Documentation

The following is a collection of documents, publications, and articles related to OpenCDISC Validator, data validation and quality assessment, CDISC standards, and regulatory agencies.

OpenCDISC Validator Documentation

Installation
GUI Usage
CLI Usage
MedDRA Setup
CDISC CT Setup
Performance and Scalability
Application Framework

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

Regulatory Documents

CDER Study Data Standards
CBER Study Data Standards
CDER Common Data Standards Issues Document v1.1
FDA Study Data Specifications v2.0
FDA Study Data Standards Resources