FHIR IG Statistics: StructureDefinition/nfdi4health-pr-mds-study
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{
"resourceType": "StructureDefinition",
"id": "nfdi4health-pr-mds-study",
"url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"version": "0.9",
"name": "NFDI4Health_PR_MDS_Study",
"title": "NFDI4Health PR MDS Study",
"status": "draft",
"publisher": "NFDI4Health",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "https://www.nfdi4health.de"
}
]
}
],
"description": "Group of items applicable only to studies, substudies.",
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "BRIDG5.1",
"uri": "https://bridgmodel.nci.nih.gov",
"name": "BRIDG 5.1 Mapping"
},
{
"identity": "v2",
"uri": "http://hl7.org/v2",
"name": "HL7 v2 Mapping"
},
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
},
{
"identity": "clinicaltrials-gov",
"uri": "http://clinicaltrials.gov",
"name": "ClinicalTrials.gov Mapping"
},
{
"identity": "w5",
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping"
},
{
"identity": "NFDI4Health",
"name": "NFDI4Health to FHIR Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "ResearchStudy",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "ResearchStudy",
"path": "ResearchStudy",
"constraint": [
{
"key": "category-interventional-a",
"severity": "error",
"human": "Cardinality: 1..*, if Design.primaryDesign == 'C98388'",
"expression": "category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "category-interventional-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.primaryDesign != 'C98388'",
"expression": "category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "category-nonInterventional-a",
"severity": "error",
"human": "Cardinality: 1..*, if Design.primaryDesign == 'C142615''",
"expression": "category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "category-nonInterventional-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.primaryDesign != 'C142615'",
"expression": "category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-mortalityData-a",
"severity": "error",
"human": "Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))",
"expression": "category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or code = 'D015331' or code = '005' or code = 'C53311').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-mortalityData-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))",
"expression": "category.extension.extension.where(url='nonInterventional').valueCoding.where(code = 'C15273' or code = 'C15208' or code = '004' or 'D015331' or code = '005' or code = 'C53311').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-statusWhenIntervention-a",
"severity": "error",
"human": "Cardinality: 0..1, if Design.primaryDesign == 'C98388'",
"expression": "category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-statusWhenIntervention-b",
"severity": "error",
"human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05')",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists() implies extension.extension.where(url='statusWhenIntervention').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-statusWhenIntervention-c",
"severity": "error",
"human": "Cardinality: 0..0, if Design.primaryDesign != 'C98388'",
"expression": "category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-statusWhenIntervention-d",
"severity": "error",
"human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05')",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '01' or code = '02' or code = '03' or code = '04' or code = '05').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-recruitmentStatusRegister-a",
"severity": "error",
"human": "Cardinality: 0..1, if Resource.provenance.dataSource != '06'",
"expression": "Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists().not() implies extension.extension.where(url='recruitmentStatusRegister').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-recruitmentStatusRegister-b",
"severity": "error",
"human": "Cardinality: 0..0, if Resource.provenance.dataSource == '06'",
"expression": "Composition.extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-provenance-data-source').valueCoding.where(code='06').exists() implies extension.extension.where(url='recruitmentStatusRegister').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "probabilityMethod-a",
"severity": "error",
"human": "0..1, if Design.sampling.method == '034'",
"expression": "extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "probabilityMethod-b",
"severity": "error",
"human": "0..0, if Design.sampling.method != '034'",
"expression": "extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "nonProbabilityMethod-a",
"severity": "error",
"human": "0..1, if Design.sampling.method == 'C127781'",
"expression": "extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "nonProbabilityMethod-b",
"severity": "error",
"human": "0..0, if Design.sampling.method != 'C127781'",
"expression": "extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "biosamples-a",
"severity": "error",
"human": "0..*, if Design.dataSource.general == 'C70699'",
"expression": "extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "biosamples-b",
"severity": "error",
"human": "0..0, if Design.dataSource.general != 'C70699'",
"expression": "extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "imaging-a",
"severity": "error",
"human": "0..*, if Design.dataSource.general == '031'",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.extension.where(url='imaging').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "imaging-b",
"severity": "error",
"human": "0..0, if Design.dataSource.general != '031'",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.extension.where(url='imaging').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "omics-a",
"severity": "error",
"human": "0..*, if Design.dataSource.general == '033'",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "omics-b",
"severity": "error",
"human": "0..0, if Design.dataSource.general != '033'",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "supportingInformation-a",
"severity": "error",
"human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "supportingInformation-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "timeFrame-a",
"severity": "error",
"human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "timeFrame-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "accessCriteria-a",
"severity": "error",
"human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "accessCriteria-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "masking-roles-a",
