The SDTM and SDTMIG Conformance Rules comprise all rules for the SDTM through version 2.0 and the SDTMIG through version 3.4. The Conformance Rules include 59 new rules, retirement of 49 rules as well as new versions of previous rules were created for 28 rules.
For a detailed list of changes, please see the "Revision History" and "Removed Rules" tabs of the SDTM and SDTMIG Conformance Rules Guide v2.0.
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.