Home Forums Where do I file…. ? DEVELOPMENT SAFETY UPDATE REPORT

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    • #3981
      Sara Kasem
      Participant

      Hello,

      Where can I file the Development Safety Update Report?

      Best Regards,
      Sara

    • #3983
      Janina Babiarz
      Participant

      Hi Sara,
      I will recommend the subsection 07.01.02 Pharmacovigilance Database Line Listing
      With best regards,
      Nina

    • #3996
      Eldin Rammell
      Participant

      Remember that a DSUR is not a trial-specific document (unless you only have 1 clinical trial in development). For this reason, many sponsors do not file the DSUR (or PSUR) in the TMF but rather file it in the Pharmacovigilance system. However, the TMF will hold any trial-specific notifications related to the DSUR e.g. notification to Ethics Committee.

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