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The following draft standards are of interest to the TAUG-DKD v1.0draft:

Proposed new standards / additions to exisiting standards

  • Domain-specific variable: MHEVTYP
    • Comments are not currently requested, but may be made to the SDTM Governance Committee.
    • See also a draft of the Medical History (MH) domain with MHEVTYP included. 
  • SDTMIG Section 6.1 - Procedure Agents (AG) domain
    • Comments on are not currently requested, but may be made to the SDS team. 
  • SDTMIG Section 8.4.4, Alternative Representation of Non-Standard Variables
    • Comments this are not currently requested, but may be made to the SDS team.

Proposed revisions to existing standards

  • SDTMIG Section 6.3 - Disease Response and Clinical Classifications (RS) domain (warning) Not yet available.
    • The revision of this domain broadens its scope beyond the oncology use cases for which it was originally crafted.