"severity": "error",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == true",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "masking-roles-b",
"severity": "error",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == false",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "masking-description-a",
"severity": "error",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == true",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "masking-description-b",
"severity": "error",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == false",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "interventional-a",
"severity": "error",
"human": "Cardinality: 0..1, Design.primaryDesign == 'Interventional'",
"expression": "category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "interventional-b",
"severity": "error",
"human": "Cardinality: 0..0, Design.primaryDesign != 'Interventional'",
"expression": "category.coding.where(code = 'C98388').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "nonInterventional-a",
"severity": "error",
"human": "Cardinality: 0..1, Design.primaryDesign == 'Non-interventional'",
"expression": "category.coding.where(code = 'C142615').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "nonInterventional-b",
"severity": "error",
"human": "Cardinality: 0..0, Design.primaryDesign != 'Non-interventional'",
"expression": "category.coding.where(code = 'C142615').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-stageStopped-a",
"severity": "error",
"human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-stageStopped-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-reasonStopped-a",
"severity": "error",
"human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "study-reasonStopped-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "recordLinkage-a",
"severity": "error",
"human": "Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes'",
"expression": "extension.extension.where(url='recordLinkage').where(value=true).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "recordLinkage-b",
"severity": "error",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No'",
"expression": "extension.extension.where(url='recordLinkage').where(value=false).exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "legalBasisDetails-a",
"severity": "error",
"human": "Cardinality: 1..1, if RecordLinkage.legalBasis == 'True'",
"expression": "extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
},
{
"key": "legalBasisDetails-b",
"severity": "error",
"human": "Cardinality: 0..0, if RecordLinkage.legalBasis == 'False'",
"expression": "extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study"
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design"
}
]
},
{
"id": "ResearchStudy.extension",
"path": "ResearchStudy.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 5
},
{
"id": "ResearchStudy.extension:descriptions",
"path": "ResearchStudy.extension",
"sliceName": "descriptions",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.descriptions"
}
]
},
{
"id": "ResearchStudy.extension:mortalityData",
"path": "ResearchStudy.extension",
"sliceName": "mortalityData",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data"
]
}
]
},
{
"id": "ResearchStudy.extension:administrativeInformation",
"path": "ResearchStudy.extension",
"sliceName": "administrativeInformation",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info"
]
}
]
},
{
"id": "ResearchStudy.extension:subject",
"path": "ResearchStudy.extension",
"sliceName": "subject",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
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]
}
]
},
{
"id": "ResearchStudy.extension:dataSource",
"path": "ResearchStudy.extension",
"sliceName": "dataSource",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source"
]
}
]
},
{
"id": "ResearchStudy.extension:recruitment",
"path": "ResearchStudy.extension",
"sliceName": "recruitment",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5"
]
}
]
},
{
"id": "ResearchStudy.extension:comparisonGroup",
"path": "ResearchStudy.extension",
"sliceName": "comparisonGroup",
"min": 0,
"max": "*",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5"
]
}
]
},
{
"id": "ResearchStudy.extension:outcomes",
"path": "ResearchStudy.extension",
"sliceName": "outcomes",
"min": 0,
"max": "*",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/StructureDefinition/nfdi4health-ex-mds-outcomemeasure-backport-r5"
]
}
]
},
{
"id": "ResearchStudy.extension:assessments",
"path": "ResearchStudy.extension",
"sliceName": "assessments",
"min": 0,
"max": "*",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments"
]
}
]
},
{
"id": "ResearchStudy.extension:dataSharingPlan",
"path": "ResearchStudy.extension",
"sliceName": "dataSharingPlan",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan"
]
}
]
},
{
"id": "ResearchStudy.extension:nonInterventional",
"path": "ResearchStudy.extension",
"sliceName": "nonInterventional",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional"
]
}
]
},
{
"id": "ResearchStudy.extension:interventional",
"path": "ResearchStudy.extension",
"sliceName": "interventional",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional"
]
}
]
},
{
"id": "ResearchStudy.extension:groupsOfDiseases",
"path": "ResearchStudy.extension",
"sliceName": "groupsOfDiseases",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.groupsOfDiseases"
}
]
},
{
"id": "ResearchStudy.extension:sampling",
"path": "ResearchStudy.extension",
"sliceName": "sampling",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling"
]
}
]
},
{
"id": "ResearchStudy.extension:recordLinkage",
"path": "ResearchStudy.extension",
"sliceName": "recordLinkage",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage"
]
}
]
},
{
"id": "ResearchStudy.identifier",
"path": "ResearchStudy.identifier",
"short": "Alternative identifiers",
"definition": "Group of items providing information about identifiers (IDs) assigned to the given [RESOURCE] by another registering systems, e.g. a registry of clinical trials or a data repository.",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.idsAlternative"
}
]
},
{
"id": "ResearchStudy.identifier.type",
"path": "ResearchStudy.identifier.type",
"short": "Type of the registry",
"definition": "Type/name of the system where the given [RESOURCE] is already registered.",
"min": 1,
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-id-type-nci-local",
"description": "Value set defining codes to specify the type of a resource identifier."
