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Thread: SUSAR Reporting for blinded studies

  1. #1
    Forum Member
    Join Date
    Nov 2011

    SUSAR Reporting for blinded studies

    Would you be able to clarify the mechanism for reporting for blinded studies? My understanding is that before reporting a SUSAR to the MHRA, it will have to be unblinded by the sponsor, questions arising from this are:
    - Who should remain blinded at the sponsor site (eg study co-ordinator, monitor, trial statistician, data manager)?
    - If the study co-ordinator is to remain blinded is it advisable to arrange for an independent co-ordinator to complete SUSAR reporting?
    - If the trial statistician is to remain blinded, I presume he shouldn't be attending the closed meetings for the DMC?
    - Should the DMC members have access to unblinded data for all patients recruited or only for SUSARs?
    - How should SUSARs be reported to investigators at sites? What information should the line listings contain for a blinded study so as not to unblind all the investigators?

    Many thanks

  2. #2
    Forum Member
    Join Date
    Feb 2012
    Please refer to the recent guidance at, section 7.11. You should get all your questions answered.

    Kind regards

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