Notification of a Serious Breach
Describing the process for identifying and reporting a serious breach of Good Clinical Practice (GCP) or the approved trial protocol.
Notification of a Serious Breach
A serious breach is any breach that is likely to:
- Significantly affect the safety, rights, or well-being of trial participants, or
- Significantly affect the reliability of trial results.
Sponsors are legally required to notify the MHRA within 7 days of becoming aware of a serious breach.
Responsibilities
This SOP applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations.
Sponsor – responsible for notifying the MHRA of a confirmed serious breach within 7 days.
- Chief Investigator (CI) / Principal Investigator (PI) – must immediately escalate any suspected breach to the sponsor/KHP-CTO.
- Trial staff – must report incidents or deviations promptly to the CI/PI for assessment and escalation.