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-ballot2 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

• Narrative Content
• XML
• JSON
• TTL

: IGBJ Protocol Narrative 2.1 - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "399866",
  "meta" : {
    "versionId" : "2",
    "lastUpdated" : "2025-09-14T18:15:51.793Z",
    "profile" : [
      "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-narratives"
    ]
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Composition IGBJ-Narrative-2.1</b></p><a name=\"IGBJ-Narrative-2.1\"> </a><a name=\"hcIGBJ-Narrative-2.1\"> </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\"/><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://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs b001}\">Protocol narrative</span></p><p><b>date</b>: 2025-06-03 12:46:00+0000</p><p><b>author</b>: <a href=\"Organization-IGBJ-Organization.html\">Organization Eli Lilly Japan K.K</a></p><p><b>title</b>: IGBJ Protocol Narrative 2.1</p></div>"
  },
  "url" : "https://fevir.net/resources/Composition/399866",
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ACSN",
            "display" : "Accession ID"
          }
        ],
        "text" : "FEvIR Object Identifier"
      },
      "system" : "https://fevir.net/FOI",
      "value" : "399866",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    }
  ],
  "status" : "final",
  "type" : {
    "coding" : [
      {
        "system" : "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs",
        "code" : "b001",
        "display" : "Protocol narrative"
      }
    ]
  },
  "subject" : [
    {
      🔗 "reference" : "ResearchStudy/399864",
      "type" : "ResearchStudy",
      "display" : "A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus (399864)"
    }
  ],
  "date" : "2025-09-14T18:15:51.793Z",
  "author" : [
    {
      🔗 "reference" : "Organization/399869",
      "type" : "Organization",
      "display" : "Eli Lilly Japan K.K (399869)"
    }
  ],
  "title" : "IGBJ Protocol Narrative 2.1",
  "custodian" : {
    🔗 "reference" : "Organization/118079",
    "type" : "Organization",
    "display" : "Computable Publishing LLC"
  },
  "relatesTo" : [
    {
      "type" : "cite-as",
      "targetMarkdown" : "IGBJ Protocol Narrative 2.1 [Database Entry: FHIR Composition Resource]. Contributors: Eli Lilly Japan K.K (399869) [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399866. Revised 2025-09-14. Available at: https://fevir.net/resources/Composition/399866. Computable resource at: https://fevir.net/resources/Composition/399866#json."
    }
  ],
  "section" : [
    {
      "title" : "2.1 Purpose of Trial",
      "code" : {
        "coding" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C218521"
          }
        ]
      },
      "text" : {
        "status" : "additional",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">|1. have had a diagnosis of either:| |a. T1DM based on the World Health Organization (WHO) diagnostic criteria, and have been on the following daily insulin therapy for at least 1 year ​ i. multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or ​ ii. continuous subcutaneous insulin infusion (CSII) | |**Or** b. T2DM based on the WHO diagnostic criteria, and have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year ​ i. insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII ​ ii. OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine | | tabl title | | ---------- | | row 1 | | row 2 | | row 3 |</div>"
      }
    }
  ]
}