ISAC (Independent Scientific Advisory Committee) for MHRA Database Research
Updated CPRD ISAC Application Form
The CPRD ISAC application form has now been updated and a copy can be downloaded from the ISAC section of our website. This form should be completed and submitted as part of the application to the ISAC.
New applications submitted on earlier versions of the CPRD ISAC Application form will not be accepted after 15 July 2013.
CPRD ISAC Applications Guidance
Guidance on the content of CPRD ISAC applications can now be downloaded from the ISAC section of our website. A PDF copy is also available for download. Please ensure that all protocols submitted to the Committee are developed along the lines of the updated guidance.
The ISAC is a non-statutory expert advisory body established in 2006 by the Secretary of State to provide advice on research related requests to access data from the Yellow Card Scheme and data provided by Clinical Practice Research Datalink (CPRD). Members were appointed by the Appointments Commission.
Terms of Reference
To consider and provide advice to MHRA on applications for Yellow Card data which fall outside Freedom of Information provisions, and all research projects which propose the use of data obtained from the Clinical Practice Research Datalink. In particular, ISAC should consider the following:
- Scientific issues
- medical aspects
- statistical/epidemiological aspects
- methodological aspects
- To provide advice at the request of the MHRA on wider aspects of the release of Yellow Card data.
- Other ISAC advice relating to other ethical or confidentiality issues is encouraged. This must be considered alongside input from other Committees such as Ethics and National Information Governance Boards (NIGB).
Members should note that the primary responsibility of the ISAC relates to 1 above.
Click the ISAC menu to the right for additional information including Members, Governance & Protocols.
Contact details for CPRD ISAC
Kendal Chidwick
ISAC Secretariat
CPRD Division, Medicines & Healthcare products Regulatory Agency
5th Floor
151 Buckingham Palace Road
Victoria
London SW1W 9SZ
United Kingdom
Tel: +44 (0)20 3080 6949
Fax: +44 (0)20 3118 9802
Electronic submission of protocols and emails to:
Reminder:
When submitting a protocol to ISAC it is essential to name all investigators and collaborators on the application form, to provide their e-mail addresses and to also copy the submission to them. Applications which do not meet this requirement will be rejected as invalid.