FHIR IG analytics
| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | ValueSet |
| Id | ValueSet-m11-blindedRoles-vs.json |
| FHIR Version | R6 |
| Source | https://build.fhir.org/ig/HL7/vulcan-udp-ig/ValueSet-m11-blindedRoles-vs.html |
| URL | http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blindedRoles-vs |
| Version | 1.0.0-ballot2 |
| Status | active |
| Date | 2026-06-22T17:54:57+00:00 |
| Name | M11BlindedRolesVS |
| Title | ICH M11 ... |
| Realm | uv |
| Authority | hl7 |
| Description | Terminology associated with the ... value set codelist of the ICH M11 protocol template.
This is ICH M11 Value Set ... drawn from the NCI Thesaurus and represented here in FHIR format. |
| Copyright | Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP.
The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license.
CDISC publishes semantics for the ICH M11 protocol data elements and valid
value sets. This terminology set is published and stored in the NCI Thesaurus
Subset C217023 - ICH M11 Terminology
(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023)
The NCI Thesaurus is released under the CC BY 4.0 license
For more licensing information and links see: [licenses.html](licenses.html) |
Resources that use this resource
| StructureDefinition |
| hl7.fhir.uv.clinical-study-protocol#current | m11-protocol-summary | M11_ProtocolSummary |
Resources that this resource uses
| CodeSystem |
| hl7.fhir.uv.clinical-study-protocol#current | Thesaurus.owl | Fragment of NCIT Code System |
Narrative
Note: links and images are rebased to the (stated) source
- Include these codes as defined in
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2| Code | Display | Definition |
| C142710 | Participant | Any individiual that has a role in a study, including study personnel and study subjects. |
| C17445 | Care Provider | The primary person in charge of the care of a patient, usually a family member or a designated health care professional. |
| 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. |
| C207599 | Outcomes Assessor | The individual who evaluates the outcome(s) of interest. |
| C70793 | Sponsor | An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary) |
| C48660 | Not Applicable | Determination of a value is not relevant in the current context. |
Source1
{
"resourceType": "ValueSet",
"id": "m11-blindedRoles-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-blindedRoles-vs",
"version": "1.0.0-ballot2",
"name": "M11BlindedRolesVS",
"title": "ICH M11 ...",
"status": "active",
"experimental": false,
"date": "2026-06-22T17:54:57+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 ... value set codelist of the ICH M11 protocol template.\nThis is ICH M11 Value Set ... drawn from the NCI Thesaurus and represented here in FHIR format.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"copyright": "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
"compose": {
"include": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept": [
{
"code": "C142710",
"display": "Participant"
},
{
"code": "C17445",
"display": "Care Provider"
},
{
"code": "C25936",
"display": "Investigator"
},
{
"code": "C207599",
"display": "Outcomes Assessor"
},
{
"code": "C70793",
"display": "Sponsor"
},
{
"code": "C48660",
"display": "Not Applicable"
}
]
}
]
}
}
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