If a serious breach is suspected, the Research Governance, Ethics & Assurance Team must be contacted as a matter of urgency as the sponsor is required to report serious breaches to the REC and MHRA (where applicable) within seven days.
Clinical Trial Research Governance (CTRG) can provide information on what should, or should not, be classified as a serious breach and on the practical arrangements for notifications.
The regulations define 'serious breaches' as any serious breach of:
- the conditions and principles of good clinical practice in connection with that study; or
- the protocol relating to that study, as amended from time to time in accordance with regulations 22 to 25.
For the purposes of this regulation, a 'serious breach' is a breach that is likely to affect to a significant degree:
- the safety or physical or mental integrity of the participants; or
- the scientific value of the trial.