@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@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 -------------------------------------------------------------------

<http://hl7.org/fhir/uv/ebm/Composition/568054> a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "568054"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "1" ] ;
     fhir:lastUpdated [ fhir:v "2026-05-30T15:21:18.907Z"^^xsd:dateTime ] ;
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-12"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-12>
     ] )
  ] ; # 
  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: Composition 568054</b></p><a name=\"568054\"> </a><a name=\"hc568054\"> </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\">version: 1; Last updated: 2026-05-30 15:21:18+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-section-12.html\">M11ReportSection12</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/568054\">https://fevir.net/resources/Composition/568054</a></p><p><b>identifier</b>: FEvIR Object Identifier/568054</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 35528-9}\">CeSHarP Report</span></p><p><b>category</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218666}\">section12-supporting-details</span></p><p><b>date</b>: 2026-05-30 15:21:18+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template</p><p><b>custodian</b>: <a href=\"Organization-118079.html\">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href=\"ResearchStudy-568025.html\">M11ResearchStudy Template</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568054. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568054. Computable resource at: https://fevir.net/resources/Composition/568054#json.</p>\n</div></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
     fhir:url [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status>
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/cited-artifact-status-type>
         ] ;
         fhir:code [ fhir:v "active" ] ;
         fhir:display [ fhir:v "Active" ]
       ] )
     ]
  ] ) ; # 
  fhir:url [
     fhir:v "https://fevir.net/resources/Composition/568054"^^xsd:anyURI ;
     fhir:l <https://fevir.net/resources/Composition/568054>
  ] ; # 
  fhir:identifier ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>
         ] ;
         fhir:code [ fhir:v "ACSN" ] ;
         fhir:display [ fhir:v "Accession ID" ]
       ] ) ;
       fhir:text [ fhir:v "FEvIR Object Identifier" ]
     ] ;
     fhir:system [
       fhir:v "https://fevir.net/FOI"^^xsd:anyURI ;
       fhir:l <https://fevir.net/FOI>
     ] ;
     fhir:value [ fhir:v "568054" ] ;
     fhir:assigner [
       fhir:display [ fhir:v "Computable Publishing LLC" ]
     ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
     fhir:coding ( [
       a loinc:35528-9 ;
       fhir:system [
         fhir:v "http://loinc.org"^^xsd:anyURI ;
         fhir:l <http://loinc.org>
       ] ;
       fhir:code [ fhir:v "35528-9" ] ;
       fhir:display [ fhir:v "Clinical trial protocol Clinical trial protocol" ]
     ] ) ;
     fhir:text [ fhir:v "CeSHarP Report" ]
  ] ; # 
  fhir:category ( [
     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 "C218666" ] ;
       fhir:display [ fhir:v "ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS" ]
     ] ) ;
     fhir:text [ fhir:v "section12-supporting-details" ]
  ] ) ; # 
  fhir:subject ( [
     fhir:l <http://hl7.org/fhir/uv/ebm/ResearchStudy/568025> ;
     fhir:reference [ fhir:v "ResearchStudy/568025" ] ;
     fhir:type [
       fhir:v "ResearchStudy"^^xsd:anyURI ;
       fhir:l fhir:ResearchStudy
     ] ;
     fhir:display [ fhir:v "M11ResearchStudy Template" ]
  ] ) ; # 
  fhir:date [ fhir:v "2026-05-30T15:21:18.907Z"^^xsd:dateTime] ; # 
  fhir:author ( [
     fhir:display [ fhir:v "Brian S. Alper, MD, MSPH" ]
  ] ) ; # 
  fhir:title [ fhir:v "M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template"] ; # 
  fhir:custodian [
     fhir:l <http://hl7.org/fhir/uv/ebm/Organization/118079> ;
     fhir:reference [ fhir:v "Organization/118079" ] ;
     fhir:type [
       fhir:v "Organization"^^xsd:anyURI ;
       fhir:l fhir:Organization
     ] ;
     fhir:display [ fhir:v "Computable Publishing LLC" ]
  ] ; # 
  fhir:relatesTo ( [
     fhir:type [ fhir:v "derived-from" ] ;
     fhir:target [
       a fhir:Reference ;
       fhir:l <http://hl7.org/fhir/uv/ebm/ResearchStudy/568025> ;
       fhir:reference [ fhir:v "ResearchStudy/568025" ] ;
       fhir:type [
         fhir:v "ResearchStudy"^^xsd:anyURI ;
         fhir:l fhir:ResearchStudy
       ] ;
       fhir:display [ fhir:v "M11ResearchStudy Template" ]
     ]
  ] [
     fhir:type [ fhir:v "cite-as" ] ;
     fhir:target [
       a fhir:Markdown ;
       fhir:v "M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568054. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568054. Computable resource at: https://fevir.net/resources/Composition/568054#json."
     ]
  ] ) ; # 
  fhir:section ( [
     fhir:title [ fhir:v "Appendix: Supporting Details" ] ;
     fhir:code [
       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 "C218666" ] ;
         fhir:display [ fhir:v "ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS" ]
       ] ) ;
       fhir:text [ fhir:v "section12-supporting-details" ]
     ] ;
     fhir:text [
       fhir:status [ fhir:v "empty" ] ;
       fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"^^rdf:XMLLiteral ]
     ] ;
     fhir:section ( [
       fhir:title [ fhir:v "Clinical Laboratory Tests" ] ;
       fhir:code [
         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 "C218667" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 12.1 Clinical Laboratory Tests" ]
         ] ) ;
         fhir:text [ fhir:v "section12.1-clinical-laboratory-tests" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Specify which laboratory parameters should be included in each clinical laboratory assessment panel (for example, for haematology, chemistry, urinalysis). A tabular presentation for such information is common. If applicable, include equations and references for locally calculated laboratory results. If not applicable, retain header and enter “Not Applicable.”]</div>"^^rdf:XMLLiteral ]
       ]
     ] [
       fhir:title [ fhir:v "Country/Region-Specific Differences" ] ;
       fhir:code [
         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 "C218668" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 12.2 Country/Region-Specific Differences" ]
         ] ) ;
         fhir:text [ fhir:v "section12.2-country-specific-differences" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Although global clinical trial practices are increasingly harmonised, some country/ region-specific differences in requirements do exist (for example, document retention periods, contraception requirements).  Where differences in requirements cannot be reconciled, sponsors should explain how they will document and communicate country/region-specific differences (for example, by country/region-specific amendments or addenda). An alternative to country/region-specific amendments is to list the specific differences by country or countries in this section, including a reference to the relevant section of the protocol where the differing requirement applies. If not applicable, retain header and enter “Not Applicable.”]</div>"^^rdf:XMLLiteral ]
       ]
     ] [
       fhir:title [ fhir:v "Prior Protocol Amendment(s)" ] ;
       fhir:code [
         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 "C218669" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)" ]
         ] ) ;
         fhir:text [ fhir:v "section12.3-prior-protocol-amendments" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[See M11 for specific guidance if not able to simply state {Not applicable.  This protocol has not been amended.} or {Not applicable.  This is the first protocol amendment.}.]</div>"^^rdf:XMLLiteral ]
       ]
     ] )
  ] ) . # 

<http://hl7.org/fhir/uv/ebm/ResearchStudy/568025> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Organization/118079> a fhir:Uv .

# -------------------------------------------------------------------------------------