FHIR IG analytics
| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | ValueSet |
| Id | ValueSet-m11-amendment-details-statement-vs.json |
| FHIR Version | R6 |
| Source | https://build.fhir.org/ig/HL7/vulcan-udp-ig/ValueSet-m11-amendment-details-statement-vs.html |
| URL | http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs |
| Version | 1.0.0-ballot2 |
| Status | active |
| Date | 2026-03-30T16:32:09+00:00 |
| Name | M11AmendmentDetailsStatementVS |
| Title | ICH M11 Amendment Details Statement Value Set Terminology |
| Realm | uv |
| Authority | hl7 |
| Description | Terminology associated with whether or not a protocol has been amended.
This is ICH M11 Value Set C217274 drawn from the NCI Thesaurus. |
Resources that use this resource
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 |
| C218486 | First Protocol Amendment | This is the first protocol amendment. |
| C218485 | Protocol Not Amended | This protocol has not been amended. |
| C218488 | Protocol Previously Amended See Summary of Changes Before the Table of Contents | This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent. |
| C218487 | Protocol Previously Amended, Details Presented | This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). |
Source1
{
"resourceType": "ValueSet",
"id": "m11-amendment-details-statement-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-amendment-details-statement-vs",
"version": "1.0.0-ballot2",
"name": "M11AmendmentDetailsStatementVS",
"title": "ICH M11 Amendment Details Statement 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 whether or not a protocol has been amended.\nThis is ICH M11 Value Set C217274 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": "C218486",
"display": "First Protocol Amendment"
},
{
"code": "C218485",
"display": "Protocol Not Amended"
},
{
"code": "C218488",
"display": "Protocol Previously Amended See Summary of Changes Before the Table of Contents"
},
{
"code": "C218487",
"display": "Protocol Previously Amended, Details Presented"
}
]
}
]
}
}
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