{
"description": "Additions for M11 not otherwise dealt with",
"_filename": "StructureDefinition-m11-research-study.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",
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"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"display": "World"
} ]
} ],
"name": "M11_ResearchStudy",
"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": "M11 Research Study Extension",
"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"
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"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": {
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"severity": "error",
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} ],
"path": "Extension",
"min": 0,
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"min": 0,
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"identity": "rim"
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}, {
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},
"isSummary": true
}, {
"constraint": [ {
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} ],
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"isModifier": false,
"short": "Original Protocol Indicator",
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"identity": "rim"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"binding": {
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"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"
},
"max": "1",
"id": "Extension.extension:originalProtocol.value[x]",
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},
"isSummary": true
}, {
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"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())"
} ],
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"definition": "An Extension",
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"short": "Extension",
"type": [ {
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} ],
"sliceName": "versionDate",
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"min": 0,
"path": "Element.extension"
},
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} ],
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"valueUrl": "id"
} ]
} ],
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"path": "Element.id"
},
"isSummary": false
}, {
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"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "Extension.extension.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
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"discriminator": [ {
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"type": "value"
} ]
},
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} ],
"max": "0",
"id": "Extension.extension:versionDate.extension",
"base": {
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"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"path": "Extension.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": "versionDate",
"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.extension:versionDate.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.extension.value[x]",
"min": 0,
"definition": "The date on which the document is versioned.",
"isModifier": false,
"short": "Protocol version date",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
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} ],
"max": "1",
"id": "Extension.extension:versionDate.value[x]",
"condition": [ "ext-1" ],
"comment": "The date on ResearchStudy is the date the resource last significantly changed - not the same as the protocol version date",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": true
}, {
"path": "Extension.url",
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"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/m11-research-study",
"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": [ {
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"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
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} ],
"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": "Value of extension",
"mapping": [ {
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"identity": "rim"
} ],
"type": [ {
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}, {
"code": "boolean"
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"code": "canonical"
}, {
"code": "code"
}, {
"code": "date"
}, {
"code": "dateTime"
}, {
"code": "decimal"
}, {
"code": "id"
}, {
"code": "instant"
}, {
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}, {
"code": "integer64"
}, {
"code": "markdown"
}, {
"code": "oid"
}, {
"code": "positiveInt"
}, {
"code": "string"
}, {
"code": "time"
}, {
"code": "unsignedInt"
}, {
"code": "uri"
}, {
"code": "url"
}, {
"code": "uuid"
}, {
"code": "Address"
}, {
"code": "Age"
}, {
"code": "Annotation"
}, {
"code": "Attachment"
}, {
"code": "CodeableConcept"
}, {
"code": "CodeableReference"
}, {
"code": "Coding"
}, {
"code": "ContactPoint"
}, {
"code": "Count"
}, {
"code": "Distance"
}, {
"code": "Duration"
}, {
"code": "HumanName"
}, {
"code": "Identifier"
}, {
"code": "Money"
}, {
"code": "Period"
}, {
"code": "Quantity"
}, {
"code": "Range"
}, {
"code": "Ratio"
}, {
"code": "RatioRange"
}, {
"code": "Reference"
}, {
"code": "SampledData"
}, {
"code": "Signature"
}, {
"code": "Timing"
}, {
"code": "ContactDetail"
}, {
"code": "DataRequirement"
}, {
"code": "Expression"
}, {
"code": "ParameterDefinition"
}, {
"code": "RelatedArtifact"
}, {
"code": "TriggerDefinition"
}, {
"code": "UsageContext"
}, {
"code": "Availability"
}, {
"code": "ExtendedContactDetail"
}, {
"code": "Dosage"
}, {
"code": "Meta"
} ],
"max": "0",
"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": "e68c7da1-d826-4453-acca-3bafd17e2866",
"kind": "complex-type",
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study",
"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": "Additional concepts for M11",
"comment": "Additional concepts required by M11 that have no other obvious home.",
"definition": "Signature and date for approval."
}, {
"id": "Extension.extension",
"min": 2,
"path": "Extension.extension"
}, {
"id": "Extension.extension:originalProtocol",
"max": "1",
"min": 1,
"path": "Extension.extension",
"sliceName": "originalProtocol",
"mustSupport": true
}, {
"id": "Extension.extension:originalProtocol.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:originalProtocol.url",
"path": "Extension.extension.url",
"fixedUri": "originalProtocol"
}, {
"id": "Extension.extension:originalProtocol.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "CodeableConcept"
} ],
"short": "Original Protocol Indicator",
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs"
},
"definition": "An indication as to whether the protocol document reflects the original version of the protocol.."
}, {
"id": "Extension.extension:versionDate",
"max": "1",
"min": 1,
"path": "Extension.extension",
"sliceName": "versionDate"
}, {
"id": "Extension.extension:versionDate.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:versionDate.url",
"path": "Extension.extension.url",
"fixedUri": "versionDate"
}, {
"id": "Extension.extension:versionDate.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "date"
} ],
"short": "Protocol version date",
"comment": "The date on ResearchStudy is the date the resource last significantly changed - not the same as the protocol version date",
"definition": "The date on which the document is versioned."
}, {
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
}, {
"id": "Extension.value[x]",
"max": "0",
"path": "Extension.value[x]"
} ]
},
"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"
}