n\nThe above condition was met, as of 17 May 2023\n\n6. Confirm that the CAG will be kept updated on the development of work with NHS Digital to make the OHCAO registry data available within NHS Digital’s Trusted Research Environment and that amendments will be submitted, as needed.\n\nThe above condition was met, as of 17 May 2023\n\n7. Favourable opinion from a Research Ethics Committee. Confirmed: 13/SC/0361\n\n8. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 2020/21 DSPT reviews for University of Warwick Clinical Trials Unit and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26 May 2022).\n\nDue to the number of participating ambulance services, where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","A02684"]
["Reference","22/CAG/0070"]
["Other Refs","IRAS Project ID: 313309  REC Reference: 22/SW/0065"]
["Application Title","Implementation of an artificial intelligence module on the online imaging portal MYO-Share for guiding the diagnosis of muscle diseases"]
["Application Summary","This application from Newcastle University (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to create an improved version of a machine-learning algorithm called MYO-Guide. \n\nMost clinicians are not specialised in identifying muscle disease type from MRI image and NGS has several well-documented limitations. Therefore, a tool that can accelerate an accurate diagnosis will have a clear impact in the medical and patient communities. Specifically, a tool that uses machine learning to automatically segment muscle regions, analyse the amount of fat present on an MRI, and suggest a list of potential diagnoses could greatly facilitate the diagnosis process. \n\nThis study aims to create an improved version of MYO-Guide to analyse a larger number of muscle diseases, which will include an automatic segmentation tool to identify and delineate all muscles and automatically quantify the muscle fat replacement using Lamminen-Mercuri scale. \n\nSupport is requested to allow the disclosure of confidential patient information from NHS medical records and NHS research records to NHS computers. This will be name, NHS number and date of birth for the purposes of tracking patient data recruitment and ensuring that a patient is not included more than once. The research teams at sites will include both clinicians and research staff who are not part of the direct care team. To ensure the study is undertaken efficiently we will need the support of the research staff to help search patient medical records to find eligible patients. Therefore, support is requested for research staff who are not part of the direct care team to access name, NHS number and date of birth to search for eligible patients in NHS medical and research records. \n\nPatient data and MRI scans will be transferred from sites to the MYO-Share platform; however, the data and scans will not contain any identifiers, and thus the transfer falls outside of the scope of support.\n\nOnly the 3 sites within England fall under CAG remit. The 15 sites outside of the UK fall outside of the scope of support. "]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Professor Jordi Diaz-Manera, Professor of Neuromuscular Diseases "]
["Address","Newcastle University, John Walton Muscular Dystrophy Research Centre"]
[null,"Translational and Clinical Research Institute"]
[null,"International Centre for Life, Central Parkway, Newcastle"]
["Postcode","NE1 3BZ"]
["Telephone"]
["Email","Steph.Clutterbuck@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Images and data from 200 participants aged one day or older with at least one of 25 selected neuromuscular diseases across 3 UK NHS sites. "]
["Description of confidential patient information used","Data sources\nNHS sites:\n- Medical records \n- Research study records \n\nIdentifiers required for linkage purposes\n1. Name \n2. NHS number \n3. Date of birth \n\nIdentifiers required for analysis purposes\nNone"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-06-24"]
["Next Review Date","2024-06-24"]
["Notes","Amendment supported 15 February 2023 to remove date of birth from data items collected, extend the duration of ‘s251’ support until 29th February 2034, and to include the option to include data for neuromuscular diseases outside of the main 25 listed, and accept as notifications all other changes as part of protocol 6\n\nAmendment supported 20 December 2022 to include The Leeds Teaching Hospitals NHS Trust as an additional participating site, and data processor for the study\n\nAmendment supported 16 December 2022 to include St Georges University Hospital NHS Foundation Trust as an additional participating site, and data processor for the study\n\n24 June 2022 - Application Supported\nSpecific conditions of support \n\n1. That PPI was conducted with a UK-based PPI group which represented one or more of the conditions under study. The PPI should be undertaken both with parents and with older children / young adults who have experience of the conditions concerned. The findings should be presented back to the CAG, including the demographics of the group, the PPI conducted and the results of the specific study activities that involve using confidential patient information without consent. \n\n2. The CAG accept that you will use name and NHS number for tracking purposes and are happy for these to be stored for 10 yrs in the interests of the study. However, should you wish to retain the identifiers after this time, then a new application to CAG must be made. \n\nCondition met 17 July 2023\n\n3. Favourable opinion from a Research Ethics Committee. Confirmed \n\n4. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:-\nThe NHS Digital 20/21 DSPT review for University College London Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Great Ormond Street Hospital for Children NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Northern Care Alliance NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Newcastle University was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) \n\nThe NHS Digital 20/21 DSPT review for Newcastle-upon-Tyne Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 24 June 2022)"]

{"sheet":"A02685","index":726,"n_rows":39,"n_cols":5,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02685"]
["Reference","22/CAG/0001"]
["Other Refs","IRAS Project ID:   283024   REC Reference: 20/NW/0266"]
["Application Title","RECAP  (Remote  Covid  Assessment  in  Primary  Care):  a learning  system  approach  to  develop  an  early  warning scorefor use by primary care practitioners"]
["Application Summary","This application by Imperial College London, for the purposes of medical research,  is looking at how to improve and how to predict the severity of COVID-19 and identify the need for patient hospitalisation. This will allow the development of an early warning score (RECAP). Data used in this CAG application relate to two sources:1.Doctaly Assist – consisting ofchoices presented by a WhatsApp chatbot that represent choices for severityof symptoms in a structured way, linked to patient’s NHS number and thence to outcome data on COVID-19 related hospital admission (via Hospital Episode Statistics) 2. Text data collected by GPs in the medical record from patients calling NHS111 CCAS (with confidential patient information removed) and also linked to outcome data.These items will be built into templates on the GP electronic record so the doctor can easily be prompted to ask particular questions and enter data. Record analysis will be used to work out which aspects of the RECAP score actually predicted severity, using three outcomes: admission to hospital, admission to ITU, and death.  Support is requested to allow the disclosure of confidential patient information from free text data held in the University of Oxford ORCHID environment to Imperial College London researchers from the expiry of the COPI Notice until August 2022.  This is data from CCAS only.  The data will be stored for 10 years after analysis and support is also requested for this, given that anonymisation of free text cannot be 100% effective.   A recommendation for class 1 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Brendan Delaney"]
["Address","Room 506, Medical School, Norfolk Place"]
[null,"St Mary's Campus"]
[null,"LONDON"]
["Postcode","W2  1PG"]
["Telephone"," "]
["Email","brendan.delaney@imperial.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A defined group of patients with clinical diagnosis of COVID-19  who  have a  series  of  remote  contacts  as  part of  remote monitoring  for  the management  of  deterioration  in  primary care."]
["Description of confidential patient information used","Data sources\nNHS 111 Covid Clinical Assessment Service (CCAS)\n\nIdentifiers required for linkage purposes:\nNone (data linked prior to COPI Notice expiry)"]
["S251 Class(es)"," ","Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null," ","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null," ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","01 July 2022 - Application supported\nSpecific conditions of support\n\n1. To update the notification materials to explain what had happened up to the point of COPI expiry, and what would happen in the future, in terms of analysis and storage of the data – Condition met 10 June 2022\n\n2. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n3. The National Data Opt Out will not apply to processing of Confidential Patient Information under Regulation 5.\n\n4. Favourable opinion from REC Received 27 May 2020\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for Imperial College London and the University of Oxford is in place once support under Regulation 5 is active. See below for further details."]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02686"]
["Reference","21/CAG/0159"]
["Other Refs","IRAS Project ID:  288316  REC Reference: 20/HRA/4718"]
["Application Title","UK-REACH:    United    Kingdom    Research    Study into Ethnicity And COVID-19 outcomes in Healthcare workers"]
["Application Summary","This application from the University of Leicester (with the controller for the activity confirmed to be the University of Leicester) sets out the purpose of the medical research which aims to examine if, how and why, ethnicity affects COVID-19 outcomes and the impact of COVID-19 on healthcare workers (HCWs). It is made up of five work packages (WP) which are briefly detailed below:\n\n1. Work package 1: Linkage and analysis of anonymised healthcare worker regulator and human resource data to electronic healthcare records\n\n2. Work package 2: Longitudinal consented cohort of healthcare workers\n\n3. Work package 3: Policy analysis of the legal and ethical issues of linking HCW data to health outcomes\n\n4. Work package 4: Qualitative study of HCWs’ experiences of working during the pandemic\n\n5. Work package 5: Stakeholder and public engagement\n\nOnly work package 1 is covered by this application. Within WP1, the primary aim is to determine whether COVID-19 diagnosis, hospitalisation and mortality rates differ between ethnic and occupational groups in HCWs. The study team will conduct both a broad analysis, encompassing all those registered as healthcare workers (HCWs) on 1 February 2020 in the UK, and a detailed sub-study analysis in those actively working during the COVID-19 pandemic, incorporating more granular ethnicity, occupation and exposure information.\n\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Dr Manish Pareek"]
["Address","Department of Respiratory Sciences"]
[null,"University of Leicester"]
[null," "]
["Postcode","LE1 5WW"]
["Telephone"," "]
["Email","manish.pareek@leicester.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Main study All healthcare workers aged 16 yrs and over with an electronic staff record, or are registered at least one of the regulators (General Medical Council, Nursing and Midwifery Council, General Dental Council, General Pharmaceutical Council, General Optical Council, or Health and Care Professions Council) as of 1st February 2020. This equates to 1.5 million people. HR Sub-Study All healthcare workers aged 16 yrs and over with an electronic staff record, or are registered at least one of the regulators (General Medical Council, Nursing and Midwifery Council, General Dental Council, General Pharmaceutical Council, General Optical Council, or Health and Care Professions Council) as of 1st February 2020, that have worked at least one day over the course of the study period."]
["Description of confidential patient information used","UK Healthcare Workers Cohort\n1. The Department of Health and Social Care; ESR (Electronic staff records) for England and ESR (Electronic staff records) for Wales.\n2. Professional registration databases i.e. General Medical Council, Nursing and Midwifery Council, General Dental Council, General Pharmaceutical Council, General Optical Council, or Health and Care Professions Council. (This data has already been disclosed and linked, however it is still retained in identifiable format by DHCW in order for ESR data to be linked to the registrant data)\n\nHealth Outcome Data from NHS Digital\n1. GPES Data for Pandemic Planning and Research (COVID-19)\n\n2. Covid-19 Second Generation Surveillance System (Pillar 1)\n\n3. Covid-19 UK Non-hospital Antigen Testing Results (Pillar 2)\n\n4. COVID-19 Hospitalization in England Surveillance System (CHESS)\n\n5. Hospital Episode Statistics (HES) including all patient episodes, including elective but excluding maternity, from 1st February 2018 (24 months prior to study start date) to the most recent data available. This will enable assessment and adjustment of confounding comorbidities in the analyses.\n\n6. Emergency Care Data Set (ECDS)\n\n7. Civil Registration (Deaths) data.\n\n8. ICNARC – applicant to confirm.\n\n9. Personal Demographics Service\n\nHealth Outcome Data from SAIL (the below has already been linked under the COPI notice, and does not require support under Regulation 5)\n\n1. Outpatient referrals from primary care (OPRD)\n\n2. GP primary care (WLGP)\n\n3. Critical care dataset (CCDS)\n\n4. Patient Episode Database for Wales (PEDW)\n\n5. Welsh Demographic Service (WDSD)\n\n6. Annual District Death Extract (WDDE)\n\n7. Intensive Care National Audit (ICNC)\n\n8. COVID-19 Pathology Test results (PATD)\n\n9. COVID-19 symptom tracker dataset (CVST)"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","01 July 2022 - Application supported\nSpecific conditions of support\n\n1.Support  under Regulation 5 Health  Service  (Control  of  Patient  Information) Regulations 2002 will  come  into effect  automatically  following expiry  of  the COPI notice.\n\n2.The National Data  Opt  Out will  apply to  processing  of  Confidential  Patient Information under Regulation 5 to datasets requested via NHS Digital.\n\n3.Favourable opinion from REC Received 21 October 2020\n\n4.Continual achievement   of ‘Standards  Met’  in  relation  to  the  relevant  DSPT submission  (or  any  future  security  assurance  changes) for  the  duration  of support.\n\nEvidence  to  be  provided  (through  NHS  Digital  confirmation they  have reviewed  and confirmed the DSPT submission as standards met’ for the duration of support, and at time   of   each annual   review. The applicant   must   ensure   that NHS   Digital confirmation of ‘standards met’ for organisations processing  confidential patient  information(Department  of  Health  and Social  Care, Digital  Health  and Care  Wales,  NHS  Digital  and  the  SAIL  Databank  i.e.  Swansea  University)is  in place once support under Regulation 5 is active. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02687","index":728,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02687"]
["Reference","21/CAG/0122"]
["Other Refs","IRAS Project ID:   281958  REC Reference:  20/SC/0158"]
["Application Title","Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses - PRINCIPLE"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to assess the effectiveness of trial treatments in reducing time to recovery and hospitalisation and/or death for patients aged 18 years and over with confirmed COVID-19 infection during time of prevalent COVID-19 infections.\n\nThis Clinical Trial of an Investigative Medicinal Product (CTIMP) began in March 2020 in order to identify interventions that may favourably modify progression of COVID-19 infection. The trial will be run as an open, prospective, individually randomised, platform, controlled clinical trial in community care. The design will be flexible to allow the addition of further interventions into the trial while it is in progress, should such suitable interventions become available. In the first instance, a drug called hydroxychloroquine will be evaluated.\n\nPatients will be recruited in a variety of ways. Patients who are concerned about Covid-19 may contact their GPs and participating GP practices will be asked to record whether a patient contacting them about Covid-19 is eligible for the study. The practice will then ask if patients are interested in participating in the study. The GP practice will then provide information or pass patient contact details to the trial team to provide information. Participating GP practices will also screen their practice list to identify suitable patients and will make contact with information about the study and request that they contact the practice or study team, in the event that they develop relevant symptoms and test positive for Covid-19. The study will also be promoted via press releases, social media, etc, and patients interested in participating may contact the study team directly.\n\nNHS Digital will provide the study team with a list of patients who have recently tested positive for Covid-19 and who fit the eligibility criteria for the trial. The applicants have been conducting this recruitment method under Regulation 3 of the Control of Patient Information (COPI) Regulations, and are now seeking support to continue this method of recruitment under Regulation 5 of COPI. NHS Digital upload confidential patient information for patients who test positive for Covid-19 to the TIBCO MFT Internet Transfer Client account on a daily basis. The PRINCIPLE Trial Manager at the University of Oxford will download the data each day and send the contact details of eligible patients to the study team. The study team will then use this list, known as the NHS Digital Pillar 2 call list, to telephone patients to provide information about the trial and invite them to take part. Should patients consent, their participation will proceed on a consented basis. The outcome of each call will be logged on a password protected online tracker for statistical and monitoring purposes. Patients details will be deleted from the call list on a monthly basis.\n\nA recommendation for class 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Christopher Butler"]
["Address","Nuffield Department of Primary Care Health Sciences"]
[null,"Woodstock Road"]
[null,"OXFORD"]
["Postcode","OX2 6GG"]
["Telephone"," "]
["Email","christopher.butler@phc.ox.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who have tested positive for Covid-19 via a home test or at a test centre"]
["Description of confidential patient information used","Data sources\n\nNHS Digital Pillar 2 call list, provided by NHS Digital.\n\nIdentifiers required for linkage purposes\n\n1. NHS Number\n2. Name\n3. NHS Number\n4. Date of birth\n5. Postcode – unit level\n6. Patients Covid-19 test result date\n7. Telephone number"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null," ","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Expired"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date"]
["Notes","Applicant confirmed in September 2023 that ‘s251’ support could be expired as processing of confidential patient information without consent has ceased.\n\nIn terms of public benefit, support has allowed researchers to contact eligible individuals to invite them to take part in covid research that had potential to benefit them and benefit their recovery.\n\n\n01 July 2022 - Application Supported\n\nSpecific conditions of support\n\n1. The below conditions are to be responded to within three months of the issuing of this outcome letter.\n\na. Contact attempts are to be limited to 3 – 4 calls.   Condition met 12 February 2022\n\nb. Provide the date that it is anticipated that confidential patient information will cease to be processed, so that the duration of support can be estimated.   Condition met 12 February 2022\n\nc. Clarify why patients’ dates of birth and postcodes are required prior to making the recruitment telephone call.  Condition met 12 February 2022\n\nd. Clarify where patients’ dates of death will be obtained from and when they will be obtained.   Condition met 12 February 2022\n\ne. Further patient notification needs to be undertaken to inform patients about the study before they are telephone. Making information about the study available on the NHS Digital website should be explored. The patient notification also needs to explain what will happen to patients’ data when they dissent.   Condition met 12 February 2022\n\nf. The information provided in the Pictorial PIS needs to be revised for simplicity and clarity.   Condition met 12 February 2022\n\n\ng. Provide details on the objections to the use of confidential patient information raised by those consulted during patient and public involvement.   Condition met 12 February 2022\n\n\nh. Provide reassurance that patients who have previously registered dissent are not re-contacted if different medications are added.   Condition met 12 February 2022\n\n\n2. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n3. The National Data Opt-Out will apply to processing of Confidential Patient Information under Regulation 5.\n\n4. Favourable opinion from REC Issued 24 March 2020.\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for the University of Oxford – Nuffield Department of Primary Care Health Services is in place once support under Regulation 5 is active. "]

{"sheet":"A02688","index":729,"n_rows":39,"n_cols":5,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02688"]
["Reference","21/CAG/0004"]
["Other Refs","IRAS Project ID:  282127  REC Reference: 20/NE/0107"]
["Application Title","Neonatal Complications of Coronavirus Disease (COVID-19) Study"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research which aims to determine the incidence of neonatal COVID-19, including hospital acquired infection, and the incidence of transmission from mother to baby during pregnancy, labour and birth by setting up a national surveillance programme.\n\nCoronavirus is a new virus and was first recognised as causing a new infection (COVID-19) in late 2019. Little information is available about how the virus affects mothers and new-born babies and it is not clear how best to care for mothers and babies affected. Little is also known about how babies become infected with Coronavirus and whether it transmits from mothers to their baby(s) while they are still pregnant, during labour and birth, or whether the infection occurs following birth. Recent UK cases raise the concern that vertical transmission is a potential issue, as both mother and baby are infected in at least one case. The virus is known to be contained within most bodily secretions and there are suggestions that faecal oral transmission occurs, raising the possibility of transmission from mother to baby at birth, if not prenatally. Understanding this will mean that better care can be given to mothers and babies and the best advice to pregnant women about the effects of Coronavirus on their baby.\n\nThe British Paediatric Surveillance Unit (BPSU) will be used to carry out the study, using standard BPSU methodology to ask for weekly responses regarding any new-born baby with Coronavirus or whose mother has Coronavirus. Wider linkages will also be made to seek data from additional sources. Identifiers will be shared with the national surveillance of maternal and perinatal deaths (MBRRACE-UK) to cross check deaths. Identifiers from MBRRACE-UK cohort are also shared with the University of Oxford to enable cross-checking. Cases meeting the second eligibility criteria will be cross-checked between UKOSS maternal study of COVID-19, to ensure complete ascertainment, and this will be performed by BPSU with no identifiers flowing between this study and UKOSS. Identifiers will be shared with the National Neonatal Research (NNRD) in order to obtain more detailed clinical information. Identifiers will be shared with the Paediatric Intensive Care Audit Network (PICANet) to ensure complete ascertainment and obtain more detailed clinical information. Cross checks will also be undertaken with Public Health England (PHE) and Public Health Wales, to ensure complete case ascertainment. Confidential Patient information also flows from Public Health England and Public health Wales to University of Oxford to enable cross checking.\n\nA recommendation for class 2, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Jennifer Kurinczuk"]
["Address","National Perinatal Epidemiology Unit"]
[null,"University of Oxford"]
[null,"Old Road Campus"]
["Postcode","OX3  7LF"]
["Telephone"," "]
["Email","jenny.kurinczuk@npeu.ox.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Any child in England and Wales that has a diagnosis of COVID-19, made on a sample taken prior to 29 days of age, who has received inpatient care for COVID-19, and their mother. OR:\n\nAny child in England and Wales whose mother had confirmed COVID-19 at the time of birth, or suspected COVID-19 and the diagnosis was later confirmed, and the baby was admitted for neonatal care, and their mother.\n\nAged 0-28 days"]
["Description of confidential patient information used","Data sources\n\n1. Paediatricians within Trusts who report eligible patients through BPSU\n2. National Neonatal Research Database (NNRD): (Chelsea & Westminster Hospital NHS Foundation Trust)\n3. Paediatric Intensive Care Audit Network (PICANet): (University of Leeds)\n4. The University of Oxford: a. The national surveillance of maternal and perinatal deaths (MBRRACE-UK) b. The UKOSS maternal study\n5. Public Health England (PHE)\n6. Public Health Wales\n\nIdentifiers required for linkage purposes\n\nFor the baby: 1. NHS Number 2. Date of Birth 3. Sex 4. Date of Death (if relevant) 5. Postcode – District Level 6. Ethnicity of baby\n\nFor the mother: 7. NHS Number"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","Amendment supported 07 Dec 2023 \nTo extend the duration of ‘s251’ support for a further 5 years, to allow the retention of confidential patient information until April 2028\n\n01 July 2022 Application Supported\n\nSpecific Conditions of Support:\n1. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n2. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5.\n\n3. Favourable opinion from REC Received 30 March 2020\n\n4. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for Chelsea & Westminster Hospital NHS Foundation Trust, University of Leeds (PICANET), The University of Oxford, Public Health England are in place once support under Regulation 5 is active, as well as a CPiP for Public Health Wales. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02689"]
["Reference","21/CAG/0156"]
["Other Refs","IRAS Project ID:  284545  REC Reference: 20/SC/0238"]
["Application Title","Understanding SARS-CoV-2 infection, immunity and its duration in care home staff and residents in the UK (VIVALDI STUDY)"]
["Application Summary","This application from University College London (with the controller for the activity confirmed to be University College London) set out the purpose of medical research which aims to find how many care home staff and residents have been infected with COVID-19, to inform decisions around the best approach to COVID-19 testing in the future.\n\nBy testing around 6500 staff and 5000 residents across >100 care homes in England, the study will estimate the proportion who have been infected with COVID-19 in the past and have antibodies, and the proportion who are infected now. These tests will be repeated over time to learn how COVID-19 spreads in care homes and how long the antibody response lasts and whether this helps to prevent re-infection with the virus. In those who are currently infected, information will also be collected on who is experiencing symptoms to help to understand how this affects spread of infection within care homes. Information about how infection spreads between care homes, the community and hospitals will be sought by linking the information collected to national data on hospital admissions and deaths.\n\nSupport is requested to allow the disclosure of confidential patient information for care home data managers to upload lists of residents, participating care home staff, and data on symptoms to the NHS Azure system held by NHS England. This is only for care homes where the research team cannot retrieve pseudonymised data directly from surveillance datasets that are already held in NHS Foundry.\n\nA recommendation for class 4 and 5 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Laura Shallcross"]
["Address","222 Euston Road"]
[null,"LONDON"]
[null," "]
["Postcode","NW1 2DA"]
["Telephone"," "]
["Email","L.Shallcross@ucl.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Residents and staff in nursing and residential homes in England aged 18 yrs to 110 yrs who have not consented via the blood sampling element of the study. This will comprise of approximately 60,000 individuals until April 2023. Between April 2023 and April 2024, the applicants plan to continue data linkage for those individuals who are already taking part in the study. Data will be collected from 230 for-profit and 100 not-for-profit care homes. The researchers anticipate that there will be 40,000 participants from for-profit and 20,000 from not-for-profit care homes."]
["Description of confidential patient information used","Data sources:\n\n1. Care homes - Care home records - Care home dataset (capacity tracker)\n\n2. NHS Digital - Care home testing dataset (Pillar 2) - Hospital Episode Statistics (Admitted Patient Care) – Hospital Episode Statistics (Accident & Emergency) – ONS Death Certificates – National Immunisation Dataset\n\n3. UK Health Security Agency - National Covid-19 testing database (Pillar 1) - Second Generation Surveillance System (SGSS) - Care Home outbreak dataset\n\n\nIdentifiers required for linkage:\n\n1. Name 2. Date of Birth 3. NHS number 4. Address"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null," ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Expired"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date"]
["Notes","Applicant confirmed in February 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and the applicants do not have the means to re-identify.\n\nIn terms of public benefit, the study has demonstrated that data linkage using NHS numbers alone is possible and is an effective approach to describing infection and outcomes among the care home population. This was particularly important during the COVID-19 pandemic when limited accurate data was available to guide policy. In addition, as the study has been delivered with regular input from providers, care staff and residents with whom findings were frequently shared, this has gained trust and support for research within the social care community. It has also showcased the importance of effective partnerships between academics, care providers, policy-makers and government officials to rapidly respond to changes in epidemiology and protect residents. As a result of this study, applicants have also been awarded funding to set up a larger infection research and surveillance dataset in care homes (23/CAG/0134 & 23/CAG/0135) to continue to build on this strong basis.  \n\n\n01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1. That individuals wanting to opt-out should not be made to read the study documentation or have to discuss with the care home manager to do so. The FAQ document should be made available to individuals before making a decision.\n\nMarch 2023 – the applicants confirmed that this condition was not complied with. However, as recruitment to the study has ended, no further action has been taken. \n\n2. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n3. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5\n\n4. Favourable opinion from REC Received 29 May 2020\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for care homes, NHS Digital and the UK Health Security Agency is in place once support under Regulation 5 is active. "]

{"sheet":"A02690","index":731,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02690"]
["Reference","21/CAG/0180"]
["Other Refs","IRAS Project ID: 282365  REC Reference: 20/LO/0688"]
["Application Title","National COVID-19 Chest Imaging Database (NCCID)"]
["Application Summary","This application from NHS England (with the joint controllers for the activity confirmed to be NHS England and the Department of Health and Social Care) set out the purpose of medical research which aims to create a research database to be used to improve the identification and triage of Covid-19 patients.\n\nThe applicants have created the National COVID-19 Chest Imaging Database (NCCID) in response to the Covid-19 crisis. The database will be used to enable the validation and development of automated analysis technologies and to promote research projects in response to the Covid-19 pandemic. Data collection is happening across the country and the applicants are seeking to consolidate these individual data collection activities into a single national database, in order to avoid duplication of effort.\n\nThe main data collection involved is the collection of chest x-rays and CT scans and a small amount of relevant clinical information from NHS trusts throughout the UK which is transferred centrally to Royal Surrey County Hospital NHS Foundation Trust. Data is then linked with other datasets and transferred to the NCCID cloud storage for subsequent access by researchers.\n\nSupport is requested to allow staff at participating NHS trusts, who are not members of the direct care team, to access confidential patient information in order to identify participants and carry out the pseudonymisation process, before the pseudonymised data is transferred to the Royal Surrey NHS Foundation Trust for inclusion in the NCCID.\n\nSupport is required for participating NHS Trusts to transfer the encrypted NHS number with clinical data and images to the Royal Surrey Hospital. The image data and clinical data flow separately. The image data will contain the encrypted NHS number that the Royal Surrey Hospital has the ability to reidentify to apply the national data opt out and for linking with the NHS England Segmentation Database.\n\nSupport is required for NHS number to flow from the Royal Surrey Hospital to the NHS England Segmentation Database, in order to gain ethnicity data (for those where this is not recorded in data from Trusts). NHSE have to reidentify the NHS number in order to gain the ethnicity data to return back.\n\nWhen setting up Trusts with the software to conduct the pseudonymisation process, Surrey have to test to make sure it is working. For many Trusts, this involves the Trust providing phantom data (i.e. no real data) to Surrey to test. However, some Trusts do not have this so, in this case, Trusts provide Surrey with hospital number of a sample of patients in order to test the system. This is expected to continue past the expiry of the COPI Notice, so support for this is required, where necessary.\n\nThe Royal Surrey will send ISARIC and PHOSP-COVID hashed NHS numbers which those study teams will match with their own hashed NHS numbers. Support will not be needed for this, as the NHS numbers are not identifiable.\n\nAlthough mentioned in the protocol, Faculty are no longer involved in the study and are thus not a data processor.\n\nThere is data processing in Scotland which falls outside of scope, with PBPP approval already in place.\n\nA recommendation for class 1, 2, 3 ,4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","NHS England"]
["Contact Name","Mr Dominic Cushnan"]
["Address","NHSX"]
[null,"Skipton House"]
[null,"80 London Road"]
["Postcode","SE1 6LH"]
["Telephone"," "]
["Email"," "]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients aged between 12 and 109 years of age who present with suspected Covid-19 and who have had an RT-PCR swab."]
["Description of confidential patient information used","Data sources:\n\n1. NHS Trusts\n2. Royal Surrey Hospital SMART portal\n\nIdentifiers Required for Linkage Purposes:\n\nNHS trusts\n1. NHS number\n2. Hospital number\n\nSMART Portal\n1. NHS number\n\nRoyal Surrey Hospital\n1. NHS number"]
["S251 Class(es)"," ","Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1. Support was only provided for the setting up of the database, and that any separate research conducted using the data from the database should be a new application.\n\n2. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n3. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5 at the Royal Surrey Hospital only – a local opt-out mechanism will be used at all other sites.\n\n4. Favourable opinion from REC Received 17 April 2020.\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for organisations processing confidential patient information (NHS Trusts and the Royal Surrey Hospital) is in place once support under Regulation 5 is active. "]

{"sheet":"A02691","index":732,"n_rows":39,"n_cols":5,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02691"]
["Reference","21/CAG/0125"]
["Other Refs","IRAS Project ID: 126600  REC Reference: 13/SC/0149"]
["Application Title","ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infection"]
["Application Summary","This application from the University of Liverpool (with the controller for the activity confirmed to be the University of Oxford) set out the purpose of medical research which aims to develop an understanding of disease processes in patients infected with severe emerging infections of public health concern.\n\nInfectious disease is the single biggest cause of death worldwide. New infectious agents, such as the recent SARS coronavirus (SARS-CoV-2), continually emerge and require new investigations to understand how the disease works and how it interacts with the person infected. This study is designed to conduct rapid, pragmatic clinical investigation of patients with severe emerging infections of public health interest. It has been designed to collect and share as much data as possible, in a format that can be easily aggregated, tabulated and analysed across many different settings. The study is also designed to have flexibility to ensure that novel emerging pathogens can be accommodated.\n\nThe study has three tiers of activity, Tiers 0, 1 and 2. Tier 0, in which routine health care data will be collected and linked to other datasets, falls under the scope of this application as consent will not be sought from patients. Tiers 1 and 2 will collect information with consent, and are outside the scope of this application.\n\nConfidential patient information is required by people considered outside of the direct care team to input the study data into the REDCap database held by the University of Oxford.\n\nConfidential patient information is required for linkage of CCP-UK research data to data held by NHS Digital and ICNARC via NHS number.\n\nA recommendation for class 1, 2, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor Calum Semple"]
["Address","Institute of Child Health"]
[null,"Alder Hey Children's Hospital"]
[null," "]
["Postcode","L12  2AP"]
["Telephone"," "]
["Email","m.g.semple@liv.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individuals in the UK, male and female, and of all ages, who have confirmed infection with or high suspicion of infection with a pathogen or exposure to agents of public health interest"]
["Description of confidential patient information used","Data sources\n\n1. NHS Trusts 2. NHS Digital: a. Hospital Episode Statistics b. General Practice Extraction Service c. Record level 111 data d. Secondary Uses Service (SUS) e. mental health services data set f. emergency care data set (ECDS) g. improving access to psychological therapies data set h. National Diabetes Audit i. COVID-19 vaccination status and vaccination adverse reactions j. Civil Registration - deaths (cause of death lines) 3. Intensive Care National Audit and Research Centre (ICNARC)\n\nIdentifiers used for linkage\n\n1. NHS Number 2. Date of birth 3. Postcode – unit level"]
["S251 Class(es)"," ","Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1. Support is only given for research for Covid-19 purposes. In order to access confidential patient information outside of the COPI Notice, once it expires, and to study outbreaks of any pathogen of public health interest, then separate applications to the CAG would need to be made, unless a COPI Notice was issued for any of these pathogens.\n\n2. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n\n3. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5\n\n4. Favourable opinion from REC Confirmed 02 March 2013. Amendment submitted to REC in May 2020 to include the collection of identifiable data (incl. NHS numbers) without consent under COPI/CAG s251 support.\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for organisations processing confidential patient information is in place once support under Regulation 5 is active. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02692","index":733,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02692"]
["Reference","21/CAG/0117"]
["Other Refs","IRAS Project ID:  285044  REC Reference:  20/EM/0205"]
["Application Title","CCP-Cancer UK: Clinical Characterisation Protocol for Severe Emerging Infections in the UK (CCP-UK) – a prospective companion study for patients with Cancer and COVID-19"]
["Application Summary","This application from University of Liverpool set out the purpose of medical research that seeks to determine the Covid-19 fatality rate within the cancer population and to identify factors associated with poor outcomes from Covid-19 in patients with cancer.\n\nLimited information is currently available on the risks posed by Covid-19 to patients with cancer. The applicants aim to understand the presentation, management and outcomes of cancer patients with Covid-19. The influence of cancer type and treatment will be explored, as well as comparing the outcomes of cancer and non-cancer patients. The information collected may also help inform practice for future outbreaks and to develop guidelines with regard to the care and management of cancer patients with viruses such as Covid-19 and similar infectious diseases.\n\nThe applicants will conduct a prospective observational cohort study to collect a cancer specific dataset from patients enrolled into the ISARIC CCP-UK study (IRAS 126600) study for patients with cancer. The CCP Cancer UK study will be run as a companion study to the ISARIC CCP-UK study. The ISARIC CCP-UK study is described by the applicants as the key national protocol for characterising COVID19 in the UK population. Participants included in the ISARIC CCP-UK study with an accompanying diagnosis of cancer will have additional cancer data provided for the CCP Cancer UK study, from participating research sites. Three tiers of patients are involved in the ISARIC CCP-UK study. Patients in Tier 0 are recruited into ISARIC CCP-UK under the COPI Notice, while patients and Tiers 1 and 2 were consented. Participants on the ISARIC CCP-UK study who fall into the subset of COVID19 patients with a diagnosis of cancer, either through the ISARIC CCP-UK CRF, or through linkage to cancer registries, will be identified and data collection completed by local research teams. Data from linkages will also be carried out with the National Cancer Registration and Analysis Service (NCRAS), the Welsh Cancer Intelligence & Surveillance Unit (WCISU), PHSISD and NICR.\n\nThe ISARIC CCP-UK entire cohort data is stored within the Scottish National Safehaven (as part of that study already). The data controller for the study (University of Oxford) have agreed, via Data Sharing Agreement, that this data can be accessed via approved researchers for the purposes of the CCP Cancer UK study.\n\nResearchers at the University of Edinburgh will identify patients within the ISARIC CCP-UK data who have a history of cancer as recorded on the CCP-UK case report forms. The researchers will remove all fields, except for the ISARIC CCP-UK study ID, NHS number, date of birth and sex and will transfer the above data to the University of Liverpool so that the CCP Cancer UK REDCap database can be populated with the patient records of eligible patients. Staff from the local research teams will log into the CCP Cancer UK REDCap database to complete the CCP Cancer UK datasets for their patients, using local medical records. The University of Liverpool will then pseudonymise the data, leaving the ISARIC CCP-UK study ID only, and will send the pseudonymised data to the PHS Scottish National Safe Haven.\n\nThe University of Edinburgh will securely transfer all ISARIC CCP-UK patient IDs and NHS numbers to Public Health England for data linkage to the National Cancer Registration and Analysis Service (NCRAS). NCRAS will remove all identifiers apart from the ISARIC CCP-UK study ID and return the pseudonymised dataset to the PHS Scottish National Safe Haven.\n\nA recommendation for class 1, 4, 5 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Liverpool"]
["Contact Name","Professor Carlo Palmieri"]
["Address","Department of Molecular and Clinical Cancer Medicine"]
[null,"University of Liverpool Sherrington Building"]
[null,"Ashton Street"]
["Postcode","L69 3JE"]
["Telephone"," "]
["Email","Carlo.Palmieri@liverpool.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","5000 patients who are recruited into the ISARIC CCP-UK who are identified as having cancer, alongside Covid-19."]
["Description of confidential patient information used","Data sources\n\n1. University of Oxford 2. NCRAS, held by Public Health England 3. Patient information from trusts contributing to the ISARIC CCP-UK study, input by trust staff into REDCap.\n\nDescription of identifiable data used\n\n1. NHS Number 2. Date of birth 3. CCP-UK study ID"]
["S251 Class(es)"," ","Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","Amendment supported 24 July 2023 to remove ‘s251’ support for disclosure of confidential patient information to SAIL, and to remove the ‘s251’ support currently in place to obtain National Cancer Registration and Analysis Service (NCRAS) data from NHS England\n\nAmendment supported 26 September 2022 \n\nTo disclose confidential patient information to SAIL for the purposes of linkage with Welsh outcome data, clarify the sample size is 5000, and clarify that only one initial data transfer was required rather than multiple\n\n01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1. Support under Regulation 5 of the Health Service (Control of Patient Information Regulations) 2002 needs to be in place for the ISARIC/WHO Clinical Characterisation Protocol (IRAS 126600), before support for this application comes into effect.\n\n2. Support under Regulation 5 of the Health Service (Control of Patient Information Regulations) 2002 will come into effect automatically following expiry of the COPI notice.\n\n3. Provide clarification on when patients’ date of birth is converted to age, and when patients date of birth is deleted.   Condition met 28 March 2022\n\n4. Provide confirmation that the research dataset, which would be retained for 15 years, does not contain any items of confidential patient information.  Condition met 28 March 2022\n\n5. Further patient and public involvement needs to be undertaken around the use of confidential patient information without consent, as proposed in this application and feedback provided to the CAG.   Condition met 28 March 2022\n\n6. The Privacy Notice needs to include a clear explanation of which patients are included in the research. The Patient and Public Involvement Groups should review the Privacy Notice to ensure that the research and who is included is sufficiently clear. The title also needs to be revised to make it clear that this is a patient notification document.   Condition met 28 March 2022\n\n7. The National Data Opt-Out will apply to processing of Confidential Patient Information under Regulation 5.\n\n8. Favourable opinion from REC Received 11 August 2020\n\n9. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for organisations processing confidential patient information (The University of Oxford and the University of Liverpool) is in place once support under Regulation 5 is active. "]

{"sheet":"A02693","index":734,"n_rows":39,"n_cols":5,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02693"]
["Reference","22/CAG/0026"]
["Other Refs","IRAS Project ID: 297802  REC Reference:  21/HRA/1844"]
["Application Title","Covid impact on RSV Emergency Presentations: BronchStart"]
["Application Summary","This application by the University Hospitals of Leicester NHS Trust, for the purpose of medical research, seeks to understand the impact of the re-emergence of respiratory syncytial virus (RSV) on the rate of bronchiolitis in those under 2 years of age.\n\nThe emergence of COVID-19 has meant that RSV has disappeared. Now that the pandemic is waning, RSV is slowly returning. Some children are at a greater risk of hospitalisation, and even death, from RSV infection, so it is important to understand the spread and whether the population at risk is of a wider age range than normal.\n\nIn order to understand the spread of RSV and whether different genotypes of RSV are responsible for different severities of disease, anonymous routine data will be collected from the clinical record and linked to samples analysed by the UK Health Security Agency.\n\nSupport is requested to allow the incidental disclosure of confidential patient information from medical records to research nurses that are considered to be outside of the direct care team by some participating sites. There is no flow of identifiable data.\n\nA recommendation for class 3 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University Hospitals of Leicester NHS Foundation Trust"]
["Contact Name","Professor Damian Roland"]
["Address","Paediatric Emergency Medicine Leicester Academic Group"]
[null,"Jarvis Building"]
[null," "]
["Postcode","LE1  5WW"]
["Telephone"," "]
["Email","dr98@le.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children under two years of age presenting to participating emergency departments with clinical features of bronchiolitis, acute lower respiratory tract infection or first episode of wheeze Approximately 11,000 records to deliver 4,000 positive cases in total across the study. There will be 300-500 records screened across the 5 sites requiring support."]
["Description of confidential patient information used","Incidental access to identifiable information within secondary care medical records"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null," ","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null," ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1. A dissent mechanism be added to the poster, with details of how any rights of dissent would be respected. Should any sites in Wales consider there to be a breach of confidence by research nurses having incidental access to medical records, then the poster should also include the information in Welsh.   Condition met 5 May 2022\n\n2. As the common law duty of confidence is being breached, it is felt that the National Data Opt-Out should apply to this study. Should the applicant still wish the National Data Opt-Out not to apply to the study, then a justification should be provided in response.   The National Data opt-out applies.\n\n3. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n4. Favourable opinion from REC Received 18 January 2022.\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for University Hospitals Dorset and Sheffield Children’s Hospital is in place once support under Regulation 5 is active. "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02694","index":735,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02694"]
["Reference","21/CAG/0157"]
["Other Refs","IRAS Project ID:  283869  REC Reference:  20/NE/0161"]
["Application Title","CVD-COVID-UK/COVID-IMPACT: UK-wide linked routine healthcare data to address the impact of cardiovascular diseases and other health conditions and health-related risk factors on COVID-19 and the impact of COVID-19 on cardiovascular diseases and other health conditions."]
["Application Summary","This application from Health Data Research UK (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to understand which patients with pre-existing conditions are most likely to be affected by Covid-19 infection.\n\nPatients with pre-existing conditions are at a higher risk of becoming infected with Covid-19, which in turn, increases the likelihood of adverse outcomes and mortality. Understanding which patients may be affected will help to develop strategies to reduce this risk. In addition, Covid-19 affects existing health conditions such as stroke and increases the risk of developing various physical and mental conditions through increased inflammation, or risk of blood clotting.\n\nTo inform government and future NHS policy, a deeper understanding of these unintended consequences is needed, including the range of conditions affected, variation by age, sex, ethnicity, deprivation and geography, effects on different in- and out-patient services, and response to mitigating actions (e.g., regional and national government advice). Nationally collated healthcare datasets from hospitals, primary care, community dispensed medicines, death registries, COVID-19 testing laboratories, COVID-19 vaccination data, and disease or service-specific audit databases, when linked together, provide a major resource for interrogating these crucial questions at scale across the four nations of the UK.\n\nSupport is requested to allow the disclosure of confidential patient information from the legal entities of the unlinked datasets listed on the Trusted Research Environment (TRE) dataset provisioning dashboard to NHS Digital (for English data) or the Trusted Third Party of the SAIL databank (for Welsh data). These datasets will be the ones that are unlinked post-COPI Notice expiry.\n\nA recommendation for class 4 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","Health Data Research UK"]
["Contact Name","Professor Cathie Sudlow"]
["Address","Health Data Research UK"]
[null,"Gibbs Building"]
[null,"215 Euston Road"]
["Postcode","NW1  2BE"]
["Telephone"," "]
["Email","Cathie.Sudlow@hdruk.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The entire populations of England and Wales"]
["Description of confidential patient information used","Data Sources\n\nICNARC · ICNARC COVID dataset\n\nBart’s Health NHS Trust (NICOR) · Adult Percutaneous Coronary Intervention (England) · Myocardial Infarction National Audit Program (England) · National Heart Failure Audit (England) · National Congenital Heart Disease Audit (England) · National Adult Cardiac Surgery Audit (England) · National Audit of Cardiac Rhythm Management (England) · Transcatheter Aortic Valve Implementation (England) · NICOR audits and registers (Wales)\n\nNHS England and Improvement · Pillar 3 antibody data (positive and negative) (England)\n\nKing’s College London · Sentinel Stroke National Audit Programme\n\nRoyal College of Surgeons of England · National Vascular Registry (England and Wales)\n\nNHS Digital (Office for National Statistics) · ONS Census 2011 (Wales)\n\nIdentifiers to be used\n\n1. NHS number 2. Name 3. Date of Birth 4. Postcode for linkage\n\n1. Date of Death 2. Postcode (LSOA level) for analysis"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null," ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","12 June 2023 - change in data processors from; \n•\tNHS Digital to NHS England, regarding the process of linking multiple data sources together in a Trusted Research Environment (TRE) hosted by NHS England (previously NHS Digital).\n•\tBarts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data sources - National Institute for Cardiovascular Outcomes Research, (NICOR) NCAP cardiac audits, including Transcatheter Aortic Valve Implementation (TAVI).\n\nAmendment supported 12 June 2023 to extend the duration of ‘s251’ support to 31 December 2024\n\n01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1.Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n2.To provide with further details about what questions were asked of the independent patient panel, what their feedback was, specifically around the use of confidential patient information without consent, and how many patients were involved.   Condition Met 17 June 2022\n\n3.The National Data Opt Out will not apply to processing of Confidential Patient Information under Regulation 5.\n\n4.Favourable opinion from REC Received 27 May 2020\n\n5.Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed theDSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’for ICNARC, Bart’s Health NHS Trust, NHS England and Improvement, King’s College London, Royal College of the Surgeons of England, NHS Digita land Digital Health and Care Wales is in place once support under Regulation 5 is active. "]

{"sheet":"A02695","index":736,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02695"]
["Reference","21/CAG/0144"]
["Other Refs","IRAS Project ID:  289579  REC Reference:  21/WA/0240"]
["Application Title","Risk of COVID-19 related hospital admission and death in cancer patients in Greater Manchester - GM-COVID CANCER"]
["Application Summary","This application, from the Christie NHS Foundation Trust (with the controller for the activity confirmed to be the Christie NHS Foundation Trust) sets out the purpose of medical research which aims to use NHS number to link additional Christie data on systemic therapies and radiotherapy treatments, blood tests and diagnostics, as well as diagnosis and staging data, with data that is already included in the Greater Manchester Integrated Digital Care Record (GM-IDCR).\n\nThis study will provide a Greater Manchester-specific insight into how cancer diagnosis and treatment affect rates of COVID-19 diagnosis, hospitalisation, complications, and death. It will determine the extent of the evidence supporting shielding by cancer patients during the COVID-19 pandemic. The results of this study may ameliorate the fear felt by many cancer patients about attending regular follow-up appointments and the potential risk of contracting COVID-19 while attending hospital.\n\nNHS number will be used to link additional Christie data points that are being added to the data already included in the Greater Manchester Integrated Digital Care Record (GM-IDCR) so that the data can be matched to the correct individual. After linkage, Graphnet (data processors) pseudonymises the data and makes it accessible to the research team in a dedicated research portal. At the point it can be accessed by the study team, the data can be considered anonymous to the study team because the study team do not hold the pseudonymisation key.\n\nA recommendation for class 1 and 4 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","The Christie NHS Foundation Trust"]
["Contact Name","Kate Wicks"]
["Address","The Christie NHS Foundation Trust"]
[null,"MANCHESTER"]
[null," "]
["Postcode","M20 4BX"]
["Telephone"," "]
["Email","Kate.Wicks@manchester.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All Christie patients diagnosed with cancer since 1st March 2015 that were still alive on 1st February 2020 – 65,000 records."]
["Description of confidential patient information used","Data sources\n\n1. The Greater Manchester Integrated Digital Care Record (GM-IDCR), which is sited within the Graphnet CareCentric record-sharing solution\n\n2. Additional Christie patient data that have been uploaded to the research area of the Graphnet CareCentric record-sharing BI solution for the purpose of this study. The additional cancer data from The Christie are data on systemic therapies and radiotherapy treatments, blood tests, and diagnostics as well as diagnosis and staging data that had not already been uploaded to Graphnet.\n\nIdentifiable data to be used\n\nNHS number"]
["S251 Class(es)"," ","Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null," ","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null," ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Expired"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date"]
["Notes","Applicant confirmed in February 2024 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised.\n\nIn terms of public benefit, the linkage provided by Graphnet to the Christie data was not of a high enough quality to be able to trust it. After numerous attempts (over the period of ~1 year) the applicants abandoned this linkage. This was the first study that linked this data, and the experience and lessons learnt from this study was vital for developing a better understanding of the linking process and the importance of evaluating the quality of the data prior and after linkage that will help shape future studies and form strategies to support data linkage in the future in this disease area.\n\n\n01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n\n1. A project-specific notification should be placed on the Trust website, not only for the cancer patients involved but also for the controls. This should explain that the study will be extended past the expiry of the COPI Notice. The notification should be provided to the CAG before 31 March 2022. CONDITION MET 27 JUNE 2022\n\n2. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n3. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5.\n\n4. Favourable opinion from REC Received 09 August 2021\n\n5. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for organisations processing confidential patient information (The Christie NHS Foundation Trust and Graphnet) is in place once support under Regulation 5 is active"]

{"sheet":"A02696","index":737,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02696"]
["Reference","22/CAG/0097"]
["Other Refs","IRAS Project ID:  282781  REC Reference: 20/WM/0136"]
["Application Title","AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment"]
["Application Summary","This application from the University of Southampton (with the joint controllers for the activity confirmed to be the University of Southampton and the University of Liverpool) set out the purpose of medical research which aims to allows incorporation of new potential treatments (candidates) that either only have laboratory data or limited patient data to indicate they may work to treat COVID-19. This early phase platform will look closely at dose, safety and evidence that they work before entering these other large phase trials.\n\nResearch sites have received data for COVID positive patients from GP practice surgeries, local and supra-regional testing laboratories (Pillar 1 and 2) and local CCGs under the COPI Notice and this has been used to identify and approach potential patients to see if they are interested to participate, and consent is gained if they agree. Under Regulation 5, this, and potentially data from other organisations listed below, are still required for Candidate-Specific Trial 5 (CST-5) that is recruiting COVID positive patients and for future CSTs to recruit COVID positive patients. CST-5 has recruited 36 patients out of a target figure of 149.\n\nSupport is requested to allow the disclosure of confidential patient information from UKHSA, GP practices, local public health authorities, and local CCGs, to site research teams for those research teams to approach potential participants by phone and take their consent. The identification, approaching and recruitment of COVID positive patients is ongoing for CST-5 now and will be starting for future CSTs.\n\nA recommendation for class 3 and 6 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Southampton and the University of Liverpool"]
["Contact Name","Babitha Jeevith/ Project Manager"]
["Address","Liverpool University Hospitals NHS Foundation Trust "]
[null,"Prescot Street"]
[null," "]
["Postcode","L7 8XP"]
["Telephone"," "]
["Email","babitha.jeevith@liverpoolft.nhs.uk  "]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 yrs and above with laboratory-confirmed (PCR) SARS-CoV-2 infection. (actual number contacted to date and the number of records to be accessed post-COPI is unknown)"]
["Description of confidential patient information used","Data sources\n\nGP surgeries (England and Wales) - Patient medical records\nUKHSA (England only) Data received by the UKHSA - patients who have had a recent positive confirmed diagnosis of COVID-19.\nLocal and Supra-regional Testing Laboratories - Pillar 1 (daily) and Pillar 2 (weekly) testing data – records of those testing positive.\nLocal CCGs - Daily records of those testing positive\nLocal Public Health Authorities (England and Wales) - Daily records of those testing positive\nLocal Clinical Commissioning Groups (England and Wales) - Daily records of those testing positive\n\nIdentifiers to be used\n\nName, DOB and telephone number"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null," ","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1. That the research team do not accept data from any source for which they do not have an assurance that the National Data Opt Out has been applied.\n\n2. Within 3 months of the date of conditional support, confirmation that the PPI group has reviewed the privacy notice for acceptability and has also discussed the acceptability of using confidential patient information without consent. Details of the demographics of the group, including what was discussed and the views of the group should be provided in response.\n\n3. Within 3 months of the date of conditional support, to provide a revised privacy notice to be clearer about what Regulation 5 support will be covering, and to include details of the opt-out mechanisms available to participants.\n\nConditions met 10 October 2022 \n\n4. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n5. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5.\n\n6. Favourable opinion from REC Received 12 May 2020\n\n7. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for (GP surgeries, local Public Health Authorities, UKHSA and local Clinical Commissioning Groups and their successors, the Liverpool University Hospital NHS Foundation Trust, the University Hospitals Southampton NHS Foundation Trust and King’s College Hospital NHS Foundation Trust) is in place once support under Regulation 5 is active."]

{"sheet":"A02697","index":738,"n_rows":36,"n_cols":5,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02697"]
["Reference","22/CAG/0082"]
["Other Refs","IRAS Project ID:  1004274   REC Reference:  21/SC/0393"]
["Application Title","PANORAMIC - Platform Adaptive trial of NOvel antiviRals for eArly treatMent of covid-19 In the Community"]
["Application Summary","This application from the University of Oxford (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to investigate the effectiveness of novel antivirals in preventing hospitalisations and/ or death in patients with confirmed COVID-19, who have a higher risk of an adverse outcome.\n\nSupport is requested to allow the disclosure of confidential patient information from Pillar-2 testing data held by NHS Digital to the University of Oxford research team for the purpose of contacting potential participants to join the study. As there is a surge in the number of COVID-19 positive cases in the UK and an effective treatment is yet to be determined, the research team believe that it is important to maximise the recruitment via various strategies. NHS Digital will upload the identifiers to the TIBCO MFT Internet Transfer Client, for which they are the legal entity. The data will be accessed from this Client by the Trial Manager at the University of Oxford.\n\nThe NHS Digital Data Processing Service will filter England test data and exclude data from devolved nations. This will involve NHS Digital matching the Pillar-2 testing data with data held in the Personal Demographics Service, also controlled by NHS Digital. Therefore, the legal basis to hold the data already exists. NHS number and date of birth will be used to link to HES data held by NHS Digital, in order to collect routinely collected patient data. This will be done with patient consent and is outside of the scope of support.\n\nA recommendation for class 3 support was requested to cover access to the relevant unconsented activities as described in the application."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Christopher Butler"]
["Address","Nuffield Department of Primary Care Health Sciences"]
[null,"Radcliffe Quarter"]
[null,"Oxford"]
["Postcode","OX2  6GG"]
["Telephone"," "]
["Email","christopher.butler@phc.ox.ac.uk"]
["Medical Purposes"," ","preventative medicine"]
[null," ","medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null," ","the provision of care and treatment"]
[null," ","the management of health and social care services"]
[null," ","informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","A daily list of 500 Covid-positive patients whose symptoms started within the last 5 days. This amounts to 117,500 additional sets of data following the expiration of the COPI notice over a period of 61 weeks."]
["Description of confidential patient information used","Data Sources\n\nNHS Digital - Pillar-2 testing data\n\nIdentifiers to be Used\n\nName, email address and telephone number"]
["S251 Class(es)"," ","Specific Support"]
[null," ","Class I - making the person less readily identifiable "]
[null," ","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null," ","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null," ","Class V - audit, monitoring, & analysis of healthcare provision "]
[null," ","Class VI - granting of access to data for purposes I-V"]
["Sponsor"," "]
["Status","Supported"]
[null," "," "," "," "]
["Outcome Date","2022-07-01"]
["Next Review Date","2024-07-01"]
["Notes","Amendment supported 01 August 2023 to amend the flows of confidential patient information so that information is no longer transferred from NHS England to the NHS Business Services Authority, and for the flow to revert back to the original data flow from NHS England to the University of Oxford to allow the research team to contact eligible English patients by text message, and to include a new flow of confidential patient information from Digital Health and Care Wales (DHCW) to Public Health Wales (PHW), and onwards to Health and Care Research Wales (HCRW), to allow the team at HCRW to contact eligible Welsh patients by text message\n\n01 August 2023 - change in data processor from NHS Digital to NHS England regarding data source Pillar-2 testing data.\n\n17 February 2023 – amendment supported to amend the flows of confidential patient information, so that information is no longer transferred to the University of Oxford to allow the research team to contact eligible patients by telephone call, instead confidential patient information will be disclosed from NHS England to the NHS Business Services Authority, which NHS BSA staff will use to send text messages to eligible patients.\n\n01 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n\n1. That, in the CAG’s view, a satisfactory notification strategy is developed and documents provided for review within 3 months of the date of this letter.\n\n2. That a clear method of local and national opt-out is developed.\n\n3. Support under Regulation 5 Health Service (Control of Patient Information) Regulations 2002 will come into effect automatically following expiry of the COPI notice.\n\n4. The National Data Opt Out will apply to processing of Confidential Patient Information under Regulation 5\n\n5. Favourable opinion from a Research Ethics Committee. Confirmed 19 November 2021 and again on 20 May 2022 for the inclusion of CAG support following expiry of the COPI Notice.\n\n6. Continual achievement of ‘Standards Met’ in relation to the relevant DSPT submission (or any future security assurance changes) for the duration of support. Evidence to be provided (through NHS Digital confirmation they have reviewed and confirmed the DSPT submission as standards met’ for the duration of support, and at time of each annual review. The applicant must ensure that NHS Digital confirmation of ‘standards met’ for University of Oxford is in place once support under Regulation 5 is active. "]

{"sheet":"A02698","index":739,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02698"]
["Reference","22/CAG/0089"]
["Other Refs","IRAS Project ID: 293790  REC Reference: 22/PR/0506"]
["Application Title","\nOutcomes of Early Psoriatic Arthritis in a UK nation-wide cohort"]
["Application Summary","This application from Royal United Hospitals Bath NHS Foundation Trust (RUH) sets out the purpose of medical research that seeks to investigate predictors of outcome (including pain, physical function, quality of life, impact of disease, medication and co-morbidities) for patients with established Psoriatic Arthritis (PsA) who are at least one year from first diagnosis, and to investigate the impact of delay to diagnosis and treatment on work disability in these patients. The application will undertake a follow-up web survey for all patients diagnosed with PsA and captured as part of the 2018 National Early Inflammatory Arthritis Audit (NEIAA), to provide a more complete picture of PsA specific outcomes.\n\nPsA is an inflammatory arthritis, affecting up to 30% of patients with psoriasis. PsA results in impaired physical function, reduced quality of life and work disability. There is evidence that a delay in diagnosis and/or treatment results in irreversible joint damage, worse physical function and quality of life. The data collected as part of the NEIAA audit is sufficient to address the audit aims but does not include disease specific data for different types of arthritis. This application plans to collect additional information with the web-based survey. The findings of this research can then be used to help predict the disease course for patients with PsA and determine the impact of delay in diagnosis and treatment. Hopefully, this better understanding leads to improved treatment of PsA and improved patient outcomes in the future.\n\nApplicants are requesting ‘s251’ support to receive identifiable NEIAA data, for people with a final diagnosis of psoriatic arthritis (PsA) between 1 May 2018 and 1 March 2021. The NEIAA operates under a non-research ‘s251’ support (18/CAG/0063), and also has a research database application operating with ‘s251’ support (19/CAG/0059). As part of their follow-up, patients with polyarticular PsA have agreed that the NEIAA can approach them in future about other similar projects. However as this was a question on a form filled in by the clinician, rather than an informed signed consent form, and it is likely that patients would expect this approach to come from NEIAA themselves rather than a third party, the applicant is requesting ‘s251 support’ regarding all eligible patients. Applicants will then check the NHS Spine portal to find updated email and postal address for patients, prior to sending invitations to consent to complete a web-based questionnaire. The applicant will later link the web-survey responses to the baseline audit data, and this would appear to be undertaken with consent as legal basis under common law.\n\nApplicants did explore the possibility of the BSR contacting potential participants, however this was not felt to be feasible by the BSR due to their small staffing levels and the fact that this project fell outside of their core audit scope. \n\n"]
["Applicant Organisation Name","Royal United Hospitals Bath NHS Foundation Trust "]
["Contact Name","Dr William Tillet"]
["Address","Royal National Hospital for Rheumatic Diseases "]
[null,"Royal United Hospitals Bath,"]
[null,"Combe Park Bath"]
["Postcode","BA1 3NG"]
["Telephone","07980960722"]
["Email","w.tillett@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","cohort: Patients over the age of 18 years seen in specialist rheumatology departments in England and Wales, with a final diagnosis of psoriatic arthritis (PsA) between 1 May 2018 and 1 March 2021\n\n‘s251’ support required for a maximum of 3000 patients, as data about all these individuals will be disclosed to the applicants for the purposes of inviting them to take part, unless they have specifically declined further contact, or have opted out via the national data opt out.\n\nData sources: \n1.\tThe National Inflammatory Early Arthritis Audit (NEIAA) data is collected and stored by the British Society for Rheumatology (BSR) – legal basis ‘s251’ non-research: 18/CAG/0063 and research 19/CAG/0059.\n\n2.\tSummary Care Records from the NHS Spine Portal (held by NHS Digital but accessed by database team at Royal United Hospital (RUH) Bath)\n\n\n\n"]
["Description of confidential patient information used","Identifiers required for linkage purposes, and for sending invitations to consent:\nRequired for linkage with Summary Care Record/NHS spine portal:\n\n1.\tPatient name\n2.\tNHS number\n3.\tDate of birth \n4.\tGender\n\nto get;\n5.\tFull postal address (inc postcode)\n6.\tEmail address\n\nIdentifiers required for analysis purposes:\n1.\tGender\n\nApplicant stated analysis will be undertaken on an effectively anonymous database – they will also have patient consent to undertake this. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-07"]
["Next Review Date","2024-09-01"]
["Notes","07 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1.\tPlease provide a supportive letter from the BSR if available. Condition met 26 July 2022\n\n2.\tPlease amend the invitation letter with the wording suggested in this letter, and provide to CAG for review within one month from the date support provided. Condition met 26 July 2022\n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 July 2022\n\n4.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT review for Royal United Hospitals Bath NHS Foundation Trust and Netsolving Ltd (on behalf of NEIAA) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 29 June 2022)\n"]

{"sheet":"A02699","index":740,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02699"]
["Reference","22/CAG/0022"]
["Other Refs","IRAS Project ID: 282174   REC Reference: 22/SC/0043"]
["Application Title","\nPatterns of Multiple Long-Term Vascular Conditions: A pilot study"]
["Application Summary","This application from King’s College London set out the purpose of medical research of linking data of patients with vascular (stroke and heart attack) episodes from national and local registries with their hospital and GP records to better understand patients health care journey and clinical outcomes, both mental and physical. This is part 2 of the project. There is a consented element, part 1, which does not require ‘s251’ support.\n\nMultimorbidity represents a significant health and societal burden, and commonly includes vascular risk factors and diseases. 32.4 million people annually suffer a stroke or heart attack worldwide, both being associated with significant mortality, morbidity and disabling conditions. Understanding the interrelationships between socio-demographics, vascular diseases, physical and mental outcomes, and early prevention and control of the development or progression of multimorbidity are all key to reducing the cumulative burden of these multiple long-term vascular conditions (MLTVCs) and their consequences. Gaps exist in effective prevention strategies in primary care; a recent analysis of 29,000 patients found that of 17,700 patients for whom a specific preventive treatment was clinically indicated before their first stroke, very few received the suitable treatments. linking of multiple health data sources has the potential to improve health outcomes among people with MLTVCs, as vascular events are largely preventable, and this linkage will help to identify which factors (social, biological, interventions) are associated with missed prevention opportunities and the data will aid in developing effective strategies for patients, their families, and clinical teams to reduce the likelihood of further vascular conditions.\n\nPatients who have had a heart attack will be identified from the MINAP dataset by NICOR, who will disclose NHS number to NHS Digital in order to be linked with HES and ONS data.  NHS Digital send the linked dataset back to NICOR, who will send this dataset, including NHS numbers, to the Clinical Data Linkage Service (CDLS) (hosted by SLaM).  Clinical Record Interactive Search (CRIS) data including NHS numbers will also be disclosed to the CDLS. South London Stroke Register (SLSR), and Lambeth Data Network (LDN), will disclose only pseudonymised NHS number to CDLS, as they will use the same software which will change the NHS number into the same pseudonymised format, ‘s251’ support is therefore not required for this disclosure. This will provide a complete picture of South London stroke patients. \n\nCDLS will then use the same algorithm used by SLSR and LDN to pseudonymise the NHS numbers in the received datasets, and will then link together the MINAP, HES, ONS, CRIS, SLSR and LDN datasets using the pseudonymised NHS number. CDLS will then fully anonymise the data and retain the final dataset for analysis within SLaM, and the researchers from KCL will then be given permission to access the dataset.  \n\n"]
["Applicant Organisation Name","Kings' College London"]
["Contact Name","Dr Abdel Douiri "]
["Address","King’s College London, School of Population Health & Environmental Sciences 4th Floor, \n\n"]
[null,"Addison House, Guy’s Campus\n"]
[null,"London \n"]
["Postcode","SE1 1UL "]
["Telephone"," 02078488224"]
["Email","abdel.douiri@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patient event between - 1st January 2003 to 31st March 2021 \n\n•\tAll adults aged 18 and over admitted to hospital with a heart attack (MINAP data)\n•\tAll adults aged 18 and over on South London Stroke Register \n•\tAll adults aged 18 and over on Lambeth DataNet database \n•\tAll adults aged 18 and over on The Clinical Record Interactive Search (CRIS)\n\nApplicants estimate this to be approximately 1.5 million individuals.\n\nData sources:\n1.\tMyocardial Ischaemia National Audit (MINAP) dataset, from National Institute for Cardiovascular Outcomes Research (NICOR), hosted at Barts Health NHS Trust, and controlled by HQIP.\n2.\tNHS Digital –\na.\tHospital episode statistics (HES)\nb.\tOffice for National Statistics (ONS) mortality data\n3.\tClinical Record Interactive Search (CRIS) data (at South London and Maudsley (SLaM)\n4.\tLambeth DataNet (LDN) – retained at South East London Clinical Commissioning Group\n5.\tthe South London Stroke Register (SLSR) -retained at Kings College London (KCL)\n\n\n"]
["Description of confidential patient information used","Identifires for linkage:\n1.\tNHS number only between MINAP, HES and ONS\n\n2.\tPseudonymised NHS number between MINAP/HES/ONS, CRIS, SLSR, LDN\n\n3.\tGP registration required regarding LDN data, to ensure catchment area, however this will not be linked to any direct identifier.\n\nIdentifiers for analysis:\n1.\tGender\n2.\tOccupation\n3.\tEthnicity\n\nThe data is anonymous for analysis\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-07"]
["Next Review Date","2024-07-07"]
["Notes","As of 01 February 2023, NHS England replaced NHS Digital as data processor for the HES and ONS data sets.\n\n07 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 11 April 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS Digital 20/21 DSPT reviews for Barts Health NHS Trust (NICOR), NHS Digital, and South London and Maudsley NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 February 2022)\n"]

{"sheet":"A02700","index":741,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02700"]
["Reference","22/CAG/0064"]
["Other Refs","IRAS Project ID: 305391 REC Reference: 22/WA/0080"]
["Application Title","\nBuilding an understanding of Ethnic minority people’s Service Use Relating to Emergency care for injuries (BE SURE)"]
["Application Summary","This application from Swansea University set out the purpose of medical research which aims to understand how people from minority ethnic backgrounds present to Emergency Ambulance Services and Emergency Departments with injuries, the care they receive and what happens to them, compared to the White British population. The applicant aims for the research to inform policy to address any differences in care, morbidity and mortality.\nInjuries are a major public health problem which can lead to disability or death. In the United Kingdom (UK) six million Emergency Department (ED) visits a year are the result of accidental injuries. However, little is known about the incidence, management and outcomes related to injuries among people from ethnic minority groups in the UK. Studies from several countries have indicated that people from ethnic minority groups have poor experience of accessing care and poor satisfaction with care compared to their White counterparts. Poor experiences have been attributed to communication, cultural barriers, feeling excluded from vital decisions related to their care and perceived limited choice of care provision. The applicant aims for this research to support ambulance service and emergency departments to improve care and outcomes for ethnic minority people who experience injuries and inform injury surveillance resources where they exist, and to include ethnicity dimension in the reporting of injury.\nThis mixed methods study encompasses 5 work packages; ‘s251’ support is not sought for WP1, WP4 or WP5. The retrospective linkage element, WP2 does require ‘s251’ support. A questionnaire element (WP3), also requires ‘s251’ support for a linkage element. Invitation letters are sent out by direct care team, inviting the patient to consent to a questionnaire, but stating that linkage will be undertaken using ‘s251’. WP2 comprises of a split file design, where ambulance services disclose clinical data alongside a pseudonym to SAIL, and an identifiable data file alongside the pseudonym to NHS Digital, in order for NHS Digital to link with Hospital Episode Statistics (HES), emergency care data (ECDS), and Office for National Statistics (ONS) mortality data (for 6 months post presentation), and send a dataset to SAIL. This data set will include full date of death, however neither unit level postcode nor full date of birth is also disclosed in this flow, as the applicant has confirmed they are able to receive week of birth, and deprivation scores from NSH Digital. SAIL can then link the 2 files together. There is also a flow of Scottish data described for WP2, however this is out of scope for ‘s251’ support.\n\n"]
["Applicant Organisation Name","Swansea University"]
["Contact Name","Dr Ashrafunnesa Khanom"]
["Address","ILS 2, floor 2, Swansea University, Singleton Park \n\n"]
[]
[]
["Postcode","SA2 8PP"]
["Telephone","01792 606649"]
["Email","a.khanom@swansea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","WP2: patients for whom a 999 call was made for an injury, recorded in ambulance dispatch data, from participating Ambulance services, between 1 August 2016 and 31 July 2021.\n\n(People of all ages; coded with injury; who contacted or were attended by the emergency ambulance service (including those not conveyed) or attended ED; who were located within the nominated ED area; classified as belonging to an ethnic minority group (using the 2011 ONS census classification, covering White minority Gypsy, Roma and Traveller groups) or classified as White British.)\n\nEstimated cohort size: n=550,000 \n\nWP3: Any adult (18 plus); coded with injury; who contacted the emergency ambulance service or were attended by emergency ambulance (including those not conveyed) or attended ED; who were located within the nominated ED area; classified as belonging to an ethnic minority group (as in WP2, above) or classified as White British, between 1 April 2022 – and 30 September 2022. \n\nEstimated cohort = 800\n\nData sources:\n1.\tNHS Digital – \n•\tOffice for National Statistics (ONS) Civil Registration (Deaths)\n•\tEmergency Care Data Set (ECDS) \n•\tHospital Episode Statistics (HES): Admitted Patient Care, Critical Care and Outpatient Care\n\nAmbulance dispatch data from;\n2.\tEast Midlands Ambulance Services\n3.\tSouth East Coast Ambulance Service\n4.\tYorkshire Ambulance Service\n\nA+E data from:\n\n5.\tLeicester Royal Infirmary – (University Hospitals of Leicester NHS Trust) \n6.\tEast Surrey Hospital, Redhill (Surrey and Sussex Healthcare NHS Trust) \n7.\tNorthern General Hospital, (Sheffield Teaching Hospitals NHS Foundation Trust)\n\n"]
["Description of confidential patient information used","Identifiers required for linkage:\n1.\tPseudonymous Study ID\n2.\tName\n3.\tNHS number\n4.\tDate of Birth\n5.\tPostcode (unit level) \n6.\tGender\n7.\tEthnicity\n\nIdentifiers required for analysis:\n1.\tDate of death \n2.\tGender\n3.\tEthnicity\n4.\tDate of birth – modified to week of birth by NHS Digital \n5.\tUnit level post code – modified to deprivation score by NHS Digital\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-07"]
["Next Review Date","2024-07-07"]
["Notes","11 September 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Office for National Statistics (ONS) Civil Registration (Deaths), Emergency Care Data Set (ECDS), Hospital Episode Statistics (HES): Admitted Patient Care, Critical Care and Outpatient Care\n\nAmendment supported 07 October 2022 to clarify that for WP2 no confidential patient information is disclosed to NHS Digital from East Surrey Redhill Hospital, The Royal Infirmary Leicester or Sheffield Northern General, as this can be sought from NHS Digital datasets,\tnotify CAG of an updated WP3 data flow diagram\tand to clarify that applicants have ‘s251’ support for both AMPDS and PCR data.\n\n07 July 2022 Outcome Supported\n\nSpecific Conditions of Support\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 5th April 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed. \n\nDue to the number of organisations involved it is the responsibility of University of Swansea, as controller for this application, to ensure that organisations processing confidential patient information without consent for the purposes of this application, meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n\nThe relevant organisations are;\n\n1.\tNHS Digital \n2.\tSAIL (8WG95)\n\nEnglish Ambulance services\n3.\tEast Midlands Ambulance Services \n4.\tSouth East Coast Ambulance Service \n5.\tYorkshire Ambulance Service \n\nEnglish Trusts\n6.\tLeicester Royal Infirmary – (University Hospitals of Leicester NHS Trust)\n7.\tEast Surrey Hospital, Redhill (Surrey and Sussex Healthcare NHS Trust)\n8.\tNorthern General Hospital, (Sheffield Teaching Hospitals NHS Foundation Trust)\n"]

{"sheet":"A02701","index":742,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02701"]
["Reference","22/CAG/0078"]
["Other Refs","IRAS Project ID:  296691 REC Reference: 22/PR/0602"]
["Application Title","EXTEND study – Needs Assessed Care for Early Psychosis"]
["Application Summary","This application from the University of Oxford (with the controller for the activity confirmed to be the same) set out the purpose of medical research which aims to develop a more tailored approach to participants undergoing Early Intervention in Psychosis (EIP) treatment, based on the needs of each individual and understand the health, social, and cost benefits of this approach.\n\nThe study will use data from the annual National Clinical Audit of Psychosis that measures aspects of care that individuals receive from every EIP service across England. The study will link audit data to routinely collected NHS hospital records. By identifying differences between people who receive longer or shorter EIP treatment, the research team can see whether differences in length of EIP care lead to different outcomes. They will also find out how differences in duration of EIP influence the short- and long-term cost-effectiveness of the service.\n"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Belinda Lennox"]
["Address","University of Oxford, Warneford Hospital, \n"]
[]
[]
["Postcode","OX3 7JX"]
[null,"01865613115\n"]
["Email","belinda.lennox@psych.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Those aged between 14 yrs and 65 yrs who took part in the 2019, 2020 and 2021 National Clinical Audit of Psychosis – approx. 30,000 records, though the same person may have taken part in all 3 audits, thus the number of people taking part will be less than 30,000."]
["Description of confidential patient information used","Data sources:\n1.\tRoyal College of Psychiatrists - National Clinical Audit of Psychosis (NCAP)\n\n2.  NHS Digital - Hospital Episode Statistics (HES), Mental Health Services Dataset (MHSDS)\n\nIdentifiers for linkage: \n1.\tNHS number\n2.\tGender\n3.\tAge\n4.\tPartial postcode\n\nIdentifiers for analysis\n1.\tDate of Death\n2.\tDistrict-level postcode will be used to produce local area-based deprivation measures (IMD), but the postcode will then be destroyed.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-26"]
["Next Review Date","2024-07-26"]
["Notes","01 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources - Hospital Episode Statistics (HES) & Mental Health Services Dataset (MHSDS).\n\nSpecific conditions of support \n1. That an easy-read version of the notification to be created and placed on the website. \n\nCondition met 18 October 2022\n\nConditions of support\n\n1. That an easy-read version of the notification to be created and placed on the website. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: 26 July 2022 \n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT review for Royal College of Psychiatrists was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 16 May 2022) \n\nThe NHS Digital 20/21 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 16 May 2022)\n"]

{"sheet":"A02702","index":743,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02702"]
["Reference","22/CAG/0118"]
["Other Refs","IRAS Project ID: 205549  REC Reference: 17/SW/0107  Supersedes 17/CAG/0078 "]
["Application Title","NICOR - Extended Use of Data V1.1 2017"]
["Application Summary","The amendment, to transfer activities supported under reference 17/CAG/0078 (including subsequent amendments) via a new research application is supported, subject to compliance with the with the pre-existing standard and specific conditions and the conditions of support outlined below\n\nThis submitted information represented a new application in relation to an existing activity under application reference 17/CAG/0078. The applicant states the current joint data controllers of the research database (for HQIP commissioned NCAP data) are NHS England & NHS Improvement (NHSE/I) and HQIP, and Barts Health NHS Trust for non HQIP commissioned NCAP data and other national registries. The data processor has been Barts Health NHS Trust (NICOR). This new application represents a change in controllership to NHSE/I. This new application also represents a change in data processor to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM). The intention is to replace 17/CAG/0078 with this new application.\n"]
["Applicant Organisation Name","NHS England & NHS Improvement"]
["Contact Name","Professor Nick Linker"]
["Address","Skipton House, 80 London Road, London \n\n"]
[]
[]
["Postcode","SE1 6LH"]
["Telephone","01642 282412"]
["Email","nick.linker@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","six existing national clinical audit datasets (22/CAG/0114 non research application)\n\nThis application covers the following specific audits:                                                                    1) (Myocardial Ischaemia National Audit Project (MINAP)                                                         2) Adult Cardiac Surgery Audit                                                                                              3) National Heart Failure Audit                                                                                                4) Congenital Heart Disease Audit                                                                                          5) Cardiac Rhythm Management Audit (CRM)\n6) Adult Cardiac Interventions Audit                                                                                              Additionally the application covers access to all nonsensitive Hospital Episode Statistics (HES) \nfields for patients included in the Cardiac Rhythm Management Audit, National Heart Failure Audit, National Adult Surgery Audit, National Audit of Percutaneous Coronary Interventions and Myocardial Ischaemia National Audit Project."]
["Description of confidential patient information used","gender, ethnicity, PCT of residence\n\n29 November 2019: Amendment supported to enable confidenital patient informaiton (NHS Number, date of birth, postcode, and sex) to be disclosed to NHS Digital to faciltate linkage with the HES and ONS datasets and NHS Wales Informatics to facilitate linkage with the Patient Episodes Database for Wales was supported. Linked data will be made available in the database for use for research purposes."]
["S251 Class(es)","□","Specific Support"]
[null,"□","Class I - making the person less readily identifiable "]
[null,"□","Class II - present or past geographical locations of patients "]
[null,"□","Class III - to identify and contact patients to obtain consent"]
[null,"Y","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"Y","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"Y","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-26"]
["Next Review Date","2024-06-28"]
["Notes","Conditions of support\n\n1.\tThis support supersedes 17/CAG/0078\n\n2.\tThe date of annual review is retained from 17/CAG/0078.\n\n3.\tAs per the NDO exemption outcome letter dated 01 July 2022, the applicant is requested to submit full refreshed applications in relation to 17/CAG/0078 (now 22/CAG/0018) and 17/CAG/0071 (now 22/CAG/0114) to ensure to scope of support is clear regarding research and non-research activity. This should be submitted in lieu of the next due annual review.\n\n4.\tFavourable Opinion from a NHS Research Ethics Committee. Confirmed 06 July 2022\n\n5.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\n\nThe NHS Digital 2021/22 DSPT reviews for NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate) were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 18 July 2022)\n"]

{"sheet":"A02703","index":744,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02703"]
["Reference","22/CAG/0019"]
["Other Refs","IRAS Project ID:  307353 REC Reference: 22/SW/0008"]
["Application Title","CUREd+: Centre for Urgent and Emergency Care Research Database - refresh"]
["Application Summary","This application from University of Sheffield (UoS) set out the purpose of medical research of updating and extending the CUREd Research Database (18/CAG/0126), to include more recent data and to extend the geographical area covered by the dataset. The CUREd Research Database refresh will expand the hospital data to cover all of England, update the linked ambulance service data, add death registration data, reduce variation within the hospital data, reduce the amount of confidential patient information processed and retained by UoS, and enable further research on a number of Urgent and Emergency Care (UEC) related topics.\n\nThe CUREd Research Database allows research from a UEC system perspective to examine patient flow through the whole system, from point of contact (e.g. call to 999/NHS 111) through different parts of the system, including the emergency department (ED) and into hospital. Understanding the system and how patients use it is key to developing appropriate patient-focused interventions that can lead to a sustainable, safe and cost-effective system of care. The CUREd database refresh will ensure that the data held reflects changing practices and continues to be useful for analyses. \n\nUpdated clinical data from NHS Digital and from Yorkshire Ambulance Service (YAS) will be combined with existing YAS data taken from the CUREd Research Database, which was originally created under ‘s251 support’ by UoS using data from YAS and a number of NHS Hospital Trusts in Yorkshire and the Humber. The existing CUREd Research Database contains clinical and operational data, and the patient identifiers used during its creation are encrypted and stored separately. NHS Digital will act as the Trusted Third Party for linkage and provide an updated dataset back to the applicants. \n\nAccess to the environment containing the pseudonymised health data will be restricted to experienced data management personnel involved in the processing of the database. Research will focus on specific cohorts of patients, pathways through the UEC services, and trends over time of service use. Limited, de‐identified extracts containing only the necessary data will be prepared as needed for analysis, and transferred to separate secure computing environments where analysis will take place. Analysis will be according to the research question of interest but will focus on how the UEC system is used. Researchers who are not part of the Applied Research Collaboration (ARC) will require approval from the UoS CUREd+ Data Release Committee to obtain data from the refreshed CUREd Research Database. \n\n"]
["Applicant Organisation Name","University of Sheffield"]
["Contact Name","Professor Suzanne Mason "]
[null,"CURE; ScHARR, Regent Court, 30 Regent Street, Sheffield \n\n"]
[]
[]
["Postcode","S1 4DA"]
["Telephone","0114 222 0694"]
["Email","s.mason@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patient episodes of care between 1st April 2011 and 31st March 2023 \n\nCohort A: \nPatients who \n1) contacted or received care from the emergency ambulance service provided by Yorkshire Ambulance Service (YAS) NHS Trust, or \n2) contacted the NHS 111 telephone triage service provided by YAS \n\nCohort B: \nPatients who \n1) received unscheduled care at a Walk-in Centre, Minor Injuries Unit, Urgent Care Centre or Emergency Department in England, or, \n2) received inpatient or outpatient NHS hospital care in England, or \n3) received care from Mental Health Services in England \n\nCohort C: \nPatients who \n1) are in cohort A, or \n2) are in cohort B, and whose care was provided by a Trust in the Yorkshire and Humber region\n\nApproximate number of patients estimated as 80 million in Cohort B, plus additional minimal numbers in cohort A and C. \n\n(however the 80 million figure is based on number of unique NHS Digital identifiers, and this may represent a lower number of individual patients) \n"]
["Description of confidential patient information used","Data sources:\n1.\tUniversity of Sheffield  - School of Health and Related Research (ScHARR) \na.\tthe YAS clinical data (999 and NHS111) extracted from CUREd Research Database”, between 2011 and 2017\nb.\tpatient identifiers for the existing YAS cohort of patients from the CUREd database\n\n2.\tNHS Digital\na.\tFor cohort B: \ni.\tHospital Episode Statistics (HES);\n1.\tEmergency Care Data Set (ECDS)\n2.\tAccident & Emergency (A&E)\n3.\tOutpatient (OP)\n4.\tAdmitted Patient Care (APC)\nii.\tMental Health Services Data Set (MHSDS)\niii.\tDemographic, and \niv.\tCivil Registration – death data (ONS Mortality)\nb.\tFor cohort C: \ni.\tMedicines Dispensed in Primary Care data, \nii.\tand address information\niii.\tDemographic, and \niv.\tCivil Registration – death data (ONS Mortality)\n\n3.\tYorkshire Ambulance Service – (2017-2023) (cohort A) \na.\telectronic Patient Records (ePR),\nb.\tComputer Aided Dispatch (CAD) and \nc.\tNHS111  \n\n\nIdentifiers required for linkage purposes\n\t1.\tUnique common pseudo-identifier\n2.\tName\n3.\tNHS number\n4.\tDate of birth\n5.\tPostcode\nIdentifiers retained but separated from CUREd+ database \n\t1.\tAddress (cohort C)\n2.\tDate of death\nIdentifiers required for analysis purposes\n\t1.\tGP registration\n2.\tYear of birth\n3.\tDate of death – this is always modified for analysis\n4.\tOutput Area LSOA \n5.\tAmbulance incident location postcode\n6.\tGender\n7.\tEthnicity\n8.\tnon‐identifiable pseudonymised Unique Property Reference Number (UPRN)\n\nEffectively anonymous to researchers \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-26"]
["Next Review Date","2024-07-26"]
["Notes","10 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Mental Health Services Data Set (MHSDS), Demographic data, Civil Registration – death data (ONS Mortality), Medicines Dispensed in Primary Care data, and address information.\n\nAmendment supported 10 March 2023 to remove cohort C, and for NHS England (previously NHS Digital) to link cohort A (instead of cohort C) to Medicines Dispensed in Primary Care data, address information, demographics, and civil registration – deaths data, as per updated data flow diagram.\n\nConditions of support:\n\n1.\tSupport provided for 5 years initially. A duration amendment will be required at this time to extend support.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 2 February 2022\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT reviews for University of Sheffield - School of Health and Related Research (8D715 – SHRR), Yorkshire Ambulance Service (RX8), and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 March 2022)\n"]

