Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: M11 Report Section 12 (Supporting Details) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

Page standards status: Informative

Raw ttl | Download


@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 -------------------------------------------------------------------

 a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "568069"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "6" ] ;
fhir:lastUpdated [ fhir:v "2026-06-22T14:50:19.677Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-12"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-12>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"/>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-description"^^xsd:anyURI ] ;
fhir:value [
a fhir:markdown ;
fhir:v "Example of M11ReportSection12 Profile"     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active" ] ;
fhir:display [ fhir:v "Active" ]       ] )     ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/Composition/568069"^^xsd:anyURI] ; # 
  fhir:identifier ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ;
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:value [ fhir:v "568069" ] ;
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: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: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:reference [ fhir:v "ResearchStudy/267245" ] ;
fhir:type [ fhir:v "ResearchStudy"^^xsd:anyURI ] ;
fhir:display [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example" ]
  ] ) ; # 
  fhir:date [ fhir:v "2026-06-22T14:50:19.677Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:display [ fhir:v "Brian S. Alper, MD, MSPH" ]
  ] ) ; # 
  fhir:title [ fhir:v "M11 Report Section 12 (Supporting Details) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"] ; # 
  fhir:custodian [
fhir:reference [ fhir:v "Organization/118079" ] ;
fhir:type [ fhir:v "Organization"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Computable Publishing LLC" ]
  ] ; # 
  fhir:relatesTo ( [
fhir:type [ fhir:v "derived-from" ] ;
fhir:target [
a fhir:Reference ;
fhir:reference [ fhir:v "ResearchStudy/267245" ] ;
fhir:type [ fhir:v "ResearchStudy"^^xsd:anyURI ] ;
fhir:display [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example" ]     ]
  ] [
fhir:type [ fhir:v "cite-as" ] ;
fhir:target [
a fhir:markdown ;
fhir:v "M11 Report Section 12 (Supporting Details) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568069. Revised 2026-06-22. Available at: https://fevir.net/resources/Composition/568069. Computable resource at: https://fevir.net/resources/Composition/568069#json."     ]
  ] ) ; # 
  fhir:section ( [
fhir:title [ fhir:v "12 APPENDIX: SUPPORTING DETAILS" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
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 "12.1 Clinical Laboratory Tests" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
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 "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>7 pages of images replaced with this statement.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "12.2 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: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 "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not applicable.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
fhir:title [ fhir:v "12.3 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: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 "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not applicable. This is the first protocol amendment.</p></div>"^^rdf:XMLLiteral ]       ]     ] )
  ] ) . #