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April 23, 2020 at 4:00 pm #3544
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.