Non-IP supply destruction documentation

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    • July 18, 2023 at 3:58 pm #5065
      Stephanie Hayden
      Participant

      Section 06.05 (Non-IP Documentation) does not have a specific location to file non-IP destruction documentation. Any suggestions where to file? 06.07.02 perhaps?

    • July 21, 2023 at 7:05 am #5066
      Meredith Lafond-Phesans
      Participant

      Hello, we file destruction documentation for non-IP under 06.05.03 Non-IP Return Documentation.
      Note: our interpretation of non-IP is anything provided by the sponsor that is not medication, like trial “supplies”. If it is medication provided during the study, whether it is the IP or not, we file it under the same artifacts as IP.

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