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Narrative

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Source1

{
  "resourceType": "Composition",
  "id": "IGBJ-Narrative-2.1",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
    ]
  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "http://hl7.org/fhir/uv/clinical-study-protocol/CodeSystem/narrative-elements-cs",
        "code": "b001",
        "display": "Protocol narrative"
      }
    ]
  },
  "subject": [
    {
      "reference": "ResearchStudy/IGBJ-ResearchStudy"
    }
  ],
  "date": "2025-06-03T12:46:00Z",
  "author": [
    {
      "reference": "Organization/IGBJ-Organization"
    }
  ],
  "title": "IGBJ Protocol Narrative 2.1",
  "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>"
      }
    }
  ]
}