FHIR IG analytics| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | ValueSet |
| Id | ValueSet-m11-blinded-roles-vs.json |
| FHIR Version | R6 |
| Source | https://build.fhir.org/ig/HL7/vulcan-udp-ig/ValueSet-m11-blinded-roles-vs.html |
| URL | http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs |
| Version | 1.0.0-ballot2 |
| Status | active |
| Date | 2026-03-30T16:32:09+00:00 |
| Name | M11BlindedRolesVVS |
| Title | ICH M11 Trial Blinding Role Value Set Terminology |
| Realm | uv |
| Authority | hl7 |
| Description | 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. |
No resources found
| CodeSystem | ||
| hl7.fhir.uv.clinical-study-protocol#current | Thesaurus.owl | Fragment of NCIT Code System |
Note: links and images are rebased to the (stated) source
Generated Narrative: ValueSet m11-blinded-roles-vs
FHIR
FHIRsmithhttp://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2| Code | Display | Definition |
| C17445 | Caregiver | The primary person in charge of the care of a patient, usually a family member or a designated health care professional. |
| C70793 | Clinical Study Sponsor | An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary) |
| C25936 | Investigator | An 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. |
| C48660 | Not Applicable | Determination of a value is not relevant in the current context. |
| C207599 | Outcomes Assessor | The individual who evaluates the outcome(s) of interest. |
| C142710 | Study Participant | Any individiual that has a role in a study, including study personnel and study subjects. |
{
"resourceType": "ValueSet",
"id": "m11-blinded-roles-vs",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 0
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
}
]
}
}
],
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs",
"version": "1.0.0-ballot2",
"name": "M11BlindedRolesVVS",
"title": "ICH M11 Trial Blinding Role Value Set Terminology",
"status": "active",
"experimental": false,
"date": "2026-03-30T16:32:09+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
},
{
"system": "email",
"value": "UDP@HL7Vulcan.org"
}
]
}
],
"description": "Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set C217281 drawn from the NCI Thesaurus.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"compose": {
"include": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept": [
{
"code": "C17445",
"display": "Caregiver"
},
{
"code": "C70793",
"display": "Clinical Study Sponsor"
},
{
"code": "C25936",
"display": "Investigator"
},
{
"code": "C48660",
"display": "Not Applicable"
},
{
"code": "C207599",
"display": "Outcomes Assessor"
},
{
"code": "C142710",
"display": "Study Participant"
}
]
}
]
}
}