File documents with tracked changes?

[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.

[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.

KR
Yasmina

[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,
Chelsea

• This reply was modified 2 years, 9 months ago by Chelsea Pamplin.

[Ehsanullah Wedee]

Hi 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

[Qiutao Yu]

We 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.

• This reply was modified 1 year, 1 month ago by Qiutao Yu.

[Chelo Ramirez]

Thank you all for your responses.
I would like to open up the scope of the discussion.
Historically we only file in the corresponding artifact the final clean approved versions of documents submitted to Regulatory & IRB/IEC authorities: IBs, Protocol, Protocol Amendments, ICFs..
But now some Sponsors are also requesting to file non-approved documents, specially in the case of ICFs.
So now we are planning to file all document versions in the eTMF, specifying in the document name if it is approved/non-approved.
The doubt is if we should create a pdf which contains both the clean and the tracked changes/redline versions or file separately.
Looking forward to your feedback,
Thanks
Chelo

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