• Type: Task
    • Resolution: Unresolved
    • Priority: Major
    • Pre-Working Draft
    • Affects Version/s: Pre-Working Draft
    • Component/s: None
    • None
    • Environment:

      Specification

    • Hide

      Any development of eTMF terms and mapping of terms should be done in phase 2, per the Charter. Overall the goal is to create a mapping of OASIS eTMF Domain terms to the TMF RM wherever possible. There may be some terms that the OASIS eTMF Standard TC adds that don't exist in the TMF RM. For example, I believe that some classifications such as medical device terms or medical imaging terms are likely not represented in the TMF RM model, but could be included in the OASIS eTMF model. In this case, there would be no way to map the OASIS eTMF term to the TMF RM since a corresponding TMF RM term wouldn't exist. Note that the word 'term' applies to both category, subcategory, content type and metadata.
      Finally, regarding numbering - since a mapping will be developed between the OASIS eTMF Std and the TMF RM, there will be a cross-reference table that can be used by current TMF RM users or application vendors.

      Show
      Any development of eTMF terms and mapping of terms should be done in phase 2, per the Charter. Overall the goal is to create a mapping of OASIS eTMF Domain terms to the TMF RM wherever possible. There may be some terms that the OASIS eTMF Standard TC adds that don't exist in the TMF RM. For example, I believe that some classifications such as medical device terms or medical imaging terms are likely not represented in the TMF RM model, but could be included in the OASIS eTMF model. In this case, there would be no way to map the OASIS eTMF term to the TMF RM since a corresponding TMF RM term wouldn't exist. Note that the word 'term' applies to both category, subcategory, content type and metadata. Finally, regarding numbering - since a mapping will be developed between the OASIS eTMF Std and the TMF RM, there will be a cross-reference table that can be used by current TMF RM users or application vendors.

      "Will the Categories, Subcategories and Content Types have attributes such as the numbering scheme, or mapping details to the DIA TMF Reference Model?" -M. Agard

            Assignee:
            Unassigned
            Reporter:
            Jennifer Alpert Palchak (Inactive)
            Votes:
            0 Vote for this issue
            Watchers:
            0 Start watching this issue

              Created:
              Updated: