{
  "description": "Extension informing about administrative information of a study.",
  "_filename": "StructureDefinition-nfdi4health-ex-mds-study-admin-info.json",
  "package_name": "de.nfdi4health.mds",
  "date": null,
  "derivation": "constraint",
  "publisher": "NFDI4Health",
  "fhirVersion": "4.0.1",
  "name": "NFDI4Health_EX_MDS_Study_Admin_Info",
  "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 Administrative Information",
  "package_version": "2.0.0",
  "status": "draft",
  "id": "2d4dbac2-fcde-46c7-884b-c00eb66ba149",
  "kind": "complex-type",
  "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info",
  "context": [ {
    "type": "element",
    "expression": "ResearchStudy"
  } ],
  "version": "0.9",
  "differential": {
    "element": [ {
      "id": "Extension",
      "max": "1",
      "min": 1,
      "path": "Extension",
      "short": "Administrative information about the [RESOURCE]",
      "definition": " Group of items providing administrative information about the [RESOURCE]."
    }, {
      "id": "Extension.extension",
      "min": 1,
      "path": "Extension.extension"
    }, {
      "id": "Extension.extension:ethicsCommiteeApproval",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Status of the ethics committee approval",
      "mapping": [ {
        "map": "Design.administrativeInformation.ethicsCommitteeApproval",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "ethicsCommiteeApproval",
      "definition": "Status of the study approval from the (leading) ethics committee"
    }, {
      "id": "Extension.extension:ethicsCommiteeApproval.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:ethicsCommiteeApproval.url",
      "path": "Extension.extension.url",
      "fixedUri": "ethicsCommiteeApproval"
    }, {
      "id": "Extension.extension:ethicsCommiteeApproval.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-ethics-committee-approval-nci-local",
        "description": "Value set defining codes to specify the status of the study ethics committee approval."
      }
    }, {
      "path": "Extension.extension",
      "min": 1,
      "definition": "Overall status of the study.",
      "short": "Overall study status",
      "mapping": [ {
        "map": "Design.administrativeInformation.status",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "status",
      "max": "1",
      "id": "Extension.extension:status",
      "comment": "Additional information: If at least one study site in a multicenter study has the status 'Ongoing', then the overall status for the study must be 'Ongoing'. | Short input help: Select one value from the list."
    }, {
      "id": "Extension.extension:status.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:status.url",
      "path": "Extension.extension.url",
      "fixedUri": "status"
    }, {
      "id": "Extension.extension:status.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-overall-status-nci-local",
        "description": "Value set defining codes to specify the overall status of a study."
      }
    }, {
      "id": "Extension.extension:status.value[x].system",
      "min": 1,
      "path": "Extension.extension.value[x].system"
    }, {
      "id": "Extension.extension:status.value[x].code",
      "min": 1,
      "path": "Extension.extension.value[x].code"
    }, {
      "path": "Extension.extension",
      "min": 0,
      "definition": "Specification whether [RESOURCE] participants receive an intervention or have completed it but are still being followed up according to the primary objective of the [RESOURCE].",
      "short": "Participants receive an intervention?",
      "mapping": [ {
        "map": "Design.administrativeInformation.statusWhenIntervention",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "statusWhenIntervention",
      "max": "1",
      "id": "Extension.extension:statusWhenIntervention",
      "comment": "Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional' AND Design.administrativeInformation.status == ('At the planning stage' OR 'Ongoing (I): Recruitment ongoing, but data collection not yet started' OR 'Ongoing (II): Recruitment and data collection ongoing' OR 'Ongoing (III): Recruitment completed, but data collection ongoing' OR 'Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing'); otherwise 0..0/ Short Input Help: Select one value from the list. / Source of the property and/or allowed values: NFDI4Health, CT.gov [2], DRKS [3]"
    }, {
      "id": "Extension.extension:statusWhenIntervention.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:statusWhenIntervention.url",
      "path": "Extension.extension.url",
      "fixedUri": "statusWhenIntervention"
    }, {
      "id": "Extension.extension:statusWhenIntervention.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-status-when-intervention-local",
        "description": "Value set defining codes to specify the status of a study when it was halted."
      }
    }, {
      "id": "Extension.extension:statusWhenIntervention.value[x].system",
      "min": 1,
      "path": "Extension.extension.value[x].system"
    }, {
      "id": "Extension.extension:statusWhenIntervention.value[x].code",
      "min": 1,
      "path": "Extension.extension.value[x].code"
    }, {
      "id": "Extension.extension:statusEnrollingByInvitation",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Participants enrolled by invitation?",
      "mapping": [ {
        "map": "Design.administrativeInformation.statusEnrollingByInvitation",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "statusEnrollingByInvitation",
      "definition": "Specification whether [RESOURCE] participants are selected from a predetermined population."
    }, {
      "id": "Extension.extension:statusEnrollingByInvitation.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:statusEnrollingByInvitation.url",
      "path": "Extension.extension.url",
      "fixedUri": "statusEnrollingByInvitation"
    }, {
      "id": "Extension.extension:statusEnrollingByInvitation.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-yes-no-not-applicable-snomedct",
        "description": "Value set used to respond to questions that can be answered Yes, No, or Not Applicable."
      }
    }, {
      "id": "Extension.extension:statusEnrollingByInvitation.value[x].system",
      "min": 1,
      "path": "Extension.extension.value[x].system"
    }, {
      "id": "Extension.extension:statusEnrollingByInvitation.value[x].code",
      "min": 1,
      "path": "Extension.extension.value[x].code"
    }, {
      "path": "Extension.extension",
      "min": 0,
      "definition": "Overall recruitment status of the [RESOURCE] as indicated in the corresponding register of clinical trials.",
      "short": "Overall recruitment status of the study from the register of clinical trials",
      "mapping": [ {
        "map": "Design.administrativeInformation.recruitmentStatusRegister",
        "identity": "NFDI4Health"
      } ],
      "sliceName": "recruitmentStatusRegister",
      "max": "1",
      "id": "Extension.extension:recruitmentStatusRegister",
      "comment": "Additional information: The item applies only to studies automatically uploaded from the registers of clinical trials."
    }, {
      "id": "Extension.extension:recruitmentStatusRegister.extension",
      "max": "0",
      "path": "Extension.extension.extension"
    }, {
      "id": "Extension.extension:recruitmentStatusRegister.url",
      "path": "Extension.extension.url",
      "fixedUri": "recruitmentStatusRegister"
    }, {
      "id": "Extension.extension:recruitmentStatusRegister.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-recruitment-register-nci-sct-local",
        "description": "Value set defining codes to specify the study recruitment status (from a register) in a ResearchStudy resource."
      }
    }, {
      "id": "Extension.extension:recruitmentStatusRegister.value[x].system",
      "min": 1,
      "path": "Extension.extension.value[x].system"
    }, {
      "id": "Extension.extension:recruitmentStatusRegister.value[x].code",
      "min": 1,
      "path": "Extension.extension.value[x].code"
    }, {
      "id": "Extension.url",
      "path": "Extension.url",
      "fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info"
    }, {
      "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"
}