{"sheet":"A02704","index":745,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02704"]
["Reference","22/CAG/0075"]
["Other Refs","IRAS Project ID: 312178   REC Reference: 22/EE/0098"]
["Application Title","Clinical and Radiographic outcomes of reverse shoulder arthroplasty performed with 36-mm CoCrMo vs 40-mmcross-linked UHMWPE glenospheres at minimum 2-years follow-up."]
["Application Summary","This application from NAMSA on behalf of Lima Corporate is submitted to undertake medical research to prospectively and retrospectively collect data from the medical records of patients who were treated with either the polyethylene glenosphere shoulder replacement compared to the cobalt chromium metal glenosphere shoulder replacement between 1st January 2013 and 1st January 2020 at Wrightington, Wigan and Leigh NHS Foundation Trust.\n\nThe purpose of the research is to gather data from assessments and images collected at hospital visits performed as per standard of care from pre-op to 2-year follow-up. Data will be analysed to measure the safety and effectiveness of the devices, both of which are CE-marked and widely used in Europe. The data may be used to submit to other geographies where the device is not currently approved for use. Measure of the safety and effectiveness of the device will determine if the device is in the continued public interest to be used in shoulder replacement surgery. The data may be submitted to other markets with a view to improving patient care in those countries.\n\nClinical data from an estimated 140 medical records will be extracted by the research delivery team. Support is requested for the direct care team to provide NHS numbers of patients who are deceased and for patients for whom 2-year patient reported outcome measures (PROMs) were provided before February 2016 (where consent for use was not provided). Support is also requested for the research delivery team (who are not considered part of the direct care team) to access medical records to extract the data.\n\nThe research will also collect data on patients for whom 2-year PROMs were provided under consent after February 2016, and all patients where 2-year PROMS are not available (patients will be contacted, and consent requested). Both these data flows are outside the scope of support, as is the provision of effectively anonymised data to the sponsor."]
["Applicant Organisation Name","Wigan and Leigh NHS Foundation Trust"]
["Contact Name","Prof Ian Trail"]
["Address","Wrightington Upper Limb & Education Unit"]
[null,"Wrightington Hospital"]
[null,"Wigan and Leigh NHS Foundation Trust"]
["Postcode","WN6 9EP"]
["Telephone","01257 256248"]
["Email","upperlimb@wrightington.org.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo (cobalt chromium molybdenum alloy) glenosphere or 40-mm cross-linked UHMWPE (ultra-high molecular weight polyethylene) glenosphere) at Wrightington Hospital between 01 January 2013 and 01 January 2020 where either: 1. The patient is deceased, or 2. The patient completed PROMs before February 2016."]
["Description of confidential patient information used","Data sources:\n\n1. Medical Records at the Wrightington Hospital\n\nIdentifiers required for linkage purpose:\n\n1. NHS number\n\nIdentifiers required for analysis purposes:\n\n1. None"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-26"]
["Next Review Date","2024-07-26"]
["Notes","Amendment supported 09 February 2024 to increase the number of participants from 200 to 217, and to extend the duration of ‘s251’ support until 31 March 2024\n\nAmendment supported 13 October 2023  to clarify that the scope of ‘s251’ support is as follows; \n\n•\tRoyal Berkshire NHS Foundation Trust - all patients treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo (cobalt chromium molybdenum alloy) glenosphere or 40-mm cross-linked UHMWPE (ultra-high molecular weight polyethylene) glenosphere) between 01 January 2013 and 31 March 2022 where either: \no\tThe patient is deceased, or \no\tThe patient completed PROMs and has a full data set and therefore does not need to be approached to consent for final follow-up, \n\n•\tWrightington Hospital - all patients treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo (cobalt chromium molybdenum alloy) glenosphere or 40-mm cross-linked UHMWPE (ultra-high molecular weight polyethylene) glenosphere) at between 01 January 2013 and 31 March 2022 where either:\no\tThe patient is deceased, or\no\tThe patient completed PROMs before February 2016\n\nAmendment supported on 06 October 2023 to extend the duration of ‘s251’ support until December 2023, and to include a new data processor - Royal Berkshire NHS Foundation Trust as a participating site.\n\nAmendment supported 02 February 2023 to extend the duration of ‘s251’ support until 30 April 2023\n\nAmendment supported 24 October 2022 \nTo confirm the manor in which the radiographic images are extracted, for the purposes of pseudonymous disclosure to CoreLab, as this will now be undertaken using electronic data transfer\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 13 July 2022.\n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed\nThe NHS Digital 20/21 DSPT review for Wrightington, Wigan and Leigh NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 02 May 2022).\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02705","index":746,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02705"]
["Reference","22/CAG/0073 "]
["Other Refs","IRAS Project ID: 305248  REC Reference: 22/SC/0136"]
["Application Title","Kidney disease and mental health: Bridging the gap "]
["Application Summary","This application from King's College Hospital NHS Foundation trust set out the purpose of medical research which aims to create a research database to address current gaps in the understanding of the link between kidney disease and mental health difficulties. The applicants hope specifically to determine the prevalence of mental health difficulties in this kidney disease population, and whether there are differences in health outcomes and access to healthcare between kidney patients with and without mental health difficulties. The dataset will also allow researchers to assess future research questions, for example symptom clustering in individuals with Chronic kidney disease (CKD) and significant mental health difficulties, medication usage of individuals with co-occurring CKD and mental health difficulties, and associations between laboratory parameters and mental health difficulties. \n\nResearch has demonstrated that chronic kidney disease is more common among patients with mental health difficulties. Life-saving treatments are demanding, and impact the everyday lives of kidney disease patients, often negatively affecting their emotional and psychological wellbeing. It has also been reported that individuals who have been hospitalised for a mental health difficulty have higher mortality rates, and that individuals with a diagnosis of schizophrenia are less likely to receive a kidney transplant. Little is known about how individuals with significant mental health difficulties access kidney care. This application aims to address knowledge gaps, in order to provide more effective long-term solutions and inform the management and support provided to kidney patients with severe mental health difficulties. \n\nThis application sought ‘s251’ support to disclose identifiers from the Renalware database from King’s College Hospital NHS Foundation Trust (KCH) to the Clinical data Linkage Service (CDLS) in order for the CDLS to link to mental health data from the South London and Maudsley NHS Foundation Trust (SLaM) Clinical Record Interactive Search (CRIS) system. Renalware is a database set up in 1998, of kidney patients receiving care at KCH. These datasets will be linked using NHS number, first name, last name, date of birth, sex, and Renalware ID. For matched records, i.e. CRIS-Renalware cases, the CRIS pseudonym (the BRCID) is added to the Renalware data. Controls are defined as Renalware patients who do not match to CRIS. Confidential patient information will then be removed from the dataset for analysis, but the BRCID and Renalware ID will remain. However ‘s251’ support not required for retention of this dataset, as applicant states it is not possible for CDLS staff to re-identify a patient using BRCID. The resulting linked dataset will be stored by the SLaM CDLS for future secondary analysis.  \n\nData will be released to researchers in anonymised format, and will be carried out within the trusted research environment at SLaM. All applications to use the linked data will be reviewed and approved by the CRIS Oversight Committee (OC). The OC is chaired by a service user and has representation from Child and Adolescent Mental Health Services, the SLaM Caldicott Committee (to which it reports), and the R&D Office. There is one lay representative on the OC, applicants are currently recruiting for a second. OC terms of reference have been provided."]
["Applicant Organisation Name","Weston Education Centre"]
["Contact Name","Dr Kate Bramham"]
["Address","Kings College London"]
[null,"Denmark Hill Campus"]
[null,"10 Cutcombe Road"]
["Postcode","SE5 9RJ "]
["Telephone",2078480439]
["Email","kate.bramham@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individuals with kidney disease, from the Renalware database - kidney patients receiving care at King's College Hospital, since 1996 \n\nApproximately 7000 \n\nApplicant has stated that patients included in CRIS who do not have kidney disease will also be included. Unclear how many, as they do not yet know prior to undertaking the linkage.  "]
["Description of confidential patient information used","Data sources \n\n1.Kings College Hospital – Renalware clinical database \n\n2.SLaM CRIS database (Mental healthcare data will be provided from the SLAM BRC Case Register)  \n\nIdentifiers required for linkage purposes \n\n1.NHS number \n2.Name \n3.Date of birth,  \n4.Sex \n5.Renalware pseudonym ID \n\nIdentifiers required for analysis purposes \n\n1.CRIS pseudonym (the BRCID) – no key retained \n2.Renalware pseudonym ID – no key retained \n3.Year of birth \n4.Year of death \n5.Gender \n6.Occupation \n7.Ethnicity \n8.sector level postcode \n9.Applicant states only de-identified data will be held in the database.  \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-02"]
["Next Review Date","2024-05-14"]
["Notes","Conditions of Support:\n\nFavourable opinion from a Research Ethics Committee. Confirmed 29th June 2022. \n\nConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 20/21 DSPT reviews for King's College Hospital NHS Foundation Trust and South London & Maudsley NHS Foundation Trust (CDLS) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13 May 2022) "]

{"sheet":"A02706","index":747,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02706"]
["Reference","22/CAG/0076 "]
["Other Refs","IRAS Project ID: 309878  REC Reference:  22/LO/0362"]
["Application Title","Suicide by patients in contact with drug and alcohol services in the year prior to death"]
["Application Summary","This  application  from the  Centre  for  Mental  Health  and Safety  at  the  University  of Manchesterset   out   the   purpose   of   medical   research   which   aims   toidentifythe characteristics and antecedents  of  suicide  in  people  incontact  with  substance  misuse services. Alcohol  and  drug  misuse  are  key  risk  factors  for  suicide.  There  is  currently  no national study of suicide by people in contact with alcohol and drug services, and following NHS  reforms,  service  provision  has  become  more  complex. Thefindings  will  help  to inform preventative efforts in this population.The  applicants  plan  a 12  monthlinkage,  case-control,and serious  incident  reports(SUI)collection  for  Englandand Wales using National  Drug  Treatment  Monitoring  System(NDTMS)and Welsh  National  Database for  Substance (WNDSM).  However astheDrug and   Alcohol   Information   System   (DAIsy), the   Scottish   database,is   in   its   infancy, applicantsplan  only  a  6  month linkage  with Scottish  data, and  do  not  plan  to  create  a control  group  or  collect  SUIsregardingScottish  data.This  application  is  in  2  phases. Phase one is  aretrospective  cohort  and  case-control  study. NCISH  at  the  University  of Manchesterhas ‘s251’  support  under PIAG-4-08(d)/2003to   maintainthe   general population  suicide  database.NCISH  will  extract  a sampleofpeople  whose deaths  have been registered as suicide (including probable suicide) at coroner’s inquest. The sample will contain unique NCISH ID number, last name, initial of first name, gender, date of birth, date  of  death,  and  NHS number. Thiswill  be  disclosedfrom  University  of Manchestertothe Office  for  Health  Improvement  and  Disparities (OHID),  part  of the  Department  of health and  Social  Care  (DHSC),  and  Digital  health  and  Care  Wales (DHCW) (previously NWIS),in  order  for  them  to  link to NDTMSandWNDSM-databases  on  all  people  in contact with drugs and alcohol services fromEngland and Wales. There isalso a flow of data  toPublic Health  Scotland(PHS)for  the  purposes  of  linkage  with the  Drug  and \nPage 4of 10Alcohol  Information  System  (DAIsy).OHIDand  DHCW  return a linked pseudonymiseddataset  containingNCISH  number  back  to Universityof Manchester.  This  flow  still requires ‘s251’ support as the University of Manchester retain identifiers  and  are  able  to re-identify  these  individuals. NCISH will  link  these  data  to another  dataset  retained  by University  of Manchester,  using  the  NCISH  number-the  database  of  suicide  deaths  in people  in  recent  (i.e.  12  month)  contact  with  mental  health  services. OHID,  DHCW  and PHS will securely deleteany unlinkedmortalitydata.OHIDandDHCWwill create a control sample(using age & sex). Controls will be people who  have  had  contact  with  alcohol  and  drug  services  and  have  not  died  by  suicideor other  causeswithin  12  months  of  the  matched  cases  date  of  death. This  data  will  also have  an  allocated  NCISH  number and  all  identifying informationwill  be  removed  prior  to disclosing to University  of  Manchester. The applicanthas statedthese  elements  donot require ‘s251’supportand that the legal basis for this processing is consent.Inphase 2, applicants will collect detailed clinical data about peoplewho died by suicide while under the  care  of  alcohol  and  drug  services,from SUIswhere  available. These Incident reports will be obtained by requesting redacted copiesfrom third sector and NHS services organisations providing publicly funded drug and alcohol services. ‘s251’ supportis required for the disclosure of name, date of birth, and date of death from University of Manchester to alcohol  and  drug  service  providers,in  order to request  a  redacted  copy  if the  SUI. Pseudonymous SUIs  are  provided  back  to  the  University  of Manchester, including  theNCISH  number.  Therefore  this flow  still  requires ‘s251’  support  as  the University of Manchester retain identifiers and are able to re-identify these individuals.There is nonotification or opt outfor the case cohort as these individualsare deceased. The  applicant  has  developeda study  notification  document to be  placed  on  the  NDTMS website to inform service users in the control cohort that the study is ongoing. This will link to  the  longer  study  notification  document  on  the  NCISH  website  should  people  wish  to obtain more information.This does not have an opt out option as the applicants state that the control group areincluded with consent."]
["Applicant Organisation Name","University of manchester"]
["Contact Name","Professor Jennifer Shaw"]
["Address","School of Health Sciences"]
[null,"University of Manchester"]
[]
["Postcode"]
["Telephone",1612750709]
["Email","jennifer.j.shaw@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Phase 1:\n\nCases:People  who  havebeen  in  contact  with  drug  and alcohol services in the year prior to suicide –Deathregistered as  suicide  or  probable  suicide,between 1st October  2021 to 30th September 2022(estimated at 545)\n\nPhase 2:\n\nPeople  who have been  in  contact  with  drug  and  alcohol services  in  the  year  prior  to  suicide  Death  registered  as suicide  or  probable  suicide  between  1st  October  2021  and 30th September 2022, with a SUI reportavailable.(estimated  at  545maximum, however,applicants  will try  to \nPage 5of 10obtain Serious Incident Reports for all cases, but there will be some  that  have  not  had  them  and  some  that cannotbeobtained)"]
["Description of confidential patient information used","Data sources\n\nPhase 1:\n\n1.University of Manchester–NCISH databases; \n\na)The  general  population  suicide  database(PIAG-4-08(d)/2003)  \n\nb)The  database  of  suicide  deaths  in  people  in  recent (i.e.  12  month)  contact  with  mental  health  services.(PIAG-4-08(d)/2003)\n\ndatabases   onpeople   in   contact   with   alcohol   and   drug services:\n\n2.Office  for  Health  Improvement  and  Disparities  (England) (OHID), (part  of Departmentof  health  and  SocialCare) -National Drug Treatment Monitoring System (NDTMS)\n\n3.Department for Health and Care Wales (previously NWIS)-Welsh   National   Databasefor   Substance   Misuse (WNDSM)\n\nOut of scope for ‘s251’ support:\n\n•Public  Health  Scotland  (PHS) -the  Drug  and  AlcoholInformation System (DAIsy).\n\nPhase 2:\n\n4.Third  sector  and  NHS  services  organisations  providing publicly   funded   drug   and alcohol   services, acrossEngland and Wales-serious incident reports (SUI)\n\nIdentifiers required forlinkage purposes\n\nPhase 1: For OHID, DHCW, PHS–from CAG form:\n\n1.Name\n\n2.Dateof birth\n\n3.Date of death\n\n4.NHS number (DHCWonly)\n\n5.unique NCISH ID number\n\nPhse 2: For SUI:\n\n1.Name\n\n2.Date of birth\n\n3.Date of death\n\nIdentifiers required for analysis purposes\n\n1.Gender\n\n2.Ethnicity\n\n3.Age\n\nApplicant states analysis will be undertaken on aneffectively anonymous dataset "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-03"]
["Next Review Date","2025-01-05"]
["Notes","Amendment Supported 21 December 2023 to extend the duration of ‘s251’ support until 31 May 2024\n\nAmendment supported 07 October 2022 to additionally disclose sex and outward postcode to OHID & DHCW, and CHI Number to PHS, for the purposes of linkage, and to additionally receive any local investigation reviews (also referred to as Mortality Case Review Documents/Incident Reviews/Structured Judgement Reviews, depending upon the service), in addition or instead of an SUI\n\nConditions of support\n\n1.Favourable opinion from a Research Ethics Committee. Confirmed 24 May 2022.\n\n2. Confirmation providedfrom the IG Delivery Team at NHS Digitalto the CAGthat the relevant DataSecurity and ProtectionToolkit (DSPT)submission(s)hasachieved the ‘Standards Met’ threshold. See section below titled ‘security  assurance  requirements’for further information. Confirmed:\n\nThe NHS Digital 20/21DSPT reviewsforUniversityof ManchesterNCISH -8D594-ECC0020, DHSC  (OHID)(currently using  PHE  (X25), will  be  replaced  byUKHSA when thisis  in  place)wereconfirmed  as ‘Standards  Met’on  the  NHSDigital DSPTTracker (checked 13 May 2022)\n\n•DHCW–a valid CPiP in currentlyin place.\n\n•Third sector and NHS services organisations providing publicly funded drug and alcohol services–more than 5, and therefore this is the responsibility of the applicantto ensure."]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02710","index":748,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02710"]
["Reference","22/CAG/0086"]
["Other Refs","IRAS Project ID: 166048  REC Reference: 15/EE/0076"]
["Application Title","The Norfolk Arthritis Register (NOAR)"]
["Application Summary","This application from the University of East Anglia set out the purpose of medical research that continues the Norfolk Arthritis Register (NOAR), which investigates and identifies the genetic and non-genetic factors which may be related to the onset of inflammatory arthritis, response to treatment and its long term outcomes.\n\nThe Norfolk Arthritis Register (NOAR) was set up in 1989 as a large community-based study investigating the cause and outcome of inflammatory polyarthritis. So far, data on over 4900 participants has been collected, and recruitment is continuing. The application was originally supported by the CAG under reference ECC 4-02(FT1)/2012. A refreshed application has been submitted at the request of the CAG.\n\nAll patients who are newly diagnosed with an inflammatory arthritis, presenting via primary or secondary care,should be referred to NOAR. New referrals are checked for eligibility and patients are then contacted by the study team by telephone and verbal consent sought to send out the study information. This information contains a consent form and participation would proceed on a consented basis. \n\nThe applicants will also undertake linkage to HES and ONS mortality data. The NOAR ID, NHS  number,  postcode,  sex  and  date  of  birth  for  all  identified  NOAR  patients  will  be extracted  from  the  NOAR  database.  Two  separate  data  extracts  will  be  created,  one  list which  will  be  processed  under  s251  and  another  list  where  patients  have  given  explicit consent. Both lists will be transferred to NHS Digital for linkage to HES and ONS data. The National  Data  Opt-Out  will  be  applied  and  the  all  identifiers  other  than  the  NOAR  ID removed.  The dataset  will  then  be  transferred  to  the  University  of Manchester  Data  Safe Haven.\n\nThe  applicants  seek  support  for  the  transfer  of  confidential  patient  information  for  newly diagnosed patients to the NOAR team, so that eligibility can be checked, and contact made. Support  is  also  sought  for  the  further  access,  retention  and  reuse  of  mortality  records supplied by ONS between 2003 and 2017 for patients recruited before 2003 or after 2015. Support  is  also  sought  for  the  further access,  retention  and reuse of  HES  data,  supplied between 2000-2017 for participants recruited prior to 2015 who have not been reconsented. S251  support  is  also  sought  to  provide  an ongoing  legal  basis  for  participants  who have died or been lost to follow up."]
["Applicant Organisation Name","University of East Anglia"]
["Contact Name","Professor Alexander Macgregor"]
["Address","Bob Champion Research and Education Building"]
[null,"Norwich Research Park"]
[null,"Norwich"]
["Postcode","NR4 7UQ"]
["Telephone",1603593570]
["Email","a.macgregor@uea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and over who meet the below inclusion criteria: Have had two or more swollen joints, lasting for 4 or more weeks. Have a clinician diagnosis of an Inflammatory Arthritis. Resident in Norfolk at time of symptom onset and registered with participating GP Practice. Onset in the last 2 years. Willing to give informed consent to take part in the study.\n\n5330 are estimated to be included"]
["Description of confidential patient information used","Data sources\n\n1. NOAR Participants (questionnaire data) \n\n2. GP's within Norfolk and Waveney CCG \n\n3.  Norfolk  and  Norwich  University  Hospital  NHS  Foundation Trust patient and clinical data (PAS, ICE, patient notes) \n\n4. NHS Digital data -\n\na) Hospital Episodes Statistics (HES) \n\nb) Office for national Statistics (ONS) mortality data \n\n5. European ProspectiveInvestigation into Cancer (EPIC)\n\nIdentifiers required for linkage purposes\n\n1. NHS number \n\n2. Date of birth \n\n3. Postcode –sector level \n\n4. Sex\n\nIdentifiers required for analysis purposes\n\n1. Postcode –district level"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-05"]
["Next Review Date","2024-08-05"]
["Notes","17 August 2023 - change in data processor from NHS Digital to NHS England regarding data sources - Hospital Episodes Statistics (HES) and Office for national Statistics (ONS) mortality data\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: 30 April 2015. \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.  \n \nConfirmed:  \n \nThe NHS Digital 2020/21 DSPT reviews for University of Manchester, University of East Anglia, Norfolk and Norwich University Hospital NHS Foundation Trust and Norfolk and Waveney CCG were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 20 June 2022). \n"]

{"sheet":"A02707","index":749,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02707"]
["Reference","22/CAG/0092 "]
["Other Refs","IRAS Project ID: 315686 REC Reference: 22/YH/0129"]
["Application Title","Establishing evidence to inform culturally competent mental health services (EVOLVE)"]
["Application Summary","Purpose of application.\n\nThis application from the University of Newcastle Upon Tynesets out the purpose of medical research that  seeks to  identify  and  quantify  changes to mental  health services,  and  their impacts on health outcomes during the COVID-19 pandemic, in ethnic minorities. Applicants plan  to  use  data  collected  routinely  by  the  NHS,  before,  during,  and  after  a  lockdown  in areas where a large proportion of ethnic minorities live,to compare changes in service use and how changes affect people.\n\nResearch has shown that aCOVID-19 diagnosis has negative effects on mental health -1 in  5  people  with  COVID-19  have  experienced  a mental  health difficultywithin  90  days  of diagnosis.  Thepandemic  has  also  worsened  longstanding  mental  health  inequalities  for ethnic minorities. Research has reported higher levels of anxiety and depression in ethnic minorities across the pandemic, but less support from mental health services. This indicates a need to understand how changes in using mental health services impact health outcomes of ethnic minorities, to establish how services should be provided to satisfy people’s needs, which is what this study aims to investigate.\n\nThree local authority areas(Newcastle upon Tyne, Middlesbrough, and Stockton-on-Tees) were  selected,  as they  have  a  high  percentage  of  ethnic minority  individuals  living  in  the region,  according  to  the  England  and  Wales  2011  Census.  6  GP  surgeries  were  then selected.  North  of  England  Commissioning  Support  Unit  (NECS)  will  identify  eligible patients and will extract their primary care data, including identifiable information. NECS will then send identifiable information to NHS Digital to link with secondary and community care outcomedata.  NECS  will  link  the  primary  care  data  from  the  GP  practices  with  the secondary and community care data from NHS Digital, pseudonymise the linked dataset, and provide the linked pseudonymised data to the University of Newcastle. Only NECS will have access to the key between the pseudo ID and confidential patient informaiton, and this will be retained for 35 months after the study has completed, to allow for any requests to check  data  analysis  following  publication.  The  applicants  at  University  of  Newcastle  will never have access to any identifiable information. "]
["Applicant Organisation Name","Population Health Sciences Institute"]
["Contact Name","Dr Yu Fu"]
["Address","Newcastle University "]
[null,"Newcastle"]
[]
["Postcode","NE2 4AX"]
["Telephone",7809759652]
["Email","Yu.Fu@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1,328 non white patients, from six GP practices across three local  authority  areas  (Newcastle  upon  Tyne,  Middlesbrough and Stockton-on-Tees), who are adults over 18 years having been  referred  or self-referred  to  NHS-funded  secondary mental health services or Improving Access to Psychological Therapies  (IAPT)  services  between  23  March  2019  and  22 March 2020."]
["Description of confidential patient information used","Data sources\n\n1.local  primary  care  electronic  health  record  from  6  GP practices:\n\na.Elswick Family Practice \n\nb.West Road Medical Centre \n\nc.Elm Tree Surgery \n\nd.Riverside Medical Practice \n\ne.Park Surgery \n\nf.Prospect Surgery\n\n2.NHS Digital:\n\na.Mental Health Services Data Set (MHSDS)\n\nb.Improving Access to Psychological Therapies data set (IAPT)\n\nc.Hospital Episode Statistics (HES), including; \n\ni.Admitted Patient Care (APC), \n\nii.Outpatients (OP), \n\niii.Accident and Emergency (A&E)\n\nd.and Community Service Data Set (CSDS)\n\nIdentifiers required for linkage purposes\n\n1.NHS number\n\n2.Name\n\n3.Date of birth\n\nIdentifiers required for analysis purposes\n\nPseudonymised data sent to Newcastle University;\n\n1.Date of birth –modified to month and year \n\n2.Date of death –modified to month and year \n\n3.Gender\n\n4.Occupation5.Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-09"]
["Next Review Date","2024-08-09"]
["Notes","Amendment supported 19 January 2024 to increase the size of the cohort to include 11,652 patients including both White British and ethnic minorities), and to extend the duration of ‘s251’ support until 31 July 2027\n\n31 October 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Mental Health Services Data Set (MHSDS), Improving Access to Psychological Therapies data set (IAPT), Hospital Episode Statistics (HES), (including; Admitted Patient Care (APC), Outpatients (OP) & Accident and Emergency (A&E)), and Community Service Data Set (CSDS).\n\nconditions of support\n\n1.Favourable opinion from a Research Ethics Committee: Confirmed 20 June 2022.\n\n2.Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further informationConfirmed:\n\nThe  NHS  Digital 21/22DSPT  review  for NHS  North  of  England  Commissioning Support Unit (0AR) was confirmed as ‘Standards Met’by email to the CAG inbox (06 July  2022)  &  the  NHS  Digital 20/21DSPT  review  for NHS  Digitalwas  confirmed  as ‘Standards Met’ by check of the NHS Digital DSPT tracker (checked 06 July 2022)"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02708","index":750,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A2708"]
["Reference","22/CAG/0102"]
["Other Refs","IRAS Project ID: 315174  REC Reference: 22/PR/0808"]
["Application Title","Exploring use and implementation of rehabilitation prescriptions for individuals admitted to UK major trauma centres: a mixed-methods study"]
["Application Summary","This application from University of Nottingham set out the purpose of medical research that seeks to explore the current use and intended purpose of the ‘Rehabilitation Prescription’ (RP) following major trauma, including the context for its implementation. Findings will inform the development of a future grant application, in which a solution to improve the implementation of the rehabilitation prescription will be developed and tested.\n\nTraumatic injuries can be life changing with many survivors experiencing a range of physical and psychological problems. More people are surviving traumatic injury following the opening of UK Major Trauma Centres in 2012, however more individuals are living with the long-term effects of trauma, often requiring rehabilitation. The RP was developed in 2010, designed to support the identification of patient rehabilitation needs. The trauma survivor and family should be involved in its completion with the aim to improve continuity of community care following hospital discharge. However, research suggests that the RP is not being used properly. Patients often feel as if they have been abandoned when they leave hospital with limited knowledge about their rehabilitation plans. The RP is not always being completed by rehabilitation experts and is not always shared with relevant healthcare professionals (e.g. GPs).\n\nThe applicant is undertaking a number of different methodologies at 3 participating trauma centres, including consented interviews and focus groups. These elements do not require ‘s251’ support. However the applicant is also undertaking ethnographic observations, of 3 major trauma centre meetings, observed twice at each site, and observations of clinical staff completing rehabilitation prescriptions. Support under Regulation 5 is required for this aspect of the study as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded. Any identifiable data that is recorded (including names of clinical staff and services) will be pseudonymised."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Dr Jade Kettlewell"]
["Address","Allied Health Research Building"]
[null,"University Park"]
[null,"Nottingham"]
["Postcode","NG7 2RD"]
["Telephone",7921098979]
["Email","Jade.Kettlewell2@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The participants in the study are NHS staff participating in MDT meetings, and completing the rehabilitation prescription in three trauma centres. However the researchers undertaking observations of MDT meetings may be exposed to confidential patient information relating to patients discussed at the MDT meetings. These will be patients admitted to one of the three major trauma centres (Nottingham, Cambridge, St. George’s London), and will have received a rehabilitation prescription."]
["Description of confidential patient information used","Data sources\n\n1. Clinical meetings in major trauma centres recorded via written field notes, at the following Trusts; · Nottingham University Hospitals NHS Trust · Cambridge University Hospitals NHS Foundation Trust · St. George’s University Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be recorded for linkage purposes\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be recorded for analysis purposes\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-08-16"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, this research will inform the improvement of rehabilitation prescription implementation for major trauma patients. It is hoped that by improving the provision of rehabilitation prescriptions, patients will better understand their rehabilitation needs when discharged from a major trauma centre, thus enabling them to access the appropriate services.\n\n\nUpdate to original conditions of support:\n\n1.\tPlease update the poster to make it clearer how to opt out (taking into account the proposed opt out mechanism), and to make it clear that patient data is not collected, and provide the updated poster to CAG within 1 month of the date of this letter.\n\nCondition met 02 September 2022\n\n\nThe application, to allow for incidental exposures of confidential patient information that may occur when the research team are undertaking observations of Multi-Disciplinary Team meetings, and observations of clinical staff completing rehabilitation prescriptions, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n1.\tPlease update the poster to make it clearer how to opt out (taking into account the proposed opt out mechanism), and to make it clear that patient data is not collected, and provide the updated poster to CAG within 1 month of the date of this letter.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 11 August 2022\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for Nottingham University Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, and St. George’s University Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ by email to the CAG inbox (received 26 July 2022)\n\n"]

{"sheet":"A02709","index":751,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02709"]
["Reference","22/CAG/0099"]
["Other Refs","IRAS Project ID: 312683   REC Reference: 22/NW/0136"]
["Application Title","ABATED -Automated Brain Image Analysis for Timely and Equitable Dementia Diagnosis"]
["Application Summary","This  application  from  Queen  Mary  University  of  London  set  out  the  purpose  of  medical research that seeks to investigate whether a new artificial intelligence technology can be used to support more timely, accurate and equitable diagnosis of dementia within memory clinics.\n\nPatients are referred to memory clinics if dementia is suspected. However, other conditions may cause memory difficulty and it is often difficult to know whether apatient has dementia when first assessed. \nThis uncertain situation is referred to as “mild cognitive disorder” (MCD). Currently, the only way to establish a diagnosis of dementia is to follow-up patients over time to see if their condition worsens. This follow-up is often not available, and patients are discharged without a clear diagnosis. Brain scans are routinely used in memory clinic assessments as dementia causes shrinking of the brain. However, when humans interpret the scans, this only provides a clear diagnosis when the dementia is quite advanced. The applicants seek to test computerised interpretation of brain scans. \n\nTwo cohorts of patients with MCD, a retrospective cohort and a prospective cohort, will be identified  from  East  London  Memory  Clinics.  Patients  in  the  prospective  cohort  will  be identified from attendance at formulation meetings and MCD groups at East London NHS Foundation  Trust  (ELFT)  Memory  Clinics.  Retrospective  patients  will  be  identified  via electronic patient records at ELFT. Support is required to allow members of the research team, working alongside members of the direct care team, to identify patients suitable for inclusion in the retrospective cohort and link records held in ELFT. The core clinical dataset is recorded in a pseudonymised CRF. Patients NHS number will be deleted after linkage to scans to make CRF anonymous before transfer to the Queen Mary University of London for analysis."]
["Applicant Organisation Name","Queen Mary University of London/Barts Health NHS Trust/East London Foundation Trust"]
["Contact Name","Dr Charles Marshall"]
["Address","Wolfson Institute of Population Health"]
[null,"Charterhouse Square"]
[]
["Postcode","EC1M 6BQ"]
["Telephone",7879408144]
["Email","charles.marshall@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1200 patients: \n\nProspective  cohort  of  200  patients  who received  an  MCD diagnosis (outside the scope of support).Retrospective  cohort  of  1000  patients  who  had  an  initial diagnosis of MCD. The prospective cohort will include patients attending memory clinic    between    01/06/2022    and    21/07/2023, and the Page 3 of 9 retrospective  cohort  will  include  patients  attending  memory clinics from 01/01/2003."]
["Description of confidential patient information used","Data sources:\n\n1.Electronic patient records at East London NHS Foundation Trust\n\n2.Electronic patient records at Barts Health NHS Trust\n\nIdentifiers required for linkage purposes:\n\n1.NHS Number\n\n2.Date of birth\n\nIdentifiers required for analysis purposes:\n\n1.Gender\n\n2.Ethnicity\n\n3.Age"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-03"]
["Next Review Date","2024-08-03"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: 08 June 2022. \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS Digital 2020/21 DSPT reviews for East London NHS Foundation Trust and Bart’s Health NHS Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 July 2022). "]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02711","index":752,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02711"]
["Reference","22/CAG/0094 "]
["Other Refs","IRAS Project ID: 269485 REC Reference: 19/LO/1624"]
["Application Title","Research to Improve the Detection and Treatment of Latent Tuberculosis Infection: Diagnostics. (Short title:RID-TB:Dx"]
["Application Summary","This application from University College Londonsets out the purpose of medical research that  seeks  to conduct  an  RCT  to  identify  if newC-Tb  skin  test  for  the  diagnosis  and subsequent  management  of  Latent  TuberculosisInfection  (LTBI)  will  be  as  good  as  the current standard-of-care IGRA blood test. This will be evaluated based on the number of participants  who then  accept  and  start treatment  for  LTBI,  based  on  a  positive  C-Tb  test result (intervention arm) or IGRA testresult (control arm). ‘s251’support for this application is requested only for thescreening andinvitation of eligiblepatients to a clinic appointment, by individuals who are notconsidered part of the direct care team.\n\nLatent  TB  infection  (LTBI)  testing  and  treatment  reduces  TB  incidence  by  preventing reactivation, and is expected to be cost-saving to the health system. However, high rates of testing, treatment uptake and treatment completion are essential to achieve these benefits.There is now a new skin test available, called C-Tb, which researchsuggests is as good as IGRA in correctly identifying LTBI. Applicantsproposeto comparethe C-Tb test to usual care using IGRA to see whether it is more accurate, easier toobtain a diagnosis, and offers better value for money for the NHS. This study will provide the evidence required to inform the use of C-Tb in UK LTBI testing strategies.\n\nRID-TB  is  a  5-year  programme  of  research  awarded  to  UCL  by  the National  Institute  of Health  Researchincluding  different  studies  on latent  tuberculosis  infection  (LTBI). There are various work packages, but ‘s251’ support is only requested foradiagnostic trial (RID-TB:Dx), and that ‘s251’ support is only related to screening and invitationto consent. This RCT has beenopen to recruitmentsince September 2021, usingthe direct careteam only toapproach eligiblepatients.And to date, 27participants have been recruited, out of the required 1530 total. Feedback from existing and potential sites about increasing recruitment rates make it clear that additional support for research staff to contact patients to invite them into clinic and approach them about thestudy is required.\n\nRecruitment will take place inparticipatingprimary and secondary care organisations. ‘s251’ support  is  required  for CRN  research  nurses/clinical  research  practitioners,  employed through  adesignatedhealth  trust  and  assigned  to  the  RID-TB  programme at  UCL and research nurses employed directly by the RID-TB programme, who are not considered part of the direct care team, to view clinical lists, and patient medical records, in order to screen for eligibility, and contact patients via telephone, in order to book them into an appointment for LTBI  testing,  and  consenting  to  the  trial. During  the  conversation  the patients  will  be asked if they are interested in taking part in TB research. If they decline, they will be booked in to attend clinic for a standard of care LTBI test. If they are interested in learning more about the research, the research nurse/practitionercan provide a brief overviewwhiston the  phone,  and  then  book them  in  for  LTBI  testing  in the  research  clinic  session.Patient records will be viewed either in person on site or by accessing the electronic patient system remotely. No confidential data will be downloaded/transferred to be stored within a different organisation.The research nurses/practitioners will also attend the clinics, to presentthe studybefore the patient receives their LTBI diagnostic test."]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Ibrahim Aboubakar"]
["Address","Institute for Global Health"]
[null,"30 Guilford Street "]
[null,"London"]
["Postcode","WC1N 1EH"]
["Telephone","+44 (0)207 905 2123"]
["Email"," i.abubakar@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Participant Inclusion Criteria;\n\n1. Age 16-65 years \n\n2. Eligible for LTBItesting with IGRA and treatment for LTBI according to UK guidance \n\n3. Willing and able to provide written informed consent \n\n4.  Willing  and  able  to  comply  with  the  trial,  including  the randomised test(s) and adherence to follow up visits \n\nParticipant Exclusion Criteria:\n\nDisplaying  anysymptoms  or  signs  of  active  TB  disease: Unexplained  fever;  Cough  (more  than  three  weeks); Haemoptysis  (Blood  in  sputum);  Unexplained  weight  loss; Drenching night sweats; Lymph node swelling.\n\nA total of 1530 participants are to berecruited.27 havebeen recruited already.\n\nHowever‘s251’support is required for all those who will have their confidential patient informationscreened.Thecohortthat will  be  screenedare all  individuals  recommended  for  LTBI testing   and   treatment (by   UKHSAand   NHS   Englandguidelines). This includes newentrants into the UK, and also contacts of TB cases.These will mostly, but not exclusively, comprise  of case  contacts  of  persons  diagnosed  with  active TB  and  persons  screened  within  the  migrant  screening programme.  The  LTBI migrant  screening  programme  isfor new entrants into the UK (individuals should be tested for LTBIif they are aged 16 to 35 years, entered the UK from a high incidence  country  (≥150/100,000  or  Sub  Saharan  Africa) within the last five years and been previously living in that high incidence country forsix months or longer).\n\nIt  is  not possiblefor  the  applicant  to  provide  an  accurateapproximation  as  to  how  many  individuals  this  might  be, however they estimate that 5-10 individuals may be booked in for   appointments   following   telephone   calls   made   to   20 individuals. Of these 5-10 individuals booked in, not all would consent. Therefore ‘s251’support will likelycover  at  least 3000 individuals, very likely more."]
["Description of confidential patient information used","Data sources\n\n1.Clinic lists at participating primary careand secondarycaresites(This  will  have  been  created  using Flag  4data accessedfor the purposes of clinical care).\n\nSecondary Care\n\n-Barts Health NHS Trust (Shrewsbury Road, Mile End, Whipps Cross) -open, recruiting\n\n-Whittington Health Trust -open,recruiting\n\n-Royal Free NHS Trust -open, recruiting\n\n-London North WestUniversity Healthcare NHS Trust (Ealing, Central Middlesex, Northwick Park) -in setup\n\n-North Middlesex University Hospital NHS Trust -in setup\n\n-Guy’s and St Thomas’ NHS Foundation Trust -in setup\n\n-Imperial College Healthcare NHS Trust (no longer participating in Dx)\n\n-University Hospitals of Leicester NHS Trust(no longer participating in Dx)\n\nPrimary Care\n\n-Newham Transitional Practice -open, recruiting\n\n-Goodmans Fields Medical Practice -inset up-Dr CM Patel's Surgery -in set up\n\n-Shrewsbury Road Surgery -in set up\n\n-Mathukia's Surgery, \n\n-Redbridge -in set up\n\n-Albion Health Centre, \n\n-Tower Hamlets –in set up\n\nIdentifiers required for screening and invitation purposes\n\n1.Medical record will be screened\n\n2.Name\n\n3.Date of Birth –for eligibility\n\n4.Telephone number\n\nIdentifiers required for analysis purposes\n\n1.N/A –analysis is undertaken with consent\n\nAdditional information\n\nData will be accessed directly from the clinic systems, with no data being copied to alternative systems, and nodata will be taken off site or passed on to any third party."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-26"]
["Next Review Date","2024-08-26"]
["Notes","Amendment supported 16 August 2023 to extend the duration of ‘s251’ support until June 2024.\n\nThe application, to allow research nurses/clinical research practitioners, who are not considered part of the direct care team, to view confidential patient information at participating trusts and primary care organisations, to identify potential participants for the RID-TB:Dx trial, and telephone these patients to arrange an appointment for LTBI testing, and further discussion about the RID-TB:Dx trial, (where they will be approached for consent), is fully supported\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: Original FO from the Harrow REC in January 2020, and amendment specifically including this CAG application provided FO on 18 August 2022.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nDue to the number of organisations involved it is the responsibility of University College London, as controller, to ensure that participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a practice.\n\n"]

{"sheet":"A02712","index":753,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02712"]
["Reference","22/CAG/0095"]
["Other Refs","IRAS Project ID: 299895   REC Reference: 22/LO/0066"]
["Application Title","UK Early Life Cohort Feasibility Study"]
["Application Summary","The Early Life Cohort Feasibility Study (ELC-FS) will test proof of concept for a new national birth cohort study for theUK. It will collect rich data on a new generation of babies, born across the UK in the year 2021, capturing the economicand social environments into which these babies are born, and their health, well-being and development in their first 6 months.\n\nData collection for the ELC-FS will take place when the baby is around 6 months old. Babies will be sampled frombirth registrations and/or health records held by statistical agencies. The proposed sample design covers three months of births and includes country-boosts in Wales, Scotland and Northern Ireland, and ethnic minority and low-income boosts in England, allowing robust estimates of recruitment rates. Data collection will cover a range of coretopics and will comprise a range of informants (both mothers and fathers, including birth parents living in a differenthousehold to the child), and modes of data collection and will include the collection of biosamples and use of biomeasures.\n\nThis application seeks ethical approval for the approach to sampling participants for the study. As the study developsfurther, a substantial amendment will be submitted to cover the data collection phase of the study (although information about the design of data collection where known now is included in this application). "]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Lisa Calderwood"]
["Address","Centre for Longitudinal Studies"]
[null,"UCL Social Research Institute"]
[null,"London"]
["Postcode","WC1H 0AL"]
["Telephone","020 7911 5510"]
["Email","l.calderwood@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 2,500 babies in England and Wales, aged 6-10 months, and their parents."]
["Description of confidential patient information used","Data Sources:\n\nBirth Registrations data and Patient Demographics Service, NHS Digital.\n\nIdentifiers required for linkage purposes:\n\n1. Name  \n\n2. NHS number  \n\n3. Date of birth  \n\n4. Date of death  \n\n5. Postcode – unit level  \n\n6. Full address \n\n\nIdentifiers required for analysis purposes:\n\n1. Date of birth  \n\n2. Date of death  \n\n3. Postcode – unit level  \n\n4. Gender  \n\n5. Occupation  \n\n6. Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-24"]
["Next Review Date","2024-08-24"]
["Notes","28 March 2023 - change in data processor from NHS Digital to NHS England, regarding Birth Notification data, Birth Registrations data and demographics data.\n\nAmendment supported 28 March 2023 to include an additional letter communication to the cohort, changing from a one stage recruitment process to a modified two-stage recruitment process\n\n30 November 2022 – amendment supported \nTo revise the cohort to children born across the UK in the year 2022 or 2023, to extend the duration of support until 31 December 2023, and to remove the pilot phase and use of the Baby Steps app.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 08 April 2022.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2021/22 DSPT reviews for University College London, Ipsos Mori and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 24 August 2022).\n\n"]

{"sheet":"A02713","index":754,"n_rows":39,"n_cols":8,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02713"]
["Reference","22/CAG/0088"]
["Other Refs","IRAS Project ID: 314190  REC Reference: 22/EM/0124"]
["Application Title","Evaluating  ICON:  A  mixed  methods  study  to  assess  the impact  of  the  ICON  programme  on  coping  strategies  for carersof crying babies, and rates of abusive head trauma in infants aged under one year."]
["Application Summary","This application from University Hospitals Bristol and Weston NHS Foundation Trust set out the purpose of medical research to evaluate the effectiveness of the ICON programme in reducing incidence of abusive head trauma (AHT) in young infants.\n\nAbusive Head Trauma (AHT) is an injury to the skull or intracranial contents of an infant or young child due to inflicted blunt impact and/or violent shaking. AHT is the most common abusive injury in young children, and occurs most frequently in children under 12 months of age,  with  an  incidence  of  20-24  per  100,000  infants  per  year  in  the  UK.  Alongside  the physical and emotional consequences for children and their families, AHT is also associated with  large  lifetime  costs  from  both  healthcare  and  wider  societal  perspectives.  Societal stressors,  which  include  financial  recession  or  natural  disasters,  are  associated  with increased AHT rates. However, the most strongly reported association has been with the peak of normal infant crying, a pattern of rising intensity andduration of crying which peaks at  5-6  weeks  of  age  and  subsequently  settles  in  an  otherwise  well  infant.  Several programmes providing education and support to families have been designed in an attempt to changeinfant/caregiver interaction, with the aim of reducing incidences of AHT. Whilst early evaluations demonstrated effectiveness of programmes in reducing rates of AHT, this has   not   subsequently   been   replicated.   However,   studies   consistently   demonstrate numerous other positive outcomes, including increased knowledge and changed response behaviours  to  normal  infant  crying,  increased  seeking  of  support,  and  reductions  in Emergency Department attendances. \n\nThe  ICON  programme  was  developed  for  implementation  in  the  UK.  This  programme consisted  of  four  simple  messages  for  parents  which  highlighted  the  normality  of  infant crying,  suggested  that  they  attempted  to  comfort  the  infant,  taking  a  short  time  away  if frustrated, and to never shake the baby. These messages were reinforced during five key touchpoints with health professionals, including antenatally, after delivery, in the community, and in primary care. Additional innovative and suggested touchpoints include social media, accessing high school children, and at every planned or unplanned contact with healthcare, including Emergency Departments. \n\nThe ICON programme has been rolled out to a number of regions since its inception, and a post-implementation  evaluation  from  one  of  these  localities  has  identified  a  number  of positive impacts. On recognising thelikely significant societal stress as a consequence of the  COVID-19  pandemic, the ICON  programme was  implemented  by  NHS  England  as  a single  touchpoint  tool  across  all  English  maternity  units  in  March  2020.  An  initial  survey-based  evaluation  of  this  implementation  demonstrated  good  uptake  but  also  identified  a number of challenges, especially in accessing male partners. The applicants seek to build on this and other ongoing work to deliver a mixed methods evaluation study.\n\nTwo  qualitative  studies  will  be conducted,  involving  interviews  with  the  parents/carers  of children with AHT and interviews with professionals involved in implementing or delivering the ICON messages. These studies are outside the scope of support. Support is needed for a quantitative study. Holders of relevant national datasets, including Hospital Episode Statistics  Admitted  Patient  Care,  Emergency  Care  and  Diagnostic  Imaging  Datasets,  the Trauma  and  Audit  Research  Network  (TARN)  dataset,  the  National  Child  Mortality Database (NCMD), andthe Paediatric Intensive Care Audit Network (PICANet), will identify patients with AHT. Confidential patient information for patients meeting the inclusion criteria will  be  disclosed  to  NHS  Digital.  NHS  Digital  will  undertake  linkage  and  disclose pseudonymised data to the research team at University Hospitals Bristol and Weston NHS Foundation Trust. NHS Digital will retain the linkage key, therefore the pseudonymised data provided to the research team will be effectively anonymised."]
["Applicant Organisation Name","Bristol Royal Hospital for Children"]
["Contact Name","Doctor Mark Lyttle"]
["Address","University Hospitals Bristol and Weston NHS Foundation Trust"]
[null,"Upper Maudlin Street"]
[null,"Bristol"]
["Postcode","BS2 8BJ"]
["Telephone",1173288243]
["Email","mark.lyttle@uwe.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Qualitative; parents/carers -(i) male and female carers aged 18 years or older, (ii) received ICON messages at least oncebefore the baby was eight weeks old, (iii) timeline from delivery to interview of 2-6 months Qualitative; professionals -those eligible will be responsible for commissioning, implementing, or delivering the ICON messages. Quantitative: patients aged up to 364 days who were diagnosed with AHT between 01 January 2016 and 31 December 2021."]
["Description of confidential patient information used","Data Sources:\n\n1.  Hospital  Episode  Statistics  Admitted  Patient  Care,  NHS Digital \n\n2.  Emergency  Care  and  Diagnostic  Imaging  Datasets,  NHS England \n\n3. The National Child Mortality Database (NCMD), University of Bristol \n\n4.  The  Trauma  &  Audit  Research  Network  (TARN)  dataset, Northern Care Alliance NHS Foundation Trust \n\n5. PICANet, Universities of Leeds and Leicester\n\nIdentifiers required for linkage purposes:\n\n1. NHS Number \n\n2. Date of birth \n\n3. Postcode –unit level\n\nIdentifiers required for analysis purposes:\n\n1. Date of birth \n\n2. Postcode –district level \n\n3. Gender \n\n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-25"]
["Next Review Date","2024-08-25"]
["Notes","16 March 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES), Admitted Patient Care (APC), Emergency Care Dataset (ECDS), the Diagnostic Imaging Dataset (DID), and ONS mortality data\n\nAmendment supported 16 March 2023 to remove National Child Mortality Database (NCMD) as a data source, and include ONS Mortality data (from NHS England) instead\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 06 July 2022. \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS Digital 2020/21 DSPT reviews for NHS Digital, NHS England, the National Child Mortality Database (University of Bristol), TARN (Northern Care Alliance NHS Foundation Trust) and PICANet (Universities of Leeds and Leicester) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 20 June 2022). \n",null,null,null,null,null,"\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02714","index":755,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02714"]
["Reference","22/CAG/0103"]
["Other Refs","IRAS Project ID:  303618  REC Reference: 22/WA/0203"]
["Application Title","Supporting the NHS Long Term Plan: An evaluation of the implementation   and   impact   of   NHS-funded   tobacco dependence services"]
["Application Summary","This  application  from  Newcastle  University  set  out  the  purpose  of  medical  research  that seeks to explore how the new NHS-funded tobacco dependence services are delivered in acute hospital, mental health inpatient and maternity settings, and the service’s impact on health and care.\n\nNHS-funded  tobacco  dependence  services  are  delivered  in  England  as  part  of  the  NHS Long Term Plan. The applicants seek to evaluate how these servicesare delivered in five geographical regions, the North-East and North Cumbria, Greater Manchester, Yorkshire and Humber, West and West Midlands.\n\nThe applicants will survey NHS staff and service users. Hospital records will be accessed to determine thenumber of smokers who have been offered and used the service and to calculate the cost of providing the service. Support is required for Work Packages B and C, where confidential patient information will be extracted from patient records by members of thedirect care team and by members of the research team. The dataset will be transferred to  Newcastle  University  and  the  pseudonymisation  key  held  by  the  participating  trusts, making the dataset at Newcastle University effectively anonymised."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Professor Eileen FS Kaner"]
["Address","Population Health Sciences Institute, Faculty of Medical Sciences"]
[null,"Newcastle University"]
[null,"Newcastle Upon Tyne"]
["Postcode","NE2 4AX"]
["Telephone","0191 208 7884"]
["Email","eileen.kaner@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who:\n\n•Identified  as  smokers  aged  18  years  or  over  where length of stay in acute settings is greater than one day\n\n•Identified as smokers accessing maternity services\n\n•Identified    as    smokers    accessing    mental    health (inpatient) services\n\nThe  applicants  estimate  that  around  180,000  patients  will  be included under support.\n\n"]
["Description of confidential patient information used","Data Sources:\n\nElectronic patient records at:\n\n•Manchester University NHS Foundation Trust\n\n•Gateshead Health NHS Foundation Trust\n\n•Cumbria,   Northumberland,   Tyne   and   Wear   NHS Foundation Trust\n\n•Northumbria Healthcare NHS Foundation Trust\n\n•South  Tyneside  and  Sunderland  NHS  Foundation Trust\n\n•Tees, Esk and Wear Valleys NHS Foundation Trust\n\n•Sandwell and West Birmingham Hospitals NHS Trust\n\n•Gloucestershire Hospitals NHS Foundation Trust\n\n•The Newcastle Upon Tyne Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes:\n\n1.NHS Number\n\n2.Postcode –unit level\n\nIdentifiers required for analysis purposes:\n\n1.Postcode –unit level\n\n2.Gender\n\n3.Ethnicity\n\n4.Age"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported "]
[]
["Outcome Date","2022-09-07"]
["Next Review Date","2024-09-07"]
["Notes","Amendment supported 21 March 2024 to extend the duration of ‘s251’ support until 30 June 2025\n\nAmendment supported 18 December 2023 to add Avon and Wiltshire Mental Health Partnership NHS Trust as a data processor\n\nAmendment supported 27 November 2023 to extend the duration of ‘s251’ support until 31 March 2024\n\nAmendment supported 17 March 2023 to include University Hospital Coventry and Warwickshire NHS Trust (UHCW) and Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) as participating sites and data processors for the application\n\nAmendment supported 16 March 2023 to reduce the length of time that confidential patient information will be accessed without consent – from ‘for 10-months, to ‘up to 10-months’\n\n09 January 2023 – amendment supported to extend the duration of support until 31 December 2023, to remove Sandwell and West Birmingham NHS Trust as a data processor and to add Great Western Hospitals NHS Foundation Trust as a data processor.\n\nConditions of support:\n\n1.\tThe website information regarding the role of the CAG needed to be revised, in line with the suggested text above.  Condition met 07 September 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed. \n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\n4.\tDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02715","index":756,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02715"]
["Reference","22/CAG/0119"]
["Other Refs","IRAS Project ID: 310244  REC Reference: 22/SW/0115"]
["Application Title","Cluster JIA-uveitis research database"]
["Application Summary","This researchapplication fromThe University of Manchestersetsout the medical purposewhich  aims  tocreate theCLUSTERJIA-uveitis  research  database.  Applicants  require ‘s251’support  toprocess identifiable clinical  trialdata  from  two previously consented trials, APTITUDE and SYCAMORE,in order to identify duplicate participantsbetween the 2  trials,and link the patient’s clinical data to their biological  data.A‘s251’applicationis required  due  to  the  original consent  being  judged  as  not  sufficient  to  cover confidentialpatient informationbeingusedin further research.\n\nThe MRC funded CLUSTER Consortium is a translational collaborative consortium which aims topool trial data tocreate biomarker tests to personalise treatment, find and test new treatments,  and  predict  disease  outcomes  forchildhood  arthritis.The  SYCAMOREtrial was the first large randomizedcontrolled trial (RCT) studying children with JIA-associated uveitis, followed by APTITUDE. It is important thatdata fromthese trials are included, to make the best use of data already collected.\n\nThe applicants already have a database containingpseudonymised IDs for participantsin otherJIA registries/studies, however,    the    applicants    no    longer    planto    link SYCAMORE/APTITUDEtrial patientsdata to otherJuvenile  Idiopathic  Arthritis(JIA)studiesas requested in 21/CAG/0124. However, some patients may still have participated in SYCAMORE and APTITUDE, and therefore in order to remove participant duplicationin the datasets producedfor analysis, theUniversityofLiverpool will discloseNHS numbers and sample IDsfor SYCAMORE/APTITUDEtrial patientsto the University of Manchester. Upon  receiving  the   datasets, the   NHS   number   will   be   pseudonymised   (using   the OpenPseudonymiser  tool)  which  will  allow  the  applicants  to  determine  if  there  are  any duplicate participants, matched by the pseudonymised NHS number. Once duplicates are linked,the original  study  ID  will  be  removedfrom  the  datasets,and participants  willbe given a  CLUSTER  specific ID  before thedatacan  be  analysed.The  applicants  will also use the datasets to link the clinical data to the corresponding biological samples, using the sample ID. Once linked, the IDs will be replaced with the CLUSTER specific ID.\n\nResearchers  wishing  to  access  the  data  from  the  CLUSTER  database  are required  to apply  to  the  CLUSTER  Data ManagementCommittee(DMC),  and the  Consortium Management Board   (CMB).Only   pseudonymous   information   is   shared. Termsof referencehave been provided, and the applicant has confirmed that theboards have lay representation."]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Professor Kimme Hyrich"]
["Address","Stopford Building"]
[null,"99 Oxford Road"]
[null,"Manchester"]
["Postcode","M13 9PG"]
["Telephone"]
["Email","kimme.hyrich@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All  participants  in  theSYCAMORE  (n=90) and  APTITUDE (n=22)trials.\n\nAll participants are children diagnosed with juvenile idiopathic arthritis and active uveitis."]
["Description of confidential patient information used","Data sources:\n\n1.Universityof Liverpool:\n\na.APTITUDE dataset\n\nb.SYCAMORE dataset\n\n2.University of Manchester:\n\na.Pseudonymised CLUSTER database \n\nIdentifiers required for linkage purposes:\n\n1.NHS number\n\n2.Sample ID number"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-09-08"]
["Next Review Date","2024-09-08"]
["Notes","The application, to allow the disclosure of confidential patient information of SYCAMORE and APTITUDE trial patients from University of Liverpool to university of Manchester, for the purposes of identifying duplicate participants, and to link the patient’s clinical data to their biological data, to create the Cluster JIA-uveitis research database, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 01 September 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for University of Liverpool and University of Manchester were confirmed as ‘Standards Met’ by email to the CAG inbox (checked 08 September 2022)\n\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02716","index":757,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02716"]
["Reference","22/CAG/0080"]
["Other Refs","IRAS Project ID: 313490  REC Reference: 22/WA/0136"]
["Application Title","Cancer  incidence  and  mortality  in  a  cohort  of  women treated for subfertility in Oxfordshire and West Berkshire"]
["Application Summary","This application from University of Oxford set out the purpose of medical research which aims  to  assess  whether  risk  of  cancers,  in  particular  those  that  are  definitely  related  to hormonal exposure, are altered depending on the cause of the woman’s subfertility and/or the types of drug treatment she received for it, if any. Applicants will also look at whether the mortality risk differs from the general population, and whether the children born to the women following subfertility treatment have any different characteristics at birth.\n\nLifetime  hormonal  exposure  is  an  important factor  in many  female  cancers.  Such  factors include the timing of menstruation, pregnancy history, age at menopause, as well as use of oral  contraceptives  and  hormone  replacement  therapy.  For  those  experiencing  difficulty conceiving, it is uncertain whether the medical conditions underlying subfertility, and/or the treatments used to aid conception, also alter risk. This study aims to investigate this.\n\nThis study began in 1992, with the appropriate permissions required at the time. No consent was   taken   for   the   data   collection,   following   regulatory   advice   given   at   the   time. Approximately 7000 women were included in the dataset. This data was linked to national records  of  cancer  incidence  and  mortality,  and  embarkation/re-entry  by  OPCS/ONS National Health Service Central Register (ONS NHSCR), under ‘s251’ support, (the general NHSCR  application -ECC  2-04(c)/2010)until  April  2013.  The  department  was  closed  in 2014, and the data have beenretained but not processed since this time. These were held with no specific legal basis under common law, but were retained in the public interest. The applicant now requires a refreshed ‘s251’ application in order to access the data and anonymise  for  analysis,  and  this  has  been  requested  by  NHS  Digital,  in  order  for  the applicant to provide a legal basis for processing under common law, which is required to renew their data sharing agreement with NHS Digital. "]
["Applicant Organisation Name","Universityof Oxford"]
["Contact Name","Dr Michael Murphy"]
["Address","Nuffield Department of Women's and Reproductive Health (NDWRH),"]
[null,"John Radcliffe Hospital"]
[null,"Headington, Oxford"]
["Postcode","OX3 7LG"]
["Telephone",1865872984]
["Email","michael.murphy@retired.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","7000 women who were investigated for a subfertility problem between 1973-89, identified from;\n\n•records  of  infertility  clinics  in  Oxfordshire  and  West Berkshire \n\n•maternity records held by the Oxford Record Linkage Study (ORLS) \n\n(definition of subfertility -failure to conceive despite adequate attempts  to  do  so  for  up  to  1  year, at the time  of  their  initial infertility clinic consultation)\n\nData  already  extracted  between  1992  and  2000  by  the research team."]
["Description of confidential patient information used","Data sources:\n\n1.University   of   Oxford   linked database   of   women   as described  above,  linked  to  outcome  data  received  until 2013   (from   ONS   NHSCR). –obtained  under  ‘s251’ support   as   part   of   NHSCR   application   (ECC   2-04(c)/2010). \n\nIdentifiers retained, and required for processing in order to anonymise the dataset:\n\n1.Womens’ forenames (and initials), \n\n2.Womens’ surnames at birth and subsequently, \n\n3.Date-of-birth\n\n4.Gender\n\n5.NHS numbers \n\n6.Hospital numbers\n\n7.unique study number\n\n8.Data received from NHS Digital up until 2013; \n\na.Cancer Registration data\n\nb.Mortality records, \n\nc.records  of  embarkation  and  exit/re-entry  to  the NHS \n\nIdentifiers required for analysis purposes:\n\n1.N/A –applicant states analysis will be undertaken on an anonymous dataset"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-09-09"]
["Next Review Date","2024-09-09"]
["Notes","The application, to allow the retention of confidential patient information by University of Oxford in order to process the dataset to anonymise it for analysis, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 08 September 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 21/22 DSPT review for University of Oxford Medical Sciences Division (8HM11) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 18 August 2022)\n\n\n"]

{"sheet":"A02717","index":758,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02717"]
["Reference","22/CAG/0055 "]
["Other Refs","IRAS Project ID: 310881  REC Reference: 22/SS/0030"]
["Application Title","Near Fatal Asthma in Children and Young People"]
["Application Summary","This application from theUniversity of Edinburgh set out the purpose of medical research that  seeks  to  understand  how  often  children  aged  5-15  yearsin  the  UK and Republic of Irelandexperience anear fatal asthma attack.\n\nNear fatal  asthma  is  the  most  severe form  of  asthmaattackand  theUK  has  the  highest rate  of  asthma  death  for  children  in  developed  healthcare.  Children  who  experience severeasthma  attacks are  more  likely  to  subsequently  die  from  asthma.Until  recently, therewas  no  agreed  definition  of  near  fatal  asthma  and  the prevalencecould  not  be estimated.  Theapplicantsrecently  created  a  definition  using  an  internationalgroup  of experts  so  that  it is  now  possible  to  measure  how  frequently  it  occurs  in  our  population.The  closest  estimatefor the prevalenceof  near  fatal  asthma attacks is  200-250  children per year  in  the  UK, based  onadmissions to  paediatric  intensive  care  with  acute  asthma. However,not  all  children  who experiencenear  fatal  asthma  will  be  admitted tointensive care and some intensive care admissions would not fit this definition. \n\nThe  applicants  will  conduct a  prospective  epidemiological  survey  of  clinicians  in  the  UK and  Republic of  Ireland  (ROI)  using  theBritish  Paediatric  Surveillance  Unit  (BPSU)Orange eCard system. This will be undertaken over 18 consecutive months with a follow-up phase at 1 and 2 years of age. The BPSU 'Orange e-Card'has a list of rare disorders under  active  surveillance  which  is  sent  electronically  every  month  to  over  4,000British andIrish consultant paediatricians and other specialities. Clinicians will return the Orange e-Card to the BPSU,notifyingany cases seen or ‘nothing to report’. The cliniciansname and  contact  details  will  be  passed  to  the  study  team  and  the  reporting  clinician  will  bedirected to the study online questionnaire, which willrequestdetails on the presentationof near fatal asthma, demographic details, investigation andmanagement. A further outcome questionnaire will be sent at one and two years following the near fatal asthmaattack.The questionnaires  will  be  run  through  the  University  of  Dundee  HIC safe  haven  server. If clinicians  are  unable  to  use  the  online  system,  questionnaires  will  be  sent  out  in  an electronic document format tothe reporting clinicians via the investigator's secure nhs.net email account. As alast resort, a paper questionnaire form will be sentby registered mail. It will be marked confidential anddoubleenveloped for datacollection with self-addressed envelope  to  be  returned  to  the chief investigator’s office in the University of Edinburgh.Limited  confidential  patient  information  will  beincluded so  that duplicate  cases  can  be identified. These  items  of  confidential  patient  information  will  be  removed  assoon  as possibleand heldseparatelyto the anonymised dataset used for analysis. "]
["Applicant Organisation Name","University of Edinburgh"]
["Contact Name","Professor Steve Cunningham"]
["Address","Dept of Child Life & Health"]
[null,"Royal Hospital for Children and Young People"]
[null,"50 Little France Crescent, Edinburgh"]
["Postcode","EH16 4TJ"]
["Telephone","0131 312 1659"]
["Email","steve.cunningham@ed.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 5-15 years considered to have experienced an episode of near fatal asthmaand who meeting any one of the following:\n\n•Survived   an   acute   episode   of   asthma,   with   the following features:\n\no Pulse oxygensaturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via nonrebreathmask)during acute presentation\n\no pH <= 7.2 and/or pCO2 >=60mmHg or 8kPa\n\no Escalation to use of intravenous bronchodilator infusion\n\n•Survived  an  acute  episode  of asthma  and who  had  a respiratory   arrest   and/or   requiredcardiopulmonary resuscitation as part of their presentation\n\n•Survived  an  acute  episode  of asthmafor  which  they were invasively ventilatedThe  applicants  anticipate  that  375  patients  in  the  UK  will  berecruitedand thatthe majority of cases will be recruited from England. "]
["Description of confidential patient information used","Data sources\n\n1.Questionnaires completed by reporting clinicians working in emergency departments, and other clinical areas within the PERUKI network (Paediatric Emergency Research UK and Ireland). Clinicians in allclinicalareas may encounterand reportcases of Near Fatal Asthma (NFA)in CYP and complete questionnaires. This will include General Paediatric, Critical Care and Emergency Medicine doctors.Clinicians in Paediatric Critical Care Units will also be able to register cases via the same system as emergency clinicians (QR code with link to BPSU –HIC questionnaire)\n\nIdentifiers required for linkage purpose\n\n1.NHS number\n\n2.Hospital IDnumber\n\n3.Date of birth\n\n4.Date of death\n\n5.Postcode –unit level\n\nIdentifiers required for analysis purposes\n\n1.Postcode –unit level\n\n2.Gender\n\n3.Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"x","Class I - making the person less readily identifiable "]
[null,"x","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"x","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"x","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"x","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-09-23"]
["Next Review Date","2024-09-23"]
["Notes","Amendment supported on 09 October 2023 to include Amazon Web Services (AWS) as a data processor the application, as the University of Dundee Health Informatics Centre (HIC) is migrating its servers to the AWS cloud service.\n\nThe application, to allow the disclosure of confidential patient information by reporting clinicians at hospital trusts and health boards who are part of the PERUKI network to the University of Dundee HIC safe haven server, and the disclosure of confidential patient information to the chief investigator at the University of Edinburgh on questionnaires returned via email or by post, is fully supported, subject to compliance with the standard conditions of support.\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 11 May 2022\n\n2.\tSecurity assurances are provided for the University of Edinburgh and the University of Dundee, in the form of an approval letter from the NHS Scotland Public Benefit And Privacy Panel For Health And Social Care, confirmed 23 September 2022\n"]

{"sheet":"A02718","index":759,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02718"]
["Reference","22/CAG/0062"]
["Other Refs","IRAS Project ID: 306500  REC Reference: 22/SC/0116"]
["Application Title","A Study of Cardiovascular Events iN Diabetes –PLUS "]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to determine whether use of Semaglutide can safely help to reduce cardiovascular problems in patients with Type 2 diabetes who have not previously had a heartattack or stroke. \n\nPeople with type 2 diabetes mellitus (T2DM) are at twice the risk of suffering cardiovascular events,  such  as  heart  attacks  and  stroke,  compared  to  those  without  diabetes.  Previous large-scale randomised clinical trials conducted involving patients with T2DM who have, or are at a high risk of developing, cardiovascular disease have established that treatment with glucagon-like  peptide-1  (GLP-1)  receptor  agonists  reduced  cardiovascular  events.  The treatments can also improve blood sugar control, reduce weight and blood pressure, and may also reduce deterioration in kidney function and the metabolic complications of T2DM. However, such treatments require regular injections and uptake of the treatments are low in the UK and globally. Oral Semaglutide is the first oral GLP-1 receptor agonist. Its effects on blood sugar, weight and blood pressure are similar to injectable GLP-1 receptor agonists. The trials conducted so far have involved patients with T2DM and existing cardiovascular disease, or  who  are  at  a  high  risk  of  developing  cardiovascular  disease.  The  applicants seek to conduct a trial to assess whether oral Semaglutide should be used in a broad range of people with T2DM at moderate to high cardiovascular risk.\n\nNHS  Digital  will  identify  potentially  eligible  patients.  The  National  Data  Opt-Out  will  be applied, as well as a study specific opt-out. NHS Digital will also undertake a vital status check and obtain up-to-date addresses. The data linkages undertaken at NHS Digital will be carried out under Directions, in line with the Pilot NHS DigiTrials Recruitment Support Services Direction 2021. Support is required to disclose the dataset, containing confidential patient  information,  will  be  disclosed  to  Paragon  Customer  Communications.  Paragon generate the invitation letter with patients NHS numbers securely encoded into the Replay Form  and  then  send  the  invitation  letters  and  information  sheets  to  patients.  Patients wishing to take part then send the Reply Form to the study team in Oxford. The patients’ participation will then proceed on a consented basis. "]
["Applicant Organisation Name","University of Oxford "]
["Contact Name","Dr David Preiss"]
["Address","Richard Doll Building"]
[null,"Old Road Campus, Headington"]
[null,"Oxford"]
["Postcode","OX3 7LF"]
["Telephone",1865743743]
["Email","ascend-plus@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients  aged  55  years  and  over  diagnosed  with  Type  2 diabetes. "]
["Description of confidential patient information used","Data sources\n\n1.NHS Digital held datasets:a.Hospital Episode Statistics Admitted Patient Careb.NHS BSA Medicines Datasetc.Personal Demographics Service Dataset.\n\nIdentifiers required for linkage purposes\n\n1.Name\n\n2.NHS number\n\n3.GP registration\n\n4.Date of birth\n\n5.Postcode –unit level\n\nIdentifiers required for analysis purposes\n\n1.Name\n\n2.Date of birth\n\n3.Postcode –unit level\n\n4.Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-09-26"]
["Next Review Date","2024-09-26"]
["Notes","23 November 2023 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES)  Admitted Patient Care, NHS BSA Medicines Dataset, & Personal Demographics Service Dataset.\n\n31 October 2022 – amendment supported To remove patients’ NHS numbers from the dataset disclosed from NHS Digital to Paragon Customer Communications Ltd and the use of a unique identifier instead.\n\nApplication supported 26 September 2022: Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 May 2022.  \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.  \n \nConfirmed:  \n \nThe NHS Digital 2021/22 DSPT reviews for NHS Digital and Paragon Customer Communications were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26 September 2022). \n\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02719","index":760,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02719"]
["Reference","22/CAG/0039"]
["Other Refs","IRAS Project ID: 303405  REC Reference: 20/LO/0160"]
["Application Title","An  investigation into  effective Antimicrobial Stewardship (AMS)  Strategies  during  a  pandemic  (COVID-19)  in  an acute care setting"]
["Application Summary","This application from University of Hertfordshire sets out the purpose of medical research that seeks to  investigate  the  effectiveness  of  antimicrobial  stewardship  (AMS)  during  the Covid-19  pandemic  in  Luton  and Dunstable  (L&D)  University  Hospital,  and  explore  the organisational  antibiotic  prescribing  behaviour  during  the  pandemic.  A  mixed  method  of quantitative research and questionnaires will be used. This CAG application is only relating to  the  retrospective  review of medical records, as ‘s251’ support is not required for the questionnaire element. \n\nAntimicrobial resistance (AMR) is a global crisis that requires urgent attention. Antimicrobial stewardship  (AMS)  is  a  set  of  actions  to  promote  the  effective  use  of  antimicrobial interventions.  In  acute-care  settings,  antibiotics  are  widely  administered,  leading  to increased  opportunities  for  AMR.  It  is  estimated  that  around  20–50%  of  antibiotics  are unnecessary or inappropriately used. The Covid-19 pandemic increased the threat of AMR -although  Covid-19  is  a  viral  infection,  there  are  overlapping  clinical  and  radiological features  with  bacterial  respiratory  tract  infection,  so  it  is  inevitable  that  antibiotics  were prescribed for many patients. It is important to identify effective AMS strategies to facilitate AMS  interventions  in  an  acute  care  setting,  especially  at  time  of  emergency  or  crisis,  to maintain  the  rational  use  of  antibiotics  and  offer  practical  solutions  to  Antimicrobial Resistance (AMR). \n\nThe  direct care  team  at  L&D  hospital  will  identify  the  eligible  cohort  from  Trust  medical records, by undertaking a search for patients prescribed antibiotics for bacterial respiratory tract infection or pneumonia. The data collection will beundertaken by the research student, who is not considered direct care team. Although no confidential patient information will be extracted for analysis, ‘s251’ support is required, as the research student will view the electronic medical records, which includes confidential patient information, such as date of birth  in  order  to  extract  age.  Information  will  be  collected  about  antibiotics  that  were prescribed upon patient admission and at 48-72 hours.  A pseudonymous study ID will be applied, and the key between the study ID and the confidential patient information will be retained by the direct care team within the Trust, although the researcher will have access to this key. ‘s251’ support is required until the researcher who is not considered direct care team, no longer has accessto the key."]
["Applicant Organisation Name","School of Life and Medical Sciences"]
["Contact Name","Dr Zoe Aslanpour"]
["Address","Department of Pharmacy, Pharmacology and Postgraduate Medicine"]
[null,"University of Hertfordshire"]
[null,"Hatfield"]
["Postcode","AL10 9AB"]
["Telephone","01707 284563"]
["Email","Z.Aslanpour@herts.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Total  of  588 patientsdiagnosed  with  bacterial  respiratory tract infection;\n\n294 patients before the onset of COVID-19:\n\n•1st week of August 2019 (low risk of respiratory tract infections or pneumonia). \n\n•1st week of October 2019 (onset of winter season and initiation offlu preventive/protective measures). \n\n•1st week of December 2019 (winter season and high risk of respiratory tract infections or pneumonia). 294 patients during COVID-19: \n\n•1st week of April 2020: Wave 1 and first lockdown. \n\n•1st  week  of  November  2020:  Wave  2  and  second lockdown \n\n•1st week of March 2021: Post wave 2 and COVID-19 vaccination"]
["Description of confidential patient information used","Data sources\n\n1.Electronic  patient  records  at  Luton  &Dunstable  (L&D) University Hospital (Bedfordshire NHS Foundation Trust)\n\nIdentifiers required for the purposes of extracting a pseudonymous dataset\n\nThe  applicant  will  view  the  patients’medical  record  and  will therefore see the following;\n\n1.Name\n\n2.NHS number\n\n3.Hospital ID\n\n4.Date of birth –required to extract age\n\n5.Date of death\n\nIdentifiers required for analysis purposes\n\n1.Gender\n\n2.Pseudonymous Study IDThis dataset can be considered anonymous for analysis (if no full date of birth and death recorded).\n\nThe applicant has clarified that patient age will be extracted, rather than date of birth.\n\n The applicant has clarified that date of death will be modified to age on admission + added days up to the age that would have been at the next birthday.\n\nAdditional information\n\nThe  link  between  patients’  identifiable  data  and  study numbers will be maintained by the pharmacist at the hospital site and PI who is the PhD student. \n\nNo confidential patient information will leave the Trust."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-09-29"]
["Next Review Date"]
["Notes","Applicant confirmed October 2023 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, this research, centred on the implementation of antimicrobial stewardship (AMS) both before and during the COVID-19 pandemic in acute care settings, offers pivotal insights for public health. It emphasises the importance of optimising antibiotic use to combat antibiotic resistance and ensure the sustained effectiveness of treatments. These insights not only advance better patient outcomes, but also protect essential antibiotics for future generations and highlight lessons learned from the COVID-19 pandemic. The findings of this study will assist policymakers in their decision-making, guide healthcare professionals in responsible antibiotic prescribing, and enhance public awareness about AMR. Appropriate antibiotic use is pivotal in tackling the AMR challenge and safeguarding lives.\n\nConditions of support:\n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 07 September 2022 \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS Digital 2021/22 DSPT review for Bedfordshire Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 March 2022). \n\n"]

{"sheet":"A02720","index":761,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02720"]
["Reference","22/CAG/0123 "]
["Other Refs","IRAS Project ID: 305936  REC Reference: 22/SC/0328"]
["Application Title","A single-centre, retrospective cohort study of CT head pathologies in infants and toddlers presenting to ED due to head injury from an accidental fall"]
["Application Summary","This  application  from Oxford  University  Hospital  NHS  Foundation  Trustset  out  the purpose  of  medical research which  aims to  identify  the  range  of  cranial  and  intracranial injury,  and theeffect  of  fall  height  and  surface  on  levels  of  head  injury,inCT  heads  of infants  and  toddlers  after  accidental  head injury  due  to  falls. Applicants will  undertake  aretrospective,  data-analysis  only,  cohort  study  of  infants  and  toddlers  (≤2  years)  who presented to the Emergency department (ED)with head injuries due to a fall within a 10 year period at the John Radcliffe hospital, and who underwent a CT scan to examine the consequences  of  those  injuries. Applicantswill  be  looking  at  CT  scans  of  the  heads  of those children who suffered falls and identifying patterns of intracranial and cranial injury.‘s251’ support is required,as confidential patient information will be processed in order to link scans to clinical history using local medical records, to extract an anonymised dataset for analysis, and this will be undertakenby amedical student who is not considered part of the direct careteam.\n\nPaediatric  head  trauma  is  an  important  cause  of  hospital  attendance  in  young  children. While these injuries are mainly minor, some result in intracranial and cranial injury which is  observable  on  CT  head.  A  significant  proportion  of  these  head  injuries is  due  to  falls. Although  there  is  reasonable  data  regarding  the  indications  for  CT  in  such  injuries,  very little  is  understood  about  the  effect  of  the  characteristics  of  falls  on  the  possible intracranial and cranial injuries sustained. Results from thisstudy will aim to helpclinicians to  better  understand  the  expected  spectrum  of particular  patternsof  injury  onCTheadcaused  by  a  fall  from  a  given  height. Applicants  alsoaim  to  identify  the  existence  of ‘outlier findings’ on CT head of children who have suffered accidentalinjuries. There is a danger  that these very  uncommon  injuries  are  more  likely  to  be  labelled  as  the  result  of abuse  due  to  theirrarity.  This shouldimprove  healthcare  for  patients  as  it  will  clarify  the CT findings which may be found as a result of accidental head injury, and reciprocally will clarify the injuries which are not seen (or are extremely unlikely) due to accidental injury.The  study  aims  to better  understandthe  relationship  between  intracranial  injury  and nature of fallto improve patient care in the future.\n\nDatawill be collectedfrom the CRIS imaging database and cross-referenced with patient notes  (via  ORBIT  and  EPR,  electronic  patient  records  at  the  Trust) to link  to  clinical information  regardingpatientsadmission  to  ED,  using  MRN number(hospital  ID). After this  linkagehas  been  undertaken,  the  patient's  MRN  number  will  be removed  from  the dataset for analysis.A pseudo ID will be applied.A linkbetween theMRN number and the pseudo  ID will  be  maintained  in  a  separate,  password  protected  database  on  hospital servers, and this will be deleted at the end of the study."]
["Applicant Organisation Name","Oxford University HospitalNHS Foundation Trust"]
["Contact Name","Mr Jayaratnam Jayamohan"]
["Address","John Radcliffe Hospital"]
[null,"Headley way"]
[]
["Postcode","OX39DU"]
["Telephone",1865234449]
["Email","jayaratnam.jayamohan@ouh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Infants and toddlers (≤2 years) who presented to the ED with head injuries due to a fall within a 10 year period (1January 2012-1January 2022)at the John Radcliffe hospital, and who underwent a CT scan to examine the consequences of those injuries\n\nApplicant  has  estimated 100patients  will  meet  the  inclusion criteria.\n\nHowever‘s251’ requiredfor   all   those   viewed   by   the researcher  who  is  not  considered  direct  careteam (ie.  all infants  who presented  to  ED  with  head  injuryand  had  a  CT head), and the applicant estimates this to be about 300"]
["Description of confidential patient information used","Data sources\n\n1.Medical records at John Radcliffe Hospital (part of Oxford University   Hospital   NHS   Foundation   Trust)including CRIS, ORBIT and EPR reporting systems, and CT scans\n\nIdentifiers required for linkage purposes\n\n1.MRN number (hospital ID)\n\n2.Date of birth\n\n3.Online medical records will be viewed in order to extract a dataset for analysis\n\nIdentifiers required for analysis purposes\n\n1.Date of birth modified to age at scan.\n\n2.Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-10-07"]
["Next Review Date","2024-10-07"]
["Notes","The application, to allow confidential patient information to be viewed by a medical student who is not considered part of the direct care team, during the extraction of an anonymised dataset for analysis at John Radcliffe Hospital (part of Oxford University Hospital NHS Foundation Trust), is fully supported, subject to compliance with the standard and specific conditions of support\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 October 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT review for Oxford University Hospital NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 03 October 2022)\n\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02721","index":762,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02721"]
["Reference","22/CAG/0093"]
["Other Refs","IRAS Project ID:  315035  REC Reference: 22/NS/0080"]
["Application Title","Emerging  eviDence  on  the  impact  of  COVID-19  on  mental  hEalth sErvices  and  health  inequalities  in  highly  dePrived  communities (DEEP"]
["Application Summary","This  application  from  Newcastle  University  set  out  the  purpose  of  medical  research  that seeks  to  investigate  the  changes  in  mental  health  services  in  response  to  Covid-19  and show how these changes have impacted health outcomes in deprived populations.\n\nThe Covid-19 pandemic has increased the incidence of mental health problems. Following the pandemic it is estimated that new or additional mental health support will be required for up to 10 million people in England. Evidence from previous studies has shown that the virus and lockdowns disproportionately affected the mental health of those living in deprived areas. A complete picture of use of mental health services by more deprived populations and  the  impact  of  the  pandemic  on  patterns  of  mental  health  service  utilisation  is  not available.  The  applicant  seeks  to  explore  changes  in  mental  health  services  during  the pandemic. The applicant will conduct a literature review to identify changes in mental health services  during  the  pandemic  and  will  conduct  a  Delphi  survey  with  key  stakeholders  to agree on the features of services.\n\nSupport is required for the applicant to collect NHS data from 20 GP practices across the North  East  and  North  Cumbria  before,  during  and  after  lockdown.  The  North  of  England Commissioning Support (NECS) Unit identify and will extract confidential patient information for  the  base  cohort.  Confidential  patient  information  will  be  shared  from  NECS  to  NHS Digital for linkage and a linked dataset will be return to NECS. NECS will then createunique identifiers and provide a pseudonymised dataset to the applicant at Newcastle University."]
["Applicant Organisation Name","Newcastle University"]
["Contact Name","Dr Ge Yu"]
["Address","Population Health Sciences Institute"]
[null,"Newcastle University"]
[null,"Newcastle"]
["Postcode","NE2 4AX"]
["Telephone",7703017334]
["Email","ge.yu@ncl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who referred or self-referred to  NHS-funded  secondary/community  mental  health  services between  3rd  March  2019  to  22nd  March  2020  in  20  selected Deep  End  GP  practices  within  the  North  East  and  North Cumbria (NENC). \n\nThe applicants estimate that 5390 patients will be included."]
["Description of confidential patient information used","Data sources\n\n1. The local primary care electronic patient records (EPRs) data \n\n2.  Mental  Health  Services  Data  Set  (MHSDS),  Improving Access  to  Psychological  Therapies  (IAPT)  data  set,  Hospital Episode Statistics (HES), including Hospital admission records (APC),  Outpatient  records  (OP),  Accident  and  Emergency records  (A&E)  and  Community  Service  Data  Set  (CSDS)  at NHS Digital.\n\nIdentifiers required for linkage purposes\n\n1. Name \n\n2. NHS number \n\n3. Date of birth\n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n\n2. Date of death \n\n3. Gender \n\n4. Occupation\n\n5. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-10-05"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed April 2024 that ‘s251’ support could be expired, as the study design has been altered to avoid any identifiable patient information being processed without consent and outside the direct care team. NHS England and NHS North of England Commissioning Support Unit (NECS) will now have separate responsibilities: \nNHS England:\n•\tExtracting and sharing participants' secondary care data\n•\tPseudonymising the secondary care data\nNECS:\n•\tExtracting and sharing participants' primary care data\n•\tPseudonymising the primary care data\nThe step of linking the primary care and secondary care data has been removed from the process. \n\n\n29 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Mental Health Services Data Set (MHSDS), Improving Access to Psychological Therapies (IAPT) data set, Hospital Episode Statistics (HES), including Hospital admission records (APC), Outpatient records (OP), Accident and Emergency records (A&E) and Community Service Data Set (CSDS).\n\nAmendment supported 17 January 2024 to extend the duration of ‘s251’ support until 31 August 2027\n\nSpecific conditions of support \n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 23 June 2022. \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS Digital 2020/21 DSPT reviews for NHS Digital and the North of England Commissioning Support Unit were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 04 July 2022). \n \n \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02722","index":763,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02722"]
["Reference","22/CAG/0049"]
["Other Refs","IRAS Project ID: 303623  REC Reference: 21/YH/0276"]
["Application Title","LOng   COvidMultidisciplinary   consortium:   Optimising Treatments and servIces across the NHS (LOCOMOTION)"]
["Application Summary","This application from the University of Leeds (with the controller for the activity confirmed to be the University of Oxford)set out the purpose ofmedical research which aims to find out the most effective rehabilitation treatment for Long Covid (LC) currently being delivered across ten UK-wide LC clinics.\n\nTo achieve this, the study will comprise three parallel related workstreams and involves the comprehensive  collection  and  examination  of  qualitative  and  quantitative  data  from potentially 5000 patients.These will involve creating a Quality Improvement Collaborative, developing  services  and  training  packages  for LC  patients  and  healthcare  professionals, and    using    wearable    devices    to    monitor    symptoms    and    improve    standard-of-care.Workstream 3 is the focus of the CAG application and aims to develop and evaluate new integrated care pathways to manage LC.\n\nFor LongCovid clinic patients, support is requested to allow the disclosure of confidential patient information from Trust direct care teams, who will transfer NHS number and DOB, to University of Oxford.These are transferred to a secure portal at Oxford and an automatic hashing algorithm is applied to the NHS number as soon as it lands in the portal. Therefore, support is required for transfer from Trusts to Oxford prior to automatic hashing.\n\nFor  linkage  with  NHSD  (for  patients  identified  in  Long  Covid  clinics),  the  hashed  data  is transferred from Oxford to NHSD.As both sides have the hashing algorithm, the data is potentially identifiable; therefore, support will be required for Oxford to hold the hashed data and transfer to NHSD to link and send back.\n\nRegulation 5 support is required to send confidential patient information from NHS Digital to ORCHID (university of Oxford). This is an existing flow of data which required support for the  data flow  specific to LOCOMOTION.  To  note  there  is  no  requirement  for ORCHID to send identifiers to NHS Digital to enable this flow.\n\nThe Salford and NW London integrated care records involved in the study are only accessed by the direct care team.No identifiable data is shared, so support is not needed for access to these records.\n\nThe  legal  basis  for  collection  of  personal  data  for  the  prospective  elements  of  the  study (Workstreams  1  and  2)  is  consent,  therefore  these  workstreams  fall  out  of  scope  and support is not required for these.\n\nSome sites are in Scotland and Northern Ireland and these fall outside of scope and are covered by their own approval mechanisms.Some of the work package 3 cohort have consented to the use of their data and are also outside the scope of support.\n\nTheResearch  and  Surveillance  Centre  was  originally  established  by  the  RCGP  for  flu surveillance work 52 years ago. This has progressed to be part of ORCHID, and therefore RCGP acts as a collaborative partner of ORCHID for surveillance work. The sharing of this data is part of the data controller’s UKHSA agreement for surveillance. This is a tri-partied legal  agreement,  thus,  is  not  a  data-source  or  entity  that  performs  research  activities  for LOCOMOTION or any other research study that uses ORCHID.This means that for those suspected to have long covid but not seen at a long covid clinic, linkage of their data will take place solely within Oxford once the identifiers have been hashed.\n\n"]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Mr Thomas Osborne, Research Project Manager"]
["Address","Leeds General Infirmary"]
[null,"D Floor"]
[null,"Martin Wing"]
["Postcode","LS21  3EX"]
["Telephone"]
["Email","Locomotion@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male or female patients aged 18 yrs and over, with Long Covid (LC) identified by:\n\n1. Being referred to one of 10 participating LC clinics.\n\n2.Not  having  been referred  but  identified  as  having  attended their GP with likely LC, but deep phenotyping of GP coded data"]
["Description of confidential patient information used","Data sources\n\nGP practices\n\n•Medical recordsNHS Digital\n\n•HES data\n\n•SUS data\n\n•eMIS(routinely collected data under Regulation 3 to be used for research purposes)\n\nIdentifiers required for linkage purposes\n\n1.NHS number\n\n2.DOB\n\nIdentifiers required for analysis purposes\n\n1.Postcode for deprivation scoring"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date"]
["Next Review Date","2024-10-12"]
["Notes","Amendment supported 12 March 2024 to extend the duration of ‘s251’ support until 30 June 2024\n\n6 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES) and Secondary Uses Service (SUS) data. \n\n1.The application to allow:\n\na.the  disclosure  of  confidential  patient  information  from Trust  direct  care teams, who will transfer NHS number and DOB, to University of Oxford\n\nb.linkage  with  NHS Digital-NHSD (for  patients  identified  in  Long  Covid clinics).  Hashed data is transferred from Oxford to NHSD.As both sides have  the  hashing  algorithm,  the  data  is  potentially  identifiable;  therefore, support will be required for Oxford to hold the hashed data and transfer to NHSD to link and send back.\n\nc.regulation  5  support to  send  confidential  patient  information  from  NHS Digital  to  ORCHID  (university  of  Oxford).  This  is  an  existing  flow  of  data which required support for the data flow specific to LOCOMOTION.\n\nis fully supported, subject to compliance with the standard and specific conditions of support\n\nSpecific conditions of support \n1. Favourable opinion from a Research Ethics Committee. Confirmed 07 December 2021 \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed. \n\nThe NHS Digital 21/22 DSPT review for the University of Oxford was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (12 September 2022) \n\nThe NHS Digital 21/22 DSPT review for Birmingham Community Healthcare NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (7 October 2022) \n\nThe NHS Digital 21/22 DSPT review for The Newcastle Upon Tyne Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (12 September 2022) \n\nThe NHS Digital 21/22 DSPT review for Leeds Community Healthcare NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (7 October 2022) \n\nThe NHS Digital 21/22 DSPT review for Oxford University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (7 October 2022) \n\nThe NHS Digital 21/22 DSPT review for Oxford Health NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (12 September 2022) \n\nThe DHCW 21/22 DSPT review for Cardiff and Vale University Health Board was confirmed as ‘Standards Met’ via email (12 October 2022) \n\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02723","index":764,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02723"]
["Reference","22/CAG/0106"]
["Other Refs","IRAS Project ID: 308387  REC Reference: 22/NW/0146"]
["Application Title","The BCIS Out of Hospital Cardiac Arrest Pilot Registry"]
["Application Summary","This application from Mid and South Essex NHS Foundation Trust set out the purpose of setting up a research database to collect data on patients who have experienced an Out of Hospital Cardiac Arrest within the network of NHS hospitals covered by regional Cardiac Arrest Centres.\n\nOut  of  Hospital  Cardiac  Arrest  (OHCA)  carries  a  high  mortality,  with  just  8%  of  patients admitted to Hospital surviving to discharge. The purpose of this registry is to capture data on  patients  who  experience  Out  of  Hospital  Cardiac  Arrest  (OHCA)  to  inform  registry research projects to ultimately improve patient outcomes. \n\nThere are two data flows, one for patients treated within Essex and one for patients treated in participating trusts outside of Essex.\n\nFor patients treated within Essex, a research fellow will use local systems at The East of England Ambulance Service NHS Trust (EEAST) and The Essex and Herts Air Ambulance Trust  (EHAAT)  to  identify  patients  who  experienced  an  OHCA.  Confidential  patient information will be collected onto the registry. For patients treated atEssex Cardiothoracic Centre at Mid and South Essex NHS Foundation Trust, a member of the research team, working  with  a  member  of  the  direct  care  team,  will  input  hospital-based  data  into  the registry. For patients treated at other hospitals within Essex, a member of the direct care team  at  the  site  will  input  the  data  into  the  registry.  If  patients  die  before  they  can  be consented,  their  data  is anonymised,  and  all  confidential  patient  information  deleted.  For patients who survive, they will be approached 3 months after discharge and consent to take part in the e-PROMS sought. Their participation will then proceed on a consented basis. \n\nFor patients treated outside of Essex, members of the local research team, which may also include  members  of  the  direct  care  team,  will  identify  patients,  and  collect  their  data. Anonymised data only will be entered into the registry."]
["Applicant Organisation Name","Mid and South Essex NHS Foundation Trust"]
["Contact Name","Dr Thomas Keeble"]
["Address","Basildon University Hospital"]
[null,"Nether Mayne"]
[null,"Basildon, "]
["Postcode","SS16 5N "]
["Telephone",7940588133]
["Email"," thomas.keeble2@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who experience an out of hospital cardiac arrest and are treated at one of the participating sites."]
["Description of confidential patient information used","Data sources\n\n1. Patient records held at: \n\na. Mid and South Essex NHS Foundation Trust \n\nb. The East of England Ambulance Service NHS Trust \n\nc. The Essex and Herts Air Ambulance Trust \n\nd. East Anglian Air Ambulance \n\ne. Princess Alexandra Hospital NHS Trust\n\nf. The East Suffolk and North Essex NHS Foundation Trust \n\ng. King’s College Hospital NHS Foundation Trust \n\nh. Barts Heart Centre, London \n\ni. The Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust \n\nj. University Hospital Southampton NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1. NHS Number \n\n2. Date of birth \n\n3. Date of death \n\n4. Postcode – sector level\n\nIdentifiers required for analysis purposes\n\n1. Postcode – sector level \n\n2. Gender \n\n3. Occupation \n\n4. Ethnicit\n\nAdditional information\n\nThe application originally listed patient date of death as being used for analysis. The applicants have now advised that this will be revised to month and year of death."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-10-17"]
["Next Review Date","2024-10-17"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 28 July 2022 \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: As there are more than 5 organisations processing confidential patient information, these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for these organisations have been assessed as ‘standards met’ by NHS Digital \n \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02724","index":765,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02724"]
["Reference","22/CAG/0122 "]
["Other Refs","IRAS Project ID: 315880  REC Reference: N/A"]
["Application Title","ROC-oN: Radiotherapy for Oropharyngeal Cancer and impact on Neurocognition"]
["Application Summary","This application from The University of Leeds set out the purpose of medical research of conducting a questionnaire study to evaluate the long term fatigue and neurocognitive impairment in patients who have received radiotherapy for oropharyngeal cancer. This application to CAG is only for contacting and inviting eligible patients to consent to the study.\n\n Oropharyngeal cancer (OPC) is a type of head and neck cancer that develops in the oropharynx (the region in and near the tonsil). Patients treated with radiotherapy for OPC receive a low dose of radiotherapy to the base of the brain. This could lead to late effects including fatigue and neurocognitive deficits (in e.g., memory, language, processing speed and attention). Findings can help with better information provision, management and/or mitigation of late effects of radiotherapy. This study will help determine whether the base of the brain should be avoided when treating future head and neck cancer patients with radiotherapy and will encourage inclusion of neurocognitive function as a primary or secondary endpoint in future head and neck cancer radiotherapy trials.\n\nEligible patients will be identified by members of the direct care team at each site, this will include a check to ensure no invite is sent to a patient who has had OPC recurrence or is deceased. The National data opt out will be applied at this stage. A database at each site will be created containing patient name, address, NHS number and an allocated study number. This will remain on the NHS site servers. ‘s251’ support is requested for members of the research team at each site, who are not members of the direct care team, to invite participants by post to consent to complete a survey consisting of several validated questionnaires. Participants will also be invited to complete the Amsterdam Cognition Scan (ACS) online as a measure of neurocognition. A sample of participants will be asked to partake in semi-structured qualitative interviews. If the survey is not completed, after four weeks, then a reminder will be sent out."]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Dr Louise Murray"]
["Address","The University of Leeds,"]
[null,"Woodhouse Lane,"]
[null,"Leeds"]
["Postcode","LS3 9JT"]
["Telephone","0113 206 8091"]
["Email","L.J.Murray@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Adult Oropharyngeal cancer (OPC) patients, irradiated over the previous 10 years, ≥ 2 years after treatment, and remain disease free An invite to take part in the study will be sent out to around 1000 potential respondents."]
["Description of confidential patient information used","Data sources\n\nPre existing clinical databases - \n\n1. Leeds Cancer Centre (Leeds Teaching Hospitals NHS Trust) \n\n2. The Christie Hospital NHS Trust\n\nIdentifiers required for inviting patients to consent\n\n1. Names \n\n2. addresses \n\n3. NHS numbers\n\nIdentifiers required for analysis purposes\n\n1. N/A all data for analysis is collected with consent"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-10-18"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed November 2023 that ‘s251’ support could be expired as all previously unconsented identifiable patient information under this support is now processed with consent.\n\nIn terms of public benefit, there are 3 main benefits;\n•\tAn increase in the evidence base regarding neurocognitive impairment and fatigue as survivorship issues in patients who received radiotherapy +/-chemotherapy for oropharyngeal cancer \n•\tAn increase in understanding of the impact of radiotherapy dose on neurocognitive function. This might change approaches to the base of the brain as an organ at risk and allow better treatment selection in patients with oropharyngeal cancer.\n•\tThe findings could improve patient health related quality of life. \n\n\nThe application, to allow the processing of confidential patient information by research staff, who are not considered direct care team, to send invitation letters to eligible patients at participating sites (Leeds Cancer Centre (at Leeds Teaching Hospitals NHS Trust) and The Christie Hospital NHS Trust, is fully supported, subject to compliance with the standard and specific conditions of support.\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 07 October 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 21/22 DSPT reviews for Leeds Cancer Centre (Leeds Teaching Hospitals NHS Trust) and The Christie Hospital NHS Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 09 September 2022)\n\n"]

