Clinical Study Protocol
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Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

ValueSet: ICH M11 Trial Blinding Role Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-02 Maturity Level: 0 Computable Name: M11BlindedRolesVVS

Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217281 drawn from the NCI Thesaurus and represented here in FHIR format.

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2
    CodeDisplayDefinition
    C17445CaregiverThe primary person in charge of the care of a patient, usually a family member or a designated health care professional.
    C70793Clinical Study SponsorAn individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)
    C25936InvestigatorAn individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures. The investigator monitors the safety of the trial subjects and investigational staff (under whose immediate direction an agent is administered or dispensed to a subject). The investigator collects and analyses data and study documents, and provides reports in compliance with applicable requirements.
    C48660Not ApplicableDetermination of a value is not relevant in the current context.
    C207599Outcomes AssessorThe individual who evaluates the outcome(s) of interest.
    C142710Study ParticipantAny individiual that has a role in a study, including study personnel and study subjects.

 

Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 6 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C17445CaregiverThe primary person in charge of the care of a patient, usually a family member or a designated health care professional.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C70793Clinical Study SponsorAn individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C25936InvestigatorAn individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures. The investigator monitors the safety of the trial subjects and investigational staff (under whose immediate direction an agent is administered or dispensed to a subject). The investigator collects and analyses data and study documents, and provides reports in compliance with applicable requirements.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C48660Not ApplicableDetermination of a value is not relevant in the current context.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C207599Outcomes AssessorThe individual who evaluates the outcome(s) of interest.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C142710Study ParticipantAny individiual that has a role in a study, including study personnel and study subjects.

Description of the above table(s).