The Conformance Rules for Define-XML v2.1 are intended to guide implementers in the construction of Define-XML documents that conform to the requirements within the Define-XML Specification and its supporting XML schema. The Conformance Rules will improve the consistency of Define-XML documents provided for SEND,SDTM, and ADaM submissions to global regulatory authorities.
The Publication Notes explain how to interpret the Rules.
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.