Independent Scientific Advisory Committee for MHRA database research

The Independent Scientific Advisory Committee for MHRA database research (ISAC) is a non-statutory expert advisory body, established in 2006 to give advice on research-related requests to access data from the Clinical Practice Research Datalink (CPRD).

Role of the committee

  1. Consider and provide advice to the MHRA on the feasibility, quality and public health value of research studies proposing use of anonymised patient level data from the CPRD.

  2. Provide timely and high quality peer reviews on the scientific (medical, epidemiological, methodological) merit of research protocols proposing access and use of CPRD data.

  3. Highlight important ethical or confidentiality issues that may arise during access and/or use of CPRD data in research studies, taking into consideration input from the Confidentiality Advisory Group or research ethics committees.

  4. Advise on, and contribute to, the scientific content of guidance relating to the development of research protocols proposing access and use of data from CPRD.

  5. Review internal workings of the Committee to ensure consistency, efficiency and high standards of peer-review are maintained.

  6. Advise on other specific issues as requested by the MHRA and/or CPRD.

Apply to ISAC to use CPRD data

To apply, please download the application form and guidance from the CPRD website and return by email to isac@cprd.com.

We accept applications at any time. Most applications will be reviewed with feedback provided within 3 to 4 weeks, assuming there is no need for discussion at a meeting of the Committee. When this is considered necessary, applicants are informed of a referral.

Requests for Yellow Card data are now reviewed by the Pharmacovigilance Expert Advisory Group (PEAG), application forms can be found here Yellow Card ISAC application form (MS Word Document, 145KB)

Appeals

We will send unsuccessful applicants a letter setting out the reasons for our refusal. The applicant has 28 days from the date of the letter to make representations in writing to the email addresses above. Once the 28 days have expired, he/she will have to make a fresh application. If an appeal is to be carried out then the licensing authority will appoint a person or persons to undertake a review of the documentation. A letter will be sent to the applicant with the outcome of the appeal. The decision of the licensing authority will be final.

Members

As of January 2017, the current ISAC membership is as follows:

  • Professor Deborah Saltman AM (Chair of the ISAC) MBBS MD MRCGP FRACGP FAFPHM GAICD

  • Professor Richard Stevens (Deputy Chair) BA MSc PhD Associate Professor, Medical Statistics Group, Nuffield Dept of Primary Care Health Sciences, University of Oxford

  • Dr Angelyn Bethel MD Deputy Director, University of Oxford Diabetes Trials Unit

  • Dr Krishnan Bhaskaran MSc PhD Senior Lecturer in Statistical Epidemiology, Department of Non-Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London

  • Professor Sinead Brophy BSc PhD Professor of CIPHER, College of Medicines, Swansea University

  • Dr Benjamin Cairns BA BSc PhD Senior Statistical Epidemiologist, Cancer Epidemiology Unit, University of Oxford

  • Mrs Rosie Cornish Lecturer, School of Social and Community Medicine, University of Bristol

  • Dr Christopher Edwards BSc (Hons) PhD MIPEM Consultant Medical Physicist, Aneurin Bevan University Health Board, St Woolos Hospital in Newport, South Wales

  • Dr Duncan Edwards BSc, MB BS, MRCGP NIHR Doctoral Research Fellow and GP. Department of Public Health and Primary Care. The School of Clinical Medicine. University of Cambridge

  • Professor Peter Helms MBBS PhD FRCP FRCPCH FFSEM Emeritus Professor of Child Health, University of Aberdeen

  • Dr Wendy Knibb MSc (Econ.) PhD (Health Econ.) Independent Health Economics consultant

  • Dr Evangelos Kontopantelis PhD Reader, Farr Institute for Health Informatics Research, The University of Manchester

  • Dr Emily McFadden MA (Cantab) MSc PhD Senior Statistical Epidemiologist - Nuffield Department of Primary Care Health Sciences, University of Oxford

  • Ms Sally Malin BA (Hons) MA (Cantab) MSc (Econ) (Lay member)

  • Professor Keith Neal Emeritus Professor in the Epidemiology of Infectious Diseases, University of Nottingham and Consultant Epidemiologist, for the Field Epidemiology Service, Public Health England

  • Dr Jennifer Quint PhD Clinical Senior Lecturer Respiratory Epidemiology, National Heart and Lung Institute, Imperial College London

  • Ms Marcia Saunders BA MA MSc (Lay member) Chair, North West London Local Education and Training Board

  • Dr Sara Thomas PhD Clinical Senior Lecturer (Epidemiology) Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine

  • Dr Hester Ward Consultant in Public Health Medicine (Health Informatics) London School of Hygiene & Tropical Medicine

  • Professor Ian Wong Chair in Pharmacy Practice, UCL School of Pharmacy London School of Hygiene & Tropical Medicine

CPRD data

Download the application form and guidance from the CPRD website.

Email: isac@cprd.com

We accept applications at any time. Most applications will be reviewed with feedback provided within 3 to 4 weeks, assuming there is no need for discussion at a meeting. When this is considered necessary, applicants informed of a referral.

Annual report

ISAC Annual Report: April 2016 to March 2017

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For previous annual reports, see the ISAC page on the National Archives.

Minutes

2017 Minutes

ISAC January 2017 Minutes (PDF, 192KB, 6 pages)

ISAC April 2017 Minutes (PDF, 264KB, 6 pages)

ISAC July 2017 Minutes (PDF, 202KB, 3 pages)

2016 Minutes

ISAC January 2016 Minutes (PDF, 144KB, 4 pages)

ISAC April 2016 Minutes (PDF, 144KB, 4 pages)

ISAC July 2016 Minutes (PDF, 185KB, 4 pages)

ISAC October 2016 Minutes (PDF, 182KB, 4 pages)

2015 Minutes

ISAC January 2015 minutes (PDF, 139KB, 4 pages)

ISAC April 2015 minutes (PDF, 146KB, 5 pages)

ISAC July 2015 minutes (PDF, 80.7KB, 4 pages)

ISAC October 2015 minutes (PDF, 25.2KB, 4 pages)

2014 Minutes

ISAC April 2014 minutes (PDF, 203KB, 3 pages)

22 January 2014 (PDF, 282KB, 3 pages)

ISAC July 2014 minutes (PDF, 223KB, 4 pages)

ISAC October 2014 minutes (PDF, 34KB, 3 pages)

2013 Minutes

ISAC January 2013 minutes (PDF, 70.9KB, 3 pages)

ISAC April 2013 minutes (PDF, 23.5KB, 3 pages)

ISAC July 2013 minutes (PDF, 126KB, 3 pages)

ISAC October 2013 minutes (PDF, 30.5KB, 3 pages)

For previous minutes, see the ISAC page on the National Archives.

Contact

If you have any general queries about ISAC or are unsure whom you should contact, please contact isac@cprd.com in the first instance.