{"sheet":"A02725","index":766,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02725"]
["Reference","22/CAG/0124 "]
["Other Refs","IRAS ID:  307842    REC Reference:   22/EM/0198"]
["Application Title","Feasibility  of  an  artificial  intelligence  system to  improve the quality and efficiency of breast cancer screening"]
["Application Summary","This  research  application  from  Imperial  College  London  set  out  the  purpose  of  medical research  which  aims  to  testthe ability  forthe  integrated  system  to  correctly  perform eligibility  checks  and provide  Artificial  Intelligence  (AI)  results  only  for  women  who  are eligible,  within  the  breast  screening  programme,  explicitly  avoiding  any  potential  for  AI outputs to influencepatient care, as part of a prospective observational feasibility study.\n\n1 in  8  women  will  be  diagnosed  with  breast  cancer  in  their  lifetime.  The  UK  National Breast Screening Service (NBSS) is proven to detect breast cancer early where treatment is  more  successful,  using  2  expert  readers  (radiologists  and  radiographers)  to  assess each  mammogram  (x-ray  of  the  breast),  with  disagreements  decided  with  the  help  of  an additional  2  readers.However,  a  radiologist  workforce  crisis  threatensthe  screeningprogramme’s long-term sustainability. AI has been shown to be as good as two expert UK Radiologists at detecting and excluding breast cancer in an experimental setting. Google Health’s  AI  system  identified  cancer  in  mammograms  with  greater  accuracy   than specialists. Thisstudy aims to test the AI system running ‘silently’ within breast screening clinics  at  two  NHS  sites,  to  provide  the  necessary  evidence  to  form  the  basis  for  a proposed  deployment  framework  to  support  progression  to  future  interventional  use ina way thatdelivers measurable benefits to public health.\n\nImperial  College  Healthcare  NHS  Trust  and  St  George’s  University  Hospitals  NHS Foundation  Trust  are  the  2  participating  sites.  The  AI  system  will  be  applied  to  all screening clinics at each site for the study. Cases for inclusion in the feasibility study are identified   through   querying   the   screening   clinics   recorded   on   the   National   Breast Screening  Service  (NBSS)  database  at  each  local  site  following  clinic  completion.  The Royal  Surrey  NHS Foundation  Trust(RSNFT)  Secure  Medical  image  Anonymisation  for Research Trials (SMART) box (a piece of software) has already been installed at the NHS sites  for the  purpose  of data  collection from the breast  screening  programme  for  several ethically approvedprojects. The SMART box queries NBSS and PACS and carries out the de-identification process to pseudonymise the clinical data and imaging data used for the study.  This  process  is  automated  and  does  not  need  any  human  intervention  and  willexclude  patientsthat  opt-out.  The  associated  images  are  retrieved  from  the  site’s mammography  PACS.  The  images  are  then  pseudonymised  and  all  identifiable  DICOM tags are stripped or replaced with pseudonyms where necessary. Clinics will run routinely with  no  changetoexisting  practises.  Pseudonymised  images  are  transmitted  to  the pseudonymised dataCloud store, hosted in the Google Cloud Platform environment. As a proof-of-concept,  some  images  will  be  re-identified  at  the  Trusts,  and  only  direct  care team will haveaccess to any confidential patient information.\n\nAll patients whose images are read by the AI will be further followed up for a period of 3 months. This will enable collection of data such as arbitration outcomes and assessment outcomes should the patientberecalled forfurther investigation. Diagnosis outcomes will provide an estimateof the sensitivity and specificity of the AI system for patients that were recalled  to  the  clinic.  3 months  after the screening  appointment  has  been  attended ,  this data will becollected by  NBSS  and  linked  to  the  pseudonymised  patient  record  on  the Trust’s research server.\n\nDespite the processes being as automated as possible, and no confidential patient leaving the Trusts, ‘s251’ support is being sought in this  case, forthe potential  for  SMARTbox technicians  employed  by  Royal  Surrey,  who  are  not  considered  members  of  the  direct care team, to occasionally have to view confidential patient information whilst carrying out technical support."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Lord Darzi"]
["Address","10th Floor, Queen Elizabeth the Queen Mother Hospital Wing"]
[null,"St Mary's CampusInstitute of Global Health Innovation & Department of Surgery and Cancer"]
[null,"Imperial College London"]
["Postcode","W2 1NY"]
["Telephone",2033121310]
["Email","a.darzi@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately   14000Women   undergoing   routine   breast cancer  screening  (age  50–70),  as  part  of  thenational  breast screening  programme  at  Imperial  College  HealthcareNHS Trust and St George’s University Hospital NHS Foundation Trust  between  the  study  dates. -Mammography  images acquired using Hologic/Lorad, Siemens, or GE devices "]
["Description of confidential patient information used","Data sources\n\n1.Screening  clinics  recorded  via  the  National  Breast Screening    Service    (NBSS)    database    at    each participating site \n\n2.Images  from  each  participating sitemammography PACS\n\nIdentifiers required for linkage purposes\n\n1.Name\n\n2.NHS number\n\nIdentifiers required for analysis purposes\n\n1.Gender\n\n2.Ethnicity\n\n3.Age\n\nTherefore,   analysis   will   be   undertaken   on   an   effectively anonymous dataset"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-10-20"]
["Next Review Date","2024-10-20"]
["Notes","The application, to allow the potential for Royal Surrey NHS Trust employed SMARTbox engineers, who are not considered part of the direct care team, to view confidential patient information about patients from Imperial College Healthcare NHS Trust and St George’s University Hospitals NHS Foundation Trust, during any technical support provided for set-up and maintenance of an AI tool for breach cancer screening is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\n\nConditions of support:\n\n1.\tPlease update patient facing materials to explain why ‘s251’ support is in place, as per the advice in this letter, and return to CAG for review within one month from the date of this letter.\n\nCondition met 22 November 2022\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 22 September 2022.\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 21/22 DSPT reviews for ‘St. George’s NHS Foundation Trust’ and ‘Imperial College Healthcare NHS Trust’ were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26 September 2022).\n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02726","index":767,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02726"]
["Reference","22/CAG/0112"]
["Other Refs","IRAS Project ID: 314379  REC Reference: 22/WA/0156"]
["Application Title","Randomised  trial  of  the  clinical  and  cost  effectiveness  of  a supraglottic   airway   device   versus   intubation   during   in-hospital cardiac arrest"]
["Application Summary","This application from the University of the West of England set out the purpose of medical research that seeks to determine the clinical and cost effectiveness of a supraglottic airway device versus tracheal intubation during in-hospital cardiac arrest. Inhospital cardiac arrest (IHCA) occurs in approximately 1 in 1000 hospital inpatients. It is a sudden, unpredictable and life-threatening event and has significant mortality and morbidity. Survival to hospital discharge following resuscitation for IHCA is around 24% in the UK. However, additional data collected for patients who require advanced airway management, such as the insertion of a tracheal tube or a supraglottic airway device, suggests that survival for this patient group is closer to 10%. \n\nEffective cardiopulmonary resuscitation (CPR) is central to achieving good patient outcomes, however chest compressions alone do not provide adequate lung ventilation and effective airway management is essential. A previous trial, AIRWAYS-2, explored use of tracheal intubation versus the i-gel supraglottic airway device in OHCA. This did not detect a significant difference in functional outcome (including mortality) between the two advanced airway management techniques. Since then, updated international resuscitation guidelines support the use of supraglottic airways (SGAs) in settings where intubation success rates are lower. Changes have been made in management of airways when paramedics treat Out of Hospital Cardiac Arrest (OHCA), but not where doctors manage the airways. The applicants seek to determine whether SGAs are superior to tracheal intubation in situations where intubation success rates are assumed to be high. The applicants will conduct a multi-centre, open-label, pragmatic, individually randomised, parallel group, superiority trial and economic evaluation. Patients will be recruited by NHS clinicians, usually the member of the in-hospital cardiac arrest team who is designated to manage the patient’s airway. The clinician will assess patient eligibility. Patients will be randomly allocated, at a ratio of 1:1, to receive either a supraglottic airway device (intervention arm) or tracheal intubation (control arm). The randomisation will be conducted using a phone progressive web application (PWA) which willinform the Warwick CTU that the randomisation has occurred. Patients will initially be recruited under the Mental Capacity Act, as patients will be unconscious when entered into the trial. Consent will be sought from patients who regain capacity. Support is required to include patients who die before consent can be sought. Confidential patient information will be disclosed to the University of Warwick. Individual level patient data will be disclosed to NHS Digital, PEDW and ICNARC for linkages to datasets these organisation hold, and a linked dataset returned to the University of Warwick. \n\nThe applicants noted that data linkage to Health Data Research UK (HDR UK)was planned. An amendment would be submitted before thiswas undertaken. "]
["Applicant Organisation Name","University of the West of England "]
["Contact Name","Professor Jonathan Benger"]
["Address","Faculty of Health and Applied Sciences"]
[null,"University of the West of England  "]
[null,"Coldharbour Lane, Bristol"]
["Postcode","BS16 1QY "]
["Telephone","0117 3421497"]
["Email","Jonathan.Benger@uwe.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who experience an in-hospital cardiac arrest, are attended by the hospital cardiac arrest team and    who    require    resuscitation    with    advanced    airway management.\n\n4190 patients will be included."]
["Description of confidential patient information used","Data sources\n\n1. Participant NHS hospital Trusts \n\n2.  NCAA  (National  Cardiac  Arrest  Audit),  held  by  Intensive Care National Audit and Research Centre (ICNARC) \n\n3. Patient Episode Database for Wales (PEDW), held by NHS Wales Informatics Service (NWIS) \n\nIdentifiers required for linkage purposes\n\n1. Name \n\n2. NHS Number \n\n3. Date of birth \n\n4. Postcode –district level\n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n\n2. Date of death \n\n3. Postcode –district level \n\n4. Gender \n\n5. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-10-31"]
["Next Review Date","2024-10-31"]
["Notes","1 February 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics (HES). \n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 22 July 2022 \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT review for, Intensive Care National Audit and Research Centre (ICNARC) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 13/09/2022) \n \nNHS Wales Informatics Service (NWIS) – CPIP in place \n \nThe applicants confirmed that the University of the West of England would not process any confidential patient information under support, therefore a DSPT was not required for this organisation.  \n\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02727","index":768,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02727"]
["Reference","22/CAG/0131"]
["Other Refs","IRAS Project ID: 308385  REC Reference: 22/LO/0636 "]
["Application Title","STandardising pAthways for diagnosing hypeRtension using routine healLthcare data: an InvestiGation of the Health and economic ouTcomes: STARLIGHT, Version 1.0"]
["Application Summary","This application from The University ofOxfordset out the purpose of medical research ofa  retrospective  cohort study,to  assess the  value  of  implementing  a  diagnostic  prediction model  for  identifying  previously  undetected  hypertension  among  hospital  inpatients,  as part   of   a   standardised   care   pathway   that   integrates   patient   information   between secondary  and  primary  care. A  hypertension  diagnostic  prediction  modelwill  be usedagainstalinked GP/Hospital  admission dataset,to  differentiate  between  those  patients whose in-hospital data predict them to have undiagnosed hypertension and those whose data do not. The study is being undertaken as part of a PhD.\n\nHypertension  is a leading  risk  factor  for  death  globally  with  12.8% of  deaths  annuallyattributed.In  England,  1  in  8  adults  has  undiagnosed  hypertension.  These  people  are  at risk of serious health problems. More needs to be done in the NHS to identify people with hypertension,  on  top  of  existing  checks  for  hypertension.  Presently,  the  only  dedicated system  for  checking  people  for  hypertension is the ‘NHS Health Check’, whichmisses  a wide  range  of  undiagnosed hypertensioncases.Evidence  suggests  that  patients  with elevated  blood  pressure  recordings  in  hospital  frequently  remain  hypertensive  in  the community,  however  this likelihoodis  often  dismissed for  various  reasons.  Untreated hypertension is associated with a progressive increase in blood pressure that can become treatment resistant. Therefore, hospital detection and timely management of hypertension offer  an  important  intervention  opportunity  to  address  this  major  cause  of  morbidity  and mortality. This project will investigate the impact and value of implementing a standardised diagnostic  pathway  for  identifying  undiagnosed  hypertension  in  patients,  using  routinely collectedblood  pressure  data  obtained  during  hospital  admissions.  The  aim  of  this,  is  to reduce the prevalence of undiagnosed hypertension.\n\nThis  study  will  use  data  collected  from  patients  registered  with  any  GP  Surgery  in Oxfordshire,  Berkshire,  Northamptonshireand  Buckinghamshire  which  contributes  to  the Oxford-Royal  College  of  General  Practitioners  Clinical  Informatics  Digital  Hub  (ORCHID) Database,  alongside  data  collected  routinely  during  an  admission  to  Oxford  University Hospitals  NHS  Foundation  Trust  for  the  same  patients. ORCHID  will  use  a  hashing algorithm to code patient NHS numbers creating a pseudonymised dataset. ORCHID will send  their  dataset,  along  with  the  hashing  algorithm  code  to  Oxford  University  Hospitals NHS   Foundation   Trust,   permitting   patient   matching   between   data   sources   and amalgamation of both ORCHID and OUHNHSFT datasets for all patients who are eligible.‘s251’ support is required for this linkage, as despite being transferred in pseudonymousformat,  both  parties  have  access tothe  hashing  algorithm  and  can  re-identify. Once linkage has been undertaken, the dataset will be effectively anonymised and disclosed to the applicants  at Nuffield  Department  of  Primary  Care  Health  Sciences,  University  of Oxford, in order for them toundertakeanalysis on this effectivelyanonymised dataset."]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Dr Laura Armitage"]
["Address","Radcliffe Observatory Quarter"]
[null,"Woodstock Road"]
[null,"Oxford"]
["Postcode","OX2 6GG"]
["Telephone",1865289340]
["Email","laura.armitage@phc.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All adult patients registered with a GP surgery in Oxfordshire, Berkshire, Northamptonshire and Buckinghamshire which contributes to the ORCHID database, for whom there is no coded diagnosis of hypertension recorded prior to June 2016\n\nApplicantisunsure how many individuals this will be -19,744 is the statistical calculation for the minimum required data."]
["Description of confidential patient information used","Data sources\n\n1.The   Oxford-Royal   College   of   General   Practitioners ClinicalInformatics   Digital   Hub   (ORCHID)   Database,Retained at University  of  Oxford  (Nuffield  Department  of Primary Care Health Sciences). \n\n2.Oxford   University   Hospitals   NHS   Foundation Trust –medical records\n\nIdentifiers required for linkage purposes\n\n1.NHS number (hashed for transfer between organisations)\n\nIdentifiers required for analysis purposes\n\n1.Ethnicity\n\n2.Indices  of  Multiple  Deprivation  for  the  GP  surgery  at which the patient is registered\n\nThe  data  will  be  effectively anonymous  to applicantsfor analysis, as they willnot have the means to re-identify"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-11-04"]
["Next Review Date","2024-11-04"]
["Notes","Amendment supported 25 May 2023 to amend the data flow, so that Oxford University transfers only the hashed NHS IDs for the eligible cohort, without any healthcare data\n\nThe application, to allow the disclosure of confidential patient information from Oxford-Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) Database (at University of Oxford (Nuffield Department of Primary Care Health Sciences)) to Oxford University Hospitals NHS Foundation Trust to allow linkage, and disclosure of an effectively anonymous dataset to the applicants at University of Oxford, is fully supported, subject to compliance with the standard conditions of support\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 September 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for University of Oxford (Nuffield Department of Primary Care Health Sciences) - EE133863-MSD-NDPCHS (regarding ORCHID) and Oxford University Hospitals' NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 18 October 2022)\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02728","index":769,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02728"]
["Reference","22/CAG/0038"]
["Other Refs","IRAS Project ID:  286823  REC Reference: 22/SC/0313"]
["Application Title","Twins’ Early Development Study (TEDS) Medical Record Linkage "]
["Application Summary","This application from King’s College London (KCL) set out the purpose of medical research that  seeks  to create  a  research  database,  to investigate  how  genetic  and environmental factors influence development, with a particular focus on psychological development and mental health.\n\nThe Twins Early Developmental Study (TEDS) is a longitudinal study which recruited over 16,000  twin  pairs  who  were  born  in  England  and  Wales  between  1994  and  1996. Approximately  10,000  families  are  still  actively  engaged.  The  twin  pairs  have  been assessed  across  cognitive,  emotional  and  behavioural  domains  from  early  infancy  into adulthood. Genotyping data is available for 10,346 individuals. The applicants now intend to link the already collected data with data from patients’ medical records, obtained from NHS Digital, in order to build predictive longitudinal, genetic and clinical models of mental health  outcomes,  such  as  disorder risk  and response  to treatment.  The applicants  noted that it was important to gather information at this stage in patients’ lives, as new mental health conditions often peak in the mid-twenties. \n\nThe  data  flow  is  separated  into  three  pathways;  obtaining up  to  datecontact  details  for participants, the secondary care linkage undertaken by NHS Digital, and linkage to primary care data undertaken by the GP practices of patients included in TEDS. \n\nIn pathway one; confidential patient information from the TEDS dataset,held in the South London  andMaudsley  Clinical  Data  Linkage  Service(SLAM  CDLS) Safe  Haven,  will  be disclosed to NHS Digital for linkage to the Personal Demographics Service (PDS), in order to obtain patients address and GP registration information. The linked dataset will then be returned to the TEDS research team. The research team will then send information about the study and how to opt-out to patients.\n\nIn  pathway  two;  confidential  patient  information  from  the  TEDS  dataset,  excluding  those who opted-out, will be disclosed to NHS Digital for linkage to the Hospital Episode Statistics (HES),   Mental   Health   Services   Dataset   (MHSDS)   and   the   Improving   Accessto Psychological Therapies (IAPT) dataset. NHS Digital will then send a linked dataset, which has been pseudonymised by removal of patients NHS number, name, address and date of birth, to the TEDS research team. The research team will use the TEDS ID to link the dataset to the existing TEDS dataset. \n\nIn pathway three; confidential patient information will be disclosed from the TEDS dataset to  patients  GPs,  firstly  to  seek  GPs  assent  to  access  the  GP  health  records  for  TEDS participants  and  then  for  linkage  to  their  primary  care  record.  The  data  from  GPs  will  be pseudonymised and returned to TEDS with the TEDS ID as the identifier. \n\nOnly  fully  anonymised  data  will  be  made  available  to  researchers.  The  policy  on  the application process to use the data was provided. Lay individuals would be included on the Data Access Committee."]
["Applicant Organisation Name","King’s College London"]
["Contact Name","Thalia C Eley"]
["Address","Box PO80, SGDP Centre, Institute of Psychiatry"]
[null,"Psychology & Neuroscience, De Crespigny Park"]
[null,"London"]
["Postcode","SE5 8AF"]
["Telephone",2078480863]
["Email","thalia.eley@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Sets of twins born between 1994 and 1996 who were enrolled into TEDS. \n\n26000 patients will be included."]
["Description of confidential patient information used","Data sources\n\n1.TEDS database at King’s College London/ SLaM CLDS Safe Haven\n2.HES and MHSDS datasets held by NHS Digital\n3.IAPT service data held by NHS Digital\n4.Locally held information contained in the lifetime primary care electronic patient record, provided by participants’ GP surgery\n\nIdentifiers required for linkage purposes\n\n1.Name\n2.NHS number\n3.GP Registration\n4.Date of birth\n5.Postcode –unit level\n\nIdentifiers required for analysis purposes\n\n1.Gender \n2.Occupation \n3.Ethnicity\n\nInclude Personal Demographics Service:\n\n1. TEDS database at King’s College London/ SLaM CLDS Safe Haven\n2. Personal Demographics Service held by NHS Digital\n3. HES and MHSDS datasets held by NHS Digital\n4. IAPT service data held by NHS Digital\n5. Locally held information contained in the lifetime primary care electronic patient record, provided by participants’ GP surgery\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-11-18"]
["Next Review Date","2024-11-18"]
["Notes","24 July 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - Personal Demographics Service (PDS), Hospital Episode Statistics (HES), Mental Health Services Dataset (MHSDS) and the Improving Access to Psychological Therapies (IAPT) dataset.\n\nAmendment supported 24 July 2023 to include TEDS data into the UK Longitudinal Linkage Collaboration (LLC), CAG reference 21/CAG/0044\n\nThe application, to allow the disclosure of confidential patient information from the TEDS dataset, at KCL/SLaM CLDS Safe Haven to NHS Digital, for linkage to the Personal Demographics Service, a second disclosure of confidential patient information to NHS Digital for linkage to the HES, MHSDS and IAPT datasets held by NHS Digital, and the return of a linked dataset to KCL/SLaM CLDS Safe Haven, also the disclosure of confidential patient information from TEDS to participants’ GP surgery, for linkage to locally held information contained in the lifetime primary care electronic patient record, and a dataset returned by the participants’ GP surgery to TEDS, for the purpose of creating a research database, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\n\nConditions of support:\n\n1.\tSupport is provided for 5 years from the date of final support, to allow the applicant time to complete the exit strategy, and gain consent from participants to undertake the proposed linkages. A duration amendment will be required at this time, if an extension of support is required. Please report on the progress of consent for linkage at each annual review\n\n2.\tPlease reaffirm the continued holding of identifiable information within the annual newsletters to ensure all participants are aware of this, reporting on this at the first annual review.\n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed 03 November 2022\n\n4.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for South London and Maudsley NHS Foundation Trust (RV5) and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 18 November 2022)\n\nRegarding participating GP surgeries; due to the number of organisations involved it is the responsibility of King’s College London, as controller, to ensure that participating practices meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a practice.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02729","index":770,"n_rows":51,"n_cols":3,"rows_kept":51,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02729"]
["Reference","22/CAG/0125 "]
["Other Refs","IRAS Project ID: 311274  REC Reference: 22/LO/0614"]
["Application Title","Management of Patients with Chronic Liver Disease Admitted to Hospital as an Emergency"]
["Application Summary","This application from King's College Hospital NHS Foundation Trust with London School of Hygiene  and  Tropical  Medicine  as  joint  data  controller, set  out  the  purpose  of  medical research  of  linking  together  data  from NHS  England  (previously NHS  Digital), Intensive Care  National  Audit  &  Research  Centre (ICNARC),  and NHS  Blood  and  Transplant (NHSBT)  about  100,000  patients  with  Chronic  Liver  Disease  (CLD).  London  School  of Hygiene and Tropical Medicine (LSHTM) will retain a linked dataset for analysis, which will contain full date of death and therefore require ‘s251’ support. The research group includes researchers from the Institute of Liver Studies at King’s College Hospital, LSHTM, the University of Exeter and King’s College London, and is funded by the National Institute for Health  Research.  The  overall  aim  is  to  identify  which  characteristics  of  treatments  and services for acutely ill people with CLD impact on care processes and outcomes, in order to improve the national organisation and delivery of care forall people acutely ill with chronic liver disease. ‘s251’ support is only required for the linkage element of this study, work package2. \n\nLiver disease is a serious and increasing health problem in the UK, responsible for many preventable  deaths.  However,  people  with  liver  disease  often  do  not  know  that  they  are affected until they need to be admitted to hospital as an emergency. These people are often very ill, and a quarter die within two months of coming into hospital. The care received in hospital, and post discharge, varies greatly across the country. This variation in care has major  effects  on survival.This  study  aims  to  understand  what  clinical  practices  have  the best results and will aim to make recommendations about how the services for patients with CLD can be made safer and more effective. \n\nNHS England (previously NHS Digital) will identify the eligible cohort using Hospital Episode Statistics and ONS Mortality Datasets. This will include patients with CLD admitted with a first emergency hospital admission between 1 April 2009 and 31 March 2022. Confidential patient information, alongside a pseudonym (HES ID) will be disclosed to ICNARC, who will link to their Case Mix Programme data. NHSBT will send confidential patient information, alongside  apseudonym  (UKT  ID)  on  UK  Transplant  Registry  patients  with  chronic  liver disease who underwent transplantation, including recipient and donor characteristics and waiting  list  data,  to NHS  England  (previously NHS  Digital),  which  will  be  linked  to  the HES/ONS cohort. All 3 organisations will send clinical data linked to a pseudo ID to LSHTM, in order for LSHTM to link the 3 datasets together. ‘s251’ support required until full date of death is deleted. "]
["Applicant Organisation Name","King's College Hospital NHS Foundation Trust"]
["Contact Name","William Bernal"]
["Address","Institute of Liver Studies"]
[null,"Denmark Hill "]
[]
["Postcode","SE5 9RS"]
["Telephone","0203 2994 458"]
["Email","william.bernal@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All  patients  older  than  18  years  with  chronic  liver  disease (CLD)  who  were  admitted  with  a  first  emergency  hospital admission between 1 April 2009 and 31 March 2022.HoweverNHSBT   also   identify   patients   planned   for   or undergoing  a  liver  transplant  in  England  between  one  year before the study period to one year after the study period.Approximately 100,000 people."]
["Description of confidential patient information used","Data sources\n\n1.NHS England (previously NHS Digital); Hospital Episodes Statistics  (HES)  data  (inpatient,  outpatient  data,  A&E attendances and linked ONS mortality data)\n\n2.NHS  Blood  and  Transplant  (NHSBT) -UK  Transplant Registry \n\n3.The  Intensive  Care  National  Audit  and  Research  Centre (ICNARC) Case    Mix    Programme    (ICNARC-CMP) database\n\nIdentifiers required for linkage purposes\n\n1.NHS Number\n2.Date of birth\n3.Sex  \n4.Postcodes\n\nIdentifiers required for analysis purposes\n\n1.Date of death\n2.Ethnicity\n3.Sex"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-11-22"]
["Next Review Date","2024-11-22"]
["Notes","Amendment supported 28 July 2023 to clarify that the cohort should be described as; ‘All patients older than 18 years (or with missing age) with chronic liver disease (CLD) who were admitted with an emergency hospital admission between 1 April 2007 and 31 March 2022’\n\nAmendment supported 20 June 2023 to remove the study specific opt out mechanism from this application, as NHS England have confirmed they do not have the capacity to apply any opt out to the dataset, and to allow the potential inclusion of individuals under 18, by including those whose age wasn't clear at the time of the event, and also by including relevant retrospective records that may be relevant to childhood history (however the index event will aways remain at 18 and above if age known)\n\nThe application, to allow \n\n•\tthe disclosure of confidential patient information from NHS England (previously NHS Digital) to ICNARC, in order for ICNARC to link to the CMP,\n•\tthe disclosure of confidential patient information from NHSBT to NHS England (previously NHS Digital), in order for NHS England (previously NHS Digital) to link to the HES/ONS cohort,\n•\tthe disclosure of confidential patient information from NHS England (previously NHS Digital), NHSBT, and ICNARC to LSHTM, in order for LHSTM to link the datasets together for analysis. (flows contains full date of death),\n•\tLSHTM to retain the full date of death for analysis,\n\nis fully supported, subject to compliance with the standard and specific conditions of support.\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 23 September 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed \n\nThe NHS Digital 21/22 DSPT reviews for Intensive Care National Audit & Research Centre, NHS Blood and Transplant and NHS Digital & London School of Hygiene and Tropical Medicine were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 22 November 2022)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]
[]
[]
[]
[]
[null," "]
[null," "]
[]
[null," "]
[]
[null," "]
[]
[null," "]

{"sheet":"A02730","index":771,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02730"]
["Reference","22/CAG/0149"]
["Other Refs","IRAS Project ID: 253774  REC Reference: 22/WM/0244"]
["Application Title","Progression of Diabetic Retinopathy from referral to treatment or vision loss: External Validation, update and net clinical benefit of a Multivariable Prediction Model"]
["Application Summary","This application from the University of Birmingham set out the purpose of medical research that seeks to determine whether a model developed in primary care to identify patients at high risk of developing diabetic retinopathy can also be used in hospitals. \n\nDiabetic retinopathy (DR), is a complication of diabetes at the back of the eye and is the fourth leading cause of preventable vision loss in the UK. Patients with diabetes are screened regularly for signs of early DR by the Diabetic Eye Screening Programme (DESP). However, when a patient develops clinical signs of advanced retinopathy, they are referred to Hospital Eye Services (HES) or surveillance clinics for closer observation and treatment to prevent vision loss. The number of patients with diabetes is increasing each year, with a consequent rise in numbers of patients with DR. This, in combination with under-resourced NHS causes an overburdening of HES, resulting in delays in patients being seen and a higher risk of harm to patients. Data from general practice has been used to develop a model to identify patients who are at a high risk of progressing to DR which requires treatment. The applicants are now seeking to test whether the same model can be used in hospital services and surveillance clinics. \n\nA retrospective review of patients with diabetes will be undertaken. At two of the three participating trusts, the identification of patients and data extraction will be undertaken by the direct care team. At South Tyneside and Sunderland NHS Foundation Trust the identification and data extraction will be undertaken by research staff. Support is only required for activity taking place at this Trust. An anonymised dataset will be extracted and sent to the University of Birmingham for analysis."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Dr Nicola Adderley Head of Research Governance & Integrity Research Strategy and Services Division "]
["Address","Public Health Building"]
[null,"UoB"]
[null,"Edgbaston"]
["Postcode","B15 2TT"]
["Telephone",1214145643]
["Email","n.j.adderley@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 12 years and over diagnosed with Diabetic Retinopathy\n\n800 patients from South Tyneside and Sunderland NHS Foundation Trust will be included."]
["Description of confidential patient information used","Data sources\n\n1. Patient records at South Tyneside and Sunderland NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1. NHS Number \n2. Date of birth \n3. Date of death\n\nIdentifiers required for analysis purposes\n\nNo identifiers will be retained for analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-12-02"]
["Next Review Date","2024-12-02"]
["Notes","Conditions of support:\n\n1. A contact telephone number and postal address need to be included on the poster. \n\nCondition met 09 December 2022. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 24 November 2022. \n\nConfirmed 24 November 2022.  \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: 24 November 2022.  \n\nConfirmed: 24 November 2022. NHS Digital 2021/22 DSPT review for South Tyneside and Sunderland NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (31/10/2022).\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02731","index":772,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02731"]
["Reference","22/CAG/0127"]
["Other Refs","IRAS Project ID: 304070  REC Reference: 22/PR/0229"]
["Application Title","Turning6 - A Clinical and Neurodevelopmental follow up of EPIPEG participants at 60 months"]
["Application Summary","This application from UCL GOS Institute of Child Health set out the purpose of medical research that seeks to investigate the association between early onset epilepsy and poor neurodevelopmental outcome.\n\nEpilepsy in the first year of life is associated with epilepsy that is difficult to treat and with poor neurodevelopmental outcomes. These can have a severe impact on the quality of life of both children and their parents, and the child’s educational outcome. Little research has been undertaken into the longer-term impact of epilepsy. The applicants seek to follow-up participants from the EpiPEG study, which recruited 119 infants who had developed epilepsy within the first year of their life. The applicants propose to follow up this unique cohort of children as they reach 6 years, and will undertake comprehensive psychological assessments with the child, their parents and teachers. \n\nThe applicants will contact still living participants to seek consent to take part in the study. The original EpiPEG study was jointly undertaken by UCL GOS Institute of Child Health and Young Epilepsy (the National Centre for Young People with Epilepsy), who are joint data controllers for the EpiPEG dataset. The applicants seek support to access mortality data, provided by NHS Digital, to establish whether patients are still alive before making contact. Confidential patient information will be disclosed from the EpiPEG dataset, held at Young Epilepsy, to NHS Digital for linkage to mortality data. A linked dataset will be returned to Young Epilepsy. The parents of living patients will be contacted and invited to take part in the study."]
["Applicant Organisation Name","UCL GOS Institute of Child Health and Young Epilepsy (The National Centre for Young People with Epilepsy)"]
["Contact Name","Professor Helen Cross (Chief Investigator) "]
["Address","30 Guilford Street"]
[null,"London"]
[]
["Postcode","WC1N 1EH"]
["Telephone","+44 (0) 207 905 2981"]
["Email","h.cross@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","117 patients who were recruited into the original EpiPEG study."]
["Description of confidential patient information used","Data sources\n\n1. EpiPEG records, held at Young Epilepsy (The National Centre for Young People with Epilepsy) \n2. The HES and Personal Demographics Service datasets, held at NHS Digital\n\nIdentifiers required for linkage purposes\n\n1. NHS number \n2. Date of birth \n3. Date of death \n4. Postcode – unit level\n\nIdentifiers required for analysis purposes\n\n1. Date of death \n2. Postcode – unit level \n3. Phone number \n4. Email address"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-12-02"]
["Next Review Date","2023-12-02"]
["Notes","Conditions of support:\n\n1. A typographical error in the Invitation Letter needs to be corrected, “…including education and metal health.” \n2. Favourable opinion from a Research Ethics Committee. Confirmed 19 May 2022. \n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: The NHS Digital 21/22 DSPT reviews for organisation ‘NHS Digital’ and ‘Young Epilepsy (the National Centre for Young People with Epilepsy)’ were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 26/09/2022).\n"]

{"sheet":"A02732","index":773,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02732"]
["Reference","22/CAG/0144"]
["Other Refs","IRAS Project ID: 317616  REC Reference: 22/SC/0280"]
["Application Title","Randomised Evaluation of SOdium dialysate Levels on Vascular Events"]
["Application Summary","This application from University College London set out the purpose of medical research that seeks to determine the optimal default dialysis sodium concentration, and the impact of higher or lower dialysate sodium concentration on cardiovascular events and death in patients with kidney failure who are receiving haemodialysis. \n\nOver 24,500 people in the UK are receiving haemodialysis to treat kidney failure. Those receiving haemodialysis have a mortality rate 10 to 100 times higher than in the general population and most deaths are due to cardiovascular disease. A main contributor to this is retention of sodium and fluid, which causes thickening of the heart muscle, wide changes in weight between dialysis sessions and vascular disease. Dialysate is a saline solution exposed to blood during the dialysis session. Most units use a default dialysate sodium prescription, meaning that all patients treated at the unit receive the same concentration, unless specifically altered by the responsible physician. There is no consensus as to the optimal dialysate sodium concentration.\n\n100 dialysis centres will participate in the study. Confidential patient information will be transferred from participating sites to the UCL Data Safe Haven. The research team at University College London will collate the data and transfer confidential patient information to NHS Digital for linkage and to the UK Renal Registry for linkage. Linked datasets will be returned from NHS Digital and the UK Renal Registry to the UCL Data Safe Haven. Linkages to NHS Digital and the UK Renal Registry will be undertaken on an annual basis."]
["Applicant Organisation Name","University College London"]
["Contact Name","Mrs Lisa French "]
["Address","UCL Comprehensive Clinical Trials Unit "]
[null,"2nd Floor, 90 High Holborn \n"]
[null,"London"]
["Postcode","WC1V 6LJ "]
["Telephone",203108977]
["Email","cctu.resolve@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over receiving haemodialysis for kidney failure. \n\nThe applicants anticipate that 12,000 patients will be recruited in England."]
["Description of confidential patient information used","Data sources\n\n1. Confidential patient information from dialysis units at participating trusts \n\n2. Hospital Episode Statistics Admitted Patient Care (HES APC), Emergency Care Data Set (ECDS), Civil Registrations (Deaths) data set, held by NHS Digital \n\n3. The UK Renal Registry\n\nIdentifiers required for linkage purpose\n\n1. NHS number \n\n2. Date of birth\n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n\n2. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-12-07"]
["Next Review Date","2024-12-07"]
["Notes","23 January 2024 - change in data processors from NHS Digital to NHS England, regarding data sources - Hospital Episode Statistics Admitted Patient Care (HES APC), Emergency Care Data Set (ECDS), and Civil Registrations (Deaths) data.\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 01 November 2022. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2021/22 DSPT reviews for University College London, NHS Digital and The Renal Association were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (11/10/2022). \n\nPending: \n\nThe NHS Digital 2021/22 DSPT review for organisation Dialysis centres at participating trusts - Due to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations. \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02733","index":774,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02733"]
["Reference","22/CAG/0146"]
["Other Refs","IRAS Project ID: 318541  REC Reference: 22/SW/0146"]
["Application Title","Evaluating Behavioural Science Informed Messaging on Cervical Cancer Screening Catch-up"]
["Application Summary","This application from Imperial College London set out the purpose of medical research that seeks to determine how the different messages used to invite women to catch-up screenings by the NHS Cervical Cancer Screening Programme affect attendance. \n\nIn the UK, women aged 25 to 64 are invited to attend cervical cancer screening. Earlier detection of cancer is estimated to save 4,500 lives each year. Despite this, the numbers of patients attending screening has fallen, with uptake as low as 49% in some areas of London. In 2021, the NHS Cervical Screening Programme in London began sending ‘catch-up’ SMS messages to invite women who had not attended their previous invitation to an appointment. In this study, the applicants seek to understand which of the different messages used for the catch-up messaging were most effective. \n\nThe NHS England Team at the North of England Commissioning support unit (NECS), who are not members of the direct care team, will extract the necessary screening dataset, including confidential patient information. The dataset will be pseudonymised before transfer to the research team at Imperial College London. The pseudonymisation key will be held by NECS until the data transfer has taken place and will then be deleted, as per NHS England’s protocol."]
["Applicant Organisation Name","Big Data Analytical Unit (BDAU), Imperial College London"]
["Contact Name","Dr Gaby Judah Lecturer in Behavioural Sciences "]
["Address","Imperial College London 10th Floor"]
[null,"St Mary's Hospital Praed Street, "]
[null,"Paddington London "]
["Postcode","W2 1NY"]
["Telephone",2033136666]
["Email","g.judah@imperial.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 25 – 64 years who have received an initial invitation to screen between 01 April 2019 to 30 November 2019, are based in London, received an 18-week reminder letter and have not attended a cervical screening appointment at the time of reminder messages being sent out."]
["Description of confidential patient information used","Data sources\n\n1. NHS Cervical Screening Programme database, retained and processed by NECS, controlled by NHS England.\n\nIdentifiers required for extraction purposes\n\n1. NHS number \n\n2. Ethnicity\n\nIdentifiers required for analysis purposes\n\n1. Ethnicity \n\n2. Age"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-12-09"]
["Next Review Date","2024-12-09"]
["Notes","Conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed: 25 October 2022. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: The NHS Digital 2021/22 DSPT review for North of England Commissioning support unit (NECS) was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 November 2022).\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02734","index":775,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02734"]
["Reference","23/CAG/0006"]
["Other Refs","IRAS Project ID: 246575  REC Reference: 20/WM/0071"]
["Application Title","Birmingham   and   Lambeth   Liver   Evaluation   Testing Strategies -10 Year Follow Up"]
["Application Summary","The application from University Hospitals Birmingham NHS Foundation Trust sets out the purpose of medical research to determine the extent to which a 'fatty liver' leads to serious liver disease later in life.\n\nNon-alcoholic fatty liver disease (NAFLD) is the most common liver condition in high-income countries, affecting 25% to 30% adults. There is no doubt that NAFLD can progress to more severe diseases; first to a condition called ‘steatosis’ and then to established cirrhosis. While the possibility of such progression is not in doubt, the risk of progression is unclear and disputed. It is important to provide scientific evidence regarding the magnitude of the risk of progression since the recommendation has been made that all people with NAFLD should be investigated by means of serial blood tests and scans of the liver. Such a policy would have massive implications in terms of costs and harms resulting from serial investigation of a fruitless ‘treadmill’ of investigations for about one third of the entire adult population. The BALLETS study provides a population of patients typical of those that might be identified in the course of routine primary care practice. To our knowledge, our proposed study would be much the largest cohort study of people with NAFLD.\n\nThe BALLETS study consented participants in 2005-2008 to participate and have been characterised into one of four groups. The group represents a ideal opportunity to determine the risk of progression. Whilst applicants consented to future follow up, the researchers at the time did not know what form that follow up would take, and the original consent is not deemed sufficient for the proposed study. This study wishes to link the original study data (held by University of Birmingham and passed to University Hospitals Birmingham NHS Foundation Trust) with ONS and HES data from NHS Digital to create a pseudonymised dataset for analysis."]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Professor Richard Lilford"]
["Address","Room 108, First Floor Murray Learning Centre "]
[null,"Institute of Applied Health Research"]
[null,"University of Birmingham, Edgbaston "]
["Postcode","B15 2TT"]
["Telephone",7824474289]
["Email","r.j.lilford@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All participants that consented to participate in the original BALLETS study. (1290 participants)"]
["Description of confidential patient information used","Data sources:\n1. University of Birmingham – Trial Data\n2. NHS Digital – ONS and HES datasets\n\nIdentifiers required for linkage purposes:\n1. Name\n2. NHS Number\n3. Date of Birth\n4. Hospital Number \n\nIdentifiers required for analysis purposes:\n1. Date of Birth\n2. Date of Death\n3. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-12-16"]
["Next Review Date"]
["Notes","Applicant confirmed in October 2023 that ‘s251’ support could be expired as all identifiable patient information held without consent under this support has been pseudonymised, and the applicants do not have access to the key.\n\nIn terms of the anticipated public benefit, this research is of importance to the general public as NAFLD is a condition thought to affect at least one in four adults in the UK. It is important that these patients, when first identified in primary care are given realistic and reliable information about their future risk of severe liver disease and survival. When fully informed about the potential risks, patients may be more proactive in their treatment or monitoring plans. It is hoped that results of this research will provide the evidence to determine whether routine assessments of the patient’s liver well-being is justified. Applicants also hope to be able to provide reliable information about the use of hospital liver services that patients with NAFLD will have, allowing hospitals to more accurately estimate the availability of these services if the prevalence of NAFLD continues to rise.\n\n\nThis submitted information represented a new application in relation to an existing activity under application reference 20/CAG/0071. As a result of the original application not providing clarity on the controllership, the main change is that of a change of data controller, from solely University Hospitals Birmingham NHS Foundation Trust to solely University of Birmingham. In addition the applicants with to update CAG in the change of the chief investigator, from Dr James Ferguson to Professor Richard Lilford. The intention is to replace 20/CAG/0071 with this new application once support is in place.\n\n\nConditions of support:\n\n1.\tFavourable opinion from REC Confirmed 26 March 2020 initially, and change given Favourable Opinion on 03 March 2022.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe 2021/22 NHS Digital DSPT reviews for University Hospitals Birmingham NHS Foundation Trust and University of Birmingham were confirmed as ‘Standards Met’ on the NHS DSPT Tracker (checked 13 December 2022). \n\n"]

{"sheet":"A02735","index":776,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02375"]
["Reference","22/CAG/0165 "]
["Other Refs","IRAS Project ID: 320847 REC Reference: 22/LO/0846"]
["Application Title","Shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of an intervention to promote regular, asymptomatic testing in care home staff."]
["Application Summary","This application from University College London set out the purpose of medical research which aims to investigate the feasibility, effectiveness and cost-effectiveness of regularly testing care home staff for COVID-19 to protect residents from severe infection and prevent outbreaks.  This is an important question for policymakers, residents, care home staff and providers because testing impacts heavily on each of these groups in different ways. There is a unique, finite opportunity to determine whether regular COVID-19 testing in staff is worthwhile.  Engagement work with providers and care home staff has shown that the issue of testing in staff is of major importance to them. This application is funded by NIHR HSDR and UKHSA.\n\nAt the start of the pandemic, policymakers’ priority was to reduce deaths, severe illness and hospital admissions. The strong link between rates of infection in the community and risk of outbreaks and severe outcomes in care home residents justified the use of staff testing to prevent infection from the community. However, most residents are now fully vaccinated (90% have received 4th dose booster vaccination), (UKHSA, Personal Communication) and many have been infected, which substantially reduces their risk of COVID-19 related severe outcomes. Providers’ main concern is that regular testing increases the risk of unnecessary care home closures due to minor outbreaks, impacting on business continuity (loss of income from new admissions) and residents’ wellbeing (e.g. restrictions on visits). But based on current evidence, it is unclear whether regular testing will increase or reduce the frequency of outbreaks. Two years into the pandemic, there remains a complete lack of evidence on whether the benefits of regular testing for COVID-19 outweigh its harms and under which scenarios. \n\n280 participating care homes are randomised to 2 arms. The intervention arm will receive multi-component testing intervention (regular asymptomatic testing of staff for Covid-19 using LFDs combined with support payments for staff who test positive,  and the control arm will follow national testing policy in place at the time. The applicant requires ‘s251’ support for 2 elements of the application. Identifiable information regarding care home residents who are admitted to hospital during the testing period will be disclosed from the care homes to NHE England, who will link these data to the NHSE Foundry (Covid-19 datastore), which includes data  on  COVID-19  test  results,  vaccination  status,  hospital admissions and deaths. Additionally, identifiable information (name, DOB, NHS number, sex, postcode and CQC identifier) will be disclosed alongside any covid-19 test taken by staff members or patients at participating  care homes during the trial period, from care homes to NHS England covid-19 testing portal, which does not require ‘s251’ support, as this is undertaken as part of usual clinical care. Regarding patients, ‘s251’ support is required for NHSE to link these data to the NHSE Foundry (Covid-19 datastore), which includes data  on  COVID-19  test  results,  vaccination  status,  hospital admissions and deaths. Regarding staff, ‘s251’ support is required for NHSE to link to the NHSE Foundry (Covid-19 datastore) but only to provide the applicant pseudonymised data on the result of the covid test taken by the staff member. No outcome data is required for staff. These data will then be pseudonymised before being provided to the research team at UCL for analysis. \n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Laura Shallcross"]
["Address","UCLInstitute of Health Informatics, "]
[null,"222 Euston Road"]
[null,"London,"]
["Postcode","NW12DA"]
["Telephone","0203 549 5540"]
["Email","l.shallcross@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All  staff  and  residents  in  participating  care  homes  during  the study  testing  period  01  December  2022 –31  March  2023.   However,   it   is   possible   that   the   testing   period   may   be extended.\n\nApplicants  estimate  this  will  include  approximately  15,400 staff (55 per home) and 9,800 residents (35 per home)"]
["Description of confidential patient information used","Data sources\n\n1.280  participating  care  homes  records  (from  the  following providers):\n\n•Four Seasons Healthcare(FSHC) \n\n•HC-One •Orders of St John Care Trust (OSJCT)\n\n2.NHS  England –COVID-19  datastore (containing  COVID-19  test  results,  vaccination  status,  hospital  admissions and  deaths  from  residents  and  staff  who  are  in  care homes  that  are  participating  in  the  trial.  These  routine datasets  are  already  held  by  NHSE  in  the  COVID-19 Datastore)\n\nIdentifiers required for linkage purposes\n\nResidents  who  are  admitted  to  hospital  during  the  testing period:\n\n1.NHS number\n\n2.Name\n\n3.Date of birth\n\n4.Sex (derived from CQC-ID)\n\n5.Postcode (derived from CQC-ID)\n\nPlus all patients and staff who are tested forCOVID-19during the trial period;\n\n1.NHS number\n\n2.Name\n\n3.Date of birth\n\n4.Sex (derived from CQC-ID)\n\n5.Postcode (derived from CQC-ID)\n\nIdentifiers required for analysis purposes\n\n1.N/A –data   will   be   pseudonymised (effectively anonymised) for analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-12-19"]
["Next Review Date"]
["Notes","Applicant confirmed that ‘s251’ support could be expired from 19th December 2023 as only anonymised patient information was extracted/received. Access to source data containing identifiable patient information without consent is now complete.\n\nIn terms of public benefit, the results of the trial have been reported back to UKHSA, providing up-to-date evidence for effective public health policy. Results have also been shared with key partners within the adult social care sector.\n\nThe research team are in the process of writing up the results as a scientific paper, which will be published open access within a peer reviewed journal. This will enable the research team to share the work widely and influence staff testing policy within the UK and beyond.\n\nAmendment supported 25 May 2023 to include additional listed care home providers as additional data processors for the application\n\nAmendment supported 18 April 2023 to allow the Chief Investigator (who is not part of the direct care team) to have access to the key between the persistent NHS England assigned pseudo-ID and the new pseudo-IDs created specifically for the trial until final export of the effectively anonymous dataset for analysis to UCL.\n\nAmendment supported 07 March 2023 to include four more care home providers as additional data processors for the application; Risedale Estates Limited, Greensleeves Care, Black Swan Care Group and Bupa\n\nThe application, to allow; \n\n1.\tthe disclosure of confidential patient information (regarding residents admitted to hospital) from care homes to NHS England, for the purposes of linkage to the NHSE Foundry (COVID-19 datastore) (which will then be pseudonymised and disclosed to UCL),\n\n2.\tand for NHS England to use confidential patient information from the COVID-19 testing portal to link to the NHSE Foundry (COVID-19 datastore) - including outcome data for patients, and COVID-19 testing results for staff, (which will then be pseudonymised and disclosed to UCL),\n\nis conditionally supported, subject to compliance with the standard and specific conditions of support.\n\n\nConditions of support:\n\n1.\tPlease provide feedback from the ongoing planned patient and public involvement, to ensure there is support from care home residents for this use of confidential patient information without consent. Please provide this to CAG as soon as it is available, but at the latest, six months from the date ‘s251’ support is provided. If strong objections are noticed in ongoing patient and public involvement, please inform CAG of these immediately. \n\nCondition met 20 June 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: FIFO with conditions 08 December 2022, and additional conditions confirmed met on 14 December 2022.\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews NHS England was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 18 November 2022)\n\nDue to the number of organisations involved it is the responsibility of University College London, as controller, to ensure that participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n"]

{"sheet":"A02736","index":777,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02736"]
["Reference","22/CAG/0160"]
["Other Refs","IRAS Project ID: 225289  REC Reference: 19/LO/0565"]
["Application Title","National Prospective Cohort Study and Surveillance of Sympathetic Ophthalmia in the United Kingdom"]
["Application Summary","This application from Moorfields Eye Hospital NHS Foundation Trust set out the purpose of medical research which aims to describe the incidence of patients newly presenting with sympathetic ophthalmia (SO) in the UK, over a one year surveillance programme operating via the British Opthalmological Surveillance Unit (BOSU) methodology, using the monthly reporting card amongst UK ophthalmologists. \n\nSO is a condition where the eye becomes inflamed and can result in loss of vision. It is a very rare but potentially blinding complication of surgery and ocular trauma, with no uniform consensus regarding its optimal management. In a previous BOSU study completed in 1998, 17 cases were reported for a 59 million UK population. The SO incidence following primary and revisional vitrectomy surgery needs to re-evaluated, as the decision to proceed with complex and repeated vitreoretinal procedures can be decided by the risk of SO, and perhaps a contemporary SO risk may not be directly associated with vitrectomy interventions. Therefore it is in the public interest to re-evaluate SO incidence so that clinicians and patients can better evaluate the risks and benefits of certain procedures. \n\nThe BOSU methodology is established and has received support in principle from the CAG. Ophthalmologists will anonymously indicate that they have seen a new patient who has sympathetic ophthalmia through the BOSU reporting system via University of Dundee. The University of Dundee system will generate the initial questionnaire for the reporting ophthalmologist to fill in via the University of Dundee data safe haven online platform. This will contain confidential patient information. Follow-up will be conducted at six-months following initial reporting, and the University of Dundee system will generate this questionnaire for the reporting ophthalmologist in the same manner as the initial questionnaire.\n\nEach case will be given a unique study number by the BOSU study centre. Hospital number, month and year of birth, gender, and postcode will be recorded alongside clinical data on the questionnaires. All identifies will be deleted once the follow-up is completed, postcode is converted to deprivation score, and duplicates identified. \n"]
["Applicant Organisation Name","Moorfields Eye Hospital NHS Foundation Trust"]
["Contact Name","Mr Mahiul MK Muqit "]
["Address","City Road"]
[null,"London"]
[]
["Postcode","EC1V2PD"]
["Telephone",2075662251]
["Email","mahi.muqit1@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 20 patients who have experienced sympathetic ophthalmia\n\nAll patients with new onset bilateral, non-necrotising, diffuse granulomatous panuveitis affecting the fellow, sympathising eye following ocular surgery, trauma or laser therapy to the inciting eye (This patient would have a diagnosis associated with a newly-diagnosed sympathetic ophthalmia) who report to a treating ophthalmologist across the 12 months reporting period, expected to be between 01 February 2023 and 01 February 2024.  \n"]
["Description of confidential patient information used","Data sources\n\n1.\tClinical records at the Trusts of BOSU reporting ophthalmologists\n\nIdentifiers required for linkage purposes\n\n1.\tHospital number (identify duplicates and identify same patient for follow up)\n\n2.\tunique study number\n\nIdentifiers required for analysis purposes\n\n1.\tMonth and Year of birth\n\n2.\tGender\n\n3.\tPostcode – converted to social deprivation score\n\nAdditional information\n\n1 year of baseline collection 01 February 2023 and 01 February 2024, and then additional 6 month follow up until 01 August 2024."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-12-19"]
["Next Review Date","2024-12-19"]
["Notes","The application, to allow the disclosure of confidential patient information from treating ophthalmologists to the research team at University of Dundee via the BOSU methodology, to enable de-duplication and linking baseline and follow-up questionnaires, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed (with conditions) 25 April 2019. Evidence of conditions met 15 August 2019.\n\n2.\tSecurity assurance requirements Confirmed: \n\nHealth Information Centre - University of Dundee – Data safe haven – security is assured via NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (PBPP) Approval 9th April 2020, and amendment regarding new BOSU methodology 01 November 2022.\n\nDue to the number of participating reporting ophthalmologists involved it is the responsibility of Moorfields Eye Hospital NHS Foundation Trust, as controller, to ensure that these participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02737","index":778,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02737"]
["Reference","19/CAG/0044"]
["Other Refs","IRAS ID: 248957  REC Reference: 19/EM/0082"]
["Application Title","Evaluating the two-week wait referral system for bowel cancer"]
["Application Summary","This application from London School of Hygiene and Tropical Medicine set out the purpose of medical research which sims to understand whether the two week wait (TWW) urgent GP referral system had provided any benefits for patients with suspected colorectal cancer. The two week wait system was introduced as part of the 2000 NHS Cancer Plan and aimed to expedite pathways for diagnosis and treatment of cancer in England. \n\nThe applicant intends to examine whether the two week wait is associated with improvements in diagnostic investigation, stage distribution, treatment and short-term mortality. Innovative analytical techniques will be used to consider what would have happened to patients diagnosed through the two week wait system in terms of cancer outcomes, had they been diagnosed through a non-urgent referral. All patients referred by their GP to the colorectal surgical outpatient clinics in Portsmouth Hospitals NHS Trust since 1986 will be identified and linked with wider clinical information held by the National Cancer Registration and Analysis Service (NCRAS) at Public Health England, Hospital Episodes Statistics held by NHS Digital and the National Bowel Cancer Audit, which is commissioned by the Health Quality Improvements Partnership (HQIP) and carried out by NHS Digital, in order to carry out the analysis."]
["Applicant Organisation Name","London School of Hygiene and Tropical Medicine"]
["Contact Name","Professor Michel Coleman"]
["Address","Keppel Street"]
[null,"London"]
[]
["Postcode","WC1E 7HT"]
["Telephone","+44 20 7927 2551"]
["Email","michel.coleman@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[]
["Cohort/Population","All patients referred to Portsmouth Hospitals NHS Trust for suspected bowel cancer between 1986 and 2017."]
["Description of confidential patient information used","The following items of confidential patient information are requested for the purposes specified below:\n\n·        NHS Number – sample validation and linkage,\n\n·        Date of birth – sample validation, linkage and analysis,\n\n·        Date of death – sample validation, linkage and analysis,\n\n·        Postcode (District Level) – sample validation, linkage and analysis,\n\n·        Sex – analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor","London School of Hygiene and Tropical Medicine"]
["Status","Expired"]
[]
["Outcome Date","2021-06-17"]
["Next Review Date"]
["Notes","Applicant confirmed in February 2024 that ‘s251’ support could be expired. \n\nAnnual review supported 15 December 2022 and additional condition of support applied;\n\n1.\tProvide an update on continued patient and public involvement that is undertaken, specifically around the use of confidential patient information without consent, at the next annual review, 17 June 2023.\n\nApplication support on 17 June 2021\n\nSpecific conditions of support\n\n1.     Provide an update on continued patient and public involvement that is undertaken at the first annual review.\n\nCondition met 15 December 2022\n\n2.     Favourable opinion from a Research Ethics Committee (Confirmed 02 April 2019).\n\n\n3.     Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Data Security and Protection Toolkit (DSPT) submission (Portsmouth Hospitals NHS Trust (by check of the NHS Digital DSPT tracker on 16 June 2021) and the Cancer Survival Group – London School of Hygiene and Tropical Medicine (by check of the NHS Digital DSPT tracker on 16 June 2021) have confirmed ‘Standards Met’ grade on DSPT submission 2019/20."]

{"sheet":"A02738","index":779,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02738"]
["Reference","22/CAG/0166"]
["Other Refs","IRAS Project ID: 317761  REC Reference: 22/EE/0278"]
["Application Title","How Do Healthcare Professionals Recognise and Respond to Deconditioning? A mixed-methods synthesis and consensus"]
["Application Summary","This application from the University of Nottingham set out the purpose of medical researchthat  seeks  to develop  a  conceptual  framework  of  how  healthcare  professionals  currently recogniseand  treathospital  acquired  deconditioning, with  the  aimof  developing  better treatments.\n\nHospital-Acquired  Deconditioning  is defined  as  a  new  loss  of independencein  activities, such as bathing, toileting, walking or eat. It is estimated to affect nearly one in three adults aged over 65 years. It isunclear how often in happens in adults aged over 18 years. The condition is associated with longerstays in hospital, increased rehabilitation or care needs on  leaving  hospital,  and increased  risk  of  mortality.  Many  programs  are  used  to prevent and to treat the condition, but little evidence supporting their use exists. \n\nSeveral work packages will be involved. Support under s251 is sought for Work Package 3, which will involveobservations in two ward settings at Nottingham University Hospitals NHS Trust.The researcher will observe, andwill not aid with patient care.Up to 56 hours of  non-participant observation  will  be  undertaken  in  two-hour  blocks  with  variable  start times. One  block  will  occur  in the  spring/summer  and  one  in  the  autumn/winter  to  reflect seasonal  variation.  Each  two-hour  block  will  begin  at  different  times  during  the  day  to reflect the 24-hour influence with the earliest block beginning before the end of the nursing night shift and the latest beginning at the start of the nursing night shift."]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Adam L Gordon, Professor of the Care of Older People "]
["Address","Room 4113 Medical School"]
[null,"Royal Derby Hospital"]
[null,"Uttoxeter Road"]
["Postcode","DE22 3DT"]
["Telephone",1132724697]
["Email","adam.gordon@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Healthcare professionals who have experience of working with peoplewho are or who have been affected by hospital-acquired deconditioningare the cohort involved in Work Package 3."]
["Description of confidential patient information used","Data sources\n\n1.Nottingham University Hospitals NHS Trust\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient informationwill be collected for linkage purposes. \n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be collected for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2022-12-30"]
["Next Review Date"]
["Notes","\nApplicant confirmed in February 2024 that ‘s251’ support could be expired as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, the period of non-participant observation has demonstrated a relationship between hospital architecture and the influence this exerts on staff practices. One key finding is how and where storage is positioned for equipment to support patient independence, which should be considered from the outset of new hospital designs. Doing so will reduce the barriers to staff accessing the right equipment to support a patient without running into further time or space constraints. Secondly, patient facilities were placed across the central corridor from the bays. Due to the central corridor layout of this clinical environment, this corridor was incredibly busy which created an unwritten expectation that the corridor was only usable by staff. Future hospital designers and policymakers should consider this and consider the use of dual corridor structures and the position of patient-specific facilities. \n\n\nConditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 22 November 2022. \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the Page 4 of 8 ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: The NHS Digital 2020/21 DSPT review for Nottingham University Hospitals NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 November 2022).\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02739","index":780,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02739"]
["Reference","22/CAG/0156"]
["Other Refs","IRAS Project ID: 279603  REC Reference: 22/LO/0536"]
["Application Title","General Health Outcomes in Subfertile Men: a UK register-based cohort study"]
["Application Summary","This application from UCL Institute of Child Health set out the purpose of medical research that seeks to establish whether men with known subfertility are at a greater risk of developing chronic malignant and non-malignant health outcomes compared to men from the general population.\n\nInfertility, defined as the inability of a sexually active couple to achieve pregnancy within one year, has substantial effects on human health at both population and individual levels. Assisted Reproductive Technology (ART) has increased the chances that infertile men will become fathers. However, the implications of the underlying infertility on the affected individuals remains uncertain. Research in the USA and Scandinavian countries has suggested that men’s reproductive health may reflect their physical health, and male infertility may be a risk factor for the subsequent development of both malignant and non-malignant disease, as well as early death. Fertility evaluation could be an opportunity to improve men’s overall health and identify risk factors for the development of diseases later in life. Little is known about how generalisable these findings are to other populations. The applicants seek to explore whether national administrative health data can be used to investigate the long-term health of men with fertility problems.\n\nStaff at the Human Fertilisation and Embryology Authority (HFEA) will identify the male partners of women who have undergone ART from patient records that they hold. Confidential patient information will be disclosed to NHS Digital for linkage to Health Episode Statistics (HES) and ONS Mortality data, and the National Cancer Registration Dataset. The linked dataset will be pseudonymised by use of a unique study member number.\n\nNHS Digital will also identify a control group, of male individuals of similar age, from the Personal Demographics Services Dataset. Two controls will be identified for everyone patient in HFEA dataset. NHS Digital will conduct linkage to HES and ONS mortality data and the NCRAS dataset. A pseudonymised dataset will be disclosed to UCL Institute of Child Health. The pseudonymisation key will be held at NHS Digital, therefore the dataset held by UCL Institute of Child Health can be considered to be effectively anonymised. NHS Digital will retain a file containing confidential patient information for both cohorts."]
["Applicant Organisation Name","UCL Institute of Child Health"]
["Contact Name","Professor Alastair G Sutcliffe, Professor of General Paediatrics"]
["Address","30 Guilford Street,"]
[null,"London"]
[]
["Postcode","WC1N 1EH"]
["Telephone",2079052367]
["Email","a.sutcliffe@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male partners of women who underwent non-donor assisted reproductive procedures for male subfertility in England and Wales between 01 August 1991- 31 September 2009. Total sample size: 500,000"]
["Description of confidential patient information used","Data sources\n\n1. NHS Digital held datasets:\na. Linked Health Episode Statistics (HES) \nb. ONS Mortality data \nc. National Cancer Registration Dataset \nd. Personal Demographics Service \ne. Civil Registration records \n2. Human Fertilisation and Embryology Authority held datasets\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS number \n3. Date of birth \n4. Postcode – district level\n\nIdentifiers required for analysis purpose\n\n1. Date of birth \n2. Postcode – district level \n3. Gender \n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-05"]
["Next Review Date","2024-01-05"]
["Notes","16 June 2023 - change in data processor from NHS Digital to NHS England, regarding data sources – Hospital Episode Statistics (HES), Office for National Statistics (ONS) Mortality data, the National Cancer Registration and Analysis Service (NCRAS) Dataset, the Personal Demographics Service and Civil Registration records\n\nAmendment supported 16 June 2023 to amend the study design to include sub-fertile males only, and remove ‘s251’ support for the creation of a control group (by NHS England)\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Favourable Opinion Confirmed 09 August 2022. \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n \nNHS Digital 2021/22 DSPT review for NHS Digital was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (31/10/2022) \n \nThe applicant and a representative from the HFEA confirmed that support under s251 was not required for the HFEA to disclosed confidential patient information to NHS Digital for linkage. \n"]

{"sheet":"A02740","index":781,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02740"]
["Reference","22/CAG/0168"]
["Other Refs","IRAS Project ID: 317515  REC Reference: 22/NI/0165"]
["Application Title","Opioid use after surgery in opioid-naive patients: a qualitative study"]
["Application Summary","This application from University College London set out the purpose of medical research that seeks to explore the themes and experiences of previously opioid-naïve patients who were discharged with opioids for pain control after surgery, the barriers to opioid taper and cessation, and drivers for continued use. \n\nLong-term opioid use for pain carries various risks and can affect patients’ quality of life. The likelihood and intensity of these risks tends to increase as dosage and duration of therapy increases. Many patients who use opioids develop a tolerance to their analgesic effects and some become dependent on them. Population surveys have found that long-term opioid use is associated with increased side effects, worse health outcomes and no improvement in pain relief. Prescription of opioids increased by 34% and the total oral morphine equivalent dose increased by 127% between 1998 and 2016. In 2017 – 2018, 12.8% of England’s population had an opioid prescription dispensed, with approximately 50% taking opioids for at least one year. There is no consensus about the most acceptable and effective way of tapering opioid use. The applicants seek to follow-up previously opioid-naïve patients’ surgical patients three months after surgery and discharge with a prescription for opioids. \n\nA list of patients aged 18 years and over who underwent any elective surgical procedure within University College London Hospitals NHS Foundation Trust (UCLH) will be created from the electronic patient record system via an automated process. A list of eligible patients and their contact details will be disclosed to the researchers. Patients will be contacted by email with information about the study and an invitation to participate. The email will be followed by telephone call after 2-7 days. Those who accept the invitation will have their eligibility status assessed and consent taken. Their participation will then proceed on a consented basis. "]
["Applicant Organisation Name","University College London "]
["Contact Name","Dr Fausto Morell-Ducos, Chief Investigator "]
["Address","Charles Bell House"]
[null,"43-45 Foley Street "]
[null,"London "]
["Postcode","W1W 7TS "]
["Telephone",2034484776]
["Email","fausto.morell-ducos@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who underwent an elective surgical procedure at UCLH in the three-month period before the report is run, were not taking opioids prior to surgery and were prescribed opioids at discharge.  \n\n60 patients will be included. \n\n\n"]
["Description of confidential patient information used","Data sources \n\n1. Electronic patient records at University College London Hospitals NHS Foundation Trust \n\nIdentifiers required for linkage purposes \n\n1. Name  \n\n2. Date of birth  \n\n3. Email address  \n\n4. Telephone number \n\nIdentifiers required for analysis purposes \n\n1. Gender  \n\n2. Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2023-01-16"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed December 2023 that ‘s251’ support could be expired as all previously unconsented identifiable patient information under this support is now processed with consent.\n\nIn terms of public benefit, the findings of this study will allow the team to make recommendations regarding the advice and follow-up given to patients discharged with opioids following surgery, and to inform the development of services to support patients reduce their opioids after surgery if they find this difficult.\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 December 2022. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \nThe NHS Digital 21/22 DSPT reviews for University College London & University College London Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 November 2022) \n"]

{"sheet":"A02741","index":782,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02741"]
["Reference","22/CAG/0147"]
["Other Refs","IRAS Project ID: 32073   REC Reference: 03/8/056"]
["Application Title","A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease (FDG-PET Study): RAPID"]
["Application Summary","This application from The Christie NHS Foundation Trust set out the purpose of medical research which aims to compare the late consequences, especially vital status, second cancers, and cardiovascular disease, of the different treatments used in the RAPID trial with a view to informing future patients and guiding national/international treatment policy.\n\nThe RAPID trial is a consented Randomised Controlled Trial (RCT) which compared standard treatment for limited stage Hodgkin lymphoma (chemotherapy + radiotherapy) with a new approach (chemotherapy alone) guided by PET scanning. Trial results published in 2015 showed a good outcome for chemotherapy alone, however long term follow up, annually until 25 years after the first patient was registered to the trial (until 2028) is required, as it may take years for any long term outcomes to be detected. Follow up was consented and planned to be undertaken via participating hospitals. However the applicant has found that as patients are now mostly discharged from conventional care, they have been lost to conventional follow-up, and are requesting ‘s251’ support for a new method of collecting follow up data which will be via NHS Digital’s DigiTrials service.\n\nUnderstanding the late consequences of chemotherapy and radiotherapy is of great importance when considering treatment options for patients and clinicians, and for policy makers. ‘s251’ support is requested to enable UCL cancer trials centre to disclose RAPID ID, NHS number and date of birth to The Christie NHS Foundation Trust. The Christie NHS Foundation Trust with then disclose this list onwards to NHS Digital (via the NHS DigiTrials service) for linkage with HES, NCRAS, and to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate) for linkage with the NICOR database. ‘s251’ support is also required for the flow of data back to the applicant, at The Christie NHS Foundation Trust, as the dataset contains full date of death, and additionally the applicant retains identifiers and can re-identify the patients. The dataset will then be disclosed to UCL cancer centre for analysis, and returned to the Christie post analysis."]
["Applicant Organisation Name","The University of Manchester"]
["Contact Name","Professor John Radford"]
["Address","Oxford Road"]
[null,"Manchester"]
[]
["Postcode","M13 9PT"]
["Telephone",1619187221]
["Email","John.Radford@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who participated in the RAPID FDG-PET study 88.9% of the rapid cohort are English and Welsh patients, and therefore relevant to this CAG application - This is 535 patients."]
["Description of confidential patient information used","Data sources\n\n1. RAPID trial database retained at the UCL Cancer trials centre \n2. NHS Digital – a. HES b. NCRAS \n3. NICOR database - (NHSE/I controllers, but processors are NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate)\n\nIdentifiers required for linkage purposes\n\n1. NHS number \n2. Date of birth \n3. RAPID participant ID\n\nIdentifiers required for analysis purposes\n\n1. Date of death\n\nAdditional information\n\nData linkage extracts will be provided by NHS Digital and NICOR twice. Once in 2022/2023 and again in 2028."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-11"]
["Next Review Date","2025-01-11"]
["Notes","Amendment support 17 November 2023 to allow the Christie to disclose confidential patient information (inclusive of date of death) for analysis to the statistician at UCL-CTU\n\n1.\tThe application, to allow; \n•\tthe disclosure of confidential patient information from UCL cancer trials centre to The Christie NHS Foundation Trust, \n•\tand then onwards to NHS England (previously NHS Digital) (via the NHS DigiTrials service), in order for NHS England (previously NHS Digital) to link to HES and NCRAS data, \n•\tand to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) in order for NICOR to link to NICOR data, \n•\tfor the disclosure of the 2 linked datasets back to The Christie NHS Foundation Trust (as contains date of death, and applicant additionally able to reidentify), \n•\tfor The Christie to link the datasets and provide access to the statistician at UCL, who will then analyse the data at The Christie,\nis fully supported, subject to compliance with the standard and specific conditions of support.\n\n\nConditions of support:\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed via Substantial Amendment 9 on 29 April 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for The Christie NHS Foundation Trust, University College London – School of Life and Medical Sciences, NHS Digital, & on behalf of NICOR; NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) and Redcentric (Harrogate) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 03 November 2022)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02742"]
["Reference","22/CAG/0154"]
["Other Refs","IRAS Project ID: 288506  REC Reference: 20/SC/0423"]
["Application Title","Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care: UK-ROX"]
["Application Summary","This application from The Intensive Care National Audit & Research Centre (ICNARC) set out the purpose of medical research which aims to evaluate the clinical effectiveness of conservative versus usual oxygen therapy on 90-day all-cause mortality. The UK-ROX trial is a multi-centre randomised clinical trial (RCT), and has already begun without the need for a CAG application. However the applicants have submitted an amendment to the REC to introduce the need for ‘s251’ support.\n\n184,000 patients annually are admitted to NHS intensive care units (ICUs) and over 30% require a ventilator. Giving oxygen through the ventilator is essential. However, it is not known how much oxygen should be given to optimise recovery. Both too much, and too little oxygen may cause harm. This study will look at the effect of a small reduction in oxygen. Results will have a large and immediate impact on ICU clinical practice and on\n\npatient outcomes throughout the NHS. Data from the 16,500 patients in this study will also contribute to a larger global study of 40,000 patients. The global study will answer similar questions about oxygen therapy in ICU patients but from an international perspective.\n\nThe purpose of linkage to the Case Mix Programme national clinical audit of patients screened but not enrolled into UK-ROX, is to review whether certain subgroups of patients are being excluded, and to ensure equality, diversity and inclusiveness of the trial population.\n\nThe purpose of linking outcome data for participants from whom patient consent, or consultee opinion, was unable to be obtained, is because excluding data from these cohorts of patients may introduce substantial bias and impact upon the safety monitoring/reporting and, ultimately, the scientific validity of the trial and may prevent evidence of significant clinical benefit from being detected.\n\nAll patients will be unconscious at the time of treatment, as by definition they become eligible once mechanical ventilation has started, and therefore patients will be recruited under a research without prior consent (RWPC) model, in accordance with the Mental Capacity Act 2005. The applicants are seeking ‘s251’ support to process confidential patient information for all patients from the end of the emergency event until patient death or until either patient consent or a consultee opinion is obtained. For non-survivors, support is needed for the collection of confidential patient information from the treating hospital, and linkage to ICNARC CMP, and NHS England (previously NHS Digital) and DHCW datasets. For surviving patients, confidential patient information will be collected until either the patient or a consultee explicitly refuses agreement to the processing of their confidential patient information. If the patient survives but the researchers are unable to contact the patient or a consultee to seek consent, support will also be needed to continue to collect confidential patient information and link to other data sources. This is in line with other applications of this type. In addition, the applicants require ‘s251’ support to link data for those patients who were screened but not enrolled into the UK-ROX trial to the CMP. This is undertaken with the ICNARC Case Mix Pro-gramme admission number, which is pseudonymous, disclosed to ICNARC from participating Trusts, however as applicants retain confidential patient information linked to the ICNARC CMP ID, and therefore have the ability to re-identify, ‘s251’ support is also required for this disclosure and linkage."]
["Applicant Organisation Name","University of Plymouth"]
["Contact Name","Professor Daniel Martin"]
["Address","John Bull Building"]
[null,"Derriford"]
[null,"Plymouth"]
["Postcode","PL6 8BU"]
["Telephone",2072699277]
["Email","daniel.martin@plymouth.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The study will include 16,500 patients from 100 UK NHS ICUs But ‘s251’ support is only relevant to: patients receiving mechanical ventilation in participating critical care units who were screened but not enrolled to UK-ROX, ~53,000 patients And participants included in UK-ROX from whom patient consent, or consultee opinion, was unable to be obtained\n\n(e.g. because the patient died or was discharged prior to regaining capacity) ~300 patients."]
["Description of confidential patient information used","Data sources\n\n1. Participating ICU’s (across England and Wales)– UK-ROX collected study data and secure electronic case report form \n2. Intensive Care National Audit & Research Centre (ICNARC) - Case Mix Programme dataset \n3. NHS England (previously NHS Digital): a) Civil Registrations (deaths) dataset b) Hospital Episodes Statistics (HES) \n4. Digital Health and Care Wales (DHCW) a) Patient Episodes Data for Wales (PEDW)\n\nIdentifiers required for linkage purposes\n\nRegarding patients who were screened but not included in UK-ROX; \n1. ICNARC Case Mix Programme admission number \nRegarding those included in UK-ROX but were discharged or died prior to consent or consultee opinion being obtained: \n1. UK-ROX Trial ID \n2. ICNARC Case Mix Programme admission number \n3. NHS Number \n4. date of birth \n5. sex \n6. postcode\n\nIdentifiers required for analysis purposes\n\n1. Date of death \n2. Gender \n3. Ethnicity\n\nAdditional information\n\nLinked extracts will be received quarterly."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-12"]
["Next Review Date","2025-01-12"]
["Notes","Amendment supported 19 January 2024 to extend the duration of ‘s251’ support until 28 February 2025\n\n1.\tThe application, to allow;\n•\tThe disclosure of confidential patient information (regarding UK-ROX participants for whom explicit patient consent, or consultee opinion was unable to be obtained (because the patient died, or was discharged prior to regaining capacity) from participating Trusts to ICNARC for the purposes of linkage with ICNARC CMP, and for the onwards disclosure of confidential patient information to NHS England (previously NHS Digital) and Digital Health and Care Wales (DHCW) for linkage with HES, ONS Mortality datasets, and PEDW, and for the flow of data back (as this contains Date of death),\n\n•\tAnd to allow the disclosure of confidential patient information (ICNARC Case Mix Programme admission number only) regarding patients who were screened but not included in UK-ROX) from participating Trusts to ICNARC for the purposes of linkage with ICNARC CMP only,\n\nis fully supported, subject to compliance with the standard and specific conditions of support\n\nConditions of support:\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 25 November 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for The Intensive Care National Audit & Research Centre (ICNARC) and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 23 November 2022)\n\nDigital Health and Care Wales (DHCW) has a valid CpiP in place as confirmed by the Welsh Information Governance team.\n\nDue to the number of participating ICU’s involved it is the responsibility of ICNARC, as controller, to ensure that these participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02743","index":784,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02743"]
["Reference","22/CAG/0145 "]
["Other Refs","IRAS Project ID: 297429  REC Reference: 22/SC/0371 "]
["Application Title","Safety and Efficacy of Managing Acute Heart Failure without Hospital Admission (SAFE v6.0) "]
["Application Summary","This application from Blackpool Teaching Hospitals NHS Foundation Trust (BTH) set out the purpose of medical research which aims to better understand short term outcomes, 60 days post treatment with intravenous furosemide in patients with heart failure (HF), in order to support feasibility of recruitment into a future multicentre randomised controlled trial (RCT) into the effectiveness and safety of out-patient based services for the management of Acute Heart Failure (AHF).  \n\n100,000 patients are admitted to hospital for AHF each year in the UK. HF is a progressive syndrome associated with substantial morbidity and mortality, and is the most common cause of hospitalisation for individuals aged 65 years and older in UK. AHF is usually managed in hospital, and is associated with 7-11% mortality rate. The NHS Long Term Plan recommended better, personalised planning for patients with the hope to reduce nights spent in hospital and reduce drug spend. Accelerated by the COVID pandemic, some hospitals are now developing out-patient based services for the management of AHF. Out-patient management (OPM) of AHF has gained popularity in the UK, however, the effectiveness and safety of this strategy is uncertain. There are no substantial randomised trials in order to inform clinicians, patients or clinical practice guidelines. A substantial multi-centre RCT to determine safety and cost-effectiveness is therefore needed to obtain robust evidence to justify more widespread investment in out-patient based treatment of AHF, and this application is testing the feasibility of a future RCT.  \n\nEligible patients are retrospectively identified at participating sites by the direct care team from existing clinical databases. Data will be collected via excel spreadsheet. Names, postcodes, hospital/NHS numbers will be removed, but pertinent dates (of admission, discharge and death) remain. These dates mean that the data is not fully anonymised at this point, and therefore ‘s251’ support is required for this transfer of confidential patient information to the applicant. Once at BTH, the Trust statistician will fully anonymise the data after using the dates to calculate the required period of risk – “days alive and out of hospital within 60 days” measure – before analysis. Full dates will then be deleted.  "]
["Applicant Organisation Name","Blackpool Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Dr Kenneth Wong  "]
["Address","Clinical Research Centre"]
[null,"Whinney Heys Road "]
[]
["Postcode","FY3 8NR"]
["Telephone",1253300000]
["Email","dr.wong@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","all consecutive patients who have had acute/decompensated/worsening heart failure with a requirement for IV diuretics at participating sites  (including inpatient stays and outpatient clinic visits) \n\nfor the period 01 August 2019 to 31 January 2021.  \n\n~3000 (however possibly more, and exact number not yet known) "]
["Description of confidential patient information used","Data sources \n\n1. Participating Trusts existing clinical databases; \n\na. Buckinghamshire Healthcare NHS Trust \n\nb. Liverpool University Hospitals NHS Trust \n\nc. Manchester University hospitals NHS Foundation Trust \n\nd. North Tees & Hartlepool NHS Foundation Trust \n\ne. Croydon Health Services NHS Trust \n\nf. Lancashire Teaching Hospitals NHS Trust \n\ng. Oxfordshire University Hospitals NHS Foundation trust \n\nh. Dudley Group NHS Foundation Trust \n\nIdentifiers required to be disclosed from participating Trusts \n\n1. Date of admission \n\n2. Date of discharge \n\n3. Date of death \n\nIdentifiers required for analysis purposes \n\n1. N/A - Analysis will be undertaken on an anonymised dataset \n\nAdditional information \n\nA second readmission from the same patient is classed as a new episode if the admission is more than 60 days from the previous episode, else it is classed as a readmission within 60 days. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-16"]
["Next Review Date","2024-01-16"]
["Notes","1.\tThe application, to allow the disclosure of confidential patient information from participating Trusts to Blackpool Teaching  Hospitals  NHS  Foundation  Trust, for the purposes of creating an anonymous dataset for analysis, is fully supported, subject to compliance with the standard and specific conditions of support.\n\nConditions of support:\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 16 January 2023. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT review for Blackpool Teaching Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 03 November 2022)\n"]

