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  1. FHIR Specification Feedback
  2. FHIR-31861

How is a master file a DocumentReference?

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive with Modification
    • Icon: Highest Highest
    • FHIR Core (FHIR)
    • R4
    • Biomedical Research & Regulation
    • MedicinalProductDefinition
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      In this context a MasterFile is an actual document (which may be physical or electronic), it is not a registry.  We will make sure this is made clear in the text.  On this basis DocumentReference is correct.

      From Smita: "Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products."

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      In this context a MasterFile is an actual document (which may be physical or electronic), it is not a registry.  We will make sure this is made clear in the text.  On this basis DocumentReference is correct. From Smita: "Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products."
    • Rik Smithies /Norman Gregory: 10-0-0
    • Correction
    • Non-substantive
    • Yes
    • R5

    Description

      Definition isn't sufficient. My understanding of 'master file' is that it's a registry of entries. If you're pointing to a registry, it should be Endpoint, not DocumentReference

      Proposed Wording:

      lloyd@lmckenzie.com

      (Comment 86 - imported by: Ron G. Parker)

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            Unassigned Unassigned
            Rongparker Ron G. Parker
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