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UK legislation, EU Directives and ICH link

How to report breaches of GCP or the trial protocol
Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004 [Statutory Instrument 2004/1031], as amended by Statutory Instrument 2006/1928, contains a requirement for the notification of "serious breaches" of GCP or the trial protocol. The MHRA has issued the following guidance on the notification of serious breaches of GCP:

Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol

This guidance:

  • outlines the practical arrangements for notifications
  • provides advice on what should and what should not be classified as a “serious breach” and what must be reported
  • outlines possible actions that may be taken by the MHRA in response to notifications of serious breaches.

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