Guidance
Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol
Information on practical arrangements for notification, what should and should not be classified as a “serious breach” and what must be reported.
Documents
Details
The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.
This guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
Updates to this page
Published 28 April 2026