Home › Forums › Where do I file…. ? › Question on Filing EDC Raw Datasets/Vendor Data in TMF

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    • January 6, 2026 at 4:12 pm #5286
      Jasmine ChengJasmine Cheng
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      Dear team,

      I would like to confirm whether EDC raw datasets or vendor data should be filed in the TMF.

      According to the TMF Reference Model:
      11.03.03: The export of raw data for interim analysis purposes. This may include CDISC datasets such as Operational Data Model (ODM) or SDTM.
      11.03.07: The export of raw data for final analysis purposes. This may include CDISC datasets such as Operational Data Model (ODM), SDTM or case report tabulation (CRT) package.

      I’m not sure if EDC raw datasets fall under these categories and should be included in the TMF. Could you please clarify? Thank you!

      Best wishes,
      Jasmine

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