SUSARs

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    • March 25, 2020 at 10:46 pm #2939
      Ken Hitchner
      Participant

      What is the typical practice for the filing location of SUSARs? Do they reside in the eTMF after being generated, or is only the notification and acknowledgment correspondence filed in the eTMF?

    • March 25, 2020 at 10:59 pm #2940
      Karin Schneider
      Participant

      If you have a separate TMF system, I would not recommend filing SUSARs in TMF – they can contain sensitive or unblinded information and require tight control. They should be cross-referenced to a dedicated safety storage location

    • March 27, 2020 at 2:59 pm #2966
      Jaclyn Verrow
      Participant

      We file only the submission and acknowledgement correspondence in the eTMF. The SUSARs remain in the system they are generated in.

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