Audit Plan, Report, Evidence of Execution and Certificates

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    • July 15, 2020 at 2:12 pm #3689
      Jane Marie Johnson
      Participant

      We currently file
      Audit Plan in 01.01.03 (Quality Plan section)
      Audit Certificates in 01.01.14 (Audit Certificates section)

      Where do others file the detailed audit reports, worksheets, checklists etc. that are deemed confidential and not required to be provided to a Regulatory auditor? Do you create a separate confidential folder within one of the above areas? Include a NTF/Pointer as to where the documents are located outside of the TMF? Other?

      All suggestions and ideas are much appreciated!

    • July 15, 2020 at 6:09 pm #3691
      Allison Grosik
      Participant

      I commonly see audit reports filed in the Company’s internal quality system. You can specify the filing location on the Study TMF Plan/EDL rather than generating a NTF.

      Best regards,
      Allison Grosik
      LMK Clinical Research Consulting

    • April 14, 2022 at 2:35 pm #4575
      Janna Gonzalez
      Participant

      Hi Allison,

      Where do you file General documents?
      They are not Study Level or Site level documents?
      For Ex.
      General Product Information
      Study Cancellation
      Study On Hold
      Suspended Study
      thanks,
      Janna

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