{"sheet":"A02744","index":785,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02744"]
["Reference","22/CAG/0105"]
["Other Refs","IRAS Project ID:  302576  REC Reference: 22/WM/0162"]
["Application Title","Improving patient outcome in the 'hotzone' during a major incident: a mixed methods medical research approach"]
["Application Summary","This application from Barts Health NHS Trust set out the purpose of medical research that seeks to investigate the causes and timeline associated with pre-hospital death following terrorism  incidents,  and  the  pre-hospital  interventions  associated  with  decreasing  pre-hospital mortality.\n\nDuring the initial phase of terrorist incidents, a “hot zone” is created, where there may be on-going  terrorist  activities  and  active  threats  to  life.  Currently  policy  is  that  emergency medical  services  are  unlikely  to  enter  the  hot  zone  until  it  has  been  made  safe  enough, which  may  take  several  hours.  Most  deaths  caused  by  these  events  occur  at  the  scene before  emergency  services  can  enter  the  hot  zone  and  autopsy  evidence  from  mass shootings  in  the  US  suggests  that  some  patients  die  from  injuries  that  could  have  been survivable had treatment been given at the scene. If these findings are consistent across other types of events and healthcare systems, providing trauma care in the hot zone could dramatically reduce deaths in terrorist events. However, to send emergency personnel into an area where there is an active terrorist threat to their own life is a major decision. Limited data is currently available as most of the information is military in origin, which is difficult to translate to civilian data due to the differences in body armour worn by military personnel and  the  resultant  injury  pattern  and  injury  prevention,  or  from  US  active  shooter  mass casualty  incidents.  A  key  area  highlighted  by  many  of  the  authors  reflected  on  how  the presence of a persistent and active threat, such as a shooter, prevented access of trained medical personnel into the hot zone. A retrospective cohort analyses of available datasets will be undertaken in addition to the use of an expert panel to determine, from the presented data sets, whether 'death/cardiac arrest' on scene was likely preventable or not with timely interventions.\n\nData  will  cumulatively  beextracted  from  terror  events  in  the  UK  and  from  London's  Air Ambulance (LAA) pre-hospital trauma deaths (non-terrorist incident).\n\nFor  Cohort  1,  the  Pre-Hospital  Trauma  deaths  (non-terrorist  incident),  members  of  the research team will extract confidential patient information from LAA. Additional patient data will be collected from London Ambulance Service (LAS). Records dating back to 2000 will be  accessed  to  capture  a  minimum  of  150  pre-hospital  trauma  deaths  which  have  the required sequence of data and information accessible. Confidential patient information will be  shared  with  HM  Coroner  Services  in  London and  the Metropolitan  Police  (MPS).  The complete data set will include LAA data, the forensic report and CCTV and/or body worn video  (BWV)  footage. Once  the  dataset  is  linked,  confidential  patient  information  will  be removed  and  the  anonymised  data  presented  to  an  expert  panel,  which  will  determine whether the death was likely preventable.\n\nFor Cohort 2, Terrorist event data, members of the research team will extract confidential patient  information  from  LAS  and  LAA  patient  records  for  deaths  related  to  terrorist incidents.  This  data  will  be  linked  to  additional  sources,  of  information,  including  HM Coroners  forensic  reports,  inquest  reports,  judicial  reports,  CCTV  and  BWV  footage. Confidential patient information will be shared with HM Coroner Services in London and the Metropolitan Police (MPS) to facilitate this linkage. Once the dataset is linked, confidential patient information will be removed and the anonymised data presented to an expert panel, which will determine whether the death was likely preventable.\n\nThe  applicants  have  advised  that  the  project  aims  to  capture  data  from  all  terror  attacks across the UK since 2000. There have been a number which have only involved one or two patients who have died and, although these would ideally be included, it was decided that the  initial  sites  would  be  the  NHS  trusts  who  have  attended  the  larger  events  in  the  first instance.    This    is    London    and    Manchester    /    North-West    Ambulance    Service (NWAS).Having  approached  NWAS,  they  were  not  able  to  participate  until  after  the Chairman    for    the    Manchester    Arena    Inquiry    publishes    his    conclusions    and recommendations. This has been delayed beyond the initial anticipated timings and is now not likely to occur until at least November of this year. After this time,colleagues working in  Manchester  who  are  collaborators  on  this  NIHR  grant  will  assist  in  bringing  the appropriate  NHS  Trust  colleagues  together  to  add  as  additional  sites  in  the  region.The applicants understand that an amendment will need to be submitted to include this data.\n\nIn  terms  of  police  data  (from  where  the  original  patient  identification  will  occur  for  the patients  from  terrorist events),  the  applicants  have  the  agreement  from  counterterrorism policing to do so for all terrorist events in the UK since 2000 (as all counter-terrorism policing ultimately  comes  under  the  Metropolitan  Police  Service,  this  can  be  done  with  one  data sharing agreement).\n\nThe confidential information will be held on a password protected spreadsheet that will be held by the Metropolitan Police Service (MPS), and as such the MPS will be the legal entity responsible for it. The MPS have requested that, as the applicants are extracting data from their  data  sources  that  has  been  collected  for  policing  purposes,  that  this  is  where  the confidential information extracted for both groups of patients, the crime and counter-terrorist patients  will  be  held.As  theirservers  are  secure  QMUL,  Barts  Health  and  London Ambulance Service are all happy with this."]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Dr Claire Park, Chief Investigator  "]
["Address","Whitechapel Road  "]
[null,"London  "]
[]
["Postcode","E1 1FR  "]
["Telephone",7702875973]
["Email","claire.park7@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male  and  female  patients,  aged  0  years  and  over,  who  meet the following criteria:\n\nCohort 1: Traumatic pre-hospital deaths (non-terrorist incident): prehospital   or   on hospital   arrival   death   (cardiac   arrest), traumatic  injury  causing  death,  patient  attended  by  the  LAS and/or LAA between 2000 and 2020.\n\nCohort 2: Terror incident data: Patient went into cardiac arrest prior to reaching hospital, UK terror event since 2000.\n\nThe applicants estimate that 250 patients will be included."]
["Description of confidential patient information used","Data Sources\n\n1.Electronic  patient  record  system  air  ambulance  and paper record patient forms from London Air Ambulance Service (part of Barts Health NHS Trust) and electronic call log for ambulance service call times\n\n2.London Ambulance Service NHS Trust\n\n3.Forensic and post-mortem reports from HM Coroner\n\n4.Judicial   documents,   such   as   inquest   reports   from previous terror attacks\n\n5.CCTV and Body Worn Camera (BWV) footage, witness statements  and  police  reports  from  the  Metropolitan Police Service\n\n6.Counter  Terrorist  Investigation  sequence  of  events accessed via the Senior Investigating Office\n\nIdentifiers required for linkage purpose\n\n1.Name\n2.NHS number\n3.Hospital ID number\n4.Date of birth\n5.Date of death\n6.Postcode\n7.Age\n8.Gender\n\nIdentifiers required for analysis purpose\n\n1.Date of death\n2.Gender\n3.Age"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-20"]
["Next Review Date","2025-01-20"]
["Notes","Amendment supported 21 March 2024 to extend the duration of ‘s251’ support until 31 March 2025\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 September 2022.\n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for London’s Air Ambulance (part of Barts Health NHS Trust), The London Ambulance Service NHS Trust, Queen Mary University London (QMUL) and The Metropolitan Police (MPS) (the applicant confirmed via email that the DSPT for MPS also covered HM coroner reports) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 20/01/2023). \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02745"]
["Reference","22/CAG/0174"]
["Other Refs","IRAS Project ID: 303762  REC Reference: 22/YH/0274"]
["Application Title","UNderstanding the Causes of hyperglycaemia in pRegNancy"]
["Application Summary","This application from King’s College London set out the purpose of medical research to characterise  the   pathophysiological   subtypes  of   gestational   diabetes   and   to   define mechanistic pathways.  Gestational  diabetes  (GDM)  is  a  condition  causing  high  blood glucose  (hyperglycaemia)  and  results  from  an  imbalance  between  decreasing  insulin sensitivity during pregnancy and beta-cell compensation. This description came from early studies in small numbers of high-risk women and used thresholds of diagnosis for GDM that are now outdated. As a result, current therapy in the UK is to counsel women for dietary change. If their glucose levels do not improve, metformin is prescribed, followed by insulin if the GDM is still not controlled. This process can take several weeks, and it is not known which therapy is most appropriate for individuals’ patients. The method of undertaking the oral  glucose  tolerance  test  (OGTT),  the  main  test  for  GDM  diagnosis  and  which  is undertaken  at  24-28  weeks  of  pregnancy,  is  not  standardised.  This  makes  global interpretation of research difficult. Practical issues also make the OGTT an unreliable and outdated method of diagnosis.\n\nPatient medical records will be screen by the research team to identify eligible patients. The research team will then make contact by telephone, text message or email in advance of their scheduled appointment. Patients will be sent a copy of the Patient Information Sheet and  Consent  Form  as  part of  an  invitation  email.  Contact  may  then  continue  via  phone, email or in person. The applicants noted that patients may be approached by researchers in clinic, if the invitation was missed or the patients do not use email or telephone. Should patients consent, their participation will proceed on a consented basis."]
["Applicant Organisation Name","King's College London"]
["Contact Name","Dr Sara Louise White, Chief Investigator"]
["Address","Dept of Women and Children's Health"]
[null,"10th Floor North Wing"]
[null,"St Thomas' Hospital"]
["Postcode","SE1 7EH"]
["Telephone",7801418174]
["Email","sara.white@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","750 pregnant women of white or South Asian descent with a singleton pregnancy."]
["Description of confidential patient information used","Data Sources\n\n1. Electronic medical records held at University Hospitals of Leicester NHS Trust \n2. Electronic medical records held at Guy's and St Thomas' NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS number \n3. Hospital ID \n4. Date of Birth \n5. Postcode \n6. Ethnicity \n7. Contact details (phone number, email and postal address)\n\nIdentifiers required for analysis purposes\n\n1. N/A as any identifiers for analysis included with consent as the legal basis under common law\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-20"]
["Next Review Date","2024-01-20"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 17 January 2023\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 21/22 DSPT reviews for King’s College London, University Hospitals of Leicester NHS Trust & Guy's and St Thomas' NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 12 November 2022)\n\n"]

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[]
[]
["Application Number","A02746"]
["Reference","22/CAG/0157"]
["Other Refs","IRAS Project ID: 318689  REC Reference: 22/PR/1374"]
["Application Title","Do  we  miss  a  common  subset  of Primary  Aldosteronism  in which  there  is  cyclical  or  exaggerated  diurnal  variation  in secretion?"]
["Application Summary","This  application  from  Queen  Mary  University  of  London  set  out  the  purpose  of  medical research  to  determine  whether  a  form  of  primary  aldosteronism  exists  which  causes  a cyclical   or   exaggerated   diurnal   variation   in   secretion   and   whether   24-hour   urine measurements help in detecting people with PA. \n\nHypertension (high blood pressure) can lead to heart attacks and stroke. Many people with hypertension  have  ‘essential’  hypertension,  for  which  no  underlying  cause  has  been identified. Around 10% of patients with hypertension have primary aldosteronism (PA), an excess production of the hormone aldosterone, which causes the body to inappropriately retain  salt.  PA  can  be  treated  with  surgery  or  medications,  however  only  around  1%  of patients  with  PA  are  diagnosed  withthe  condition  and  better  ways  of  identifying  the condition need to be developed. Gene mutations in the adrenal gland affect the rhythm with which  aldosterone  is  produced  and  may  cause  fluctuations  in  aldosterone  production throughout  the  day.  PA  may  have been  missed  in  patients  whose  aldosterone  levels fluctuate. The applicants aim to identify patients with a potentially missed diagnosis of PA by studying 24-hour urine samples.\n\nPatients  will  be  consented  into  the  study.  Suitable  participants  will  be  recruited  from endocrinology and hypertension clinics, either referred from their responsible clinicians or by interrogation of the databases of patients in these clinics. This will be undertaken by the direct care team and is outside the scope of support. Patients who had taken part in previous research  but  did  not  meet  the  criteria  for  PA  may  also  be  recruited.  Similarly,  some participants will also be recruited from previous results sourced from laboratory databases. These two  recruitment methods  will require processing  of  confidential  patient  information by research staff. Once suitable patients have been identified, they will be contacted by post for  consent  to  take  part  in  the  research.  If  patients  do  not  respond  to  the  postal  contact within one month, they will be followed up by telephone. Patients participation will proceed on a consented basis."]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Dr Yun Ni Lee, student researcher"]
["Address","73 Ontario Point"]
[null,"28 Surrey Quays Road"]
[]
["Postcode","SE167EE"]
["Telephone",7876742776]
["Email","w.m.drake@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with suspected PA who did not meet the diagnostic threshold for PA\n\nPatients with diagnosed PA and with previous aldosterone samples of <277 pmo/L \n\nPatients with fluctuating aldosterone results that indicate variability in production Total sample size: 100"]
["Description of confidential patient information used","Data Sources\n\n1. Patient records, records from previous researchand laboratory databases held at Barts Health NHS Trust\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS number \n3. Hospital ID number \n4. Full postcode\n\nIdentifiers required for analysis purposes\n\n1. Name \n2. Date of birth \n3. Gender \n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-24"]
["Next Review Date","2024-01-24"]
["Notes","Conditions of support:\n\n1.\tThe second paragraph on the Outpatient Notification documents needs to be revised. The paragraph currently reads, “This will involve looking at historical blood test results. If the results meet our research criteria, we will contact them and invite them to join our study if they wish to.”  The references to “them” need to be revised to clarify who is being referred to. The revised patient notification is to be provided within one month of the issuing of this letter. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: 04 January 2023\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed:\n\nNHS Digital 2021/22 DSPT reviews for Barts Health NHS Trust and Queen Mary University of London were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (31/10/2022)\n"]

{"sheet":"A02747","index":788,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02747"]
["Reference","23/CAG/0016 "]
["Other Refs","IRAS Project ID: 317939  REC Reference:  22/WS/0171"]
["Application Title","How are people with motor neuron disease (MND) are supported by their clinical teams to make decisions about gastrostomy feeding tube: a multiple case study"]
["Application Summary","This application from Sheffield Teaching Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to understand how healthcare professionals (HCPs), operating within multidisciplinary team (MDT)s, support people with motor neuron disease (MND) to make decisions about gastrostomy placement. The applicant will observe real-world MND MDT practice, to inform the development of professional guidance and recommendations for practice. The research and guidance will better inform MND MDTs on the decision support they deliver to people with MND regarding placement of a gastrostomy feeding tube.\n\nPeople with MND are offered a gastrostomy feeding tube (a narrow plastic tube placed directly into the stomach) when they are unable or at risk of not being able to take enough diet and fluids orally. Research has found that people with MND and HCPs find it difficult to make the decision to have a gastrostomy, due to the unpredictability of the rate of disease progression and uncertainties about the effectiveness of the intervention. There is currently no clear guidance about when HCPs should introduce the option of gastrostomy placement to people with MND or the best time to have the gastrostomy placed. There is a need to understand the process, enablers and challenges around how people with MND make decisions about gastrostomy in the context of a progressive disease and supported by a wide MDT. \n\nThe applicant is undertaking a number of different methodologies at 3 participating MND clinics, including consented interviews and focus groups, reviews of medical notes, documentation reviews, and verbally consented observed interactions between patients and HCPs. These elements do not require ‘s251’ support. However the applicant is also undertaking ethnographic observations, of 2 x 60 minute MND Clinic MDT meetings at each site, in total. There is no sample size pre-selected for HCP observations,  the researcher will take opportunities to observe HCPs as they present themselves while in the field. Support under Regulation 5 is required for this aspect of the study as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded. \n"]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Foundation Trust "]
["Contact Name","Mr Sean White "]
["Address","Department of Neuroscience, University of Sheffield, \n\n"]
[null,"Sheffield Institute for Translational Neuroscie"]
[null,"385A Glossop Road, Sheffield "]
["Postcode","S10 2HQ"]
["Telephone","0114 2222295"]
["Email","smwhite1@sheffield.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","People with MND who were discussed during Multidisciplinary Team Meetings (MDTs)"]
["Description of confidential patient information used","Data sources\n\n1.\tClinical meetings in MND clinics recorded via written field notes, at the following Trusts;\n\nEngland; \n•\tUniversity Hospitals of North Midlands NHS Trust \n•\tNorthern Care Alliance NHS Foundation Trust\nWales:\n•\tSwansea Bay University Local Health Board\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be recorded for linkage purposes.\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be recorded for analysis purposes."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2023-01-27"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in April 2024 that ‘s251’ support could be expired, as support was in place to cover potential incidental disclosures whilst undertaking observational activities. These activities have now been completed.\n\nIn terms of public benefit, ‘s251’ support ensured that the researcher was able to capture in his observations some of the discussions that HCPs have with people with MND about gastrostomy, and provided observational data about how these discussions take place in real-world practice. The benefit to the public is that this data provides greater breadth to the research findings, that should better inform any recommendations for practice that are the result of this research.\n\n\nThe application to allow for incidental exposures of confidential patient information that may occur when the researcher is undertaking observations of Multi-Disciplinary Team meetings, and ad-hoc observations of clinical practice, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 14 December 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for University Hospitals of North Midlands NHS Trust & Northern Care Alliance NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (24 January 2023)\n\nSwansea Bay University Local Health Board - Welsh IG team confirmed submission of the Welsh IG toolkit, via email correspondence. \n"]

{"sheet":"A02748","index":789,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02748"]
["Reference","22/CAG/0141"]
["Other Refs","IRAS Project ID:   REC Reference: "]
["Application Title","Do patients with autoimmune hepatitis (AIH) have an excessive incidence of cardio- and cerebrovascular disease and is this related to corticosteroid treatment?\n\n"]
["Application Summary","This application from Sheffield Teaching Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to investigate whether the rate of new hospital admissions and/or deaths is higher after a diagnosis of autoimmune hepatitis (AIH) than that in a general population cohort.\n\nAutoimmune hepatitis (AIH) is a chronic inflammatory liver disease that affects about 11,000 people in the UK and is becoming more common. It can affect all populations and age groups, although most patients are female. Untreated, AIH is a serious and fatal disease. Drug treatments, such as steroids, are effective in improving outcomes, but have side effects such as weight gain, diabetes, and increases in blood pressure and fat levels in the blood and liver. Patients with other steroid treated conditions, such as rheumatoid arthritis, have a higher rate of vascular disease compared to the general population. The applicants seek to establish whether this is also true of patients with AIH and if there is a link to steroid therapy, in order to inform the development of newer, non-steroid treatments. \n\nThe three participating trusts, Sheffield Teaching Hospitals NHS Foundation Trust, Kings College Hospital NHS Foundation Trust and University Hospitals Birmingham will disclose confidential patient information, collected from the autoimmune hepatitis patient datasets they hold, to NHS Digital. NHS Digital will generate a control group, consisting of 10 controls per patient, matched to the patient group in age, sex and postcode (LSOA). NHS Digital will then link data for both the patients and controls with the HES Admitted Patient Care Dataset and ONS Mortality Dataset. The dataset will then be disclosed to the Chief Investigator at Sheffield Teaching Hospitals NHS Foundation Trust. The dataset for the case data will be pseudonymised, as the name, NHS number, date of birth, sex and post code will be replaced by the unique Study ID. The control dataset will be completely anonymous, with each patient identified only by their corresponding “case” Study ID. \n"]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Foundation Trust \n"]
["Contact Name","Dr Jemima Clarke  "]
["Address","Glossop Road "]
[null,"Sheffield "]
[]
["Postcode","S10 2JF "]
["Telephone",7930220216]
["Email","s.flatley@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who were diagnosed with AIH between 1989 and 2021, and who are under the care of the Liver Units at Sheffield Teaching Hospitals, Kings College Hospital NHS Foundation Trust or University Hospitals Birmingham.\n\nIn total there will be 8580 patients involved: 780 “cases” and 7800 “controls”.\n"]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic patient records at:\na.\tSheffield Teaching Hospitals NHS Foundation Trust\nb.\tKings College Hospital NHS Foundation Trust\nc.\tUniversity Hospitals Birmingham\n2.\tThe HES Admitted Patient Care Dataset and ONS Mortality Dataset, held by NHS Digital\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tDate of birth\n4.\tPostcode – sector level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n2.\tPostcode – sector level\n3.\tGender\n4.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-30"]
["Next Review Date","2025-01-30"]
["Notes","Conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 01 November 2022.\n  \n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2021/22 DSPT reviews for Sheffield Teaching Hospitals NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, Kings College Hospital NHS Foundation Trust and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (30/01/2022) \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02749","index":790,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02749"]
["Reference","23/CAG/0010"]
["Other Refs","IRAS Project ID: 308896   REC Reference: 22/EM/0238"]
["Application Title","The SHIPS Study: Sharing Information at the Primary / Secondary care interface – improving patient care by ensuring that GPs get the information they need when someone is discharged from hospital"]
["Application Summary","This application from University of Bristol – Bristol Medical School set out the purpose of medical research that seeks to explore the communication of poor prognosis between secondary care and primary care when a patient is discharged from hospital. The aim is to understand what information should be shared with General Practitioners (GPs) after a hospital stay, and how it might best be shared. GPs find it challenging to identify patients with advanced illness, who might have limited life expectancy, and would welcome clear communication from hospital specialists concerning these patients. Communication of this information to GPs enables better continuity and coordination of care. Advance care planning discussions can then enable patients’ wishes to be identified and respected, including preferences for place of care and death, and future admission avoidance.\n\nOn average, people dying in Britain spend three weeks of their last year of life in hospital as a result of one or more emergency admissions. The SHIPS study is relevant, and needed now, as emergency admissions in the last year of life are predicted to translate to a need for 8000 extra hospital beds by 2038. Strategies that improve continuity of care lower hospital admissions, potentially improving the quality of end of life care, while reducing its cost. To ensure the delivery of well-coordinated and continuous care by GPs, applicants need to establish how primary and secondary care can communicate effectively and efficiently.\n\nPart 1 of The SHIPS study is already underway regarding a literature review to inform part 2. Part 2 includes a number of different methodologies at 2 participating Trusts, including consented interviews and reviewing anonymised discharge information. These elements do not require ‘s251’ support. However the applicant is also undertaking ethnographic observations, of multidisciplinary team meetings, board round meetings, observed daily at each site, informal interactions between HCPs on hospital wards, and observations of clinicians preparing discharge communications about patients on the ward. Support under Regulation 5 is required for this aspect of the study as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded, but the researcher may record age, gender and ethnicity, which would be effectively anonymous to the researcher.\n\nThe researcher will spend approximately 48 days in total on six wards (three wards per study site), conducting interviews and 80-100 hours of observations. The study sites are Great Western Hospitals NHS Foundation Trust and North Bristol NHS Trust. The wards will be purposively sampled focusing on respiratory, oncology and care of the elderly wards, as these wards are most likely to be caring for patients in the last year of life. Other wards, including surgery and cardiology may also be selected, to include wards who are known to be effectively identifying and communicating limited life expectancy at discharge, and wards who may have development needs in this area. \n"]
["Applicant Organisation Name","University of Bristol "]
["Contact Name","Dr Lucy Pocock"]
["Address","University of Bristol, Canynge Hall"]
[null,"39 Whatley Rd"]
[null,"Bristol"]
["Postcode","BS8 2PS"]
["Telephone","0117 4550992"]
["Email","lucy.pocock@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individual observation of secondary care clinicians: 30-40 clinicians, each clinician observed up to 1-3 times \n\nOut of scope for ‘s251’:\nSecondary care clinician interviews: 24-28 interviews \nGP interviews: 18-22 interviews \nInterviews with patients and carers: 24-28 interviews \nAnonymised discharge documentation: 30-40 items\n\nThe researchers undertaking observations of MDT meetings may be exposed to confidential patient information relating to patients discussed at the MDT meetings. It is these patients who are the cohort for ‘s251’ support.\n"]
["Description of confidential patient information used","Data sources\n\n1.\tClinical meetings recorded via written field notes, at the following Trusts;\n\n•\tGreat Western Hospitals NHS Foundation Trust \n•\tNorth Bristol NHS Trust\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be recorded for linkage purposes\n\nIdentifiers required for analysis purposes\n\n1.\tAge \n2.\tGender\n3.\tEthnicity\n\nTis is effectively anonymous to the researcher"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-30"]
["Next Review Date","2024-01-30"]
["Notes","The application, to allow for incidental exposures of confidential patient information that may occur when the researcher is undertaking observations of multidisciplinary team meetings, board round meetings, interactions between HCPs and observations of clinicians preparing discharge communications about patients on the ward, is fully supported, subject to compliance with the standard conditions of support.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 December 2022\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for Great Western Hospitals NHS Foundation Trust & North Bristol NHS Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (24 January 2023)\n"]

{"sheet":"A02750","index":791,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02750"]
["Reference","23/CAG/0003"]
["Other Refs","IRAS Project ID: 316668  REC Reference: 23/WM/0011"]
["Application Title","PRemature Infant Outcome Risk study – PRIOR "]
["Application Summary","The overall aim of the study is to develop a risk score using routinely collected neonatal electronic data for neonatal mortality and morbidity that is applicable to the UK setting.\n \nThe research team has developed a prediction tool to identify babies at high risk of dying or developing serious diseases using routinely recorded healthcare data. The tool will support timely personalised treatment decisions. This study will determine how well the developed tool performs in clinical practice and compare its performance with previously developed tools. The study will test how well the tool works in clinical practice by studying 1,300 premature babies born before 32 weeks of pregnancy until two years of age. \n"]
["Applicant Organisation Name","University of Nottingham"]
["Contact Name","Professor Don Sharkey"]
["Address","Centre for Perinatal Research"]
[null,"University of Nottingham"]
[null,"Queens Medical Centre"]
["Postcode","NG7 2UH"]
["Telephone","01158230602\n"]
["Email","don.sharkey@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1300 premature infants born below 32 weeks of gestational age and admitted in participating neonatal units within 24 hours of age. \n \n"]
["Description of confidential patient information used","Data sources\n\nNHS Trusts in England and Wales which use the BadgerNet system \n \n1.\tPatient case notes \n\nIdentifiers required for linkage purposes\n\n1.\tNHS number \n2.\tClevermed pseudonymisation code \n\nIdentifiers required for analysis purposes\n\n1.\tSex \n2.\tEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-02-02"]
["Next Review Date","2025-02-02"]
["Notes","Conditions of support:\n\nThe application to allow the disclosure of confidential patient information from NHS Trusts to the Clevermed Microsoft Azure environment (BadgerNet). This is usually collected at part of routine clinical care; however, support is required for the data to flow for research purposes.   \n\nFollowing pseudonymisation of the data by Clevermed, support is required for continued holding of this information until after the 2-yr follow-up data has been collected.  This is because the pseudonymisation code can be used by Clevermed to link the data from different NHS Trust for individual participants, is conditionally supported, subject to compliance with the standard and specific conditions of support.\n\nSpecific conditions of support \n\n1.\tPlease add a contact email address to the participant information sheet. Condition met 15 February 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 18th January 2023\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThere are more than 5 DSPTs, thus this is a data controller’s responsibility to arrange.\n\nAs the above conditions have been accepted or met, this letter provides confirmation of final support.  I will arrange for the register of approved applications on the HRA website to be updated with this information.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02751","index":792,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A025751"]
["Reference","22/CAG/0130 "]
["Other Refs","IRAS Project ID: 313140  REC Reference: 22/EE/0220"]
["Application Title","ELUCIDate: ELUcidate long-term consequences of Childhood Infections using administrative and research Data "]
["Application Summary","This application from the University of Bristol and the London School of Hygiene and \nTropical Medicine (as joint data controllers) sets out the purpose of medical research\nwhich aims to investigate the health consequences of SARS-CoV-2 infection in children \nand young people (CYP) using two school surveys: the Schools Infection Survey (SIS) in \nEngland, and the Bristol-based COVID-19 Mapping and Mitigation in Schools (CoMMinS) \nstudy.\n\nData will be linked from the surveys to electronic health records held by NHS Digital and \nthe Bristol, North Somerset and South Gloucestershire System-Wide Dataset. \nThis research will help quantify the burden of short- and long-term adverse health \noutcomes of SARS-CoV-2 infection in CYP and the link between them. It will help \ndetermine the risk factors for developing disease, such as age, gender, ethnicity and the \nnature of the SARS-CoV-2 infection itself.\n\nONS will send NHS Digital NHS number, date of birth and a unique study identifier from \none dataset for SIS held at ONS (the personal data dataset). NHS Digital will remove NHS \nnumber and date of birth from the data it sends back to ONS. ONS will make available in \ntheir Secure Research Service (SRS) a second, separate dataset for SIS held at ONS \n(which is actually composed of a number of data tables, all de-identified) containing only \nthe attributes data, along with the data from NHS Digital. We understand that, in practice, \nwhat will happen is that ONS will put their attributes datasets, and the data from NHS \nDigital, in the SRS, with each dataset containing the unique study identifier, so that UoB \nand LSHTM researchers can link the files together in the SRS.\n\nONS split their project areas and access permissions so that the data linkage team have \naccess to the files with the unique IDs and personal data and then the analysts have \naccess to the pseudo IDs (a random number that is a 1-1 match with the NHS number but \nis not actually the NHS number) plus the attributes data needed for analysis but all \npersonal identifiers are removed from these files.\n\nThe linkage of electronic health records to CoMMinS data has been done entirely \nseparately, through the BNSSG Integrated Care Board (ICB). NHS Governance for the\nCoMMinS linkage has gone through the BNSSG ICB’s governance structure. This \napplication is not to request ethical approval for linkage for the CoMMinS study, only for \nSIS. The researchers mentioned CoMMinS because similar analyses will also be done on \nthe linked CoMMinS data (independently, and in a separate environment), and the results \ncompared to those obtained from SIS through meta-analysis of aggregate estimates. At \nno point will the individual-level data from CoMMinS be brought together with the \nindividual-level data from SIS.\r"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Dr Katharine Looker"]
["Address","Bristol Medical School"]
[null,"Oakfield House"]
[null,"Oakfield Grove\n"]
["Postcode","BS8 2BN"]
["Telephone"]
["Email","Katharine.Looker@bristol.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children aged between 4 and 18 years who participated in the Schools Infection Survey (SIS)\r"]
["Description of confidential patient information used","Data sources \n\nOffice of National Statistics\n\n• Schools Infection Survey\n\nNHS Digital\n\n• General Practice Extraction Service (GPES) Data for Pandemic Planning and Research (GDPPR) data\n• Emergency Care Dataset\n• Hospital Episode Statistics\n• Covid-19 Second Generation Surveillance Systems\n• Medicines Dispensed in Primary Care (NHSBSA) data\n• Covid-19 Second Generation Surveillance Systems (held by NHS Digital but a subset of the UKHSA second generation surveillance system)\n\nIdentifiers required for linkage purposes\n\n1. Identifiers required for \n2. linkage purposes\n\nIdentifiers required for analysis purposes\n\n1. Postcode for deprivation scoring prior to deidentification. This will be MSOA, local authority district, integrated care system and deprivation score from ONS in their Secure Research Service (SRS).\n\nAdditional information\n\nData will be split into two tranches from April 2019 to March 2022 and from April 2022 to March 2023. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date"]
["Next Review Date","2025-02-02"]
["Notes","10 May 2023 - change in data processor from NHS Digital to NHS England, regarding data sources - General Practice Extraction Service (GPES), Data for Pandemic Planning and Research (GDPPR) data, the Emergency Care Dataset (ECDS), Hospital Episode Statistics (HES), Covid-19 Second Generation Surveillance Systems, Medicines Dispensed in Primary Care (NHSBSA) data, and Covid-19 Second Generation Surveillance Systems (a subset of the UKHSA second generation surveillance system).\n\nAmendment supported 10 May 2023 to include a further purpose for processing, in the form of an additional research question; ‘Do children and adolescents experience long-term health outcomes of (any) infection, and how is this characterized?\"’, and to change the name of this application from ‘Enhancing The Utilisation Of COVID-19 Testing In Schools Studies: The Joint Analysis Of The COVID-19 Schools Infection Survey (SIS) And The COVID-19 Mapping And Mitigation In Schools (CoMMinS) Study’ to an umbrella term – ‘ELUCIDate: ELUcidate long-term consequences of Childhood Infections using administrative and research Data’\n\nConditions of support:\n\n1.A sentence about ‘withdrawing’ from the study (with a phone number and email) is added to the SIS website under the section on ‘How else will you use my data?’. The opting out information should also be added to the study-specific website. Condition met 13 March 2023\n\n2.Favourable opinion from a Research Ethics Committee. Confirmed 02 February 2023\n\n3.Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the  relevant  Data  Security  and  Protection  Toolkit  (DSPT)  submission(s) has achieved  the  ‘Standards  Met’  threshold.  See  section  below  titled  ‘security assurance requirements’ for further information. Confirmed 04 October 2022 \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02752"]
["Reference","22/CAG/0141"]
["Other Refs","IRAS Project ID: 307046  REC Reference: 22/SC/0381"]
["Application Title","Do patients with autoimmune hepatitis (AIH) have an excessive incidence of cardio- and cerebrovascular disease and is this related to corticosteroid treatment?"]
["Application Summary","This application from Sheffield Teaching Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to investigate whether the rate of new hospital admissions and/or deaths is higher after a diagnosis of autoimmune hepatitis (AIH) than that in a general population cohort. \n\nAutoimmune hepatitis (AIH) is a chronic inflammatory liver disease that affects about 11,000 people in the UK and is becoming more common. It can affect all populations and age groups, although most patients are female. Untreated, AIH is a serious and fatal disease. Drug treatments, such as steroids, are effective in improving outcomes, but have side effects such as weight gain, diabetes, and increases in blood pressure and fat levels in the blood and liver. Patients with other steroid treated conditions, such as rheumatoid arthritis, have a higher rate of vascular disease compared to the general population. The applicants seek to establish whether this is also true of patients with AIH and if there is a link to steroid therapy, in order to inform the development of newer, non-steroid treatments.\n\nThe three participating trusts, Sheffield Teaching Hospitals NHS Foundation Trust, Kings College Hospital NHS Foundation Trust and University Hospitals Birmingham will disclose confidential patient information, collected from the autoimmune hepatitis patient datasets they hold, to NHS Digital. NHS Digital will generate a control group, consisting of 10 controls per patient, matched to the patient group in age, sex and postcode (LSOA). NHS Digital will then link data for both the patients and controls with the HES Admitted Patient Care Dataset and ONS Mortality Dataset. The dataset will then be disclosed to the Chief Investigator at Sheffield Teaching Hospitals NHS Foundation Trust. The dataset for the case data will be pseudonymised, as the name, NHS number, date of birth, sex and post code will be replaced by the unique Study ID. The control dataset will be completely anonymous, with each patient identified only by their corresponding “case” Study ID."]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Dr Jemima Clarke "]
["Address","Sheffield Teaching Hospitals"]
[null,"NHS Foundation Trust"]
[null,"Glossop Road, Sheffield\r"]
["Postcode","S10 2JF"]
["Telephone",7930220216]
["Email","s.flatley@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who were diagnosed with AIH between 1989 and 2021, and who are under the care of the Liver Units at Sheffield Teaching Hospitals, Kings College Hospital NHS Foundation Trust or University Hospitals Birmingham.\n\nIn total there will be 8580 patients involved: 780 “cases” and 7800 “controls”."]
["Description of confidential patient information used","Data sources\n\n1. Electronic patient records at: \na. Sheffield Teaching Hospitals NHS Foundation Trust \nb. Kings College Hospital NHS Foundation Trust c. University Hospitals Birmingham \n\n2. The HES Admitted Patient Care Dataset and ONS Mortality Dataset, held by NHS Digital\n\nIdentifiers required for linkage purposes \n\n1.Name\n2. NHS Number \n3. Date of birth \n4. Postcode – sector level\n\nIdentifiers required for analysis purposes\n\n1. Date of death \n2. Postcode – sector level \n3. Gender \n4. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-01-30"]
["Next Review Date","2024-01-30"]
["Notes","Conditions of support:\n\n1. Favourable opinion from a Research Ethics Committee. Confirmed 01 November 2022.  \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \nThe NHS Digital 2021/22 DSPT reviews for Sheffield Teaching Hospitals NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, Kings College Hospital NHS Foundation Trust and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (30/01/2022) \n"]

{"sheet":"A02753","index":794,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02753"]
["Reference","22/CAG/0135 "]
["Other Refs","IRAS Project ID: 317640  REC Reference: 06/MRE02/4"]
["Application Title","UK Genetic Prostate Cancer Study "]
["Application Summary","This application from The Institute of Cancer Research sets out the purpose of medical \nresearch that seeks to find genetic changes which are associated with prostate cancer risk. \nThe UK Genetic Prostate Cancer Study (UKGPCS) was first established in 1993 and is the \nlargest prostate cancer study of its kind in the UK, involving nearly 200 hospitals. Individuals \nare included with consent. If applicants can find alterations in genes that increase the \nchances of getting prostate cancer, it may be possible to screen family members to see if \nthey are also at a higher risk of developing prostate cancer, and to develop new prostate \ncancer treatments in the future. \n\nAn amendment in 2008 included the collection of survival data through the Office of National \nStatistics, and this was updated on consent forms from v5 onwards. From 2011, the \napplicant received the cause and date of death for participants consented to UKGPCS from \nthe Health and Social Care Information Centre (HSCIC) (the predecessor to NHS Digital). \nApplicants have been receiving quarterly updates on date of death and cause of death for \nparticipants on the study until recently. NHS Digital has now concluded that for participants \nconsented prior to 2008, on forms v1-v4, the consent forms are insufficient to meet the \ncommon law duty of confidentiality. Therefore, for those participants consented prior to \n2008, NHS Digital has asked the study team to apply to CAG."]
["Applicant Organisation Name","The Institute of Cancer Research "]
["Contact Name","Professor Rosalind Eeles "]
["Address","15 Cotswold Road"]
[null,"Sutton"]
[null,"Surrey"]
["Postcode","SM2 5NG\r"]
["Telephone",2034376415]
["Email","ros.eeles@icr.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Prostate cancer patients consented into the UK GENETIC \nPROSTATE CANCER STUDY prior to 2008, on consent form \n1-4. \nThe number of cases flagged on Consent form V1 to V4 total \n8720 (out of which 4280 have died). Therefore ‘s251’ support \nwill be relevant to these 8720 individuals"]
["Description of confidential patient information used","Data Sources\n\n1. UK GENETIC PROSTATE CANCER STUDY Dataset \nretained at The Institute of Cancer Research\n2. NHS Digital ONS mortality dataset\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS Number\n3. Date of birth\n4. Postcode\n\nIdentifiers required for analysis purposes\n\n1. Date of death\n2. Cause of death (not directly identifiable)\n\nAdditional information\n\nQuarterly updates of mortality outcomes are provided to the \napplicant from NHS Digital. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-11-21"]
["Next Review Date","2024-11-21"]
["Notes","13 February 2023 - change in data processor from NHS Digital to NHS England, regarding data source ONS Mortality Data\n\nAmendment supported 13 February 2023 \nTo extend the scope of ‘s251’ support to also include the cohort of patients consented on consent form v5\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed for amendment regarding CAG input - AM2204-44; 27 September 2022\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews for The Institute of Cancer Research, and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 19 October 2022)\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02754","index":795,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02754"]
["Reference","22/CAG/0096"]
["Other Refs","IRAS Project ID:  306690  REC Reference: 22/SC/0038"]
["Application Title","The use of machine learning to identify patients with rapidly declining chronic kidney disease"]
["Application Summary","This application from the Royal Berkshire NHS Foundation Trust set out the purpose of medical research that seeks to determine whether Machine Learning Algorithms (MLAs) can assist with the identification of patients with rapidly declining Chronic Kidney Disease (CKD). \nCKD is a condition characterised by a reduction in kidney function. For patients whose renal function declines rapidly, earlier counselling and patient education is associated with improved health outcomes and increased patient choice in treatment options. The applicants seek to undertake a pilot study, which will focus on training and contrasting a set of MLAs using available laboratory parameters routinely collected by renal physicians at the Royal Berkshire NHS Foundation Trust. The applicants hope that the results could be used to identify patients at greatest risk of declining renal function in both primary care and renal unit setting. The outcomes of the pilot will be used in development of end-to-end machine learning architecture. A larger-scale project may also be undertaken. \n\nThe study will be comprised of two parts. In the first, laboratory data will be collected for 80% of all incident dialysis patients within a 6-year period, prior to December 2019. Laboratory data will also be collected for patients with stages 3 and 4 non-progressive CKD to be used as a comparator. This data will be used, with the aid of machine learning, to develop an algorithm to determine the predicted date of onset of end stage kidney disease (ESKD). The second part of the study is a validation study, where the algorithm developed in part 1 will be used to analyse the data for the remaining 20% of patients who attended the clinic over the same period to determine whether the actual date of onset of ESKD could have been accurately predicted. \n\nSupport is required as the data will be collected by a postdoctoral researcher who is not part of the direct care team. The dataset, containing confidential patient information, will be collated from electronic patient records at the Royal Berkshire NHS Foundation Trust. Patients will be assigned a Study Research Number (SRN) and the master document will be held at the Trust. A pseudonymised dataset, containing the SRN, will be transferred to the University of Reading to be used for analysis.\n"]
["Applicant Organisation Name","Royal Berkshire NHS Foundation Trust"]
["Contact Name","Dr Umanath (Nitin) Bhandary  "]
["Address","Royal Berkshire NHS Foundation Trust "]
[null,"London Road, Reading"]
[null,"Berkshire"]
["Postcode","RG1 5AN  "]
["Telephone",7958586758]
["Email","nitin.bhandary@royalberkshire.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over with stable chronic kidney stages 3 & 4 and treated at Royal Berkshire NHS Foundation Trust between 01/01/2014 – 31/12/2019. The applicants anticipate that 6600 patients will be included."]
["Description of confidential patient information used","Data sources\n\n1. Electronic patient records at the Royal Berkshire Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS number \n3. Hospital ID number \n4. Date of birth\n\nIdentifiers required for analysis purposes\n\n1. Year of birth only"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-02-15"]
["Next Review Date","2024-02-15"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: 24 February 2022.  \n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS Digital 2021/2022 DSPT review for Royal Berkshire NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 07 July 2022). \n"]

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[]
[]
["Application Number","A02755"]
["Reference","23/CAG/0004"]
["Other Refs","IRAS Project ID: 297267  REC Reference: 22/YH/0250"]
["Application Title","Using AI and Data Analysis to Better Predict Cardiovascular Disease"]
["Application Summary","This application from Manchester Metropolitan University set out the purpose of medical research that seeks to identify digital signatures that relate to cardiovascular disease risk. \n \nPrediction models are widely used in clinical practice. The NHS currently uses QRISK to quantify the risk of acute coronary syndromes (ACS) or stroke in primary care in patients not previously diagnosed with cardiovascular disease. QRISK demonstrates a good capacity to discriminate between those at a higher or lower risk, but it should be possible to improve performance by using computer aided analysis of patient data to develop understanding of the interaction between different indicators of risk and how they cluster in patients that suffer heart attacks.  \n\nPatients will be identified from records at Salford Royal Infirmary, part of the Northern Care Alliance NHS Foundation Trust, and Wythenshawe Hospital and Manchester Royal Infirmary, part of Manchester University NHS Foundation Trust. The data will be collated into a single dataset by research staff at Salford Royal Infirmary. Once linked, the dataset will be anonymised and uploaded to the Northern Care Alliance NHS Foundation Trust. \n\nThe anonymised dataset will be analysed by staff at Northern Care Alliance NHS Foundation Trust and Manchester Metropolitan University. \n\nA separate file linking the study participant study number and NHS number will be securely retained within the NCA NHS system. The need to retain this file will be reviewed at least annually by the study team and will be deleted at the end of the study, or at the latest 5 years from ethical approval, unless permission to extend the study is obtained. \n"]
["Applicant Organisation Name","Manchester Metropolitan University"]
["Contact Name","Dr Stephen J White Reader in Cardiovascular Pathology "]
["Address","Manchester Metropolitan University"]
[null,"John Dalton Building Chester Street"]
[null,"Manchester"]
["Postcode","M1 5GD"]
["Telephone",1612471159]
["Email","stephen.white@mmu.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","5000 patients.  \n\n2200 – 2500 patients aged 18 years and over who experienced ACS between 01 April 2015 – 31 March 2018 and were treated Manchester Royal Infirmary or Wythenshawe.  \n\n2200 – 2500 validation cohort of patients treated between 01 April 2018 – 31 March 2021 \n"]
["Description of confidential patient information used","Data sources \n\n1. Primary healthcare data held in Salford integrated record  \n2. Secondary healthcare data held in electronic patient records at Northern Care Alliance NHS Foundation Trust and Manchester University NHS Foundation Trust  \n3. MINAP data from Wythenshawe and Manchester Royal Infirmary for patients that have a Salford postcode  \n4. BCIS data from Wythenshawe and Manchester Royal Infirmary for patients that have a Salford postcode \n\nIdentifiers required for linkage purposes \n\n1. Name  \n2. NHS Number \n3. Date of birth  \n4. GP Registration  \n5. Postcode – unit level \n\nIdentifiers required for analysis purposes \n\n1. Date of birth  \n2. Postcode – sector level  \n3. Gender  \n4. Ethnicity  \n5. Age at time of clinical event \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-03-06"]
["Next Review Date","2024-03-06"]
["Notes","Conditions of support:\n\n1. The CAG asked that paragraph 4 of the patient information leaflet was revised to describe CAG as an “independent group of experts and lay people”, rather than as a government group. The revised patient information leaflet is to be provided within 30 days of the issuing of this letter. \n\n2. Favourable opinion from a Research Ethics Committee. Confirmed (REC Favourable Opinion issued 02 November 2022) \n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: The NHS Digital 21/22 DSPT reviews DSPT for Northern Care Alliance NHS Foundation Trust and Manchester University NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 23 January 2023)\n"]

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[]
[]
["Application Number","A02756"]
["Reference","22/CAG/0140"]
["Other Refs","IRAS Project ID: 299034  REC Reference: 299034 REC: 22/WM/0212"]
["Application Title","Exploring the effectiveness and cost-effectiveness of text-message reminders and telephone patient navigation to improve the uptake of faecal immunochemical test screening among non-responders in London."]
["Application Summary","This application from University College London sets out the purpose of medical research that seeks to test the effectiveness of text message reminders in improving patient take up of bowel cancer screening. \n\nBowel cancer is a leading cause of cancer-related mortality in England. Previous randomised controlled trials have shown that faecal occult blood test screening every two years can improve bowel cancer outcomes by detecting cases earlier. NHS England commenced a national bowel cancer screening programme (BCSP) in 2006. Uptake of this screening has been low. In June 2019, the English BCSP changed to a new test, the faecal immunochemical test (FIT), which increased uptake by around 7%. However, an important issue that has not yet been addressed is lower uptake of screening in London. Several interventions, such as sending pre-invitation letters, GP endorsement and postal reminders have ben trialled. Text message reminders and patient navigation (PN) have not yet been implemented, although a recent service evaluation in Southeast London showed that a combination of text message reminders and PN facilitated uptake increased take up of breast screening. The applicants are seeking to determine whether these interventions can be used to improve uptake of bowel cancer screening. \n\nThe NHS Bowel Cancer Screening invitation process will continue, unaffected by this study. Only those who do not participate within 13 weeks of invitation will be included in the study. During the pre-trial period, at week 0, pre-invitation letters will be sent to the potentially eligible participants. At week 1, the screening kit will be dispatched. At week 5, a reminder letter will be sent to the bowel non-responders. At week 13, it will be the end of screening episode, and non-responders will be identified and randomised at this point. NHS Digital will identify eligible patients from the NHS Continuing Health Care (CHC) Patient Level Data Set and National Bowel Cancer Screening Database. Patients who have registered a National Data Opt-Out will be removed. The data will be transferred to iPlato. iPlato will randomise patients into one of three groups, 1) no intervention ('usual care'), 2) a text-message reminder, which will be sent 13 weeks after invitation, followed by additional text-message reminders at 15, 17 and 19 weeks if there is no response, or 3) a text-message reminder, sent 13 weeks after invitation, followed by PN calls at 15, 17 and 19 weeks if there is no response. iPlato will use telephone numbers from the GP Clinical System at NHS Digital to send patient reminder texts and to undertake Patient Navigations calls. Patient navigation (PN) involves specially trained individuals giving tailored support to help patients overcome barriers. The end of data accrual period will be week 24, which will be 11 weeks after randomisation of the final randomised participants. The dataset will be returned to NHS Digital where outcomes and demographics will be added. The dataset will be anonymised and sent to UCL for analysis.\n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Mr Pushpsen Joshi, Research Governance Manager"]
["Address","1st Floor Maple House (Suite B)"]
[null,"149 Tottenham Court Road"]
[null,"London"]
["Postcode","W1T 7DN"]
["Telephone","020 3447 5696"]
["Email"," UCLH.randd@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 60 – 74 years who have been routinely invited for bowel cancer screening, but not returned their test kit within 13 weeks of dispatch, during the trial period. \n\nPatients must also be registered with a GP located within the London Boroughs of Brent, Ealing, Lambeth, Lewisham, Redbridge or Barking and Dagenham. \n\n2703 patients will be included.\n"]
["Description of confidential patient information used","Data sources\n\n1. NHS Continuing Health Care (CHC), Patient Level Data Set and National Bowel Cancer Screening Database, held at NHS Digital\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS Number\n\nIdentifiers required for analysis purposes\n\n1. Gender \n2. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-03-06"]
["Next Review Date","2024-04-06"]
["Notes","Conditions of support:\n\n1.\tThe text needs to be reworded to give a clearer explanation of the National Data Opt Out.\n\n2.\tProvide the CAG with the definition of “ecological validity”, as used in this application. \n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 February 2023. \n\n4.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\n5.\tThe NHS Digital 2021/22 DSPT reviews for iPlato and NHS Digital were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (11/10/2022)\n"]

{"sheet":"A02757","index":798,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02757"]
["Reference","23/CAG/0015 "]
["Other Refs","IRAS Project ID: 19816  REC Reference: 22/YH/0211"]
["Application Title","Flatiron Health UK Oncology Real-World Database v2.0"]
["Application Summary","This application from Flatiron Health UK Ltd set out the purpose of creating a research database to collect real world data (RWD) for cancer patients aged 18 years and over.\n\nProgress in cancer treatment is dependent upon high-quality evidence to demonstrate that specific interventions are safe and effective. The gold standard for evidence development has traditionally been prospectively conducted clinical trials. For the 80% of patients not participating in clinical trials, “real world data” has the potential to contribute to understanding of what happens in routine clinical care. Also, clinical trials do not generate a diagnosis to outcome record and most often examine the impact of one line of therapy, and not the relationship between different lines of therapy. While the UK has a strong record of using real-world data and real-world evidence, the existing public and industry-funded databases have limitations that mean they are less suited for oncology observational research, drug development, HTA decision-making, clinical decision support and other high-impact uses. The Cancer Outcome and Services Data set (COSD) has been the national standard for reporting cancer in the NHS in England since January 2013, but the data quality is acknowledged to be inadequate to support clinical, academic or commercial research. The applicants seek to address these existing limitations through rapid, structured and unstructured data processing to create data for use across the oncology system.\n\nThe applicants, Flatiron Health UK, have partnered with Leeds Teaching Hospitals NHS Trust (LTHT) to create a representative, population-based cancer cohort. The database will be comprised of routinely collected retrospective data for patients aged 18 years and over who received treatment for cancer within a Flatiron Health UK partner trust. This will initially be LTHT, however, the applicants also aim to partner with 5-10 additional NHS trusts. Source data will be extracted from NHS Trust clinical systems in formats including both structured and unstructured data. This data extraction will be undertaken by members of the direct care team at LTHT. The trust will extract the relevant data and transfer the confidential patient information to a “Landing Zone” within an NHS Trust Firewall. Flatiron Health UK will access the dataset to remove the identifiers from the structured and unstructured data. The pseudonymised dataset will then be transferred to a “Joint Research Environment.” There, Flatiron Health UK will undertake the initial processing and anonymise the data, before transfer to the Flatiron Health UK Environment. All data processed by Flatiron Health UK after this point will be anonymised."]
["Applicant Organisation Name","Flatiron Health UK Ltd."]
["Contact Name","Dr Arunan Sujenthiran"]
["Address","Ivy House, 107 St Peter’s Street "]
[null,"St Albans"]
[null,"Hertfordshire"]
["Postcode","AL1 3EW "]
["Telephone","020 4592 1785"]
["Email","arun.sujenthiran@flatiron.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The initial cohort will be inactive and deceased patients treated within two participating Trusts, aged 18 years and over with a diagnosis of cancer.\n\nThe applicants anticipate that the one-time historical data extract undertaken at LTHT will contain ~32,000 cancer patients, and about 4,000-5000 new cancer patients. The numbers will vary between trusts."]
["Description of confidential patient information used","Data sources\n\n1. Clinical information systems, including Electronic Health Records, chemotherapy ordering system, scheduling system, PACS and others, within participating Trusts\n\nIdentifiers required for linkage purposes\n\n1. NHS Number\n\nIdentifiers required for analysis purposes\n\n1. Gender \n2. Ethnicity\n\nIdentifiers held in research database\n\n1. NHS Number \n2. Hospital ID Number \n3. Date of birth \n4. Year of birth \n5. Date of death \n6. Postcode – unit level \n7. Gender \n8. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-03-20"]
["Next Review Date","2025-03-20"]
["Notes","Amendment conditionally supported 13 February 2024  to add a new data processor - University Hospitals of Leicester NHS Trust (UHL) to the Flatiron Health Research Database in the United Kingdom (FHRD-UK)\n\nUpdated specific conditions of support: \n\n1.\tAt annual review, (or any future amendment), please provide the tangible benefits to the NHS Trusts, NHS patients, and services that can be improved though association with the programme, in order for CAG to assess the patient benefit of this activity. Condition met at 2024 annual review\n\n2.\tAt annual review, please provide comparative opt out rates for each site, both Flatiron specific opt out rates and NDOO rates if possible. Condition met at 2024 annual review\n\n3.\tIn one month, please provide re-assurance that researchers working within the NHS would not have to pay commercial rates for accessing the data.  Condition met at 2024 annual review\n\n4.\tIn one month, please amend the patient notifications in line with advice in this letter. This includes;\na)\tCorrect spelling errors on the poster\nb)\tPlease add a final opt out deadline to the posters, or provide justification as to why the poster should not have an opt out deadline.\nc)\tInclude details on potential patient benefits, and details of Trust partnerships in FAQs\nd)\tInclude the common law legal basis for processing on the notifications using the example wording in this letter.  \n\n\n\nConditions of support:\n \n1.\tUndertake further patient and patient involvement, specifically with the local community in Leeds on topics such as commercial relationship between Flatiron Health UK Ltd and Leeds Teaching Hospitals NHS Trust, the processing of confidential patient information without consent and the opt-out mechanism. This should include a minimum of 50 patients and progress reported six months from the date of the final outcome letter.  Condition met 03 November 2023. \n \nThe applicants agreed that Flatiron Health UK would conduct this activity, jointly with Leeds Teaching Hospitals NHS Trust, and report progress back to the CAG.  \n \n2.\tA minimum of 2 lay members, with minimal experience in research and use of data, to be added to the Patient Voices Panel. Progress should be reported to CAG within 4 months from the date of the final outcome letter. Condition met 03 November 2023. \n \nThe Patient Voices Panel (PVP) currently consists of 6 patients and carers. The group was created to reflect and respond to the voices and experiences of UK cancer patients and carers in Flatiron Health UK’s work.  The PVP contains individuals with lay knowledge, as it relates to research and data.  \n \nThe applicants advised that they remain committed to continuing to grow the panel and include individuals with a mix of data experiences as well as other PPIE related experience to ensure it is a representative group.  \n \nThe applicants queried whether the CAG was satisfied with the proposed recruitment strategy and that two further members with minimal experience and use of patient data did not need to be recruited. The applicants also noted that, based on their experience of recruiting members to the PVP, a 6-month time-frame may not allow enough time to identify a panel member, particularly with a specific background.  \n \nThe CAG noted the response given and the details around the PVP and the justification for not seeking two additional members. The CAG agreed that further members needed to be recruited to the PVP. The two recruited should be articulate, confident in a mixed group, have no professional or senior position qualifications and no personal experience of any illness which may come into the scope of the application. They will represent the patients whose medical data is contributing to the Flatiron project without their consent and therefore need to be as impartial as possible whilst able to make a meaningful and considered contribution to the work of Patients Voices. This requirement is obligatory and continued support under Regulation 5 is dependent on this condition being fulfilled. \n \nThe CAG has made these decisions to fulfil its role in ensuring that the use of confidential medical records from within the NHS are used transparently and ethically especially when large commercial organisations are involved. \n \nAn update on the recruitment process and progress in recruiting an additional two members needed to be provide within 4 months of the issuing of this Conditionally Supported outcome letter.  \n \n \n3.\tA minimum of 1 lay member, with minimal experience in research and use of data, added to the Flatiron Research Oversight Committee. Progress should be reported to CAG in six months from the date of the final outcome letter. \nThe applicants advised that Flatiron Health UK will conduct this activity and report progress back to the CAG.  \n \n4.\tIt is suggested that the patient notification materials are reworded to make it clear that opting out via the National Data Opt Out will opt out of their data being used for all secondary research and planning uses, not just this Flatiron application. Condition met 03 November 2023. \nThe following sentence has been included “You can also opt out via the National Data Opt Out. However, this will result in opting your data out of being used for all NHS research and planning uses, not just from this Flatiron partnership.”.  \n  \nThis sentence has been added to the letter templates to active, inactive and new patients. This has also been added to the information leaflet. The CAG noted this and raised no further queries. \n \n5.\tAny future support issued will be for Leeds Teaching Hospitals NHS Foundation Trust only. Additional Trusts should be added by submission of an amendment. Condition met 03 November 2023. \nThe applicants agreed with this condition. The CAG noted this and raised no further queries.  \n6.\tFuture amendments related to this application will be considered at a full meeting of the Confidentiality Advisory Group. \nThe applicants agreed with this condition. The CAG noted this and raised no further queries. \n \n7.\tFuture annual reviews related to this application will be considered at a full meeting of the Confidentiality Advisory Group. \nThe applicants agreed with this condition. The CAG noted this and raised no further queries. \n \n8.\tFavourable opinion from a Research Ethics Committee. Confirmed: 16 February 2023 \n9.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \nThe NHS Digital 21/22 DSPT reviews DSPT for Leeds Teaching Hospitals NHS Trust and Flatiron Health UK Ltd were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 23 January 2023) \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02758"]
["Reference","22/CAG/0158"]
["Other Refs","IRAS Project ID: 293055  REC Reference: 23/LO/0031"]
["Application Title","Investigation into sex-specific differences in mortality and complications following elective abdominal aortic aneurysm repair and association with pre-operative co-morbid status"]
["Application Summary","This application from Imperial College London set out the purpose of medical research that seeks to examine the sex-specific different in co-morbid status and the standard of care prior to aortic surgery, and to explore association with long term post-operative outcomes.\n\nAn abdominal aortic aneurysm (AAA) is a swelling in part of the main vessel supplying blood to the lower body. AAA rupture can be fatal. To prevent this, AAA can be repaired by open abdominal surgery or by endovascular surgery. Women are more likely than men to die or suffer complications from elective AAA repair, and the reason for this is unknown. Current guidance for AAA treatment has been based on what works best in men, however women experience worse results. The applicants will use data collected in national datasets to compare the difference in health status and investigations pre-operatively, and outcomes following repair. The results will be used to identify whether there are key differences between outcomes of men and women, which require more detailed examination.\n\nThe National Vascular Registry (NVR) will extract a file containing items of confidential patient information for patients who have undergone an aortic repair. This will be disclosed to NHS Digital for linkage to the Civil Registration Deaths, HES admitted patient care, Medicines dispenses in primary care datasets. The NVR and NHS Digital will each disclose a pseudonymised dataset to the Big Data and Analysis Unit (BDAU) at Imperial College London. Both datasets will have a unique patient identifier applied to allow linkage of the two datasets."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Professor Janet Powell "]
["Address","Department of Surgery & Cancer, Imperial College London "]
[null,"4E04, 4th Floor, Charing Cross Hospital "]
[]
["Postcode","W6 8RE"]
["Telephone",7912651686]
["Email","anna-louise.pouncey@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who have undergone an aortic aneurysm repair. \n\nApproximately 31,500 patients will be included."]
["Description of confidential patient information used","Data sources\n\n1. The National Vascular Registry, held by the Royal College of Surgeons of England \n\n2. Civil Registration Deaths, HES admitted patient care, Medicines dispenses in primary care, datasets held by NHS Digital\n\nIdentifiers required for linkage purposes\n\n1. NHS number \n2. Date of birth \n3. Postcode – unit level \n4. Sex\n\nIdentifiers required for analysis purposes\n\n1. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-03-20"]
["Next Review Date","2024-03-20"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 16 January 2023.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2021/22 DSPT reviews for NHS Digital and National Vascular Registry (Royal College of Surgeons of England) were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 November 2022).\n"]

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[]
[]
["Application Number","A02759"]
["Reference","23/CAG/0017 "]
["Other Refs","IRAS Project ID: 320934  REC Reference: 23/LO/0120"]
["Application Title","Application of the Clinithink Natural Language Processing tool and Machine Learning methods to Clinical Notes for the Screening of Lung Cancer"]
["Application Summary","This application from Barts Health NHS Trust set out the purpose of medical research which \naims to examine the feasibility of Clinithink, a clinical Natural Language Processing (NLP) \ntool, to extract SNOMED codes from GP and hospital notes of patients referred for chest x-rays, and to use the extracted data to identify risk factors for lung cancer and to develop \ndiagnostic models for GPs for early-stage lung cancer, and prognostic models for lung \ncancer outcomes. The study is a retrospective observational cohort study, and uses an NLP \ntool to anonymise free-text notes and extract relevant clinical information. ‘s251’ support is \nrequested because the identification of eligible patients and the running of free-text notes \nthrough the NLP software is undertaken by 2 researchers who are not considered direct \ncare team, and in undertaking these activities these individuals will be viewing confidential \npatient information.\n\nAround 48,500 new cases of lung cancer are diagnosed each year in the UK. Death from \nlung cancer is the most common of all cancers, with only 10% of patients surviving for ten \nor more years. Most lung cancer is diagnosed in the later stages of the disease, making \ntreatment more difficult and putting strain on the NHS. However, when diagnosed sooner, \ntreatment is much more effective, with survival rates increasing to 30-80% from 2-15%. \nTherefore, this research aims to develop tools to identify patients at high risk of lung cancer \nbefore they otherwise would be in the clinical pathway. At present, the process for referral \nis heavily reliant on the referrer’s personal judgment and ability to recognise symptoms, \npotentially delaying a diagnosis or misdiagnosing the cancer as a less serious ailment. \nMedical notes are rich sources of information, however, due to their unstructured nature, \nextraction of relevant information from free-text notes is a time and labour intensive process. \nFor this reason, the use of unstructured data for the screening of many diseases is largely \nunexplored. Clinithink is an NLP tool that extracts requested information from medical notes, \nformatting the output into a structured dataset (SNOMED-codes) which can be more easily \nanalysed. In implementing a tool such as Clinithink, the limitations associated with \nunstructured data could be mitigated. The intention of this study is to investigate the viability \nof using the Clinithink NLP tool to extract information from the medical notes of a targeted \ndemographic of patients and test the viability of then applying newly developed predictive \nmodels to the extracted information to identify which patients are risk of lung cancer, so that \nlung cancer can be detected, and patients can be treated earlier and more effectively, and \nlives are saved. \n\nTwo researchers employed by Barts Health NHS Trust, who are not considered direct care \nteam, will identify eligible patients by searching the Trust records via the inclusion criteria, \nrecording the relevant NHS numbers. The National Data Opt Out will then be applied. \nFollowing identification of participants, a ‘third party’ who is a member of the direct care \nteam within Barts Health NHS Trust, who is not a member of the study team, will link the \nNHS numbers to secondary care data, and send a request to the Data Discovery Service \n(held at North East London ICB), in order to gain access to primary care free-text notes. \nThe third party will then remove the NHS number and replace it with a pseudonymous \n‘PERSON_ID’, and disclose the free text data back to the applicants, alongside \npseudonymous structured data extracted from medical records. Barts Health NHS Trust \ndata warehouse team will hold the pseudonymisation key. ‘s251’ support is still required at \nthis stage, as although the structured data is pseudonymised, the researchers still have \naccess to the free text documents provided, and it is expected that these may contain \nconfidential patient information. \n\nFree-text information will then be fed into Clinithink's NLP tool, Clix, by the researchers. The \ntool will extract an anonymised dataset including biopsychosocial variables from the text, \nand will not extract sensitive and personal information which could be used to identify a \npatient. In order to verify that Clinithink has performed this task correctly, the direct care \nteam will audit the data extracted from the free-text to ensure it is free from confidential \npatient information. This will involve cross-referencing a random sample of patient notes \nagainst the information extracted by Clinithink. Should identifiable information be extracted, \nthe NLP queries will be amended and the extraction process re-run. Following a satisfactory \naudit, the free-text information will be deleted. The retained data will then be analysed and \nused to develop a series of diagnostic and prognostic models for lung cancer. Upon \nconclusion of the study, the generated research datasets will be stored in the Trust \nCorporate Records Centre for 5 years, in accordance with the sponsors archiving SOP and \nthe UK Policy Framework for Health and Social Care Research. "]
["Applicant Organisation Name","Barts Health NHS Trust"]
["Contact Name","Dr John Conibear"]
["Address","Consultant Clinical Oncologist, Barts Health NHS Trust"]
[null,"Canary Wharf, 8th Floor, 20 Churchill Place"]
[null,"London"]
["Postcode","E14 5HJ\r"]
["Telephone","07779 785642"]
["Email","john.conibear@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","ll patients aged ≥ 40 years old, who have received a chest xray at any of the hospitals within Barts Health NHS Trust between 01 Jan 2016 – 31 Dec 2019 AND 01 Jan 2022 – 31 \nDec 2022, with at least one primary or secondary care data entry after the initial chest x-ray\n\nApproximately 250000 individuals (5000 patients with a positive diagnosis for lung cancer and 245000 with no diagnosis of lung cancer)\r"]
["Description of confidential patient information used","Data sources\n\n1. Barts Health NHS Trust;\n\na. Secondary care data; \ni. Electronic medical records\nii. The referral letter for the chest x-ray \nPage 4 of 9\niii. Report from the chest x-ray \niv. Free-text medical records 1-year prior to the \nchest x-ray \nv. Free-text pathology records for the subsequent \n3 years and 364 days after the chest x-ray \n\nNorth East London ICB (data processor Voror Health Technologies Ltd);\n\na. Discovery Data service - Primary care data; \n(primary care facilities across Northeast London)\ni. Free-text medical records 1-year prior to \nthe chest x-ray \nii. The subsequent free-text GP record \nfollowing the scan \n\nIdentifiers required for identification of eligibility purposes, and running through NLP\n\n1. NHS Number\n2. Full Health Record (free text notes)\n3. Date of death\n\nIdentifiers required for analysis purposes\n\nAnalysis will be on an effectively anonymised dataset –\n1. sex\n2. ethnicity \n3. occupation \n4. post code will be modified to Indices of social \ndeprivation\n5. Date of death will be modified to time from diagnosis \nto death"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2023-03-27"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in April 2024 that ‘s251’ support could be expired, as processing of confidential patient information without consent and outside the direct care team is not occurring. Pseudonymised data was received from NEL ICB and therefore support for the transfer of such data is no longer required. With regards to free-text data, natural language process was applied to transform the unstructured data into pseudonymised structured information. Additionally, Barts Health NHS Trust now recognises data scientists as members of the direct care team given the nature of their role. As such, no individual outside the direct care team requires access to identifiable data without consent.\n\n\n\nThe application, to allow the disclosure of confidential patient information to researchers, who are not considered direct care team, at Barts Health NHS Trust, during the process of identifying and screening the cohort for eligibility, linking primary and secondary data within the Trust systems, and using Clinithink's NLP tool (Clix) to extract an effectively anonymised structured dataset from free-text data,  and also to allow (as part of this process) the disclosure of confidential patient information from Barts Health NHS Trust to North East London ICB (and its data processor Voror Health Technologies Ltd), in order to link to primary care data held by the Data Discovery Service, and provide this information back to Barts Health NHS Trust, is fully supported, subject to compliance with the standard conditions of support\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 23 March 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 21/22 DSPT review for Barts Health NHS Trust, Voror Health Technologies Ltd and North East London ICB were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (03 February 2023)\n"]

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[]
[]
["Application Number","A02760"]
["Reference","23/CAG/0002"]
["Other Refs","IRAS Project ID: 316920  REC Reference: 23/NE/0007\r"]
["Application Title","Haematological inflammatory markers and survival in \nmesothelioma"]
["Application Summary","This application from University Hospitals of Leicester NHS Trust set out the purpose of \nmedical research that seeks to contribute to the body of evidence on the role on \ninflammation in MPM prognosis, specifically within a UK population, where very few studies \nhave been conducted in this regard. \n\nMalignant pleural mesothelioma (MPM) is an uncommon cancer which is related to previous \nasbestos exposure. The disease has a poor survival, with studies quoting a median overall \nsurvival (OS) time of 9–17 months regardless of the tumour stage at diagnosis. The British \nThoracic Society mesothelioma guideline quotes a high neutrophil-lymphocyte ratio (NLR) \nas an independent predictor of poor survival in MPM. However, there is limited evidence on \nother prognostic inflammatory markers such as the platelet-lymphocyte ratio (PLR), \nlymphocyte-monocyte ratio (LMR) and systemic immune inflammation index (SII) in the \nliterature. These markers have been well-studied in other cancer sites, such as lung cancer, \nand have been associated with similar poor survival. \n\nConfidential patient information from the mesothelioma MDT database at the University \nHospitals of Leicester NHS Trust will be disclosed to the Chief Investigator, who is not \nconsidered direct care team, and therefore requires ‘s251’ support. The Chief Investigator \nwill use the hospital number to obtain data from medical records of all patients with a pleural \nmesothelioma diagnosis from 2014-2021 (expected to number 250 to 300 patients). Date \nof death will be used to calculate overall survival time from diagnosis in days. It will be \ndeleted from the database once this has been calculated, and analysis will be undertaken \non an effectively anonymous dataset.\n\n"]
["Applicant Organisation Name","University Hospitals of Leicester NHS Trust"]
["Contact Name","Dr Claire Vella, Consultant Respiratory Physician with a special interest in Lung Cancer "]
["Address","Glenfield Hospital "]
[null,"University Hospitals of Leicester NHS Trust "]
[]
["Postcode"]
["Telephone"]
["Email","claire.vella@uhl-tr.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All University Hospitals of Leicester NHS Trust patients aged 18 \nyears and above, with a pleural mesothelioma diagnosis from \n2014-2021 (expected to number around 250-300 patients)\r"]
["Description of confidential patient information used","Data sources\n\nUniversity Hospitals of Leicester NHS Trust\n\n1. Mesothelioma MDT database (local cancer register)\n2. Patient medical records\n\nIdentifiers required for linkage purposes\n\n1. Hospital number\n\nIdentifiers required for analysis purposes\n\n1. Date of death will be used to calculate overall survival time from diagnosis in days. It will be deleted from the database once this has been calculated."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-03-22"]
["Next Review Date","2024-03-22"]
["Notes","Amendment supported 12 October 2023 to extend the duration of support until 28 February 2024\n\nSpecific conditions of support \n \n1.\tThe poster needs to be revised, as below: \n \na.\tThe typographical error in paragraph 5, “No identifying data will be retained or presenting” needs to be corrected.    \n \nb.\tA telephone and postal address needs to be provided, for patients to make contact and register dissent to use of their information.  \n \nCondition met 04 April 2023\n\n2.\tThe specific question about the acceptability of use of confidential patient information needs to be put to the CEO of Mesothelioma UK and their response provided back to the CAG within 3 months of the issuing of this letter. \n \nCondition met 04 April 2023\n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed 10 January 2023 \n \n4.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS Digital 21/22 DSPT review for University Hospitals of Leicester NHS Trust was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (24 January 2023) \nAs the above conditions have been accepted and/or met, this letter provides confirmation of final support. I will arrange for the register of approved applications on the HRA website to be updated with this information. \n\n"]

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[]
[]
["Application Number","02761"]
["Reference","23/CAG/0012"]
["Other Refs","IRAS Project ID: 319652  REC Reference: 23/SW/0010"]
["Application Title","Utilising data linkage to investigate the health impact of carrier status for common genetic disorders"]
["Application Summary","This application from Cardiff University set out the purpose of medical research that seeks to explore the effects on health of carrying the Cystic Fibrosis gene.\n\nCystic fibrosis (CF) is a common life-limiting genetic disease. A person is affected by CF when they inherit two changed copies of the CFTR gene. Individuals with only one changed copy are called 'carriers'. Carriers are usually unaffected by severe disease. However, there is emerging evidence that being a carrier for conditions such as CF may still have health implications that are not well understood. This study aims to examine the health implications for CF carriers in the Welsh population. \n\nThe applicants will collect CF genotype data from the All Wales Medical Genomics Service (AWMGS). The CF genotype data will be pseudonymised and submitted to the Secure Anonymised Information Linkage (SAIL) Databank. In SAIL the CF genotype data will be linked to anonymised health data from the Welsh population.\n\nConfidential patient information from the CF genotypes database at All Wales Medical Genomics Service (AWMGS) will be submitted securely to Digital Health and Care Wales (DHCW). The data will be separated into demographic and clinical information. Confidential patient information will be removed from the demographic data and replaced with an Anonymous Linking Field (ALF), allowing linkage to electronic health records within the SAIL Databank. The clinical data will be imported to SAIL directly and recombined in SAIL to give the recombined, anonymised CF-carrier cohort consisting of genotypes linked with data from the electronic health records. Control data will be exclusively sourced from existing data held by SAIL and support for matching controls to the project data will be provided by a SAIL engineer. The researcher will access the linked dataset within the Secure eResearch Platform (SeRP) through SAIL Gateway exclusively. No data will be disclosed to Cardiff University systems at any point. \n"]
["Applicant Organisation Name","Cardiff University"]
["Contact Name","Dr Andrew Fry "]
["Address","Clinical Senior Lecturer in Medical Genetics  "]
[null,"University Hospital Wales "]
[null,"Heath Park, Cardiff "]
["Postcode","CF14 4XW "]
["Telephone","+44 (0)2921 84 3151"]
["Email","FryAE@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients who are:\n\nCF-carriers (patients with a genetic test result consistent with a diagnosis of heterozygous for one CF causing mutation on the CFTR gene according to the CF8 or EU2-50 mutation lists)\nCF-patients (patients with a genetic test consistent with homozygous or compound heterozygous for CF-causing mutations in the CFTR gene according to the CF8 or EU2-50 mutation lists\nPatients who underwent CF-screening and came back negative \nControl groups (a suitable age- and sex- matched control group with 10 controls per CF carrier derived from the general Welsh population)\n\n4000 is the total UK patient sample size, plus 40,000 controls. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tAll Wales Medical Genomics Service (AWMGS), hosted by Cardiff and Vale University Health Board\n2.\tSAIL Databank\n\nIdentifiers required for linkage \n\n1.\tName\n2.\tNHS number\n3.\tDate of birth\n4.\tPostcode\n\nIdentifiers required for analysis purposes\n\n1.\tPostcode\n2.\tGender\n3.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Expired"]
[]
["Outcome Date","2023-04-03"]
["Next Review Date","N/A"]
["Notes","Applicant confirmed in April 2024 that ‘s251’ support could be expired, as all identifiable patient information held without consent under this support has been pseudonymised, and the applicant does not have access to any means of re-identifying.\n\nIn terms of public benefit, ‘s251’ support has allowed the applicant to index the tested people with CF (pwCF) and CF carriers populations in Wales and have begun to use linked data for these people to ask questions about the impact being a CF carrier has on a persons health, how well distributed genetic testing is socioeconomically, and further to collaborate with clinical colleagues to calculate up to date mutation frequencies for CF in the Welsh population. \n\nUpdated mutation frequencies will make a direct contribution to clinical risk assessment for CF families. \n\nAs with many research studies, the benefit to specific individuals whose data form a part of the study is unlikely to be significant, but this project is allowing us to learn lessons about adapting routine testing data for linkage studies, which will make more resources available for public health research concerning genetic testing efficacy, service provision, and epidemiology. These insights will help ensure that public data is used to its greatest effect.  \n\n\nConditions of support:\n\n1.\tFeedback on the reception of the presentation given to 10-14-year-olds is to be provided at the first annual review.  \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 02 March 2023. \n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nSAIL Databank and SeRP (within Swansea University) – DSPT in place for 2021/22 \n\nCardiff and Vale University Health Board – CPiP in place \n"]

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[]
[]
["Application Number","A02762"]
["Reference","23/CAG/0032"]
["Other Refs","IRAS Project ID: 293404  REC Reference: 23/LO/0253"]
["Application Title","Natural language processing of histopathology reports"]
["Application Summary","This application from University College London set out the purpose of medical research \nthat seeks to investigate use of natural language processing (NLP) in the analysis of \nhistopathology reports.\n\nHistopathology is a medical specialty in which cellular and tissue specimens from patients \nare examined to identify and characterise disease. Histopathological findings are described in histopathology reports. These contain a wealth of information of clinical and scientific value; however, analysing them in a systematic way at scale in an automated manner is generally not possible because of their unstructured nature. The applicants seek to establish a dataset of histopathology reports from multiple NHS Trusts. Natural language processing (NLP), a computational methodology used to process, analyse and extract information from natural language text, will be implemented to enable high quality, reliable and accurate data extraction at scale. In doing so, this study aims to provide novel \npathological, epidemiological and clinical insights.\n\nPatients at participating NHS trusts will be identified by the pathology or informatics \ndepartment by staff with an existing legal basis to process the data. The data will be \nanonymised as much as possible prior to transfer to University College London. However, \nthe applicants stated that items of confidential patient information could be included in the \nfree text health data, as it was not possible to guarantee that data was completely de-identified. To enable data from the same individual both within and across different NHS Trusts to be linked, the NHS number will be converted into a pseudonymised identifier via a unidirectional hash algorithm with a shared key that is held by each NHS Trust and not accessible to researchers."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Adam P. Levine, NIHR Academic Clinical Lecturer in Histopathology"]
["Address","UCLH Cellular Pathology"]
[null,"60 Whitfield Street"]
[null,"London"]
["Postcode","W1T 4EU"]
["Telephone",7875741050]
["Email","a.levine@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients at participating hospital NHS Trusts who had a \nhistopathology specimen processed from the time of \ncommencement of computerised pathology records \n(approximately 01/01/1990)\r"]
["Description of confidential patient information used","Data sources\n\n1. Electronic patient records at participating NHS trusts\n\nIdentifiers required for linkage puposes\n\nNone\n\nIdentifiers required for analysis purposes\n\nNone"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-04-06"]
["Next Review Date","2024-04-06"]
["Notes","Amendment supported 11 October 2023 to include Whittington Health NHS Trust, North Middlesex University Hospital NHS Trust and Homerton Healthcare NHS Foundation Trust, as participating sites and data processors for the study\n\nAmendment supported 14 August 2023  to include Great Ormond Street Hospital Trust and Barts Health NHS Trust as participating sites and data processors for the study, and to include date of death as an item of confidential patient information collected\n\nConditions of support:\n\n. The patient notification needs to be revised as follows: \na.\tA clear opt-out process needs to be described.  \nb.\tThe patient notification materials need to be reviewed by lay people.  \n \nCondition met as of 07 July 2023. \n\n2.\tConsider whether an email address should be provided for each participating trust, should patients wish to opt-out or have questions about the study. This needs to be reported back on at the first annual review. \n \nCondition met as of 07 July 2023. \n\n3.\tPlease report at annual review whether any items of confidential patient information have been found in the free text data.  \n\n4.\tIf a research database, for use by organisations other than University College London, will be created then a research database application will need to be submitted.  \n\n5.\tAn amendment is to be submitted if additional data processors are included.   \n \nFavourable opinion from a Research Ethics Committee. Confirmed 16 March 2023. \n \nConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Pending: \n \nConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: As there are more than 5 organisations processing confidential patient information, these will not be individually checked by the CAT team, and it is the responsibility of the applicant to ensure the DSPTs for these organisations have been assessed as ‘standards met’ by NHS Digital \n\n"]

{"sheet":"A02763","index":804,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02763"]
["Reference","23/CAG/0034 "]
["Other Refs","IRAS Project ID: 319964 REC Reference: 23/WS/0008"]
["Application Title","Precision Treatment Strategies in Multiple Sclerosis Using Next-generation Machine Learning"]
["Application Summary","This application from University College London set out the purpose of medical research \nthat seeks to explore how multiple sclerosis types that will predict treatment effects and the \nrisk of worsening disability can be redefined.\n\nMultiple sclerosis (MS) is an incurable disease, but more than 15 treatments are in \nexistence that can help to modify its course. These treatments vary in strength and the risk \nof side effects. It is known that the stronger treatments delay disability, but many have \ngreater risks, alongside more demanding administration and monitoring schedules. As \nbalancing the harms and benefits of the treatments is challenging, many patients switch \ntherapies within two years of initiating therapies. The applicants seek to define MS types \nbased on the underpinning pathobiological changes to address these ambiguities and \nbenefit patients by recommending the right treatment to the right patients according to \nbiological sub-types.\n\nCare teams at participating trusts will review patient records to identify eligible patients and \ncompile a list of patients. The care team and the research team within the trusts will extract \nthe required data from electronic health records and linked to MRI data. All confidential \npatient information will be stored and analysed within individual trusts and will not be \ndisclosed outside the trust."]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Arman Eshagh, NIHR Advanced Fellow"]
["Address","10-12 Russell Square\r"]
[null,"Russell Square House\r"]
[null,"London\r"]
["Postcode","WC1B5EH\r"]
["Telephone",2031087420]
["Email","arman.eshaghi@gmail.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over and diagnosed with multiple sclerosis at participating NHS Trusts within the last 20 years. \n\n13,000 patients will be included. "]
["Description of confidential patient information used","Data sources \n\n1. Patient records at participating NHS trusts:\na. University College London Hospitals NHS \nFoundation Trust\nb. Imperial College NHS Healthcare Trust\nc. Sheffield Teaching Hospitals \nd. King’s College Hospital NHS Foundation Trust \ne. Public Health Wales NHS Trust \nf. Cambridge University Hospitals NHS Foundation \nTrust\ng. Leeds Teaching Hospitals NHS Trust\nh. Barts Health NHS Trust \ni. University Hospital Coventry and Warwickshire \nNHS Trust\nj. NHS Bedfordshire, Luton and Milton Keynes \nIntegrated Care Board\n\nIdentifiers required for linkage purposes\n\n1. NHS number\n2. Hospital ID number\n\nIdentifiers required for analysis purposes\n\n1. Ethnicity\n2. Patient reported sex"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-04-06"]
["Next Review Date","2024-04-06"]
["Notes","Amendment supported 31 August 2023 \nTo include Nottingham University Hospitals NHS Trust as an additional participating site, and new data processor under ‘s251’ support, and to clarify that Public Health Wales is replaced with University Hospital of Wales (which his part of Cardiff and Vale University Health Board), and Bedfordshire Integrated Health Board is replaced with Bedfordshire Hospitals NHS Foundation Trust.\n\nSpecific conditions of support \n\n1.\tClarify when all patient identifiers will be deleted from the dataset. \n\nCondition met 28 April 2023.\n\n2.\tConfirm that no items of confidential patient information will be included in the dataset disclosed from participating trusts.\n\nCondition met 28 April 2023.\n\n3.\tPatient notifications need to adopt a layered approach making simple, easy-read versions available, with more detailed information to be provided on request. Please provide posters in clinical areas including QR codes or links leading to further information.\n\nCondition met 28 April 2023.\n\n4.\tThe study specific opt out option needs to be displayed more prominently than the National Data Opt-out. \n\nCondition met 28 April 2023.\n\n5.\tFavourable opinion from a Research Ethics Committee. Confirmed 24 January 2023.\n\n6.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of participating organisations involved it is the responsibility of researcher as controller, to ensure that participating Organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n\nAs the above conditions have been accepted or met, this letter provides confirmation of final support.  I will arrange for the register of approved applications on the HRA website to be updated with this information.\n\n"]

