C. Purpose of this Guidance, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA
- To outline the practical arrangements for notification.
- To provide advice on what should and what should not be classified as a “serious breach” and what must be reported.
- To outline possible actions that may be taken by the MHRA in response to notifications of serious breaches.
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