eTMF system documentation

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    • September 26, 2023 at 8:45 am #5102
      Sarah Wilmschen-Tober
      Participant

      Dear all,
      where would you file documentation regarding eTMF system management (e.g. eTMF system setup verification, eTMF change requests, eTMF user account requests and agreements)?
      I would file it in 01.01.01 (and in 10.04.01 only system documentation from the eCRF). Do you agree?
      Thank you in advance for your help!
      Sarah

    • September 26, 2023 at 10:19 am #5103
      Eldin Rammell
      Participant

      Hi Sarah,

      Remember that the TMF is a trial-specific repository. So whilst the records you mention need to be retained and could be reviewed in an inspection, they would not be expected in the TMF. Most companies have a separate system in which they maintain validation records and records of system management, such as user access requests, change requests etc.

      Kind regards,
      Eldin.

      • September 26, 2023 at 10:52 am #5104
        Sarah Wilmschen-Tober
        Participant

        Hi Eldin,
        thank you for your response.
        Maybe I was not clear. All the documents I refer to are trial-specific so we need to file these records in the TMF.
        Thanks a lot in advance for your feedback!
        Kind regards,
        Sarah

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