Home Forums Where do I file…. ? SUSARs

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    • #2939
      Ken Hitchner

      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?

    • #2940
      Karin Schneider

      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

    • #2966
      Jaclyn Verrow

      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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