{
"description": "Narrative content for the ResearchStudy.",
"_filename": "StructureDefinition-narrative-elements.json",
"package_name": "hl7.fhir.uv.clinical-study-protocol",
"date": "2026-04-08T21:16:18+10:00",
"derivation": "constraint",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": "6.0.0-ballot3",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"name": "NarrativeElements",
"mapping": [ {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
} ],
"abstract": false,
"copyright": "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nCDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
"type": "Extension",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "Narrative Elements",
"package_version": "1.0.0-ballot2",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
"valueCode": "can-bind"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 2
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
} ]
}
} ],
"snapshot": {
"element": [ {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "Extension",
"min": 0,
"definition": "Narrative content for the ResearchStudy.",
"isModifier": false,
"short": "Narrative Elements",
"max": "*",
"id": "Extension",
"base": {
"max": "*",
"min": 0,
"path": "Extension"
}
}, {
"path": "Extension.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"max": "0",
"id": "Extension.extension",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.url",
"min": 1,
"definition": "Source of the definition for the extension code - a logical name or a URL.",
"isModifier": false,
"short": "identifies the meaning of the extension",
"fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "uri"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "Extension.url",
"comment": "The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.",
"base": {
"max": "1",
"min": 1,
"path": "Extension.url"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.value[x]",
"min": 0,
"definition": "Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).",
"isModifier": false,
"short": "Pointer to the narrative content for the protocol",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ]
} ],
"max": "1",
"id": "Extension.value[x]",
"condition": [ "ext-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "6.0.0-ballot3"
} ]
},
"status": "active",
"id": "226abd56-a76b-48b8-8791-479018d2c371",
"kind": "complex-type",
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
"context": [ {
"type": "element",
"expression": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy"
} ],
"version": "1.0.0-ballot2",
"differential": {
"element": [ {
"id": "Extension",
"path": "Extension",
"short": "Narrative Elements",
"definition": "Narrative content for the ResearchStudy."
}, {
"id": "Extension.extension",
"max": "0",
"path": "Extension.extension"
}, {
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"
}, {
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives" ]
} ],
"short": "Pointer to the narrative content for the protocol"
} ]
},
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "UDP@HL7Vulcan.org",
"system": "email"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}