{"sheet":"A02764","index":805,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02764"]
["Reference","22/CAG/0120"]
["Other Refs","IRAS Project ID: 290705   REC Reference: 22/EE/0085"]
["Application Title","A Retrospective Follow-up of Two Services for High Risk Offenders with Personality Disorder"]
["Application Summary","This application from the East London NHS Foundation Trust set out the purpose of medical research that seeks to evaluate re-offending and psychosocial wellbeing outcomes after interventions provided by two Offender Personality Disorder (OPD) Pathway programmes.\n\nPersonality disorders (PDs) are a group of mental health disorders that are characterised by inflexible, maladaptive patterns of behaviour, emotional expression and cognition. These patterns are long-standing and affect a range of personal and social situations. The Offender Personality Disorder (OPD) Pathway programme is a jointly commissioned initiative between NHS England and Her Majesty’s Prison & Probation Service. It encompasses psychologically informed services for offenders who are likely to have a PD. These treatment services are set in prisons, secure hospitals, and community settings, and all aim to reduce repeat offending and improve psychological wellbeing. There is limited evidence that various treatments have a positive impact of recidivism rates and psychological behaviours and behavioural outcomes among personality disordered offenders, however few follow-up studies have been undertaken. The applicants are seeking to examine the long-term psychosocial and reoffending outcomes, and the impact of services on sentence progression, for all men who have passed through two OPD Pathway services since they opened; a Psychologically Informed Planned Environment (PIPE) at HMP Swaleside and an adapted therapeutic community model run by the Millfields Unit. Data will be gathered from existing service, prison, probation and police records. The results could help to inform the future development and improvement of similar services, in order to improve the availability and effectiveness of services supporting offenders with PD. \n\nResearch teams at Millfields Unit and Swaleside will identify suitable patients from their local records. At the Millfields Unit, patient names and dates of birth will be transferred to a password-protected database and assigned unique study IDs. This database, which will include confidential patient information and the unique study IDs will be transferred to HMP Swaleside via encrypted email."]
["Applicant Organisation Name","East London NHS Foundation Trust"]
["Contact Name","Dr Celia Taylor "]
["Address","John Howard Centre"]
[null,"12 Kenworthy Road"]
[null,"London"]
["Postcode","E9 5TD"]
["Telephone",2085102624]
["Email","celia.taylor2@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All men who have ever been admitted to and discharged from the Millfields Unit between 01 January 2005 – 31 December 2021 or the PIPE at HMP Swaleside between 01 January 2014 – 31 December 2021 \n\nFor the control group, men who were referred to the PIPE, but not admitted, between 01 January 2014 – 31 January 2019 are eligible for inclusion. 150 patients will be included in the control group. \n\nApproximately 80 patients will be recruited from Millfields Unit and 100 from Swaleside PIPE.\n"]
["Description of confidential patient information used","Data sources\n\n1. Patient records at the Millfields Unit (East London NHS Trust) and HMP Swaleside\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. Date of birth\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth \n2.\tDate of death \n3.\tPrison/hospital security level \n4.\tAccommodation type \n5.\tGender \n6.\tOccupation \n7.\tEthnicity\n\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date"]
["Next Review Date","2024-04-13"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: 22 July 2022.\n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2021/22 DSPT review for East London NHS Foundation Trust is confirmed.\n"]

{"sheet":"A02765","index":806,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02765"]
["Reference","23/CAG/0021"]
["Other Refs","IRAS Project ID: 302622  REC Reference: 22/SW/0130"]
["Application Title","CSOR: Children’s Surgery Outcome Reporting Research Database v1.0"]
["Application Summary","This application from National Perinatal Epidemiology Unit, University of Oxford set out the purpose of creating a research database containing data relating to children treated for necrotising enterocolitis (NEC), Hirschsprung’s disease (HD), gastroschisis, posterior urethral valves (PUV), congenital diaphragmatic hernia (CDH) and oesophageal atresia (OA). \n\nThe database will be comprised of three linked sources of data about children with specific surgical conditions. The data collected will be used to identify unwarranted variation in practice and for the conduct of approved research to improve outcomes for children with these conditions. A consented and an unconsented cohort will be included in the database. Should local site staff, which may be either the clinical care team and research nurses, come into contact with the parents of a child who is eligible for participation, they will speak to the parents about the CSOR database. Patients may also be flagged to the CSOR Research Database team via a flag placed on the infant's electronic patient record (EPR), highlighting that infant’s data for extraction, by the presence of an ICD10 code in the NHS England record of a child who has been admitted to one of the participating sites over the past month, or via parental self-registration through the CSOR parent portal. \n\nSupport under s251 is required to allow collection of confidential patient information for eligible children directly from the EPR at participating trusts and HES data from NHS England without consent. Surgeons at participating trusts will flag the records of eligible patients in their trusts EPR. Monthly reports of eligible infants will be generated by hospital Informatics teams at participating trusts and transferred to Oxford University Hospitals NHS Foundation Trust. Confidential patient information will be disclosed from Oxford University Hospitals NHS Foundation Trust to NHS England for linkage to the HES dataset. A monthly extract of confidential patient information for patients meeting the eligibility criteria will also be provided by NHS England. The research data will be linked and pseudonymised by staff at Oxford University Hospitals NHS Foundation Trust and the pseudonymised dataset transferred to the University of Oxford for analysis. Quality of life data will also be collected from parents of a consented subset of these infants and linked to data collected from the other sources.\n"]
["Applicant Organisation Name","National Perinatal Epidemiology Unit, University of Oxford"]
["Contact Name","Professor Marian Knight "]
["Address","Department for Population Health "]
[null,"Old Road Campus, Headington "]
[null,"Oxford"]
["Postcode","OX3 7LF "]
["Telephone",1865289727]
["Email","marian.knight@npeu.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children diagnosed with any of the following six conditions: 1.Hirschsprung’s disease \n2.Oesophageal atresia \n3.Gastroschisis \n4.Necrotising enterocolitis \n5.Posterior urethral valves\n6.Congenital diaphragmatic hernia  \n\nWho were admitted to any of the participating sites.\n"]
["Description of confidential patient information used","Data sources\n\n1. Hospital Episode Statistics (HES) dataset, NHS England \n2. Infants' Electronic Patient Records, held at participating sites:\na. Oxford University Hospitals NHS Foundation Trust \nb. Southampton Children’s Hospital \nc. Alder Hey Children’s Hospital \nd. Manchester Children’s Hospital \ne. Great Ormond Street Hospital for Children\nf. Chelsea and Westminster Hospital \ng. Addenbrookes Hospital, Cambridge \nh. Birmingham Children’s Hospital \ni. Evelina Children’s Hospital, Guy's and St Thomas' NHS Foundation Trust \n3. Parent (participant) provided Schedule for the Evaluation of Individual Quality of Life – Direct Weighting (SEIQoL-DW) data\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS number \n3. GP Registration \n4. Date of birth \n5. Date of death \n6. Postcode – unit level\n\nIdentifiers required for analysis purposes\n\n1. Postcode – unit level \n2. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date"]
["Next Review Date","2025-04-17"]
["Notes","Amendment supported 15 December 2023 to include the communications service vital status check as an additional NHS England data source, and to include Parental/next of kin name (s), Parental/next of kin postal address (es), Parental/next of kin telephone numbers (including mobile numbers), and Parental/next of kin email address(es) as additional data items\n\nAmendment supported 13 October 2023 to include Civil registration – Deaths and demographics dataset as additional NHS England data sources, and to include date of death as an additional data item\n\nAmendment supported 20 June 2023 to include the use of the NHS England Communications Service, to increase the frequency of disclosures of confidential patient information between University of Oxford and NHS England to weekly, and to clarify that ‘s251’ support is in place for the disclosure of confidential patient information from Oxford University Hospitals NHS Foundation Trust to the University of Oxford.\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed (Favourable Opinion issued 10/11/2022) \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nDue to the number of NHS Trusts involved, it is the responsibility of NHS England, as controller, to ensure that NHS Trusts meet the minimum required standard in complying with DSPTs and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a Trust. \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02766","index":807,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02766"]
["Reference","21/CAG/0092"]
["Other Refs","IRAS Project ID: 298182  REC Reference: 21/SC/0178"]
["Application Title","Pre-hospitAl RAndomised trial of MEDICation route in out-of-hospital cardiac arrest (PARAMEDIC3)"]
["Application Summary","This application from the University of Warwick sets out the purpose of medical research that seeks to determine whether giving drugs through a vein or into the bone improves survival at 30-days in adults that have an out-of-hospital cardiac arrest.\n\nCardiac arrest is an important health condition. Each year NHS ambulance services treat 30,000 patients who have experienced an out-of-hospital cardiac arrest (OHCA). Survival is poor, with less than 10% of patients surviving to hospital discharge. The main treatments for cardiac arrest are chest compressions, defibrillation, artificial ventilations and drug treatments. The results of the previous PARAMEDIC-2 trial, conducted by the same applicants, had shown that drug treatments are effective at restarting the heart. However, in the PARAMEDIC-2 trial, the drug treatments were given 21 minutes after the cardiac arrest, on average. This delay likely influenced the effectiveness of the treatment. The statistical analysis from that study showed that, for every one-minute reduction in the time taken to give treatment, survival increased by 0.7%. Currently, guidelines advise that paramedics administer drugs into a vein, referred to as intravenous (IV) route. It can take several minutes to insert a drip into a vein. If paramedics are unable to insert the drip after two attempts, then an alternative form of vascular access, intraosseous route (IO) may be used. IO is a faster way of giving drugs, which involves the insertion of a small needed into an arm or leg bone, and allows drugs to be injected directly into the rich blood supply found in the bone marrow. It is currently unknown whether use of IO access, rather than IV access, as a first attempt would allow vascular access to be obtained more quickly and, consequently, improve survival. Data from research audits has found that use of the IO route has doubled between 2014 and 2018 and the London Ambulance Service reported that the amount of money spend on IO equipment has doubled over a two-year period, which provides evidence of a change in clinical practice in the absence of evidence. The International Liaison Committee on Resuscitation (ILCOR) have conducted a systematic route in which they evaluated the current studies on IO and IV routes for administering drugs, and concluded that there is insufficient evidence to support the routine use of IO access and highlighted the need for a randomised controlled trial to determine the most effective approach. \n\nPatients that sustain an out-of-hospital cardiac arrest will be enrolled into the trial by the treating ambulance clinician. On arrival at the scene, the treating ambulance clinician will assess patient eligibility and, where appropriate, randomise the patient to receive either IO (the intervention arm) or IV (the control arm) as a first strategy. For patients randomised to the intervention group, initial vascular access attempts will be via the IO route and two attempts at vascular access will be made. Once IO vascular access has been successfully achieved, cardiac arrest drugs (including fluid) will be administered through the IO cannula. If the treating clinician has made two attempts at vascular access via the IO route and been unsuccessful at both attempts, then further attempts at vascular access may be made via the IO or IV route at the clinician’s discretion. In patients randomised to the control group, initial vascular access attempts will be via the intravenous route and the usual NHS guidelines will be followed. The treating paramedics will inform the treating hospital that the patient has been recruited into PARAMEDIC-3 on the patient report form, routinely used by ambulance services to record the treatment received from the ambulance service. The ambulance service NHS trust research team will also be informed via the patient report form or other secure communication method, such as telephone call or secure email. Once the research paramedic is aware of the recruitment, they will enter the patient’s information on to the secure Warwick CTU database. \n\nInformation about patients’ cardiac arrest and hospital stay will be collected from patients’ records by research paramedics and from other data linkage sources. Long-term follow up will be conducted at 3 and 6 months following randomisation, to investigate how patients recover from their cardiac arrest. Survival status will be obtained from NHS Digital or other electronic data sources. Quality of life questionnaires will be posted by the research paramedics to the patient for completion at 3 and 6 months, and patients will be asked to return these to the Warwick CTU. Alternatively, if the research paramedic completed the follow up questionnaire with the patient over the telephone or in person, the research paramedic will enter the participant’s responses directly on to the CTU database. These questionnaires may be completed on the participant's behalf by someone that has a good awareness of their health state. \n\nAll patients will be unconscious at the time of treatment, therefore patients will be recruited under a deferred consent model, in accordance with the Mental Capacity Act 2005. The applicants are seeking support to process confidential patient information for all patients from the end of the emergency event until patient death or until either patient consent or a consultee opinion is obtained. For non-survivors, support is needed for the collection of confidential patient information from the treating hospital and linkage to other data sources. For surviving patients, confidential patient information will be collected until either the patient or a consultee explicitly refuses agreement to the processing of their confidential patient information. If the patient survives but the researchers are unable to contact the patient or a consultee to seek consent, support will also be needed to continue to collect confidential patient information and link to other data sources. \n\nConfidential patient information will also be disclosed from the Warwick CTU to NHS Digital, the Out-of-hospital cardiac arrest outcome registry, the Intensive Care National Audit and Research Centre (ICNARC), the Patient Episode Database for Wales (PEDW), the National Institute for Cardiovascular Outcomes Research (NICOR), ONS mortality data, GP records, the UK Transplant Registry (UKTR) and Health Data Research UK (HDR UK).\n\n\nNotes:\n•\tSome aspects of the study are under a consented model and are therefore outside the scope of this support.\n•\tThe study also uses an emergency research model under the Mental Capacity Act 2005. REC have a specific remit to approve studies using this design and this application currently has a REC Provisional Outcome (outcome email included). Under the process, treatment under this study may be started prior to either consent from the participant or a consultee declaration under the Mental Capacity Act given the emergency nature. \n•\tOnce the urgent phase of treatment is over the research team will either gain consent from surviving patients (where there is capacity) or advice from a consultee (where there is no capacity). Advice received from senior HRA staff for other applications with a similar design is that “where it is required for persons to assess the eligibility of a person for a medical intervention (even in the research setting) those persons should not be regarded as outside of the care team.  They are integral to the care team, in the situation at hand.  Their legal basis for access is necessity for care purposes. As such, any review of medical records prior to consent is outside the scope of support as the legal basis for access is direct care.\n•\tPatients who lack capacity will, under approved processes through the Mental Capacity Act, continue to be included in the study following consultee advice from a relative or potentially a clinician independent from the research. As above, advise has previously been sought by the CAT as to whether this was sufficient for onward sharing of confidential patient information under the common law duty of confidentiality. The advice received was that “consultee advice will not meet the DPA threshold for being considered consent but will meet that under common law.  With GDPR we moved strongly away from reliance upon consent as a statutory legal basis so this negates the DPA issues.  So, from a common law perspective, we can regard consultee advice as adequate for disclosure. As such, any disclosure of confidential patient information under consultee advice meets the common law duty of confidentiality.\n•\tFor patients who do not survive, s251 support is sought to process confidential patient information for these patients. \n•\tTo reiterate – the REC have a specific remit regarding MCA processes and, while the REC have requested changes to correct the terminology for Consultees is used in the study documentation, the REC have raised no major concerns over the study design.\n\nHowever, there are a small proportion of patients that will have died or been discharged prior to gaining any form of consent or consultee advice. As such there is no legal basis for the sharing of confidential patient information from Trusts to University of Warwick, and for the onward linkage with NHS Digital, NWIS and ICNARC, etc. and support will also be needed for this processing. \n"]
["Applicant Organisation Name","University of Warwick"]
["Contact Name","Professor Gavin Perkins"]
["Address","University of Warwick"]
[null,"Gibbet Hill Road"]
[null,"Coventry"]
["Postcode","CV4 7AL"]
["Telephone","02476 150925"]
["Email","g.d.perkins@warwick.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 18 years and over who have experienced an out of hospital cardiac arrest. \n\n15,000 patients will be included, recruited on a 1:1 ration between control and intervention. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tParticipating NHS hospital trusts – to be confirmed\n2.\tParticipating NHS ambulance trusts:\na.\tNorth East Ambulance Service NHS Foundation Trust\nb.\tNorth West Ambulance Service NHS Trust\nc.\tWest Midlands Ambulance Service University NHS Foundation Trust\nd.\tEast Midlands Ambulance Service NHS Trust\ne.\tSouth Western Ambulance Service NHS Foundation Trust \nf.\tSouth Central Ambulance Service NHS Foundation Trust\ng.\tSouth East Coast Ambulance Service NHS Foundation Trust \nh.\tLondon Ambulance Service NHS Trust \ni.\tEast of England Ambulance Service NHS Trust\nj.\tWelsh Ambulance Services NHS Trust \nk.\tPotentially the Yorkshire Ambulance Service NHS Trust (participation to be confirmed).\n3.\tHES and Mortality datasets at NHS Digital \n4.\tOut-of-hospital cardiac arrest outcome registry\n5.\tIntensive Care National Audit and Research Centre (ICNARC)\n6.\tPatient Episode Database for Wales (PEDW)\n7.\tNational Institute for Cardiovascular Outcomes Research (NICOR)\n8.\tONS mortality data\n9.\tGP records\n10.\tUK Transplant Registry (UKTR)\n11.\tHealth Data Research UK (HDR UK)\n\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tDate of birth\n4.\tDate of death\n5.\tPostcode – unit level\n6.\tEthnicity\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death\n3.\tPostcode – unit level\n4.\tGender \n5.\tEthnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2021-07-22"]
["Next Review Date","2024-07-22"]
["Notes","\n\n07 September 2023 - change in data processor from\n\n•\tNHS Digital to NHS England regarding data sources – Hospital Episode Statistics (HES) and office for National Statistics (ONS) Mortality Data\n•\tBarts Health NHS Trust to NHS Arden and Greater East Midland Commissioning Support Unit (Arden & GEM) & Redcentric (Harrogate), regarding data source - National Institute for Cardiovascular Outcomes Research, (NICOR) database\n\n\nConditions of support:\n\n1. Further patient and public involvement is to be undertaken while the study is \nongoing. This further involvement is to include the families of those who had suffered \ncardiac arrest and to explore their views on the issue. Feedback is to be provided at \nthe first annual review. Condition met 07 September 2023\n2. Favourable opinion from a Research Ethics Committee. Confirmed 12 July 2021\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the \nrelevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved \nthe ‘Standards Met’ threshold. See section below titled ‘security assurance \nrequirements’ for further information.\n• The NHS Digital DSPT review for University of Warwick Clinical Trials Unit \nfor 2019/20 was confirmed as ‘Standards Met’ on the NHS DSPT Tracker \n(checked 12 July 2021).\n"]

{"sheet":"A02767","index":808,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02767"]
["Reference","23/CAG/0041 "]
["Other Refs","IRAS Project ID: 312387  REC Reference: 23/SW/0034"]
["Application Title","Management of Patients with Chronic Liver Disease \nAdmitted to Hospital as an Emergency: MAP-CLD Social \nScience (CAG)\r"]
["Application Summary","This application from Kings College Hospital NHS Foundation Trust set out the purpose of \nmedical research that seeks to explore patients experience of chronic liver disease and \nhow this is impacted by their local healthcare system and their life circumstances. \n\nRecent studies have noted the increasing prevalence of liver disease in the UK, the \nresulting increase in morbidity and mortality, and regional variations in survival. Patients \nwith chronic liver disease (CLD) living in the most deprived areas of England are likely to \ndie nearly 10 years earlier and have a mortality rate nearly twice as high as those living in \nthe most affluent areas. Several factors may cause these unequal mortality rates, including \nvarying access across regions to specialist care, differences in ability to access high \ndependency or ICU units promptly, and continued engagement with liver specialists post discharge.\n\nThe applicants will undertake ethnographic observations of different types of liver services \nto explore the day-to-day running of the services, who and what are present at different \ntimes and places, what is talked about, by whom, when and where. The observations will \nbe conducted at four sites, Kings College Hospital NHS Foundation Trust, the Royal \nBlackburn Teaching Hospital at East Lancashire Hospitals NHS Trust, The William Harvey \nHospital at East Kent Hospitals University NHS Foundation Trust and Derrisford Hospital at \nUniversity Hospitals Plymouth NHS Trust. The researcher will observe team meetings and \nwill shadow clinicians and patients. When patients or clinicians come into incidental contact \nwith the researcher, the lead clinician will introduce the researchers to the patients and ask \nfor verbal consent for the researcher to observe. The researcher will also attend clinical \nand multi-disciplinary team meetings, where patients are not in attendance, and patient \ncare is discussed. Support is required for these observations. "]
["Applicant Organisation Name","Kings Healthcare NHS Foundation Trust"]
["Contact Name","Professor Will Bernal, Professor of Liver Critical Care Medicine"]
["Address","Kings Healthcare NHS Foundation Trust"]
[null,"Denmark Hill"]
[null,"London"]
["Postcode","SE5 9RS"]
["Telephone","+44 2032 994 458"]
["Email","william.bernal@kcl.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who have experienced an emergency admission or been seen by outpatient liver or medicine clinics for liver disease in one of the participating trusts."]
["Description of confidential patient information used","Data sources\n\n1. The researcher may be exposed to confidential patient information while undertaking observation of patient care and clinical meetings at the four participating trusts: \n\na. Kings College Hospital NHS Foundation Trust \nb. The Royal Blackburn Teaching Hospital, East Lancashire Hospitals NHS Trust \nc. The William Harvey Hospital, East Kent Hospitals University NHS Foundation Trust \nd. Derrisford Hospital, University Hospitals Plymouth NHS Trust\n\nIdentifiers required for linkage purpose\n\nNo items of confidential patient information are needed for linkage purposes.\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information are needed for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-04-21"]
["Next Review Date","2025-04-21"]
["Notes","Conditions of support:\n\n1.\tThe patient notification leaflet needs to be revised to advise that patients can opt-out by informing their care team or the researcher, in line with the information given on the poster. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 March 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\n\nThe NHS England 21/22 DSPT reviews for King’s College Hospital NHS Foundation Trust, East Lancashire Hospitals NHS Trust, East Kent Hospitals University NHS Foundation Trust and University Hospitals Plymouth NHS Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (18 April 2023)\n"]

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[]
[]
["Application Number","A02768"]
["Reference","23/CAG/0020"]
["Other Refs","IRAS Project ID: 321680  REC Reference: 23/LO/0142"]
["Application Title","Early behaviour predicting adherence to Continuous \nPositive Airway Pressure therapy in patients with \nObstructive Sleep Apnoea: a growth mixture modelling \nanalysis\r"]
["Application Summary","This application from Imperial College London set out the purpose of medical research \nthat seeks to investigate patterns of Continuous Positive Airway Pressure (CPAP) usage \npatients with Obstructive Sleep Apnoea (OSA) develop when they first starting using\nCPAP therapy. \n\nOne billion people worldwide and 8 million people in the UK (24.5% of the population) are \nestimated to have Obstructive Sleep Apnoea (OSA). It is the most common sleep \ndisorder and is characterised by frequent pauses in breathing during sleep due to airway \nblockage, caused by intermittent relaxation of the throat muscles. Patient’s sleep is \nbroken, causing patients to complain of sleepiness, fatigue, difficulty in concentrating, \nmemory impairment and feelings of irritability and depression. Patients’ and their bed \npartner’s, quality of life is reduced. Patients are also at a higher risk of developing Type 2 \ndiabetes, high blood pressure, heart disease, strokes, and are more likely to die of all \ncauses, compared to those without OSA. Patients with OSA may receive CPAP therapy, \nwhere a device with a facemask is worn whilst sleeping. This device delivers air at \npositive pressure. Used regularly, CPAP therapy improves quality of life for patients and \ntheir bed partners and reduces patient’s risk of death. However, within 3 months of \nstarting CPAP therapy, between 48% and 73% of patients are not using CPAP for 4 \nhours per night for 70% of nights. In the UK in 2020, 58% of patients were not using \nCPAP 3 months after beginning therapy. Interventions, such as behavioural interventions, \nhave been developed, however these interventions are complex and are not costeffective or feasible for clinical adoption. The applicants seek to develop an intervention \nwhich can be translated into clinical practice.\n\nThe applicants have already collected data from remote monitoring of CPAP devices for \nfive centres. The applicants require support to process confidential patient information for \npatients treated by Wythenshawe Hospital, part of Manchester University NHS \nFoundation Trust, to collect data for a validation cohort. A consecutive list of 100 patients \nwill be extracted from the Airview database for Wythenshawe Hospital, Manchester \nUniversity NHS Foundation Trust, from 2019, avoiding patients used for the previous\nanalysis. Each individual patient will be checked for eligibility and patients excluded as \nnecessary. CPAP-usage datafiles will be downloaded for each patient at each of the \nrelevant time points over three months and recorded in the results database under a code \nnumber. The relevant clinical data obtained from the electronic patient records system will \nbe recorded in the results database. The process will be continued until data from 100 \npatients is collected. The process will be repeated for a second patient sample treated in \n2021 and therefore treated under a different clinical pathway. This database and the pre-\nexisting database of 1000 patients, both pseudo-anonymised, will be transferred to the \nstatistician."]
["Applicant Organisation Name","Imperial College London"]
["Contact Name","Dr S. Amanda Sathyapala"]
["Address","Airway Disease, Brompton Campus, "]
[null,"National Heart Lung Institute, Room 305, Guy Scadding Building, Dovehouse Street "]
[null,"Imperial College London, London"]
["Postcode","SW3 6LY"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Male and female patients aged 18 years and diagnosed with \nObstructive Sleep Apnoea (OSA)\n1200 patients will be included in total, 100 of which will come \nunder the scope of support"]
["Description of confidential patient information used","Data sources\n\n1. Electronic patient records at Wythenshawe Hospital, part of \nManchester University NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1. Hospital ID number \n2. Date of birth\n\nIdentifiers required for analysis purposes\n\n1. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-04-26"]
["Next Review Date","2024-04-26"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 28 February 2023.\n \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\nThe NHS Digital 21/22 DSPT reviews for Manchester University NHS Foundation Trust and Imperial College London were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 17 February 2023)\n\n"]

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[]
[]
["Application Number","A02769"]
["Reference","23/CAG/0005"]
["Other Refs","IRAS Project ID: 322370  REC Reference: 23/LO/0010"]
["Application Title","A randomised controlled trial of no routine gastric residual monitoring to guide enteral feeding in paediatric intensive care units."]
["Application Summary","This application from Edge Hill University set out the purpose of medical research that seeks to determine whether or not measuring the stomach contents of critically ill children \nreceiving invasive breathing support impacts on the length of time the child spends on \nbreathing support and their calorie intake.\n\nPaediatric Intensive or Critical Care (PICU) provides care for children who require specialist care for serious medical or surgical conditions and may require mechanical ventilation. Providing adequate nutrition is a key component of care. The sickest children may require para-enteral feeding and other feeding via a nasogastric tube. For tube-fed patients, it is standard practice to aspirate the stomach contents (called gastric residual volume or GRV) before the next feed to check the volume that remains and to make a visual assessment of its composition and status, as these may indicate if something is wrong. The residual may then be returned to the stomach or discarded depending on local guidelines and clinical opinion. The volume of enteral food to then give may then be determined by how much was left from the earlier feed. The practice of GRV measurement in critically ill children is not evidence-based and there is growing concern that GRV may provide little benefit to patients. \n\nThe applicants aim to conduct an evaluation to assess the clinical benefits of intervening or \nnot, and the cost-effectiveness of such practices. Eligible patients will be randomised to one of two groups. The intervention arm will not have GRV measurements taken and will be monitored for signs of feed intolerance using clinical signs only. The control group will have GRV measures taken. Due to the emergency nature of admission to PICU, patients will be randomised to either the intervention or control group before consent is sought. Participating NHS trusts will send confidential patient information to ICNARC. ICNARC will disclose confidential patient information to PICANet for linkage to baseline characteristics, treatment and outcome data. ICNARC will also disclose confidential patient information to NHS Digital for linkage to the Civil Registrations Dataset and HES, and to Digital Health and Care Wales for linkage to Patient Episodes Data. ICNARC will combine the data with data from the GASTRIC-PICU trial database and pseudonymise the dataset. Pseudonymised data only will be shared with the London School of Hygiene and Tropical Medicine for analysis. \n\nFor most patients, the applicants will seek consent from patient or their parents before they \nare discharged. However, some patients will be discharged or die before consent can be \nsought. For these patients, research staff, who are part of the direct care team, will \ntelephone and send letters to parents of patients discharged home prior to consent to inform them about their child being enrolled in the study. If patients or parents do not respond within 4 weeks to register an opt-out, their data will be included."]
["Applicant Organisation Name","Edge Hill University\r"]
["Contact Name","Professor Lyvonne Tume, Professor of Critical Care Nursing"]
["Address","Edge Hill University"]
[null,"Faculty of Health, Social Care & Medicine"]
[null,"St Helen’s Road, Ormskirk"]
["Postcode","L39 4QP"]
["Telephone","07710 412 142"]
["Email","lyvonne.tume@edgehill.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged between 37 weeks and 16 years, who are receiving invasive mechanical ventilation (with extubation not planned in the next 48 hours), and where the intention is to \nstart feeding via the gastric route (including gastrostomy).\n\n700 patients will be included in total. The applicants expect that most patients will be recruited in England and that 4500 patients from England and Wales will be included. Around 10-12% of these patients will be included under s251 support. "]
["Description of confidential patient information used","Data sources\n\n1. PICANet dataset, held at University of Leeds\n2. Civil Registrations Dataset and HES, held by NHS \nDigital\n3. Patient Episodes Data for Wales, held by Digital \nHealth and Care Wales\n\nIdentifiers required for linkage purposes\n\n1. NHS Number\n2. Date of birth\n3. Postcode \n\nIdentifiers required for analysis purposes\n\n1. Date of death\n2. Gender"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-05-12"]
["Next Review Date","2024-05-12"]
["Notes","Amendment supported 19 February 2024 to include The Royal London Hospital, Barts Health NHS Trust, as an additional participating site (and data processor for the CAG application), and to update the study protocol to include clarification on data collection in case of consent decline/withdrawal\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 09 May 2023. \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT reviews DSPT for PICANet (University of Leeds, NHS Digital and ICNARC were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 24 January 2023).\n\nDigital Health and Care Wales - CPiP in place.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

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[]
[]
["Application Number","A02770"]
["Reference","23/CAG/0036 "]
["Other Refs","IRAS Project ID: 313393  REC Reference: 23/EM/0079"]
["Application Title","re-clinical biomarker analyses for Gastrointestinal and Hepato\u0002pancreatobiliary disease: cancers and inflammatory disorders\r"]
["Application Summary","This application from University of Nottingham set out the purpose of medical research \nwhich aims to investigate biomarkers using a variety of cancerous and inflammatory tissue \nof the gastrointestinal (GI) and hepato-pancreatobiliary (HPB) tract, to create prognostic, \ndiagnostic, preventative, and predictive models to improve disease outcome and treatment.\nIn the cancer research section, researchers will investigate a range of biomarkers within GI \nand HPB tumours and their metastases to facilitate diagnosis, prognosis, preventative \nmeasures and predictions to therapy. In the inflammatory disease section, researchers will \ninvestigate biomarker quality and expressions within GI and HPB inflammatory diseases \nthat may be infective, metabolic, immunological, allergic or drug induced.\n\nGI and HPB diseases, including inflammatory and malignant conditions with associated \nmorbidity and mortality, are common, and cancer in general accounts for 166,533 deaths \nannually in the UK. There are a number of limitations to the current methods of\nhistopathologic diagnosis. Consequently, the use of biomarkers has become a rapidly \nexpanding field playing a central role in diagnosis and in the selection of tailored anti-cancer \ntherapies. Furthermore, biomarkers are increasingly important to aid with screening, \ndiagnosis, prognosis and predictions to therapy in disease. Hence, research into biomarkers \nfor both cancer and inflammatory diseases is paramount to improve patient diagnosis and\nprognosis.\n\nThe project will use surplus tissue from retrospective diagnostic samples taken as part of \nstandard of care, at Nottingham University Hospitals NHS Trust. Eligible patients will be\nidentified the Data Management Team, who are not considered direct care team, hence the \nrequirement for ‘s251’ support. NHS Trust pathology computer systems will be searched to \nidentify eligible participants, and linked to clinical data surrounding diagnosis from medical \nrecords. A pseudonymous ID is added, and confidential patient information removed by the \nData Management Team. Subsequently, the tissue samples from identified participants will \nonly be extracted by clinical colleagues (histopathologists at NUH). Therefore, this element\ndoes not require ‘s251’ support.\n\nA key between the pseudonymous ID and identifiable information will be retained within the \nTrust, by the direct care team, for 7 years after the study has ended as per standard \nprocedure under the University of Nottingham sponsor arrangements. ‘s251’ support is not \nrequired for this, as only direct care team will access the key. Only pseudonymous data will \nbe provided to the research team at the University of Nottingham, who will not have the\nmeans to re-identify, and hence the data will be effectively anonymous. Tissue samples will \nbe provided by the Department of Histopathology in Formalin Fixed Paraffin Embedded \n(FFPE) tissue blocks. The FFPE samples will have been taken during diagnostic surgical \nprocedures and then prepared and stored under the local NHS procedures. Researchers \nwill have access to the anonymised FFPE tissue and digital diagnostic images for analysis.\nApplicants may need to send anonymised material to different institutes outside of the UK, \nincluding Europe and the US for further analysis – this activity does not require ‘s251’ \nsupport if appropriately anonymised in line with ICO code of practice, and the applicant has \nconfirmed that this will be the case."]
["Applicant Organisation Name","The University of Nottingham "]
["Contact Name","Dr Abhik Mukherjee"]
["Address","Biodiscovery Institute 3, University Park"]
[null,"The University of Nottingham "]
[null,"Division of Cancer and Stem Cells"]
["Postcode","NG7 2RD\r"]
["Telephone",7902548545]
["Email","Abhik.Mukherjee1@nottingham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","~5000 retrospective patients who have had a procedure to remove tissue from the GI or HPB tract at Nottingham University Hospitals, if there is surplus tissue available after diagnosis has been made. \n\nTissue samples will have originally been taken from patients >5 years ago (between approximately 2000-2016). Microscopy image samples will have originally been taken \nfrom patients >1 year ago (between approximately 2000-2022)."]
["Description of confidential patient information used","Data sources\n\n1. The Nottingham University Hospitals NHS Trust. \n\na. Histopathology samples/ Microscopy image samples\nb. Histopathologic diagnosis from clinical records\n\nIdentifiers required for linkage purposes\n\n1. NHS number\n2. Hospital ID\n3. Date of birth\n4. Date of death\n\n\nIdentifiers required for analysis purposes\n\n1. Gender\n2. Ethnicity\n(this is effectively anonymous to the applicant)"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-05-26"]
["Next Review Date","2024-05-26"]
["Notes","The application, to allow the disclosure of confidential patient information to the Data Management Team (who are not considered direct care team) at The Nottingham University Hospitals NHS Trust during the identification of eligible patients, and the extraction and pseudonymisation of a clinical dataset alongside histopathology samples which are sent to University of Nottingham for analysis, is fully supported, subject to compliance with the standard conditions of support\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 02 May 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS England 21/22 DSPT review for The Nottingham University Hospitals NHS Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 29 March 2023)\n"]

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[]
[]
["Application Number","A02771"]
["Reference","22/CAG/0170 "]
["Other Refs","IRAS Project ID: 319067  REC Reference: 22/EM/0260"]
["Application Title","Greater Manchester Care Record Research Database"]
["Application Summary","This research application submitted by NHS Greater Manchester Integrated Care, sets out \nthe medical research purpose of creating a pseudonymised copy of the Greater Manchester\nCare Record (GMCR), to create an effectively anonymised research database, to facilitate \nresearch projects seeking to use routine data to address important research questions \nabout the health of the Greater Manchester population. Research undertaken using this \ndatabase will include epidemiological (including Covid-19) studies, population health, and\noperational studies. Examples of previous research undertaken before the COPI notice \nexpired includes trends in primary care-recorded self-harm during and beyond the Covid19 pandemic, and ethnic inequalities in Covid-19 vaccination uptake. Examples of non \ncovid-19 related research questions include investigating mental health outcomes for \nwomen and partners who have experienced pregnancy not ending in live births, and looking\nat 5 year survival after a diagnosis of dementia, and how it is affected by socioeconomic \ngroup.\n\nIn response to the Covid-19 pandemic, health and care organisations in Greater \nManchester established the GMCR, a shared care record which amalgamates essential \ninformation for the city-region's 2.8m citizens from across health and care. This enables\nbetter informed direct care, digital transformation of care pathways, and was established for \nthe purposes of direct care. This has been established since April 2020.\n\nUnder the Covid-19 COPI notice, the applicants data processor Graphnet created\ndeidentified datasets for use for Covid-19 related population health research and other non-research secondary uses, also related to Covid-19. 15 university-led research studies have \nso far been approved looking at the impact of Covid-19 in Greater Manchester on cancer \npatients, mental health/self-harm, diabetes patients and the treatment of rheumatoid \narthritis, amongst others. Some are still ongoing but are not currently processing identifiable \ninformaiton and so do not require ‘s251’ support.\n\nApplicants have confirmed that there has been no processing of the data for secondary \nuses between the expiry of the COPI notice (end of June 2022) and now. After the ‘s251’ \nsupport has been provided, the GMCR purposes are going to be wider than Covid-19\npurposes.\n\nThis application for ‘s251’ support is to allow the disclosure of confidential patient \ninformation to Graphnet Health Ltd during the processing of the Greater Manchester Care \nRecord, to create a pseudonymised dataset for research purposes. There is a sister non-research application for non-research secondary uses – 22/CAG/0169. The De-identified\ndata mart provides de-identified, linked row level data and is designed to be used for \naggregate anonymised outputs for research purposes.\n\nUniversity of Manchester Research Data Engineers (RDEs) access the data mart via secure \nlogin and, for each research project, create a bespoke data extract that goes through \nseveral further rounds of de-identification. This data extract can be accessed via the data \nportal by named members of the group proposing the project. Data can only be downloaded \nfrom the portal in aggregate form once checked for disclosure control by a second project \nteam member, and all downloads are monitored by Graphnet. RDEs and project team \nmembers cannot access the linkage key between the pseudonymised GMCR ID and \nconfidential patient information. \n\nData access applications are restricted to research teams from UK HEIs only. The following \nrestrictions will be applied for operations and capacity reasons: \n\n• Undergraduate and master’s students are not permitted to apply for data access \n• PhD students registered at a Greater Manchester HEI may apply for data access \n• PhD students from other UK HEIs may only apply for data access if the study is led \nby a Greater Manchester researcher who takes responsibility for the student’s \ninvolvement.\n\nStudy proposals must be approved by the GMCR Secondary Uses and Research Groups \n(SURG) before researchers are granted data access. The Research Operations Group \n(ROG) provides advice to the study team and assists them in progressing their proposal \nthrough the approvals process. Both groups will consider the following in their approval \ndecision: \n\n• Scientific robustness and relevance \n• Data quality of the requested data \n• Data minimisation principle \n• Re-identification risks \n• Completion of relevant data protection training by the applicants \n• Relevant analysis expertise in the study team\n\nGMCR Secondary Uses and Research Groups (SURG) contains lay representation, and \nCAG have been provided with their terms of reference. A list of all approved projects and \nany research outputs arising from the project is maintained, and more information on \ncompleted studies can be found at https://gmwearebettertogether.com/research-and planning./"]
["Applicant Organisation Name","NHS Greater Manchester Integrated Care "]
["Contact Name","Mr Matt Hennessey"]
["Address","NHS Greater Manchester Integrated Care "]
[null,"Floor 4, 3 Piccadilly Place,"]
[null,"Manchester"]
["Postcode","M1 3BN "]
["Telephone",7783812611]
["Email","matt.hennessey@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 3 million patients of all ages; \n(a) registered with a GP in Greater Manchester, or \n(b) have interacted with NHS services in Greater \nManchester.\n\nThis includes people that may have deceased since the GMCR was established. Records are not removed from the research database as they are needed for longitudinal research."]
["Description of confidential patient information used","Data sources\n\n1. Graphnet Ltd shared care records already linked together for purposes of clinical care, created from 500+ organisations including Primary Care, Secondary Care, Mental Health Trusts, Community Trusts, Out-of-Hours Services, Specialist Trusts, Social Care & North-West Ambulance Service, and local authorities.\n\nIdentifiers required for linkage purposes\n\nGraphnet will have access to the patient’s entire medical record in the process of removing all items of confidential patient information\n\nIdentifiers required for analysis purposes\n\n1. N/A – all analysis undertaken without the use of identifying information\n\nAdditional information\n\nApproved researchers can access the data via a secure virtual environment provided by Graphnet.\n\nSource data is de-identified on a weekly basis – applicants have confirmed this has not happened since the expiry of the COPI notice."]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-05-30"]
["Next Review Date","2024-05-30"]
["Notes","The application, to allow to allow the disclosure of confidential patient information to Graphnet Health Ltd during the processing of the Greater Manchester Care Record, to create a pseudonymised dataset for research purposes, to support health and care research across Greater Manchester (GM) is conditionally supported, subject to compliance with the standard and specific conditions of support\n\n\nConditions of support:\n\n1.\tPlease provide a detailed report at annual review, (or SDE application if before), to provide data on activities undertaken, which will be reviewed at a full CAG meeting.\n\n2.\tPlease provide feedback within 6 months from the date of this letter, on patient and public involvement undertaken to establish the acceptability of the use of data without consent, for the purposes of this research application to CAG. \n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed 11 January 2023\n\n4.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 21/22 DSPT review for Graphnet Health ltd was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 02 December 2022)\n"]

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[]
[]
["Application Number","A02772"]
["Reference","22/CAG/0150"]
["Other Refs","IRAS Project ID: 315751   REC Reference: 22/YH/0157"]
["Application Title","United Kingdom Register of Stored Ovarian and Testicular Tissue"]
["Application Summary","This application from the University of Leeds set out the purpose of medical research which aims to establish a research database of all stored ovarian and testicular tissue obtained from young people in the UK. \n\nThe UK Register of Stored Ovarian and Testicular Tissue (UKSTORE) will be the first registry of stored ovarian and testicular tissue collected from young people in the UK. The registry will be used to support service development, evaluation and research. \n\nThe data will be obtained from all centres where ovarian and testicular tissue were collected and stored from patients aged 0-24 years. Storage centres will identify eligible patients via clinical records and local databases, and the confidential patient information transferred to UKSTORE. Confidential patient information will be used to perform data linkage to extract relevant data from existing databases. Additional data will be collected from patient medical records, directly from patients and from their GP's. \n\nUKSTORE data is divided into two main components; data captured without consent and data captured only with written informed consent. Data captured without consent comprises most data for UKSTORE. This is referred to as “core data” and includes confidential patient information. “Core” data will be captured for all patients who preserve tissue in the UK and are aged 0-24 when they do so. “Core” data will be captured for retrospective (who have already had tissue preserved) and prospective patients (who preserve tissue after UKSTORE has been established). \n\nData captured with informed written consent will only be sought from patients who are aged 16 years and above and is referred to as “additional data.” This data is focused on reproductive outcomes. Patients aged 16 years and over in England will be invited to consent when they attend a follow up appointment, or at any other appointment as deemed appropriate by their clinical team. Patients who are no longer attending routine follow up appointments will be sent an approved UKSTORE information sheet about additional data capture and invited to contact the tissue storage centre or UKSTORE directly, to give informed consent. This information will be sent alongside the next routine correspondence sent from tissue storage centres that confirms ongoing tissue storage. Storage centres will perform an additional safety check to screen and exclude patients they know have registered an opt out.\n"]
["Applicant Organisation Name","University of Leeds"]
["Contact Name","Professor Adam W Glaser "]
["Address","Leeds Inst of Medical Research (LIMR) "]
[null,"School of Medicine "]
[null,"University of Leeds "]
["Postcode","LS2 9JT "]
["Telephone",1133436265]
["Email","a.glaser@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients whose ovarian or testicular tissue was collected when they were aged 0-24 years. \nThe timeframe for inclusion will go back to the first point at which tissue preservation began so that it includes all patients (whole population). Records in England go back to 2013.\n"]
["Description of confidential patient information used","Data sources\n\n1.\tPatients clinical records, including regional paediatric, teenage and young adult cancer centres \n2.\tNHS centres in the UK that store ovarian and testicular tissue harvested from people when they were aged 0- 24 years. \n3.\tPatients (self-reported) \n4.\tNHS England (previously NHS Digital) held datasets: \na.\tCancer registry \nb.\tCancer pathway \nc.\tSACT \nd.\tRTDS \ne.\tHospital Episode Statistics (HES) admitted care \nf.\tNational Disease Registration Service for patients with cancer, congenital anomalies and rare diseases (NCARDRS) \ng.\tNational Cancer Registration Analysis Service (NCRAS) \n5.\tGP data via GPES \n6.\tExternal disease registries, including: \na.\tThe Welsh Cancer Intelligence & Surveillance Unit (WCISU) \nb.\tThe European Society for Blood and Marrow Transplantation (EBMT) Registry. United Kingdom Primary Immunodeficiency (UKPID) Registry. \nc.\tThe British Society for Paediatric and Adolescent Rheumatology (BSPAR). \nd.\tThe National Haemoglobinopathy Registry (NHR).\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS Number \n3. Hospital ID number\n4. GP Registration \n5. Date of birth \n6. Date of death \n7. Postcode – unit level\n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n2. Date of death \n3. Postcode – unit level \n4. Gender \n5. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-05-26"]
["Next Review Date","2024-05-26"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 September 2022 \n\n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nDue to the number of participating organisations involved, it is the responsibility of University of Leeds, as controller, to ensure that these participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised. \n"]

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[]
[]
["Application Number","A02773"]
["Reference","23/CAG/0082 "]
["Other Refs","IRAS Project ID: 264286  REC Reference: 20/LO/0347"]
["Application Title","The Prognostic Performance of the Enhanced Liver Fibrosis Test in UK Patients with Chronic Liver Disease Assessed 20 Years After Recruitment to the EUROGOLF study (EVenti)"]
["Application Summary","This application from the Royal Free London NHS Foundation Trust set out the purpose of medical research which aims to determine the value of using the enhanced liver fibrosis test (ELF) as part of an evaluation of liver disease risk in middle life.\n\nAn original cohort of 921 participants (497 in the UK) were consented into the EUROGOLF study between 1998 and 2000, which identified and validated the ELF test. In 2008/09 the investigators interrogated the 497 records in the UK which established it was at least equal, if not superior to, a liver biopsy in predicting liver related and all cause mortality at 7 years. It has now been 20 years since participants were enrolled and many patients have likely reached clinical endpoint. The applicants wish to use confidential patient information related to these 497 patients held by the Royal Free London NHS Foundation Trust to link to HES, cancer registry and mortality data from NHS Digital. The resulting data will be used to understand the value of the ELF test as part of an evaluation of liver disease in middle life.\n\nSince the previous deferral the applicants have consulted with legal advice to determine the legal basis, under the common law duty of confidentiality, for holding of the existing data. This concluded that there is no legal basis, and the applicants additionally request support prospectively for the data to be held by the Royal Free London NHS Foundation Trust."]
["Applicant Organisation Name","University College London"]
["Contact Name","Pushpsen Joshi Research Governance Manager "]
["Address","University College London 4th Floor, "]
[null,"West 250 Euston Road"]
[null,"London"]
["Postcode","NW1 2PG "]
["Telephone",2034479928]
["Email","uclh.randd@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All 497 patients recruited into the original EUROGOLF study"]
["Description of confidential patient information used","Data sources\n1. NHS Digital\n\nIdentifiers required for linkage purposes\n1. NHS number\n2. Date of Birth\n3. Gender\n\nIdentifiers required for analysis purposes\n1. Date of birth \n2. Date of death\n3. Postcode"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-15"]
["Next Review Date","2024-10-12"]
["Notes","\nSupported 15 June 2023: This submitted information represented a new application in relation to an existing activity under application reference 20/CAG/0122. As a result of NHS England (previously NHS Digital) requesting that controllership be amended, the main change is that of a change of data controller, from solely Royal Free London NHS Foundation Trust to solely University College London. The Chief Investigator remains the same.\n\nIn addition, the applicants wish to update CAG with regards to the fact that health-economic analysis is now included in the data analyses, the Trial Co-ordinator is changed, and the Trial Statistician is changed to a member of UCL staff who has access to the UCL Data Safe Haven. Associated updated protocol, data flow diagram, and patient notification documents are provided.\n\nThe applicant has also informed CAG of other changes to the application as part of this new controllership amendment; All references to 20 years of follow up have been changed to 23 years of follow up, and 2020 as the censor date is replaced by 2023 as the censor year. All other changes relate to the change of data controllership.\n\nThe amendment supported in January 2022 to clarify that support is in place for study ID, NHS number, date of birth and gender to be disclosed from Royal Free London NHS Foundation Trust to NHS England (previously NHS Digital), in order for NHS England to supply the applicant with a dataset linked to Study ID, (but with NHS Number, date of birth and gender removed), is noted, and this is now changed to University College London.\n\nAs part of the original Regulation 5 support, NHS Digital is listed in the application as a data processor regarding the data sources Hospital Episode Statistics (HES), Cancer registry and ONS mortality data. Due to organisational changes outside your control, the data processor for this source has changed to NHS England. Therefore, this letter confirms Regulation 5 support has been updated for this application to continue using data sources Hospital Episode Statistics (HES), Cancer registry and ONS mortality data, with NHS England as the new data processor. \n\nThe intention is to replace 20/CAG/0122 with this new application (23/CAG/0082).\n\n\nConditions of support:\n\n1.\tFavourable opinion from REC Confirmed 23 April 2020 initially, and change given Favourable Opinion on 22 November 2022.\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe 2021/22 NHS England DSPT reviews for University College London - Data Safe Haven (EE133902-SLMS) & NHs England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 12 June 2023). \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02774"]
["Reference","23/CAG/0055 "]
["Other Refs","IRAS Project ID: 320086  REC Reference: 23/NE/0066"]
["Application Title","Understanding patient uptake and experience of interpreter services in primary care"]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research that seeks to investigate how interpreting services are currently implemented in primary care. \n\nIn the UK there is a growing and ageing population of people for whom English is not their first language. Interpreter services are provided to ensure patients, carers and clinicians understand each other, and to try to avoid worsening inequalities in healthcare access and outcomes. This is particularly important in primary care because it is the main source of NHS healthcare. Over 98% of people in the UK are registered with a GP, so provision of good interpreter services in primary care is key to the reduction of health inequalities. Research suggests that providing interpreters improves quality of care, and when patients with limited language proficiency have access to trained professional interpreters, they report higher patient satisfaction, higher comprehension and there are fewer errors of potential clinical consequence and equalisation of healthcare access. Findings will help understanding of the potential impacts of interpreting services on reducing health inequalities in primary healthcare access.\n\nA researcher is undertaking a number of different methodologies at 4 participating General Practitioner (GP) surgeries, including consented staff interviews and consented interviews with commissioners and policy-makers at local and national levels, documentation reviews, and verbally consented observations of patient consultations. These elements do not require ‘s251’ support. \n\nHowever the researcher, who is not considered direct care team, is also undertaking ethnographic observations, of clinical meetings of different types e.g. primary care staff meetings, commissioning meetings. Support under Regulation 5 is required for this aspect of the study as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded. \n"]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Dr Georgia Black, Reader in Health Services Research"]
["Address","Centre for Prevention, Detection and Diagnosis Wolfson Institute of "]
[null,"Population Health"]
[null,"Charterhouse Square, London"]
["Postcode","EC1M 6BQ"]
["Telephone","020 7882 3802"]
["Email","g.black@qmul.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who were discussed during clinical observations at participating GP practices"]
["Description of confidential patient information used","Data sources\n\nClinical meetings/observations in participating GP practices, recorded via written field notes, at the following sites;\n1.\tPage Hall Medical Centre, 101 Owler Lane, Sheffield, S4 8G\n2.\tEvergreen Surgery, 1 Smythe Close, Edmonton, N9 0TW \n3.\tMathukia Surgery, 281 Ilford Ln, Ilford, IG1 2SF\n4.\tJubilee Street Practice, 368-374 Commercial Road, Tower Hamlets, E1 0LS \n5.\tSt Andrews Health Centre, 2 Hannaford Walk, Bow, E3 3FF\n6.\tBromley by Bow Health Centre, St Leonards Street, London, E3 3BT\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be recorded for linkage purposes\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be recorded for analysis purposes\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-20"]
["Next Review Date","2024-06-20"]
["Notes","The application, to allow for incidental exposures of confidential patient information that may occur when the researcher is undertaking observations of clinical meetings at participating GP practices, surrounding the use of interpreter services, is fully supported, subject to compliance with the standard conditions of support\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 29 March 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nDue to the number of participating organisations involved it is the responsibility of Queen Mary University of London as controller, to ensure that participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n"]

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[]
[]
["Application Number","A02775"]
["Reference","23/CAG/0029"]
["Other Refs","IRAS Project ID: 320240  REC Reference: 22/LO/0854"]
["Application Title","Catch-up Screen: A urine test for cervical screening"]
["Application Summary","This application from the London School of Hygiene & Tropical Medicine set out the purpose of medical research that seeks to measure patient response rates, HPV prevalence and histological outcomes among older women to estimate the likely impact on cervical cancer incidence and mortality of introducing a nationwide catch-up screening programme. \n\nThe NHS Cervical Screening Programme (CSP) prevents an estimated 5000 deaths per year by offering regular cytology screening. HPV screening has replaced cytology in many countries, including in the UK. Currently, screening in the UK is stopped at 65 years of age, which is unchanged since the introduction of the screening programme in 1988. Australia offer HPV screening up until the age of 74 and Denmark offer screening to all women born before 1948. Most cervical cancers in young women are diagnosed at stage 1 but the proportion diagnosed at stage 2 or worse increases with time since last screening test, and the ratio of mortality to incidence increases after age 65 when cytology screening stops. The justification for ceasing screening at 65 is that it is unlikely that women aged over 64 years who have been regularly screened will go on to develop the disease. However, around 1 in 1200 women who were regularly screened after 50 years of age and 1 in 230 women who were unscreened after age 50 to develop cervical cancer after the age of 65. Around half the relevant population were either unscreened or inadequately screened after age 50. The applicants seek to offer a catch-up HPV test, via a urine test that patients can do at home and use the results to measure response rates, HPV prevalence and histological outcomes to estimate the likely impact on cervical cancer incidence and mortality of nationwide introduction.\n\nSupport is sought to enable researchers, who are not part of the direct care team, to access patient records at participating GP practices in order to identify and make contact with eligible patients. Support is also required to allow the extraction of confidential patient information from GP practices and transferred to NHS England for linkage to cervical screening record, current status, and registrations of cancer and death. Patients NHS number and date of birth will be removed before the linked dataset is transferred to the London School of Hygiene & Tropical Medicine. GP practice data and the linked dataset will be linked via the study ID.\n"]
["Applicant Organisation Name","London School of Hygiene & Tropical Medicine"]
["Contact Name","Ms Clare Gilham, Assistant Professor "]
["Address","Department of Non-Communicable Disease Epidemiology "]
[null,"Keppel Street "]
[null,"London "]
["Postcode","WC1E 7HT "]
["Telephone",2079272068]
["Email","clare.gilham@lshtm.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women aged 60 – 79 years of age who ceased from the NHS CSP without an exit primary HPV test.\n18000 women will be included.\n"]
["Description of confidential patient information used","Data sources\n\n1. Patient records at participating GP practices \n2. NHS England DARS for current patient status, cancer registration and mortality from national registers and the NHS Cervical Screening Programme (Open Exeter).\n\nIdentifiers required for linkage purposes\n\n1. NHS number \n2. Date of birth\n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n2. Date of death \n3. Postcode – unit level \n4. Gender \n5. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-07"]
["Next Review Date","2024-06-07"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Favourable Opinion issued 16 January 2023 \n2.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \nThe NHS Digital 21/22 DSPT reviews for London School of Hygiene & Tropical Medicine and NHS England were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 14 March 2023). \n \nDue to the number of participating GP sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations. \n"]

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[]
[]
["Application Number","A02776"]
["Reference","23/CAG/0044"]
["Other Refs","IRAS Project ID: 323909   REC Reference: 23/SW/0050"]
["Application Title","Optimisation of the FAST MRI protocol: an evaluation of what makes a good breast MRI through detailed analysis of scans from multiple NHS sites contributing to the FAST MRI Programme"]
["Application Summary","This application from North Bristol NHS Trust set out the purpose of medical research that seeks to define the parameters of scan acquisition that together produce a ‘good’ quality set of FAST-MRI images.\n\nDespite effective treatments, 30 women die every day from breast cancer in the UK. Early detection of breast cancer saves lives and is the aim of the NHS Breast Screening Programme (NHSBSP), which screens 2.2 million women in England each year. However, mammograms are not good at showing some cancers. Delayed breast cancer diagnosis results in a worse prognosis, a much higher chance of the morbidity associated with metastatic breast cancer and its treatment, and ultimately of mortality. Recent studies have shown FAST-MRI (First post-contrAst SubtracTed Magnetic Resonance Imaging) has potential as a breast cancer screening test. It overcomes the shortcomings of mammography, including poor sensitivity for aggressive cancers. FAST-MRI is much quicker to acquire and interpret (cheaper for the NHS) than the gold standard breast screening modality, full protocol MRI (fpMRI), which is currently reserved to screen only women at high risk of breast cancer. FAST-MRI holds promise to save more lives through breast cancer screening because it can detect aggressive cancers earlier than mammography.\n\nThe applicants seek to define the parameters that provide optimal scan quality to produce guidelines for use of FAST-MRI. Clinical staff at participating NHS trusts will identify 10 breast MRI scans which show the types of cancers difficult to detect with mammograms, 5 scans showing grade 3 (aggressive) cancers and 5 showing cancers with lobular histology at diagnosis. These scans will be identified from the local radiology information system and prepared for image transfer. Image transfer SciCom will set up dedicated Cloud storage and a dedicated node on the Image Exchange Portal (IEP) for image transfer. This node will enable automated de-identification of incoming images. To register that an image is being sent, sites will make use of the RSNFT SMART portal to register the case in advance. This portal will include a proforma to be completed by the clinical team that will detail the parameters used to acquire each scan and specific additional information from the scan’s report and cancer histology. The proforma information associated with each study ID will be stored automatically along with the images (using a linked complex salted hash) by SciCom. The applicants do not anticipate that confidential patient information will be accessed by the researchers undertaking analysis but noted that technical issues may occur in the automatic de-identification process. Should this happen, then Royal Surrey County Hospital staff, rather than staff at the patient’s site, would have to intervene and may process confidential patient information.\n"]
["Applicant Organisation Name","North Bristol NHS Trust"]
["Contact Name","Dr Katherine Klimczak "]
["Address","Breast Care Centre, Southmead Hospital "]
[null,"Southmead Road "]
[null,"Bristol "]
["Postcode","BS10 5NB "]
["Telephone",1174149330]
["Email","Katherine.Klimczak@nbt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 16 years and over who underwent breast MRI scans at participating hospital trusts from 01 January 2019 onwards. "]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic patient records at:\na.\tRoyal Surrey NHS Foundation Trust \nb.\tUniversity Hospitals Coventry & Warwickshire Gloucestershire Hospitals NHS Foundation Trust\nc.\tNorth Bristol NHS Trust\nd.\tRoyal Cornwall Hospitals NHS Trust\ne.\tUniversity Hospitals Plymouth NHS Trust\nf.\tSt. George’s University Hospitals NHS Foundation Trust\ng.\tGreat Western Hospital\n\nIdentifiers required for linkage purposes\n\n1.\tNHS Number\n2.\tMRN Number\n3.\tDate of birth\n4.\tDate of death\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tDate of death\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-16"]
["Next Review Date","2024-06-16"]
["Notes","Conditions of support:\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 2 May 2023. \n \n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information.  \nDue to the number of participating organisations involved it is the responsibility of North Bristol NHS Trust as controller, to ensure that participating Trusts/Organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised. \n"]

{"sheet":"A02777","index":818,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02777"]
["Reference","23/CAG/0072 "]
["Other Refs","IRAS Project ID: 320333  REC Reference: 23/NW/0085"]
["Application Title","Listen2Baby - Improving monitoring of the baby during \nuncomplicated labour: a study using experience-based \nco-design"]
["Application Summary","This application from University of Oxford set out the purpose of medical research which \naims to improve the quality and safety of fetal monitoring in uncomplicated labours \nthrough an improved understanding of the organisational context and practice of \nintermittent auscultation (IA) during labour, and ultimately improve care for women and \nbabies, by the development and initial evaluation of a 'toolkit' to improve IA practice.\n\nFor approximately 30,000 women annually experiencing an uncomplicated labour, UK \nguidance recommends that midwives monitor the baby’s heart rate using a hand-held fetal \nstethoscope or ultrasound device, known as IA or ‘listening at regular intervals’. Several \nnational investigations have found issues with the way IA is carried out in practice that \nhave contributed to death or severe injury in babies. Problems include IA not being carried \nout at the right time or often enough; the baby’s heart rate not being recorded properly; \nand midwives not recognising or acting on concerns about the baby’s heart rate. There is \nno research evidence about the best way to do IA in practice. This research will explore \nhow midwives do IA in practice, and what IA is like for women and their partners. \nApplicants plan to use this information to design and test a practical ‘toolkit’ to help \nmidwives do IA in the best way to ensure safety for babies.\n\nThis study has many elements which do not require ‘s251’ support, as they are \nconsented, or do not use confidential patient information without consent. The applicants \ndo require ‘s251’ support for a researcher to extract an effectively anonymous dataset for \nanalysis from 8 participating Trusts. The extraction will happen twice, once during the \ninitial study work package (ii), and then again during work package (v), which will be after \nthe implementation of the developed toolkit to improve IA practice. Anonymised data \nabout IA quality and compliance with guidance will be extracted from case notes, which \nare screened for eligibility and provided to the researcher by the direct care team. The \napplicants also require ‘s251’ support for potential incidental disclosure of confidential \npatient information, during observations of closed space clinical meetings, where it will not \nbe possible to verbally consent the patients, as the patients will not be present. "]
["Applicant Organisation Name","University of Oxford "]
["Contact Name","Associate Professor Rachel Rowe, Senior Health Services Researcher\n"]
["Address","National Perinatal Epidemiology Unit"]
[null,"Nuffield Department of Population Health"]
[null,"Old Road Campus, Oxford"]
["Postcode","OX3 7DQ"]
["Telephone","01865 289713"]
["Email","rachel.rowe@npeu.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","240 case notes in total: \n\nup to 20 consecutive women from each site, (total of 160 in work package (ii)) and up to 10 consecutive women from each site, (total of 80 in work package (v)) who were monitored during labour with a hand-held monitor before the observation period. \n\nAnd any patients discussed in relevant meetings.  "]
["Description of confidential patient information used","Data sources \n\n1. Maternity notes from participating hospitals \n\nIdentifiers required for the purposes of extracting a dataset for analysis \n\n1. Name \n2. Date of birth \n3. Maternity clinical records \n\nIdentifiers required for analysis purposes \n\n1. N/A data is effectively anonymous for analysis "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-23"]
["Next Review Date","2024-06-23"]
["Notes","Amendment supported 12 March 2024 to include Gloucester Hospitals NHS Trust as a participating site, and additional data processor for the application\n\nThe application, to allow confidential patient information to be viewed by a University of Oxford researcher, who is not considered part of the direct care team, during the extraction of an effectively anonymised dataset for analysis at participating sites (work package (ii)). This will be repeated after implementation of a toolkit to improve IA practice (work package (v)), and to allow for incidental exposures of confidential patient information that may occur when the researcher is undertaking observations of relevant clinical meetings at participating sites, including handover/unit meetings surrounding IA practice, is fully supported, subject to compliance with the standard conditions of support.\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 16 May 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of participating organisations involved it is the responsibility of University of Oxford, as controller, to ensure that organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation.\n\n"]

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[]
[]
["Application Number","A02778"]
["Reference","23/CAG/0007"]
["Other Refs","IRAS Project ID: 317747  REC Reference: 23/WA/0031"]
["Application Title","A UK-wide study of paediatric-onset chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) epidemiology, clinical presentation and outcomes."]
["Application Summary","This application from University College London Hospitals NHS Foundation Trust set out the purpose of medical research that seeks to determine the epidemiology, clinical presentation, natural history and outcomes of individuals with paediatric-onset chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in the UK. \n\nCIDP is a chronic, treatable, immune-mediated inflammatory disorder of the peripheral nervous system, often with a mixture of motor and sensory impairment. Onset is usually in adulthood, but childhood (paediatric)-onset cases are recognised. As CIDP is rare, little is known about its natural history and the epidemiology of paediatric-onset CIDP in the UK is unknown. \n\nThe National Immunoglobulin Database holds the records of all patients undergoing immunoglobulin treatment, which is a very common, first-line treatment for CIDP, in England, Scotland and Northern Ireland. The applicants seek to obtain confidential patient information from this database and to disclose this information to local clinicians to be cross-referenced with patient records.\n\nA Redcap database (Data Safe Haven version) will be set up. Confidential patient information will be disclosed from the National Immunoglobulin Database to the Redcap database held at University College London. Confidential patient information will then be disclosed to the NHS trusts which treated each patient. If patients are under ongoing follow-up by local clinicians, local clinicians will attempt to obtain informed consent for prospective data collection. If individuals have moved to different areas or have been discharged from treating services, then patients will not be contacted directly to obtain consent for retrospective analysis of their previous medical records. Clinicians who have patients with paediatric-onset CIDP will also report patients to the study group. This identifiable information will be used to identify patients to approach for consent."]
["Applicant Organisation Name","The National Hospital for Neurology and Neurosurgery, part of the University College London Hospitals NHS Foundation Trust"]
["Contact Name","Professor Michael PT Lunn, Consultant Neurologist and Clinical Lead for Neuroimmunology and CSF Laboratory, Institute of Neurology"]
["Address","National Hospital for Neurology and Neurosurgery Centre for Neuromuscular Diseases\n"]
[null,"National Hospital for Neurology and Neurosurgery"]
[null,"Queen Square, London"]
["Postcode","WC1N 3BG"]
["Telephone",2034488121]
["Email","michaellunn@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients of any current age diagnosed at any point in life with confirmed or probable CIDP by an adult or paediatric neurologist, whose onset of symptoms was at or under 18 years of age."]
["Description of confidential patient information used","Data sources\n\n1. National Immunoglobulin Database, held by MDSAS on behalf of NHS England \n2. Data from the hospital trusts that provided treatment\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS Number \n3. Hospital ID number \n4. Date of birth \n5. Date of death \n6. Postcode – district level \n7. Sex\n\nIdentifiers required for analysis purposes \n\n1. Name \n2. Date of birth \n3. Date of death \n4. Postcode – district level \n5. Gender \n6. Ethnicity \n7. Treating hospital/NHS trust"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-22"]
["Next Review Date","2024-06-22"]
["Notes","Conditions of support:\n\n1.\tFeedback from the further activity carried out needed to be provided at the first annual review. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed. \n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \nThe NHS Digital 21/22 DSPT reviews DSPT for University College London, University College London Hospitals NHS Foundation Trust and MDSAS were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 22 June 2023).\n"]

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[]
[]
["Application Number","A02779"]
["Reference","23/CAG/0052"]
["Other Refs","IRAS Project ID: 326555   REC Reference: 23/EE/0114"]
["Application Title","The health effects of police diversion for drug-involved suspects"]
["Application Summary","This application from The University of Kent (with both The University of Kent and the Department for Health and Social Care confirmed to be joint data controllers), set out the purpose of medical research that seeks to study the effect of ‘police diversion’ on people who have some involvement in use of controlled drugs. ‘Police diversion’ happens when someone is in contact with the police, for example because they have been found in possession of controlled drugs, and is offered an alternative solution instead of traditional punishments such as a caution or charge. The alternative solution might include educational programmes, one-to-one support, and referral to structured treatment for drug dependence. These schemes exist in some police forces and not others. Currently, the benefits of police diversion are not well understood. \n\nMany police officers and government policy-makers recognise that people involved in drugs have poor health and social outcomes. Traditional punishments used by the police can worsen these outcomes by affecting employment prospects, social relationships, and mental health. ‘Diversion’ to educational or treatment programmes may have substantial benefits both for the individual involved in drugs and for society. However, there is very little robust research into these benefits, which means that diversion schemes do not attract long-term sustainable funding. The study aims to estimate the effect of police diversion schemes on reoffending rates and the health and wellbeing outcomes of people who use illicit drugs. This is a population with poor health outcomes and high health and social care costs. The frequent contact with the police means that police diversion is an opportunity to provide health interventions to a vulnerable and under-served group. This supports the NHS Long Term Plan and the Prevention Programme. The results are intended to inform policies that improve health outcomes and reduce health and social care costs for this group. Local partnerships of police and healthcare organisations (such as drug and alcohol treatment services) will use the results to design pathways that reduce criminalisation, stigmatisation, and harm from controlled drugs. The descriptive data will also help the NHS understand the health needs of this population, which are not well-known because illicit drug use is not well-recorded in routine data.\n\nParticipating police forces will identify individuals who are suspected of offenses related to drugs, meeting the eligibility criteria. Data disclosed from police force to the Office for Health Improvement and Disparities (OHID) part of the Department for health and Social Care (DHSC) is not in scope for ‘s251’ support. The police force will disclose identifying information such as PNC ID if available; name, sex, gender, date of birth, and postcode, (which does not meet the criteria for confidential patient information as it is not in association with a health record), alongside ethnicity if available, and baseline police data. Name, sex, gender, date of birth and postcode will be disclosed to NHS England, for the purposes of linkage to the personal demographics service (PDS), in order to provide the applicants with NHS number. This linkage requires ‘s251’ support, as this constitutes confidential patient information. Identifiers are linked by OHID (DHSC) to the NDTMS dataset, alongside the police information and MoJ (PNC) data, to create a pseudonymised dataset for analysis, none of which requires ‘s251’ support as the ministry of Justice data is not confidential patient information, and the NDTMS cohort are consented. Linkage with PNC and NDTMS will be undertaken at 2 separate timepoints. NHS number is then used to link within DHSC to Hospital Episode Statistics and ONS mortality data, which also requires ‘s251’ support as this constitutes confidential patient information. Applicants will create a pseudonymous dataset for analysis. \n\nThe main analysis will be based on comparing individuals in areas with diversion schemes to those in areas without these schemes. The two primary outcomes are; hospital episodes related to drugs, alcohol, or accidents, and reoffending, defined as any proven offense in the 12 months after the index police contact. Secondary outcomes will be entry into structured treatment for drug or alcohol use in a community setting; and among those who start drug or alcohol treatment, retention in treatment for at least 28 days.\n\nA recommendation for class 4 and 6 support was requested to cover access to the relevant unconsented activities as described in the application.  \n\n"]
["Applicant Organisation Name","The University of Kent"]
["Contact Name","Professor Sir Alex Stevens"]
["Address","University of Kent"]
[null,"Giles Lane"]
[null,"Canterbury"]
["Postcode","CT2 7NZ"]
["Telephone"]
["Email","a.w.stevens@kent.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individuals will be eligible to participate if they were in contact with the police in relation to drugs between October 2021 and September 2022. Applicants estimate the cohort will be between 3,600 and 8,400 individuals.\n\nParticipating police forces will identify individuals meeting the following criteria: \n(1) Had police contact between 1 October 2021 and 30 September 2022 (inclusive) \n(2) Contact was in relation to a qualifying offence committed in the police force area (listed in application) \n(3) Lived in the police force area at date of police contact \n(4) Was aged 18+ years at date of police contact\n"]
["Description of confidential patient information used","Data sources\n\n1.\tNHS England – Patient Demographic Service\n2.\tOHID (DHSC) –Hospital Episode Statistics (HES), Office for National Statistics (ONS) mortality data\n\nOut of scope for ‘s251’:\n•\tPolice force data\n•\tMoJ – PNC data\n•\tOHID (DHSC) – NDTMS,\n\nIdentifiers required for linkage purposes\n\nLinkage to PDS:\n1.\tName\n2.\tSex or gender?\n3.\tDate of Birth\n4.\tPostcode\n\nLinkage to HES/ONS:\n1.\tNHS number\n\nIdentifiers required for analysis purposes\n\nPseudonymous for analysis;\n\n•\tMonth and year of death (derived full date of death)\n•\tEthnicity\n•\tAge\n•\tMultiple Deprivation score (derived from postcode)"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-29"]
["Next Review Date","2024-06-29"]
["Notes","The application, to allow the processing of confidential patient information by NHS England during linkage of name, date of birth, sex, gender, and postcode to the personal demographics service (PDS) to obtain NHS number, and for the flow back to the Office for Health Improvement and Disparities (OHID) part of the Department for health and Social Care (DHSC), and also to allow the processing of confidential patient information by OHID during linkage of NHS number to internally held Hospital Episode Statistics (HES) and ONS mortality datasets, is supported, subject to compliance with the standard conditions of support.\n\nSpecific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 June 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n  \nThe NHS England 21/22 DSPT reviews for OHID (DHSC) and NHS England were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 17 April 2023).  \n"]

{"sheet":"A02780","index":821,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02780"]
["Reference","23/CAG/0068"]
["Other Refs","IRAS Project ID: 315456  REC Reference: 23/EM/0100"]
["Application Title","Maximising the value of the Caerphilly Prospective Study (CaPS)"]
["Application Summary","This application from the University of Bristol set out the purpose of continued holding of confidential patent information collected for the Caerphilly Prospective Study. \n\nThe Caerphilly Prospective Study (CaPS) recruited patients between 1979 and 1988. 2512 men aged 45-59 years were recruited from the town of Caerphilly and adjoining villages between 1979 and 1983, with an additional 447 recruited between 1984 and 1988. Men were initially seen at an evening clinic, where they completed a questionnaire, had anthropometric measures (measurements of the proportions, size, and weight of the human body) and an electrocardiogram (ECG) taken to check the heart’s rhythm and electrical activity. They also completed a food frequency questionnaire at home. They subsequently re-attended an early morning clinic to have fasting blood samples for a wide variety of tests. \n\nPatients were initially recruited under consent. Most of the participants have died and the remaining survivors are likely to be frail and/or cognitively impaired. After 35 years of follow-up, it was decided to no longer collect any new data directly from the cohort, but to update any new clinical events through routine linkage with NHS England. The applicants seek support to continue to hold confidential patient information for the cohort and disclosure of a unique patient ID and patients dates of birth to NHS England for linkage to ONS and cancer registry data. \n\n"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Yoav Ben-Shlomo"]
["Address","University of Bristol"]
[null,"PHS, 39 Whatley Road"]
[null,"Bristol"]
["Postcode","BS8 2PS"]
["Telephone"]
["Email","y.ben-shlomo@bristiol.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients recruited into the Caerphilly Prospective Study"]
["Description of confidential patient information used","Data sources\n\n1.\tCaerphilly Prospective Study records, at University of Bristol\n2.\tONS and cancer registry data, held by NHS England\n\nIdentifiers required for linkage purposes\n\n1.\tUnique ID \n2.\tDate of birth\n\nIdentifiers held in database\n\n1.\tFull Name\n2.\tNHS number\n3.\tDate of birth\n4.\tYear of birth\n5.\tDate of death\n6.\tPostcode – unit level\n7.\tGender\n8.\tOccupation\n9.\tEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-30"]
["Next Review Date","2024-06-30"]
["Notes","Specific conditions of support \n\n1.\tAppropriate patient notification materials need to be created.\n\n2.\tFurther patient and public involvement need to be undertaken with local groups and the discussions need to include the use of confidential patient information without consent as proposed in the application.\n\n3.\tProvide further details on the Data Access Committee and how requests to access the data are handled.\n\n4.\tClarify whether any linkages will be conducted to data held within Wales and whether support is needed for this. \n\n5.\tFavourable opinion from a Research Ethics Committee. Confirmed 11 May 2023\n\n6.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 21/22 DSPT review for University of Bristol (Bristol Medical School) and NHS England was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (21 June 2023) \n\n"]

{"sheet":"A02781","index":822,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02781"]
["Reference","23/CAG/0046 "]
["Other Refs","IRAS Project ID: 317097   REC Reference: 22/SC/0330 "]
["Application Title","Thames Valley and Surrey (TVS) sub national secure data environment (SNSDE) programme "]
["Application Summary","This application from Oxford University Hospitals NHS Foundation Trust sets out the purpose of medical research. \n\nThe Thames Valley and Surrey (TVS) area represents approximately 4.3 million people. This application proposes to collect all primary and secondary care patient data into a Sub-National Secure Data Environment (SNSDE) for the purposes of conducting medical research. A data access committee will review and approve applications to access extracts from the database, with a particular interest in research proposals from within the Thames Valley and Surrey region. Upon approval, researchers will be provided with secure access to the data to undertake analysis, without the data leaving the NHS. The SNSDE will be used to conduct translational research to improve delivery or patient care across a broad spectrum of disease and clinical areas.\n\nSupport is requested for the flows of confidential patient information from participating organisations to Oxford University Hospitals NHS Foundation Trust to create the SNSDE. Confidential Patient Information will flow from GP practices (via system suppliers such as EMIS/TPP) and NHS Trusts (including mental health and ambulance Trusts). Specialist data (e.g. radiology data) may flow direct from a processor (e.g. Insignia) rather than the Trust extracting the data themselves. A core set of data will flow at time intervals agreed with each processor, with additional specialist extracts required for specific research projects. Data will retrospectively be collected from the time that a full electronic patient record is available and prospectively, and shared care records will not be used to collate data.\n\nPatient data will be checked, linked, de-identified, filtered, and transformed in the data processing environment, to produce a research database that can be used to produce extracts for research purposes. This will be held within the data processing environment and not made available to researchers. It can be accessed only by the data management team for the TVS SNSDE, all of whom are employed by or contracted to the coordinating organisation, Oxford University Hospitals NHS Foundation Trust. Extracts from the database – produced for specific, approved research programmes – will be prepared within the data processing environment and subjected to additional checks before being securely copied across the area that researchers will access.\n\n"]
["Applicant Organisation Name","Oxford University Hospitals NHS Foundation Trust "]
["Contact Name","Mr David Walliker"]
["Address","Level 3, John Radcliffe Hospital"]
[null,"Headley Way, Headington"]
[null,"Oxford"]
["Postcode","OX3 9DU"]
["Telephone"]
["Email","David.walliker@ouh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients receiving NHS treatment within the Thames Valley and Surrey (TVS) area. "]
["Description of confidential patient information used","Data sources\n\n\tElectronic patient records held at:   \n1.\tBuckinghamshire, Oxfordshire, and Berkshire West (BOB ICS)* \n2.\tOxford University Hospitals NHS Foundation Trust \n3.\tOxford Health NHS Foundation Trust \n4.\tBerkshire Healthcare NHS Foundation Trust \n5.\tRoyal Berkshire NHS Foundation Trust \n6.\tBuckinghamshire Healthcare NHS Trust \n7.\tSouth Central Ambulance Service NHS Foundation Trust \n8.\tFrimley Health and Care (ICS)* \n9.\tFrimley Health NHS Foundation Trust \n10.\tSurrey Heartlands Health and Care Partnership (ICS)* \n11.\tAshford and St. Peter’s NHS Foundation Trust \n12.\tRoyal Surrey County Hospital NHS Foundation Trust \n13.\tSurrey and Sussex Healthcare NHS Trust \n14.\tSurrey and Borders NHS Foundation Trust \n15.\tSouth East Coast Ambulance Service NHS Foundation Trust \n16.\tEpsom and St Helier University Hospitals NHS Trust \n17.\tCSH Surrey (Central Surrey Health) \n18.\tFirst Community Health and Care \n19.\tGreat Western Hospitals NHS Foundation Trust \n20.\tMilton Keynes University Hospital NHS Foundation Trust \n*this includes a total of 343 GP practices within the TVS \n\n\nIdentifiers required for linkage purposes\n\n\t1.\tName \n2.\tNHS number \n3.\tHospital ID number \n4.\tGP registration \n5.\tDate of birth \n6.\tDate of death \n7.\tPostcode – unit level \n\nIdentifiers held in the data processing environment\n\n1.\tInitials  \n2.\tFull name  \n3.\tAddress  \n4.\tNHS number  \n5.\tHospital ID number  \n6.\tGP registration  \n7.\tDate of birth  \n8.\tYear of birth  \n9.\tDate of death  \n10.\tPostcode – unit level \n\nIdentifiers available to researchers\t\n\n1.\tPostcode – sector level \n2.\tGender \n3.\tEthnicity \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-30"]
["Next Review Date","2024-06-30"]
["Notes","Conditions of support: \n\n1.\t Support is for research purposes only\n\n2.\tSupport is provided for 5 years from 30 June 2023. \n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed 14 June 2023\n\n4.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed \n\nThe NHS Digital 21/22 DSPT reviews for Oxford University Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 17 April 2023)  \n"]

{"sheet":"A02782","index":823,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02782"]
["Reference","23/CAG/0056"]
["Other Refs","IRAS Project ID: 325193  REC Reference: 23/WM/0120"]
["Application Title","How to improve communication from GPs to hospital specialists at the point of referrals?"]
["Application Summary","This application from the University of Cambridge set out the purpose of medical research that seeks to examine the impact of use of a primary-secondary care interface on communication and relationships between GPs and hospital specialists. \n\nA recent study by the James Lind Alliance Priority-Setting Partnership in the UK identified communication issues between primary and secondary care systems as the third most important unanswered research question in improving patient safety. Most research exploring the communication processes across primary-secondary care interface has concentrated on discharge processes from hospital care to community care, rather than the reverse, i.e., the initial GP referrals from primary care to specialists.\n\nThe applicants will undertake a qualitative study to evaluate the Granta model of integrated care between GPs and hospital consultants. Interviews will be held with GPs from the Granta Primary Care Network (PCN), and a neurologist from Cambridge University Hospitals and a psychiatrist from Cambridge and Peterborough NHS Foundation Trust who frequently work with this GP group. Interviews will also be held with other stakeholders within the Trusts and PCN. Focus groups will also be held with Granta staff and teleconference meetings between the Consultant Neurologist or Psychiatrist and the Granta GPs will be observed. \n\nThe applicants sought support under the Regulations due to the possibility that confidential patient information may be disclosed during the observations of meetings. The researcher will take notes about the interactions occurring in the teleconference, but will not record any patient identifiable information, and no audio or video recordings will take place.\n"]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Shan   He, NIHR In-Practice Fellow "]
["Address","Strangeways Research Laboratory"]
[null,"2 Worts' Causeway, Cambridge  "]
[null,"UK"]
["Postcode","CB1 8RN"]
["Telephone",1223748600]
["Email","anneka.he@thisinstitute.cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort included in the study are members of staff. However, incidental disclosures of confidential patient information may be made when observations of staff meetings take place. "]
["Description of confidential patient information used","Data sources\n\n1.\tIncidental disclosures of confidential patient information may be made during observations of staff meetings at:\n\na.\tThe Granta Primary Care Network (PCN)\nb.\tCambridge University Hospitals NHS Foundation Trust\nc.\tCambridge and Peterborough NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information are required for linkage purposes\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information are required for analysis purposes\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-06-27"]
["Next Review Date","2024-06-27"]
["Notes","Conditions of support:\n\n1.\tThe wording on the poster describing the CAG role needs to be revised to the following, “The Health Research Authority, following advice from the Confidentiality Advisory Group, agreed that s251 support should be given for the application activity” was used. The amended poster needed to be provided for review. \nCondition met 03 July 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 June 2023. \n\n3.\tConfirmation provided from the IG Delivery Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Pending:\n\nThe NHS England 21/22 DSPT reviews for Granta Medical Practices, Cambridge University Hospitals NHS Foundation Trust & Cambridge and Peterborough NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 27 June 2023).\n"]

{"sheet":"A02783","index":824,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02783"]
["Reference","23/CAG/0073"]
["Other Refs","IRAS Project ID: 323504  REC Reference: 23/WA/0184"]
["Application Title","CompreHensive GeriAtRician led MEdication Review (CHARMER) - Work Package 4 Definitive Trial"]
["Application Summary","This application from the University of Leicester set out the purpose of medical research that aims to test the effectiveness of the refined CHARMER intervention developed in the feasibility study, which is an intervention to support geriatricians and hospital pharmacists to proactively deprescribe for older people whilst they are in hospital,  by measuring the impact proactive deprescribing has on readmission rates to hospital.\n\nResearch shows that almost half of older people in hospital are prescribed a medication with a risk of harm, but these medicines are rarely stopped.  The reasons why geriatricians and hospital pharmacists do not proactively deprescribe for older people have been ascertained in a previous study.   The research team has used this work to develop an intervention to support and encourage proactive deprescribing. This study has the potential to benefit patients in hospital by supporting clinicians caring for them to stop medicines that may cause harm. Stopping medicines should also reduce medicines administration burden and potentially improve medication adherence. \n\nThe deprescribing intervention developed and refined in earlier CHARMER studies will be compared to usual care on older people's medicine wards at twenty hospital sites in England. Twenty four hospitals will take part, in case hospital sites drop out during the study. Hospitals will begin as control sites and advance to receive the intervention at different stages in a stepped wedge design. Geriatricians and pharmacists at participating hospitals will receive the intervention, which will be tested for 4 weeks. All patients receiving care from clinicians on the study ward for the duration of the study will be enrolled. Routine data collection from site medical records will be collected for all patients. Consent will be taken where possible. ‘s251’ support will be required where consent is not possible. NHS number, Date of birth, and postcode, alongside a pseudo-ID will be disclosed to Norfolk and Norwich University Hospital NHS Foundation Trust, who will then disclose onwards to NHS England for the purposes of linkage to Hospital Episode Statistics (HES) (to identify readmissions), ONS data (to identify mortality) and prescribing datasets (to assess medication changes in primary care post discharge i.e. whether deprescribing was sustained). Most patient identifiers will be removed once data linkage is complete, however full date of death alongside other data is returned to Norwich Clinical Trials unit for analysis, therefore this flow also requires ‘s251’ support. This approach was tested in a recent feasibility study of CHARMER (22/CAG/0071).\n"]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Professor David Wright, Co-Chief Investigator"]
["Address","University of Leicester"]
[null,"University Road"]
[null,"Leicester"]
["Postcode","LE1 7RH"]
["Telephone","0116 252 5992"]
["Email","D.J.Wright@Leicester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients under the care of a participating geriatrician on a study ward during the active study window who do not consent to the study.   \n\nTotal of 24,000 participants. Applicant estimates that a maximum of 3000 patients will provide consent to take part, therefore a minimum of 21,000 will require ‘s251’ support\n"]
["Description of confidential patient information used","Data sources\n\n1.\t24 Participating NHS sites\na)\tMedical records\n\n2.\tNHS England:\na)\tHospital Episode Statistics \nb)\tONS Mortality Data \nc)\tNHS Prescription Dataset \n\nIdentifiers required for linkage purposes\n\n1.\tNHS number\n2.\tDate of birth\n3.\tPostcode\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-07-06"]
["Next Review Date","2024-07-06"]
["Notes","Amendment supported on 14 December 2023 to request A&E and outpatient data from NHS England\n\nConditions of support:\n\n1.\tPlease provide an update about the ongoing activities and further feedback from patient and public involvement, at annual review.  \n \n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 04 July 2023. \n \n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:  \n \nThe NHS England 21/22 DSPT reviews for Norfolk and Norwich University Hospital NHS Foundation Trust, NHS England, & Norwich Clinical Trials Unit (EE133853-NMS-CTU) were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 20 June 2023) \n \nDue to the number of participating organisations involved it is the responsibility of University of Leicester, as controller, to ensure that organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation. \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02784","index":825,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02784"]
["Reference","23/CAG/0083 "]
["Other Refs","IRAS Project ID: 266410  REC Reference: 19/LO/1393"]
["Application Title","Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy"]
["Application Summary","This application from Imperial College Healthcare NHS Trust set out the purpose of medical research that seeks to assess the efficacy of the EmboTrap Revascularisation Device in a real-world setting. \n\n15 million people worldwide suffer from a stroke each year. Approximately 90% of all strokes are Acute Ischemic Strokes (AIS), the majority of which are due to Large Vessel Occlusions (LVO) Numerous studies have shown that removing the blood clot or occlusion can limit disability and drastically improve the patient’s chances of having a good functional outcome. Intravenoustissues plasminogen activator (IV t-PA) is routinely used to treat patients experiencing AIS in the United States, Europe and other regions. However, many patients do not meet the therapy’s eligibility criteria and IV t-PA has been shown to be less effective in recanalizing proximal LVOs. Previous trials have shown that mechanical thrombectomy can be a safe and effective alternative to IV t-PA alone. Previous trials have used stent retrievers, however successful revascularisation is not achieved in all patients. The applicants seek to test the effectiveness and safety of the EmboTrap Revascularisation Device in treatment of AIS. \n\nEligible patients will be identified by the direct care team who will inform the research team and provide them with the patients contact details. The research team will also access patient records to check eligibility. Patients will then be contacted by the research team and their consent sought to take part in the study. \n"]
["Applicant Organisation Name","Imperial College Healthcare NHS Trust"]
["Contact Name","Dr Kyriakos Lobotesis"]
["Address","Second Floor, North Wing Charing Cross"]
[null,"Charing Cross Hospital"]
[null,"Fulham Palace Road, London"]
["Postcode","W6 8RF"]
["Telephone","020 331 10329 "]
["Email","k.lobotesis@nhs.uk  "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients with Acute Ischemic Stroke treated with the EmboTrap or Embovac Revascularization Devices.\n\n150 patients will be recruited within the UK. \n"]
["Description of confidential patient information used","Data sources\t\n\n1.\tPatient records at Imperial College Healthcare NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tHospital ID\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n2.\tGender\n3.\tEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-07-14"]
["Next Review Date","2024-07-14"]
["Notes","Specific conditions of support \n\n1.\tFurther methods of patient notification need to be developed, making information available in brief, accessible posters in clinical areas. The patient notification needs to explain how patients can dissent to inclusion and provide appropriate contact details. \n\n2.\tPatient and public involvement needs to be undertaken with a small group including stroke patients. \n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed: 04 November 2023\n\n4.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 21/22 DSPT review for Imperial College Healthcare NHS Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (05 July 2023)\n"]

