# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 29A: Notification of serious breaches


(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 good clinical practice in connection with that trial; or
(b) the protocol relating to that trial, as modified from time to time in accordance with regulations 20 to 22C,
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 participants of the trial; or
(b) the scientific value of the trial.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/29A (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-29A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.