ISAC (Independent Scientific Advisory Committee) for MHRA Database Research
CPRD advice on changes to the ISAC Applications
A new ISAC application form/guidance is now available for use. All users are advised to prepare research protocols along the lines of the new ISAC application form and guidance. Please also be aware of the new sections/ requirements relating to CPRD's Transparency policy. Updated guidance on the content of protocols is also now available.
We will continue to accept submissions using the old application form up to 1st October 2016. Applications submitted on the old application form after this date will be returned to applicants. Only the updated ISAC application form will be accepted from 1st October 2016.
The ISAC is a non-statutory expert advisory body established in 2006 by the Secretary of State for Health to provide scientific advice on research related requests to access data provided by Clinical Practice Research Datalink (CPRD). Up to 2015, members were appointed by the Department of Health (DH) Appointments Commission; the MHRA now appoints members directly.
Terms of Reference
- 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
- Provide timely and high quality peer reviews on the scientific (medical, epidemiological, methodological) merit of research protocols proposing access and use of CPRD data
- 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
- Advise on, and contribute to, the scientific content of guidance relating to the development of research protocols proposing access and use of data from the CPRD
- Review internal workings of the Committee, to ensure consistency, efficiency and high standards of peer-review are maintained.
- Advise on other specific issues as requested by the MHRA and/or CPRD
Click the ISAC menu to the right for additional information including Members, Governance & Protocols.
Medicines & Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ, UK England
Tel: +44 (0)20 3080 7182
Fax: +44 (0)20 3118 9802
Electronic submission of protocols and emails to: