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

The UK MHRA has updated the Notification of a Serious Breach form and associated guidance, with the aim of improving the completeness and quality of information being received by the agency for review and assessment of the breach.

The purpose of this guidance is:

• 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.