The following is a collection of documents, publications, and articles related to Pinnacle 21 Community, data validation and quality assessment, CDISC standards, and regulatory agencies.
Pinnacle 21 Community Documentation
Publications and Articles
Dec 2010 Validator Review by Meta-Xceed, Inc.
PharmaSUG 2012 - SDTM, ADaM and define.xml with OpenCDISC
Controlling OpenCDISC Validator using R
FDA Datafit - Data Standards in Clincial Trials, A Regulatory Perspective