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If a serious breach is suspected, CTRG 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.
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:
For the purposes of this regulation, a 'serious breach' is a breach that is likely to affect to a significant degree: