{
  "description": "This observation captures if the patient participated in one or more interventional clinical trials.",
  "_filename": "Profile-Observation-InterventionalClinicalTrialParticipation.json",
  "package_name": "de.gecco",
  "date": "2020-10-29",
  "derivation": "constraint",
  "publisher": "Charité",
  "fhirVersion": "4.0.1",
  "name": "InterventionalClinicalTrialParticipation",
  "mapping": [ {
    "uri": "http://hl7.org/fhir/workflow",
    "name": "Workflow Pattern",
    "identity": "workflow"
  }, {
    "uri": "http://snomed.info/conceptdomain",
    "name": "SNOMED CT Concept Domain Binding",
    "identity": "sct-concept"
  }, {
    "uri": "http://hl7.org/v2",
    "name": "HL7 v2 Mapping",
    "identity": "v2"
  }, {
    "uri": "http://hl7.org/v3",
    "name": "RIM Mapping",
    "identity": "rim"
  }, {
    "uri": "http://hl7.org/fhir/fivews",
    "name": "FiveWs Pattern Mapping",
    "identity": "w5"
  }, {
    "uri": "http://snomed.org/attributebinding",
    "name": "SNOMED CT Attribute Binding",
    "identity": "sct-attr"
  } ],
  "abstract": false,
  "type": "Observation",
  "experimental": null,
  "resourceType": "StructureDefinition",
  "title": "Interventional Clinical Trial Participation",
  "package_version": "1.0.5",
  "status": "active",
  "id": "ed80b4a3-64f4-4e96-9ac6-299350f1bcba",
  "kind": "resource",
  "url": "https://www.netzwerk-universitaetsmedizin.de/fhir/StructureDefinition/interventional-clinical-trial-participation",
  "version": "1.0",
  "differential": {
    "element": [ {
      "id": "Observation.meta",
      "path": "Observation.meta",
      "mustSupport": true
    }, {
      "id": "Observation.meta.profile",
      "path": "Observation.meta.profile",
      "mustSupport": true
    }, {
      "id": "Observation.category",
      "min": 1,
      "path": "Observation.category",
      "mustSupport": true
    }, {
      "id": "Observation.category.coding",
      "min": 1,
      "path": "Observation.category.coding",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "pattern"
        } ]
      }
    }, {
      "id": "Observation.category.coding:observationCategory",
      "max": "1",
      "min": 1,
      "path": "Observation.category.coding",
      "sliceName": "observationCategory",
      "patternCoding": {
        "code": "survey",
        "system": "http://terminology.hl7.org/CodeSystem/observation-category"
      }
    }, {
      "id": "Observation.category.coding:observationCategory.system",
      "min": 1,
      "path": "Observation.category.coding.system"
    }, {
      "id": "Observation.category.coding:observationCategory.code",
      "min": 1,
      "path": "Observation.category.coding.code"
    }, {
      "id": "Observation.code",
      "path": "Observation.code",
      "mustSupport": true
    }, {
      "id": "Observation.code.coding",
      "min": 1,
      "path": "Observation.code.coding",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "pattern"
        } ]
      },
      "mustSupport": true
    }, {
      "id": "Observation.code.coding:trialParticipation",
      "max": "1",
      "min": 1,
      "path": "Observation.code.coding",
      "sliceName": "trialParticipation",
      "patternCoding": {
        "code": "03",
        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes"
      }
    }, {
      "id": "Observation.code.coding:trialParticipation.system",
      "min": 1,
      "path": "Observation.code.coding.system"
    }, {
      "id": "Observation.code.coding:trialParticipation.code",
      "min": 1,
      "path": "Observation.code.coding.code"
    }, {
      "id": "Observation.subject",
      "min": 1,
      "path": "Observation.subject",
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Patient", "http://hl7.org/fhir/StructureDefinition/Group" ]
      } ],
      "mustSupport": true
    }, {
      "id": "Observation.effective[x]",
      "path": "Observation.effective[x]",
      "mustSupport": true
    }, {
      "id": "Observation.value[x]",
      "min": 1,
      "path": "Observation.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "type"
        } ]
      },
      "mustSupport": true
    }, {
      "id": "Observation.value[x]:valueCodeableConcept",
      "path": "Observation.value[x]",
      "type": [ {
        "code": "CodeableConcept"
      } ],
      "sliceName": "valueCodeableConcept"
    }, {
      "id": "Observation.value[x]:valueCodeableConcept.coding",
      "min": 1,
      "path": "Observation.value[x].coding",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "pattern"
        } ]
      }
    }, {
      "id": "Observation.value[x]:valueCodeableConcept.coding:snomed",
      "max": "1",
      "min": 1,
      "path": "Observation.value[x].coding",
      "binding": {
        "strength": "required",
        "valueSet": "https://www.netzwerk-universitaetsmedizin.de/fhir/ValueSet/yes-no-unknown-other-na",
