@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/568057> a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "568057"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "2" ] ;
     fhir:lastUpdated [ fhir:v "2026-05-30T15:48:01.025Z"^^xsd:dateTime ] ;
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-container"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-container>
     ] )
  ] ; # 
  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 568057</b></p><a name=\"568057\"> </a><a name=\"hc568057\"> </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: 2; Last updated: 2026-05-30 15:48:01+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-container.html\">M11ReportContainer</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/568057\">https://fevir.net/resources/Composition/568057</a></p><p><b>identifier</b>: FEvIR Object Identifier/568057</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>date</b>: 2026-05-30 15:48:01+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report 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 for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568057. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568057. Computable resource at: https://fevir.net/resources/Composition/568057#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/568057"^^xsd:anyURI ;
     fhir:l <https://fevir.net/resources/Composition/568057>
  ] ; # 
  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 "568057" ] ;
     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: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 "2026-05-30T15:48:01.025Z"^^xsd:dateTime] ; # 
  fhir:author ( [
     fhir:display [ fhir:v "Brian S. Alper, MD, MSPH" ]
  ] ) ; # 
  fhir:title [ fhir:v "M11 Report 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 for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568057. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568057. Computable resource at: https://fevir.net/resources/Composition/568057#json."
     ]
  ] ) ; # 
  fhir:section ( [
     fhir:title [ fhir:v "Title Page" ] ;
     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 "C222769" ] ;
         fhir:display [ fhir:v "ICH M11 Protocol Section Title Page" ]
       ] ) ;
       fhir:text [ fhir:v "section0-title-page" ]
     ] ;
     fhir:text [
       fhir:status [ fhir:v "additional" ] ;
       fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><td>Full Title:</td><td>M11ResearchStudy Template</td></tr><tr><td>Sponsor Protocol Identifier:</td><td>[Replace with a unique alphanumeric identifier for the trial, designated by the sponsor.]</td></tr><tr><td>Original Protocol:</td><td>[Original Protocol Indicator]</td></tr><tr><td>Version Number:</td><td>[For use by the sponsor at their discretion.]</td></tr><tr><td>Version Date:</td><td>[For use by the sponsor at their discretion.]</td></tr><tr><td>Sponsor’s Investigational Product Code(s):</td><td>[Enter the sponsor’s unique identifier for investigational product(s) in the trial.Add fields as needed.]</td></tr><tr><td>Investigational Product Name(s):</td><td>[Omit nonproprietary name field if a nonproprietary name has not yet been assigned. Omit proprietary name field if not yet established.]</td></tr><tr><td>Trial Phase:</td><td>[For trials combining investigational drugs or vaccines with devices, classify according to the phase of drug development.]</td></tr><tr><td>Sponsor Name and Address:</td><td><p>[Enter Sponsor Name.]</p><p>[Enter Sponsor Legal Address.]</p><p>[Add headings and lines for each Co-Sponsor Name and Address: and Local Sponsor Name and Address: if needed.]</p></td></tr><tr><td>Device Manufacturer Name and Address:</td><td>[Manufacturer name and address information is required only for drug / device combination protocols that include investigational device(s) and should not be included for other protocols.Include the manufacturer address only if the manufacturer is different than the sponsor listed above. Add additional fields as needed if multiple investigational devices will be used in the trial or if there are multiple manufacturers for a single device. Delete this line if not applicable.]</td></tr><tr><td>Regulatory or Clinical Trial Identifier(s):</td><td><p>FOI 568025</p><p>identifier [To be replaced] assigned by [To be replaced]</p></td></tr><tr><td>Sponsor Approval:</td><td>[Enter Sponsor Approval Date or State location where sponsor approval information can be found]</td></tr></tbody></table><p>Sponsor Signatory: [Enter sponsor signatory (e.g., name, title, signature and date, or tate location where sponsor signatory information can be found (e.g., electronic signature)]</p><p>Medical Expert Contact: [Enter Medical Expert contact information(as designated by sponsor, or State location where Medical Expert contact information can be found]</p><p>Amendment Details [For an original protocol that has not been amended, state { This protocol has not been amended.} Otherwise state { This is the first protocol amendment.} Or { This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).}]</p></div>"^^rdf:XMLLiteral ]
     ]
  ] [
     fhir:title [ fhir:v "Sections 1-14" ] ;
     fhir:code [
       fhir:text [ fhir:v "sections" ]
     ] ;
     fhir:text [
       fhir:status [ fhir:v "empty" ] ;
       fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Entries should Reference Composition Resource (M11ReportSection01 through M11ReportSection14 Profiles).]</div>"^^rdf:XMLLiteral ]
     ] ;
     fhir:entry ( [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568043> ;
       fhir:reference [ fhir:v "Composition/568043" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 1 (Protocol Summary) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568044> ;
       fhir:reference [ fhir:v "Composition/568044" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 2 (Introduction) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568045> ;
       fhir:reference [ fhir:v "Composition/568045" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568046> ;
       fhir:reference [ fhir:v "Composition/568046" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 4 (Trial Design) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568047> ;
       fhir:reference [ fhir:v "Composition/568047" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 5 (Trial Population) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568048> ;
       fhir:reference [ fhir:v "Composition/568048" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 6 (Trial Intervention) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568049> ;
       fhir:reference [ fhir:v "Composition/568049" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 7 (Participant Discontinuation) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568050> ;
       fhir:reference [ fhir:v "Composition/568050" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568051> ;
       fhir:reference [ fhir:v "Composition/568051" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 9 (Adverse Events) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568052> ;
       fhir:reference [ fhir:v "Composition/568052" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 10 (Statistical Considerations) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568053> ;
       fhir:reference [ fhir:v "Composition/568053" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 11 (Trial Oversight) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568054> ;
       fhir:reference [ fhir:v "Composition/568054" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568055> ;
       fhir:reference [ fhir:v "Composition/568055" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 13 (Glossary) for M11ResearchStudy Template" ]
     ] [
       fhir:l <http://hl7.org/fhir/uv/ebm/Composition/568056> ;
       fhir:reference [ fhir:v "Composition/568056" ] ;
       fhir:type [
         fhir:v "Composition"^^xsd:anyURI ;
         fhir:l fhir:Composition
       ] ;
       fhir:display [ fhir:v "M11 Report Section 14 (References) for M11ResearchStudy Template" ]
     ] )
  ] ) . # 

<http://hl7.org/fhir/uv/ebm/ResearchStudy/568025> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Organization/118079> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568043> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568044> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568045> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568046> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568047> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568048> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568049> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568050> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568051> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568052> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568053> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568054> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568055> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Composition/568056> a fhir:Uv .

# -------------------------------------------------------------------------------------