{"sheet":"A02785","index":826,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4]]}
[]
[]
["Application Number","A02785"]
["Reference","23/CAG/0081"]
["Other Refs","IRAS Project ID: 325766  REC Reference: 23/LO/0559"]
["Application Title","Remote monitoring in virtual wards for acutely unwell patients being managed and treated on an ambulatory care pathway: feasibility study"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that seeks to test the feasibility of continuous remote vital-sign monitoring in people receiving care in an NHS delivered home-based acute-virtual ward.\n\nVirtual wards for admission avoidance are already being implemented across the NHS. They are being used to deliver health care to people who are otherwise reluctant to spend time in hospital and to help free up the limited number of hospital beds. When at home patients are regularly called and visited by doctors and nurses. To find out how their patients are feeling whilst at home, the NHS team might ask their patient to use devices to measure their blood oxygen levels using a pulse oximeter and then report this over the phone. Remote vital-sign monitoring has the potential to reduce the number of visits by nurses to carry out in-person vital-sign observations, but where vital-sign monitoring is carried out by patients and reported by phone, there is a possibility of inaccurate readings. Remote vital-sign monitoring has the potential to reduce the number of visits by nurses to carry out in-person vital-sign observations, but where vital-sign monitoring is carried out by patients and reported by phone, there is a possibility of inaccurate readings.\n\nThe applicants have developed a system using a vital-sign chest patch and a pulse oximeter finger probe to automatically collect health measurements. Patients will also be asked to use a blood pressure monitor and an in-ear thermometer, which will not be automated, regularly over the course of the monitoring period, to establish whether these devices can be consistently used by patients. 35 patients will be recruited from the Ambulatory Assessment Unit (AAU) at Oxford University Hospitals NHS Foundation Trust. Patient records will be screened for eligibility by members of the research team by accessing each patients’ electronic notes for the current admission and their general contact details. A record with a unique study ID will be created in the secure screening log, which will include the patients age, gender, the date of screening and their eligibility based on initial checks. If a patient is found to be eligible their name and NHS number will be used to immediately approach the patient about the study. Patients will be given a copy of the patient information sheet and study overview. Participants will either be consented by research staff during their hospital attendance or, if lacking capacity, will have a personal or professional consultee advise on their behalf.\n"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Andrew Farmer"]
["Address","Nuffield Department of Primary Care Health Sciences"]
[null,"Woodstock Road"]
[null,"Oxford"]
["Postcode","OX2 6GG"]
["Telephone","01865 289280"]
["Email","andrew.farmer@phc.ox.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who the Ambulatory Assessment Unit at Oxford University Hospitals NHS Foundation Trust have determined are clinically appropriate to be managed at home via the Hospital at Home virtual ward."]
["Description of confidential patient information used","Data sources\n\n1.\tPatient records at Oxford University Hospitals NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS number\n3.\tPostcode – district level\n4.\tAge\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tAge\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-07-14"]
["Next Review Date","2024-07-14"]
["Notes","Amendment supported 08 April 2024 to clarify that the eligible cohort are patients referred to hospital at home services at Oxford University Hospitals NHS Foundation Trust (instead of restricted to hospital at home referrals from the OUH Ambulatory Assessment Unit (AAU)), and to increase the recruitment period from 12 weeks to 24 weeks\n\nSpecific conditions of support \n\n1.\tFurther patient and public involvement needs to be undertaken to include discussion of the specific question regarding access to records prior to gaining consent.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: 10 July 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 21/22 DSPT review for University of Oxford and Oxford University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (04 July 2023)\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02786","index":827,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02786"]
["Reference","23/CAG/0019 "]
["Other Refs","IRAS Project ID: 314867  REC Reference: 23/WA/0048"]
["Application Title","CLEOPATRAA Trial - Breast cancer molecular typing and grading trial"]
["Application Summary","This application from Leeds Teaching Hospitals NHS Trust set out the purpose of medical research which aims to determine whether 4D Path’s Technology Q-Plasia OncoReader Breast, that has been developed in the research setting, works robustly and reproducibly in the clinical diagnostic environment, to confirm its real-life clinical utility, in terms of breast carcinoma grading and molecular subtyping. Applicants will also establish the cost-effectiveness of the 4D Path platform. Applicants also wish to examine the long-term characteristics of the patient cohort, and the future potential applications of the technology.\n\nBreast cancer is the most commonly diagnosed cancer worldwide, with approximately 55,900 new cases a year diagnosed in the UK. In order to determine the correct treatment for breast cancer patients, a biopsy is usually taken and reviewed by a pathologist, to obtain a definite diagnosis. The biopsy tumour tissue is also tested for oestrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) status – i.e. its ‘molecular subtype’. The results from these tests inform oncologists in their choice of the most appropriate treatment for each patient. The results of these markers can also aid prognosis. These tests are usually interpreted by a pathologist. Carrying out of these tests requires extra work from pathology laboratories as well as the extra reporting time/expertise from the pathologist. With only 3% of the UK’s current pathology departments fully staffed to meet current demand, there is a need for a tool to help provide accurate and efficient reporting of breast cancer biopsies.\n\nIt is hoped that this tool could; \n•\timprove earlier diagnosis of breast cancer, including molecular subtype results, to provide treatment-critical information to oncologists sooner, \n•\treduce cost to NHS laboratories by negating the need to perform additional tests when digital images of breast cancer biopsies can be used instead, \n•\teliminate the time a pathologist needs to spend interpreting these additional tests, freeing up time for more complex diagnostic work, \n•\tfreeing up laboratory staff who would otherwise be performing these extra tests, allowing allocation of their time to other critical tasks, \n•\tavoid destruction of biopsy tissue which is otherwise needed to carry out these additional tests, leaving tissue for further potential research or testing, \n•\timprove the diagnostic accuracy of grade on biopsy specimens (which is incorrect relative to the resection/excision specimen in about 20% of cases): this is clinically relevant in instances where patient receive neoadjuvant therapy. \n\nThe trial will run alongside the normal pathology workflow at St James’s University Hospital (SJUH), (part of Leeds Teaching Hospitals NHS Trust), and make use of existing digitised pathology workflows, since slides for all cases that are reported by the department are digitally scanned for routine diagnostics. Eligible cases will be identified by the direct care team within the pathology laboratory system CoPath. At this stage, the National data Opt Out will be applied, by the Trusts Data Access Committee.  ‘s251’ support is required as the research team, who are not considered direct care team, will extract the digital images, clinical and pathological data required from the Trust digital pathology server, Sectra, and electronic patient records, which will require the research team to view confidential patient information. The research team are required to undertake these processes in order to keep the direct care team blinded. Digitised images of malignant breast cancer biopsies will be effectively anonymised prior to disclosing to 4D Path. Once the 4D Path algorithm has produced a result, this will then be compared to the result produced by the reporting pathologist. The unblinding and comparison of the case diagnostic output comparison will be performed by the research team to avoid bias, which will also involve access to confidential patient information, and require ‘s251’ support.  The baseline clinical and pathological data will create a study database. This database will be retained by the direct care team only, so no ‘s251’ support will be required for retention of the database. The database will contain LH number, (but no other identifying information), which the direct care team will use at 5 and 10 years to search the Trust clinical records for outcome data. Again, this will be outside the scope of ‘s251’ support.\n"]
["Applicant Organisation Name","Leeds Teaching Hospitals NHS Trust"]
["Contact Name","Dr Nicolas Orsi"]
["Address","Industrial Clinician Scientist in Histopathology"]
[null,"Wellcome Trust Brenner Building, St James's University Hospital, Beckett Street,"]
[null,"Leeds, West Yorkshire"]
["Postcode","LS9 7TF"]
["Telephone",1133438625]
["Email","N.M.Orsi@leeds.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients with a breast biopsy specimen processed at the pathology laboratory at St James's University Hospital, Leeds Teaching Hospitals Trust\n\napproximately 700-800 patients over 12 months. This will start once all appropriate approvals are in place. \n"]
["Description of confidential patient information used","Data sources\n\n\t1.\tLeeds Teaching Hospitals NHS Trust:\na.\tSectra imaging software - imaging\nb.\tLTHT laboratory information management system CoPath – specimen reports\nc.\telectronic health record (PPM+)\n\nIdentifiers required for purposes of creating a pseudonymised data set for analysis\n\n1.\tNHS number \n2.\tLH specimen number \n3.\tElectronic patient record will be viewed\n\nIdentifiers required for analysis purposes\n\n1.\tAge\n2.\tGender\n\nAdditional information\n\nFollow up at 5 and 10 years will be undertaken by the direct care team only, and therefore no ‘s251’ support required for this. \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-07-13"]
["Next Review Date","2024-07-13"]
["Notes","Amendment supported 14 December 2023 to allow earlier image extraction (before the National Data Opt Out (NDOO) checks are completed), which will now only be done by the direct care team rather than the research team, as the NDOO will be applied after this timepoint - therefore the requirement for ‘s251’ support to allow the research team to initially extract the digital images will no longer be required.\n\nThe application, to allow the disclosure of confidential patient information to researchers who are not considered direct care team, at Leeds Teaching Hospitals NHS Trust, during the process of extracting and pseudonymising image data for disclosure to 4D Path Inc, and extracting a clinical/pathological dataset for analysis which will be retained by the direct care team, and also during the unblinding and comparison of the case diagnostic output, is conditionally supported, subject to compliance with the standard and specific conditions of support\n\n\nConditions of support:\n\n1.\tOngoing patient and public involvement needs to be undertaken specifically with breast cancer patients, to ensure public interest in the activity. Please also ensure that the wording of the online information and any other patient notification materials, such as posters, is reviewed by a relevant Patient and Public Involvement group, and feedback from this is to be provided to the CAG within 3 months from the date of this letter. Condition met 14 December 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 13 July 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\n\nThe NHS England 21/22 DSPT review for Leeds Teaching Hospitals NHS Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 03 February 2023)\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02787","index":828,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02787"]
["Reference","23/CAG/0051"]
["Other Refs","IRAS Project ID: 325926  REC Reference: 23/LO/0427"]
["Application Title","Retrospective analysis of real-world evidence on the use of glycopyrronium bromide in children under 3 years of age with sialorrhea "]
["Application Summary","This application from Alder Hey Children's NHS Foundation Trust and Proveca Ltd set out the purpose of medical research that seeks to Evaluate the safety and efficacy of using enteral Sialanar® (glycopyrronium bromide) to treat sialorrhoea (excessive drooling) in children under 3 years old, in terms of adverse events, suspected serious adverse events and the associated treatment discontinuation due to such events.\n\nSialanar® (glycopyrronium bromide) is currently licensed for the treatment of severe drooling in children and adolescents aged 3 years and older with chronic neurological disorders. The existing indication for Sialanar® was based on the position that salivary continence is not normally reached until 15–18 months of age in developmentally normal children. Consequently, drooling is not considered pathological below 3 years of age.  Nevertheless, severe drooling is a significant issue for a proportion of children with chronic neurodevelopmental issues below 3 years of age, and it has become apparent that there is significant interest in and use of Sialanar® in children under 3, prescribed off label (use outside of the product license). This study will use retrospective patient data, of children under 3 who have been treated with this drug. It is hoped that a retrospective analysis of this age group, if shown to be an effective treatment, could evidence an expansion of the Sialanar® licence. This would give younger patients easier access to a product to help manage excessive drooling. \n\nThe study is limited to the review of existing medical records of participants from birth to 3 years of age treated with glycopyrronium bromide for sialorrhoea, at participating Trusts. ‘s251’ support is requested for the identification of potential participants, who will be identified through review of the available medical records at participating sites by research staff who are not considered direct care team. ‘s251’ support is also requested for the research staff to view medical records during the process of data extraction. Data will be collected for each individual participant for up to 36 months following the commencement of glycopyrronium bromide treatment, or to the age of 3 years whichever is less. ‘s251’ support is requested to allow date of birth and date of death to be uploaded to Redcap (hosted by University of Liverpool), alongside other clinical data, including sex, gestational age, body weight, length at birth, and medical history. Confidential patient information will then be removed by University of Liverpool, prior to analysis being undertaken on an effectively anonymous dataset by Alder Hey Children's NHS Foundation Trust. Any data onwardly disclosed to Proveca Ltd is effectively anonymised.\n"]
["Applicant Organisation Name","Alder Hey Children's NHS Foundation Trust (and Proveca Ltd)"]
["Contact Name","Dr Louise Bracken"]
["Address","Senior Research Pharmacist/ Co-Director PMRU"]
[null,"Clinical Research Division, 1st Floor Institute in the Park"]
[null,"Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool"]
["Postcode","L12 2AP"]
["Telephone",1512525570]
["Email"," Louise.Bracken@alderhey.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Participants from birth to 3 years of age treated with glycopyrronium bromide for sialorrhoea\n\nPlanned sample size of approximately 50-100 patients\n\nData will go back up to 10 years, starting with the most recent available data.\n"]
["Description of confidential patient information used","Data sources\n\nMedical notes from 5 Participating sites:\n•\tAlder Hey Children's NHS Foundation Trust\n•\tGateshead Health NHS Foundation Trust\n•\tNottingham University Hospitals NHS Trust\n•\tGuy's and St Thomas' NHS Foundation Trust\n•\tUniversity Hospitals Bristol & Weston NHS Foundation Trust\n\nIdentifiers required to be uploaded to RedCap\n\n1.\tDate of birth\n2.\tDate of death\n3.\tSex\n\nMedical records will be reviewed to extract this data.\n\nIdentifiers required for analysis purposes\n\nN/A analysis will be undertaken on a pseudonymised dataset.\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-07-17"]
["Next Review Date","2024-07-17"]
["Notes","The application, to allow researchers who are not considered direct care team to view medical records during the identification of eligible patients, and extraction of a dataset for analysis, at participating Trusts, and to allow the disclosure of confidential patient information from participating sites to a REDcap database hosted by the University of Liverpool (UoL), is fully supported, subject to compliance with the standard conditions of support\n\n\nConditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 May 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nDue to the number of organisations involved it is the responsibility of Alder Hey Children's NHS Foundation Trust and Proveca Ltd, as controllers, to ensure that participating Trusts meet the minimum required standard in complying with DSPT’s and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a Trust.\n"]

{"sheet":"A02788","index":829,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02788"]
["Reference","22/CAG/0090"]
["Other Refs","IRAS Project ID:  276106 REC Reference: 22/LO/0443"]
["Application Title","ISIS 2 Second International Study of Infarct Survival: Legacy Database"]
["Application Summary","This application from the University of Oxford set out the purpose of medical research that \nseeks to continue analysis of confidential patient information collected for the ISIS-2 trial, \nwhich was initiated in 1985 to explore treatment of acute heart attack.  \n\nRecruitment for the ISIS-2 main trial took place in hospitals between March 1985 and \nDecember 1987. 6,213 patients were recruited within the UK. The study population was \npatients who had suffered an acute heart attack. Participants were randomised to receive \neither intravenous streptokinase or a matching placebo, plus oral aspirin or a matching \nplacebo. After recruitment ended in December 2981, the ISIS-2 study team continued to \ncollect medical information held by UK Central Registries, such as the Office for National \nStatistics (ONS), until 1997. The findings from the ISIS-2 trial were that patients taking \nstreptokinase and/or aspirin were more likely to survive than those taking the placebo and \nthe benefit seem to last for at least 10 years. \n\nSupport is only requested for the continued holding of confidential patient information \ncollected during ISIS-2. The applicants are reapplying to CAG as, while some of the data \ncollected is part of the applicants’ Data Sharing Agreement with NHS Digital, after \ndiscussion with NHS Digital it was determined that the original consent was not sufficient \nand that previous Section 251 support had expired. Although the applicants only seek to \ncontinue to hold the confidential patient information and have no current plans for further \ndata linkages or research, the applicants note that the data collected may be used to \nundertake research in future, such as subgroup analysis and long-term data linkage. The \napplicants also noted that, while the original trial was conducted several years ago, ISIS-2 \nremains one of the few trials to demonstrate the benefits and safety of treatment with \nstreptokinase. It is also the only trial that has demonstrated the benefit of aspirin in the \nsetting of acute heart attack. \n\nThe applicants advised that amendments will be submitted should confidential patient \ninformation collected for ISIS-2 be used to undertake data linkages and/or further \nresearch in the future. "]
["Applicant Organisation Name","University of Oxford (Nuffield Department of Population Health) "]
["Contact Name","Prof Rory Collins\r"]
["Address","CTSU, Nuffield Department of Population Health\r"]
[null,"Richard Doll Building, University of Oxford"]
[null,"Oxford"]
["Postcode","OX3 7LF"]
["Telephone",1865743743]
["Email","rory.collins@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The ISIS-2 cohort were recruited between March 1985 and December 1987. \n\n6,213 participants were randomised into the trial in hospitals in the UK. 4666 patients were recruited within England and Wales.  \nPatients had had an acute heart attack (MI) and were a median age of 60-69 years old at randomisation. "]
["Description of confidential patient information used","Data sources \n\nData collected for the ISIS-2 Trial, held at University of Oxford (Nuffield Department of Population Health) \n\nIdentifiers required for linkage purposes\n\n1. NHS number \n2. Name \n3. Address \n4. Date of birth \n5. Postcode \n6. Gender \n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n2. Date of death \n3. Gender \n\nAdditional information\n\nDate of death, date of birth and gender will be kept within the main trial database to retain the usefulness of the dataset. All other identifiers will be stored separately."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-07-04"]
["Next Review Date","2024-07-04"]
["Notes","05 January 2024 – amendment supported to allow the Nuffield Department of Population Health (NDPH) Information Governance Team act as a Trusted Third Party, holding confidential patient information until the ISIS-2 dataset can be used for further linkages. \n\nAmendment supported 24 July 2023 to extend the duration of support for a further 6 months, until 04 January 2024\n\nSpecific conditions of support\n\n1. The dataset is to be retained in an identifiable format until 04 January 2024. After this date, the dataset is to be anonymised and all items of confidential patient information deleted. \n\nConfirmed. Following further discussion with CAG it has been agreed that the organisational IG team will hold the identifiers separately under this support, with no access to this file until a further application to CAG is supported.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed: 17 June 2022\n\n3. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 2020/21 DSPT review for University of Oxford (Nuffield Department of Population Health) was confirmed as ‘Standards Met’ on the NHSDigital DSPT Tracker (checked 27 June 2022)\n\nAs the above conditions have been accepted or met, this letter provides confirmation of \nfinal support. I will arrange for the register of approved applications on the HRA \nwebsite to be updated with this information.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02789","index":830,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02789"]
["Reference","23/CAG/0064"]
["Other Refs","IRAS Project ID: 322303  REC Reference: 23/EE/0124"]
["Application Title","Stroke Audit Machine Learning"]
["Application Summary","This application from the University of Exeter College of Medicine and Health set out the purpose of medical research that seeks to investigate what a machine-learning model based on SSNAP data should look like and how it should be delivered.  \n\nStroke is a leading cause of death and disability, with over 85,000 people hospitalised in the UK each year. One way of treating stroke and preventing disability is to treat with thrombolysis, where medication that breaks down blood clots is given. Thrombolysis is not suitable for all patients and can involve risk for some patients. For thrombolysis to be useful it needs to be given as soon after the stroke as possible. The use of thrombolysis varies hugely, even for patients with similar treatment pathways and with similar characteristics. Some hospitals rarely use it, some use it in a quarter of stroke patients. The speed of giving thrombolysis also varies. Some hospitals take an average of 90 minutes, others less than 40 minutes, to administer the drug. In a previous study, SAMUeL-1, reasons for variations in use of thrombolysis were investigated. One reason was clinical decision-making. The applicants are now seeking to collect further information on the clinical decision-making process.  \n\nThe applicants will trace how physicians currently make decisions around stroke/thrombolysis in real time, and the resources and decision-making tools they have available. As part of this process of observation, the researcher will observe Multi-Disciplinary Team meetings during the sections where stroke care and thrombolysis are discussed. Observations of patient care will also take place. The researcher will overhear confidential patient information, but will not document, gather or process the information as it not relevant to the study. No confidential patient information will be used for research purposes. "]
["Applicant Organisation Name","University of Exeter College of Medicine and Health "]
["Contact Name","Dr Michael Allen, Senior Modeller "]
["Address","University of Exeter Medical School "]
[null,"St Luke's Campus "]
[null,"Heavitree Road "]
["Postcode","EX1 2LU "]
["Telephone","01392 726080"]
["Email","m.allen@exeter.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","194 members of NHS staff will be included.  \n\nObservations will be conducted in 3 hospital sites. It is not possible to give a precise figure for those included in the observations.  "]
["Description of confidential patient information used","Data sources \n\n1.Incidental disclosures of confidential patient information may be made during observations of staff meetings at: \n\na. University Hospitals Sussex Foundation Trust \n\nb. The Royal Cornwall hospital Foundation Trust \n\nc. Northern Lincolnshire and Goole Foundation Trust \n\nIdentifiers required for linkage purposes \n\nNo items of confidential patient information will be used for linkage. \n\nIdentifiers required for analysis purposes \n\nNo items of confidential patient information will be used for analysis purposes. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-07-31"]
["Next Review Date","2024-07-31"]
["Notes","Conditions of support:\n\n1.\tEngagement with the Patient and Carer’s Involvement Group is to be continued, including engagement with new volunteers, and ongoing patient and public involvement specifically related to this study. Feedback is to be provided at the first annual review.   \n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 25 July 2023 \n3.\tConfirmation provided from the IG Delivery Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Pending: \nThe NHS England 21/22 DSPT reviews for University Hospitals Sussex Foundation Trust & The Royal Cornwall Hospitals NHS Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 31 May 2023) \n \nThe applicant advised that the DSPT for Northern Lincolnshire and Goole NHS Foundation Trust is no longer required, as this Trust has been removed from the application.  \n\n"]

{"sheet":"A02790","index":831,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02790"]
["Reference","22/CAG/0129 "]
["Other Refs","IRAS Project ID:  308194  REC Reference: 22/HRA/3277"]
["Application Title","Assessment, Management and Outcomes for children and young people referred to a National Gender Identity Development Service"]
["Application Summary","This application from University of York sets out the purpose of medical research which seeks to describe the clinical and demographic characteristics of children and young people referred to the Tavistock and Portman NHS Foundation Trust’s Gender Identity Development Service (GIDS) and their clinical management, as well as assess the intermediate outcomes of this population. \n\nSome children and young people may experience significant levels of gender-related distress, arising from a persistent mismatch between a young person’s felt gender identity and the sex they were registered as/assigned at birth. The Tavistock and Portman NHS Foundation Trust’s GIDS is currently the only NHS funded service for young people with gender-related distress in England and Wales, and the number referred to the service has risen markedly over the last decade. As well, the demographic of those referred has changed, for example an increase in people who were registered as female at birth, and those who have autistic traits or are autistic. The evidence base on which current and future support to this changing population can be provided is limited and generally small in scale and short in term. This application is designed to enhance the existing evidence which will inform an independent review of gender identity development services for young people (The Cass Review) that will report to NHS England\n\nClinical data of children, teenagers or young adults aged under 18 years old at the point of referral to GIDS, and referred between 2009-2020, will be extracted from Tavistock and Portman NHS Foundation Trust GIDS clinical notes. This clinical data will be shared with the University of York in a pseudonymised format. Due to how clinical data have been recorded at the Tavistock and Portman NHS Foundation Trust between 2009-2020 this needs to be a manual extraction. Support is requested for six research assistants to undertake this extraction as the clinical care team do not have the capacity to undertake this. This has additionally been extended to all Adult Gender Identity Clinics.\n\nConfidential patient information of the same cohort (Date of birth, NHS Number, Postcode, Birth registered sex) will be also shared from the following organisations to NHS Digital:\na)\tTavistock and Portman NHS Foundation Trust\nb)\tTwo paediatric endocrine clinics that provide services to GIDS\nc)\tSeven adult gender identity clinics (GICs - additionally will send GIC serial number). This flow will be for all service users aged up to 30 years (the maximum age of the first service users from 2009) due to not being able to extract only GIDS service users. \n\nNHS Digital will link to data sources they hold and return to all the above organisations a unique study ID. Where a service user has changed their gender (and therefore obtained a new NHS number) NHS Digital will use a modified matching process based on postcode and date of birth to identify the two NHS numbers. All the above organisations will send clinical information, identified by the unique study ID only, to the University of York, to enable merging the datasets together. However, those seen at adult GICs that but not at the Tavistock and Portman NHS Foundation Trust GIDS will not have any clinical information shared with University of York, and identifiers are only sent to NHS Digital for matching purposes.\n\nAt no time will University of York have access to identifiable data items. All data items transferred will be structured data only and at no time will free text be extracted from clinical notes from any organisation.\n"]
["Applicant Organisation Name","University of York"]
["Contact Name","Professor Tim Doran"]
["Address","Department of Health Sciences"]
[null,"University of York"]
[null,"Heslington, York"]
["Postcode","YO10 5DD"]
["Telephone",1904321524]
["Email"," tim.doran@york.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1.The Tavistock and Portman NHS Foundation Trust (Gender identity development service – GIDS)\n•\tAll children, teenagers or young adults aged ≤ 18 years old at the point of referral to Tavistock GIDS, who have been referred to GIDS between 2009-2020 (approximately 9000).\n\n2. Adult Gender Identity Clinics (GICs)\n•\tAll service users aged up to age 30 years\n\n3. Paediatric Endocrine Clinics\n•\tAll children, teenagers or young adults aged ≤ 18 years old at the point of referral to Tavistock GIDS, who have been referred from GIDS between 2009-2020.\n"]
["Description of confidential patient information used","Data sources\n\n1.\tThe Tavistock and Portman NHS Foundation Trust (Gender identity development service – GIDS)\n2.\tNHS Digital, with use of following datasets:\na.\tHospital Episodes Data – Admitted Patient Care\nb.\tHospital Episodes Data – A and E (pre 2019) and Emergency care dataset (from 2019)\nc.\tHospital Episodes Data – Outpatient\nd.\tMental Health Minimum data set\ne.\tCommunity prescribing data\nf.\tDeath Registration data\n3.\tUniversity College London Hospitals NHS Foundation Trust (paediatric endocrinology service)\n4.\tLeeds Teaching Hospitals Trust (paediatric endocrinology service)\n5.\tNHS Gender Identity Clinics for Adults in England \na.\tThe Tavistock and Portman NHS Foundation Trust (Gender Identity Clinic)\nb.\tLeeds and York Partnership NHS Foundation Trust (Leeds Gender Identity Clinic) \nc.\tNorthamptonshire Healthcare NHS Foundation Trust (Northampton Gender Identity Clinic) \nd.\tCumbria, Northumberland, Tyne and Wear NHS Foundation Trust (Northern Region Gender Dysphoria Service) \ne.\tNottinghamshire Healthcare NHS Trust (The Nottingham Centre for Transgender Health) \nf.\tSheffield Health and Social Care NHS Foundation Trust (Porterbrook Clinic Gender Identity Service)\ng.\tDevon Partnership NHS Trust (The Laurels Gender Identity Clinic) \n\nIdentifiers required for linkage purposes\n\n1.\tThe Tavistock and Portman NHS Foundation Trust \na.\tDate of birth\nb.\tNHS Number\nc.\tPostcode\nd.\tBirth registered sex\n2.\tNHS Gender Identity Clinics for Adults in England \na.\tDate of birth\nb.\tCurrent NHS Number\nc.\tPostcode\nd.\tBirth registered sex\n3.\tPaediatric Endocrine Clinics\na.\tDate of birth\nb.\tCurrent NHS Number\nc.\tPostcode\nd.\tBirth registered sex\n\nIdentifiers required for analysis purposes\n\n1.\tMonth and year of birth\n2.\tMonth and year of death (where relevant)\n3.\tLower Super Output Area\n4.\tGender – both at birth and current, where relevant\n5.\tEthnicity\n\nAdditional information\n\nThis will be a one-off extraction from each organisation, with no further follow up extractions planned.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-08-10"]
["Next Review Date","2024-08-10"]
["Notes","Specific conditions of support\n\n1.\tAll confidential patient information, and the resultant dataset held at the University of York, should only be used within the scope of this application. It should not be used for other purposes without further CAG advice.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 10 August 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 21/22 DSPT review for the following organisations was confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 15 August 2022):\n\na.\tThe Tavistock and Portman NHS Foundation Trust \nb.\tNHS Digital \nc.\tUniversity College London Hospitals NHS Foundation Trust \nd.\tLeeds Teaching Hospitals Trust \ne.\tLeeds and York Partnership NHS Foundation Trust \nf.\tNorthamptonshire Healthcare NHS Foundation Trust  \ng.\tCumbria, Northumberland, Tyne and Wear NHS Foundation Trust \nh.\tNottinghamshire Healthcare NHS Trust \ni.\tSheffield Health and Social Care NHS Foundation Trust \nj.\tDevon Partnership NHS Trust  \n\n"]

{"sheet":"A02791","index":832,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[14,1,14,4],[21,1,21,4],[22,1,22,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[35,1,35,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4]]}
[]
[]
["Application Number","A02791"]
["Reference","23/CAG/0047"]
["Other Refs","IRAS Project ID: 316593  REC Reference: 23/WA/0137"]
["Application Title","A randomised controlled phase III trial of a novel behavioural intervention for primary care teams to promote the earlier diagnosis of cancer (ThinkCancer!)"]
["Application Summary","This application from Bangor University set out the purpose of medical research that seeks to assess the effectiveness of use of the ThinkCancer! Intervention by general practice teams, compared with usual care. \n\nEarly diagnosis of cancer is key to improving patient outcomes. Over 70% of cancers present in primary care, meaning general practice is a good setting for behaviour change, quality improvement and education. The main aim of this randomised trial is to see how a behavioural and educational package can help the whole general practice team to pick up early symptoms and signs of cancer that mean the patient should receive an urgent referral. The ThinkCancer! intervention will be delivered remotely as an educational and quality improvement workshop via three distinct workshops. Each member of practice staff will take part in two workshops. Interviews will also be held with stakeholders and patients and carers.\n\nThe applicants will collect primary care interval (PCI) data by search of patient records at participating GP practices. The PCI is time from first symptom suggestive of cancer, to time to referral to secondary care. This will be undertaken by research staff who are trained in these methods working alongside general practice staff. An anonymised dataset will be extracted.\n\n To examine other factors which may be related to delayed Urgent Suspected Cancer (USC) referral or diagnosis, the applicants also intend to conduct a review of case notes for a sample of 60 patients. Consent will not be sought for this and the applicants are seeking support under s251. Records will be screened by a researcher to identify eligible patients and extract an anonymised dataset."]
["Applicant Organisation Name","Bangor University"]
["Contact Name","Professor Clare Wilkinson"]
["Address","North Wales Centre for Primary Care Research"]
[null,"Cambrian 2 Wrexham Tech Park"]
[null,"Wrexham"]
["Postcode","LL13 7YP"]
["Telephone","01248 351 151"]
["Email","c.wilkinson@bangor.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over with a primary care interval exceeding the 75th and 90th centile for a given cancer type. \n\n60 patients will be included in the case note review. \n\nThe applicants anticipate that 3078 will need to be reviewed in order to identify 60 patients."]
["Description of confidential patient information used","Data sources\n\n1. Patient records at participating GP practices\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS Number \n3. Date of birth\n\nIdentifiers required for analysis purposes\n\n1. Postcode – district level"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-08-22"]
["Next Review Date","2024-08-22"]
["Notes","Amendment supported 14 February 2024 to include further additional participating GP practices, (Paxton Medical Group (NW England), Vauxhall Health Centre (NW England), Eastham Group Practice (NW England) & Brynteg surgery (HDUHB)), to the application, as additional data processors under ‘s251’ support\n\nAmendment supported 08 February 2024 to include further additional participating GP practices, (listed in the amendment form dated 19 January 2024), to the application, as additional data processors under ‘s251’ support\n\nConditions of support: \n \n1. Favourable Opinion from REC review: Confirmed \n\n2. Confirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. \n\nConfirmed: \n\nDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations.\n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02792","index":833,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02792"]
["Reference","23/CAG/0068"]
["Other Refs","IRAS Project ID: 315456  REC Reference: 23/EM/0100"]
["Application Title","Maximising the value of the Caerphilly Prospective Study (CaPS)"]
["Application Summary","This application from the University of Bristol set out the purpose of continued holding of confidential patent information collected for the Caerphilly Prospective Study. \n\nThe Caerphilly Prospective Study (CaPS) recruited patients between 1979 and 1988. 2512 men aged 45-59 years were recruited from the town of Caerphilly and adjoining villages between 1979 and 1983, with an additional 447 recruited between 1984 and 1988. Men were initially seen at an evening clinic, where they completed a questionnaire, had anthropometric measures (measurements of the proportions, size, and weight of the human body) and an electrocardiogram (ECG) taken to check the heart’s rhythm and electrical activity. They also completed a food frequency questionnaire at home. They subsequently re-attended an early morning clinic to have fasting blood samples for a wide variety of tests. \n\nPatients were initially recruited under consent. Most of the participants have died and the remaining survivors are likely to be frail and/or cognitively impaired. After 35 years of follow-up, it was decided to no longer collect any new data directly from the cohort, but to update any new clinical events through routine linkage with NHS England. The applicants seek support to continue to hold confidential patient information for the cohort and disclosure of a unique patient ID and patients dates of birth to NHS England for linkage to ONS and cancer registry data. \n"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Nick Reynolds"]
["Address","Newcastle University Translational and Clinical Research Institute"]
[null,"William Leech Building "]
[null,"Newcastle University"]
["Postcode","NE2 4HH"]
["Telephone","+44 (0) 191 208 5840"]
["Email","nick.reynolds@ncl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients recruited into the Caerphilly Prospective Study"]
["Description of confidential patient information used","Data sources\n\n1. Caerphilly Prospective Study records, at University of Bristol\n2. ONS and cancer registry data, held by NHS England\n\nIdentifiers required for linkage purposes\n\n1.\tUnique ID \n2.\tNHS number\n3.\tFull Name\n4.\tNHS number\n5.\tDate of birth\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-11"]
["Next Review Date","2024-09-11"]
["Notes","Conditions of support: \n \n 1. Favourable opinion from a Research Ethics Committee. Confirmed: 30 March 2023 \n\n2. Confirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \nThe NHS England 21/22 DSPT review for Newcastle University, Newcastle upon Tyne Hospitals NHS Foundation Trust, North of England Commissioning Support Unit and Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (04 July 2023) \n\nDue to the number of participating organisations involved it is the responsibility of Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation Trust as controller, to ensure that participating GP practices meet the minimum required standard in complying with DSPTs and take remedial action if they become aware of any that fall below this, or where any concerns are raised.\n\n"]

{"sheet":"A02793","index":834,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02793"]
["Reference","23/CAG/0067"]
["Other Refs","IRAS Project ID: 324217  REC Reference: 23/NE/0109"]
["Application Title","An evaluation of the clinical efficacy and risk profile of routine spinal operations performed in the National Health Service"]
["Application Summary","This application from Queen Mary University of London set out the purpose of medical research that seeks to assess the clinical outcomes of common spinal surgery procedures for low back pain. \n\nBack pain is a common disorder, affecting over three quarters of people at some point. Although more common in the elderly, younger people who suffer with bulging spinal discs also often suffer. Back pain drastically affects an individual’s quality of life, preventing them from performing key daily activities such as walking, using the bathroom, exercise and sleeping. Back pain also costs the economy over £12 billion per year through lost work hours, painkiller consumption and disability benefits. Around one in ten of those affected go on to develop chronic back pain, which is linked to several mental health conditions. Spinal research undertaken so far have been limited in numbers and in follow-up, and there is little understanding in how effective spinal surgery is and the risk of complications. \n\nConfidential patient information from the British Spine Registry (BSR) will be disclosed to NHS England for linkage to HES data. BSR will also disclose a dataset containing the study identifier, but otherwise de-identified, to Queen Mary University of London. The study identifier will be used to link the two datasets. The final dataset, anonymised other than patient date of death, will be used for analysis. \n"]
["Applicant Organisation Name","Queen Mary University of London"]
["Contact Name","Dr Hasan Mohammad"]
["Address","Barts Bone & Joint Health"]
[null,"Blizard Institute, 4 Newark St"]
[null,"Queen Mary University London"]
["Postcode","E1 2AT"]
["Telephone",7841873244]
["Email","hasan.mohammad@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who underwent any of the following spinal surgical procedures; Discectomy, Fusion, Laminectomy, Cauda equina decompression surgery, Kyphoplasty, Intervertebral disc replacement, Deformity surgery (scoliosis, kyphosis).\n\nThe applicants will obtain data from HES for patients who underwent spinal surgery between 01 January 2000 – 01 January 2023. \n\nAs the BSR was not set up until 2012, data from BSR will be collected between 01 January 2012 – 01 January 2023.\n\nThe applicants estimate that 1,000,000 patients will be included. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tBritish Spine Registry, held by British Association for Spine Surgeons\n2.\tHES-APC, HES-PROMS and ONS data, held by NHS England\n\nIdentifiers required for linkage purposes\n\n1.\tNHS Number\n2.\tDate of birth\n3.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n2.\tGender \n3.\tEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-12"]
["Next Review Date","2024-09-12"]
["Notes","Conditions of support: \n \n1. An update on recruitment to the patient and public involvement group needs to be provided in the first annual review.\n2. Favourable opinion from a Research Ethics Committee. Confirmed 19 June 2023\n3. Confirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\nThe NHS England 21/22 DSPT reviews for NHS England and Amplitude Clinical Services Ltd were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 12 September 2023)\n"]

{"sheet":"A02794","index":835,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02794"]
["Reference","23/CAG/0088"]
["Other Refs","IRAS Project ID: 289095  REC Reference: 21/WM/0016"]
["Application Title","Community based continuity of midwifery care models for women living in areas of ethnic diversity and social disadvantage"]
["Application Summary","This application from King’s College London set out the purpose of medical research to evaluate the impact of the LEAP caseload midwifery team on care of women living in areas of ethnic diversity and social disadvantage.\n\nRecent enquiries into maternal and perinatal death in the UK have consistently found that women and babies from the poorest backgrounds and those from Black, Asian, and Minority Ethnic (BAME) groups are at the greatest risk of severe morbidity and mortality.  The proportion of preterm births also varies by ethnicity, with infants of BAME parents more likely to be born preterm. Socioeconomic circumstances could also be contributing to the differences in birth outcomes across ethnic groups, with women who live with social complexity also experiencing poorer quality maternity care. The NHS Long-Term Plan aims to reduce stillbirth, maternal and neonatal mortality, and serious neonatal brain injury by 50% by 2025. It includes a commitment to implementing a targeted model of continuity of midwifery care for 75% of women from BAME communities and a similar percentage of women from the most deprived groups to help improve outcomes for the most vulnerable mothers and babies.\n\nWomen eligible to take part in the survey will be given information in the postnatal period by the midwife prior to discharge from midwifery care. At each site, a monthly report will be run by the PI or a supporting IT midwife. This report includes the relevant information of postnatal women who gave birth (alive baby) less than 3-6 months ago and live in the LEAP postcodes. Support is needed as potential participants will be identified by the IT team/midwife, who will provide the list of potential participants to a member of the clinical research team who will subsequently send the invitation for the survey. Participation will then proceed on a consented basis. \n"]
["Applicant Organisation Name","King’s College London"]
["Contact Name","Professor Jane Sandall, Chief Investigator\n"]
["Address","Department of Women and Children’s Health Faculty of Life Sciences and Medicine"]
[null,"10th floor North Wing "]
[null,"St Thomas’ Hospital"]
["Postcode","SE1 7EH"]
["Telephone","+44 (0)20 7188 8149"]
["Email","jane.sandall@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Women aged 16 – 50 years of age, who live in LEAP postcodes and underwent a live birth."]
["Description of confidential patient information used","Data sources\n\n1.\tMaternity health records at:\n\na.\tGuy’s and St Thomas’ NHS Foundation Trust\nb.\tKing's College Hospital NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID\n4.\tDate of birth\n5.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tPostcode – unit level\n3.\tOccupation\n4.\tEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-13"]
["Next Review Date","2024-09-13"]
["Notes","Conditions of support: \n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: 10 February 2021\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\n\nThe NHS England 21/22 DSPT reviews for King’s College London, Guy’s and St Thomas’ NHS Foundation Trust and King's College Hospital NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (19/07/2023)\n\nAs the above conditions have been accepted or met, this letter provides confirmation of final support. I will arrange for the register of approved applications on the HRA website to be updated with this information.\n"]

{"sheet":"A02795","index":836,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02795"]
["Reference","23/CAG/0086"]
["Other Refs","IRAS Project ID: 326650  REC Reference: 23/WS/0107"]
["Application Title","Transforming Ovarian Cancer diagnostic pathways (TranSforming Ovarian caNcer diAgnosTic pAthways - SONATA)"]
["Application Summary","This application from the University of Birmingham set out the purpose of medical research that seeks to determine the accuracy of the ROMA algorithm in diagnosing ovarian cancer. \n\nApproximately 7,500 women in the UK are diagnosed with Ovarian cancer (OC) each year. 5-year survival is around 45%, lower than comparable European countries. Improved diagnostics are critical to improving outcomes. Standard of care tests in the NHS for primary care are sequential CA125 and ultrasound. Standard care of test in the NHS for secondary care is an algorithm that combines CA125 and an ultrasound score called the Risk of Malignancy Index algorithm (RMI). The same tests are used at both primary care and secondary care, often with ultrasound repeated in secondary care. ROMA, a newer algorithm, incorporates cancer antigen 125 (CA125), human epididymal protein 4 (HE4), ultrasound findings and menopausal status and has been shown to be superior to RMI. A pilot study conducted in primary care demonstrated that ROMA had a better diagnostic performance. The applicants now seek to undertake a larger scale evaluation, testing the ROMA algorithm incorporating CA125, HE4 and ultrasound results to CA125 testing.\n\nConfidential patient information for patients who underwent CA125 testing for ovarian cancer at the request of their GP will be disclosed from Black Country Pathology Services and South Tyne and Wear Pathology Service to Sandwell and West Birmingham Hospitals NHS Trust. Confidential patient information from Gateshead Health NHS Foundation Trust, The Royal Wolverhampton NHS Trust will be disclosed to Sandwell and West Birmingham NHS Trust, for linkage to the pathology services data. Confidential patient information for patients treated at Sandwell and West Birmingham NHS Trust will also be linked to the pathology services data. Any data not needed for analysis will be deleted. NHS numbers will be replaced with a study identifier and dates of birth amended to age group and time to cancer/non-cancer diagnosis. The anonymised data set will be encrypted for secure transfer for analysis at the University of Birmingham. \n"]
["Applicant Organisation Name","University of Birmingham"]
["Contact Name","Professor Sudha S Sundar"]
["Address","Institute of Cancer and Genomic Sciences"]
[null,"University of Birmingham"]
[null,"Birmingham"]
["Postcode","B15 2TH"]
["Telephone",1214144477]
["Email","S.S.Sundar@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Female patients who presented to primary with symptoms of ovarian cancer and underwent a CA125 test after the study start date, which is currently planned for 31 August 2023. \n\nThe applicants estimate that 41000 patients will be included. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tConfidential patient information from patient records held at:\na.\tBlack Country Pathology Services\nb.\tSouth of Tyne and Wear Pathology Service\nc.\tGateshead Health NHS Foundation Trust \nd.\tThe Royal Wolverhampton NHS Trust\ne.\tSandwell and West Birmingham NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tNHS number\n2.\tDate of birth\n3.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tPostcode – unit level\n3.\tEthnicity\n\nAdditional information\n\nDates of birth will be amended to age group and time to cancer/non-cancer diagnosis before the dataset is transferred to the University of Birmingham for analysis. \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-20"]
["Next Review Date","2024-09-20"]
["Notes","Conditions of support: \n \n1.\tThe Privacy Notice needs to be revised to contain the following text about the role of the CAG, “The application was reviewed by the Confidentiality Advisory Group (CAG). CAG is an independent group of lay people and professionals which provides expert advice on the use of confidential patient information without consent. CAG recommended that our application should be supported and the Maker within the Health Research Authority approved this.” \n\nCondition met 06 October 2023\n\n2.\tFurther patient and public involvement is to be carried out and feedback provided at the first annual review. \n\n3.\tFavourable Opinion from a Research Ethics Committee. Confirmed (17 July 2023)\n\n4.\tDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations.\n"]

{"sheet":"A02796","index":837,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02796"]
["Reference","22/CAG/0173"]
["Other Refs","IRAS Project ID: 318730   REC Reference: 22/SW/0098 "]
["Application Title","Preservation of the Boyd Orr Cohort Database Version 1 (CAG)"]
["Application Summary","This application from the University of Bristol set out the purpose of continued storing of confidential patient information retained for patients who participating in the “The Carnegie Survey of Family Diet and Health in Pre-war Britain”. \n\nThe Survey was originally conducted in England and Scotland between 1937 – 1939. In the early 1990s, the applicants used the information originally collected for around 85% of the cohort on the NHS Central Register and, until 2013, the applicants received death and cancer notifications for the cohort. The applicants have agreed a data retention period for ONS cancer and mortality data to 2039 but there has been no research activity on the database since 2013, and no processing of data from NHS Digital since 2008. The applicants advised that the dataset was unique, as the detailed records of childhood diet and health for patients held is older than those collected in any other dataset. The dataset has been used to investigate childhood body size and diet in relation to adult chronic disease, and to demonstrate protective associations between childhood fruit and vegetable intake and adult cancer risk. \nThe application had support previously under CAG reference CR19/2014. The applicants are now seeking support to allow one final download and linkage of cancer registration and death certificate data from NHS Digital and to allow secondary analysis of the data. Once the applicants have obtained mortality outcomes on all participants, which is likely to be achieved within the next 3-5 years, they will explore the use of a pseudonymised approach. The applicants note that this process will be relatively easy with the electronic data they hold, however they also hold an archive of paper records covering a thirty-year period which will be more challenging to anonymise. The applicants therefore seek to hold the confidential patient information until this process can be completed. \n"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Professor Richard Martin, Chief Investigator "]
["Address","University Of Bristol"]
[null,"Bristol Medical School, Population Health Sciences  "]
[null,"Canynge Hall, 39 Whatley Road"]
["Postcode","BS8 2PS"]
["Telephone",441174553987]
["Email","richard.martin@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who participated in the Carnegie Survey of Family Diet and Health in Pre-war Britain 1937-1939."]
["Description of confidential patient information used","Data sources\n\n1.\tData held in the Boyd-Orr dataset at the University of Bristol \n2.\tONS Death Certificates and Cancer Registrations datasets held by NHS Digital.\n\nIdentifiers required for linkage purposes\n\n1. Name \n2. NHS Number \n3. Date of birth \n4. Postcode – unit level\n\nIdentifiers required for analysis purposes\n\n1. Date of birth \n2. Postcode – unit level \n3. Gender \n4. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-21"]
["Next Review Date","2024-09-21"]
["Notes","Conditions of support: \n \n1.\tExplore with the University of Bristol archives data management professionals to agree a process that will ensure no confidential patient information is stored within the archives and provide feedback from these discussions at the next annual review. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed (23/08/2022)\n\n3.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS Digital 21/22 DSPT reviews for University of Bristol – Bristol Medical School & NHS England were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 20 September 2023).\n"]

{"sheet":"A02797","index":838,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02797"]
["Reference","23/CAG/0089"]
["Other Refs","IRAS Project ID: 263964  REC Reference: 23/LO/0586"]
["Application Title","Hospitalisation decision-making in Primary Care: How do, and how should clinicians approach decisions regarding hospital admission for those living with frailty or who could be near the end of their life?"]
["Application Summary","This application from University of Bristol set out the purpose of medical research that seeks to how Primary Care clinicians approach hospitalisation decisions for frail people and those near the end of life. \n\nThis project will look at care for people living with frailty and other complex, incurable medical problems who may be near the end of their lives. It will focus on admissions to hospital and the decisions that can lead to this. A literature review has been conducted to explore what is already known about hospitalisation decisions for frail people. \n\nObservations of staff who make decisions whether patients should be admitted to hospital will be undertaken at nursing homes, care homes, residential homes where a clinician attends to visit patients within the Bristol, North Somerset and South Gloucestershire Integrated Care System. The specific sites are Severn Side Integrated Urgent Care and Weston Care Home GP group in Weston-Super-Mare. At these sites the researcher will accompany the clinician and observe interactions with, and discussions about, frail patients who they are considering admitting to hospital. The researcher will also have informal conversations directed at understanding the decision-making process. Verbal consent will be sought from patients should their care be directly observed. Support is sought to allow for disclosures of confidential patient information that occur when the researcher is observing meetings where patients won’t be present but their information may be discussed.\n"]
["Applicant Organisation Name","University of Bristol"]
["Contact Name","Mr Adam Taylor"]
["Address","Research Governance Team"]
[null,"St Augustine's Courtyard"]
[null,"Bristol"]
["Postcode","BS15DS"]
["Telephone","+44 (0)1173940177"]
["Email","research-governance@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years and over who are potentially towards the end of their life as per the GSF-PIG:\n\n•\tThose with advanced, chronic, incurable disease. \n•\tGeneral frailty and coexisting conditions meaning they may be in the final 12 months of life. \n•\tExisting conditions leading to risk of a sudden catastrophic event that may be terminal.\n"]
["Description of confidential patient information used","Data sources\n\nObservations of staff meetings at:\n\n•\tUniversity Hospitals Bristol and Weston NHS Foundation Trust\n•\tWeston Super Mare Care Home Hub, part of Pier Health\n•\tSevernside Urgent Care Service\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information are required for linkage purposes. \n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information are required for analysis purposes.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-22"]
["Next Review Date","2024-09-22"]
["Notes","Conditions of support: \n \n1.\tContinue to undertake patient and public involvement. Consideration needs to be given on how the residents and family members from the two participating homes can be involved.   Feedback from the patient and public involvement needs to be provided at the first annual review. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed:14 August 2023.\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 21/22 DSPT review for Bristol, North Somerset and South Gloucestershire Integrated Care System was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (19/07/2023)\n"]

{"sheet":"A02798","index":839,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02798"]
["Reference","23/CAG/0080"]
["Other Refs","IRAS Project ID: 328338  REC Reference: 23/EE0147"]
["Application Title","eLIXIR Research Tissue Bank/Database"]
["Application Summary","This application from King’s College London set out the purpose of seeking support under s251 for an existing research tissue bank and database, set up to investigate the temporal and demographic influences on the health of pregnant women and their children.\n\nThe eLIXIR Research Tissue Bank (RTB) was created in 2018. The aim of the Research Tissue Bank and Database is to investigate the mechanisms underlying common and less common disorders of pregnancy and neonatal health and their longer-term effects on the health of the mother and child.\n\nSupport is sought to allow researchers, who are not part of the direct care team, to pre-screen the medical records of potential donors to identify suitable participants and make contact ahead of their antenatal appointments to seek consent to participate in the Tissue Bank. The applicants also seek to retain a minimal dataset about potential participants who decline taking part, to ensure that the recruitment is representative of the general population served by Guy’s and St Thomas’ NHS Foundation Trust.\n"]
["Applicant Organisation Name","King’s College London - Department of Women and Children's Health"]
["Contact Name","Dr Cally Gill, Tissue Bank Manager "]
["Address","Department of Women and Children's Health"]
[null,"10th floor North Wing St Thomas’ Hospital"]
[null,"Westminster Bridge Road, London"]
["Postcode","SE1 7EH"]
["Telephone",2071888151]
["Email","carolyn.gill@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients receiving antenatal care at Guy’s and St Thomas’ NHS Foundation Trust"]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic maternity records at Guy’s and St Thomas’ NHS Foundation Trust\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tHospital ID Number\n4.\tDate of birth\n5.\tPostcode – sector level\n\nIdentifiers retained in the database\n\n1.\tInitials \n2.\tFull name \n3.\tAddress \n4.\tNHS number \n5.\tHospital ID number \n6.\tGP registration \n7.\tDate of birth \n8.\tYear of birth \n9.\tDate of death \n10.\tPostcode\n\nAdditional information\n\nThe identifiers held in the database will be held under consent. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-26"]
["Next Review Date","2024-09-26"]
["Notes","Conditions of support: \n \n1.\tProvide output from patient and public involvement discussions within the next annual review submission. Furthermore, ensure that there is an increase in participation and contribution from younger individuals. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 29 August 2023.\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\n\nThe NHS England 22/23 DSPT review for Guy’s and St Thomas’ NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (26/09/2023)\n\nThe NHS England 22/23 DSPT review for King’s College London - Department of Women and Children's Health was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (04/07/2023)\n"]

{"sheet":"A02799","index":840,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02799"]
["Reference","23/CAG/0099"]
["Other Refs","IRAS Project ID: 252956  REC Reference: 18/YH/0486"]
["Application Title","Defining delirium and its impact in Parkinson’s Disease (DELIRIUM-PD)"]
["Application Summary","This application from Newcastle upon Tyne Hospitals Foundation Trust set out the purpose of medical research which aims to find out how well and how accurately a new Parkinson’s-specific delirium tool (developed in the DELIRIUM-PD study - 18/CAG/0207), can identify delirium in people with Parkinson’s in hospital compared to a detailed examination by an expert. Applicants will also identify if the tool can improve the care of people with Parkinson’s while in hospital and shorten their length of stay. The applicants aim to make this new tool freely available, as raising awareness and correctly identifying delirium in Parkinson’s will lead to better care and could improve patient outcomes.\n\n18/CAG/0207 had ‘s251’ support for access to confidential patient information for the purposes of identifying potential participants to approach for informed consent. Recruitment closed in January 2022 to the original study, and therefore ‘s251’ support was expired. The applicant has since received additional funding to validate the tool that was developed as per the original study aims. The sponsor has agreed that this should be a Substantial Amendment to the original study as it is a direct continuation and will include the same participants and identical protocols, however as the ‘s251’ support was expired, a new application to CAG was required. \n\nAll patients with Parkinson’s who attend movement disorder services in Newcastle upon Tyne will receive a letter and information sheet about the study which will explain that, should they be admitted to hospital, they will be approached by a researcher about the study. An electronic alert; a system already in use by the hospitals (Recurring Admission Patient Alerts or RAPA), will notify researchers of their admission. Applicant’s will visit participants who consent to participate over consecutive days whilst in hospital and will complete a delirium assessment.\n"]
["Applicant Organisation Name","Newcastle upon Tyne Hospitals Foundation Trust"]
["Contact Name","Dr Alison Yarnall, Clinical Fellow/Honorary Consultant"]
["Address","Clinical Ageing Research Unit"]
[null,"Campus for Ageing and Vitality"]
[null,"Newcastle upon Tyne"]
["Postcode","NE4 5PL"]
["Telephone","0191 208 1279"]
["Email","alison.yarnall@newcastle.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patient with a diagnosis of Parkinson's disease or Parkinson’s disease dementia according to UK Brain Bank Criteria made by a movement disorder specialist, that have attended the Newcastle Newcastle-upon-Tyne Hospital (NuTH) Foundation NHS Trust movement disorder clinics for the management of their Parkinson’s within 18 months of the start of the study. \n\nApplicant will recruit/consent 100 more patients, however - \nApproximately 1100 letters will be sent, and approximately 1600 patient records screened for eligibility \n"]
["Description of confidential patient information used","Data sources\n\n1.\tNewcastle Newcastle-upon-Tyne Hospital (NuTH) Foundation NHS Trust movement disorder clinics medical records\n\nIdentifiers required for facilitating invitation process\n\n1.\tName\n2.\tAddress including postcode\n3.\tHospital number\n\nIdentifiers required for analysis purposes\n\n1.\tN/A analysis is undertaken with consent as the legal basis under common law\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-22"]
["Next Review Date","2024-09-22"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed regarding amendment 18/YH/0486/AM11 on 29 August 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed:\n\nThe NHS England 22/23 DSPT review for Newcastle upon Tyne Hospitals NHS Foundation Trust was confirmed as Standards Met on the NHS England DSPT Tracker (checked 22 August 2023).\n"]

{"sheet":"A02800","index":841,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02800"]
["Reference","23/CAG/0094"]
["Other Refs","IRAS Project ID: 326577  REC Reference: 23/WS/0114"]
["Application Title","NSIGHT-2: Mechanistic Studies into Pregnancy Complications and their Impact on Maternal and Child Health"]
["Application Summary","This application from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust set out the purpose of medical research that aims to understand how complications deviate from the normal trajectory of a healthy pregnancy. Applicants will investigate how maternal exposures and health (pre-pregnancy and during pregnancy) and alterations in the pregnancy environment can impact on in utero fetal wellbeing and subsequent maternal, infant and child health, with the eventual aim of developing prediction tools, preventative therapies and treatments that benefit both the mother and child. The study will be consented, and ‘s251’ support is only required for the purposes of identifying patients to seek consent. \n\nWomen will be recruited through self-referral, which does not require ‘s251’ support, and also from the general antenatal setting, specialist obstetric clinics, and potentially autoimmunity clinics.  Potential participants will be identified by members of the research team from electronic medical records, routine clinics and clinic attendances at Guy’s and St Thomas’ NHS Foundation Trust. Potential participants will be contacted ahead of their scheduled appointment and sent a copy of the patient information sheet regarding the study to read prior to being approached in person. If participants do not wish to be approached in person, they will have the opportunity to inform the research team ahead of their appointment. This process requires ‘s251’ support. Should patients consent, their participation will proceed on a consented basis.\n"]
["Applicant Organisation Name","King’s College London and Guy’s and St Thomas’ NHS Foundation Trust are joint data controllers"]
["Contact Name","Professor Rachel Tribe, Professor of Maternal and Perinatal Sciences"]
["Address","Department of Women and Children’s Health"]
[null,"St Thomas’ Hospital"]
[null,"London"]
["Postcode","SE1 7EH"]
["Telephone","020 7188 3638"]
["Email","rachel.tribe@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 2500 pregnant women. This will comprise women who have no underlying health problems and a healthy pregnancy outcome, or some form of pregnancy complication (or existing disease). \n\nThe study will comprise of 3 cohorts:\n(A) general pregnancy cohort. Additionally, patients might be eligible for one or both of the following: \n(B) Preterm birth (PTB) risk sub-cohort with a high risk and a low risk arm; \n(C) Prenatal Drivers of Islet Autoimmunity (PISA) sub-cohort.\n\n‘s251’ support only required for those who have not self-referred\n"]
["Description of confidential patient information used","Data sources\n\n1.\tElectronic medical records held at Guy's and St Thomas' NHS Foundation Trust and any additional sites that are added (Additional sites, including King’s College Hospital, may be included at a later date)\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS number\n3.\tHospital ID\n4.\tDate of Birth\n5.\tPostcode\n6.\tEthnicity\n7.\tContact details (phone number, email and postal address)\n\nIdentifiers required for analysis purposes\n\n1.\tN/A as any identifiers for analysis included with consent as the legal basis under common law\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-09-22"]
["Next Review Date","2024-09-22"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 01 September 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Guy's and St Thomas' NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 22 September 2023)\n "]

{"sheet":"A02801","index":842,"n_rows":36,"n_cols":3,"rows_kept":36,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4]]}
[]
[]
["Application Number","A02801"]
["Reference","22/CAG/0104"]
["Other Refs","IRAS Project ID: 298458  REC Reference: 22/EM/0153"]
["Application Title","Peripheral arterial disease, High blood pressure and Aneurysm Screening Trial -A cluster randomised trial of screening men for peripheral arterial disease, high blood pressure and abdominal aortic aneurysm vs screening men for abdominal aortic aneurysm"]
["Application Summary","This application from the University of Leicester set out the purpose of medical research that seeks to investigate whether screening men for peripheral arterial disease and high blood pressure when screening for abdominal aortic aneurysm is effective. \n\nPeople with peripheral arterial disease (PAD) (furred up blood vessels in the legs) and high blood pressure (BP) are at high risk of heart attacks, strokes and other cardiovascular problems. 30% to 40% of people over the age of 65 have PAD and/or high BP, and at least two-thirds don’t know that they have these conditions. Men aged 65 are invited for an ultrasound scan to check of abdominal aortic aneurysm (AAA). Attendance for AAA screening is good, with 8 out of 10 men attending. The AAA screening also presents an opportunity to screen for PAD and/or high BP with little extra effort. The trial will be undertaken to provide evidence for the UK National Screening Committee to make a recommendation for or against screening men for PAD and high BP when screening for AAA. \n\nSupport is sought for Work Package 3 (WP3), a cluster crossover trial of combined PAD, high BP and AAA screening vs AAA screening. Over 2 screening years, AAA screening units will deliver 1 year of AAA+PAD+BP screening and 1 year of AAA screening in a randomised order. Confidential patient information will be disclosed from the NHS Screening Programmes to NHS Digital for linkage to HES and mortality data. The data will then be disclosed to the research team at the University of Leicester in a pseudonymised format. \n\nConfidential patient information would be disclosed at two time points. The first, from 31 March 2027 will be to establish the linkage process and obtain preliminary data. This first dissemination will allow the research team to set up data processing algorithms and an analysis pipeline in preparation for the second dissemination after 31 March 28. This approach is because there is a short timescale from the end of the trial follow-up period (31 March 28) to the point where outcome reporting needs to be complete (the end of the funding period). Confidential patient information will therefore be disclosed from 31 March 2027 due to the initial linkage but will not be kept for research outputs and will be deleted when the analysis processes/pipeline has been established. After 31 March 2028 the second dissemination will be retained and used for research analysis.\n"]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Professor Matthew Brown   "]
["Address","University of Leicester"]
[null,"Cardiovascular Sciences"]
[]
["Postcode"]
["Telephone",7535713650]
["Email","mjb42@leicester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Men invited to participate in the AAA screening programme between 01 April 2023 – 31 March 2024, and 01 April 2024 and 31 March 2025."]
["Description of confidential patient information used","Data sources\n\n1.\tPatient information from the NHS Screening Programme\n2.\tHES and mortality data from NHS Digital\n\nIdentifiers required for linkage purposes\n\n1.\tDate of birth\n2.\tNHS Number\n\nIdentifiers required for analysis purposes\n\n1.\tEthnicity\n2.\tAAA screening programme unit\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2022-08-06"]
["Next Review Date","2024-08-06"]
["Notes","20 September 2023 - change in data processor from NHS Digital to NHS England, regarding data sources Hospital episode Statistics (HES) and ONS mortality data.\n\nSpecific conditions of support \n\nThe following sets out the specific conditions of support.  \n\n1.\tThe poster needs to be reviewed by a PPI group, or other appropriate group of patients and the revised poster provided to CAG within 2 months of the issuing of this outcome letter. Condition met 28 September 2022.\n\n2.\tConfirmation is to be provided that the National Data Opt-Out will be applied. Condition met 28 September 2022.\n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed: 03 August 2022\n\n4.\tConfirmation provided from the IG Delivery Team at NHS Digital to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. See section below titled ‘security assurance requirements’ for further information. Confirmed: \n\nThe NHS Digital 2021/22 DSPT reviews for NHS Digital and NHS England were confirmed as ‘Standards Met’ on the NHS Digital DSPT Tracker (checked 05 October 2022).\n"]

