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Hi, how do you manage the protocol deviation log and other running records that are constantly updated during a trial in the eTMF?

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  • #1Do you keep them in draft until the end unless there is an audit (in which case you send to final so the auditor can see the document in the system)?
  • #2Do you keep them in draft most of the time, but send to final periodically (every month or quarter) and before an audit and before archiving?
  • #3Do you finalize after each single update and then file a new version (either as a separate document or superseding the old one through stacking) whenever there is an update?
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    • August 8, 2024 at 2:06 am #5181
      Anke Fronius
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      Hi, how do you manage the protocol deviation log and other running records that are constantly updated during a trial in the eTMF?
      1) Do you keep them in draft until the end unless there is an audit (in which case you send to final so the auditor can see the document in the system)?
      2) Do you keep them in draft most of the time, but send to final periodically (every month or quarter) and before an audit and before archiving?
      3) Do you finalize after each single update and then file a new version (either as a separate document or superseding the old one through stacking) whenever there is an update?

      • This topic was modified 1 month, 1 week ago by Anke Fronius.
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