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
: ICH M11 Amendment Details Statement Value Set Terminology
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:ValueSet ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "m11-amendment-details-statement-vs"] ; #
fhir:language [ fhir:v "en"] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet m11-amendment-details-statement-vs</b></p><a name=\"m11-amendment-details-statement-vs\"> </a><a name=\"hcm11-amendment-details-statement-vs\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-ncit-cs.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title=\"Version is not explicitly stated, which means it is fixed to the version provided in this specification\"> version ?1.0.0-ballot2</span><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218486\">C218486</a></td><td>First Protocol Amendment</td><td>This is the first protocol amendment.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218485\">C218485</a></td><td>Protocol Not Amended</td><td>This protocol has not been amended.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218488\">C218488</a></td><td>Protocol Previously Amended See Summary of Changes Before the Table of Contents</td><td>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.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C218487\">C218487</a></td><td>Protocol Previously Amended, Details Presented</td><td>This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).</td></tr></table></li></ul></div>"^^rdf:XMLLiteral ]
] ; #
fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm> ] ;
fhir:value [
a fhir:Integer ;
fhir:v 0 ]
] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg> ] ;
fhir:value [
a fhir:Code ;
fhir:v "brr" ]
] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status> ] ;
fhir:value [
a fhir:Code ;
fhir:v "trial-use" ;
( fhir:extension [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom> ] ;
fhir:value [
a fhir:Canonical ;
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol> ] ] ) ]
] ) ; #
fhir:url [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs>
] ; #
fhir:version [ fhir:v "1.0.0-ballot2"] ; #
fhir:name [ fhir:v "M11AmendmentDetailsStatementVS"] ; #
fhir:title [ fhir:v "ICH M11 Amendment Details Statement Value Set Terminology"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:experimental [ fhir:v false] ; #
fhir:date [ fhir:v "2026-04-02T08:57:07+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "UDP@HL7Vulcan.org" ] ] )
] ) ; #
fhir:description [ fhir:v "Terminology associated with whether or not a protocol has been amended.\nThis is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm> ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:compose [
( fhir:include [
fhir:system [
fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl> ] ;
( fhir:concept [
fhir:code [ fhir:v "C218486" ] ;
fhir:display [ fhir:v "First Protocol Amendment" ] ] [
fhir:code [ fhir:v "C218485" ] ;
fhir:display [ fhir:v "Protocol Not Amended" ] ] [
fhir:code [ fhir:v "C218488" ] ;
fhir:display [ fhir:v "Protocol Previously Amended See Summary of Changes Before the Table of Contents" ] ] [
fhir:code [ fhir:v "C218487" ] ;
fhir:display [ fhir:v "Protocol Previously Amended, Details Presented" ] ] ) ] )
] . #
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