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!
- This reply was modified 1 month ago by Chelsea Pamplin.