Third Party Training

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    • December 8, 2023 at 7:41 pm #5128
      Sally Quinn
      Participant

      Hello Everyone,

      Where to file 3rd party training records( protocol, eTMF, etc.)? I was thinking to file with 3rd party CVs and note this as a sub-artifact on the study specific TMF Index. Any ideas?

      Thank you.

    • January 26, 2024 at 1:36 pm #5133
      Donna Dorozinsky
      Participant

      Hi Sally, This should be filed with the rest of the training documents in Zone 1.4.4 Trial Team Evidence of Training. If you want to align the training to a specific vendor you can always add that as metadata in that artifact. I would not recommend filing training with the CVs as this will make it more difficult to find the CVs in the event of an inspection

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