Version 3.1.3 of the Study Data Tabulation Model Implementation Guide (SDTMIG) for Human Clinical Trials corresponds to SDTM version 1.3. Updates to the guide and the model include:
- Additional variables to 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.