MHRA guidance on reporting serious breaches of GCP or the trial protocol

MHRA guidance on reporting serious breaches of GCP or the trial protocol

The Medical and Healthcare products Regulatory Agency (MHRA) has published new guidance
on reporting serious breaches of Good Clinical Practice or the trial protocol, as required by the
Clinical Trial Amendment Regulations 2006. The guidance outlines the practical arrangements
for notifications, and provides advice on what should and what should not be classified as a
“serious breach” and what must be reported. The guidance also outlines possible actions that
may be taken by the MHRA in response to notifications of serious breaches.