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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    {
      "resourceType" : "Composition",
      "id" : "Narrative-Complex",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
        ]
      },
      "language" : "en",
      "text" : {
        "status" : "generated",
        "div" : "<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>"
      },
      "contained" : [
        {
          "resourceType" : "Binary",
          "id" : "exemplar-logo",
          "contentType" : "image/jpeg",
          "data" : " "
        }
      ],
      "status" : "final",
      "type" : {
        "coding" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C207508"
          }
        ]
      },
      "date" : "2025-06-30T12:46:00Z",
      "author" : [
        {
          🔗 "reference" : "Organization/Narrative-Organization"
        }
      ],
      "title" : "Narrative 15",
      "relatesTo" : [
        {
          "type" : "supported-with",
          "targetReference" : {
            "reference" : "#exemplar-logo"
          }
        }
      ],
      "section" : [
        {
          "title" : "1.1.2 Overall Design - {this is the Section Title}",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218517",
                "display" : "ICH M11 Protocol Section 1.1.2 Overall Design"
              }
            ]
          },
          "text" : {
            "status" : "additional",
            "div" : "<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 \\&quot;lorem ipsum\\&quot; incipiunt, sed ita translatae non sunt textus laetus.</p></div>"
          }
        },
        {
          "title" : "1.1.2 Overall Design - {this is the Section Title}",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218518",
                "display" : "ICH M11 Protocol Section 1.2 Trial Schema"
              }
            ]
          },
          "text" : {
            "status" : "additional",
            "div" : "<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 \\&quot;lorem ipsum\\&quot; incipiunt, sed ita translatae non sunt textus laetus.</p></div>"
          }
        },
        {
          "title" : "Formatting Possibilities",
          "code" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218519"
              }
            ]
          },
          "text" : {
            "status" : "additional",
            "div" : "<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 \\&quot;lorem ipsum\\&quot; 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\tStudy 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>"
          }
        },
        {
          "title" : "Section 15 - {this is the Section Title}",
          "code" : {
            "text" : "Uncoded Special Section"
          },
          "text" : {
            "status" : "additional",
            "div" : "<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 \\&quot;lorem ipsum\\&quot; incipiunt, sed ita translatae non sunt textus laetus.</p></div>"
          }
        }
      ]
    }