Home › Forums › General Discussion Forum › File documents with tracked changes?
- This topic has 4 replies, 5 voices, and was last updated 2 months, 2 weeks ago by
Qiutao Yu.
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June 21, 2021 at 10:11 am #4178
Chelo Ramirez
ParticipantShould 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.
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June 30, 2021 at 11:44 am #4189
Yasmina Bourima
ParticipantIt 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.
KR
Yasmina -
June 30, 2021 at 8:09 pm #4191
Chelsea Pamplin
ParticipantHi 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,
Chelsea-
This reply was modified 1 year, 11 months ago by
Chelsea Pamplin.
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November 30, 2022 at 3:19 pm #4836
Ehsanullah Wedee
ParticipantHi All,
Was there a consensus on this? I have conflicting practices in my past, where we would only file final versions of ICF’s. But now, we have our partner organizations which have requirements in their policy to file tracked change documents (specifically thinking of ICF’s).
Should we file these documents?
Thanks,
Ehsan
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This reply was modified 1 year, 11 months ago by
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March 21, 2023 at 10:42 am #4985
Qiutao Yu
ParticipantWe file them (CSR/IB/MICF tracking versions) in Regulatory binder, but not repeatedly file into study eTMF as the 2 repositories working for different purposes/functions. In my view, Study eTMF cannot be exclusive for all regulatory required documents. For example, some compound level of documents generated from CMC/GMP.
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This reply was modified 2 months, 2 weeks ago by
Qiutao Yu.
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This reply was modified 2 months, 2 weeks ago by
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