File documents with tracked changes?

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    • #4178
      Chelo Ramirez

      Should a final document with tracked changes be filed to easily view changes from previous versions. I understand draft changes should not be filed, but not sure how to proceed with the final document with tracked changes. Thanks for your feedback.

    • #4189
      Yasmina Bourima

      It depends on the document. For instance, the documents (ICFs, CTP, IB, etc.) that are submitted to Authorities/IEC-IRB should always be found in the TMF because the track change version is also submitted, at least this is the case in Germany.


    • #4191
      Chelsea Pamplin

      Hi All,

      My team is also interested in advice on how to manage tracked changes documentation. I agree Yasmina, in my experience I usually only come across tracked changes documents that were submitted to IRB/IEC for review.

      We’re also curious what sub-artifact applies to these documents, are they to be filed under the same sub-artifact as the clean version?

      In the TMF RM v3.2.1 there is a ‘Review and Approval’ sub-artifact (e.g. in 02.01.04 and 02.02.03) so we are wondering if this sub-artifact is more suitable for tracked changes documents.

      I look forward to hearing feedback about this!

      Best Wishes,

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