{
"description": "Extension zur Abbildung des Ethikvotums eines Forschungsvorhabens mit Status, Ethikkommission und Bearbeitungsnummer.",
"_filename": "StructureDefinition-mii-ex-studie-ethikvotum.json",
"package_name": "de.medizininformatikinitiative.kerndatensatz.studie",
"date": "2026-01-09",
"derivation": "constraint",
"meta": {
"profile": [ "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablestructuredefinition", "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablestructuredefinition" ],
"extension": [ {
"url": "http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-license",
"valueCode": "CC-BY-4.0"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/package-source",
"extension": [ {
"url": "packageId",
"valueId": "de.medizininformatikinitiative.kerndatensatz.studie"
}, {
"url": "version",
"valueString": "2027.0.0-ballot"
}, {
"url": "uri",
"valueUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie"
} ]
} ]
},
"publisher": "NUM-DIZ",
"fhirVersion": "4.0.1",
"jurisdiction": [ {
"coding": [ {
"code": "DE",
"system": "urn:iso:std:iso:3166",
"display": "Germany"
} ]
} ],
"name": "MII_EX_Studie_Ethikvotum",
"abstract": false,
"type": "Extension",
"experimental": "false",
"resourceType": "StructureDefinition",
"title": "MII EX Studie Ethikvotum",
"_description": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "de"
}, {
"url": "content",
"valueString": "Extension zur Abbildung des Ethikvotums eines Forschungsvorhabens mit Status, Ethikkommission und Bearbeitungsnummer."
} ]
}, {
"url": "http://hl7.org/fhir/StructureDefinition/translation",
"extension": [ {
"url": "lang",
"valueCode": "en"
}, {
"url": "content",
"valueString": "Extension describing the ethics approval of a research study including status, ethics committee and reference number."
} ]
} ]
},
"package_version": "2027.0.0-ballot",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm",
"valueCoding": {
"code": "semver",
"system": "http://hl7.org/fhir/version-algorithm",
"display": "SemVer"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability",
"valueCode": "shareable"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability",
"valueCode": "publishable"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy",
"valueCodeableConcept": {
"coding": [ {
"code": "package",
"system": "http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes",
"display": "Package",
"version": "3.0.0"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-usage",
"valueMarkdown": "Use this extension to exchange data for content of the corresponding Medical Informatics Initiative logical model that is not represented in the FHIR core resource structure."
}, {
"url": "http://hl7.org/fhir/StructureDefinition/resource-approvalDate",
"valueDate": "2026-01-09"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/resource-effectivePeriod",
"valuePeriod": {
"start": "2027"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-topic",
"valueCodeableConcept": {
"coding": [ {
"code": "C15206",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-topic",
"valueCodeableConcept": {
"coding": [ {
"code": "C15429",
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-author",
"valueContactDetail": {
"name": "Matthias Löbe",
"telecom": [ {
"value": "matthias.loebe@imise.uni-leipzig.de",
"system": "email"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
"valueContactDetail": {
"name": "Taskforce Core Data Set"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
"valueContactDetail": {
"name": "Thomas Debertshäuser",
"telecom": [ {
"value": "thomas.debertshaeuser@charite.de",
"system": "email"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
"valueContactDetail": {
"name": "Margaux Gatrio",
"telecom": [ {
"value": "margaux.gatrio@bih-charite.de",
"system": "email"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer",
"valueContactDetail": {
"name": "Interoperability Working Group",
"telecom": [ {
"value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group",
"system": "url"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer",
"valueContactDetail": {
"name": "National Steering Committee",
"telecom": [ {
"value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee",
"system": "url"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser",
"valueContactDetail": {
"name": "Interoperability Working Group",
"telecom": [ {
"value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group",
"system": "url"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser",
"valueContactDetail": {
"name": "National Steering Committee",
"telecom": [ {
"value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee",
"system": "url"
} ]
}
} ],
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"path": "Extension.url"
},
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}, {
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"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": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum",
"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": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"xpath": "@value|f:*|h:div",
"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://hl7.org/fhir/R4/extensibility.html) for a list).",
"isModifier": false,
"short": "Value of extension",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "base64Binary"
}, {
"code": "boolean"
}, {
"code": "canonical"
}, {
"code": "code"
}, {
"code": "date"
}, {
"code": "dateTime"
}, {
"code": "decimal"
}, {
"code": "id"
}, {
"code": "instant"
}, {
"code": "integer"
}, {
"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": "Coding"
}, {
"code": "ContactPoint"
}, {
"code": "Count"
}, {
"code": "Distance"
}, {
"code": "Duration"
}, {
"code": "HumanName"
}, {
"code": "Identifier"
}, {
"code": "Money"
}, {
"code": "Period"
}, {
"code": "Quantity"
}, {
"code": "Range"
}, {
"code": "Ratio"
}, {
"code": "Reference"
}, {
"code": "SampledData"
}, {
"code": "Signature"
}, {
"code": "Timing"
}, {
"code": "ContactDetail"
}, {
"code": "Contributor"
}, {
"code": "DataRequirement"
}, {
"code": "Expression"
}, {
"code": "ParameterDefinition"
}, {
"code": "RelatedArtifact"
}, {
"code": "TriggerDefinition"
}, {
"code": "UsageContext"
}, {
"code": "Dosage"
}, {
"code": "Meta"
} ],
"max": "0",
"id": "Extension.value[x]",
"base": {
"max": "1",
"min": 0,
"path": "Extension.value[x]"
},
"isSummary": false
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.0.1"
} ]
},
"status": "active",
"id": "90358a75-cd4e-4bad-815a-fe478da125d1",
"kind": "complex-type",
"url": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum",
"context": [ {
"type": "element",
"expression": "ResearchStudy"
} ],
"version": "2027.0.0-ballot",
"differential": {
"element": [ {
"id": "Extension",
"path": "Extension"
}, {
"id": "Extension.extension",
"min": 3,
"path": "Extension.extension"
}, {
"id": "Extension.extension:status",
"max": "1",
"min": 1,
"path": "Extension.extension",
"sliceName": "status",
"mustSupport": true
}, {
"id": "Extension.extension:status.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:status.url",
"path": "Extension.extension.url",
"fixedUri": "status"
}, {
"id": "Extension.extension:status.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.extension:kommission",
"max": "1",
"min": 1,
"path": "Extension.extension",
"sliceName": "kommission",
"mustSupport": true
}, {
"id": "Extension.extension:kommission.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:kommission.url",
"path": "Extension.extension.url",
"fixedUri": "kommission"
}, {
"id": "Extension.extension:kommission.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.extension:ethiknummer",
"max": "1",
"min": 1,
"path": "Extension.extension",
"sliceName": "ethiknummer",
"mustSupport": true
}, {
"id": "Extension.extension:ethiknummer.extension",
"max": "0",
"path": "Extension.extension.extension"
}, {
"id": "Extension.extension:ethiknummer.url",
"path": "Extension.extension.url",
"fixedUri": "ethiknummer"
}, {
"id": "Extension.extension:ethiknummer.value[x]",
"path": "Extension.extension.value[x]",
"type": [ {
"code": "string"
} ]
}, {
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum"
}, {
"id": "Extension.value[x]",
"max": "0",
"path": "Extension.value[x]"
} ]
},
"contact": [ {
"name": "NUM-DIZ",
"telecom": [ {
"value": "https://www.netzwerk-universitaetsmedizin.de",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}