(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 http://www.who.int/ictrp/network/trds/en/ .
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.
CDISC CTR2 Project
CDISC is currently seeking funding for CTR2, which will include: Registration & Results, Protocol and IDMP compliance. Kick off is planned 2016 Q3/4. Please contact Paul Houston regarding project proposal.
The focus of CTR2 will shift to fully structured protocol and results summary elements. The CTR2 standard will utilize and necessitate development of an updated Protocol standard, which will introduce new CDISC data elements while also utilizing those that currently exist for CDISC CTR, SDM, SDTM and ODM.
To ensure global regulatory compliance, CTR2 will also map to the ISO IDMP Standards (Identification of Medicinal Products) introducing a greater level of substance and product granularity to increase the richness, reliability and traceability of registry information.
CTR2 and the Protocol standard will leverage the new CDISC SHARE metadata repository .