Registering a Clinical Trial

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Type Standard / Implementation Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Standard
Final
Pilot
Rating 1
No
Free
N/A
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)
  • The CDISC Clinical Trial Registry (CTR-XML) is used internationally, but in the US, the primary area for registering Clinical Trials is via ClinicalTrials.gov.
  • CTR-XML standard is based on CDISC ODM. It is an extension of the ODM standard.
  • Feedback requested

Comment

updates

CTR-XML is no longer just balloted. It was released (2016-march 28). 

In preconditions for considerations add the following:

"CTR-XML standard is based on CDISC ODM. It is an extension of the ODM standard."

On behalf of Wayne Kubick,…

On behalf of Wayne Kubick, CTO of HL7: "Again, while ODM can be adoption level 5 for exchanging clinical trial databases between research systems, ODM has no adoption that I’m aware of for this context."