Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : Example Narrative Complex - Other Patterns and Non M11 Content Suggestion

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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-Complex"] ; #
      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-Complex</b></p><a name=\"Narrative-Complex\"> </a><a name=\"hcNarrative-Complex\"> </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>: Narrative 15</p><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Supported With</td><td><a href=\"#hcNarrative-Complex/exemplar-logo\">Binary: image/jpeg (16936 bytes base64)</a></td></tr></table><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Binary #exemplar-logo</b></p><a name=\"Narrative-Complex/exemplar-logo\"> </a><a name=\"hcNarrative-Complex/exemplar-logo\"> </a><p><b>contentType</b>: image/jpeg</p><p><b>data</b>: (base64 data - 16,936 base64 chars)</p></blockquote></div>"^^rdf:XMLLiteral ]
      ] ; #
      fhir:contained ( [
    a fhir:Binary ;
    fhir:id [ fhir:v "exemplar-logo" ] ;
    fhir:contentType [ fhir:v "image/jpeg" ] ;
    fhir:data [ fhir:v " "^^xsd:base64Binary ]
      ] ) ; #
      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 "Narrative 15"] ; #
      fhir:relatesTo ( [
    fhir:type [ fhir:v "supported-with" ] ;
    fhir:target [
    a fhir:Reference ;
    fhir:l <#exemplar-logo> ;
    fhir:reference [ fhir:v "#exemplar-logo" ]     ]
      ] ) ; #
      fhir:section ( [
    fhir:title [ fhir:v "1.1.2 Overall Design - {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 "C218517" ] ;
    fhir:display [ fhir:v "ICH M11 Protocol Section 1.1.2 Overall Design" ]       ] )     ] ;
    fhir:text [
    fhir:status [ fhir:v "additional" ] ;
    fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h3>1.1.2 Overall Design</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 ]     ]
      ] [
    fhir:title [ fhir:v "1.1.2 Overall Design - {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 "C218518" ] ;
    fhir:display [ fhir:v "ICH M11 Protocol Section 1.2 Trial Schema" ]       ] )     ] ;
    fhir:text [
    fhir:status [ fhir:v "additional" ] ;
    fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h2>1.2 Trial Schema</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></div>"^^rdf:XMLLiteral ]     ]
      ] [
    fhir:title [ fhir:v "Formatting Possibilities" ] ;
    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 "C218519" ]       ] )     ] ;
    fhir:text [
    fhir:status [ fhir:v "additional" ] ;
    fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><h2>1.3 Schedule of Activities</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><p>This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic.</p><p style=\"text-align: center\"><img src=\"#exemplar-logo\" alt=\"Exemplar Logo\"/></p><p style=\"text-align: center\"><b>Aromasin®</b></p><p>Figure 1	Study Schema</p><p>IV = intravenous; PBO = placebo; TCZ = tocilizumab.</p><p>This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic This section should contain a graphic.</p></div>"^^rdf:XMLLiteral ]     ]
      ] [
    fhir:title [ fhir:v "Section 15 - {this is the Section Title}" ] ;
    fhir:code [
    fhir:text [ fhir:v "Uncoded Special Section" ]     ] ;
    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>15 SPECIAL PURPOSE - NON M11</h1><h2>A section not in M11</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></div>"^^rdf:XMLLiteral ]     ]
      ] ) . #