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.
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.
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.