        "description": "Yes | No | Unknown"
      },
      "sliceName": "snomed",
      "patternCoding": {
        "system": "http://snomed.info/sct"
      }
    }, {
      "id": "Observation.value[x]:valueCodeableConcept.coding:snomed.system",
      "min": 1,
      "path": "Observation.value[x].coding.system"
    }, {
      "id": "Observation.value[x]:valueCodeableConcept.coding:snomed.code",
      "min": 1,
      "path": "Observation.value[x].coding.code"
    }, {
      "id": "Observation.bodySite",
      "max": "0",
      "path": "Observation.bodySite"
    }, {
      "id": "Observation.specimen",
      "max": "0",
      "path": "Observation.specimen"
    }, {
      "id": "Observation.component",
      "path": "Observation.component",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "code",
          "type": "pattern"
        } ]
      },
      "mustSupport": true
    }, {
      "id": "Observation.component:eudraCT",
      "path": "Observation.component",
      "short": "EudraCT number",
      "sliceName": "eudraCT",
      "definition": "EudraCT (European Union Drug Regulating Authorities Clinical Trials) registration number",
      "mustSupport": true
    }, {
      "id": "Observation.component:eudraCT.code",
      "path": "Observation.component.code",
      "mustSupport": true,
      "patternCodeableConcept": {
        "coding": [ {
          "code": "04",
          "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes"
        } ]
      }
    }, {
      "id": "Observation.component:eudraCT.code.coding",
      "min": 1,
      "path": "Observation.component.code.coding",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "pattern"
        } ]
      },
      "mustSupport": true
    }, {
      "id": "Observation.component:eudraCT.code.coding:eudraCT",
      "max": "1",
      "min": 1,
      "path": "Observation.component.code.coding",
      "sliceName": "eudraCT",
      "patternCoding": {
        "code": "04",
        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes"
      }
    }, {
      "id": "Observation.component:eudraCT.code.coding:eudraCT.system",
      "min": 1,
      "path": "Observation.component.code.coding.system"
    }, {
      "id": "Observation.component:eudraCT.code.coding:eudraCT.code",
      "min": 1,
      "path": "Observation.component.code.coding.code"
    }, {
      "id": "Observation.component:eudraCT.value[x]",
      "min": 1,
      "path": "Observation.component.value[x]",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "type"
        } ]
      },
      "mustSupport": true
    }, {
      "id": "Observation.component:eudraCT.value[x]:valueString",
      "min": 1,
      "path": "Observation.component.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "sliceName": "valueString"
    }, {
      "id": "Observation.component:nct",
      "path": "Observation.component",
      "short": "NCT number",
      "sliceName": "nct",
      "definition": "A unique identification code given to each clinical study registered on ClinicalTrials.gov.",
      "mustSupport": true
    }, {
      "id": "Observation.component:nct.code",
      "path": "Observation.component.code",
      "mustSupport": true,
      "patternCodeableConcept": {
        "coding": [ {
          "code": "05",
          "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes"
        } ]
      }
    }, {
      "id": "Observation.component:nct.code.coding",
      "min": 1,
      "path": "Observation.component.code.coding",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "pattern"
        } ]
      },
      "mustSupport": true
    }, {
      "id": "Observation.component:nct.code.coding:nctNumber",
      "max": "1",
      "min": 1,
      "path": "Observation.component.code.coding",
      "sliceName": "nctNumber",
      "patternCoding": {
        "code": "05",
        "system": "https://www.netzwerk-universitaetsmedizin.de/fhir/CodeSystem/ecrf-parameter-codes"
      }
    }, {
      "id": "Observation.component:nct.code.coding:nctNumber.system",
      "min": 1,
      "path": "Observation.component.code.coding.system"
    }, {
      "id": "Observation.component:nct.code.coding:nctNumber.code",
      "min": 1,
      "path": "Observation.component.code.coding.code"
    }, {
      "id": "Observation.component:nct.value[x]",
      "min": 1,
      "path": "Observation.component.value[x]",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "$this",
          "type": "type"
        } ]
      }
    }, {
      "id": "Observation.component:nct.value[x]:valueString",
      "path": "Observation.component.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "sliceName": "valueString"
    } ]
  },
  "contact": [ {
    "telecom": [ {
      "value": "https://www.bihealth.org/en/research/core-facilities/interoperability/",
      "system": "url"
    } ]
  } ],
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Observation"
}