A. Legal Requirement, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA

Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004 [Statutory Instrument 2004/1031], as amended by Statutory Instrument 2006/1928, contains a requirement for the notification of “serious breaches” of GCP or the trial protocol:

“29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of –

(a) the conditions and principles of GCP 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.

(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree –

(a) the safety or physical or mental integrity of the subjects of the trial; or

(b) the scientific value of the trial”.

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