The following draft standards are of interest to the TAUG-DKD v1.0draft:
Proposed new standards / additions to exisiting standards
- Domain-specific variable: MHEVDTP
- 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 MHEVDTP 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
Under construction.- The revision of this domain broadens its scope beyond the oncology use cases for which it was originally crafted.
| Parent Standard | Section | Name | Notes |
|---|---|---|---|
| SDTM | 2.2.11 | MHEVDTP |
|
| SDTMIG | 6.1 | Procedure Agents (AG) | |
| SDTMIG | 6.3 | Disease Response and Clinical Classifications (RS) | Under construction |
| SDTMIG | 8.4.4 | Alternative Representation of Non-Standard Variables |