{
  "description": "Extension providing information about the arm(s)/group(s)/cohort(s) and intervention(s)/exposure(s) in a study.",
  "_filename": "StructureDefinition-nfdi4health-ex-mds-study-comparison-group.json",
  "package_name": "de.nfdi4health.mds",
  "date": null,
  "derivation": "constraint",
  "publisher": "NFDI4Health",
  "fhirVersion": "4.0.1",
  "name": "NFDI4Health_EX_MDS_Study_Comparison_Group",
  "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 Comparison Group",
  "package_version": "1.0.0",
  "status": "draft",
  "id": "b33a5e29-5ea1-494b-9056-29de8221907a",
  "kind": "complex-type",
  "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group",
  "context": [ {
    "type": "element",
    "expression": "ResearchStudy"
  } ],
  "version": "0.9",
  "differential": {
    "element": [ {
      "id": "Extension",
      "path": "Extension",
      "short": "Arms or groups/cohorts of the study",
      "comment": "[Extension based on ResearchStudy.comparisonGroup (R5).]",
      "mapping": [ {
        "map": "1.17.30 Resource.studyDesign.armsGroups",
        "identity": "NFDI4Health"
      } ],
      "definition": "Group of items providing information about arms or groups/cohorts of the study."
    }, {
      "id": "Extension.extension",
      "min": 1,
      "path": "Extension.extension"
    }, {
      "path": "Extension.extension",
      "min": 1,
      "definition": "Short name used to identify the arm/group.",
      "short": "Name of the arm/group",
      "mapping": [ {
        "map": "1.17.30.1 Resource.studyDesign.armsGroups.label",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "name",
      "max": "1",
      "id": "Extension.extension:name",
      "comment": "Additional information: For interventional studies: 'Arm' means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. For non-interventional studies: 'Group' means a predefined group (cohort) of participants to be studied."
    }, {
      "id": "Extension.extension:name.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:name.url",
      "path": "Extension.extension.url",
      "fixedUri": "name"
    }, {
      "id": "Extension.extension:name.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ]
    }, {
      "path": "Extension.extension",
      "min": 0,
      "definition": "Role of the given arm in the study.",
      "short": "Role of the arm",
      "mapping": [ {
        "map": "1.17.30.2 Resource.studyDesign.armsGroups.type",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "type",
      "max": "1",
      "id": "Extension.extension:type",
      "comment": "Short input help: Select one value from the list."
    }, {
      "id": "Extension.extension:type.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:type.url",
      "path": "Extension.extension.url",
      "fixedUri": "type"
    }, {
      "id": "Extension.extension:type.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "Coding"
      } ],
      "binding": {
        "strength": "required",
        "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-arm-group-type-umls",
        "description": "Value set defining codes to specify the role of a study arm or group in a ResearchStudy resource."
      }
    }, {
      "id": "Extension.extension:type.value[x].system",
      "min": 1,
      "path": "Extension.extension.value[x].system"
    }, {
      "id": "Extension.extension:type.value[x].code",
      "min": 1,
      "path": "Extension.extension.value[x].code"
    }, {
      "path": "Extension.extension",
      "min": 0,
      "definition": "Additional descriptive information about the given arm/group.",
      "short": "Additional information about the arm/group",
      "mapping": [ {
        "map": "1.17.30.3 1.17.30.2 Resource.studyDesign.armsGroups.description",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "description",
      "max": "1",
      "id": "Extension.extension:description",
      "comment": "Additional information: For interventional studies: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the clinical trial. For non-interventional studies: Explanation of the nature of the study group (for example, those with a condition and those without a condition; those with an exposure and those without an exposure)."
    }, {
      "id": "Extension.extension:description.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:description.url",
      "path": "Extension.extension.url",
      "fixedUri": "description"
    }, {
      "id": "Extension.extension:description.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ]
    }, {
      "path": "Extension.extension",
      "min": 0,
      "definition": "Group of items providing information about study interventions or exposures.",
      "short": "Interventions/exposures of the study",
      "mapping": [ {
        "map": "1.17.31 Resource.studyDesign.interventions",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "intendedExposure",
      "max": "*",
      "id": "Extension.extension:intendedExposure",
      "comment": "Additional information: The items may be not applicable for non-interventional studies."
    }, {
      "id": "Extension.extension:intendedExposure.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:intendedExposure.url",
      "path": "Extension.extension.url",
      "fixedUri": "intendedExposure"
    }, {
      "id": "Extension.extension:intendedExposure.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "Reference",
        "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/EvidenceVariable" ]
      } ]
    }, {
      "id": "Extension.url",
      "path": "Extension.url",
      "fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group"
    }, {
      "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"
}