FHIR IG Statistics: StructureDefinition/nfdi4health-ex-mds-study-admin-info
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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",
"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 request for 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 status",
"definition": "Overall status of the [RESOURCE].",
"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": "Is the intervention ongoing or completed?",
"definition": "Short input help: \tSelect one value from the list.",
"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 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 study as indicated in the corresponding register of clinical trials.\t",
"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"
}
]
}
}