Module 12 2019

Other CDISC Models/Initiatives Coalition for Accelerating Standards and Therapies (CFAST) has also developed over 30 Therapeutic Area standards. It provides standards, tools and methodology for conducting research in key therapeutic areas. CDISC has also introduced a standard for Clinical Trial Registries, Clinical Trial Registry (CTR) XML to support submissions from a single file to multiple, global clinical trial registries, especially the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov. This standard has been inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 20-item WHO Trial Registration Data Set as well as EudraCT specific extensions.

The Organisation for Professionals in Regulatory Affairs