CDISC Unveils Clinical Trial Registry Standard

May 6, 2016

The Clinical Data Interchange Standards Consortium (CDISC) announces the availability of a new standard allowing pharmaceutical companies to register their clinical trials from a single files into regulatory databases of the EMA, FDA and WHO.

The Clinical Data Interchange Standards Consortium (CDISC) has announced the availability of a new standard, Clinical Trial Registry (CTR) XML.    The standard will make it possible to build applications that generate submissions of clinical research for multiple, global clinical trial registries; specifically the World Health Organization (WHO), European Medicines Agency (EMA) and to ClinicalTrials.gov from a single file.   The CTR standard was 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, according to a statement from CDISC. It maximizes the re-use of existing CDISC transport standards by extending the Operational Data Model (ODM-XML) and including Study/Trial Design Model (SDM-XML) content. This makes the standard a more general solution that any trial registry can use as the means to populate their registry with structured content from a clinical trial sponsor's systems.   The next stage will extend the standard, creating an underlying structured protocol standard, results summaries and Identification of Medicinal Products (IDMP) compliance (an ISO standard), to further increase the richness, reliability and traceability of registry information.   Editor’s Note: CDISC is looking for volunteers and sponsors to join the CTR team for stage two. Contact phouston@cdisc.org for details. Read here for more information about CTR-XML http://www.cdisc.org/ctr-xml.