Clinical Study Protocol
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## : Example Narrative Composition per M11 Section - Section 2

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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:Composition ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "Narrative-Composition-per-M11-Section-2"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives>     ] )
      ] ; #
      fhir:language [ fhir:v "en"] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    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: Composition Narrative-Composition-per-M11-Section-2</b></p><a name=\"Narrative-Composition-per-M11-Section-2\"> </a><a name=\"hcNarrative-Composition-per-M11-Section-2\"> </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-narratives.html\">Research Study Narratives</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207508}\">Narrative Content Text</span></p><p><b>date</b>: 2025-06-30 12:46:00+0000</p><p><b>author</b>: <a href=\"Organization-Narrative-Organization.html\">Organization Exemplar Pharmaceuticals Co.</a></p><p><b>title</b>: Example Narrative Composition per M11 Section - Section 21 - (this is the Composition Title}</p></div>"^^rdf:XMLLiteral ]
      ] ; #
      fhir:status [ fhir:v "final"] ; #
      fhir:type [
        ( 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 "C207508" ]     ] )
      ] ; #
      fhir:date [ fhir:v "2025-06-30T12:46:00Z"^^xsd:dateTime] ; #
      fhir:author ( [
    fhir:l fhir:Organization/Narrative-Organization ;
    fhir:reference [ fhir:v "Organization/Narrative-Organization" ]
      ] ) ; #
      fhir:title [ fhir:v "Example Narrative Composition per M11 Section - Section 21 - (this is the Composition Title}"] ; #
      fhir:section ( [
    fhir:title [ fhir:v "2 INTRODUCTION  - {this is the Section Title}" ] ;
    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 "C218520" ] ;
    fhir:display [ fhir:v "ICH M11 Protocol Section 2 INTRODUCTION" ]       ] )     ] ;
    fhir:text [
    fhir:status [ fhir:v "additional" ] ;
    fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h1>2 INTRODUCTION</h1><h2>2.1 Purpose of Trial</h2><p>Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus.</p><h2>2.2 Assessment of Risks and Benefits</h2><p>Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus.</p><h3>2.2.1 Risk Summary and Mitigation Strategy</h3><p>Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus.</p><h3>2.2.2 Benefit Summary</h3><p>Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus.</p><h3>2.2.3 Overall Risk-Benefit Assessment</h3><p>Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus.</p></div>"^^rdf:XMLLiteral ]     ]
      ] ) . #