Metadata - Protocol Full Title, Protocol Brief Title, Indications, Study Phase, Reg Submission, Tracking Numbers

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    • Type: Task
    • Resolution: Unresolved
    • Priority: Minor
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    • Affects Version/s: Pre-Working Draft
    • Component/s: Vocabulary Layer
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    • Environment:

      Specification

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      This metadata is 'non-core' and is specific to the eTMF domain. We will address eTMF domain metadata in Phase 2 of this project, per the Charter. There are three metadata terms for the eTMF domain that could be considered for core: Study ID, Country and Sponsor. It could be argued that these three terms should be present for every content item in the eTMF domain. Also, I believe Study ID and Country are part of every 'artifact' in the TMF RM so they are essential core terms.

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      This metadata is 'non-core' and is specific to the eTMF domain. We will address eTMF domain metadata in Phase 2 of this project, per the Charter. There are three metadata terms for the eTMF domain that could be considered for core: Study ID, Country and Sponsor. It could be argued that these three terms should be present for every content item in the eTMF domain. Also, I believe Study ID and Country are part of every 'artifact' in the TMF RM so they are essential core terms.

      "Will the eTMF standard manage other protocol attributes such as: Protocol Full Title, Protocol Brief Title, Indication(s), study phase, regulatory submission and tracking numbers? I assume these should be the same properties used in HL7." - Michael Agard

            Assignee:
            Unassigned
            Reporter:
            Jennifer Alpert Palchak (Inactive)
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              Created:
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