Study-specific TMF Functional Owner

Home Forums Adopting the Reference Model Study-specific TMF Functional Owner

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      Janna Gonzalez

      Each Document contains a Function Owner Field, which corresponds to the Sponsor Clinical Research that is accountable for confirming the classification is file appropriately within the TMF.

      1. Should the Study Team file document and classify the documents into the staging area and file the document to the correct zone? or Should we have another study team classify the document to the correct Zone.

      2. Is this correct, You can not Qc’d your own Document?
      Sponsor functional QC vs Partner Functional QC.

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