},
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.idsAlternative.scheme"
}
]
},
{
"id": "ResearchStudy.identifier.value",
"path": "ResearchStudy.identifier.value",
"definition": "Identifier",
"min": 1,
"example": [
{
"label": "Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository.",
"valueString": "ISRCTN91495258"
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "esource.idsAlternative.identifier"
}
]
},
{
"id": "ResearchStudy.status",
"path": "ResearchStudy.status",
"comment": "The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies.",
"fixedCode": "active"
},
{
"id": "ResearchStudy.primaryPurposeType",
"path": "ResearchStudy.primaryPurposeType",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.primaryPurpose"
}
]
},
{
"id": "ResearchStudy.primaryPurposeType.coding",
"path": "ResearchStudy.primaryPurposeType.coding",
"short": "Primary purpose of the [RESOURCE]",
"definition": "Specification of the main purpose of the [RESOURCE].",
"comment": "Additional Information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected. | Short Input Help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones.",
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-purpose-hl7-nci",
"description": "Value set defining codes to specify the primary purpose of a (sub-)study in a ResearchStudy resource."
}
},
{
"id": "ResearchStudy.phase",
"path": "ResearchStudy.phase",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.interventional.phase"
}
]
},
{
"id": "ResearchStudy.phase.coding",
"path": "ResearchStudy.phase.coding",
"short": "Numerical phase",
"definition": "If applicable, numerical phase of the [RESOURCE].",
"comment": "Short input help: Select one value from the list.",
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-phase-nci",
"description": "Value set defining codes to specify the phase of a (sub-)study in a ResearchStudy resource."
}
},
{
"id": "ResearchStudy.category",
"path": "ResearchStudy.category",
"short": "Is the study design non-interventional or interventional?",
"min": 1,
"max": "1",
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-design-nci",
"description": "Value set defining codes for primary designs of (sub-)studies in a ResearchStudy resource."
},
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.primaryDesign"
}
]
},
{
"id": "ResearchStudy.category.extension",
"path": "ResearchStudy.category.extension",
"min": 1
},
{
"id": "ResearchStudy.category.extension:studyType",
"path": "ResearchStudy.category.extension",
"sliceName": "studyType",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type"
]
}
]
},
{
"id": "ResearchStudy.focus",
"path": "ResearchStudy.focus",
"short": "Primary focus of the [RESOURCE]",
"definition": "Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.).",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.focus"
}
]
},
{
"id": "ResearchStudy.focus.coding.extension",
"path": "ResearchStudy.focus.coding.extension",
"min": 1
},
{
"id": "ResearchStudy.focus.coding.extension:codeableConcept",
"path": "ResearchStudy.focus.coding.extension",
"sliceName": "codeableConcept",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.focus.code"
},
{
"identity": "NFDI4Health",
"map": "Design.focus.classification"
}
]
},
{
"id": "ResearchStudy.focus.text",
"path": "ResearchStudy.focus.text",
"short": "Focus area",
"definition": "Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.).",
"comment": "Additional Information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed. | Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).",
"min": 1,
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.focus.label"
}
]
},
{
"id": "ResearchStudy.condition",
"path": "ResearchStudy.condition",
"short": "Primary health conditions or diseases considered in the [RESOURCE]",
"definition": "Group of items providing information about primary health conditions or diseases considered in the [RESOURCE].",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.conditions"
}
]
},
{
"id": "ResearchStudy.condition.coding.extension",
"path": "ResearchStudy.condition.coding.extension",
"min": 1
},
{
"id": "ResearchStudy.condition.coding.extension:codeableConcept",
"path": "ResearchStudy.condition.coding.extension",
"sliceName": "codeableConcept",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.conditions.code"
},
{
"identity": "NFDI4Health",
"map": "Design.conditions.classification"
}
]
},
{
"id": "ResearchStudy.condition.text",
"path": "ResearchStudy.condition.text",
"short": "Health condition or disease",
"definition": "The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.",
