Reply To: File documents with tracked changes?

[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