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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 28 April 2026

Documents

Notification of Serious Breaches of GCP or the trial protocol

HTML

Template - Notification of serious breach form

MS Word Document, 80.5 KB

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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.

Published 28 April 2026