Home Forums Where do I file…. ? Source Document Worksheets

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    • #3535
      Jenn Leaning
      Participant

      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 🙂

    • #3544
      Todd Tullis
      Participant

      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.

    • #3545
      Jenn Leaning
      Participant

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

    • #3643
      Sarah Wilmschen
      Participant

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

    • #3644
      Todd Tullis
      Participant

      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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