Notification of serious breaches of GCP or the trial protocol

28th April 2026

Summary:
This guidance sets out the requirements for notifying the MHRA of serious breaches of Good Clinical Practice (GCP) or the clinical trial protocol. It explains what constitutes a serious breach, including those likely to significantly affect participant safety or the scientific value of a trial, and provides clear expectations on timelines and reporting processes. Sponsors are required to report such breaches promptly, typically within seven days of becoming aware, and ensure appropriate follow-up actions are taken. The publication supports consistent compliance and reinforces the importance of maintaining high standards in the conduct and oversight of clinical trials.

Link: https://www.gov.uk/government/publications/clinical-trials-for-medicines-notification-of-serious-breaches-of-gcp-or-the-trial-protocol

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