{ "description": "Group of items providing information about interventional studys", "_filename": "StructureDefinition-nfdi4health-ex-mds-study-interventional.json", "package_name": "de.nfdi4health.mds", "date": null, "derivation": "constraint", "publisher": "NFDI4Health", "fhirVersion": "4.0.1", "name": "NFDI4Health_EX_MDS_Study_Interventional", "mapping": [ { "uri": "http://hl7.org/v3", "name": "RIM Mapping", "identity": "rim" }, { "name": "NFDI4Health to FHIR Mapping", "identity": "NFDI4Health" } ], "abstract": false, "type": "Extension", "experimental": null, "resourceType": "StructureDefinition", "title": "NFDI4Health EX MDS Study Interventional", "package_version": "2.0.0", "status": "draft", "id": "8fda55ab-6014-46ce-83d2-c3cfc89568cd", "kind": "complex-type", "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional", "context": [ { "type": "element", "expression": "ResearchStudy" } ], "version": null, "differential": { "element": [ { "id": "Extension", "max": "1", "path": "Extension", "short": "Interventional aspects of the [RESOURCE]", "mapping": [ { "map": "Design.interventional", "identity": "NFDI4Health" } ], "definition": "Group of items providing information about specific interventional aspects of the [RESOURCE]." }, { "id": "Extension.extension:masking", "max": "1", "min": 0, "path": "Extension.extension", "type": [ { "code": "Extension", "profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-masking" ] } ], "sliceName": "masking" }, { "path": "Extension.extension", "min": 0, "definition": "Type of allocation/assignment of individual participants of the [RESOURCE] to an arm.", "short": "Type of allocation of participants to an arm", "mapping": [ { "map": "Design.interventional.allocation", "identity": "NFDI4Health" } ], "sliceName": "allocation", "max": "1", "id": "Extension.extension:allocation", "comment": "Short input help: Select one value from the list." }, { "id": "Extension.extension:allocation.extension", "max": "0", "path": "Extension.extension.extension" }, { "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." } }, { "path": "Extension.extension", "min": 0, "definition": "Unapproved (off-label) use of a drug product.", "short": "Off-label use of a drug product", "mapping": [ { "map": "Design.interventional.offLabelUse", "identity": "NFDI4Health" } ], "sliceName": "offLabelUse", "max": "1", "id": "Extension.extension:offLabelUse", "comment": "Short input help: Select 'Yes' or 'No' only for a drug [RESOURCE] and 'Not applicable' for any other [RESOURCE]." }, { "id": "Extension.extension:offLabelUse.extension", "max": "0", "path": "Extension.extension.extension" }, { "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]", "max": "0", "path": "Extension.value[x]" } ] }, "contact": [ { "telecom": [ { "value": "https://www.nfdi4health.de", "system": "url" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension" }