SDTMIG v3.2 Conformance Rules v1.0

The SDTMIG v3.2 details the structure and conventions for compliant SDTM domains. The majority of the SDTMIG v3.2 is published in a data definition table format, which allows the information to be used programmatically. Business and conformance rules (e.g., assumptions and examples), however, are expressed outside of the data definition tables, making them difficult to identify and program.

SDTMIG v3.2 Conformance Rules v1.0 aim to identify all conformance rules and case logic from the SDTM and SDTMIG, classifying and codifying them in a form that supports SDTM quality processes and tool development. 

The Conformance Rules team has created a user guide that provides information on the structure of the rules and conventions for rules content. 

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.