Sponsor versus Third Party

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    • June 12, 2020 at 4:52 pm #3664
      Jordan St Charles
      Participant

      We are keeping the TMF for a study in which a third party CRO acted as sponsor for the study. Should the training, CVs, and other files pertaining to the vendor who ran the study be filed with the trial team documents in Zone 1 or should they be filed as a third party in Zone 9?

      Thank you in advance!

    • June 15, 2020 at 5:49 pm #3666
      Karen Roy
      Participant

      Hi
      Assuming there is still a Sponsor funding the project, I would put the CVs in Zone 9. If the CRO is also the Sponsor, then Zone 1.
      Karen

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