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Interesting question! First, since 05.04.11 Source Documentation is currently indicated as NOT a Sponsor TMF artifact, a case could be made that such records don’t belong…but if a Sponsor is giving ‘direction’/’suggestion’ to an Investigator for information as important as source data, seems like the right thing to do to preserve the worksheet templates in the Sponsor TMF.
I’d lean towards 02.01.07 Sample Case Report Form – I feel that is the “closest” artifact in definition/purpose to Source Document Worksheets/Templates
Blank forms / templates in paper form or e-Format to capture the data points of the protocol.
In the TMF Reference Model, translation documentation is a kind of “progeny record” (this is the term used on the Instructions and Glossary tab). The TMF RM states that progeny records belong filed with their related artifact (as described by Jennifer above).
eTMF systems have various ways of dealing with progeny records, but as long as the translation documentation can be seen as related & is accessible from the primary record that was translated, you should be good.
The Adobe-signed situation is a bit more difficult for me to say. My experience with Adobe-signed pdf files is that there is a “Signature Panel” that can be displayed when the file opens in an Adobe software program (in Acrobat Reader, there is a banner across the top that says “Signed and all signatures are valid…” and has a button “Signature Panel”). However, this panel would not be visible if the PDF had been e-signed, then printed, then wet-signed, then scanned.
If pressed to make a recommendation, I would use your eTMF to certify as a copy the final/combo-signed file, and also upload to your eTMF the originally e-signed pdf file (the file with the signature panel) as an attachment, or as an alternative rendition, or as a related document. In this way, you would be preserving the original, partially executed record together with the certified copy of the fully executed record.
Hello Katie – my understanding is that your CROs are providing you with wet-ink original signed documents, and you want to know how to turn such documents into (electronic) certified copies in your eTMF system. Hopefully your eTMF system already has (or can be setup with) a process for a user to upload a scan of a wet-ink document and attest that the scan is an exact copy of the original, with all of the same attributes and information. In this way, your eTMF audit trail captures the relevant information about this important decision.
As for the documents that are partially wet-signed and partially Adobe-signed, do the Adobe signatures also include some kind of signature certificate file/information? If so I would try to include/attach/relate such files in your eTMF system so that they are always available for review with the record in your eTMF system.
Todd