Published Date:
Version 1.3 of SDTM v1.3 primarily support SDTMIG v3.1.3 and includes:
- Additional variables in the general observation classes for clinical and non-clinical trials
- Content previously published in the SDTM Amendment 1
- Changes to the trial design section
- Document formatting updates
- TU/TR/RS Oncology domains developed as the Oncology Disease-specific Therapeutic Area Supplement.
Note: Amendment 1 to the SDTM v1.2, originally published in 2011, has been incorporated in SDTM v1.3.