Serious breaches of GCP or the Protocol
The MHRA have a definition of a serious breach of GCP: 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.
In the event that a serious breach is suspected, the OUH R&D Department must be contacted so that an investigation of the concern can be undertaken as a matter of urgency.
The Clinical Trials regulations state that the Sponsor is required to report serious breaches to the REC, and MHRA (where applicable) within seven days of becoming aware of the breach.
OUH R&D 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. [Of the Medicines for Human Use (Clinical Trials) Regulations 2004 ].
- Medicines for Human Use (Clinical Trials) Regulations 2004 - www.legislation.gov.uk
