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:
 

dance for the Notification of Serious Breaches of GCP or the Trial Protocol (223Kb) 
ification of Serious Breaches of GCP or Trial Protocol form  (201Kb) 

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.