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Thread: 'Clock start' times for reporting serious breaches

  1. #1

    'Clock start' times for reporting serious breaches

    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?

  2. #2
    Forum Member
    Join Date
    Jul 2018
    Pennsylvania, USA
    It is astounding to think that this question has not received a response in over 6 years!

    In my opinion, the logical time for a clock start is the time at which the Sponsor formally identifies the activity to be a (likely) serious breach. The Sponsor (or representative) should have a robust process in place to get potential quality events reported into the quality organization rapidly. Subsequent analysis and assessment of the quality event should include, among other assessments, a determination of whether or not a serious breach has occurred. This assessment should be prompt (I would suggest within 24 hours, if possible) and, once made, would be the clock start.

    It should also be noted that in the (hopefully unlikely) event that the Sponsor decides a serious breach has not occurred BUT the the CRO disagrees, there is an obligation for the CRO to report this as a serious breach under their processes.

    Obviously, I welcome feedback form MHRA or other forum users...

  3. #3
    Forum Member
    Join Date
    Nov 2011
    Obviously the MHRA SB guidance is a good place to look. I should warn you that the EMA draft guidance on SB (on the Inspection Working Group website) which is based on the MHRA guidance, does not include the MHRA "pragmatic" approach to clock start. Unless things change by the final guidance, it looks like they are playing "hard ball" in wanting reporting 7 days after first knowledge of the event. Obviously there needs to be a robust deviation escalation process so that all potential SBs are evaluated and reported if they are possible SBs.

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