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Thread: SAE reporting to sponsor when trial outsourced

  1. #1
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    SAE reporting to sponsor when trial outsourced

    The regulation state all SAEs should be reported to the sponsor within 24 Hours. If the sponsor delegate this task to a third party, does third party still obliged to report these SAE to the sponsor?
    What mechanism should be in place to ensure sponsor has the oversight on safety reporting.

  2. #2
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    Information that I have come across:-
    The 24 hours is the time to get the SAE report to the Sponsor performing SAE/SUSAR reception and evaluation. If the Sponsor has set up a system where that notification has to go to the CRO first, then they need a robust process to ensure that the CRO passes it on immediately to the sponsor to meet that requirement.

    There could be a scenario where a Sponsor outsources almost everything (but obviously not the oversight of the CROs by the sponsor,- that always remains a sponsor responsibility). This would mean that the reception and evaluation of SAE/SUSARs will be performed by a legally contracted vendor/CRO. In that scenario it would be expected that the investigator report in 24 hours to the CRO essentially the timeline is there to make sure that the information gets quickly to those that need to report it, and of course within the legislative timelines to the Regulatory Authorities

  3. #3
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    With regard to "oversight" I suggest that you look at the MHRA blog on GCP oversight. Also the EMA TMF guidance (on the EMA Inspectors Working Group website) has information about contacts and oversight with CROs that perform TMF tasks, this could be useful when deciding what might be useful for oversight of other duties.

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