Version 3.4 of the Study Data Tabulation Model Implementation Guide (SDTMIG): Human Clinical Trials is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets may be used for various purposes, including publication, warehousing, meta-analyses, and regulatory submission. It should be used in close concert with SDTM v2.0.
SDTMIG v3.4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM.
Noteworthy changes from the previous version (SDTMIG v3.3) include:
- The Subject Visits (SV) domain includes additional variables and contains information for each subject's actual and planned visits.
- Addition of two new domains: Genomics Findings (GF) and Cell Phenotype Findings (CP). GF is a findings domain that contains data related to the structure, function, evolution, mapping, and editing of subject and non-host organism genomic material of interest. CP is also a findings domain that contains data related to the characterization of cell phenotype, lineage, and function based on expression of specific markers in single cell or particle suspensions.
- The Morphology (MO) domain has been decommissioned.
- Biospecimen Events (BE), Biospecimen Findings (BS), and Related Specimens (RELSPEC) have been copied from SDTMIG-PGx v1.0, which has been deprecated with the publication of SDTMIG v3.4.
SDTMIG v3.4 supersedes all prior versions of the SDTMIG. Please visit Appendix E for an overview of all changes to the SDTMIG since SDTMIG v3.3.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.