Home Forums Where do I file…. ? Post-Use Investigational Product Inspection

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    • #4556
      Dennis Hannigan
      Participant

      The company receives post-use investigational product for inspection and analytical testing. Should the records associated with the returned post-use IP be in Section 08? Some think these are IP Returns falling under Section 06 because they are not blood or similar specimens for analysis.
      Dennis

    • #4567
      Janna Gonzalez
      Participant

      Hi Dennis,
      What zone are you looking at for Section 08?
      Janna

    • #4568
      Janna Gonzalez
      Participant

      06 IP and Trial Supplies 06.01 IP Documentation 06.01.10 IP Return Documentation To record details of returns to/from a distribution center, depot and/or trial site. Examples include courier documentation and packing/ inventory listing. “Acknowledgement of Return
      IP Return Documentation
      IP Return Form

      Non-IP-
      06 IP and Trial Supplies 06.05 Non-IP Documentation 06.05.03 Non-IP Return Documentation To inventory the returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot and/or site. Examples include courier documentation and packing/ inventory listing. “Acknowledgement of Return
      Non-IP Return Documentation
      Non-IP Return Form”

      Please follow your SOP.
      hope this helps!
      Janna

    • #4569
      Janna Gonzalez
      Participant

      Example for Non-IP Documents,
      Non IP Example of documents (if applicable)
      Study Supplies Log
      Subject Accountability Log
      Other Site Logs

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