{"sheet":"A02802","index":843,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[36,2,36,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02802"]
["Reference","23/CAG/0060"]
["Other Refs","IRAS Project ID: 318257  REC Reference: 23/LO/0472"]
["Application Title","Kid’s Environment and Health Cohort"]
["Application Summary","This application from UCL Great Ormond Street Institute of Child Health set out the purpose of creating a research database, a data resource which researchers will use to study the links between school and home environments and children’s health and education. \n\nThe health of children, as well as their cognitive development and associated school outcomes, are disproportionately affected by the physical environment in and around homes and schools. This includes their exposure to indoor and outdoor air pollution, busy roads and noise, and access to green and blue spaces. The social environment of the local area, including availability of local services, such as nurseries, and exposure to fast food, or gambling outlets may influence child health and development. The applicants seek to create a research database, containing data on all children born in England from 2006 onwards. Information for the children’s mothers will also be collected from hospital patient records and Census records. Both live births and still births will be included in the cohort, but only live born children will be followed up via linkage to health and education data. \n\nRegulation 5 support is sought for the disclosure of confidential patient information (NHS numbers, dates of birth, sex and full postcode) from ONS to NHS England for linkage to Birth Registrations and Mortality data. The linked dataset will then be held within the ONS Secure Research Service. The research team at University College London will only have access to anonymised data. \n\nThe applicants also seek support for ONS to store PDS derived UPRNs and postcodes separately to the KITE cohort. Researchers, other than the UCL team, will be able to request linkage to external environmental data mapped to UPRNs/postcodes to the cohort via UPRNs and/or postcodes from the PDS or birth registration. UPRNs & postcodes will be encrypted by ONS before placed in the SRS for linkage.\n"]
["Applicant Organisation Name","UCL Great Ormond Street Institute of Child Health"]
["Contact Name","Dr Pia Hardelid"]
["Address","UCL Great Ormond Street Institute of Child Health"]
[null,"30 Guilford Street "]
[]
["Postcode","WC1N 1EH"]
["Telephone",2079052979]
["Email","p.hardelid@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The initial database will contain data from all infants born (both live and still births) in England between 01 January 2006 and 31 December 2023. The applicants estimate that 11 million children will be included in the database when created. Data for patients’ mothers will also be required. The initial cohort will comprise approximately 22 million people. \n\nThe database will be updated annually. Around 585,000 live births occur in England each year. Including both patients and mothers will mean around 1 million patients will be included in the database each year. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tBirth Registrations and Mortality data, Office of National Statistics (ONS) \n2.\tPersonal Demographics Service, NHS England\n3.\tMedicines dispensed in Primary Care (NHSBSA data)\n4.\tHospital Episode Statistics Admitted Patient Care (HES APC)\n5.\tHospital Episode Statistics Accident and Emergency (HES A and E)\n6.\tEmergency Care Data Set (ECDS)\n7.\tMental Health Services Data Set (MHSDS)\n8.\tMaternity Services Data Set (MSDS) v2\n\nIdentifiers required for linkage purposes\n\nInfants:\n\n1.\tName\n2.\tDate of birth\n3.\tNHS number\n4.\tGender\n5.\tPostcode\n\nMothers:\n\n1.\tNHS numbers \n2.\tDate of Birth\n3.\tPostcode\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tEthnicity\n3.\tAge of mother at birth\n\nAdditional information\n\nThe applicants have clarified that patients’ hospital number (i.e. the MRN number at individual trusts) is not needed for linkage. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-10-03"]
["Next Review Date","2024-10-03"]
["Notes","Conditions of support: \n \n1. Favourable opinion from a Research Ethics Committee. Confirmed\n2. Confirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\n\nThe NHS England 2022/23 DSPT reviews for UCL Great Ormond Street Institute of Child Health, the Office for National Statistics, and NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 03 October 2023) \n"]
["National Data Opt-out Status"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02803","index":844,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02803"]
["Reference","23/CAG/0150"]
["Other Refs","IRAS Project ID: 54370  REC Reference: 10/H1010/70"]
["Application Title","Intimate partner violence"]
["Application Summary","This application from ALSPAC (University of Bristol) set out the purpose of medical research to investigate the relationships between exposure to intimate partner violence (IPV), parental mental health and children’s mental health. \n\nIn any two-year period, almost one quarter of children are exposed to maternal mental illness. Mother’s mental health problems are associated with problems in children’s cognitive development, physical and mental health. Exposure to intimate partner violence (IPV) and parental substance misuse during childhood increases the risk of negative mental health outcomes. There is some evidence that parental mental health problems may reduce children’s resilience to the impact of IPV. However, the relationships between IPV, parental mental health and children’s mental health and factors that promote resilience in children exposed to IPV. \n\nThe applicants seek to undertake a specific project to investigate these relationships, using data collected by ALSPAC. The research proposes to include all the young people whose families have enrolled into the study, who have been sent fair processing information and who have not explicitly withdrawn from the study or denied consent for record linkage to their health records. ALSPAC will undertake the data extraction and linkage in line with their standard methodology. When the data is received by ALSPAC it will be pseudonymised as soon as it has been linked to the ALSPAC dataset and processed. The processing occurs in the ALSPAC Data Safe Haven. The research team will only have access to anonymised data within the UKSERP system. The identifiable NHS data will remain within the ALSPAC Data Safe Haven and will be stored on encrypted hardware. "]
["Applicant Organisation Name","ALSPAC (University of Bristol) "]
["Contact Name","Dr Rebecca Lacey "]
["Address","University College London"]
[null,"Department of Epidemiology and Public Health"]
[]
["Postcode","WC1E 6BT"]
["Telephone",2076791795]
["Email","rlacey@sgul.ac.uk  "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All ALSPAC participants who have been contacted for consent to extraction of their medical records but have not responded. 15,000 patients will be included in total, around 7,500 of which will be under s251 support.  "]
["Description of confidential patient information used","Data sources \n\n1.HES and data, NHS England \n2.GP Records \n3.Local health records \n4.ALSPAC Databank \n\nIdentifiers required for linkage purposes \n\n1.NHS number \n2.Date of birth \n3.Postcode – sector level \n\nIdentifiers required for analysis purposes \n\n1.Gender "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-10-20"]
["Next Review Date","2024-10-20"]
["Notes","Specific conditions of support\n\n1.\tThe specific wording used within the Fair Processing Information Leaflet, explain the consequences of non-response, needs to be provided for review. Confirmed: 14 December 2023\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: 03 February 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for University of Bristol (ALSPAC) and NHS England was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (20 October 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02804","index":845,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02804"]
["Reference","23/CAG/0100"]
["Other Refs","IRAS Project ID: 298553  REC Reference: 21/EE/0227"]
["Application Title","GP Management After Transition Events (GP-MATE) - Developing an intervention to assist older patients’ communication with their GP practice after discharge from hospital in order to improve patient safety"]
["Application Summary","This application from the University of Warwick set out the purpose of medical research to produce an intervention to aid older patients in communication with their GP practice after discharge from hospital. \n\nDischarge from hospital is a potentially risky stage of the patient journey, particularly for older patients who may have multiple morbidity and poly pharmacy. Communication at the interface of secondary and primary care has been identified by the James Lind Alliance as one of the top three priorities for primary care patient safety. Clear communication via discharge summaries is essential in providing a safer discharge experience. Currently discharge summaries are designed for inter-professional communication, but patients have indicated their preference for receiving a copy of the discharge summary and want to be involved in conversations about their post-discharge care. The applicants seek to produce a tool, GP-MATE, to be used by older patients and their carers to aid communication with their GP practice about their care after discharge.  \n\nThe study will take place over a four-year period. During the first year, a film will be made of patients experiences following discharge from hospital. In year two, three groups of patients and GP staff will create the GP-MATE tool. In the third year, the GP-MATE tool will be used at eight GP practices. Patients and staff will also be interviewed and surveyed. The records of around 300 patients will also be reviewed. In year 4, the findings will be drawn on to finalise the tool. Support under s251 is required to allow the research team to access the notes of all patients at the GP practices who are over 65 and have been admitted to hospital in the previous year. For the retrospective cohort, rates of readmission to hospital and links between the index admission and subsequent admissions will be investigated. For the prospective cohort, a weekly rolling search will be undertaken to identify all patients aged 65 or over admitted to hospital during the study period. The GP-MATE pack will be mailed out to suitable patients, and the research team will assist with the mail-out. Patients will complete and return the questionnaires, which will not be identifiable to the research team. The research team will collect data from the GP records of all patients in the prospective cohort from baseline (discharge) to 3 months after the GP-MATE consultation to determine: uptake, length and mode of appointment, and participating clinician’s roles. "]
["Applicant Organisation Name","University of Warwick "]
["Contact Name","Dr Rachel Spencer"]
["Address","Warwick Medical School"]
[null,"University of Warwick"]
[null,"Coventry"]
["Postcode","CV4 7AL"]
["Telephone",2920743107]
["Email","sarah.bell3@wales.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","PQDC - 300 retrospective cohort, 300 prospective cohort, anticipated 150 questionnaire cohort (50% response rate) 24 patient/carer interviewees (100% overlaps with PQDC prospective cohort). \n\nRetrospective cohort: patients treated between 01 July 2022 and 30 September 2023. \n\nProspective cohort: patients treated for a 9-month period from 01 November 2023 to 31 July 2024. "]
["Description of confidential patient information used","Data sources \n\n1.The electronic healthcare records and appointment systems at participating GP practices.\n\nIdentifiers required for linkage purposes  \n\n1.Name \n2.Date of birth \n3.Date of death \n\nIdentifiers required for analysis purposes \n\n1.GP practice \n2.Gender \n3.Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-10-16"]
["Next Review Date","2024-10-16"]
["Notes","Conditions of support: \n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 07 January 2023.\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 2021/22 DSPT review for University of Warwick was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02805","index":846,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02805"]
["Reference","23/CAG/0138"]
["Other Refs","IRAS Project ID: 328748  REC Reference: 23/LO/0775"]
["Application Title","A qualitative investigation of a novel Parkinson’s Disease Hub: an integrated multidisciplinary service for patients with Parkinson’s and related disorders with rapidly declining condition or unmet palliative needs "]
["Application Summary","This application from University of Bristol set out the purpose of medical research that aims to understand how the Parkinson’s Disease (PD) Hub is experienced by people with PD, their informal carers and service providers.  \n\nStandard NHS care for people with PD has been criticised for detecting worsening condition too late. This can result in patients having to go to hospital for long stays when, had they been seen by a specialist sooner, their condition would not have become so bad as to need in-patient hospital care. A new service in North Bristol NHS Trust – the PD Hub - aims to ensure that people with PD whose condition rapidly gets worse are seen quickly by specialists and receive appropriate treatment, so that they do not need to be admitted to hospital. \n\nA researcher is undertaking research using a number of different methodologies at Bristol PD Hub, including consented interviews and verbally consented observations of patient consultations. These elements do not require ‘s251’ support. However the researcher, who is not considered direct care team, is also undertaking ethnographic observations of multidisciplinary team (MDT) meetings. Support under Regulation 5 is required for this aspect of the study as the applicant may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes or audio recorded voice notes. Identifiable patient information will not be recorded, and audio recordings will not be made of the meetings directly. The researcher will aim to make approximately 12 visits to the clinic over the course of nine months. MDT online meetings are also held online once a week. The researcher will aim to join approximately 15-18 of these meetings during the nine months. "]
["Applicant Organisation Name","University of Bristol "]
["Contact Name","Dr Elisabeth Grey"]
["Address","University of Bristol, ARC West, \n"]
[null,"9th Floor Whitefriars"]
[null,"Lewins Mead, Bristol\n"]
["Postcode","BS1 2NT"]
["Telephone","0117 4560487"]
["Email","e.b.grey@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who were discussed during multidisciplinary team (MDT) meetings of a Parkinson’s disease service in North Bristol NHS Trust "]
["Description of confidential patient information used","Data sources \n\nMulti-disciplinary Team (MDT) Meeting observations, recorded via written field notes, at North Bristol NHS Trust \n\nIdentifiers required for linkage purposes \n\nNo items of confidential patient information will be recorded for linkage purposes \n\nIdentifiers required for analysis purposes \n\nNo items of confidential patient information will be recorded for linkage purposes "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-10-31"]
["Next Review Date","2024-10-31"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 30 October 2023 \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for North Bristol NHS Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 31 October 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02806","index":847,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02806"]
["Reference","23/CAG/0155 "]
["Other Refs","•\tFull study title: Development of a Live Attenuated Vaccine against Salmonella Paratyphi A (VASP) IRAS Project ID: 249094 REC: 21/SC/0330\n\n•\tFull study title: A single-blind, randomised, phase II multi-centre study to determine reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules in adolescents (COMCOV-3) IRAS Project ID: 304450 REC: 21/SC/0310\n\n•\tFull study title: A phase I study to determine the safety and immunogenicity of a new vaccine against Middle East Respiratory Syndrome Coronavirus in Adults aged 50 to 70 (MERS) IRAS Project ID: 1006223 REC: 23/SC/0047\n\n•\tFull study title: A phase 1 safety and immunogenicity study of a Crimean-Congo haemorrhagic fever virus vaccine, ChAdOx2 CCHF, in healthy adult volunteers in the UK (CCHF) IRAS Project ID: 1007128 REC: 23/LO/0420\n\n•\tFull study title: An open label Phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the malaria vaccine candidate RH5.2-virus-like particle (VLP) in Matrix-MTM, and to compare the safety and immunogenicity of the malaria vaccine candidates RH5.2-VLP in Matrix-MTM and RH5.1 soluble protein in Matrix-MTM used in various regimens (BIO-001) IRAS Project ID: 1005729 REC: 23/LO/0412\n\n•\tFull study title: Phase I clinical trial to assess the safety and immunogenicity of the malaria vaccine candidate RH5.1 soluble protein in Matrix-MTM using two dosing regimens (BIO-002) IRAS Project ID: 1005754 REC: 23/LO/0058\n\n•\tFull study title: Heterologous Boosting for Hexavalent Paediatric Vaccines in the UK Schedule (6in1 Part 2) IRAS Project ID: 1006942 REC:23/EE/0121(REC PO)\n\n"]
["Application Title","CAG Overarching Application for Oxford Vaccine Group (OVG) Studies"]
["Application Summary","This application from the University of Oxford set out the purpose of recruitment of patients to vaccine clinical trials. \n\nThe Oxford Vaccine Group (OVG), based in the Department of Paediatrics at the University of Oxford, conducts studies of new and improved vaccines for children and adults. It conducts a range of clinical trials on the basis of consent each with relevant approvals from the MHRA and REC. Previously, a range of recruitment methods have been used but because the number of studies has increased the applicants wish to undertake a range of identification and recruitment procedures.\n\nThis application, specifically for the studies below, requests support to allow NHS England to search for eligible patients within specific postcodes surrounding the Oxford area (where the trial centre is based). This extract of name, address and postcode will be transferred to PSL Print Management Ltd to send invitations. Oxford Vaccines Group will not receive any confidential patient information until the patient proactively contacts them if interested in a particular study, at which point all activities operate under consent. Patients will be sent no more than 3 mailouts in any given year, with at least a three-month period between mailouts.\n"]
["Applicant Organisation Name","University of Oxford"]
["Contact Name","Professor Sir Andrew Pollard"]
["Address","University of Oxford"]
[null,"Oxford Vaccine Group"]
[null,"Headington, Oxford"]
["Postcode","OX3 7LE"]
["Telephone","01865 611400"]
["Email","andrew.pollard@paediatrics.ox.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients meeting the broad inclusion criteria for the above studies."]
["Description of confidential patient information used","Data sources\n\n1.\tThe Personal Demographics Service (PDS) held by NHS England\n\nIdentifiers required to determine eligibility\n\n1.\tDate of birth\n2.\tPostcode \n\nIdentifiers required for sending of invitation letters\n\n1.\tName\n2.\tAddress\n3.\tPostcode \n\nAdditional information\n\nDate of birth is used to ensure eligibility and are not transferred to PSL Print Management Ltd.\n\nNo identifiers are sent to Oxford Vaccines Group. They will not have any contact until a patient proactively approaches them interested in a trial.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-08"]
["Next Review Date","2024-11-08"]
["Notes","Conditions of support:\n\n\n1.\tFor the current eight vaccine trials listed within the initial application, undertake patient and public involvement within areas local to the currently known trial sites, and outside of the Oxford Vaccines Group patient and public involvement group. A report on these trial sites should be provided at first annual review.\n\n2.\tFuture vaccine trials from Oxford Vaccines Group should be submitted as an amendment before Section 251 support is confirmed. Each amendment submitted to CAG to add a new vaccine trial should include the following:\na.\tCompleted CAG amendment form.\nb.\tSupporting document that provides:\ni.\tA summary of the vaccine trial (as per the lay summary of the study provided to REC and MHRA as part of the combined review form).\nii.\tA description of the cohort to be included in the trial.\niii.\tThe target number of participants to be recruited.\niv.\tAn estimated number of letters to be mailed through NHS England/ PSL Print Management Ltd.\nv.\tInformation as to whether this is a single site (in Oxford) or multi-site vaccine trial.\nvi.\tA summary of why this recruitment method is necessary for this application.\nvii.\tA summary of the study specific patient and public involvement within the area local to sites (including numbers, format of event, what was presented and asked of attendees and summary of comments).\n\n3.\tBefore any future amendment for new vaccine trials, the applicants should consider the necessity of using this recruitment approach and why other less disclosive approaches alone are not viable.\n\n4.\tFor future vaccines trials which use new trial sites to Condition 1, undertake patient and public involvement within these local areas and provide a report with the amendment to add the trial.\n\n5.\tNotify CAG when a vaccine trial completes recruitment and therefore is no longer reliant on Section 251 support.\n\n6.\tAnnual reviews will be considered at a full meeting of the CAG.\n\n7.\tFavourable opinion from a Research Ethics Committee. Confirmed \n\n8.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for NHS England and PSL Print Management Ltd were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02807","index":848,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02807"]
["Reference","23/CAG/0157 "]
["Other Refs","IRAS Project ID: 54370   REC Reference: 10/H1010/70"]
["Application Title","Young people's barriers to mental health services"]
["Application Summary","This application from ALSPAC (University of Bristol) set out the purpose of medical research to explore inequalities in mental health service utilisation of young people experiencing emotional mental health problems and to identify characteristics of young people experiencing long-term emotional mental health problems yet not receiving mental health services. \n\nResearch has discovered that every day in England, 28.5% of young people experience mental health problems, and that as little as one in four receive formal support for these problems. Mental health problems have been shown to limit economic, vocational, and social functioning. The applicants seek to use data to determine which young people are less likely to receive professional support for their mental health problems and the characteristics are of those young people not receiving mental health services for their problems. It will also be determined how many young people who do not receive mental health services for their problems continue to experience mental health problems in young adulthood and how resilient these young people were during the COVID pandemic.  \n\nThe applicants seek to undertake a specific project to investigate these relationships, using data collected by ALSPAC. The research proposes to include all the young people whose families have enrolled into the study, who have been sent fair processing information and who have not explicitly withdrawn from the study or denied consent for record linkage to their health records. ALSPAC will undertake the data extraction and linkage in line with their standard methodology. When the data is received by ALSPAC it will be pseudonymised as soon as it has been linked to the ALSPAC dataset and processed. The processing occurs in the ALSPAC Data Safe Haven. The research team will only have access to anonymised data within the UKSERP system. The identifiable NHS data will remain within the ALSPAC Data Safe Haven and will be stored on encrypted hardware.  "]
["Applicant Organisation Name","ALSPAC (University of Bristol)"]
["Contact Name","Dr Corine Driessens, Senior Research Fellow "]
["Address","Southampton Science Park, Innovation Centre "]
[null,"2 Venture Rd, Chilworth \n"]
[null,"Southampton "]
["Postcode","SO16 7NP "]
["Telephone","02380 597983"]
["Email","C.M.Driessens@soton.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All ALSPAC participants who have been contacted for consent to extraction of their medical records but have not responded. 15,000 patients will be included in total, around 7,500 of which will be under s251 support. "]
["Description of confidential patient information used","Data sources \n\n1.HES and MHSDS datasets, NHS England  \n\n2.GP Records \n\n3.ALSPAC Databank  \n\nIdentifiers required for linkage purposes \n\n1.NHS Number \n\n2.Date of birth \n\n3.Date of death \n\n4.Postcode – sector level \n\nIdentifiers required for analysis purposes \n\n1.Gender \n\nAdditional information \n\nDate of Birth will be used (by ALSPAC) to derive 'Age at Event' (expressed in days, minutes, seconds) and time intervals. This allows ALSPAC to provide information to researchers in event sequence order without disclosing Date of Birth or event date "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-10"]
["Next Review Date","2024-11-10"]
["Notes","Conditions of support:\n \n1.\tPlease clarify where processing of confidential patient information will be undertaken under ‘Section 251’ support, within one month. \n \n2.\tPlease clarify whether any new data will be collected, and how this data would be managed, within one month. \n \n3.\tA link to the study information is to be included on the front page of the ALSPAC communication document, and provided to CAG, within one month. \n \n4.\tFavourable opinion from a Research Ethics Committee. Confirmed - This application activity is covered by main ALSPAC FO, and addition of this study into main ALSPAC protocol has also been submitted as an amendment to REC - Date of FO 20 March 2023 \n \n5.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:  \n \nDue to the number of participating organisations involved it is the responsibility of the applicant, as controller, to ensure that all organisations processing confidential patient information meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation. These will not be individually checked by the CAT team due to the number of organisations involved. \n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02808","index":849,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02808"]
["Reference","23/CAG/0161 "]
["Other Refs","IRAS Project ID: 54370  REC Reference: 10/H1010/70"]
["Application Title","The link between questionnaire-reported disordered eating and eating disorder medical diagnosis"]
["Application Summary","This application from ALSPAC (University of Bristol) set out the purpose of medical research to explore the association between disordered eating, self-reported on questionnaires, and eating disorder diagnoses. \n\nEating disorders (including Anorexia Nervosa (AN) Bulimia Nervosa (BN), Binge Eating Disorder (BED) and Other Specified Feeding and Eating Disorders (OSFED)) are severely impairing and have the highest mortality of any psychiatric condition. Prevalence of eating disorders in the general population is around 5% but up to a third of young women and one fifth of young men report disordered eating behaviours, such as fasting, purging, binge-eating, excessive exercise, that are impacting their lives. However, very little research has been conducted into the association between disordered eating behaviours (often reported on questionnaires) and eating disorder diagnoses (confirmed by medical records), or on factors that lead to a lack of eating disorder diagnosis in individuals who report disordered eating behaviours consistent with diagnostic criteria. The applicants will look broadly at the association between disordered eating captured by questionnaire reports and eating disorder diagnoses from linked medical records. Firstly, to assess whether individuals with disordered eating reported on questionnaires also have an eating disorder medical diagnosis. Secondly, to explore what factors are associated with obtaining an eating disorder diagnosis in the whole sample and in those reporting diagnostic level disordered eating behaviours via questionnaire.  \n\nGP records for consenting cases have been extracted, anonymised and transferred securely into the UKSeRP system at Swansea University via the NHS Wales Informatics Service. ALSPAC will use existing information within ALSPAC. The data will be extracted into ALSPACs Data Safe Haven before being migrated to UKSeRP. Within UKSeRP, ALSPAC will combine (using effectively anonymous identifiers which cannot be linked back to the ALSPAC databases) the consenters and non-consenters' GP/HES/MHSDS/LOCAL NHS, ALSPAC self-reported data/other relevant information, and clean and process these within the UKSeRP system. ALSPAC Data Safe Haven staff will make a subset of the combined data available to this project as a study specific dataset within a study specific (access controlled to allow only individuals working on this project) partition of UKSeRP. The research team will only have access to anonymised data within the UKSERP system. The identifiable NHS data will remain within the ALSPAC Data Safe Haven and will be stored on encrypted hardware.   "]
["Applicant Organisation Name","ALSPAC (University of Bristol)   "]
["Contact Name","Dr Helen Bould, Consultant Senior Lecturer, Bristol Medical School (PHS), "]
["Address","University of Bristol "]
[null,"Oakfield House"]
[null,"Oakfield Grove"]
["Postcode","BS8 2BN "]
["Telephone"]
["Email","helen.bould@bristol.ac.uk  "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All ALSPAC participants who have been contacted for consent to extraction of their medical records but have not responded. 15,000 patients will be included in total, around 7,500 of which will be under s251 support.  "]
["Description of confidential patient information used","Data sources \n\n1.Civil Registrations – Deaths, HES and MHSDS datasets, NHS England   \n\n2.GP Records  \n\n3.ALSPAC Databank   \n\nIdentifiers required for linkage purposes \n\n1.NHS Number \n\n2.Date of birth \n\n3.Date of death \n\n4.Postcode – sector level \n\nIdentifiers required for analysis purposes \n\n1.Gender \n\nAdditional information \n\nDate of Birth will be used (by ALSPAC) to derive 'Age at Event' (expressed in days, minutes, seconds) and time intervals. This allows ALSPAC to provide information to researchers in event sequence order without disclosing Date of Birth or event date  "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-10"]
["Next Review Date","2024-11-10"]
["Notes","Conditions of support:\n\n1.\tPlease clarify whether new data will be collected, or whether these data are already stored within an ALSPAC secure location, within one month. \n \n2.\tPlease clarify what level of de-identified data is to be used for analysis in Workflow 2 and retained for results storage, as it is currently unclear why section ‘251 support’ would be required for this, within one month. \n \n3.\tThe notification materials need to be published on the public facing website. The notification materials need to explain how the data collected would be used, within one month. \n \n4.\tA link to the study information is to be included on the front page of the ALSPAC communication document, and provided to CAG, within one month. \n \n5.\tFavourable opinion from a Research Ethics Committee. Confirmed - This application activity is covered by main ALSPAC FO, and addition of this study into main ALSPAC protocol has also been submitted as an amendment to REC - Date of FO 01 August 2022 \n \n6.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:  \n \nDue to the number of participating organisations involved it is the responsibility of the applicant, as controller, to ensure that all organisations processing confidential patient information meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation. These will not be individually checked by the CAT team due to the number of organisations involved. \n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02809","index":850,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02809"]
["Reference","23/CAG/0075 "]
["Other Refs","IRAS Project ID: 323067  REC Reference: 23/EE/0137"]
["Application Title","A Multi-Center Registry of Cardiovascular Magnetic Resonance Data for Research, Education, and Quality Control Purposes"]
["Application Summary","This application from King's College London and Guy's and St Thomas NHS Foundation Trust set out the purpose of creating a research database to evaluate the impact and benefit of cardiac magnetic resonance imaging for the diagnosis and prognosis of cardiac pathology. \n\nOver 100,000 patients each year in the UK receive cardiac MRI imaging for the purpose of diagnosis or the evaluation of heart disease. Most exams are reviewed for immediate clinical needs only and are not used to evaluate the cost/benefit or for quality assessment. The applicants seek to use data already collected as part of clinical care to evaluate which types of imaging protocols are run, and the relationship between imaging markers and outcomes. The applicants also seek to develop and validate machine learning methods of deriving imaging biomarkers.  \n\nAn anonymised database of patients who have undergone MRI imaging for the diagnosis or evaluation of heart disease will be created. Patients meeting the inclusion criteria will be identified by either the clinical care team or by a member of the research team at the participating sites. A dataset containing items of confidential patient information will be disclosed to NHS England for linkage to HES and ONS datasets. Once the linked data is returned to the participating Trust, an anonymised dataset will be disclosed to King’s College London to create the SCMR Registry.  "]
["Applicant Organisation Name","Guy's and St Thomas NHS Foundation Trust "]
["Contact Name","Professor Alistair Young"]
["Address","King's College London/Guy's and St Thomas NHS Foundation Trust"]
[null,"School of Biomedical Engineering and Imaging Sciences; King’s College London, 5th Floor Becket House, 1 Lambeth Palace Road"]
[null,"London"]
["Postcode","SE1 7EU"]
["Telephone","020 7188 5848"]
["Email","Alistair.Young@kcl.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients who underwent MRI imaging for the diagnosis or evaluation of heart disease at Guy’s and St Thomas’ NHS Foundation Trust or Leeds Teaching Hospitals NHS Trust between 1 Jan 2010 and present (1 Jan 2024 at the latest). "]
["Description of confidential patient information used","Data sources \n\n1.Electronic and paper patient records at Guy’s and St Thomas’ NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust \n\n2.HES and ONS data, held by NHS England \n\nIdentifiers required for linkage purposes \n\n1.Name \n\n2.NHS number \n\n3.Postcode \n\n4.Date of birth \n\n5.Gender\n\nIdentifiers required for analysis purposes \n\n1.Gender \n\n2.Ethnicity \n\nIdentifiers retained in the research database \n\n1.Year of birth \n\n2.Gender \n\n3.Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-14"]
["Next Review Date","2024-11-14"]
["Notes","Conditions of support:\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 22 June 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Guy's and St Thomas' NHS Foundation Trust, King’s College London and Leeds Teaching Hospitals NHS Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02810","index":851,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02810"]
["Reference","23/CAG/0139"]
["Other Refs","IRAS Project ID: 328044  REC Reference: 23/LO/0784\r"]
["Application Title","Retrospective cohort study of professional footballers in England "]
["Application Summary","This application from the Institute of Occupational Medicine (IOM) sets out the purpose of creating a research database of former professional footballers aged over 40 who have died to understand whether mortality rates from neurological disorders are higher in former professional footballers than the general population of England and Wales. It also aims to look at aspects of participants playing career such as the estimated lifetime numbers of headers, playing position and level played at, which may be important in relation to risk of neurological disorders.  \n\nThe study cohort (as detailed below) will be identified and collected by the IOM from the publicly available database Barry Hugman's Footballers (barryhugmansfootballers.com). The study cohort identifiers will be sent from IOM to NHS England for linkage and to request mortality data. Support is requested to allow the disclosure of confidential patient information for the study cohort from NHS England’s mortality data to the IOM and for IOM to create a pseudonymised research database. \n\n "]
["Applicant Organisation Name","Institute of Occupational Medicine "]
["Contact Name","Prof Damien McElvenny "]
["Address","Institute of Occupational Medicine, Research Avenue North\n"]
[null,"Riccarton"]
[null,"Edinburgh"]
["Postcode","EH14 4AP"]
["Telephone","01314498085 or 07980738106"]
["Email","damien.mcelvenny@iom-world.org"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Professional footballers aged over 40"]
["Description of confidential patient information used","Data sources \n\n1.Barry Hugman’s Footballers database \n\nIdentifiers required for linkage purposes \n\n1.Name \n\n2.Date of birth \n\n3.Date of death \n\n4.Geographic location based on the club played for e.g. Nottingham Forest = Nottingham \n\nIdentifiers required for analysis purposes \n\n1.Month and year of birth \n\n2.Month and year of death \n\n3.Region of England at time of death \n\n4.Ethnicity \n\nAdditional information \n\n1.Estimated number of participants 15-20,000 "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-14"]
["Next Review Date","2024-11-14"]
["Notes","Conditions of support: \n\n1.\tSection 251 support is provided for the duration required to link the data\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 18 September 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed\n\nThe NHS England 22/23 DSPT review for Institute of Occupational Medicine was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 26 September 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02811","index":852,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02811"]
["Reference","23/CAG/0090 "]
["Other Refs","IRAS Project ID: 321402  REC Reference: 23-NI-0077"]
["Application Title","King's College London Cardiovascular Diseases Database "]
["Application Summary","This application from King's College Hospital NHS Trust set out the purpose of medical research, of aiming to create a research database collecting data on all patients admitted with cardiovascular disease (CVD), or seen in cardiology outpatient clinic at King's College Hospital NHS Trust (KCH) and Guy’s & St Thomas’ NHS Trust (GStT). The database aims to advance prevention, early diagnosis and treatment of cardiovascular disease in the locality, and will support research into 4 cardiovascular disease research themes; Acute & Chronic Coronary Syndromes, structural and Valvular Heart Disease, arrhythmia and Complex Electrophysiology, and heart Failure & Cardiomyopathy.  \n\nStructured and unstructured data collected during routine delivery of cardiology care will be extracted from electronic patient notes (EHR) by machine-learning artificial intelligence software (Cogstack), into 2 site-specific research databases:  King’s Electronic Records Research Interface (KERRI), and Guy’s & St Thomas’ Electronic Records Research Interface (GERRI). This will involve free text data such as patient appointment systems, pathology results, imaging and diagnostics, and letters and scanned documents for the purposes of research. The data will be extracted and structured to facilitate analysis and research. The applicant is not requesting ‘s251’ support for this process. During the extraction process, identifiable information will be removed from the clinical datasets (i.e, name, hospital and NHS ID) or weakened (i.e., date of birth and address). However NHS number and full date of birth will still be retained in 2 separate files at each Trust, alongside assigned registry specific IDs, to create the GStT and KCH linkage files held separate from the pseudonymised clinical data. The GStT Linkage File and the pseudonymised GStT clinical data file are both transferred to KCH, and the GStT linkage file will be linked to the KCH linkage file, for the purposes of de-duplication, and to create a single KCL-CVD Registry Linkage File (containing identifiers), that is accessible only to CI & database manager. Pseudonymised clinical data from KCH is then combined with clinical data from GStT in a single pseudonymised KCL-CVD Disease Registry retained by KCH.  \n\nThe KCL-CVD Registry Linkage File containing NHS number, full Date of Birth, and registry ID is shared with NHS England to enable linkage with Hospital Episode Statistics (HES) & ONS Mortality Data. NHS England will disclose a dataset back to the applicant containing full date of death amongst other outcome data.  The data will be linked to the clinical data within the registry, and the full date of death will then be modified for analysis. After completion of the database, it will be stored for 10 years.  \n\nResearchers who have a substantive contract with KCH or GStT, or a substantive contract with KCL and honorary contract with KCH/GStT, will be able to request datasets for specific research questions. All proposed research projects require approval by an Oversight Committee. The Oversight Committee will review the proposal in respect to the scientific validity, the skill-mix of the research team, the potential benefit to patients and the risk for potential patient reidentification. At present, there is no plans for a lay person to sit on the Oversight Committee, however the oversight committee will meet on a 6monthly basis with the PPI Oversight Group to review research priorities and ongoing governance. If approval is issued, the researchers will receive the minimal required dataset for their analysis. Data will remain within the Trust firewall at all times and can only be removed in the form of graphs and scientific reports. "]
["Applicant Organisation Name","King's College Hospital NHS Trust "]
["Contact Name","Dr Nilesh Pareek, Chief Investigator"]
["Address","Department of Cardiology "]
[null,"King's College Hospital "]
[null,"London "]
["Postcode","SE5 9RS"]
["Telephone","020 3299 9000"]
["Email","nileshpareek@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients admitted with cardiovascular disease (CVD),  or seen in cardiology outpatient clinic at KCH or GSsT, between April 2012 to March 2022  \n\nApproximately 150,000 individuals  "]
["Description of confidential patient information used","Data sources \n\n1.Participating Trusts Electronic patient Records; \n\na.King’s College Hospital NHS Trust (KCH)  \n\nb.Guy’s & St Thomas’ NHS Trust (GStT) \n\n\n2.NHS England: \n\na.Hospital Episode statistics \n\nb.ONS mortality data \n\nIdentifiers required for linkage purposes \n\n1.NHS number \n\n2.Date of birth \n\n3.Registry specific ID  \n\nIdentifiers required for analysis purposes \n\n1.Date of death – received form NHS England, and modified for analysis \n\n2.Month and year of birth   \n\n3.Sector level postcode in order to calculate deprivation score \n\n4.Gender \n\n5.Ethnicity \n\n6.Registry specific ID \n\nAdditional information \n\nlinkage file with NHS number, D.o.B. & Registry ID held separately from the pseudonymised clinical data, that is only accessible to the applicant and the Clinical Informatics lead, who share leadership of the resource. \n\nKCL-CVD Registry Database locked following NHS Digital linkage – the linkage key to NHS number is deleted after 5 years. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-09"]
["Next Review Date","2024-11-09"]
["Notes","Amendment fully supported 23 April 2024 to include Cardiac and Intracoronary imaging data into the KCL-CVD Database\nAnd conditionally supported to inform CAG of the potential sharing of de-identified data with external collaborators for validation of methods & performance of novel analyses\n\nConditions of support applied\n\n1.\tThe applicant is to ensure that any external data sharing proposal is reviewed and approved by the Oversight Committee, including patient representatives.\n\n2.\tWhere de-identification effectiveness may be found to be limited after a DPIA assessment, external collaborators should be provided with access in the data safe haven rather than transmission of the dataset to the collaborators.\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold Confirmed: \n\nThe NHS England 22/23 DSPT reviews for King's College Hospital NHS Trust, Guy’s & St Thomas’ NHS Trust & NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 19 April 2024)\n\n4.\tConfirmation of a favourable opinion from a Research Ethics Committee. Confirmed 11 March 2024\n\n\nConditions of support:\n\n1.\tPlease provide updated information to CAG, which shows how many people respond to the PPI questionnaire, such as a summary of issues/concerns raised or whether people are generally supportive, within one month.\n\nCondition met 18 January 2024\n\n2.\tThe presence of a lay member should be a condition of the quorum requirements for the Oversight Committee (which assesses data access requests). Please confirm to CAG within one month, with updated Terms of Reference.\n\nCondition met 18 January 2024 \n\n3.\tPlease revise the NDOO section on the poster to align with the changes made to the leaflet, to state they any choice previously made through the National Data Opt-out will be respected, and provide an updated poster to CAG for review, within one month.\n\nCondition met 18 January 2024\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 10 July 2023\n\n5.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for King's College Hospital NHS Trust, Guy’s & St Thomas’ NHS Trust & NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 09 November 2023)\n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02812","index":853,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02812"]
["Reference","23/CAG/0141 "]
["Other Refs","IRAS Project ID: 330081  REC Reference: 23/NI/0124"]
["Application Title","Kings College Hospital Liver Intensive Therapy Unit Research Database"]
["Application Summary","This application from King's College Hospital NHS Foundation Trust set out the purpose of medical research which aims to create a research database from existing information relating to people treated at the Liver Intensive Therapy Unit (LITU). The LITU is a unique specialist Intensive Care Unit that has been in existence since 1973, and since opening has cared for a very large number of critically ill people with a wide variety of liver diseases. The database will enable new studies in important aspects of the care of critically ill people with liver disease, which will include understanding the natural history of the conditions treated at the LITU, the changes seen over time and the effects of specific treatments, detailed statistical modelling to identify thresholds for the use of particular treatments including liver transplantation, and ‘bench-marking’ the outcome for specific conditions, to allow comparison to be made over time and between treating units. \n\nThe database will collate existing datasets relating to patients treated at the Liver Intensive Therapy Unit (LITU) at the Institute for Liver Studies (ILS) at Kings College Hospital, London. Identifiable data relating to the adult patients treated at the LITU is currently held securely in 3 legacy systems accessed only by the Direct Care Team. The research database will include data only for adult patients treated on the LITU, covering the period 1973-2023 with a core dataset of demographics, diagnosis and outcome common to all datasets. The only current plans for future data collection are for periodic updating of survival and opt-out status to be undertaken independently by the Business Intelligence Unit at Kings College Hospital using the hospital numbers held separately from the research database as part of the linkage file that contains both hospital and Study numbers. ‘s251’ support is required because the Trust Caldicott guardian has confirmed that the Business Intelligence Unit are not considered to be part of the direct care team.  \n\nAll access to and use of the database for research projects will be approved by the Data Access Committee (DAC) which will report regularly to the Care Group Research Governance Committee. The DAC will have lay representation, and terms of reference have been submitted. All research will be for a medical purpose, and assessed by the DAC as being in the public interest. All outputs provided to researchers will not include any identifying information."]
["Applicant Organisation Name","King's College Hospital NHS Foundation Trust "]
["Contact Name","Professor William Bernal, Chief Investigator"]
["Address","Institute of Liver Studies, Kings College Hospital \n"]
[null,"Denmark Hill"]
[null,"London "]
["Postcode","SE5 9RS "]
["Telephone",2032994458]
["Email","william.bernal@kcl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 15,000 adult patients treated on the LITU, covering the period 1973-2023 \n\n(poster states 2024) "]
["Description of confidential patient information used","Data sources \n\n1. Medical records from King's College Hospital NHS Foundation Trust from the following sources;\n \na.LITU Acute Liver Failure Registry. \nb.The MEDTRACK Dataset.  \nc.Intellispace Critical Care and Anaesthesia (ICCA) data management system.  \nd.Physiology and labroratory data from KCHNHSFT data warehouse \n\n\n2. NHS England  \n\na.NHS Spine \n\nIdentifiers required to be retained in the database \n\n1.Date of birth (for updating survival) \n2.Date of death (modified for analysis)  \n3.Gender \n4.Ethnicity \n5.Sector level postcode \n6.Hospital number (for updating survival) \n7.Database number \n\nIdentifiers required for analysis purposes \n\n1.N/A analysis will be on pseudonymous data only \n\nAdditional information \n\nIdentifiers will not be held in the same database as the clinical data, but separately in a distinct database held elsewhere within the Trust network with access limited to senior staff managing the database and the from the Trust Business Intelligence Unit who will undertake any required update of case survival and opt-out status. This linking database will include both hospital number and a unique database number. \n\nNHS Spine checks will be annual. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-09"]
["Next Review Date","2024-11-09"]
["Notes","Conditions of support:\n\n1.\t‘s251’ support is in place for 5 years from the date of this letter. A duration amendment will be required at that time if ‘s251’ support is still required.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 17 October 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for King's College Hospital NHS Foundation Trust & NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 09 November 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02813","index":854,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02813"]
["Reference","23/CAG/0156 "]
["Other Refs","IRAS Project ID: 321836  REC Reference: 23/SW/0089"]
["Application Title","Development of Pathways for the Diagnosis and Management of Latent Tuberculosis Infection in Wales "]
["Application Summary","This application from Cardiff University (with the data controller confirmed to be Public Health Wales) set out the purpose of medical research that aims to develop new screening guidelines for Tuberculosis (TB) in Wales, for patients due to be immunosuppressed, by retrospectively reviewing existing data to determine what method would be most cost-effective and have the fewest problems related to antibiotic treatment (WP1). There are further aims relating to WP2, but this is out of scope for CAG support. \n\nTB is an infectious disease. When a person becomes infected, they may either develop an active and infectious form of the disease, or their immune system can control it, such that it lies dormant until potentially 'activated' later. This is called latent TB infection (LTBI). Identifying and treating people with LTBI is crucial to preventing the spread of TB, and this is done with a blood test that measures how immune cells release specific chemical signal.  \n\nIn WP1, Participants will be identified through Public Health Wales (PHW) databases containing retrospective LTBI screening data from the last 7 years. WP1 requires ‘s251’ support for the disclosure of confidential patient information (name, date of birth and NHS number), alongside IGRA screening test outcome and adverse treatment outcomes, from the LTBI Screening Database at PHW, and from the LTBI Screening Database at Oxford Immunotec Ltd (for which PHW is controller), to the applicant via a PHW laptop. Confidential patient information is necessary, as results of screening tests and adverse effects of antibiotic treatment may need to be accessed for clarification. This will only done by the applicant, if data is missing, by undertaking checks using name, NHS number and date of birth, by accessing the Welsh Clinical Portal controlled by Digital Health and Care Wales (DHCW). The data will then be anonymised and disclosed to Cardiff University - Centre for Trials Research. "]
["Applicant Organisation Name","Public Health Wales  "]
["Contact Name","Dr Emma Thomas-Jones"]
["Address","Centre for Trials Research, Cardiff University\n"]
[null,"Neuadd Meirionydd, Heath Park\n"]
[null,"Cardiff"]
["Postcode","CF14 4YS "]
["Telephone","029206 87520"]
["Email","Thomas-jonesE@cardiff.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","WP1: approximately 20,000 patients of any age in Wales who have been screened for latent TB using an IGRA from 2015 – 2022 "]
["Description of confidential patient information used","Data sources \n\n1.LTBI Screening Database - Public Health Wales \n\n2.LTBI Screening Database - Oxford Immunotec Ltd (Public Health Wales are controller for this data)  \n\n3.Welsh Clinical Portal – Digital Health and Care Wales (DHCW) \n\nIdentifiers required for linkage purposes \n\n1.Date of birth \n\n2.NHS number \n\n3.Name? Applicant has added this on as part of query responses (on data flow diagram), but is not stated in the CAG form.  \n\nIdentifiers required for analysis purposes \n\n1.District level postcode  \n\nApplicant states anonymous for analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-10"]
["Next Review Date","2024-11-10"]
["Notes","Conditions of support:\n\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 5 September 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Oxford Immunotec Ltd was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 10 November 2023)\n\nPublic Health Wales (PHW) & Digital Health and Care Wales (DHCW) security assurances are confirmed by the Welsh IG team, in the form of valid CPiP reports or Welsh IG toolkits.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02814","index":855,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02814"]
["Reference","23/CAG/0133 "]
["Other Refs","IRAS Project ID: 316598  REC Reference: 23/SC/0270"]
["Application Title","Co-producing an Ambulance Trust national fatigue risk management system for improved Staff And Patient Safety (CATNAPS) "]
["Application Summary","This application from University of East Anglia set out the purpose of medical research that aims to co-produce and test a comprehensive fatigue risk management system for the NHS Ambulance sector, that meets the needs of staff and operations and is most likely to improve patient and staff safety. The primary output from the collected data is a collection of recommended actions to reduce fatigue and promote sleep health in NHS ambulance staff, collectively referred to as a fatigue risk management system (FRMS). To help meet this aim, the applicants have a number of different work packages, including undertaking observations whilst out on call with the ambulance crews and in the emergency operations centres (EOC - call centres). \n\nThe applicants have discussed with the data controllers – ie. the Ambulance Trusts, who have agreed that an application to CAG is required for individuals who are not considered part of the direct care team, to undertake observations in the described scenarios. Support under Regulation 5 is requested for this aspect of the study as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded, and patients are not the focus of the observations.  \n\nObservers will accompany ambulance crews and EOC staff on a run of 4 consecutive shifts, typically 2 day and 2 overnight (or late) shifts, and including one weekend shift where possible. The study will aim to observe the same members of staff over the consecutive observation period, however this may not always be possible due to staffing or sickness etc.  "]
["Applicant Organisation Name","University of East Anglia "]
["Contact Name","Professor Kristy Sanderson, Chair in Applied Health Research "]
["Address","University of East Anglia"]
[null,"School of Health Sciences,"]
[null,"Norwich Research Park "]
["Postcode","NR4 7TJ"]
["Telephone",7913737331]
["Email","Kristy.Sanderson@uea.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients whose confidential patient information was discussed during clinical observations at participating Ambulance Trusts  \n\nIt is difficult to estimate a number of patients, as this will be an unknown quantity until the observations have taken place. Approximate estimate of 6 patients per shift. "]
["Description of confidential patient information used","Data sources \n\n1. Clinical observations in participating Ambulance Trust ambulances and operations centres, recorded via written field notes, at the following Trusts; \n\na. South East Coast Ambulance Service NHS Foundation Trust  \n\nb. East of England Ambulance Service NHS Trust   \n\nc. South Western Ambulance Service NHS Foundation Trust  \n\nScottish Ambulance Service – (outside of CAG remit and will be covered by PBPP) \n\nIdentifiers required for linkage purposes \n\nNo items of confidential patient information will be recorded for linkage purposes \n\nIdentifiers required for analysis purposes \n\nNo items of confidential patient information will be recorded for analysis purposes "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-11-22"]
["Next Review Date","2024-11-22"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 September 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for South East Coast Ambulance Service NHS Foundation Trust , East of England Ambulance Service NHS Trust, & South Western Ambulance Service NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 22 November 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02815","index":856,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02815"]
["Reference","23/CAG/0176"]
["Other Refs","IRAS Project ID: 329779   REC Reference: 23/PR/1345"]
["Application Title","An Anthropological Study of the Role of Music in the Diagnosis and Treatment of Psychotic Disorders"]
["Application Summary","This application from University of Cambridge set out the purpose of medical research that seeks to understand the role of music in the diagnosis and treatment of psychotic disorders. \n\nA researcher is undertaking a number of different methodologies at Fulbourn Hospital (part of Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), including consented staff observations and interviews and consented observations of group music therapy sessions. These elements do not require ‘s251’ support. \n\nHowever the researcher, who is not considered direct care team, is also undertaking ethnographic observations of Multi-Disciplinary Team (MDT) meetings of mental health professionals. Support under Regulation 5 is required for this aspect of the study, as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded without consent. \n"]
["Applicant Organisation Name","University of Cambridge"]
["Contact Name","Dr Iza Kavedzija"]
["Address","Department of Social Anthropology"]
[null,"Free School Lane"]
[null,"Cambridge"]
["Postcode","CB2 3RF"]
["Telephone","01223 334 599 "]
["Email","ik406@cam.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 10 patients diagnosed with psychotic disorders, from two inpatient wards in Fulbourn hospital: Mulberry 1 (hyperacute ward) and 2 (chronic ward), who were discussed during the Fulbourn Hospital MDT meetings, and have not provided consent. "]
["Description of confidential patient information used","Data sources\n\n1.\tClinical meetings/observations in Fulbourn Hospital (part of Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), recorded via written field notes.\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be recorded for linkage purposes\n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be recorded for analysis purposes\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-05"]
["Next Review Date","2024-12-05"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Cambridgeshire and Peterborough NHS Foundation Trust (CPFT) was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 24 November 2023)\n"]
["National Data Opt-out Status","Exempt"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02816","index":857,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02816"]
["Reference","23/CAG/0140"]
["Other Refs","IRAS Project ID: 316282  REC Reference: 23/WA/0250 "]
["Application Title","Suicide Prevention in Probation"]
["Application Summary","This application from the University of Manchester sets out the purpose of examining death by suicide occurring under probation supervision in England and Wales to better identify prevention and intervention opportunities.\n\nIn order to build a comprehensive profile of suicide by people on probation, one of the central aims of the study is to establish (and test feasibility) of the national case series of suicide deaths by people on probation. The study will link information held by HM Prison & Probation Service on all individuals who were under probation supervision who have died by suicide in England & Wales since April 2019 up to March 2025 with information held by NCISH at the University of Manchester on all registered deaths by suicide in the general population and suicide deaths of people who had been in contact with health services prior to death (up to 12 months prior to death).\n\nSupport is requested to link identifiable NCISH data on registered suicides and open verdicts with identifiable HMPPS data on deaths under probation supervision to identify people who have died by suicide while under probation supervision since April 2019. The data linkage will also be used to identify deaths of people under probation supervision who were in contact with health services prior to death (up to previous 12 months). The linked dataset will be pseudonymised by HMPPS and sent from HMPPS back to NCISH. After the initial dataset is provided, NCISH will undertake an annual update to identify new suicide cases that have occurred in the last 12 months and identify reclassified cases for inclusion/ exclusion.\n"]
["Applicant Organisation Name","University of Manchester"]
["Contact Name","Laura Pope"]
["Address","68 Vespan Road"]
[null,"Address:  68 Vespan Road, London, W12 9QQ"]
[]
["Postcode","W12 9QQ"]
["Telephone","07900 184342"]
["Email","laura.pope@postgrad.manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals who were under probation supervision who have died by suicide in England & Wales since April 2019 up to March 2025"]
["Description of confidential patient information used","Data sources\n\n1.\tNational Confidential Inquiry into Suicide & Safety in Mental Health (University of Manchester) – registered morality data, clinical and health service contact prior to death, diagnosis, treatment\n2.\tHM Prison & Probation Service:\na)\tnDelius - Offence & sentence details, supervision and contact prior to death\nb)\tOASys - Offence details/ risk and criminogenic needs, prior self harm history\nc)\tPNOMIS/DPS - Time spent in custody prior to release/ self-harming behaviours, ACCT, adjudications/ family contact\n\n3.\tOther relevant reports (e.g. serious incident reports, Prison and Probation Ombudsman reports (where applicable and available) - Circumstances leading up to death, contact with services\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tDate of birth\n3.\tDate of death\n4.\tPostcode – sector level\n5.\tGender\n6.\tProbation case reference number/prison number\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth\n2.\tPostcode - sector level\n3.\tGender\n\nAdditional information\n\nEstimated cohort number is 300\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-05"]
["Next Review Date","2024-12-05"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 23/2024 DSPT review for University of Manchester NCISH was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 05 December 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02817","index":858,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02817"]
["Reference","23/CAG/0143"]
["Other Refs","IRAS Project ID:  322545 REC Reference: 23/LO/0812"]
["Application Title","Development of the International Stillbirth Alliance Perinatal Death Classification System for Ending Preventable Stillbirths and Neonatal Deaths in Data-Rich Settings"]
["Application Summary","This application from the University of Leicester sets out the purpose of medical research to establish a classification system to accurately classify perinatal deaths. The research will also compare and evaluate the recently developed International Stillbirth Alliance (ISA) Classification System, in comparison to existing classification systems. The aim is to establish a cause of death (COD) coding system (either the ISA system, an existing system, or an adapted version of either) that allows the collection of the highest quality data in respect to causes of perinatal death, thus allowing for data comparison between international settings and prioritisation for prevention strategies to minimise unexplained stillbirths and neonatal deaths.\n\nFor the purpose of this project, the applicant requires access to 100 mother and baby hospital notes for perinatal deaths occurring in July to December 2019 that have already been supplied to and processed by MBRRACE-UK under the terms of the Confidential Enquiry (CE) programme commissioned by HQIP. The processing of these records without consent for the purpose of the MBRRACE-UK Confidential Enquiry Programme has been undertaken using Section 251 approval (15/CAG/0119).  \n\nSupport is requested for this specific project as the purpose of the data processing is research and is in addition to the Section 251 support for a non-research purpose for MBRRACE-UK for the CE programme. \n"]
["Applicant Organisation Name","University of Leicester"]
["Contact Name","Professor Elizabeth Draper"]
["Address","George Davies Building 15 Lancaster Road"]
[null,"Leicester "]
[]
["Postcode","LE17HA"]
["Telephone",1162584867]
["Email","msn@leicester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","100 cases of perinatal death in England and Wales in 2019*"]
["Description of confidential patient information used","Identifiers required for linkage purposes\n\n1.\tDate of birth – infant\n2.\tDate of death – infant\n3.\tGender – infant and mother\n4.\tEthnicity – infant\n\nIdentifiers required for analysis purposes\n\n1.\tDate of birth – infant\n2.\tDate of death – infant\n3.\tGender – infant and mother\n4.\tEthnicity – infant\n\nAdditional information\n\n*cases already processed by MBRRACE-UK for the Confidential Enquiry Programme under 15/CAG/0119\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-06"]
["Next Review Date","2024-12-06"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 23/2024 DSPT review for University of Leicester - College of Life Sciences was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 20 October 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02818","index":859,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02818"]
["Reference","23/CAG/0069"]
["Other Refs","IRAS Project ID: 321111 REC Reference: 23/LO/0379"]
["Application Title","A study examining the outcomes of blood transfusions where \"least incompatible blood\" has been issued due to the rarity of available red cell units "]
["Application Summary","This application from NHS Blood and Transplant (NHSBT) set out the purpose of medical research that aims to follow up the transfusion outcomes of approximately 120 patients who have received \"least incompatible\" blood in England. The study will seek and examine hospital laboratory parameters to assess whether the transfusions, if given, led to an expected rise in haemoglobin (the oxygen carrying bit of the blood) and no reported reactions or rise in laboratory markers of haemolysis (destruction of red cells by antibodies). \n\nSome patients have antibodies in their blood which makes finding perfectly matched, or compatible red blood cells for transfusion hard to find. These antibodies are often to red cell antigens that are found in the majority of the donor population, and therefore there is not compatible blood available. In these rare instances, the UK blood services select \"least incompatible\" (weakly reactive Vs the patient) blood for transfusion. As these instances are rare, very little is known about the outcomes of these transfusions, and whether the patient benefitted from the transfusion, if given. This study  will help inform transfusion decision making when treating other patients with these rare antibodies in future, as it will provide additional information as to the clinical significance of the rare antibodies in question, and will inform future blood selection policies, which should improve patient care. \n\nPatients who had an antibody to a high frequency antigen and whom NHSBT had issued red blood cells (RBC) for transfusion have been identified from the NHSBT clinical systems, retrospectively and dating back to around 10 years ago. The applicants currently do not know if these patients were actually transfused, and outcome data will only be collected for those that have received at least one unit of 'least incompatible' red cells issued by NHSBT as per inclusion criteria. However, the final fate of the units will be established for all patients, and ‘s251’ support is therefore required for all 120, as their confidential patient information will be processed regardless of whether or no they end up fitting the inclusion criteria. An enquiry will be made by the NHSBT research team, via telephone or secure nhs.net e-mail, to hospital transfusion departments, as to the outcomes of the transfusion of least incompatible units. Data returned will include clinical data surrounding the transfusion, which will be linked back to the NHSBT data. Analysis will be undertaken on a pseudonymous dataset.  "]
["Applicant Organisation Name","NHS Blood and Transplant "]
["Contact Name","Dr Tom Bullock"]
["Address","NHS Blood and Transplant - Red Cell Immunohaematology "]
[null,"500 North Bristol Park, North way \n"]
[null,"Bristol "]
["Postcode","BS34 7QH "]
["Telephone",7823351868]
["Email","tom.bullock@nhsbt.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","120 patients who have been identified as having a rare antibody which led to the selection of 'least incompatible blood' issued by NHSBT  "]
["Description of confidential patient information used","Data sources \n\n1. NHSBT - laboratory Information Management System (LIMS) \n\n2. Referring hospital transfusion departments where least incompatible units sent to, and patients were transfused – medical records \n\nIdentifiers required for linkage purposes \n\n1. Name \n\n2. Date of Birth  \n\n3. NHS number \n\nIdentifiers required for analysis purposes \n\n1. Analysis undertaken on a pseudonymous dataset "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-07"]
["Next Review Date","2024-12-07"]
["Notes","Conditions of support: \n\n1.\t Favourable opinion from a Research Ethics Committee. Confirmed 02 May 2023 \n \n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:  \n \nThe NHS England 2022/23 DSPT review for NHS Blood and Transplant was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 07 December 2023) \n \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02819","index":860,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02819"]
["Reference","23/CAG/0134"]
["Other Refs","IRAS Project ID:  330194  REC Reference: 23/SW/0105"]
["Application Title","VIVALDI Social Care Database "]
["Application Summary","This application from University College London set out the purpose of medical research which aims to create a research database including data on infections, hospital attendances, vaccinations, antibiotic prescriptions, and deaths in older adults who live in care homes. Applicants will create the research database by collecting and linking data on residents in these homes. The aim is to collect data from at least 500 homes and up to 30,000 residents in England. This is a pilot project – if it is a success, the goal is to establish a long-term programme of research and surveillance for infection in care homes, informed by learning from this application. \n\nEvery year care home residents experience infections and outbreaks, which reduce their physical and mental health and well-being and cause avoidable hospital admissions and deaths. Many of these infections could be avoided with better evidence on ‘what works in care homes’ and systems to keep track of and therefore stop infection.  \n\nThe research database will require confidential patient information to be collected from care homes and disclosed to Arden & GEM CSU, in order for NHS England to link to NHS and public health datasets, including records of vaccination, hospitalisation, and death. The database will then be effectively anonymised before it is shared with the applicants at University College London. It will be stored in the UCL Data Safe Haven. The effectively anonymous data collected will be used to measure and prevent infections in residents and stop them spreading. There is an associated non-research surveillance study, which has been submitted to CAG separately – 23/CAG/0135. \n\nThe applicants anticipate the research database will be used for research on infectious diseases, outbreaks, and Antimicrobial Resistance (AMR), subject to approval by the study Data Access Committee (DAC). Researchers will be required to access the data for analysis within the UCL Data safe haven. If this pilot is successful, applicants anticipate that the scope of the research database could be extended to support research on infectious and non-infectious diseases. The DAC will include representation from residents, families, care providers and policymakers. \n\n "]
["Applicant Organisation Name","University College London "]
["Contact Name","Professor Laura Shallcross"]
["Address","Institute of Health Informatics"]
[null,"222 Euston Rd\r"]
[null,"London"]
["Postcode","NW1 2DA"]
["Telephone"]
["Email","l.shallcross@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The cohort will include approximately 15,000-30,000 residents from 500-1500 care homes for adults older than 65 years in England. \n\nThe data will be collected prospectively between 01 October 2023 and 31 March 2025 (but will be for a maximum of 12 months at each care home) "]
["Description of confidential patient information used","Data sources \n\n1. Participating care homes records  \n\n2. NHS England – Linked routine datasets:  \n\n-COVID-19 / Influenza tests \n\n-NIMS vaccination data \n\n-APC / ECDS hospital attendances data \n\n-ONS mortality data  \n\n-SGSS microbiology and virology results \n\n-Antimicrobial prescriptions  \n\n-HPZone, care home level data on outbreaks \n\nIdentifiers required for linkage purposes \n\n1. NHS number \n\n2. Care home post code based on care home CQC-ID (only the first 3 characters) \n\n3. National Commissioning Data Repository (NCDR) pseudo-identifier \n\nIdentifiers required for analysis purposes \n\n1. Applicants are linking to mortality data but are only receiving date of death in MM/YY format. \n\n2. Gender \n\n3. Ethnicity \n\n4. Age \n\n5. Care home post code based on care home CQC-ID (only the first 3 characters) \n\nTherefore data will be pseudonymised (effectively anonymised) for analysis \n\nAdditional information \n\nThe pseudonymisation key will be held by NHS England. \n\nData will be linked daily. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-07"]
["Next Review Date","2024-12-07"]
["Notes","Conditions of support: \n\n1.\tIncrease the number of care home residents in further patient and public involvement undertaken over the next year and report these discussions to CAG at annual review.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 06 December 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for NHS England & Arden and GEM Commissioning Support Unit (AGEM CSU/DSCRO) were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 20 November 2023)\n\nDue to the number of care providers and/or software vendor organisations involved, it is the responsibility of University College London, as controller, to ensure that processing organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02820","index":861,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A12820"]
["Reference","23/CAG/0096 "]
["Other Refs","IRAS Project ID: 326510  REC Reference: 23/NW/0242"]
["Application Title","Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial"]
["Application Summary","This application from Cardiff and Vale Health Board and Cardiff University set out the purpose of medical research that seeks to test the effectiveness of the Obstetric Bleeding Strategy intervention in treating excess bleeding during childbirth.  \n\nExcess bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1L (2 pints) of blood or more. Many women need a blood transfusion or are admitted to intensive care and find the experience of bleeding traumatic, developing mental health issues after having their baby. There is a lack of knowledge about how best to treat the excess bleeding and, despite comprehensive national guidelines being in place, outcomes have not improved over the last 10 years.  \n\nThe applicants have developed the Obstetric Bleeding Strategy (OBS). The strategy includes an assessment of every woman’s bleeding risk, the real-time measurement of blood lost after all births, a consistent approach to managing excess bleeding and bedside tests to rapidly identify and treat abnormal blood clotting. This would be a change to current UK guidelines, which recommend measuring blood loss only after excess bleeding is identified. Confidential patient information will be extracted from patient records at participating NHS trusts and health boards by members of the local research team. The confidential patient information will be disclosed to Cardiff University and collated into the OBS UK database. Confidential patient information will then be disclosed to NHS England and Digital Health and Care Wales for linkage to national datasets, and the return of the linked dataset to Cardiff University. A pseudonymised dataset will be held within SAIL.  "]
["Applicant Organisation Name","Cardiff and Vale University Local Health Board and Cardiff University "]
["Contact Name","Dr Sarah Bell (Chief Investigator)"]
["Address","Cardiff and Vale Health Board  "]
[null,"Department of Anaesthetics and Intensive Care, Cardiff and Vale University Health Board, Heath Park"]
[null,"Cardiff"]
["Postcode","CF14 4XW"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,"X","the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","189,000 Total international sample size (including UK). \n\nPatients will be recruited from 32 NHS maternity units in England. All women giving birth in these units will be included. The applicants estimate that 235,200 patients in England will be included.  "]
["Description of confidential patient information used","Data sources \n\n1. Hospital Episode Statistics, Maternity Services Dataset, Children and Young People's Health Services Dataset, Child Health Surveillance System \n\n2. Data provided from participating maternity units, disclosed to Cardiff University and collated in the OBS study dataset.  \n\nIdentifiers required for linkage purposes \n\n1. NHS Number \n\n2. Date of birth \n\n3. Postcode – unit level \n\nIdentifiers required for analysis purposes \n\n1. Postcode – unit level \n\n2. Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-10-26"]
["Next Review Date","2024-10-26"]
["Notes","Conditions of support: \n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 October 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02821","index":862,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[null,"Dr Jennifer Hall"]
[]
["Application Number","A02821"]
["Reference","23/CAG/0062"]
["Other Refs","IRAS Project ID: 307157  REC Reference: 23/SC/0184"]
["Application Title","Exploring determinants of pregnancy intention and relationships between pregnancy intention and outcome using routine data"]
["Application Summary","This application from Imperial College London set out the purpose of medical research to explore the relationships between pregnancy intention and adverse pregnancy outcomes.  \n\nThere is evidence of linkage between unplanned pregnancies and poor pregnancy outcomes, such as pre-term birth or low birthweight and postnatal depression. This may be due to additional stress and anxiety that an unplanned pregnancy may cause or because women whose pregnancy is unplanned may be less likely to have prepared for pregnancy or accessed pregnancy related services later. The applicants seek to include questions in antenatal care to develop understanding of the relationships between unplanned pregnancy and pregnancy outcomes, with the aim of identifying those at increased risk of worse outcomes.  \n\nThe applicants seek to use data already collected as part of routine antenatal care to investigate the links between pregnancy intention and adverse pregnancy outcomes. Information will be extracted from patient records by those with an existing legal basis to process the information and also by research midwives. A pseudonymised dataset will be extracted and transferred to the Data Safe Haven at University College London for analysis.  "]
["Applicant Organisation Name","University College London "]
["Contact Name","Dr Jennifer Hall"]
["Address","UCL, Medical School Building"]
[null,"74 Huntley St"]
[null,"London"]
["Postcode","WC1E 6AU"]
["Telephone",7789682865]
["Email","jennifer.hall@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used","Data sources \n\n1. Patient records held at: \n\na. University College London Hospitals NHS Foundation Trust \n\nb. Guy’s and St Thomas’ NHS Foundation Trust \n\nIdentifiers required for linkage purposes\n\n1. NHS number \n\n2. Postcode \n\nIdentifiers required for analysis purposes \n\n1. Postcode \n\n2. Occupation \n\n3. Ethnicity "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-13"]
["Next Review Date","2024-12-13"]
["Notes","Specific conditions of support\n\n1. Review and update the notification material to ensure it accurately describes the\nbreach of confidentiality. Provide a response and any updated materials within 3 \nmonths.\n\n2. Favourable opinion from a Research Ethics Committee. Confirmed 15 June 2023\n\n3. Confirmation provided from the DSPT Team at NHS England to the CAG that the \nrelevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the \n‘Standards Met’ threshold. Confirmed:\n\nThe NHS England 22/23 DSPT review for University College London, University \nCollege London Hospitals NHS Foundation Trust and Guy’s and St Thomas’ NHS \nFoundation Trust and Homerton Healthcare NHS Foundation Trust were\nconfirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 13 \nDecember 2023)\n\nAs the above conditions have been met, this letter provides confirmation of final support. I \nwill arrange for the register of approved applications on the HRA website to be updated \nwith this information.\r"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02822","index":863,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02822"]
["Reference","23/CAG/0148 "]
["Other Refs","IRAS Project ID: 1006239 REC Reference: 23/SC/0015 "]
["Application Title","Aspirin Esomeprazole Chemoprevention Trial – EXtension Long-term Clinical Study : A cohort follow up of a phase III randomised study of Aspirin and Esomeprazole Chemoprevention in Barrett’s Metaplasia"]
["Application Summary","This application from University College London (UCL) set out the purpose of medical research that aims to collect the health status of previously consented AspECT participants (alive and deceased), to confirm if aspirin and proton pump inhibitor (PPI)s effectiveness increases long term, to see if aspirin effectiveness increases, and to see if any complications from PPI use occur over a longer period of follow up.\n\nAspEXT EXceL is a follow up trial to the original AspECT consented trial which tested 2 drugs – a high and low dose PPI, with and without aspirin in patients with Barrett’s oesophagus (a condition which can develop into oesophageal cancer many years later) with the aim of investigating the benefits in reducing the risk of cancer in these patients. The results showed that high dose PPI significantly reduced the occurrence of cancer. In addition, high dose PPI with aspirin appeared to be more effective than when used alone. However, the trial was not long enough to determine whether conversion to oesophageal cancer was significant for each/both drugs. \n\nMost of the patients will be alive, and data collection will be undertaken with consent, and is not relevant for ‘s251’ support. Some of the patients, however, may have died and will therefore not be able to consent. Participating sites will be asked to provide as much information as possible regarding oesophageal adenocarcinoma diagnosis, date and cause of death and PPI and Aspirin use prior to death using hospital notes, and this will be entered into an electronic case report form (eCRF) called OpenClinica (hosted by Amazon Web Services). ‘s251 support is required for this.\n\nWhere this information is missing, sites will send confidential patient information (AspECT ID, NHS number, date of birth and sex at birth) regarding deceased participants to the UCL Data safe haven (DSH). ‘s251 support is also required for this.\n\nIf the participating sites cannot provide the NHS number or date of birth, then UCL will request this information from the original AspECT sponsor (Oxford Clinical Trials Unit) using AspECT ID. ‘s251’ support is also required for this flow and the flow back, as the pseudo-ID will be used to re-identify the patient, and provide confidential patient information to UCL. UCL will in turn disclose NHS number and date of birth to NHS England, in order for NHS England to link to the listed datasets, and return the data back to UCL for analysis. Once in UCL DSH, the data will be linked back to clinical data from the original AspEXT trial, using the using AspECT ID, that will have been separately disclosed to UCL. \n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Janusz Jankowski, Chief Investigator"]
["Address","University College London (UCL)"]
[null,"90 High Holborn"]
[null,"London"]
["Postcode","WC1V 6LJ"]
["Telephone",2076704814]
["Email","j.jankowski@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","1587 AspECT participants in total (alive and deceased) (across all of UK)\n\n‘s251’ support only relevant regarding the deceased patients on England and Wales, however the applicant cannot yet estimate how many people this is relevant for.\n\n"]
["Description of confidential patient information used","Data sources\n\n1.\t20-35 Participating Aspect sites in England and Wales – (high recruiting AspECT sites with at least 20 participants)\na.\tAspECT screening/enrolment logs \nb.\tmedical records\n2.\tUniversity of Oxford \na.\toriginal AspECT database\n3.\tNHS England \na.\tHospital Episode Statistics (HES) \nb.\tAdmitted Patient Care (APC)\nc.\tEmergency Care Data Set (ECDS)\nd.\tCivil Registrations (Deaths) data set\n\nIdentifiers required for linkage purposes with original AspECT trial\n\n1.\toriginal AspECT trials ID number (to identify NHS number and date of birth if missing from trust data, and to link to AspECT data)\n\nIdentifiers required for linkage purposes with NHS England\n\n1.\tNHS number\n2.\tDate of birth\n3.\tsex\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death \n2.\tCAG form states date of birth – it is not clear from query responses if this is modified for analysis.\n3.\tsex\n\nCause of death, diagnosis of oesophageal cancer or dysplasia at time of death, date of diagnosis and PPI and Aspirin use prior to death will also be provided back to the applicant.\n\nAdditional information\n\nThe identifiable patient data will be held separately to the clinical data. This separation happens at the point of data entry at a site/trust level. OpenClinica will hold the clinical data which will contain the clinical data including full date of death, and UCL DSH will hold confidential patient information \n\n\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-15"]
["Next Review Date","2024-12-15"]
["Notes","Conditions of support: \n \n\n1.\tContinue ongoing patient and public involvement with additional participants, and report back with further feedback at annual review.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 May 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of participating organisations involved it is the responsibility of the applicant, as controller, to ensure that all organisations processing confidential patient information meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation. These will not be individually checked by the CAT team due to the number of organisations involved.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02823","index":864,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02823"]
["Reference","23/CAG/0178 "]
["Other Refs","IRAS Project ID: 54370   REC Reference: 10/H1010/70 "]
["Application Title","Genetics of neurodevelopmental traits and disorders in ALSPAC"]
["Application Summary","This application from the University of Bristol (ALSPAC) set out the purpose of medical research to study the contribution of rare and common variants to the genetic architecture of neurodevelopment in the general population and related neurodevelopmental conditions such as global developmental delay, ADHD, and autism. A secondary goal is to generate exome sequence data on ~11,000 ALSPAC participants to create an important resource that will enable many other genetic studies within the cohort. \n\nThe applicants seek support to process confidential patient information regarding mental health from GP records, NHS England and Avon and Wiltshire Mental Health Partnership, in line with ALSPAC’s existing approval.\n\nALSPAC wish to:\n•\tRepurpose sensitive data already collected though a previous project specific s251 support within ALSPAC, for this specific project, in order to reduce flow of confidential information,\n•\tAnd for data not already collected though a previous project specific s251 support, request data from GP providers, NHS England and Avon and Wiltshire Mental Health Partnership using existing processes.\n\nThe data will then be combined/anonymised by the ALSPAC team within UKSeRP (managed by the University of Swansea but managed by ALSPAC staff). ALSPAC staff will then make the anonymised combined data available to the researchers within UKSeRP.\n"]
["Applicant Organisation Name","University of Bristol (ALSPAC)"]
["Contact Name","Prof Matthew Hurles, Head of Human Genetics"]
["Address","Wellcome Sanger Institute"]
[null,"Wellcome Genome Campus"]
[null,"Hinxton, Cambridge"]
["Postcode","CB10 1SA"]
["Telephone","(0)1223 495377"]
["Email","meh@sanger.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","individuals enrolled in ALSPAC (excluding those who have explicitly withdrawn from ALSPAC, declined consent to linkage to their health record, have not received ALSPAC fair processing information or have consented to data linkage)\n\n13,500 ALSPAC participants have been contacted, of whom over 5,500 have responded. This support is therefore regarding approximately 8000 individuals. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tALSPAC administrative database (University of Bristol)\n2.\tNHS England\na.\tHospital Episode Statistics (HES), \nb.\tMental Health Minimum Dataset (MHMD)\nc.\tMental Health and Learning Disabilities Data Set (MHLDDS)\nd.\tMental Health Services Data Set (MHSDS)\n\n3.\tGP data software providers \n4.\tAvon and Wiltshire Mental Health Partnership NHS Trust\n\nIdentifiers required for linkage purposes\n\n1.\tStudy IDs\n2.\tNHS number\n3.\tDate of birth\n4.\tsex\n5.\tpostcode\n\nFor those in the ALSPAC database where linkage has already been undertaken:\n\n1.\tNHS ID to ALSPAC ID pseudonymised linkage ID number.\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tAge at event\n\nEffectively anonymous for analysis.\n\nAdditional information\n\nOf the 15,000 ALSPAC participants around 5500 consented (or dissented) to data linkage and are not part of this request for support.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-12-19"]
["Next Review Date","2024-12-19"]
["Notes","Conditions of support: \n \n1.\t The study specific notification materials should be provided to CAG within 3 months. Condition met 07 March 2024\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed: This application activity is covered by main ALSPAC FO (3 February 2011), and addition of this study into main ALSPAC protocol has also been submitted an amendment to REC (AM21) - Date of FO for amendment 20 March 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of participating organisations involved it is the responsibility of the applicant, as controller, to ensure that all organisations processing confidential patient information meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation. These will not be individually checked by the CAT team due to the number of organisations involved.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02824","index":865,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02824"]
["Reference","24/CAG/0021 "]
["Other Refs","IRAS Project ID:   REC Reference: "]
["Application Title","National cohort study of late effects of Hodgkin lymphoma treatment\n"]
["Application Summary","This application from the Institute of Cancer Research set out the purpose of the proposed study was to investigate the range of long- term late-effects of treatment in young women with Hodgkin Lymphoma (HL), in order to provide better information for patients and for decisions on treatment and follow-up.  This study will collect and analyse treatment and follow-up data on women treated for HL across England and Wales at ages ≤35 years during 1956-2010.  This application was to expand an existing national cohort study, which has collected cohort data on 5,000 women with HL. The cohort would be doubled in size to include HL patients with a wider range of treatments and more-recent patients, in order to increase the power, especially for less-common and more-recent treatment types, and would extend the range of morbidity and mortality outcomes examined.  The existing cohort was the largest and most powerful worldwide on treatment-related effects in HL, and has already produced several key publications on this. By expanding the cohort the aim was to improve understanding of late-effects of different treatment alternatives, of longer follow-up periods (important because these patients are treated young, with good survival), expand greatly the range of long-term effects for which rigorous data are available, and draw implications for treatment choice and personalised follow-up and screening schedules.  The principal aim of this study was to improve understanding of the risks of the wide range of long -term fatal and nonfatal morbidities in women treated for HL at young ages in relation to their treatment, and to create a unique risk profile of incidence and severity of multiple long- term co morbidities, in order to enable clinicians and patients to understand patients’ personalised risk profile when deciding on and consenting for treatment, and when managing follow-up and screening for late-effects.  \n"]
["Applicant Organisation Name","The Royal Marsden NHS Foundation Trust"]
["Contact Name","Professor David Cunningham, Consultant Medical Oncologist, Head of Gastro Intestinal Unit/ Lymphoma. "]
["Address","Fulham Road"]
[null,"London "]
[]
["Postcode","SW3 6JJ "]
["Telephone","020 8661 3155 "]
["Email","David.Cunningham@rmh.nhs.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Cohort size 10,000 [5,000 from the original study and 5,000 to be added in this study)             To collect and analyse treatment and follow-up data on women treated for HL across England and Wales at ages ≤35 years during 1956-2010.\n"]
["Description of confidential patient information used","Data from;\nCancer registries, case notes, electronic records and clinical databases at hospitals, and existing cohort data that ICR Hold.\nPatient's demographic details: name, NHS number, date of birth, address.\nDiagnosis, including cancer diagnosis and dates of diagnosis, treatments and dates of treatments.\nDate and cause of death.\n\n\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2023-05-23"]
["Next Review Date","2024-05-23"]
["Notes","Conditions of support:\n\n1.\t16/CAG/0049 is superseded from the date of this letter.\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 October 2021\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Royal Marsden Hospital NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 29 December 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02825","index":866,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02825"]
["Reference","23/CAG/0098 "]
["Other Refs","IRAS Project ID: 318080  REC Reference: 23/LO/0062"]
["Application Title","Epidemiological Surveillance of Deterioration Of Sight Caused By Delay In Review Or Treatment in the UK: Frequency and morbidity "]
["Application Summary","This application from Moorfields Eye Hospital NHS Foundation Trust set out the purpose of medical research which aims to establish a current incidence rate, diagnosis and severity for patients suffering sight loss as a result of delay in their ophthalmic care treatment or review, over a one year surveillance programme operating via the British Opthalmological Surveillance Unit (BOSU) methodology, using the monthly reporting card amongst UK ophthalmologists.  \n\nA previous surveillance project established the frequency of sight loss due to delay in review or treatment was undertaken March 2015 - February 2016. The majority of cases were in patients with chronic eye conditions requiring long-term continuous follow-up, most notably glaucoma. Delayed follow-up appointments were the cause in most cases, indicating a lack of system capacity. In addition to pre-existing service pressures, the cessation of normal clinical practice during the coronavirus pandemic and reduced capacity in the return to normal service provision and the created backlog will have influenced the number and length of delays. Re-running the previous study will help to identify the magnitude of any changes in morbidity caused by harm due to delays.  \n\nThe BOSU methodology is established and has received support in principle from the CAG. Ophthalmologists will anonymously indicate that they have seen a new patient who has suffered sight loss as a result of delay in their ophthalmic care, through the BOSU reporting system via University of Dundee. The University of Dundee system will generate the initial questionnaire for the reporting ophthalmologist to fill in via the University of Dundee data safe haven online platform. The completion of this questionnaire will contain confidential patient information, and therefore requires ‘s251’ support. Each case will be given a unique study number by the BOSU study centre. Hospital number, month and year of birth, gender, ethnicity, and postcode will be recorded alongside clinical data on the questionnaires. All identifies will be deleted once the follow-up is completed, postcode is converted to deprivation score, and duplicates identified.  "]
["Applicant Organisation Name","Moorfields Eye Hospital NHS Foundation Trust "]
["Contact Name","Ms Rashmi Mathew"]
["Address","Glaucoma Service, Moorfields Eye Hospital"]
[null,"City Road"]
[null,"London"]
["Postcode","EC1V 2PD "]
["Telephone",7947454614]
["Email","rashmi.mathew1@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 168 – 264 (but actual incidence as yet unclear) patients suffering sight loss as a result of delay in their ophthalmic care treatment or review who report to a treating ophthalmologist across the 12 months reporting period, expected to be between October 2023 – September 2024 "]
["Description of confidential patient information used","Data sources \n\nClinical records at the Trusts of BOSU reporting ophthalmologists \n\nIdentifiers required for de-duplication purposes \n\nUnique BOSU study number \n\nGender \n\nAge \n\nDiagnosis \n\nPostcode \n\nIdentifiers required for analysis purposes \n\nMonth and Year of birth \n\nGender \n\nPostcode – converted to social deprivation score \n\nEthnicity \n\nApplicant states this will be an effectively anonymised dataset for analysis. \n\nAdditional information \n\n1 year of baseline collection - Expected start date October 2023 – September 2024 "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-01-09"]
["Next Review Date","2025-01-09"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 13 September 2023\n\n2.\tSecurity assurances for Health Information Centre - University of Dundee – Data safe haven. Confirmed in the form of PBPP approval, dated 13 October 2023\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02826","index":867,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02826"]
["Reference","23/CAG/0177 "]
["Other Refs","IRAS Project ID: 329323  REC Reference: 23/PR/1214"]
["Application Title","Investigating potential health and health equality impacts of planning deregulation: The case of permitted development housing in England"]
["Application Summary","This application from University College London set out the purpose of medical research that seeks to use hospital admission and death records to determine the health effects of living in housing created through Permitted Development (PD) regulations, which is a category of building activity that does not require full planning permission. This research fills a vital gap in existing work to consider the health impacts and inequalities associated with PD housing in England. Poor-quality housing is linked to numerous health problems, with significant costs to health and social care systems. The Building Research Establishment estimated that the NHS spends about £2.5 billion per annum on housing and health-related conditions. Housing quality is therefore a significant public health issue. Low-quality housing disproportionately impacts lower socioeconomic groups, widening inequalities, whilst interventions which create healthy homes can help improve both health and broader social and economic outcomes. This study will inform wider policy debate about whether reduced regulation in the planning of urban spaces is aligned with the goal of creating healthier places for people to live. \n\nTo estimate the influence of PD housing on hospital admissions and deaths it is necessary to know who is living or has historically lived at a PD address and the most comprehensive way to identify these individuals is via the Personal Demographics Service (PDS). It is not possible to determine who the participants are until the point they are identified by linking an address to an entry in the PDS, which makes obtaining prior informed consent impossible. The study requires ‘s251 support’ to allow NHS England to link between the PD housing addresses (and comparator non-PD housing addresses) that the UCL study team will provide, (which do not constitute confidential patient information), and the PDS, to identify name, NHS number, date of birth and address. These individuals are then linked to Hospital Episode Statistics (HES), Emergency Care Data Set (ECDS), and Civil registration deaths. Once linkage is complete, NHS England will pseudonymise the data to send to the UCL research team, after which, NHS England will delete the identifiable data.\n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Professor Benjamin Clifford "]
["Address","Bartlett School of Planning"]
[null,"14 Upper Woburn Place"]
[null,"London"]
["Postcode","WC1H 0NN"]
["Telephone",2031089524]
["Email","ben.clifford@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All individuals with an NHS number who have lived at an address on the PD or non-PD (comparator group) housing lists between 2010 to 2023. \n\nBased on estimates of 100,000 PD housing units - estimate sample size of approximately 230,000 people in the PD housing group.\n\n‘s251’ support is also required for approximately 230,000 people in the comparator group.\n"]
["Description of confidential patient information used","Data sources\n\n1.\tCombined list of addresses for the study (with PD and non-PD indicator variable) created at University College London and does not constitute CPI. \n2.\tNHS England:\na.\tPersonal Demographics Service\nb.\tHospital Episode Statistics (HES) APC and A&E\nc.\tEmergency Care Data Set (ECDS)\nd.\tCivil registration - Deaths data\n\nIdentifiers required for linkage purposes\n\n1.\tName \n2.\tNHS number\n3.\tDate of birth \n4.\tAddress (including postcode)\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tEthnicity\n\nThis will be effectively anonymous to the applicant for analysis. \n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-01-10"]
["Next Review Date","2025-01-10"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 11 December 2023 \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for NHS England was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 10 January 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02827","index":868,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02827"]
["Reference","23/CAG/0096"]
["Other Refs","IRAS Project ID: 326510  REC Reference: 23/NW/0242"]
["Application Title","DUPLICATE ENTRY Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial"]
["Application Summary","This application from Cardiff and Vale Health Board and Cardiff University set out the purpose of medical research that seeks to test the effectiveness of the Obstetric Bleeding Strategy intervention in treating excess bleeding during childbirth. \n\nExcess bleeding is the most common complication of childbirth. Every year about 50,000 women in the UK lose 1L (2 pints) of blood or more. Many women need a blood transfusion or are admitted to intensive care and find the experience of bleeding traumatic, developing mental health issues after having their baby. There is a lack of knowledge about how best to treat the excess bleeding and, despite comprehensive national guidelines being in place, outcomes have not improved over the last 10 years. \n\nThe applicants have developed the Obstetric Bleeding Strategy (OBS). The strategy includes an assessment of every woman’s bleeding risk, the real-time measurement of blood lost after all births, a consistent approach to managing excess bleeding and bedside tests to rapidly identify and treat abnormal blood clotting. This would be a change to current UK guidelines, which recommend measuring blood loss only after excess bleeding is identified. Confidential patient information will be extracted from patient records at participating NHS trusts and health boards by members of the local research team. The confidential patient information will be disclosed to Cardiff University and collated into the OBS UK database. Confidential patient information will then be disclosed to NHS England and Digital Health and Care Wales for linkage to national datasets, and the return of the linked dataset to Cardiff University. A pseudonymised dataset will be held within SAIL. \n"]
["Applicant Organisation Name","Cardiff and Vale University Local Health Board and Cardiff University"]
["Contact Name","Dr Sarah F Bell, Consultant Anaesthetist"]
["Address","Cardiff and Vale Health Board  "]
[null,"Department of Anaesthetics and Intensive Care"]
[null,"Cardiff and Vale University Health Board, Heath Park, Cardiff"]
["Postcode","CF14 4XW"]
["Telephone",2920743107]
["Email","sarah.bell3@wales.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","189,000 Total international sample size (including UK).\n\nPatients will be recruited from 32 NHS maternity units in England. All women giving birth in these units will be included. The applicants estimate that 235,200 patients in England will be included. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tHospital Episode Statistics, Maternity Services Dataset, Children and Young People's Health Services Dataset, Child Health Surveillance System\n\n2.\tData provided from participating maternity units, disclosed to Cardiff University and collated in the OBS study dataset. \n\nIdentifiers required for linkage purposes\n\n1.\tNHS Number\n2.\tDate of birth\n3.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tPostcode – unit level\n2.\tEthnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Duplicate entry"]
[]
["Outcome Date"]
["Next Review Date","2024-10-26"]
["Notes","Conditions of support: \n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 October 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of participating sites where confidential patient information will be accessed, individual DSPT submissions are not required for the purpose of the application. Support is recommended on the basis that the applicant ensures the required security standards are in place at each site prior to any processing of confidential patient information with support under the Regulations\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02828","index":869,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02828"]
["Reference","23/CAG/0162"]
["Other Refs","IRAS Project ID: 276490  REC Reference: 21/EE/0060"]
["Application Title","Database of UK recipients of pituitary-derived human growth hormone"]
["Application Summary","This application from University College London set out the purpose of setting up two research databases which will be used to conduct research investigating whether people who received injections of pituitary-derived cadaveric human growth hormone (c-hGH) are at risk of developing a disease called iatrogenic cerebral amyloid angiopathy (iCAA).\n\nBetween 1959 and 1985, nearly 2000 individuals in the UK were treated with cadaveric human growth hormone (c-hGH). Some people who received this treatment went on develop a disease called iatrogenic cerebral amyloid angiopathy (iCAA). iCAA is a disease associated with strokes caused by bleeding in the brain, as well as seizures (or fits) and cognitive changes. This occurred because some batches of pituitary-derived human growth hormone were contaminated with an abnormal form of one particular protein, called the prion protein, which went on to cause their disease. \n\nThe applicants seek to investigate whether patients who received pituitary-derived human growth hormone have been affected by diseases caused by iatrogenic protein transmission by using an existing historical database of recipients of pituitary-derived human growth hormone between 1959 and 1985, held by the UK Health Security Agency (HSA), to create two databases. \n\nThe first, the “Surveillance Snapshot” Research Database, will be created by linking data from the existing dataset to HES and ONS data, held by NHS England. This will provide a “snapshot” of data relating to admissions, A&E attendances, outpatients appoints and deaths, and to determine whether patients who received c-hGH are at an increased risk of neurological illness.  \n\nThe second, the “Permission to Contact” Research Database, which will be used to invite patients who received pituitary-derived human growth hormone to participate in future research studies. The database will be created by linking data from the existing dataset to Personal Demographics Service (PDS) data, provided by NHS England to the UK HSA. This database will be retained at the UCL Data Safe Haven and used to contact patients in the database via their GP to ask for explicit consent to be included in the database. Patients will be contacted a maximum of three times and their data will be deleted if they dissent or do not respond. \n"]
["Applicant Organisation Name","University College London"]
["Contact Name","Dr Gargi Banerjee"]
["Address","MRC Prion Unit at UCL, Institute of Prion Diseases\nCourtauld Building\n"]
[null,"33 Cleveland Street"]
[null,"London"]
["Postcode","W1W 7F"]
["Telephone",7796675357]
["Email","gargi.banerjee@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients included in a pre-existing database of recipients of cadaveric human growth hormone between 1959 and 1985, held at the UK Health Security Agency"]
["Description of confidential patient information used","Data sources\n\n1.\tBoth databases:\n\na.\tPatient information in a pre-existing database of recipients of cadaveric human growth hormone between 1959 and 1985, held at the UK Health Security Agency\n\n•\t“Surveillance Snapshot” Research Database\n\n1.\tThe MESH (National Data Opt-Out) data set, and the HES and ONS datasets at NHS England\n\n•\t“Permission to contact” Research Database\n\n1.\tThe MESH (National Data Opt-Out) data set, and the HES and ONS datasets at NHS England\n2.\tPersonal Demographics Service (PDS) data set at UK Health Security Agency\n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tNHS Number\n3.\tGP Registration\n4.\tDate of death\n5.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n\nAdditional information\n\nThe below data items will be retained in the Permission to contact” Research Database under consent. \n\nPatient name\nDate of birth\nNHS number\nGender\nAddress including postcode, email address and telephone number\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-01-17"]
["Next Review Date","2025-01-17"]
["Notes","Conditions of support: \n \n1. Favourable opinion from a Research Ethics Committee. Confirmed 12 April 2021\n2. Confirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:\nThe NHS England 2022/23 DSPT reviews for University College London, Institute of Prion Diseases, UK Health Security Agency and NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 17 January 2024).\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02829","index":870,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A01829"]
["Reference","23/CAG/0093 "]
["Other Refs","IRAS Project ID: 327396  REC Reference: 23/PR/0763"]
["Application Title","Natural Experiment of the impact of supervised Opiate Agonist Therapy (OAT) consumption on drug related harm and treatment outcomes"]
["Application Summary","This application from The University of Bristol set out the purpose of medical research, to \ndetermine and compare rates of drug related harm. This includes hospital admissions, \nnon-fatal overdoses, self-harm, drug related deaths, suicide death and all-cause mortality. \nThese outcomes are examined during supervised and unsupervised Opioid Agonist \nTreatment (OAT) (methadone or buprenorphine) and periods off OAT, before, during and \nafter the COVID-19 pandemic. Applicants will also assess duration and retention on \nsupervised compared with unsupervised OAT, before, during and after the COVID-19 \npandemic.\n\nDaily supervised prescription and consumption (DSC) for OAT medicines used to treat \nopioid dependence/opioid drug use disorders was the norm before COVID-19 lockdown \nfor a substantial number of patients managed by community drug agencies (CDA). \nAlthough implemented to reduce drug related deaths (DRDs), evidence for intended \nbenefits of DSC of OAT is limited, imposes additional costs on OAT delivery and patients \noften find DSC stigmatising and restrictive. The COVID-19 pandemic led to patients being \nsupplied with weekly or fortnightly supplies of OAT. Face to face support has also stopped. \nTelephone appointments offer efficiency savings but may impact on patient experience. \nEvidence on the impact of lockdown on management of opioid use and drug related harm \nis emerging. In Scotland there was some evidence that uptake of harm reduction services \ndeclined and have not yet recovered to pre-pandemic levels. In North America drug related \ndeaths increased. In UK changes to the delivery of OAT, including dispensing for up to 14 \ndays for self-administration, has been well-received by patients. It’s no longer possible to \nstudy DSC in a controlled trial. As the COVID-19 pandemic necessitated a shift away from \nDSC on DHSC advice, it has created a “natural experiment” allowing applicants to study \nthe impact of DSC on fatal and non-fatal overdose and DRDs and wider impacts of \nchanges to drug treatment on patients.\n\nApplicants will use data about patients prescribed either methadone or buprenorphine, \nidentified by Change, Grow, Live (CGL), a CDA. Date of birth, postcode and NHS number, \nsex, and CGL pseudo ID will be disclosed to NHS England with ‘s251’ support’, and linked \nwith hospital episode statistics (HES) and civil registration mortality data, and the \npseudonymous dataset provided to the University of Bristol for analysis. Clinical data such \nas OAT prescription details, assessment information and health and safety information\nalongside a CGL pseudo-ID will be disclosed from CGL to the University of Bristol in \neffectively anonymous format, and applicants will link the HES and mortality data to the \nPage 3 of 9\n\nCGL clinical data using CGL's patient ID number. Analysis will be undertaken on the \neffectively anonymous dataset."]
["Applicant Organisation Name","Bristol Medical School"]
["Contact Name","Professor Matthew Hickman, Professor of Public Health and Epidemiology"]
["Address","Population Health Sciences"]
[null,"Bristol Medical School"]
[null,"Canynge Hall, 39 Whatley Rd, Bristol"]
["Postcode","BS8 2PS"]
["Telephone",1174552480]
["Email","Matthew.Hickman@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients registered with Change, Grow, Live and prescribed opioid agonist treatment between 2015 and end of 2022.\n\nApproximately 6000"]
["Description of confidential patient information used","Data sources\n\n1.Change, Grow, Live\na. Clinical records\n\n2.NHS England:\na. Hospital Episode Statistics (HES)\nb. Civil registration mortality data \n\nIdentifiers required for linkage purposes.\n\n1.Date of birth\n2.Post code \n3.NHS number\n4. Sex\n5. CGL patient ID\n\nIdentifiers required for analysis purposes.\n\n1.N/A analysis will be undertaken on an anonymous dataset"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-01-18"]
["Next Review Date","2025-01-18"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 21 August 2023.\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for Change, Grow, Live and NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 18 January 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02830","index":871,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02830"]
["Reference","24/CAG/0016"]
["Other Refs","IRAS Project ID: 299359  REC Reference: 22/YH/0246 "]
["Application Title","Collaboration on Prevent In-Place Extremism Referrals "]
["Application Summary","This application from Birmingham and Solihull Mental Health Foundation Trust set out the medical research purpose of creating a research database for the purpose of analysing the full cohort of referrals to the West Midlands Prevent-in-Place (PiP) team. This application aims to evaluate the relationship between mental health and susceptibility to terrorism, and the PiP service. The overall purpose is to improve understanding, transparency, and delivery of these services, which is expected to inform health related benefits to patients, communities, healthcare professionals, and policy makers.\n\nThe applicants seek to develop a database to be used in a programme of research to conduct a detailed analysis of referrals to the West Midlands Prevent-in-Place (PiP) team. The database is a collaboration between Birmingham and Solihull Mental Health Foundation Trust, West Midlands Police and University College London. The database will be used to answer questions about the mental health needs experienced by those managed within Counter Terrorism (CT) policing, service gaps or barriers and outcomes for those supported by mental health services. \n\nEligible patients will be identified from the West Midlands PiP, held at a West Midlands Police Secure location, by a PiP administrator, and the National Data Opt Out applied. No ‘s251’ support is required for this element, as the individual will be ‘direct care team’. Confidential patient information will then be disclosed (still within West Midlands Police), to both the police, and to UCL research staff. The police will use the identifiers to search CT Policing - Prevent Case Management Tracker System (PCM Tracker) for relevant entries from case notes. Data from the PCM Tracker is outside the scope of ‘s251’ support as this is not confidential patient information. Police will then email relevant extracts alongside name and other identifiers to UCL research staff (still within West Midlands Police), for them to link the PCM data to the PiP data, in an excel spreadsheet. ‘s251’ support is required for this element, as UCL research staff are not members of the direct care team, and ‘s251’ support is therefore required for them to link the PCM and PiP data, and the extract the relevant PiP data from medical records, at the secure police location. All identifiers will then be removed from the excel spreadsheet, before disclosing to University College London, for retention in this anonymous format. \n\nThe Study Steering Board comprising researchers from each organisation (BSMHFT, UCL, WMCTU), R&I, legal IG and other professionals will continue to be held regularly. The research will have oversight from the Prevent In-Place Governance board which is held monthly, the WMCTU Senior leadership Team and Operation Cicero (Police Commissioners for the Prevent In-Place service). The data will be used by the three organisations engaged in the collaboration only. \n"]
["Applicant Organisation Name","Birmingham and Solihull Mental Health Foundation Trust"]
["Contact Name","Dr Nicola Fowler "]
["Address","Thomas Telford, Ardenleigh "]
[null,"Erdington "]
[null,"Birmingham "]
["Postcode","B24 9SA "]
["Telephone",1213011111]
["Email","nfowler@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Individuals referred to the Prevent In-Place (PiP) Service from 2016 to the present.\n\nActive cases and individuals that have opted out of NHS research will have been removed.\n\nApproximately >3,500\n"]
["Description of confidential patient information used","Data sources\n\n1.\tWest Midlands Police:\n\na)\tPrevent-in-Place (PiP) records:\n•\tpaper files for cases referred between April 2016 – April 2019\n•\telectronic records after April 2019 \n\nb)\tCT Policing - Prevent Case Management Tracker System (PCM Tracker) – out of the scope of support as this does not contain confidential patient information.\n\nIdentifiers required during data extraction and linkage at West Midlands Police\t\n\nResearchers would have access to the following whilst extracting a dataset from PiP records, and during linkage\n1.\tName\n2.\tAddress\n3.\tNHS number\n4.\tGP registration\n5.\tDate of birth\n6.\tPostcode\n7.\tGender \n8.\tOccupation \n9.\tEthnicity\n\nIdentifiers required for analysis purposes and retained at UCL.\n\n1.\tPostcode – district level\n2.\tAge\n3.\tGender\n4.\tOccupation\n5.\tEthnicity\n\nNo direct identifiers, and is effectively anonymous.\n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-01-30"]
["Next Review Date","2025-01-30"]
["Notes","Conditions of support: \n \n1. Favourable opinion from a Research Ethics Committee. Confirmed FIFO 6 January 2023\n\n2. Security assurance for West Midlands Police is confirmed - The force has to adhere to the PSN codes of connection.\n\nAs the above conditions have been met, this letter provides confirmation of final support. I will arrange for the register of approved applications on the HRA website to be updated with this information.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02831","index":872,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02831"]
["Reference","23/CAG/0182 "]
["Other Refs","IRAS Project ID: 319697  REC Reference: 23/NE/0228"]
["Application Title","Suicide crisis and self-harm attendance at A&E in autistic children and young people"]
["Application Summary","This application from Liverpool John Moores University sets out the purpose of medical research that aims to look at rates of admission for children and young people (CYP) with autism who arrive in A&E for suicidal crisis, self-harm, or following a suicide attempt, to assess the prevalence of the issue and review the services accessed to determine whether the most effective pathways for CYP are accessed.  \n\nIt is estimated that 1 in 100 CYP in the UK are diagnosed with autism. Suicide is the leading cause of death for young people aged between 20 and 34 years in the UK. CYP with autism are at a higher risk of suicide than non-autistic CYP, and are more than four times as likely as their typical peers to be admitted to the hospital after harming themselves. It is currently unknown why self-harm rates are higher in CYP with autism, how mental health disorders present in CYP with autism, and how services and support should be best placed to accommodate the needs of CYP with autism.  \n\nThis study requires ‘s251’ support for data extraction at A&E sites only, all other elements of the study are out of scope for ‘s251’ support. The initial identification of potential participants medical notes, using the electronic databases at each of six A&E sites, will be undertaken by the direct care team, who will inform the researcher. The named researcher, who is not a member of the direct care team, will have on-site access to patient medical records, which include confidential patient information. Retrieving information will be a time-consuming activity, and the direct care team have indicated that they do not have the time and resources to complete this work. Therefore ‘s251’ support is required. Potential participants will be screened by the named researcher, and if eligible, pseudonymised data will be recorded. Although a key is retained between the NHS number and the unique anonymised study ID, this is retained by the direct care team only. Therefore support is not required for this retention, and the collected dataset can be considered anonymous to the named researcher. No confidential patient information will be recorded or retained by the researcher. Data will subsequently be analysed at Liverpool John Moores University.  "]
["Applicant Organisation Name","Liverpool John Moores University "]
["Contact Name","Dr Pooja Saini"]
["Address","Reader in Suicide and Self-Harm Prevention"]
[null,"Room 317 Tom Reilly Building"]
[null,"Byrom Street"]
["Postcode","L3 3AF"]
["Telephone",7946169335]
["Email","P.Saini@ljmu.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children and young people (CYP) aged 5-30, with autism who arrive in A&E for suicidal crisis, self-harm, or following a suicide attempt \n\nBetween the time period January 2015 – January 2025.   \n\nEstimated 1200 per A&E site (a total of 7,200 for 6 A&E sites proposed)  "]
["Description of confidential patient information used","Data sources \nElectronic databases at 6 A&E departments, and associated Trust medical records: \n\nAlder Hey NHS Foundation Trust – Alder Hey Children’s Hospital   \n\nGreater Manchester Mental Health NHS Foundation Trust - Royal Manchester Children’s Hospital & North Manchester General  \n\nCheshire and Wirral Partnership NHS Foundation Trust  - Arrowe Park & Countess of Chester Hospital   \n\nMersey care NHS Foundation Trust – Royal Liverpool University Hospital    \n\nIdentifiers required for data extraction purposes\n\n1.Researcher will view medical notes to extract a pseudonymised dataset \n\n2. Hospital ID \n\n3. NHS number \n\n4.Date of Birth \n\n5.Post code \n\n6.Unique anonymised study number  \n\nIdentifiers required for analysis purposes \n\n1.Age  \n\n2.Sex \n\n3.Ethnicity \n\n4.Partial postcode (district level) \n\n5.Unique anonymised study number \n\nIt is not possible for the researcher to re-identify a patient from this data extract. \n\nAdditional information \nA key that will be held within each Trust linking NHS number to a unique anonymised study number. If researcher needs to go back to a patient file this key will allow re-identification, however only the Trust would hold this information. No identifiable data will be held by the researcher. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-02"]
["Next Review Date","2025-02-02"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 25 January 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for Alder Hey NHS Foundation Trust (re Alder Hey Children’s Hospital), Greater Manchester Mental Health NHS Foundation Trust (re Royal Manchester Children’s Hospital & North Manchester General) & Cheshire and Wirral Partnership NHS Foundation Trust (re Arrowe Park & Countess of Chester Hospital were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 02 February 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02832","index":873,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02832"]
["Reference","23/CAG/0181 "]
["Other Refs","IRAS Project ID: 328086  REC Reference: 23/LO/1005"]
["Application Title","Does living by the coast negatively impact palliative and end-of-life care outcomes? An explanatory sequential mixed methods study exploring the inequality of provision and access to palliative care in a coastal region "]
["Application Summary","This application from Norfolk And Norwich University Hospitals NHS Foundation Trust set out the purpose of medical research which aims to identify if there are differences in palliative and end of life care (PEOLC), for patients who live in coastal regions compared to patients that live further in land.  \n\nOver the last few years, it has become apparent that people who live in coastal communities are more disadvantaged. This is in terms of social deprivation, job opportunities, and access to healthcare. People that live in deprived areas are more likely to have health problems, including terminal illnesses. There is no current research looking at whether coastal communities are disadvantaged when it comes to palliative and end of life care, and this study hopes to fill that gap.  \n\n‘s251 support’ is requested to allow the disclosure of confidential patient information (name, NHS number) from \n\nJames Paget University Hospital (JPUH) and East Coast Community Healthcare (ECCH) to Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH), in order for the CI to use NHS number for de-duplication. Support is further requested for the researcher (who is not considered direct care team) to access electronic health records of the deceased patients at East Coast Community Healthcare (ECCH), in order to extract an anonymous dataset for analysis, however no ‘251’ support is required for the researcher to extract a dataset for analysis from James Paget University Hospital, as she is direct care team at that Trust.  "]
["Applicant Organisation Name","Norfolk And Norwich University Hospitals NHS Foundation Trust "]
["Contact Name","Dr  Abigail  Hensley"]
["Address","Specialist Registrar in Palliative Medicine"]
[null,"Norfolk and Norwich University Hospital"]
[null,"Colney Lane, Norwich"]
["Postcode","NR4 7UY"]
["Telephone",1603286286]
["Email","abigail.hensley@nnuh.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 800 Patients deceased between April 2023-September 2023 from the Great Yarmouth and Waveney region of the Norfolk and Waveney Integrated Care Board, who meet the inclusion criteria: \n\nPatient over 18  \n\nPatient died at JPUH or died in community hospital or died in their usual residence receiving care from ECCH  \n\nElectronic records available  \n\nExclusion criteria: Traumatic or unexplained death (as these will not have received PEoLC) "]
["Description of confidential patient information used","Data sources \n1. James Paget University Hospital (JPUH) and East Coast Community Healthcare (ECCH) electronic health records \n\n2. Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) electronic health records \n\nIdentifiers required for deduplication and data extraction purposes \n\nDe-duplication: \n\n1.Name \n\n2.NHS number \n\nTo extract anonymous dataset: \n\n3.Postcode \n\n4.Date of death \n\n5.Medical records \n\nIdentifiers required for analysis purposes \n\n1.N/A anonymous dataset for analysis \n\nAdditional information  \n\nThe deceased patient records will be allocated a unique study number for pseudonymisation at time of identification, with no identifiable data recorded. A look-up table will be kept with the unique study number and the NHS number of the record, so the two data sets from the different trusts can be cross referenced to avoid duplication of records being included. The look-up table will be kept on the NNUH trust computer which is password protected, and will only be able to be accessed by the CI. Once data collection is completed this will be deleted. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-01"]
["Next Review Date","2025-02-02"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 01 February 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for James Paget University Hospitals NHS Foundation Trust, East Coast Community Healthcare (ECCH) & Norfolk And Norwich University Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 02 February 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02833","index":874,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02833"]
["Reference","24/CAG/0023 "]
["Other Refs","IRAS Project ID: 320085  REC Reference: 23/NW/0310"]
["Application Title","Stroke and atrial fibrillation (AF) with a focus on prevalent and incident stroke and/or AF in one area of North West England, and associated clinical risk factors, multimorbidity, time trends, and outcomes, and development and evaluation of clinical risk models and dynamic changes in stroke risk"]
["Application Summary","This application from Mersey & West Lancashire teaching hospitals NHS Trust set out the purpose of medical research that aims to recognise factors that may modify cardiovascular risk in AF and in stroke, and to identify new predictors of stroke in patients with AF. Applicants specifically aim to determine the predictive ability of, and the association between coronary artery calcification (CAC) and intracranial arterial calcification (IAC) and adverse outcomes (such as AF, stroke, stroke recurrence, all death and stroke related death). There is a secondary aim of the creation of computer programs (risk prediction models) that use advanced technology (artificial intelligence and machine learning) to incorporate CAC and IAC in predicting the likelihood of experiencing strokes and heart rhythm issues such as AF.\n\nIn short, ‘s251’ support is requested to allow the disclosure of confidential patient information from Mersey & West Lancashire teaching hospitals NHS Trust to Graphnet, for the purposes of linking to the Combined Intelligence for Population Health Action (CIPHA) platform, before providing an effectively anonymous dataset for analysis to the applicants, via provided access within Graphnet Trusted Research Environment. ‘s251’ support is also specifically required for Graphnet to process NHS number and date of death from CIPHA, in order to pseudonymise the NHS number for linkage, and modify the date of death for analysis.\n\nThe rate of recurrent stroke and post-stroke complications and death, as well as death related to atrial fibrillation (AF), remains high despite current management. Clinical risk scores such as CHADS2 and CHA2DS2-VASc have been fully validated and widely used in clinical practice to identify AF patients at higher risk of stroke, who will need certain treatment (i.e., blood thinners). Nevertheless, recent evidence has emerged proposing new markers of risk of AF and/or stroke that are yet to be studied in a larger population size before they can be incorporated into new risk scores and clinical risk models, which this study aims to do.\n\nThe applicants intend to link a patient’s hospital record (including their CCTA report) to their individual baseline characteristics, comorbidities, and outcomes as recorded in the Shared Care Records within CIPHA. Outcomes of interest include recurrent stroke + mortality, stratified as AF vs no AF. The cohort will be identified by the direct care team at Mersey and West Lancashire Teaching Hospitals NHS Trust (MWL). The cohort will consist of a CAC group: All adult patients who had CAC assessment on a CCTA at MWL Trust in the period between May 2010 and May 2018 (which allows for at least 5 years of follow up data), and an IAC group: adult stroke patients who had CT head (namely brain CT angiography) between July 2021 and July 2022 at Whiston hospital (part of MWL). This dataset will comprise 25 patients with (cases) and 20 patient without (controls) visually evident IAC on their scans). This analysis will serve as a pilot study to assess feasibility and prove concept.\n\nTo facilitate linkage to CIPHA, the transfer of patient identifying information (NHS numbers and dates of birth) to Graphnet (along with limited data e.g. the recorded calcium score on CT) will take place, which requires ‘s251’ support. Graphnet will pseudonymise the NHS number, before linking it to CIPHA data using the pseudonymised NHS number. Date of birth will be modified to age. Data regarding the CAC groups and IAC groups are both sent to Graphnet for linkage. Graphnet also requires ‘s251’ support for processing NHS number and date of death of the CIPHA dataset, in order to pseudonymise the NHS number for linkage, and modify the date of death for analysis. Pseudonymised scans of the IAC group only will also be sent to University of Liverpool for IAC assessment and calcification scoring which are not done routinely. Graphnet will create an effectively anonymous dataset for analysis within their own Trusted Research Environment (TRE) where the data can be analysed by the MWL researchers. ‘s251’ support will be required for 3 years after linkage, for the applicant at Mersey & West Lancashire teaching hospitals NHS Trust to retain a key between identifiers and the study ID. \n"]
["Applicant Organisation Name","Mersey & West Lancashire teaching hospitals NHS Trust"]
["Contact Name","Associate Professor Andrew Hill "]
["Address","Whiston Hospital"]
[null,"Warrington Road"]
[null,"Prescot"]
["Postcode","L35 5DR"]
["Telephone","0151 426 1600"]
["Email","andrew.hill2@sthk.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","CAC group: All adult patients who had CAC assessment on a CCTA at MWL Trust in the period between May 2010 and May 2018 (which allows for at least 5 years of follow up data) -  \n\nThe CAC group is 2509 patients\n\nIAC group: And adult stroke patients who had CT head (namely brain CT angiography) between July 2021 and July 2022 at Whiston hospital (part of MWL). (this dataset will comprise 25 patients with (cases) and 20 patient without (controls) visually evident IAC on their scans). This analysis will serve as a pilot study to assess feasibility and prove concept.\n\nThe IAC group is 45 total patients\n"]
["Description of confidential patient information used","Data sources\n\n1.\tMersey & West Lancashire teaching hospitals NHS Trust –\n•\tCT/CTA scans from -Radiology PACS system at MWL\n•\tElectronic patient records\n2.\tGraphnet (processor) - Combined Intelligence for Population Health Action (CIPHA) platform – the data controller for CIPHA is individual GP practices within Cheshire and Merseyside. Currently this is a shared care record for direct care purposes. \n\nIdentifiers required for linkage (and within Graphnet)\n\nLinkage:\n\n1.\tNHS number – required to pseudonymise for linkage\n\nProcessed for analysis:\n2.\tDate of Birth – disclosed to Graphnet from Trust and modified to age for analysis\n3.\tDate of death – modified to MM/YY from the full date in CIPHA\n\nIdentifiers retained within the key by the Trust\n\n1.\tStudy specific pseudo-ID\n2.\tNHS number\n3.\tDate of birth\n\nIdentifiers required for analysis purposes\n\n1.\tGender\n2.\tEthnicity\n3.\tDistrict level postcode\n4.\tDate of death – in MM/YY\n\nThis is effectively anonymous for analysis within Graphnet\n\nAdditional information\n\nParticipants will be allocated a unique study number, and this will be used by the study team in communications with the collaborating research teams (e.g. University of Liverpool). The local NHS Trust (MWL) will hold that link code. The Chief Investigator and authorised delegated members of the research team will have access to the link code to the identifying data. ‘s251’ support required for as long as the key between this code and identifiers is held, and this will be deleted 3 years after linkage. \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-13"]
["Next Review Date","2025-02-13"]
["Notes","Conditions of support: \n \n1.\tWithin one month, please update the poster and send to CAG for review with the following changes included:\na.\tImprove the poster layout, increase the text size, and correct the text on the poster, in line with advice in the minutes.\nb.\tCorrect the spelling error of Graphnet on both the patient notification leaflet and poster\nc.\tInclude a phone number and/or postal address for patients to opt out in addition to the email address.\n\nCondition met 06 March 2024\n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 20 November 2023\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for Mersey and West Lancashire Teaching Hospitals NHS Trust  (in the form of  St Helens and Knowsley Teaching Hospitals NHS Trust (RBN) and Southport and Ormskirk Hospital NHS Trust (RVY) as these have formally come together as one Trust – Mersey & West Lancashire) & Graphnet Health Limited were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 12 February 2024)\n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02834","index":875,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02834"]
["Reference","24/CAG/0017"]
["Other Refs","IRAS: 337552 (on CAG IRAS form) 239332 (on REC Application) REC Reference: 20/SC/0088"]
["Application Title","CRIS Linkage with the Police National Computer (PNC)"]
["Application Summary","This application from South London and Maudsley NHS Foundation Trust set out the purpose of creating a research database, containing linked data from the CRIS dataset at South London and Maudsley NHS Foundation Trust and the Police National Computer dataset, held by the Ministry of Justice. \n\nOne in seven adults in the UK is an offender or ex-offender, and a large proportion will suffer from at least one mental health disorder. Surveys of offenders within the court, prison, and probation services reveal far higher rates of psychiatric disorders compared to the general population. Despite the burden and complexity of mental health issues experienced by offender populations, resources dedicated to understanding and responding to these needs is limited. The creation of the proposed database will be used in research to provide evidence to help patients, their families, treating clinicians, and health and justice policy makers understand the offender related risk factors for poor outcomes for major mental illness throughout the life course.\n \nSupport is required to allow the South London and Maudsley NHS Foundation Trust (SLaM) to create a SLaM Patient Identifiers table for all patients within SLaMs clinical records. SLaM’s Clinical Data Linkage Service (CDLS) will disclose the Patient Identifiers table to the Ministry of Justice (MoJ) for linkage to the Police National Computer (PNC) database. The MoJ will match the SLaM Patient Identifiers against their PNC identifiers. Matches will be extracted and the SLAaM BRCID pseudonym will be added. The resultant table, the CRIS cases, will be stripped of all identifiers other than the BRCID and sent to the CDLS. Researchers seeking to use the dataset will apply to the CRIS Oversight Committee. Applications will be evaluated on three points - research value; research governance; likelihood of identification of cases, e.g. due to rare conditions and/ or combined rare demographic. Researchers will compile clinical data from CRIS for approved analyses and send to the CDLS who will link CRIS and PNC data using the BRCID. CDLS will fully anonymise resultant tables by replacing the BRCID with a one-way encrypted project specific anonym and send linked tables back to researchers for analysis.\n\nThe SDE will be set up in stages depending on the maturity of the organisation. However, support is sought for all organisations to contribute to the SDE.\n"]
["Applicant Organisation Name","South London and Maudsley NHS Foundation Trust"]
["Contact Name","Dr Johnny Downs "]
["Address","Department of Child and Adolescent Psychiatry  "]
[null,"King's College London "]
[null,"16 De Crespigny Park, London "]
["Postcode","SE5 8AZ "]
["Telephone",2032288586]
["Email","johnny.downs@kcl.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 470,000 individuals, approximately 40,000 of whom will be under the age of 18, who had contact with SLaM and held within CRIS between 01/01/2008-the date of extraction.  "]
["Description of confidential patient information used","Data sources\n\n1.\tCRIS dataset at South London and Maudsley NHS Foundation Trust\n2.\tPolice National Computer dataset, held by the Ministry of Justice \n\nIdentifiers required for linkage purposes\n\n1.\tName\n2.\tDate of birth\n3.\tPostcode – unit level\n\nIdentifiers required for analysis purposes\n\n1.\tDate of death\n2.\tPostcode – sector level\n3.\tGender\n4.\tEthnicity\n5.\tMonth of birth\n\nAdditional information\n\nThe applicants advised that as new patients are continually added, the cut-off date will be date of data extraction, so that the dataset is as up to date as possible. \n\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-14"]
["Next Review Date","2025-02-14"]
["Notes","Specific conditions of support \n \n1.\tAmend the data flow diagram to include step seven. \n \n2.\tUndertake further patient and public engagement and involvement. \n \n3.\tExplore engagement with youth offenders, for example by contacting relevant charities. \n \n4.\tRevise the patient information leaflet to include links and QR codes to further sources of information. \n \n5.\tExplore further ways of promoting the study, so that patients who don’t receive the leaflet will be aware of the study. \n \n6.\tClarify what efforts the research team will make to help ensure that all new patients receive the CRIS leaflet, or a link, explaining the overall project. \n \n7.\tFavourable opinion from a Research Ethics Committee. Confirmed 31 July 2020 \n \n8.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:  \n \nThe NHS England 22/23 DSPT review for South London and Maudsley NHS Foundation Trust and Ministry of Justice was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 14/02/2024) \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02835","index":876,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02835"]
["Reference","24/CAG/0029"]
["Other Refs","IRAS Project ID: 54370  REC Reference: 10/H1010/70"]
["Application Title","Parenting and children’s behavioural problems: Micro- and macro-processes at play in the context of intervention "]
["Application Summary","This application from the University of Bristol (ALSPAC) set out the purpose of medical research which aims to understand parent-child behaviour processes across childhood as a function of Mental Health Service referral, contact and use.  \n\nOne in six school-aged children now have a probable mental health disorder -- up from one in nine three years ago. Services for children and young people’s mental health are stretched more than ever before, such that maximising resources is a key priority. The effectiveness of mental-health interventions can be optimised by enhancing our understanding of how an intervention leads to improved outcomes. Parent and child behaviours are primary intervention targets for children’s mental health, yet little is known about their assumed mechanistic role. This study aims to address this gap, with specific focus on children’s disruptive behaviour as one of the most common reasons for children to receive mental health services.  \n\nThe applicants seek support to process confidential patient information regarding mental health from GP records, NHS England and Avon and Wiltshire Mental Health Partnership, in line with ALSPAC’s existing approval. \n\nALSPAC wish to: \n\nRepurpose sensitive data already collected though a previous project specific s251 support within ALSPAC, for this specific project, in order to reduce flow of confidential information, \n\nAnd for data not already collected though a previous project specific s251 support, request data from GP providers, NHS England and Avon and Wiltshire Mental Health Partnership using existing processes. \n\nThe data will then be combined/anonymised by the ALSPAC team within UKSeRP (managed by the University of Swansea but managed by ALSPAC staff). ALSPAC staff will then make the anonymised combined data available to the researchers within UKSeRP. "]
["Applicant Organisation Name","University of Bristol (ALSPAC) "]
["Contact Name","Dr Jon Heron, Associate Professor"]
["Address","University of Bristol\r"]
[null,"Oakfield House, Oakfield Grove"]
[null,"Bristol"]
["Postcode","BS8 2BN\r"]
["Telephone","N/A"]
["Email","jon.heron@bristol.ac.uk "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","individuals enrolled in ALSPAC (excluding those who have explicitly withdrawn from ALSPAC, declined consent to linkage to their health record, have not received ALSPAC fair processing information or have consented to data linkage) \n\n13,500 ALSPAC participants have been contacted, of whom over 5,500 have responded. This support is therefore regarding approximately 8000 individuals.  "]
["Description of confidential patient information used","Data sources \n\n1. ALSPAC administrative database (University of Bristol) \n2. NHS England \n\na. Hospital Episode Statistics (HES),  \nb. Mental Health Minimum Dataset (MHMD) \nc. Mental Health and Learning Disabilities Data Set (MHLDDS) \nd. Mental Health Services Data Set (MHSDS)\n\n3.GP data software providers  \n4.Avon and Wiltshire Mental Health Partnership NHS Trust \n\nIdentifiers required for linkage purposes \n\n1.Study IDs \n2.NHS number \n3.Date of birth \n4.sex \n5.postcode \n\nFor those in the ALSPAC database where linkage has already been undertaken: \n1. NHS ID to ALSPAC ID pseudonymised linkage ID number. \n\nIdentifiers required for analysis purposes \n\nGender \n\n1. Age at event \n2. Effectively anonymous for analysis. \n\nAdditional information \n\nOf the 15,000 ALSPAC participants around 5500 consented (or dissented) to data linkage and are not part of this request for support. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-22"]
["Next Review Date","2025-02-22"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: This application activity is covered by main ALSPAC FO (03 February 2011), and addition of this study into main ALSPAC protocol has also been submitted as an amendment to REC (AM21) Date of FO 20 March 2023\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of organisations involved it is the responsibility of ALSPAC, as controller, to ensure that participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02836","index":877,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02836"]
["Reference","24/CAG/0030"]
["Other Refs","IRAS Project ID: 54370  REC Reference: 10/H1010/70\r"]
["Application Title","Mapping Neurodevelopmental Trajectories for Adult Psychiatric Disorder: A focus on Autism and Psychosis"]
["Application Summary","This application from the University of Bristol (ALSPAC) set out the purpose of medical research which aims to explore the neurological association between autistic traits and psychotic experiences. \n\nThis project will investigate neurodevelopmental trajectories for psychiatric disorders, in particular autism and subclinical autistic traits and their overlap with psychosis and psychotic experiences, using longitudinally acquired MRI data from the ALSPAC-MRI-I + II datasets. Analyses will explore the influence of environmental (perinatal and postnatal) and genetic exposures on behaviour. Multi-modal brain imaging scans will be used to illuminate possible interactions between the brain, behaviour, genetics and environmental exposures. \n\nThe applicants seek support to process confidential patient information regarding mental health from GP records, NHS England and Avon and Wiltshire Mental Health Partnership, in line with ALSPAC’s existing approval. \n\nALSPAC wish to: \n\nRepurpose sensitive data already collected though a previous project specific s251 support within ALSPAC, for this specific project, in order to reduce flow of confidential information, \n\nAnd for data not already collected though a previous project specific s251 support, request data from GP providers, NHS England and Avon and Wiltshire Mental Health Partnership using existing processes. \n\nThe data will then be combined/anonymised by the ALSPAC team within UKSeRP (managed by the University of Swansea but managed by ALSPAC staff). ALSPAC staff will then make the anonymised combined data available to the researchers within UKSeRP. "]
["Applicant Organisation Name","University of Bristol (ALSPAC) "]
["Contact Name","Professor Anthony David (CI), Professor of Mental Health Director & Sackler Chair"]
["Address","UCL Institute of Mental Health"]
[null,"Division of Psychiatry"]
[null,"149 Tottenham Court Road, London"]
["Postcode","W1T 7NF"]
["Telephone",2031086433]
["Email","anthony.s.david@ucl.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","individuals enrolled in ALSPAC (excluding those who have explicitly withdrawn from ALSPAC, declined consent to linkage to their health record, have not received ALSPAC fair processing information or have consented to data linkage) \n\n13,500 ALSPAC participants have been contacted, of whom over 5,500 have responded. This support is therefore regarding approximately 8000 individuals.  "]
["Description of confidential patient information used","Data sources \n1.ALSPAC administrative database (University of Bristol) \n\n2. NHS England \na.Hospital Episode Statistics (HES),  \nb.Mental Health Minimum Dataset (MHMD) \nc.Mental Health and Learning Disabilities Data Set (MHLDDS) \nd.Mental Health Services Data Set (MHSDS) \n\n3. GP data software providers  \n4.Avon and Wiltshire Mental Health Partnership NHS Trust \n\nIdentifiers required for linkage purposes \n\n1.Study IDs \n2.NHS number \n3.Date of birth \n4.sex \n5.postcode \n\nFor those in the ALSPAC database where linkage has already been undertaken: \n\n1.NHS ID to ALSPAC ID pseudonymised linkage ID number. \n\nIdentifiers required for analysis purposes \n\n1.Gender \n2.Age at event \n\nEffectively anonymous for analysis. \n\nAdditional information \n\nOf the 15,000 ALSPAC participants around 5500 consented (or dissented) to data linkage and are not part of this request for support. "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-22"]
["Next Review Date","2025-02-22"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: This application activity is covered by main ALSPAC FO (03 February 2011), and addition of this study into main ALSPAC protocol has also been submitted as an amendment to REC (AM14) Date of FO 1 December 2021\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of organisations involved it is the responsibility of ALSPAC, as controller, to ensure that participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02837","index":878,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02837"]
["Reference","24/CAG/0002 "]
["Other Refs","IRAS Project ID: 305267  REC Reference: 23/NS/0134\r"]
["Application Title","MyWay IQ (MWIQ); safety and efficacy testing of a diagnosis and precision medicine tool for diabetes management."]
["Application Summary","This application from MyWay Digital Health Ltd set out the purpose of medical research \nthat aims to generate early clinical safety/efficacy data towards the registration of \nMyWayIQ (MWIQ) as a medical device, to identify if the use of MWIQ is safe, usable and \neffective when used by primary care health care practitioners (HCPs) involved in the care \nof people with diabetes, in comparison to usual care. In order to answer this question, the \nsystem must be deployed within a real-world environment.\n\nDiabetes affects ~10% of the world’s population and rising, with treatment costs ~15% of \nNHS budget; mainly spent treating preventable complications. 80% of costs are due to \ndiabetes-related complications. The majority are preventable through better clinician \nevidence-based management and patient self-management. Despite clear evidence for \npre-emptive personalised approaches, care remains suboptimal, and outcomes poor. \nPrecision medicine approaches through clinician-focused computer decision-support \ncould transform care.\n\nThe applicants will test MWIQ within 7 general practices within Greater Manchester. Up to \n14 HCPs involved in the care of people with diabetes will be invited to use MWIQ within \ndiabetes clinics over a period of 6-9 months. Feedback will be sought via online \ninterviews and questionnaires. Investigators will also analyse how the computer was used \nby the HCP during the clinic and if there were any changes in clinical outcomes (e.g. \nglucose control, weight, blood pressure, change in medication) using an anonymised data \nset. The use of the tool does not require ‘s251’ support, as no confidential patient \ninformation is processed. \n\nThe use of confidential patient information is limited to one specific task - the pre\u0002screening clinic attendees by clinical experts – ‘Validator Participants’, who are not part of \nthe direct care team. In order to pre-screen clinic attendees, the Validator Participants will \nrequire access to the MyWay Clinical system, including confidential patient information. \nAccessing identifiers will allow them to systematically review MWIQ outputs for eligible \npatients attending diabetes clinics, in advance of the consultation. These data will be \nviewed within the web-based electronic patient record (MyWay Clinical platform) and shall \nnot be downloaded/archived/stored. Validator Participants will report any safety issues \nlinked to each patient scheduled to be seen at the GP surgeries engaged in testing. This \nis to ensure that any potential risks are highlighted at an early stage, for patient safety \npurposes. "]
["Applicant Organisation Name","MyWay Digital Health Ltd "]
["Contact Name","Dr Nicholas Conway"]
["Address","NHS Tayside, Tayside Children's Hospital"]
[null,"MACHS building"]
[null,"Ninewells Hospital"]
["Postcode","DD1 9SY"]
["Telephone",1382660111]
["Email","nicholas.conway@nhs.scot"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients aged 18 years or over with a diagnosis of diabetes (any type), and attendance at an investigation site diabetes Page 6 of 6clinic during the period of study \n\nThe anticipated study period is 05 February 2024 – 02 August 2024, however this will begin once CAG support is in place. \n\nApproximately 1000 patients"]
["Description of confidential patient information used","Data sources\n\n1. MyWay Digital Health Ltd - MyWay Clinical (MWC) \nplatform; Diabetes clinic lists at 7 general practices in \nManchester, UK:\n• Northenden Group Practice \n• Cornbrook Medical Practice \n• Peel Hall Medical Practice \n• The Park Medical Practice \n• Brooklands Medical Practice \n• Northern Moor Medical Practice \n• Woodlands Medical Practice\n\nIdentifiers required for purposes of validator review\n\n1. Name\n2. NHS number\n3. GP registration\n4. Date of Birth\n5. Address including Postcode\n6. Gender\n\nIdentifiers required for analysis purposes\n\n1. N/A – no identifiers required for analysis. "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-26"]
["Next Review Date","2025-02-26"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed FIFO 08 January 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for MyWay Digital Health Ltd – (0DS code SP378) was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (confirmed by email 22 February 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02838","index":879,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02838"]
["Reference","24/CAG/0006 "]
["Other Refs","IRAS Project ID: 330790  REC Reference: 24/LO/0037"]
["Application Title","Evaluating the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire: A cluster randomised GP pilot trial Picture "]
["Application Summary","This application from University of Hull set out the medical research purpose of aiming to \nunderstand if free door to door transport can help to increase the number of women \nattending their breast screening appointments in Yorkshire. As a feasibility trial, the \nprimary aim is to assess the feasibility of conducting the future definitive RCT.\n\nBreast cancer is the most commonly diagnosed cancer in women in Yorkshire, causing \nmore than 800 deaths per year in the region. Breast screening is one of the key tools to \nhelp diagnose breast cancer at an early stage and improve survival rates. Across \nYorkshire, in the three years up to 2019/20 an average of 28.6% of invited women had \nnot attended their appointment. Among the non-attenders, a major reason was the \ndifficulty in travelling to the appointment. This study will assess whether offering free, \nbookable, door-to-door transport to and from breast cancer screening appointments could \nincrease the number of women attending screening. Applicants will compare two groups.\n Women registered at GPs in group one will receive information about booking free \ntransport alongside their breast screening invitation. Women registered at GPs in group \ntwo will receive the breast screening invitation as normal with no additional offer of \ntransport. No ‘s251’ support is required for sending this information as this is undertaken \nas part of direct care. Applicants expect that providing free transport will increase the \noverall screening rates, resulting in earlier breast cancer diagnosis and improved survival \nrates. The findings from this study will inform a larger study.\n\n‘s251’ support is requested to use data collected by Humber and East Riding Breast \nScreening Service (retained at Hull University Teaching Hospitals NHS Trust) on women \ninvited for a breast screening appointment, in order to disclose confidential patient \ninformation to NHS England, for linkage to Hospital Episode Statistics (HES) to identify \nethnicity and deprivation index. An anonymous dataset will be disclosed to University of \nHull for analysis. The applicants are also undertaking other methodologies which do not \nrequire ‘s251’ support, such as consented interviews with patients, and travel providers."]
["Applicant Organisation Name","University of Hull "]
["Contact Name","Dr Charlotte Kelly"]
["Address","Hull York Medical School"]
[null,"Allam Medical Building "]
[null,"University of Hull, Hull\n"]
["Postcode","HU6 7RX"]
["Telephone",7597684421]
["Email","charlotte.kelly@hyms.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 8000 eligible women (between ages 50- 70) at eight average sized GP practices, who are due to be invited for a routine breast screening appointment by the Humber and East Riding Breast Screening Service in 2024 and early 2025.\r"]
["Description of confidential patient information used","Data sources\n\n1. Hull University Teaching Hospitals NHS Trust -\nHumberside Breast Screening Service – BSS/NHS Breast Screening Programme (NHSBSP) data Page 6 of 6\n\n2. NHS England – Hospital Episode Statistics (HES)\n\nIdentifiers required for linkage purposes\n1. NHS Number\n2. GP registration\n3. Date of Birth \n4. Attendance data \n5. postcode\n\nIdentifiers required for analysis purposes\n\n1. Effectively anonymous for analysis"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-26"]
["Next Review Date","2025-02-26"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 19 February 2024 \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for Hull University Teaching Hospitals NHS Trust (re Humber and East Riding Breast Screening Service) & NHS England were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 26 February 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02839","index":880,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02839"]
["Reference","24/CAG/0025 "]
["Other Refs","IRAS Project ID: 333310  REC Reference: 24/YH/0022"]
["Application Title","West Midlands Sub National Secure Data Environment"]
["Application Summary","This application, from University Hospitals Birmingham NHS Foundation Trust, sets out \nthe medical purpose to create a research database.\n\nUniversity Hospitals Birmingham NHS Foundation Trust are developing the West \nMidlands sub-national Secure Data Environment (SNSDE). This is part of a national \ninitiative to move towards access of NHS data by default, rather than data sharing and is \npart of the Data Saves Lives strategy. SNSDEs across the country will also become \ninteroperable to enable access. Further details on this national initiative and progress to \ndate is here.\n\nThe West Midlands SDE will consist of different areas. One area will allow for patient \ninformation to flow into the SDE environment from participating organisations, where \napproved staff will support the temporary reidentification and linkage process to create the \nresearch database. A Trusted Research Environment area will enable approved \nresearchers to access the data relevant for their research in a non-identifiable form.\nSupport is requested for all primary and secondary care organisations to share \nconfidential patient information with University Hospitals Birmingham NHS Foundation \nTrust. Depending on the organisation this may be in a pseudonymised or identifiable form. \nSupport is also requested for University Hospitals Birmingham NHS Foundation Trust to \ntemporarily reidentify the information to enable linkage across organisations, and for \nretention within the SDE environment. \n\nThe data will consist of structured and unstructured data from each organisation. This \nincludes unstructured images, clinic letters and radiology/pathology reports, plus \nstructured data from free text medical records from GPs. A number of highly sensitive \ntypes of data relevant to health are excluded, notably data on religion or sexual \norientation. \n\nWest Midlands SDE will be used to enable research that will improve the health and \nwellbeing of WM residents and have outputs of both national and global relevance across \na broad range of clinical areas. A separate research use case document is provided for \nCAG review. There is a 4-stage process to consider requests to access data, with stage 3 \nbeing the Data Trust Committee (DTC). This is a public advisory body that will provide \npublic advice on the application to the SDE. Whilst advisory, no application will be \napproved if the DTC does not support it."]
["Applicant Organisation Name","University Hospitals Birmingham NHS Foundation Trust "]
["Contact Name","Dr Elizabeth Sapey"]
["Address","Birmingham Acute Care Research Group"]
[null,"Edgbaston"]
[null,"Birmingham"]
["Postcode","B15 2TH "]
["Telephone",1214142000]
["Email","e.sapey@bham.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients within the West Midlands SDE footprint (Black Country ICB, Birmingham and Solihull ICB, Coventry and Warwickshire ICB, Staffordshire & Stoke-on-Trent ICB, Herefordshire and Worcestershire ICB), unless opted out.\r"]
["Description of confidential patient information used","Data sources\n\n1. All NHS primary and secondary care organisations within the West Midlands SDE footprint\n\nIdentifiers required for linkage purposes\n\n1. NHS Number\n2. Date of Birth\n3. Postcode\n\nIdentifiers required for analysis purposes\n\n1. Age\n2. Postcode (sub-sector level)\n3. Ethnicity\n4. Sex\n\nAdditional information\n\nWhere NHS organisations are able to, data will be flowed in a pseudonymised form to University Hospitals Birmingham NHS Foundation Trust, though it is expected a number will \nflow this in an identifiable manner. For all organisations, University Hospitals Birmingham NHS Foundation Trust will reidentify for a limited period to enable linkage"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-16"]
["Next Review Date","2025-02-16"]
["Notes","Conditions of support:\n\n1.\tThe CAG asked that the notifications be updated to promote the use of application specific opt-out, whilst still stating the National Data Opt-Out would be respected. Feedback should be provided in 3 months.\n\n2.\tThe CAG requested an update on progress on applying the National Data Opt-Out as early as possible at source. Feedback should be provided in 3 months.\n\n3.\tFavourable opinion from a Research Ethics Committee. Confirmed \n\n4.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for University Hospitals Birmingham NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 14/02/2024)\n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02840","index":881,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02840"]
["Reference","24/CAG/0011"]
["Other Refs","IRAS Project ID: 338740   REC Reference: 24/SW/0007"]
["Application Title","Pre-hospital Research and Audit Network (PRANA)"]
["Application Summary","This is an application from University Hospital Southampton NHS Foundation Trust that \nproposed to create a resource on all patients who receive pre-hospital critical care at the \nrequest of NHS ambulance services, for non-research and research uses. \n\nAmbulance services in 2022/23 nationally attended to 8 million patients. A small proportion \n(estimated 0.5%) of these patients were so severely ill or injured that their lives were \nimmediately threatened (40,000 patients). These patients received high level pre-hospital \ncritical care from a range of specialist NHS and independent sector CQC registered pre-hospital critical care services. Although these patients are proportionally a small subset of the medical and trauma patients cared for by ambulance services, the potential benefits in \nterms of reducing morbidity and mortality are disproportionately significant. Whilst patient \nspecific data is collected by the ambulance services across their pre-hospital care \npathway, data regarding pre-hospital critical care treatment is not currently collated beyond \nprovider organisations nor linked to outcome. Therefore, the potential systematic \nimprovements created through national data collection, analysis, review and publication \nare currently absent within UK pre-hospital critical care. \n\nThe PRANA registry intends to enable data from critically ill and injured patients’ whole \ncare pathways (from moment of recognition of illness or injury onwards) to be utilised to \nimprove understanding of pre-hospital disease, improved diagnosis and treatments of prehospital disease, reduce risk for patients and clinicians, evaluate the impact of new \nprofessional roles on the UK health economy, enable future service planning and \nimprovement, evaluate the effectiveness of health policy, identify targets for disease \nprevention, inform prevention of injury and illness and enable future research and \ninnovation. \n\nAll pre-hospital services (ambulances/air-ambulances) in England and Wales will flow \nidentifiable information to the Wessex SDE held at University Hospital Southampton NHS \nFoundation Trust on a quarterly basis. This data will be linked with a range of relevant \nnational datasets and national audits to create a resource to be used for research and nonresearch purposes. All requests for use of data will be considered by a PRANA data \naccess committee, which includes a lay representative, before agreement by the Wessex \nSDE data access committee. "]
["Applicant Organisation Name","University Hospital Southampton"]
["Contact Name","Dr Philip Hyde"]
["Address","Tremona Road\r"]
[null,"Southampton"]
[]
["Postcode","SO16 7YD\r"]
["Telephone",7818442123]
["Email","phyde1@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Every patient who has received pre-hospital enhanced or critical care at the request of NHS ambulance services, unless they have chosen that their data should not be used. Estimated to be approximately 40,000 per year, and will be a prospective data collection only."]
["Description of confidential patient information used","Data sources \n\n1. University Hospital Southampton NHS Foundation Trust \n2. East Midlands Ambulance Service \nPage 6 of 6\n3. East of England Ambulance Service \n4. Isle of Wight Ambulance Service \n5. London Ambulance Service \n6. North East Ambulance Service \n7. South East Ambulance service \n8. South West Ambulance service \n9. West Midlands Ambulance Service \n10. Yorkshire Ambulance service \n11. Welsh Ambulance Service \n12. London’s Air Ambulance \n13. Great North Air Ambulance \n14. Air Ambulance Kent Surrey Sussex \n15. East Anglia Air Ambulance \n16. Lincolnshire, Nottinghamshire Air Ambulance \n17. Thames Valley Air Ambulance \n18. MAGPAS air ambulance \n19. Hampshire and Isle of Wight Air Ambulance \n20. North West Air Ambulance \n21. Essex and Hertfordshire Air Ambulance \n22. West Midlands Air Ambulance \n23. Devon Air Ambulance \n24. Derbyshire, Leicestershire, Rutland Air Ambulance \n25. Warwickshire, Northamptonshire Air Ambulance \n26. Cornwall Air Ambulance \n27. Great Western Air Ambulance \n28. Wiltshire Air Ambulance \n29. Dorset and Somerset Air Ambulance \n30. Yorkshire Air Ambulance \n31. Emergency Medical Retrieval and Transport Service \nWales \n32. Paediatric Intensive Care Audit Network (PICANet) \n33. National Major Trauma Registry (previously called \nTrauma Audit Research Network) \n34. Intensive Care National Audit and Research Centre \n(ICNARC) \n35. Department for Transport – STATS-19 \n36. Hospital Event Statistics \n37. Ambulance data set (NHS England) \n38. National Organ Donation Registry \n39. Out of hospital Cardiac Arrest Outcomes registry \n(OHCAO) \n40. All Coroner services in England and Wales\n\nIdentifiers required for linkage purposes\n\n1. NHS number \n2. Patient’s first name \n3. Patient’s family name \n4. Patient’s date of birth \n5. Patient’s home postcode\n\nIdentifiers required for analysis purposes\n\n1. Name \n2. Date of birth \n3. Date of death \n4. Postcode \n5. Gender \n6. Occupation \n7. Ethnicity"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-05"]
["Next Review Date","2025-03-05"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed \n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for University Hospital Southampton NHS Foundation Trust  was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 05 March 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02841","index":882,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02841"]
["Reference","23/CAG/0110"]
["Other Refs","IRAS Project ID:  323896 REC Reference: 24/NE/0008"]
["Application Title","Royal Hospital for Neuro-disability (RHN) patients Database"]
["Application Summary","This application from Sanome Limited sets out the purpose of medical research.\nThe RHN is a specialised hospital and medical charity treating adults with complex neurodisabilities from both the NHS and private sector. This application proposes to collect \npatient data from all past patients who have been treated at the RHN into a research \ndatabase for the purposes of conducting medical research. The database will be used to \ndevelop an early warning detection system to detect early signs of health deterioration or \nimprovement in patients. The database will also be used to develop tools to identify \npotential links between variables and patient outcomes.\n\nSupport is requested for the flow of confidential patient information from the electronic \npatient record (EPR) system (Patient Source) at RHN for Sanome Limited to \npseudonymise the data and create a research database held within the Patient Source \ncloud environment. Support is also requested for Sanome Limited and researchers at RHN \nto access the database.\n\nA recommendation for class 5 support was requested to cover access to the relevant \nunconsented activities as described in the application."]
["Applicant Organisation Name","Sanome Limited "]
["Contact Name","Benedikt von Thungen"]
["Address","20 St Andrew Street"]
[null,"Holborn Circus"]
[]
["Postcode","W14 8UJ"]
["Telephone","07985 696803"]
["Email","benedikt@sanome.com"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All past patients who have been treated since implementation of electronic patient records at the Royal Hospital for Neuro-Disability* "]
["Description of confidential patient information used","Data sources \n\nElectronic patient records held at the Royal Hospital for Neuro-Disability \n\nIdentifiers required for validation purposes \n\n1.Year of birth \n2.Date of death \n3.Postcode (sector level) \n4.Gender \n5.Ethnicity \n6.Free text and attachments forming part of a patient’s medical record: \n7.Nursing daily progress notes \n8.HCA personal care record \n9.Summary of nursing care \n10.National Early Warning System 2 (NEWS2) actions \n11.Notes from other role types within the hospital e.g. physiotherapy notes \n\nIdentifiers required for analysis purposes \n\n1.Year of birth \n2.Date of death \n3.Postcode (sector level) \n4.Gender \n5.Ethnicity \n6.Free text and attachments forming part of a patient’s medical record: \n-Nursing daily progress notes \n-HCA personal care record \n-Summary of nursing care \n-National Early Warning System 2 (NEWS2) actions \n-Notes from other role types within the hospital e.g. physiotherapy notes \n\nAdditional information \n\n*Number of past patients is 606 "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-05"]
["Next Review Date","2025-03-05"]
["Notes","Conditions of support: \n1.\tSection 251 support is limited to 2 years from the date of this letter. \n \n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 04 March 2024 \n \n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed:  \n \nThe NHS England 2022/23 DSPT review for RHN, Sanome Ltd and Patient Source was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 05 March 2024) \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02842","index":883,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02842"]
["Reference","24/CAG/0033"]
["Other Refs","IRAS Project ID: 333482  REC Reference: 24/EE/0035"]
["Application Title","North West Sub National Secure Data Environment: Cheshire and Merseyside ICB"]
["Application Summary","This application from Cheshire and Merseyside Integrated Care Board (C&M ICB) sets out \nthe medical purpose to create a create a research database.\n\nCheshire and Merseyside ICB are developing the Northwest sub-national Secure Data \nEnvironment (SNSDE). This is part of a national initiative to move towards access of NHS \ndata by default, rather than data sharing and is part of the Data Saves Lives strategy. \nSNSDEs across the country will also become interoperable to enable access. Further \ndetails on this national initiative and progress to date is here. Note that the Northwest SDE \nis using a federated approach and each ICB in the North West is submitting separate \napplications (Greater Manchester ICB in this meeting, and Lancashire and Cumbria at a \nlater date). \n\nC&M ICB are linking data from multiple sources to create a deidentified dataset for \nresearch use. Support is requested for Graphnet to pseudonymise the local shared care \nrecord and share with Arden and GEM CSU (processing on behalf of C&M ICB), for Arden \nand GEM CSU to pseudonymise national datasets processed by Data Service for \nCommissioners Regional Office (DSCRO) for use in the SDE, and for local organisations \nto share identifiable information to Arden and GEM CSU, where they are unable to \npseudonymise at source. Other national sources are shared under Directions, or \npseudonymised at source and are outside the scope of CAG. Support is also requested for \nthe retention of confidential patient information within the SNSDE environment.\nRequests for data access are governed by the Data Access and Asset Group. The group \ncontains a range of members, including two lay members. Whilst this is currently specific \nfor C&M ICB, there are plans to consolidate to have one data access route in the \nNorthwest."]
["Applicant Organisation Name","Cheshire and Merseyside ICB"]
["Contact Name","Mrs Helen Duckworth"]
["Address","No 1 Lakeside\r"]
[null,"Centre Park"]
[null,"Warrington"]
["Postcode","WA1 1QY"]
["Telephone","07557 503105"]
["Email","helen.duckworth@nhs.net "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The registered and resident population of Cheshire and Merseyside and the individuals who have received care at the providers within Cheshire and Merseyside. "]
["Description of confidential patient information used","Data sources\n1. Local Shared Care record (GP data via Graphnet)\n2. Data sources processed by Data Service for \nCommissioners Regional Office (DSCRO) at Arden and \nGEM CSU\na. Alcohol Dependence\nb. Ambulance Data\nc. Assuring Transformation (learning disabilities)\nd. Community Services Dataset\ne. Clinical Audits and Registries\nf. Continuing Health Care \ng. CVD Prevent\nPage 6 of 6\nh. Diagnostics Imaging Dataset\ni. e-referral system dataset\nj. Faster Data Flows\nk. Maternity Services Dataset\nl. Medicines dispensed in primary care \nm. National cancer waiting times \nn. NHS Pathways Dataset (111/999)\no. Patient reported outcomes dataset (PROMS) \np. Patient Level Contract Monitoring (Pathology tests \ndone)\nq. Virtual Wards\nr. Telehealth Service\ns. Civil Registrations Births\nt. Civil Registrations Deaths\n3. National Data Sources covered under the national NHS \nDirection from health and social care for use for research\na. Secondary Users Service (SUS) \nb. COVID 19 Data Assets\nc. Improving Access to Psychological Therapies \nd. Mental Health Minimum Dataset\ne. National Diabetes Audit \nf. Summary Hospital Mortality Indicator set (SHMI)\ng. Adult Social Care\n4. Local organisation data\na. Pseudonymised at source\nb. Unable to be pseudonymised at source\n\nIdentifiers required for linkage purposes\n1. NHS number \n2. Date of birth \n3. Date of death \n4. Postcode\n\nIdentifiers required for analysis purposes\n1. Year of birth \n2. Gender \n3. Ethnicity \n4. Lower Super Output Area"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-06"]
["Next Review Date","2025-03-06"]
["Notes","Conditions of support:\n\n1.\tThe CAG requests the following regarding patient notification materials: \na.\tConfirm whether a Welsh version of the patient notification materials was possible.\nb.\tProvide CAG with the most up to date lay-friendly patient notification materials.\n\n2.\tEnsure that the data access process includes consideration of the medical purpose.\n\n3.\tProvide a summary of the outputs of further public involvement work at first annual review, as well as a summary whether any changing attitudes that had resulted in a change of approach\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 05 March 2024\n\n5.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Graphnet and Arden and GEM CSU were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (04 March 2024)\n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02843","index":884,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02843"]
["Reference","24/CAG/0036"]
["Other Refs","IRAS Project ID: 329574  REC Reference: 24/EM/0042"]
["Application Title","Can performing extra tests on non-diagnostic biopsy samples avoid the need for further invasive biopsies in people with suspected cancer of the lung lining?"]
["Application Summary","This application from the University of Bristol set out the purpose of medical research that \nseeks to determine whether additional tests on biopsy samples taken from patients with \nsuspected pleural malignancy, who did not receive a diagnosis from an initial biopsy, \ncould have removed the need for further invasive procedures. \n\nDiagnosing pleural malignancy can be challenging. Radiology supports diagnosis but \ntaking a biopsy for diagnosis is the gold standard. Some patients present with fluid around \nthe lining of the lung but malignancies such as pleural mesothelioma (PM) are difficult to \nidentify when this fluid is sampled. Biopsy of the lung lining gives a diagnosis more \nfrequently than fluid, but does not always provide a diagnosis, meaning that a group of \npatients undergo multiple investigations, with increased risk of complications and delays \nto treatment initiation. A previous trial, the TARGET trial, had shown that use of PET-CT \ndid not improve diagnostic rates and some repeat biopsies were also non-diagnostic. \nAdvances since the TARGET trial have broadened the panel of tests available for biopsy \nsamples, including tests for markers known as BAP1, p16 and MTAP. If these markers \nare absent, then a diagnosis of PM can be made. This project aims to evaluate the \ndiagnostic benefit of BAP1, p16 FISH and MTAP in suspected mesothelioma by re-testing \nthe initial non-diagnostic or negative biopsy samples from TARGET trial participants. \n\nConfidential patient information from the TARGET study database at University Hospitals \nBristol and Weston NHS Foundation Trust will be disclosed to the North Bristol NHS Trust. \nNorth Bristol Trust will disclose confidential patient information to participating sites to \nobtain laboratory contact details and patients date of death. North Bristol NHS Trust will \nthen disclose confidential patient information to the relevant NHS pathology laboratories to \nobtain clinical biopsy samples. The retrieved samples and confidential patient information \nwill then be disclosed to pathology services at North Bristol NHS Trust so further analysis \ncan be undertaken on the samples. The results of the further analysis, along with patient \nidentifiers, will then be disclosed to the research team at North Bristol NHS Trust. A \npseudonymised dataset will be used for analysis."]
["Applicant Organisation Name","North Bristol NHS Trust"]
["Contact Name","Professor Nick A Maskell"]
["Address","North Bristol NHS Trust"]
[null,"Learning & Research (Level 3), Southmead Hospital\r"]
[null,"Bristol"]
["Postcode","BS10 5NB"]
["Telephone",1174146479]
["Email","Nick.Maskell@bristol.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who participated in the TARGET trial"]
["Description of confidential patient information used","Data sources\n\n1. Data from the TARGET study, stored on study database \nat University Hospitals Bristol and Weston NHS \nFoundation Trust.\n2. Electronic patient records at participating trusts\n\nIdentifiers required for linkage purposes\n1. Name\n2. NHS Number\n3. Hospital ID Number\n4. Date of birth\n5. Date of death\n\nIdentifiers required for analysis purposes\n1. Gender\n\nAdditional information\nThe date of birth and date of death will not be included in the \ndataset used for analysis."]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-28"]
["Next Review Date","2025-02-28"]
["Notes","Conditions of support:\n\n1.\tCreate an online patient notification material, specific to this project, for the hosting Trust website. please provide back to CAG within one month. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 28 February 2024\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of organisations involved it is the responsibility of University of Bristol Medical School, as controller, to ensure that participating organisations meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about an organisation.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02844","index":885,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02844"]
["Reference","24/CAG/0005 "]
["Other Refs","IRAS Project ID: 334199  REC Reference: 24/EM/0005"]
["Application Title","PremPath: Improving the optimisation and stabilisation of the preterm infant"]
["Application Summary","This application from University of Leicester set out the purpose of medical research that \naims to understand how the care pathway for preterm infants (before 37 weeks of \npregnancy) works in practice, and to make recommendations to policy makers to \nimprove care.\n\nWhen babies are born premature, they are at greater risk of needing neonatal care. The \nearlier in pregnancy a baby is born, the higher the chance of the baby not surviving or \nhaving a long-term illness. There is a specific care pathway to make sure babies who are \nborn prematurely have the best chance of survival and quality of life. This research \nproject will look at how well this care pathway is currently working. If the pathway looks \ndifferent in different hospitals, applicants will try to understand why.\n\nA researcher is undertaking research using a number of different methodologies at four \nNHS Trusts. One is University Hospitals of Leicester, however 3 sites are not yet \nconfirmed, and will be added via amendment. Observation locations are likely to include \npreterm birth clinics, medical assessment units, antenatal clinic, antenatal ward, foetal \nmedicine, obstetric and neonatal units. Some elements of the study, including consented \ninterviews and viewing procedural documents do not require ‘s251’ support. However the \nresearcher, who is not considered direct care team, is also undertaking ethnographic \nobservations of staff caring for babies, mums and families. The focus of the observations \nwill be team working and work processes around the optimisation of care for preterm \ninfants, including how parents are involved in these processes. This will include preterm \nbirth clinics, medical assessment units, antenatal clinic, antenatal ward, foetal medicine, \nobstetric and neonatal units, hand-overs and multidisciplinary team (MDT) meetings. \nSupport under Regulation 5 is required for this aspect of the study as the applicant may \nbe exposed to confidential patient information when undertaking the observations. \nObservations will be recorded via handwritten field notes. Identifiable patient information \nwill not be recorded. The researcher will aim to observe each site for approximately 3-4 \ndays, between 1 February and 1 December 2024."]
["Applicant Organisation Name","University of Leicester "]
["Contact Name","Professor Nicola Mackintosh "]
["Address","Professor in Social Science applied to Health "]
[null,"SAPPHIRE Research group "]
[null,"George Davies Centre "]
["Postcode","LE1 7RH"]
["Telephone","0116 2584867"]
["Email","nicola.mackintosh@leicester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients whose confidential patient information was discussed during observations of preterm birth clinics, medical assessment units, antenatal clinic, antenatal ward, foetal medicine, obstetric and neonatal units between approximately 01 February and 1 December 2024. \nThere will be 3-4 days of observations at each site.\nThe size of the cohort will vary by site:\nPage 6 of 6\n• University Hospitals of Leicester have 30 cots in NICU and \n12 in SCBU, therefore on any day, there may be 42 preterm \ninfants being cared for across the Trust. \n• Site 2 (tbc) 32 cots\n• Site 3 (tbc) 20 cots\n• Site 4 (tbc) 15 cots"]
["Description of confidential patient information used","Data sources\n\nObservations of team working, clinical processes, and decisionmaking, recorded via written field notes, at four NHS Trusts:\nUniversity Hospitals of Leicester \n3 not yet confirmed, will be added via amendment.\n\nIdentifiers required for linkage purposes\nNo items of confidential patient information will be recorded for linkage purposes.\n\nIdentifiers required or analysis purposes\n\nNo items of confidential patient information will be recorded for linkage purposes"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-02-29"]
["Next Review Date","29/02/2025"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 26 February 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for University Hospitals of Leicester was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 29 February 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02845","index":886,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02845"]
["Reference","23/CAG/0151"]
["Other Refs","IRAS Project ID: 329069  REC Reference: 23/SW/0069"]
["Application Title","The UK Colorectal Cancer Intelligence Hub"]
["Application Summary","This application from the University of Oxford set out the purpose of setting up a research \ndatabase containing data for all individuals who are at risk of, or are diagnosed with, \ncolorectal cancer in the UK.\n\nColorectal cancer is a major public health problem. In the year UK, around 41,000 each \nyear are diagnosed with the disease and 16,000 die from it. High-quality data could be \nused to improve the outcomes of patients diagnosed with colorectal cancer. Linked \ncolorectal cancer data are already available from some data providers in England, \nScotland, Wales and Northern Ireland. However, a UK wide cancer data resource does not \nexist resulting in researchers and analysts being forced to go through lengthy, resource \nintensive and costly processes to access numerous cuts of data. The applicants anticipate \nthat CORECT-R will reduce this duplication of effort and increase the security of the data. \nThe first iteration of CORECT-R sought to undertake linkage of datasets within the \nNational Disease Registration Service (NDRS). However, the remit of the NDRS is data \ngenerated within England only and the applicants seek to include data from all 4 UK \nnations. \n\nSupport is sought to link data from consented cohort & trial datasets and from datasets \nheld by National Cancer Registration and Analysis Service, NHS England, NHS Bowel \nCancer Screening Programme, Health Quality Improvement Partnership, Welsh Cancer \nIntelligence and Surveillance Unit and Public Health Wales. The datasets will be disclosed \nto the University of Oxford for linkage. A dataset containing confidential patient information \nwill be held within the CORECT-R Trusted Research Environment.\n\nResearchers seeking to access data will apply via the Hub team. Individuals submit a \nrequest and are contacted to discuss their request and availability of data. If the project is \nfeasible, they are then supported to complete a study protocol and to discuss their planned \nwork with the Patient-Public Group. Once complete, the study protocol is considered by the \nHub Access Committee. If accepted, and after necessary checks, access is provided to a \nproject specific folder in the CORECT-R Trusted Research Environment. Researchers are \nonly given access to tailored, project specific, pseudonymised datasets in line with their \napproved protocol."]
["Applicant Organisation Name","University of Oxford\r"]
["Contact Name","Professor Eva JA Morris\r"]
["Address","Big Data Institute, Nuffield Department of Population Health\r"]
[null,"Oxford"]
[]
["Postcode","OS3 7LF"]
["Telephone",7765255941]
["Email","eva.morris@ndph.ox.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients in England and Wales with a diagnosis of, or suspect diagnosis of, colorectal and/or anal cancer since 01 January 1997."]
["Description of confidential patient information used","Data sources\n\n1. National Cancer Registration and Analysis Service \na. Cancer Registry Data \nb. National Radiotherapy Dataset (RTDS)\nc. Systematic Cancer Therapy Dataset (SACT)\nd. Patient Reported Outcomes (PROMS) \ne. Patient Reported Experience Survey \n2. NHS England \na. Hospital Episode Statistics (HES) \nb. Diagnostic Imaging Dataset (DID) \nc. Cancer Waiting times (CWT) \nd. NHS Bowel Cancer Screening Programme \n3. Health Quality Improvement Partnership (controller) \na. National Bowel Cancer Audit (processors - NHS \nEngland and Royal College of Surgeons of \nEngland)\nb. National Emergency Laparotomy Audit \n(processors - Royal College of Anaesthetists and \nRoyal College of Surgeons of England)\n4. Welsh Cancer Intelligence and Surveillance Unit \na. Cancer Registry Data \nb. National Radiotherapy Dataset (RTDS)\nc. Systematic Cancer Therapy Dataset (SACT) \nd. Patient Reported Outcomes (PROMS) \ne. Patient Reported Experience Survey \n5. Public Health Wales \na. Patient Episode Database Wales (PEDW) \nb. Bowel Screening Wales\n\nIdentifiers required for linkage purposes\n\n1. Name\n2. NHS number\n3. Hospital ID number\n4. GP Registration\n5. Date of birth\n6. Date of death\n7. Postcode – unit level\n\nIdentifiers required for analysis purposes\n\n1. Postcode – unit level\n2. Gender \n3. Occupation\n4. Ethnicity\n\nIdentifiers held in database\n\n1. Initials \n2. Full name \n3. Address \n4. NHS number \n5. Hospital ID number\n6. GP registration \n7. Date of birth \n8. Year of birth \n9. Date of death \n10. Postcode – unit level\n11. Gender \n12. Occupation\n13. Ethnicity\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-05"]
["Next Review Date","2025-03-05"]
["Notes","Conditions of support: \n \n1.\tThe CAG asked that the website information was revised so the study specific opt out is stated first. A statement also needs to be added to advise that patients do not need to make a study specific opt-out request if they have already registered dissent via the National Data Opt-Out. Please provide the revised website information text within one month of the issuing of this letter. \n\n2.\tFavourable opinion from a Research Ethics Committee. Confirmed 02 June 2023.\n\n3.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 2022/23 DSPT reviews for NHS England, Royal College of Surgeons of England, Royal College of Anaesthetists were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 05 March 2024).\n\nCaldicott Principles in Practice (CPiP) are in place for Welsh Cancer Intelligence and Surveillance Unit and Public Health Wales.\n\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","Yes"]

