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Source1
{
"resourceType": "StructureDefinition",
"id": "nfdi4health-ex-mds-study-interventional",
"url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional",
"name": "NFDI4Health_EX_MDS_Study_Interventional",
"title": "NFDI4Health EX MDS Study Interventional",
"status": "draft",
"publisher": "NFDI4Health",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "https://www.nfdi4health.de"
}
]
}
],
"description": "Group of items providing information about interventional studys",
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
},
{
"identity": "NFDI4Health",
"name": "NFDI4Health to FHIR Mapping"
}
],
"kind": "complex-type",
"abstract": false,
"context": [
{
"type": "element",
"expression": "ResearchStudy"
}
],
"type": "Extension",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "Extension",
"path": "Extension",
"short": "Interventional aspects of the [RESOURCE]",
"definition": "Group of items providing information about specific interventional aspects of the [RESOURCE].",
"max": "1",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.interventional"
}
]
},
{
"id": "Extension.extension:masking",
"path": "Extension.extension",
"sliceName": "masking",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-masking"
]
}
]
},
{
"id": "Extension.extension:allocation",
"path": "Extension.extension",
"sliceName": "allocation",
"short": "Type of allocation of participants to an arm",
"definition": "Type of allocation/assignment of individual participants of the [RESOURCE] to an arm.",
"comment": "Short input help: Select one value from the list.",
"min": 0,
"max": "1",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.interventional.allocation"
}
]
},
{
"id": "Extension.extension:allocation.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:allocation.url",
"path": "Extension.extension.url",
"fixedUri": "allocation"
},
{
"id": "Extension.extension:allocation.value[x]",
"path": "Extension.extension.value[x]",
"type": [
{
"code": "Coding"
}
],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-allocation-nci",
"description": "Value set defining codes to specify the subject allocation in a (sub-)study in a ResearchStudy resource."
}
},
{
"id": "Extension.extension:offLabelUse",
"path": "Extension.extension",
"sliceName": "offLabelUse",
"short": "Off-label use of a drug product",
"definition": "Unapproved (off-label) use of a drug product.",
"comment": "Short input help: Select 'Yes' or 'No' only for a drug study and 'Not applicable' otherwise.",
"min": 0,
"max": "1",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.interventional.offLabelUse"
}
]
},
{
"id": "Extension.extension:offLabelUse.extension",
"path": "Extension.extension.extension",
"max": "0"
},
{
"id": "Extension.extension:offLabelUse.url",
"path": "Extension.extension.url",
"fixedUri": "offLabelUse"
},
{
"id": "Extension.extension:offLabelUse.value[x]",
"path": "Extension.extension.value[x]",
"type": [
{
"code": "Coding"
}
],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-yes-no-not-applicable-snomedct",
"description": "Value set used to respond to questions that can be answered Yes, No, or Not Applicable."
}
},
{
"id": "Extension.url",
"path": "Extension.url",
"fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional"
},
{
"id": "Extension.value[x]",
"path": "Extension.value[x]",
"max": "0"
}
]
}
}