CTR-XML v1.0

Published Date:

(An ODM extension for Clinical Trial Registration)

Version 1.0 of the CDISC CTR-XML standard is a provisionally approved standard based on the CDISC Operational Data Model (ODM) for clinical trial registry submissions primarily to the: World Health Organization (WHO), European Medicines Agency (EMA) EudraCT Registry and United States ClinicalTrials.gov.

CTR-XML provides a means for generating harmonized messages to each of the registries listed above. The intent of the CTR-XML standard is to provide technology vendors with the ability to implement tools that support a "write once, use many times" solution based on a single XML file that holds the information needed to generate submissions for multiple clinical trial registries. This standard is based upon the common elements mapped between the registries, which are based upon the 20-item WHO Trial Registration Data Set.

CTR-XML v1.0 will remain provisional until the CDISC Controlled Terminology is finalized and the standard has been fully implemented and tested. CDISC will be happy to work with implementation vendors to update the standard where any issues are found.

We would like to thank our sponsor



and the CTR Team volunteers for their work.