Serious Breach of Good Clinical Practice or Protocol

If a serious breach is suspected, CTSC 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.

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.

The Clinical Trials Regulations require the reporting of serious breaches of GCP or the protocol (regulation 29A of S12004-1031 as amended). Guidance on the definition and reporting requirements can be found on the HRA webpages.

For non-CTIMP research, serious breaches of GCP or the protocol should be reported to the relevant ethics committee in accordance with the regulations. The CTSC can provide information on what should, or should not, be classified as a serious breach and on the practical arrangements for notifications.

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