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ISAC (Independent Scientific Advisory Committee) for MHRA Database Research

CPRD ISAC Applications Guidance


The Guidance on the content of CPRD ISAC applications has been updated and can be found under the ISAC section of our website. A PDF copy is also available for download. Changes and additions to the previous guidance document are highlighted - we would urge all applicants including regular CPRD users to read the updates. Please ensure that all protocols submitted to the Committee are developed along the lines of the updated guidance.


ISAC audit of publications


The ISAC will be undertaking an audit of all publications in 2013 which resulted from studies using CPRD data. The primary purpose of the audit is for ISAC to better understand the level of concordance between approved protocols and the resultant studies. The ISAC guidance on amendments to approved protocols is available under the ISAC section of our website.

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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:

  1. Scientific issues
  • medical aspects
  • statistical/epidemiological aspects
  • methodological aspects
  1. To provide advice at the request of the MHRA on wider aspects of the release of Yellow Card data.
  2. 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.