DEVELOPMENT SAFETY UPDATE REPORT

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    • January 28, 2021 at 12:27 am #3981
      Sara Kasem
      Participant

      Hello,

      Where can I file the Development Safety Update Report?

      Best Regards,
      Sara

    • January 28, 2021 at 1:32 pm #3983
      Janina Babiarz
      Participant

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

    • February 11, 2021 at 1:43 pm #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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