CDISC Unveils New Standard for Clinical Trial Registries

Posted 09 May 2016

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The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov from a single file.

The standard, known as the Clinical Trial Registry (CTR) XML, is 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 CTR standard 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,” CDISC said in a statement. “This makes the standard a more general solution that any trial registry could potentially use as the means to populate their registry with structured content from a clinical trial sponsor’s systems.”

CTR-XML will help companies harmonize messages to international registries, and technology vendors will be able to support a "write once, use many times" tool based on a single XML file, CDISC said. The standard is based upon the common elements mapped between the registries, which are based upon the 20-item WHO Trial Registration Data Set.

“This standard will save the industry a lot of time in registering trials with multiple registries and is an essential step toward creating registries that house consistent, high-quality data, which will make them more useful to patients seeking research trials,” said Paul Houston, head of the CDISC Europe Foundation. “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.”

CDISC is looking for volunteers and sponsors to join the CTR team and those interested can email phouston@cdisc.org for details.

CTR-XML page

 

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Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, News, US, Canada, Europe, EMA, WHO

Tags: CDISC, clinical trial registries, XML

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