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{
  "resourceType": "StructureDefinition",
  "id": "nfdi4health-ex-mds-study-admin-info",
  "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info",
  "version": "0.9",
  "name": "NFDI4Health_EX_MDS_Study_Admin_Info",
  "title": "NFDI4Health EX MDS Study Administrative Information",
  "status": "draft",
  "publisher": "NFDI4Health",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "https://www.nfdi4health.de"
        }
      ]
    }
  ],
  "description": "Extension informing about administrative information of a study.",
  "fhirVersion": "4.0.1",
  "mapping": [
    {
      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
    },
    {
      "identity": "NFDI4Health",
      "name": "NFDI4Health to FHIR Mapping"
    }
  ],
  "kind": "complex-type",
  "abstract": false,
  "context": [
    {
      "type": "element",
      "expression": "ResearchStudy"
    }
  ],
  "type": "Extension",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "Extension",
        "path": "Extension",
        "short": "Administrative information about the [RESOURCE]",
        "definition": " Group of items providing administrative information about the [RESOURCE].",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Extension.extension",
        "path": "Extension.extension",
        "min": 1
      },
      {
        "id": "Extension.extension:ethicsCommiteeApproval",
        "path": "Extension.extension",
        "sliceName": "ethicsCommiteeApproval",
        "short": "Status of the ethics committee approval",
        "definition": "Status of the study approval from the (leading) ethics committee",
        "min": 0,
        "max": "1",
        "mapping": [
          {
            "identity": "NFDI4Health",
            "map": "Design.administrativeInformation.ethicsCommitteeApproval"
          }
        ]
      },
      {
        "id": "Extension.extension:ethicsCommiteeApproval.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "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."
        }
      },
      {
        "id": "Extension.extension:status",
        "path": "Extension.extension",
        "sliceName": "status",
        "short": "Overall study status",
        "definition": "Overall status of the study.",
        "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.",
        "min": 1,
        "max": "1",
        "mapping": [
          {
            "identity": "NFDI4Health",
            "map": "Design.administrativeInformation.status"
          }
        ]
      },
      {
        "id": "Extension.extension:status.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:status.url",
        "path": "Extension.extension.url",
        "fixedUri": "status"
      },
      {
        "id": "Extension.extension:status.value[x]",
        "path": "Extension.extension.value[x]",
        "min": 1,
        "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",
        "path": "Extension.extension.value[x].system",
        "min": 1
      },
      {
        "id": "Extension.extension:status.value[x].code",
        "path": "Extension.extension.value[x].code",
        "min": 1
      },
      {
        "id": "Extension.extension:statusWhenIntervention",
        "path": "Extension.extension",
        "sliceName": "statusWhenIntervention",
        "short": "Participants receive an intervention?",
        "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].",
        "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]",
        "min": 0,
        "max": "1",
        "mapping": [
          {
            "identity": "NFDI4Health",
            "map": "Design.administrativeInformation.statusWhenIntervention"
          }
        ]
      },
      {
        "id": "Extension.extension:statusWhenIntervention.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:statusWhenIntervention.url",
        "path": "Extension.extension.url",
        "fixedUri": "statusWhenIntervention"
      },
      {
        "id": "Extension.extension:statusWhenIntervention.value[x]",
        "path": "Extension.extension.value[x]",
        "min": 1,
        "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",
        "path": "Extension.extension.value[x].system",
        "min": 1
      },
      {
        "id": "Extension.extension:statusWhenIntervention.value[x].code",
        "path": "Extension.extension.value[x].code",
        "min": 1
      },
      {
        "id": "Extension.extension:statusEnrollingByInvitation",
        "path": "Extension.extension",
        "sliceName": "statusEnrollingByInvitation",
        "short": "Participants enrolled by invitation?",
        "definition": "Specification whether [RESOURCE] participants are selected from a predetermined population.",
        "min": 0,
        "max": "1",
        "mapping": [
          {
            "identity": "NFDI4Health",
            "map": "Design.administrativeInformation.statusEnrollingByInvitation"
          }
        ]
      },
      {
        "id": "Extension.extension:statusEnrollingByInvitation.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:statusEnrollingByInvitation.url",
        "path": "Extension.extension.url",
        "fixedUri": "statusEnrollingByInvitation"
      },
      {
        "id": "Extension.extension:statusEnrollingByInvitation.value[x]",
        "path": "Extension.extension.value[x]",
        "min": 1,
        "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",
        "path": "Extension.extension.value[x].system",
        "min": 1
      },
      {
        "id": "Extension.extension:statusEnrollingByInvitation.value[x].code",
        "path": "Extension.extension.value[x].code",
        "min": 1
      },
      {
        "id": "Extension.extension:recruitmentStatusRegister",
        "path": "Extension.extension",
        "sliceName": "recruitmentStatusRegister",
        "short": "Overall recruitment status of the study from the register of clinical trials",
        "definition": "Overall recruitment status of the [RESOURCE] as indicated in the corresponding register of clinical trials.",
        "comment": "Additional information: The item applies only to studies automatically uploaded from the registers of clinical trials.",
        "min": 0,
        "max": "1",
        "mapping": [
          {
            "identity": "NFDI4Health",
            "map": "Design.administrativeInformation.recruitmentStatusRegister"
          }
        ]
      },
      {
        "id": "Extension.extension:recruitmentStatusRegister.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:recruitmentStatusRegister.url",
        "path": "Extension.extension.url",
        "fixedUri": "recruitmentStatusRegister"
      },
      {
        "id": "Extension.extension:recruitmentStatusRegister.value[x]",
        "path": "Extension.extension.value[x]",
        "min": 1,
        "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",
        "path": "Extension.extension.value[x].system",
        "min": 1
      },
      {
        "id": "Extension.extension:recruitmentStatusRegister.value[x].code",
        "path": "Extension.extension.value[x].code",
        "min": 1
      },
      {
        "id": "Extension.url",
        "path": "Extension.url",
        "fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info"
      },
      {
        "id": "Extension.value[x]",
        "path": "Extension.value[x]",
        "max": "0"
      }
    ]
  }
}

name : NFDI4Health_EX_MDS_Study_Admin_Info

{

}