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Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains

HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R)

DESCRIPTION

HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R), Release 1 focuses on the development and maintenance of an HL7 V3 message in support of the global data exchange requirements brought about by the increasing number of national, regional, global and organizational clinical trial registries and trial results databases. In doing so, this standard will be providing a mechanism to transport the protocol-related descriptive information needed to register a clinical trial along with the capability to exchange information summarizing trial result outcomes.

ALTERNATIVE NAMES

HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R) may also go by the following names or acronyms:

"V3: Clinical Trial Registration and Results (CTR&R), R1", CTR&R, V3, CTRR

TARGETS

  • Pharmaceutical Companies/Clinical Research
  • Clinical Trial Registration Authorities
  • Clinical Research Organizations
  • Computer Software Vendors to support of Pharmaceutical Companies/Clinical Research

BENEFITS

  • Data exchange standard to meet the current global requirements for trial registration and basic results reporting
  • Utilizes the RCRIM BRIDG model in the analysis process and extend, as needed, to meet trial registry and result database requirements
  • Provides an important element in the electronic exchange of both the protocol-related descriptive information needed to register a clinical trial, as well as a capability to define the exchange of information summarizing trial result outcomes
  • Establish a roadmap for evolving the standard into an ISO-approved, global exchange standard

IMPLEMENTATIONS/CASE STUDIES

  • Software consultants and vendors using the DSTU include: Pharmaceutical Companies, Computer Software Vendors, National Cancer Institute, National Institute of Health – ClinicalTrials.gov, FDA, CDISC, WHO, and EMA.

DEVELOPMENT BACKGROUND

The project is intended to address the exchange of clinical trial-level summary data and will not be used to transport individual patient-related data. In addition, while this effort is assuming the development of a single message in recognition of the overlap of data between the processes of registering clinical trials and then subsequently reporting the results of those trials, it is also understood that it is possible that two individual messages may be required to fully support each of these processes.

In addition, this specification is complemented by a domain analysis model to depict the platform independent view of the behavioral and information requirements for the clinical trial registration and reporting process. The model is the basis for harmonizing requirements from the multiple stakeholders in preparation for development of interoperability specifications within the clinical trial registration and reporting domain.

RELATED DOCUMENTS

HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R)
HL7 Version 3 Domain Analysis Model: Clinical Trials Registration and Results (CTR&R), Release 1 (View Brief)

(Download) (774 KB)

ADDITIONAL DETAILS

For specifications and information about workgroups, training, projects and more, visit the
HL7 Wiki page for this project at http://wiki.hl7.org/index.php?title=Clinical_Trials_Registration_and_Results.

TOPIC

  • Regulated Studies

BALLOT TYPE

  • DSTU

STATUS DATE

2013-11-11

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

FAMILY

  • V3

CURRENT STATE

  • Retired

REALM

  • Universal