Notification of a Serious Breach

The Medicines for Human Use (Clinical Trails) Regulations state that clinical trials involving medicinal products MUST be authorised by the MHRA and conducted according to the Principles of GCP.

Regulation 29A of the Regulations state that:

"The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of—

(a) The conditions and principles of good clinical practice in connection with that trial; or

(b) The protocol relating to that trial, as amended from time to time in accordance with Regulations 22 to 25, within 7 days of becoming aware of that breach."

This SOP describes the process for notification of serious breaches of GCP or the approved trial protocol.

SOP: Notification of a Serious Breach (.pdf 4Kb)

Related Documentation

MHRA Notification of a Serious Breach form (.doc 180Kb)

MHRA Guidance on Serious Breaches (.doc 240Kb)

Notification of a Serious Breach - Examples (.doc 17Kb)