Hello all

I wonder if anyone could provide some insight into the ?clock start? times for reporting serious breaches to the MHRA.

The current MHRA guidance states that if a CRO is managing a trial on behalf of a sponsor, the clock starts from when the CRO becomes aware of the breach OR at the point where the Sponsor is made aware of it by the CRO.

In the case where the sponsor retains the notification function, if the CRO becomes aware of a deviation that MAY constitute a breach and investigation is required before that decision can be made, is the clock start time from when the CRO learns of the deviation or from when the Sponsor / CRO has investigated and the decision has been taken by the Sponsor that a serious breach has occurred? This assumes that the CRO has immediately notified the Sponsor of the potential breach in order to investigate.

My interpretation is that the clock starts when the CRO learns of the deviation. What are other?s interpretations of this and has anyone experienced of this with the MHRA?