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ISAC (Independent Scientific Advisory Committee) for MHRA Database Research

CPRD advice on changes to the ISAC Applications


The ISAC application process will be changing from the 1st of July 2015. From this date the new ISAC application form must be submitted. A new Guidance to Applicants document is available to download. A brief description of the changes to the ISAC application form can be found here. All users are advised to make themselves aware of the changes to the ISAC application process, and the changes to CPRD's policies with respect to Transparency. Please note, the old form will no longer be accepted from the 1st of July 2015.

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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

James Ellis
ISAC Secretariat
Medicines & Healthcare products Regulatory Agency
CPRD Division
151 Buckingham Palace Road, London, SW1W 9SZ, UK England
Tel: +44 (0)20 3080 7095
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.