{
  "resourceType" : "Composition",
  "id" : "568045",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2026-05-30T15:21:18.398Z",
    "profile" : ["http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-03"]
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Composition 568045</b></p><a name=\"568045\"> </a><a name=\"hc568045\"> </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\">version: 1; Last updated: 2026-05-30 15:21:18+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-report-section-03.html\">M11ReportSection03</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/568045\">https://fevir.net/resources/Composition/568045</a></p><p><b>identifier</b>: FEvIR Object Identifier/568045</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://loinc.org 35528-9}\">CeSHarP Report</span></p><p><b>category</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218526}\">section3-estimands</span></p><p><b>date</b>: 2026-05-30 15:21:18+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template</p><p><b>custodian</b>: <a href=\"Organization-118079.html\">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href=\"ResearchStudy-568025.html\">M11ResearchStudy Template</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568045. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568045. Computable resource at: https://fevir.net/resources/Composition/568045#json.</p>\n</div></blockquote></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
    "valueCodeableConcept" : {
      "coding" : [{
        "system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
        "code" : "active",
        "display" : "Active"
      }]
    }
  }],
  "url" : "https://fevir.net/resources/Composition/568045",
  "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" : "568045",
    "assigner" : {
      "display" : "Computable Publishing LLC"
    }
  }],
  "status" : "final",
  "type" : {
    "coding" : [{
      "system" : "http://loinc.org",
      "code" : "35528-9",
      "display" : "Clinical trial protocol Clinical trial protocol"
    }],
    "text" : "CeSHarP Report"
  },
  "category" : [{
    "coding" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "code" : "C218526",
      "display" : "ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"
    }],
    "text" : "section3-estimands"
  }],
  "subject" : [{
    "reference" : "ResearchStudy/568025",
    "type" : "ResearchStudy",
    "display" : "M11ResearchStudy Template"
  }],
  "date" : "2026-05-30T15:21:18.398Z",
  "author" : [{
    "display" : "Brian S. Alper, MD, MSPH"
  }],
  "title" : "M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template",
  "custodian" : {
    "reference" : "Organization/118079",
    "type" : "Organization",
    "display" : "Computable Publishing LLC"
  },
  "relatesTo" : [{
    "type" : "derived-from",
    "targetReference" : {
      "reference" : "ResearchStudy/568025",
      "type" : "ResearchStudy",
      "display" : "M11ResearchStudy Template"
    }
  },
  {
    "type" : "cite-as",
    "targetMarkdown" : "M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568045. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568045. Computable resource at: https://fevir.net/resources/Composition/568045#json."
  }],
  "section" : [{
    "title" : "3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS",
    "code" : {
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C218526",
        "display" : "ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"
      }],
      "text" : "section3-estimands"
    },
    "text" : {
      "status" : "empty",
      "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No narrative text.]</p></div>"
    },
    "section" : [{
      "title" : "3.1 Primary Objective(s) and Associated Estimand(s)",
      "code" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218527",
          "display" : "ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)"
        }],
        "text" : "3.1-Primary-Objective(s)-and-Associated-Estimand(s)"
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Primary objective label: Primary Objective 1: [Replace with short label.]</p><p>Primary objective description: [Replace with description for a primary objective.]</p></div>"
      },
      "section" : [{
        "title" : "3.1.1 Primary Objective 1",
        "code" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C218528",
            "display" : "ICH M11 Protocol Section 3.1.1 Primary Objective"
          }]
        },
        "focus" : {
          "type" : "EvidenceVariable",
          "display" : "[Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]"
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>[Replace with short label for an outcome measure.]</p><p>Endpoint title: [Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]</p><p>Outcome description: [Replace with description for an outcome measure.]</p></td></tr></tbody></table></div>"
        },
        "entry" : [{
          "type" : "EvidenceVariable",
          "display" : "[Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]"
        }]
      }]
    },
    {
      "title" : "3.2 Secondary Objective(s) and Associated Estimand(s)",
      "code" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218529",
          "display" : "ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)"
        }],
        "text" : "3.2-Secondary-Objective(s)-and-Associated-Estimand(s)"
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: Secondary Objective 1: [Replace with short label.]</p><p>Secondary objective description: [Replace with description for a secondary objective.]</p></div>"
      },
      "section" : [{
        "title" : "3.2.1 Secondary Objective 1",
        "code" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C218530",
            "display" : "ICH M11 Protocol Section 3.2.1 Secondary Objective"
          }]
        },
        "focus" : {
          "type" : "EvidenceVariable",
          "display" : "[Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]"
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>[Replace with short label for an outcome measure.]</p><p>Endpoint title: [Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]</p><p>Outcome description: [Replace with description for an outcome measure.]</p></td></tr></tbody></table></div>"
        },
        "entry" : [{
          "type" : "EvidenceVariable",
          "display" : "[Replace with reference to an EvidenceVariable (VariableDefinition Profile)for a structured definition of an outcome measure.]"
        }]
      }]
    },
    {
      "title" : "3.3 Exploratory Objective(s)",
      "code" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218531",
          "display" : "ICH M11 Protocol Section 3.3 Exploratory Objective(s)"
        }],
        "text" : "3.3-Exploratory-Objective(s)"
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Not applicable</p></div>"
      }
    }]
  }]
}