PART 4GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
F1Notification of serious breaches29A
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.