Source Document Worksheets

[Jenn Leaning]

I know it is not as common anymore, but some of our studies include providing the site with Source Document Worksheets to complete. Any recommendations on where these should be filed?
It’s not CRF…
It’s not really Subject Information Sheet…
…I was thinking maybe Subject Questionnaire??

Any advice would be greatly appreciated! Thank you 🙂

[Todd Tullis]

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.

[Jenn Leaning]

Ahh great suggestion! Thank you so much for your input – very helpful 🙂

[Sarah Wilmschen]

Todd, maybe you could also help me: would you file blank eCRF in 02.01.07 then? Thank you very much in advance!

[Todd Tullis]

Hello Sarah, blank eCRFs are intended to be filed in 02.01.07. You will notice “Blank CRF” specified for that artifact as an “Alternate Name” in column G.

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