Notification of a Serious Breach

Statutory Instrument 2004/1031 – the Medicines for Human Use (Clinical Trials) Regulations 2004 transposed the European Union Directive 2001/20/EC for Clinical Trials into UK law effective from the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU Good Clinical Practice Directive (2005/28/EC) as Statutory Instrument 2006/1928.

The Regulations state that Clinical Trials involving medicinal products MUST be authorised by the MHRA and conducted according to the Principles of GCP as defined in the Amended Regulations and any subsequent amendments.

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 5.21MB)

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