Do we need to Keep a hard copy in the Paper Document in file Room

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    • August 10, 2021 at 4:58 pm #4231
      Janna Gonzalez
      Participant

      Hi All,

      In what cases would we need to maintain a hard copy of each document in our eTMF system and when would we not have to maintain a hard copy?

      thank you,
      Janna

    • August 10, 2021 at 5:01 pm #4232
      Janna Gonzalez
      Participant

      Hi All,

      Hard Copy Requirements for Clinical Trial Documents?

      Thank you,
      Janna

    • August 16, 2021 at 6:05 pm #4233
      Christy Nini
      Participant

      I think it would depend on what your SOPs define for you. If they are not yet defined, then I think that once you have a Part 11 compliant eTMF system, then you don’t need to duplicate your work by retaining hard paper copies UNLESS there are certain exemptions surrounding cases like wet-ink signatures.

    • August 25, 2021 at 11:22 am #4240
      Janna Gonzalez
      Participant

      Thank you,
      Christy.

      Janna

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