Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains
HL7 Version 3 Domain Analysis Model: Clinical Trials Registration and Results (CTR&R), Release 1
HL7 Version 3 Standard: Clinical Trial Registration and Results (CTR&R), Release 1 represents the behavioral and information requirements for the CTR&R domain. It serves as a tool for subject matter experts to examine, express, and evaluate their requirements for use in guiding development of technical interoperability specifications.
HL7 Version 3 Domain Analysis Model: Clinical Trials Registration and Results (CTR&R), Release 1 may also go by the following names or acronyms:
- Clinical Trial Registration Authorities
- Pharmaceutical Companies/Clinical Research
- Clinical Research Organizations
- Computer Software Vendors to support of Pharmaceutical Companies/Clinical Research
- Facilitates the development of information system interoperability specifications that facilitate the required exchange of information between parties involved in the registration of clinical trials and the reporting of results for registered trials
- Utilizes the RCRIM BRIDG model in the analysis process and extend, as needed, to meet trial registry and result database requirements
- Interim deliverable of an ongoing requirements specification effort to represent the universal requirements of clinical trial sponsor organizations and registration authorities world wide and will include clinical trial results reporting
This Domain Analysis Model considers the behavioral and information requirements of the U.S. National Instititutes of Health ClinicalTrials.gov registry, World Health Organization (WHO) clinical trials registry, and EMA registries.
These constructs were arrived at by conducting extensive interviews, work sessions, and collaborations with subject matter experts from sponsoring organizations, registration authorities, and other interest parties (regulatory, public, and private) from throughout the world.
|HL7 Version 3 Domain Analysis Model: Clinical Trials Registration and Results (CTR&R), Release 1||
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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.
- Regulated Studies
RESPONSIBLE WORK GROUP
- Domain Analysis Model