"comment": "Preferably, use terms from terminologies such as SNOMED CT.",
"min": 1,
"example": [
{
"label": "Example of a health condition",
"valueString": "SARS-CoV-2"
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.conditions.label"
}
]
},
{
"id": "ResearchStudy.relatedArtifact",
"path": "ResearchStudy.relatedArtifact",
"max": "1",
"type": [
{
"code": "RelatedArtifact",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-related-artifact-resource"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.ids"
},
{
"identity": "NFDI4Health",
"map": "Resource.idsNfdi4health"
},
{
"identity": "NFDI4Health",
"map": "Resource.webpage"
}
]
},
{
"id": "ResearchStudy.keyword",
"path": "ResearchStudy.keyword",
"short": "Keywords",
"definition": "Group of items providing information about keywords describing the [RESOURCE].",
"comment": "Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated.",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.keywords"
}
]
},
{
"id": "ResearchStudy.keyword.coding.code.extension",
"path": "ResearchStudy.keyword.coding.code.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
}
},
{
"id": "ResearchStudy.keyword.coding.code.extension:code",
"path": "ResearchStudy.keyword.coding.code.extension",
"sliceName": "code",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-code"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.keywords.code"
}
]
},
{
"id": "ResearchStudy.keyword.text",
"path": "ResearchStudy.keyword.text",
"short": "label",
"definition": "Keyword(s) describing the [RESOURCE].",
"comment": "Additional information: The use of terms from established classifications/vocabularies (e.g. SNOMED CT, MeSH, UMLS) is preferred. However, also self-assigned keywords are allowed. | Short input help: Preferably, use terms from SNOMED CT or MESH.",
"min": 1,
"example": [
{
"label": "Keyword label",
"valueString": "SARS-CoV-2"
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Resource.keywords.label"
}
]
},
{
"id": "ResearchStudy.period.start",
"path": "ResearchStudy.period.start",
"short": "Start date",
"definition": "In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date.",
"comment": "Additional information: Preferred date format: DD.MM.YYYY. | Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date.",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.administrativeInformation.startDate"
}
]
},
{
"id": "ResearchStudy.period.end",
"path": "ResearchStudy.period.end",
"short": "End date",
"definition": "In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit.",
"comment": "Additional information: Preferred date format: DD.MM.YYYY. | Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date.",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.administrativeInformation.endDate"
}
]
},
{
"id": "ResearchStudy.site",
"path": "ResearchStudy.site",
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-centers"
]
}
]
},
{
"id": "ResearchStudy.reasonStopped.coding",
"path": "ResearchStudy.reasonStopped.coding",
"short": "Stopping stage",
"definition": "Specification of the stage at which the [RESOURCE] was prematurely stopped.",
"comment": "Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); 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]",
"max": "1",
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-status-halted-stage-local"
},
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.administrativeInformation.stageStopped"
}
]
},
{
"id": "ResearchStudy.reasonStopped.text",
"path": "ResearchStudy.reasonStopped.text",
"short": "Stopping reason",
"definition": "Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design.",
"comment": "Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0 / Short Input Help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc. / Source of the property and/or allowed values: CT.gov [2], DRKS [3]",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.administrativeInformation.reasonStopped"
}
]
},
{
"id": "ResearchStudy.note",
"path": "ResearchStudy.note",
"max": "1"
},
{
"id": "ResearchStudy.note.text",
"path": "ResearchStudy.note.text",
"short": "Additional information about the [RESOURCE]",
"definition": "Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields..",
"comment": "Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields.",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.comment"
}
]
},
{
"id": "ResearchStudy.objective.name",
"path": "ResearchStudy.objective.name",
"short": "Research questions/hypotheses",
"definition": "Statement of the research questions and/or hypotheses underlying the [RESOURCE].",
"min": 1,
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.hypotheses"
}
]
}
]
}
}
FHIR