{"sheet":"A02846","index":887,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02846"]
["Reference","22/CAG/0111 "]
["Other Refs","IRAS Project ID: 288273  REC Reference: 22/SW/0131"]
["Application Title","Research database for Biliary Atresia (England & Wales)"]
["Application Summary","This research application from Kings College Hospital NHS Foundation Trust (KCH) set out the purpose of creating a research database of all infants with biliary atresia in England and Wales from Jan 1999 onwards.\n\nA non-research registry has ‘s251’ support in place (CAG ref: 21/CAG/0150) in order to monitor the outcome of the clinical management of biliary atresia. This registry has been in existence since 1999 when the Department of Health mandated that a record be kept of all infants in England and Wales with this diagnosis. The purpose of the research database is to allow the applicant to perform research analyses on the data collected, as further analysis on this unique and valuable resource will lead to a better understanding of the aetiology of this disease. An example of a research question is to determine demographic features of cohort of infants born within England and Wales with diagnosis of Biliary Atresia, and the protocol for this epidemiology study has been included. The data from this research database will not be supplied to researchers who are not linked to the non-research registry, as such there is no data access committee. Rather it is to allow the Chief Investigator and other co-investigators at the hospital sites an opportunity to analyse the data for research purposes. \n\nBiliary atresia is a rare, potentially life-threatening, condition of new-borns characterised by persisting jaundice and the development of liver fibrosis and cirrhosis. It requires early identification and prompt surgical management to try and forestall liver failure. The research database is required to continue to analyse the demographics and outcomes of all infants with biliary atresia, to continue to improve outcomes of infants and children with this disease. Data is collected by the direct care team in individual centres, and name is removed. At the end of each year, confidential patient information including hospital number, date of birth and gender and NHS number alongside a pseudo-Identifier and clinical information about each new patient treated in the centre for biliary atresia is transferred via a password-protected spreadsheet using NHS emails, to the central database (in KCH) together with a yearly record of outcome of all infants previously registered. These annual updates of patient management and outcome for previously registered children are then linked to baseline measures via the hospital ID. Data are stored on password-protected hospital server at KCH and only accessible by Mark Davenport, and a nominated deputy.\n"]
["Applicant Organisation Name","Kings College Hospital NHS Foundation Trust"]
["Contact Name","Professor Mark Davenport, Chief Investigator "]
["Address","Kings College Hospital, "]
[null,"Denmark Hill,"]
[null,"London,"]
["Postcode","SE5 9RS"]
["Telephone",2032993350]
["Email","mark.davenport@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All infants diagnosed with biliary atresia and managed in one of the three national centres, from January 1999 onwards\n\nApproximately 850 infants, and more prospectively. \n"]
["Description of confidential patient information used","Data sources\n\n\tMedical records at the three national centres;\n•\tKings College Hospital, London\n•\tBirmingham Women's and Children's Hospital\n•\tLeeds Children's Hospital\nIdentifiers required for linkage purposes (for annual follow up)\t1.\tHospital ID\nIdentifiers retained in registry\t1.\tHospital ID – to allow linkage\n2.\tNHS number – as suggested by CAG (to ensure future linkage is possible if required)\n3.\tDOB – to allow linkage and for analysis\n4.\tMaternal Postcode – for analysis\n5.\tGender – to allow linkage and for analysis \n6.\tEthnicity – for analysis\n7.\tDate of surgical (Kasai) intervention – for analysis\n8.\tClearance of jaundice – Primary outcome measure\n9.\tAssociated anomalies – for analysis\n10.\tType of BA – for analysis\n11.\tNeed for and date of transplant – for analysis\n12.\tDate of death – for analysis\n\nIdentifiers required for analysis purposes\n\n1.\tMaternal postcode (at time of childs birth) \n2.\tEthnicity, \n3.\tAssociated congenital anomalies, \n4.\tType of biliary atresia, \n5.\tDate of surgical (Kasai) intervention\n6.\tDate of liver transplant\n7.\tDate of death\n8.\tDate of Birth \n9.\tGender\n\nAdditional information\t\n\nAn update of patient management and outcomes for all previously registered children is also sent annually to KCH.\n\nThese annual outcomes will cease once a child turns 16, but their previously collected data will remain in the registry\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date"]
["Next Review Date","2025-03-06"]
["Notes","Conditions of support:\n\n1.\tSupport will be provided for 5 years in the first instance. A duration amendment will be required at this time to ensure continuing ‘s251’ support.\n\n2.\tOngoing Patient and Public Involvement and Engagement is required to be undertaken and reported to CAG at annual review. This is specifically requested to focus on;\na)\tThe acceptability of this use of confidential patient information without consent.\nb)\tTheir opinions on the level of confidential patient information retained; \nc)\tFeedback surrounding newly developed notification materials; \nd)\tThe research uses of the database\n\n3.\tThe NDOO is to be applied to any research use of the database for children included post 1st August 2022\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 25 April 2023\n\n5.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for Kings College Hospital NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust & Leeds Teaching Hospitals NHS Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 06 March 2024). \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02847","index":888,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02847"]
["Reference","24/CAG/0013"]
["Other Refs","IRAS Project ID: 334643   REC Reference: 24/NE/0028"]
["Application Title","Wessex sub national secure data environment (SNSDE) programme"]
["Application Summary","This application, from University Hospital Southampton NHS Foundation Trust, sets out the \nmedical purpose to create a research database.  \n\nUniversity Hospital Southampton NHS Foundation Trust are developing the Wessex subnational Secure Data Environment (SNSDE). This is part of a national initiative to move \ntowards access of NHS data by default, rather than data sharing and is part of the Data \nSaves Lives strategy. \n\nThe Wessex SNSDE will consist of two separate parts: the data processing environment \n(DPE) and the trusted research environment (TRE). Patient data will flow from each of the \ncontributing organisations to the data processing environment, where it is checked, linked, \nde-identified, filtered, and transformed to produce a research database that can be used to \nproduce extracts for research purposes. Data from each individual processing environment \nis only linked with data from other environments once an approved programme of research \nhas been identified. A core dataset will be transferred to the SNSDE for use. Any data that \nsits outside the core dataset will only be transferred for research specific purposes once \nthe research has been approved.  \n\nSupport is requested for the flow of Confidential Patient Information from individual \norganisations within the Wessex SDE area to University Hospital Southampton NHS \nFoundation Trust, and retention within the SDE. Whilst the flow itself will be \npseudonymised, University Hospital Southampton NHS Foundation Trust will have access \nto the keys to enable reidentification for specific purposes. Linkage to HES and SUS data \nis also requested, but this will only be undertaken on a per project basis only. \n \nThe SNSDE will be used for data-driven translational research in any field of health or \nsocial care. Research projects will be approved by a single, dedicated Data Access \nCommittee (DAC). This committee will comprise lay members, alongside representatives \nfrom the participating healthcare organisations. The University Hospital Southampton’s \nexisting DAC will be used whilst the Wessex SNSDE is set up. There is wider work \nongoing at a national level to standardise and streamline the data access approach.  \nThe SDE will be set up in stages, with specific datasets initially used to test the success of \nthe linkage processes before moving to wider primary and secondar care organisations \nwithin the SDE footprint once success confirmed. "]
["Applicant Organisation Name","University Hospital Southampton NHS Foundation Trust"]
["Contact Name","Prof. Christopher Kipps\r"]
["Address","Tremona Road"]
[null,"Southampton"]
[]
["Postcode","SO22 5EN\r"]
["Telephone",2381205134]
["Email","christopher.kipps@uhs.nhs.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All normally resident patients plus any patient accessing services in the Wessex area (Hampshire, Dorset and Isle of Wight ICBs) unless registered an opt out (approximately 2.7 \nmillion people).  "]
["Description of confidential patient information used","Data sources \n\n1. All primary and secondary care organisations within the Wessex SDE footprint  \nPage 5 of 5\n2. Specific datasets held by University Hospital Southampton NHS Foundation Trust:  \na. data from NIHR Health Informatics Collaborative (HIC), (Viral Hep: IRAS ID 289900, Myeloma: IRAS ID 310036, Cardio/COVID: IRAS ID 174052)  \nb. data from ECRIN and IDX2 lung projects (IRAS ID 186109 and 283721 respectively)  \nc. data for clinical trial feasibility assessments  \nd. data from PRANA (IRAS ID 338740)\n\nIdentifiers required for linkage purposes\n\n1. NHS number  \n2. Hospital ID  \n3. Name  \n4. Address  \n5. Gender  \n6. Date of birth  \n7. Postcode  \n8. Date of death \n\nIdentifiers required for analysis purposes\n\n1. Postcode (sector level)  \n2. Gender  \n3. Occupation  \n4. Ethnicity \n\nAdditional information\n\nWhilst the flows of CPI will be pseudonymised to minimise risk during the transfer, University Hospital Southampton NHS Foundation Trust, will be able to identify the CPI.  Whilst the applicants state that data source 4b is consented, the consent does not extend to use within the Wessex SDE"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-14"]
["Next Review Date","2025-03-14"]
["Notes","Conditions of support:\n\n1.       Favourable opinion from a Research Ethics Committee. Confirmed \n\n2.       Confirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for University Hospital Southampton NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker.\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02848","index":889,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02848"]
["Reference","24/CAG/0043"]
["Other Refs","IRAS Project ID: 333953  REC Reference: 24/YH/0006"]
["Application Title","Geriatric Medicine, Care and the End of Life: Appreciating Clinical Uncertainty in the Acute Care of Older Adults"]
["Application Summary","This application from University of St. Gallen set out the purpose of medical research that \nseeks to understand the nature and extent of palliative care within geriatric medicine amid \nthe clinical uncertainty that defines the health status of the populations geriatricians care \nfor.\n\nA researcher is undertaking a number of different methodologies at 3 participating Trusts, \nincluding consented staff observations and interviews and consented interviews with \npatients. These elements do not require ‘s251’ support. Fieldwork will take place over six 1 \nmonth-long periods.\n\nHowever the researcher, who is not considered direct care team, is also undertaking \nethnographic observations, including shadowing geriatricians, and observing clinical \nsettings where geriatricians work – such as Multi-Disciplinary Team (MDT) meetings and \nstaff handovers. Support under Regulation 5 is required for this aspect of the study, as the \napplicants may be exposed to confidential patient information when undertaking the \nobservations. Observations will be recorded via handwritten field notes. Identifiable patient \ninformation will not be recorded without consent."]
["Applicant Organisation Name","University of St. Gallen\r"]
["Contact Name","Mr Luke Stalley, Doctoral Researcher"]
["Address","Technology Studies"]
[null,"Unterer Graben 91, 9000"]
[]
["Postcode"]
["Telephone",7597126218]
["Email","lukealan.stalley@unisg.ch"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 30 patients in each site, under the care of geriatricians, who may, or may not be approaching the end of life, from participating Trusts who were discussed during clinical observations/MDT meetings, and have not provided consent. "]
["Description of confidential patient information used","Data sources \n\n1. Clinical meetings/observations of geriatricians in Nottingham University Hospitals NHS Trust, Barnet Hospital (part of Royal Free London NHS Foundation Trust) & Cambridge University Hospitals NHS Foundation Trust, recorded via written field notes.\n\nIdentifiers required for linkage purposes\n\nNo items of confidential patient information will be recorded for linkage purposes\n\nIdentifiers required for analysis purposes \n\nNo items of confidential patient information will be recorded for analysis purposes\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-15"]
["Next Review Date","2025-03-15"]
["Notes","Specific conditions of support\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed: 20 February 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Nottingham University Hospitals NHS Trust, Barnet Hospital (part of Royal Free London NHS Foundation Trust) and Cambridge University Hospitals NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 12 March 2024). \n \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02849","index":890,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02849"]
["Reference","23/CAG/0180 "]
["Other Refs","IRAS Project ID: 331721   REC Reference: 23/LO/0983"]
["Application Title","An analysis of the malignancy risk following Gamma Knife Stereotactic Radiosurgery"]
["Application Summary","This application from Sheffield Teaching Hospitals NHS Foundation Trust set out the purpose of medical research which aims to evaluate the risk of Gamma Knife Stereotactic Radiosurgery (GKSRS) treatment in causing malignant transformation of benign tumours, for the purposes of improving patient care. The results are expected by the applicant to be generalisable to the worldwide population of patients treated by GKSRS.  \n \nThis activity has previously been undertaken twice by the Trust, once under Section 60 support between 2002-2005 (MR777), and most recently in 2016 under ‘S251 support’ (CAG ref 16/CAG/0009). The outcome from this project will further support the outcomes from those previous pieces of work. \n  \nGamma Knife Stereotactic Radiosurgery (GKSRS) is used worldwide to treat several different pathologies in the head. Most of these are non-cancerous (benign) tumours or vascular malformations. As with any radiation treatment, there is a theoretical risk of the tumour becoming malignant or the treated area developing a new cancer as a response to the treatment. This project aims to evaluate the risk of malignant transformation, or induced malignancies, that could reasonably be attributable to the treatment of patients with Gamma Knife. There are many thousands of patients treated by the Gamma Knife worldwide every year and this risk is incredibly small. Large centres such as Sheffield, with many years of patient treatment data, are in a unique position to be able to accurately evaluate the real risk of this malignant development to aid accurate patient counselling and consent. This would improve patient care both in the UK and internationally as patients worldwide will benefit from strengthened and updated information on the real risk of malignant induction or transformation after radiation treatment for mainly benign disease. \n \n‘s251’ support is requested to allow the applicant to flow identifiable information about all patients treated by the National Centre for Stereotactic Radiosurgery, Sheffield, prior to 01 January 2023, to NHS England. NHS England will link the confidential patient information provided to Civil Registrations of Death dataset and Cancer Registrations dataset, and return the following information to the applicant - date of cancer diagnosis, cancer type and location, and date and cause of death.  \n"]
["Applicant Organisation Name","Sheffield Teaching Hospitals NHS Foundation Trust"]
["Contact Name","Mr Julian Cahill"]
["Address","Sheffield Teaching Hospitals NHS Foundation Trust "]
[null,"The National Centre for Stereotactic Radiosurgery"]
[null,"C Floor, The Royal Hallamshire Hospital, Glossop Road, Sheffield"]
["Postcode","S10 2JF"]
["Telephone",1142713572]
["Email","julian.cahill@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","All patients treated before 01 January 2023 by the National Centre for Stereotactic Radiosurgery, Sheffield excluding those who have opted out of data usage. Approximately 17,400 patients  "]
["Description of confidential patient information used","Data sources \n\n 1.\tSheffield Teaching Hospitals NHS Foundation Trust - Radiosurgery Patient Database (STH GKSRS database), clinical database retained by direct care team (out of scope for ‘s251’ support).  \n \n2.\tNHS England \n•\tCivil registration of deaths dataset \n•\tCancer registration dataset  \n\nIdentifiers required for linkage purposes \n\n 1.\tNHS Number \n2.\tGender \n3.\tDate of Birth  \n\nIdentifiers required for analysis purposes \n\n 1.\tDate of death – modified to survival times \n2.\tDate of birth – did not answer if this would be modified for analysis, but I think it is \n3.\tGender \n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-21"]
["Next Review Date","2025-03-21"]
["Notes","Conditions of support:\n\n1.         Please clarify how many individuals participated within the patient and public involvement and engagement group discussions, and provide CAG with the questions asked to the engagement groups, particularly around the use of identifiable patient information without consent. The CAG request for these details to be provided to CAG within the next 6 months.\n\n2.         Favourable opinion from a Research Ethics Committee. Confirmed 20 March 2024\n\n3.         Confirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for NHS England & Sheffield Teaching Hospitals NHS Foundation Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 15 December 2023)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02850","index":891,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4]]}
[]
[]
["Application Number","A02850"]
["Reference","24/CAG/0015 "]
["Other Refs","IRAS Project ID: 302635  REC Reference: 22/WM/0003"]
["Application Title","The Rituals of Integrated Working: Promoting and Improving Integrated Care"]
["Application Summary","This application from University of Kent set out the purpose of medical research that seeks to explore how, and to what extent, everyday interactions promote or hinder integrated working, in integrated health care, including mental health services, acute services and community health services.  Interactions can include activities such as meetings, informal conversations and/or clinical group discussions.\n\nBringing together services is often when different agencies, such as mental health and social care, join up to coordinate care around patient needs. This is sometimes referred to as ‘joined up’ or ‘integrated care’. However, bringing together services can be very difficult. Different organisations and teams operate differently, and there can be confusion, and sometimes tension, around who will do what, who will pay for it, and who has access to certain types of information. Staff and service users/carers often try to resolve these difficulties through meetings and visits. Unresolved challenges can result in poorer patient care. This study looks at what it is like to deliver and receive joined up care. It focuses on how different groups of people come to trust each other and work collaboratively through everyday encounters. Learning from this study will help improve integrated care services.\n\nA researcher is undertaking a number of different methodologies at 4 participating Trusts, including consented staff and patient interviews and focus groups, and further work as part of work packages 2, 3 and 4. These elements do not require ‘s251’ support.\n\nHowever as part of Work Package 1, the researcher, who is not considered direct care team, is also undertaking ethnographic observations of the interactions and relationships that enable integrated and multidisciplinary working of Health care professionals working in integrated care. These include professional interactions conducted in the course of care away from patients, for example, board rounds, ward round briefings and wrap ups, referrals and Multi-Disciplinary Team (MDT) meetings, as well as informal conversations between professionals. Support under Regulation 5 is required for this aspect of the study, as the applicants may be exposed to confidential patient information when undertaking the observations. Identifiable patient information will not be recorded. The researcher will conduct staff observations for six weeks at the research sites to understand situated practices and interaction rituals (6 months total).  \n"]
["Applicant Organisation Name","University of Kent"]
["Contact Name","Dr Jenelle Clarke "]
["Address","School of Social Policy, Sociology and Social Research "]
[null,"Cornwallis East "]
[null,"Canterbury, Kent "]
["Postcode","CT2 7NF"]
["Telephone","01227 764000"]
["Email"," j.clarke-2261@kent.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients over the age of 16, who are under the care of participating integrated health service teams, who are discussed during staff member interactions during routine clinical discussions and team meetings, and have not provided consent. "]
["Description of confidential patient information used","Data sources\n\n\tClinical meetings/observations in the following participating Trusts: \n•\tDerbyshire Healthcare NHS Foundation Trust\n•\tKent Community Health NHS Foundation Trust\n•\tKent and Medway NHS Social Care Partnership Trust\n•\tLincolnshire Community Health Services NHS Trust\n\nIdentifiers required for linkage purposes\n\n\tNo items of confidential patient information will be recorded for linkage purposes\n\nIdentifiers required for analysis purposes\n\n\tNo items of confidential patient information will be recorded for analysis purposes\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-22"]
["Next Review Date","2025-03-22"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 02 January 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT reviews for Derbyshire Healthcare NHS Foundation Trust, Kent Community Health NHS Foundation Trust, Kent and Medway NHS Social Care Partnership Trust & Lincolnshire Community Health Services NHS Trust were confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 22 March 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02851","index":892,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02851"]
["Reference","24/CAG/0034"]
["Other Refs","IRAS Project ID: 338265  REC Reference: 24/EE/0036"]
["Application Title","North West Sub National Secure Data Environment: Greater Manchester ICB"]
["Application Summary","This application from Greater Manchester Integrated Care Board (GM ICB) sets out the medical purpose to create a create a research database\n\nGreater Manchester ICB are developing the North West sub-national Secure Data Environment (SNSDE). This is part of a national initiative to move towards access of NHS data by default, rather than data sharing and is part of the Data Saves Lives strategy. SNSDEs across the country will also become interoperable to enable access. Further details on this national initiative and progress to date is here. Note that the North West SDE is using a federated approach and each ICB in the North West is submitting separate applications (Cheshire and Merseyside ICB in this meeting, and Lancashire and Cumbria at a later date).\n\nGM ICB are linking data from multiple sources to create a deidentified dataset for research use. Support is requested for Graphnet to pseudonymise the local shared care record and share with Arden and GEM CSU (processing on behalf of GM ICB),  for Arden and GEM CSU to pseudonymise civil registrations and deaths for use in the SDE, and for local organisations to share identifiable information to GM ICB, where they are unable to pseudonymise at source. Other national sources are shared under Directions, or pseudonymised at source and are outside the scope of CAG.\n\nRequests for data access are governed by the Data Access Committee (DAC), who are advised and informed by the Application Review Group (ARG). The ARG contained 2 public members. The DAC make the final decision, based on advice received by the ARG. Whilst this is currently specific for GM ICB, there are plans to consolidate to have one data access route in the North West.\n"]
["Applicant Organisation Name","NHS Greater Manchester Integrated Care Board (ICB)"]
["Contact Name","Matt Hennessey"]
["Address","Ground Floor, Parkway 3"]
[null,"Parkway Business Centre"]
[null,"Princess Road"]
["Postcode","M14 7LU"]
["Telephone","07896 562481"]
["Email","matt.hennessey@nhs.net"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","The registered and resident population of Greater Manchester and the individuals who have received care at the providers within Greater Manchester."]
["Description of confidential patient information used","Data sources\n\n1.\tLocal Shared Care record (GP data via Graphnet)\n2.\tData sources processed by Data Service for Commissioners Regional Office (DSCRO) at Arden and GEM CSU \na.\tAlcohol Dependence\nb.\tAmbulance Data\nc.\tAssuring Transformation (learning disabilities)\nd.\tCommunity Services Dataset\ne.\tClinical Audits and Registries\nf.\tContinuing Health Care\ng.\tCVD Prevent\nh.\tDiagnostics Imaging Dataset\ni.\te-referral system dataset\nj.\tFaster Data Flows\nk.\tMaternity Services Dataset\nl.\tMedicines dispensed in primary care\nm.\tNational cancer waiting times\nn.\tNHS Pathways Dataset (111/999)\no.\tPatient reported outcomes dataset (PROMS)\n3.\tNational Data Sources processed by Data Service for Commissioners Regional Office at Arden and GEM (CSU)\na.\tcivil registrations - births\nb.\tcivil registrations - deaths\n4.\tNational Data Sources covered under the national NHS Direction from health and social care for use for research (described in section 2.2.2 of the protocol)\n5.\tLocal organisation data\na.\tPseudonymised at source\nb.\tUnable to be pseudonymised at source\n\nIdentifiers required for linkage purposes\n\n1.\tNHS number\n2.\tDate of birth\n3.\tDate of death\n4.\tPostcode\n\nIdentifiers required for analysis purposes\n\n1.\tYear and quarter of birth\n2.\tYear and month of death\n3.\tGender\n4.\tEthnicity\n5.\tLower Super Output Area\n\nAdditional information\n\nOnly data sources 1, 2, 3 and 5b require Section 251 support. All others either have a pre-existing legal basis or do not involve the use of Confidential Patient Information outside the care team.\n"]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-03-27"]
["Next Review Date","2025-03-27"]
["Notes","Conditions of support: \n\n1.\tClarify whether organisations that are unable to pseudonymise at source will flow information to Greater Manchester ICB or Arden and GEM Commissioning Support Unit (CSU). \n\n2.\tProvide a summary on whether there were any changing attitudes that had resulted in a change of approach at first annual review. \n\n3.\tInvestigate whether notification or signposting to the study can added onto the NHS app and provide an update at first annual review.  \n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 27 March 2024\n\n5.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 2023/24 DSPT review for NHS Greater Manchester Integrated Care Board, Arden and GEM CSU and Snowflake Computing UK Limited was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 27 March 2024)\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02852","index":893,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02852"]
["Reference","24/CAG/0026"]
["Other Refs","IRAS Project ID: 297802  REC Reference: 21/HRA/1844"]
["Application Title","Covid impact on RSV Emergency Presentations: BronchStart"]
["Application Summary","This application by the University Hospitals of Leicester NHS Trust, for the purpose of medical research, seeks to understand the impact of the re-emergence of respiratory syncytial virus (RSV) on the rate of bronchiolitis in those under 2 years of age.  \n\nThe emergence of COVID-19 has meant that RSV has disappeared.   Now that the pandemic is waning, RSV is slowly returning.   Some children are at a greater risk of hospitalisation, and even death, from RSV infection, so it is important to understand the spread and whether the population at risk is of a wider age range than normal.  \n\nIn order to understand the spread of RSV and whether different genotypes of RSV are responsible for different severities of disease, anonymous routine data will be collected from the clinical record and linked to samples analysed by the UK Health Security Agency.  \n\nSupport is requested to allow the incidental disclosure of confidential patient information from medical records to research nurses that are considered to be outside of the direct care team by some participating sites.  There is no flow of identifiable data.  \n"]
["Applicant Organisation Name","University Hospital of Leicester NHS Trust"]
["Contact Name","Professor Will Dixon"]
["Address","University of Manchester"]
[null,"Centre for Epidemiology versus Arthritis, Room 2900, Stopford Building"]
[null,"Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health,"]
["Postcode","M13 9PT"]
["Telephone",1612751642]
["Email","Will.Dixon@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Children under two years of age presenting to participating emergency departments with clinical features of bronchiolitis, acute lower respiratory tract infection or first episode of wheeze\n\nApproximately 11,000 records to deliver 4,000 positive cases in total across the study.\n\nThere will be 300-500 records screened across the 5 sites requiring support. \n"]
["Description of confidential patient information used","Data sources\n\n1.\tSecondary care medical records\n\nIdentifiers required for linkage purposes\n\n1.\tNone – incidental access to identifiable data within medical records.\n\nIdentifiers required for analysis purposes\n\n1.\tNone\n"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,"X","Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date"]
["Next Review Date","2025-03-28"]
["Notes","Conditions of support: \n \n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 07 February 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 2022/23 DSPT review for Northern Care Alliance NHS Foundation Trust was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 27 March 2024).\n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

{"sheet":"A02853","index":894,"n_rows":39,"n_cols":3,"rows_kept":39,"cut":false,"hidden":false,"merged":[[7,1,7,4],[8,1,8,4],[2,1,2,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[9,0,11,0],[9,1,9,4],[10,1,10,4],[11,1,11,4],[13,1,13,4],[12,1,12,4],[14,1,14,4],[15,0,20,0],[15,2,15,4],[16,2,16,4],[17,2,17,4],[18,2,18,4],[19,2,19,4],[20,2,20,4],[21,1,21,4],[22,1,22,4],[23,0,29,0],[23,2,23,4],[24,2,24,4],[25,2,25,4],[26,2,26,4],[27,2,27,4],[28,2,28,4],[29,2,29,4],[37,2,38,4],[30,1,30,4],[31,1,31,4],[33,1,33,4],[34,1,34,4],[35,1,35,4],[36,2,36,4]]}
[]
[]
["Application Number","A02853"]
["Reference","24/CAG/0057"]
["Other Refs","IRAS Project ID: 341571  REC Reference: 24/NW/0111"]
["Application Title","NHS Bristol, North Somerset, South Gloucestershire Integrated Care Board (BNSSG ICB) "]
["Application Summary","This application from NHS Bristol, North Somerset, South Gloucestershire Integrated Care Board (BNSSG ICB) sets out the medical purpose to create a research database \n\nBNSSG ICB are developing and will host the Great Western Secure Data Environment (GWSDE). This is part of a national initiative to move towards access of NHS data by default, rather than data sharing and is part of the Data Saves Lives strategy. SDEs across the country will also become interoperable to enable access. Further details on this national initiative and progress to date is here. \n\nBNSSG ICB are linking data from multiple sources to create a deidentified dataset for research use. Support is requested for: \n\n-Processing and sharing of confidential patient information (CPI) from direct care providers (except primary care) to the GWSDE (hosted by BNSSG ICB) by a member of the provider team who is not considered part of the direct care team  \n\n-Processing and sharing of CPI for secondary uses from the Shared Care Record to the GWSDE  \n\n-Processing and sharing of CPI for secondary uses from the primary care data processor to the GWSDE \n\n-Processing, pseudonymisation and linkage of data within the GWSDE by named members of staff \n\n-Storage of the pseudonymisation key within a separate area of the GWSDE \n\nRequests for data access are governed by the Data Access Committee. The Committee contains a range of members from health and social care providers across the region, including two lay members. "]
["Applicant Organisation Name","NHS Bristol, North Somerset, South Gloucestershire Integrated Care Board (BNSSG ICB) "]
["Contact Name","Dr Charlie Kenward "]
["Address","360 Bristol - Three Six Zero"]
[null,"Marlborough Street"]
[null,"Bristol"]
["Postcode","BS1 3NX"]
["Telephone",785096344]
["Email","charlie.kenward@nhs.net  "]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Approximately 5.15 million patients using health and social care services in the Great Western region (Bristol, Cornwall (including the Isles of Scilly), Devon, Gloucestershire, Somerset and Wiltshire) as well as regionally supported ambulance and not for profit services. This will include those permanently residing, visiting or in the region for specialist tertiary care. "]
["Description of confidential patient information used","Data sources \n1. Primary Care \n a. Demographic data \n b. Diagnostic Records \n c. Prescribing Data \n d. Referral data \n e. Appointment information \n\n2. Secondary and Tertiary Care including; \n a. Electronic Health Record Systems data, including demographic data \n b. Prescribing Data \n c. Diagnostic Data i.e. Radiology, Pathology,   Microbiology etc.  \n d. Specialist Treatment Systems Datasets for example Cardiology, Respiratory, Bariatric, Stroke etc.  \n e. Theatres \n f. Maternity and Paediatric Systems \n g. Critical Care Systems \n h. Community Care \n i. Outpatient Care \n j. Operational data \n\n3. Local Authority (Social Care data)  \n4. Mental Health Trust data, including inpatient and community-based mental health care \n5. South West Genomics Medicines Alliance, Genomics data (these are unstructured data) \n6. South Western Ambulance Service data for the region (SWAFST) \n\nIdentifiers required for linkage purposes \n1.Name \n2.NHS number \n3.Hospital number \n4.GP registration \n5.Date of birth \n6.Date of death \n7.Unit level postcode \n8.Any geographical information contained in clinical notes, reports, or metadata: for example, the fact that a particular Xray was performed at a particular hospital. \n9.Any identifiers, including the names of members of the clinical team responsible for the care of a patient, that may be included in clinical notes or reports. \n\nIdentifiers required for analysis purposes \n1.Date of birth \n2.Date of death \n3.Sector level postcode \n4.Gender \n5.Ethnicity \n6.Sex "]
["S251 Class(es)",null,"Specific Support"]
[null,"X","Class I - making the person less readily identifiable "]
[null,"X","Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,"X","Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-04-11"]
["Next Review Date","2025-04-11"]
["Notes","Specific conditions of support\n\n1.\tUpdate the patient notifications to inform patients that the project is also planning to collect social care data as well as health care data within 3 months.\n\n2.\tContinued ongoing PPI is to be undertaken and a progress report should be presented at annual review.\n\n3.\tThe CAG requested that the following data flows should be presented to CAG as amendments when the applicant is ready to do so:\n\n•\tSecondary uses of local ICB data flowing into the SDE. \n•\tCohort data linkage (health studies) such as ALSPAC and Exter 10,000\n•\tData flows from disease and civil registries and national datasets\n\n4.\tFavourable opinion from a Research Ethics Committee. Confirmed 09 April 2024\n\n5.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nThe NHS England 22/23 DSPT review for Bristol, North Somerset, South Gloucestershire Integrated Care Board was confirmed as ‘Standards Met’ on the NHS England DSPT Tracker (checked 11 April 2024)\n \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number","A02854"]
["Reference","24/CAG/0045 "]
["Other Refs","IRAS Project ID: 335429  REC Reference: 24/NW/0071"]
["Application Title","Evaluating the impact of artificial intelligence triage in online consultations to reduce delays in urgent and emergency primary care: a qualitative process evaluation "]
["Application Summary","This application from The University of Manchester set out the purpose of medical research that seeks to explore how different GP practices implement AI triage and its impact on the service they provide. This will include identifying how well an AI triage system called PATCHS is working in GP practices. PATCHS is an online consultation system that enables patients to request help from their GP practice online.  Outcomes will be used to help NHS England and online consultation companies to decide whether, and how best to use AI triage, and also to help patients and GP practice staff from diverse communities to understand what AI triage is and how it can best be used for patient care/ improved patient outcomes. \n\nA researcher is undertaking a number of different methodologies at 7 participating GP practices, including consented staff observations and interviews and consented interviews with patients. These elements do not require ‘s251’ support. Fieldwork will take place over a 12 month period. The time taken for observations will be up to 25 days in each practice with a maximum of 4-6 hours per day. \n\nHowever the researcher, who is not considered direct care team, is also undertaking ethnographic observations, including shadowing clinicians who use the AI triage system, and observing clinical settings. Support under Regulation 5 is required for this aspect of the study, as the applicants may be exposed to confidential patient information when undertaking the observations. Observations will be recorded via handwritten field notes. Identifiable patient information will not be recorded without consent.  "]
["Applicant Organisation Name","The University of Manchester "]
["Contact Name","Dr Benjamin Brown "]
["Address","Williamson Building"]
[null,"Division of Population Health, Health Services "]
[null,"Research and Primary Care, School of Health Sciences School of Health Sciences \n"]
["Postcode","M13 9PL"]
["Telephone",1612755436]
["Email","benjamin.brown@manchester.ac.uk"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,"X","medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population","Patients who submit online consultation requests during the observation periods, from participating GP practices and have not provided consent.  \n\nApplicant estimates this might be 5-10 patients per day (25 days per site, x 7 sites = 875-1750 patients records) \n\n \n\n"]
["Description of confidential patient information used","Data sources \n\nClinical meetings/observations of clinicians who use the AI triage system in 7 participating GP practices \n\nIdentifiers required for linkage purposes \n\nNo items of confidential patient information will be recorded for linkage purposes \n\nIdentifiers required for analysis purposes\n\nNo items of confidential patient information will be recorded for analysis purposes "]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,"X","Class V - audit, monitoring, & analysis of healthcare provision "]
[null,"X","Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status","Supported"]
[]
["Outcome Date","2024-04-10"]
["Next Review Date","2025-04-10"]
["Notes","Conditions of support:\n\n1.\tFavourable opinion from a Research Ethics Committee. Confirmed 21 March 2024\n\n2.\tConfirmation provided from the DSPT Team at NHS England to the CAG that the relevant Data Security and Protection Toolkit (DSPT) submission(s) has achieved the ‘Standards Met’ threshold. Confirmed: \n\nDue to the number of organisations involved (5+) it is the responsibility of University of Manchester, as controller, to ensure that practices hosting researchers meet the minimum required standard in complying with DSPTs, and take remedial action if they become aware of any that fall below this, or where any concerns are raised about a practice. These will not be individually checked by the Confidentiality Advice Team. \n"]
["National Data Opt-out Status","Applied"]
["English Confidential Patient Information","Yes"]
["Welsh Confidential Patient Information","No"]

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[]
[]
["Application Number"]
["Reference"]
["Other Refs","IRAS Project ID:   REC Reference: "]
["Application Title"]
["Application Summary"]
["Applicant Organisation Name"]
["Contact Name"]
["Address"]
[]
[]
["Postcode"]
["Telephone"]
["Email"]
["Medical Purposes",null,"preventative medicine"]
[null,null,"medical diagnosis"]
[null,null,"medical research, approved by a research ethics committee"]
[null,null,"the provision of care and treatment"]
[null,null,"the management of health and social care services"]
[null,null,"informing individuals about their physical or mental health or condition, the diagnosis of their condition or their care and treatment"]
["Cohort/Population"]
["Description of confidential patient information used"]
["S251 Class(es)",null,"Specific Support"]
[null,null,"Class I - making the person less readily identifiable "]
[null,null,"Class II - present or past geographical locations of patients "]
[null,null,"Class III - to identify and contact patients to obtain consent"]
[null,null,"Class IV - linking multiple sources;validating quality and completeness; avoiding error"]
[null,null,"Class V - audit, monitoring, & analysis of healthcare provision "]
[null,null,"Class VI - granting of access to data for purposes I-V"]
["Sponsor"]
["Status"]
[]
["Outcome Date"]
["Next Review Date"]
["Notes"]
["National Data Opt-out Status"]
["English Confidential Patient Information"]
["Welsh Confidential Patient Information"]

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["National Data Opt-out Status"]
["English Confidential Patient Information"]
["Welsh Confidential Patient Information"]