[Chelo Ramirez]

We merge in one file the original and translated document and add the COT at the end.
Hope this helps.

[Chelo Ramirez]

As per your experience, are Sponsors requesting to file redacted documents submitted to CTIS, also in the eTMF. If so, do you compile the complete and redacted versions in one file or do you file separetly?

Many thanks in advance,
KRs
Chelo

[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

[Chelo Ramirez]

Dear both, thank you so much for your feedback.
Usually, the Translation Plan is included in the Project Management Plan but some Sponsors include it as an independent Manual.

KRs
Chelo
CTA/eTMF Manager
CRO PIVOTAL

[Author]

Posts