The following draft standards are of interest to the TAUG-TBI v1.0:
Proposed new standards
- SDTMIG Section 6.3 - Ophthalmic Examinations (OE) domain
- Click here to view or download the file.
- Comments are not currently requested on this file, but may be made to the SDS team.
- SDTMIG-MD Section 4.8 - Device-Device Relationships (RELDEV)
- Click here to view or download the file.
- Comments are not currently requested on this file, but may be made to the Medical Devices team.
Proposed revisions to existing standards
- SDTMIG Section 8.4.4, Alternative Representation of Non-Standard Variables
- Comments are not currently requested on this file, but may be made to the SDS team.
- SDTMIG Section 6.3 - Disease Response and Clinical Classifications (RS) domain
- File not yet available.
Please note that although these files have been provided to aid readers in implementing the TAUG-TBI, they are not yet ready for general consumption.