Clinical Study Protocol
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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

: JPMA0001 Provided Example - Japanese Language

Page standards status: Informative

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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:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "JPMA0001-jpn"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy JPMA0001-jpn</b></p><a name=\"JPMA0001-jpn\"> </a><a name=\"hcJPMA0001-jpn\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-research-study-profile.html\">M11 Research Study Profile</a></p></div><blockquote><p><b>M11 Research Study Extension</b></p><ul><li>originalProtocol: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218485}\">Protocol Not Amended</span></li><li>versionDate: 2026-01-14</li></ul></blockquote><p><b>Narrative Elements</b>: <a href=\"Composition-JPMA0001-Section5-jpn.html\">Composition JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria)</a></p><p><b>identifier</b>: Sponsor Identifier/JPMA001 (use: usual, )</p><p><b>version</b>: 2.0</p><p><b>title</b>: 経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験</p><h3>Labels</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/title-type short-title}\">Short title</span></td><td>2型糖尿病患者への投与</td></tr></table><p><b>status</b>: Active</p><p><b>phase</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}\">Phase III Trial</span></p><h3>Recruitments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Eligibility</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Group-JPMA0001-Criteria-JPN.html\">Group Japanese Protocol from Vulcan UDP Eligibility Criteria</a></td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
    ( fhir:extension [
fhir:url [
fhir:v "originalProtocol"^^xsd:anyURI ;
fhir:l fhir:originalProtocol       ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
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:code [ fhir:v "C218485" ] ;
fhir:display [ fhir:v "Protocol Not Amended" ]         ] )       ]     ] [
fhir:url [
fhir:v "versionDate"^^xsd:anyURI ;
fhir:l fhir:versionDate       ] ;
fhir:value [
a fhir:Date ;
fhir:v "2026-01-14"^^xsd:date       ]     ] ) ;
fhir:url [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study>     ]
  ] [
fhir:url [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements>     ] ;
fhir:value [
a fhir:Reference ;
fhir:l fhir:Composition/JPMA0001-Section5-jpn ;
fhir:reference [ fhir:v "Composition/JPMA0001-Section5-jpn" ]     ]
  ] ) ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "usual" ] ;
fhir:type [
fhir:text [ fhir:v "Sponsor Identifier" ]     ] ;
fhir:system [
fhir:v "https://exemplarSponsor.com/sponsor-identifier"^^xsd:anyURI ;
fhir:l <https://exemplarSponsor.com/sponsor-identifier>     ] ;
fhir:value [ fhir:v "JPMA001" ]
  ] ) ; # 
  fhir:version [ fhir:v "2.0"] ; # 
  fhir:title [ fhir:v "経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験"] ; # 
  fhir:label ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/title-type>         ] ;
fhir:code [ fhir:v "short-title" ] ;
fhir:display [ fhir:v "Short title" ]       ] )     ] ;
fhir:value [ fhir:v "2型糖尿病患者への投与" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:phase [
    ( fhir:coding [
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:code [ fhir:v "C15602" ] ;
fhir:display [ fhir:v "Phase III Trial" ]     ] )
  ] ; # 
  fhir:recruitment [
fhir:eligibility [
fhir:l fhir:Group/JPMA0001-Criteria-JPN ;
fhir:reference [ fhir:v "Group/JPMA0001-Criteria-JPN" ]     ]
  ] . #