{
  "description": "Extension informing the unapproved (off-label) use of a drug product in a study.",
  "_filename": "StructureDefinition-nfdi4health-ex-mds-off-label-use.json",
  "package_name": "de.nfdi4health.mds",
  "date": null,
  "derivation": "constraint",
  "publisher": "NFDI4Health",
  "fhirVersion": "4.0.1",
  "name": "NFDI4Health_EX_MDS_Off_Label_Use",
  "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 Off Label Use",
  "package_version": "1.0.0",
  "status": "draft",
  "id": "37bdc7a4-f894-478c-84a8-bfa0ffad6f27",
  "kind": "complex-type",
  "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-off-label-use",
  "context": [ {
    "type": "element",
    "expression": "ResearchStudy"
  } ],
  "version": "0.9",
  "differential": {
    "element": [ {
      "id": "Extension",
      "max": "1",
      "path": "Extension",
      "short": "Off-label use of a drug product",
      "comment": "Short input help: Select 'Yes' or 'No' only for drug studies and 'Not applicable' for all other studies.",
      "mapping": [ {
        "map": "1.17.37.4 Resource.studyDesign.interventional.offLabelUse",
        "identity": "NFDI4Health"
      } ],
      "definition": "Unapproved (off-label) use of a drug product."
    }, {
      "id": "Extension.extension",
      "max": "0",
      "path": "Extension.extension"
    }, {
      "id": "Extension.url",
      "path": "Extension.url",
      "fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-off-label-use"
    }, {
      "id": "Extension.value[x]",
      "min": 1,
      "path": "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.value[x].system",
      "min": 1,
      "path": "Extension.value[x].system"
    }, {
      "id": "Extension.value[x].code",
      "min": 1,
      "path": "Extension.value[x].code"
    } ]
  },
  "contact": [ {
    "telecom": [ {
      "value": "https://www.nfdi4health.de",
      "system": "url"
    } ]
  } ],
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}