Conformance Rules v1.1 for SDTMIG v3.2 and v3.3

Published Date:

Version 1.1 of the Conformance Rules for the Study Data Tabulation Model (SDTM) and its Implementation Guide (SDTMIG) includes the initial release of the Conformance Rules for SDTMIG v3.3 and a minor version update to the Conformance Rules for SDTMIG v3.2. CDISC Conformance Rules allow users to evaluate conformance of the data structure to the standard. The Conformance Rules v1.1 aim to identify all conformance rules and case logic from SDTM v1.4, SDTM v1.7, SDTMIG v3.2, and SDTMIG v3.3, classifying and codifying them in a form that supports SDTM quality processes and tool development.

Development and Documentation Guide

The Development and Documentation Guide provides information on the structure of the rules and conventions for rules content to allow users to both understand the rules in approved rules catalogs and be able to create their own rules if needed. 

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.