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Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-568045.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Composition 568045

version: 2; Last updated: 2026-06-06 15:13:20+0000

Profile: M11ReportSection03

Artifact Description:

Example of M11ReportSection03 Profile

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568045

identifier: FEvIR Object Identifier/568045

status: Final

type: CeSHarP Report

category: section3-estimands

date: 2026-06-06 15:13:20+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template

custodian: Computable Publishing LLC

relatesTo

type: Derived from

target: M11ResearchStudy Template

relatesTo

type: Cite As

target:

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 2026-06-06. Available at: https://fevir.net/resources/Composition/568045. Computable resource at: https://fevir.net/resources/Composition/568045#json.


Source1

{
  "resourceType": "Composition",
  "id": "568045",
  "meta": {
    "versionId": "2",
    "lastUpdated": "2026-06-06T15:13:20.281Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-03"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
      "valueMarkdown": "Example of M11ReportSection03 Profile"
    },
    {
      "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": "2026-06-06T15:13:20.281Z",
  "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": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "derived-from",
            "display": "Derived from"
          }
        ]
      },
      "targetReference": {
        "reference": "ResearchStudy/568025",
        "type": "ResearchStudy",
        "display": "M11ResearchStudy Template"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/artifact-relationship-type",
            "code": "cite-as",
            "display": "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 2026-06-06. 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>"
          }
        }
      ]
    }
  ]
}