Version 3.3 of the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) is available in PDF or HTML format.
Enhancements, Key Additions and Revisions
SDTMIG v3.3 provides the following enhancements, key additions and revisions to prior versions:
- Revised Disposition (DS) assumptions to facilitate greater clarity
- Introduction of morphology/physiology domains to support specific body systems
- New Functional Tests (FT) domain supporting QRS supplements
- Expanded Disease Response and Clin Classification (RS) domain to include QRS clinical classification content
- New class of Study References (e.g., Non-host Organism Identifiers)
- Many new examples, revisions, and corrections across domains
- New variables and assumptions for Demographics (DM)
- Associations to supplemental implementation guides (e.g., SDTMIG-PGx, SDTMIG-MD)
- Significant revisions to microbiology domains
- Additional new supporting domains (e.g., ML, TM, SM)
- Greater guidance on managing text strings that are more than 200 characters
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.