SDTM v2.0 is the first major release since the model's original publication in 2004. Among many modifications and updates, the most significant change is that variable metadata is represented in a new structure.
- "Role" is split into "Role" and "Variables Qualified".
- Information previously in "Description" now appears in "Notes", "Usage Restrictions", "Examples" and, where present, "Definition".
- "Variable Definitions" and "C-codes" are included for many, but not all, variables.
- "Format" values of "ISO 8601" have been updated to be more specific (e.g., "ISO 8601 datetime or interval" or "ISO 8601 duration").
How do these changes affect the SDTMIG v3.4?
- Domain Specifications: No affect. SDTMIG domain specifications have never included "Variables Qualified". Users will still have to refer to the SDTM v2.0 to understand variables qualified by Synonym Qualifiers or Variable Qualifiers.
- CDISC Notes: No affect. The SDTMIG v3.4 did not move information from CDISC Notes to other metadata columns.
- Variable Definitions and Corresponding C-Codes: The SDTMIG v3.4 does not include variable definitions or corresponding C-codes. Users will have to consult the SDTM v2.0 for variable definitions and corresponding C-codes.
- Format Information: Format information in the SDTMIG is included in the "Controlled Terms, Codelist, or Format" column. The SDTM includes only Format. Format values in both the SDTM v2.0 and SDTMIG v3.4 were updated to be more specific; the information in the two standards is aligned.