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16. After regulation 29 of the principal Regulations (conduct of trial in accordance with clinical trial authorisation etc.), insert the following regulation—
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 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.
(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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