Pharmaceutical Research Protocol (Vulcan UDP), 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-ballot 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
: Study Amendment Reason Value Set - TTL Representation
Raw ttl | Download
@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-study-amendment-reason-vs"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet m11-study-amendment-reason-vs</b></p><a name=\"m11-study-amendment-reason-vs\"> </a><a name=\"hcm11-study-amendment-reason-vs\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.5.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C218490</td><td>Regulatory Agency Request To Amend</td></tr><tr><td>C218491</td><td>New Regulatory Guidance</td></tr><tr><td>C218492</td><td>IRB/IEC Feedback</td></tr><tr><td>C218493</td><td>New Safety Information Available</td></tr><tr><td>C218494</td><td>Manufacturing Change</td></tr><tr><td>C218495</td><td>IMP Addition</td></tr><tr><td>C218496</td><td>Change In Strategy</td></tr><tr><td>C218497</td><td>Change In Standard Of Care</td></tr><tr><td>C218498</td><td>New Data Available (Other Than Safety Data)</td></tr><tr><td>C218499</td><td>Investigator/Site Feedback</td></tr><tr><td>C218500</td><td>Recruitment Difficulty</td></tr><tr><td>C218501</td><td>Inconsistency And/Or Error In The Protocol</td></tr><tr><td>C218502</td><td>Protocol Design Error</td></tr><tr><td>C17649</td><td>Other</td></tr><tr><td>C48660</td><td>Not Applicable</td></tr></table></li></ul></div>"^^rdf:XMLLiteral
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
fhir:value [
a fhir:integer ;
fhir:v 2 ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "brr" ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
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:value [
a fhir:canonical ;
fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol> ] ] ) ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"^^xsd:anyURI] ; #
fhir:version [ fhir:v "1.0.0-ballot"] ; #
fhir:name [ fhir:v "M11StudyAmendmentReasonVS"] ; #
fhir:title [ fhir:v "Study Amendment Reason Value Set"] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:experimental [ fhir:v false] ; #
fhir:date [ fhir:v "2025-07-31T20:39:04+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 "Codes drawn from NCI Thesaurus to represent the reasons a study was amended."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
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:concept [
fhir:code [ fhir:v "C218490" ] ;
fhir:display [ fhir:v "Regulatory Agency Request To Amend" ] ] [
fhir:code [ fhir:v "C218491" ] ;
fhir:display [ fhir:v "New Regulatory Guidance" ] ] [
fhir:code [ fhir:v "C218492" ] ;
fhir:display [ fhir:v "IRB/IEC Feedback" ] ] [
fhir:code [ fhir:v "C218493" ] ;
fhir:display [ fhir:v "New Safety Information Available" ] ] [
fhir:code [ fhir:v "C218494" ] ;
fhir:display [ fhir:v "Manufacturing Change" ] ] [
fhir:code [ fhir:v "C218495" ] ;
fhir:display [ fhir:v "IMP Addition" ] ] [
fhir:code [ fhir:v "C218496" ] ;
fhir:display [ fhir:v "Change In Strategy" ] ] [
fhir:code [ fhir:v "C218497" ] ;
fhir:display [ fhir:v "Change In Standard Of Care" ] ] [
fhir:code [ fhir:v "C218498" ] ;
fhir:display [ fhir:v "New Data Available (Other Than Safety Data)" ] ] [
fhir:code [ fhir:v "C218499" ] ;
fhir:display [ fhir:v "Investigator/Site Feedback" ] ] [
fhir:code [ fhir:v "C218500" ] ;
fhir:display [ fhir:v "Recruitment Difficulty" ] ] [
fhir:code [ fhir:v "C218501" ] ;
fhir:display [ fhir:v "Inconsistency And/Or Error In The Protocol" ] ] [
fhir:code [ fhir:v "C218502" ] ;
fhir:display [ fhir:v "Protocol Design Error" ] ] [
fhir:code [ fhir:v "C17649" ] ;
fhir:display [ fhir:v "Other" ] ] [
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ] ] ) ] )
] . #
|
Propose a change