{
"description": "Group of items applicable only to studies, substudies.",
"_filename": "StructureDefinition-nfdi4health-pr-mds-study.json",
"package_name": "de.nfdi4health.mds",
"date": null,
"derivation": "constraint",
"publisher": "NFDI4Health",
"fhirVersion": "4.0.1",
"name": "NFDI4Health_PR_MDS_Study",
"mapping": [ {
"uri": "https://bridgmodel.nci.nih.gov",
"name": "BRIDG 5.1 Mapping",
"identity": "BRIDG5.1"
}, {
"uri": "http://hl7.org/v2",
"name": "HL7 v2 Mapping",
"identity": "v2"
}, {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
}, {
"uri": "http://clinicaltrials.gov",
"name": "ClinicalTrials.gov Mapping",
"identity": "clinicaltrials-gov"
}, {
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping",
"identity": "w5"
}, {
"name": "NFDI4Health to FHIR Mapping",
"identity": "NFDI4Health"
} ],
"abstract": false,
"type": "ResearchStudy",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "NFDI4Health PR MDS Study",
"package_version": "2.0.0",
"status": "draft",
"id": "b627708a-e067-46a1-98a9-0e313e61d9d3",
"kind": "resource",
"url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"version": "0.9",
"differential": {
"element": [ {
"id": "ResearchStudy",
"path": "ResearchStudy",
"mapping": [ {
"map": "Design",
"identity": "NFDI4Health"
} ],
"constraint": [ {
"key": "category-interventional-a",
"human": "Cardinality: 1..*, if Design.primaryDesign == 'C98388'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()"
}, {
"key": "category-interventional-b",
"human": "Cardinality: 0..0, if Design.primaryDesign != 'C98388'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()"
}, {
"key": "category-nonInterventional-a",
"human": "Cardinality: 1..*, if Design.primaryDesign == 'C142615''",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()"
}, {
"key": "category-nonInterventional-b",
"human": "Cardinality: 0..0, if Design.primaryDesign != 'C142615'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()"
}, {
"key": "study-mortalityData-a",
"human": "Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "study-mortalityData-b",
"human": "Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "study-statusWhenIntervention-a",
"human": "Cardinality: 0..1, if Design.primaryDesign == 'C98388'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()"
}, {
"key": "study-statusWhenIntervention-b",
"human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05')",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "study-statusWhenIntervention-c",
"human": "Cardinality: 0..0, if Design.primaryDesign != 'C98388'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()"
}, {
"key": "study-statusWhenIntervention-d",
"human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05')",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "study-recruitmentStatusRegister-a",
"human": "Cardinality: 0..1, if Resource.provenance.dataSource != '06'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "study-recruitmentStatusRegister-b",
"human": "Cardinality: 0..0, if Resource.provenance.dataSource == '06'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "probabilityMethod-a",
"human": "0..1, if Design.sampling.method == '034'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()"
}, {
"key": "probabilityMethod-b",
"human": "0..0, if Design.sampling.method != '034'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()"
}, {
"key": "nonProbabilityMethod-a",
"human": "0..1, if Design.sampling.method == 'C127781'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()"
}, {
"key": "nonProbabilityMethod-b",
"human": "0..0, if Design.sampling.method != 'C127781'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()"
}, {
"key": "biosamples-a",
"human": "0..*, if Design.dataSource.general == 'C70699'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()"
}, {
"key": "biosamples-b",
"human": "0..0, if Design.dataSource.general != 'C70699'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()"
}, {
"key": "imaging-a",
"human": "0..*, if Design.dataSource.general == '031'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.extension.where(url='imaging').exists()"
}, {
"key": "imaging-b",
"human": "0..0, if Design.dataSource.general != '031'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.extension.where(url='imaging').exists().not()"
}, {
"key": "omics-a",
"human": "0..*, if Design.dataSource.general == '033'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()"
}, {
"key": "omics-b",
"human": "0..0, if Design.dataSource.general != '033'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()"
}, {
"key": "supportingInformation-a",
"human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()"
}, {
"key": "supportingInformation-b",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()"
}, {
"key": "timeFrame-a",
"human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()"
}, {
"key": "timeFrame-b",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()"
}, {
"key": "accessCriteria-a",
"human": "Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()"
}, {
"key": "accessCriteria-b",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()"
}, {
"key": "masking-roles-a",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == true",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()"
}, {
"key": "masking-roles-b",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == false",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()"
}, {
"key": "masking-description-a",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == true",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()"
}, {
"key": "masking-description-b",
"human": "Cardinality: 0..*, if Design.interventional.masking.general == false",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()"
}, {
"key": "interventional-a",
"human": "Cardinality: 0..1, Design.primaryDesign == 'Interventional'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()"
}, {
"key": "interventional-a",
"human": "Cardinality: 0..1, Design.primaryDesign == 'Interventional'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()"
}, {
"key": "nonInterventional-a",
"human": "Cardinality: 0..1, Design.primaryDesign == 'Non-interventional'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "nonInterventional-b",
"human": "Cardinality: 0..0, Design.primaryDesign != 'Non-interventional'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "study-stageStopped-a",
"human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()"
}, {
"key": "study-stageStopped-b",
"human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()"
}, {
"key": "study-reasonStopped-a",
"human": "Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()"
}, {
"key": "study-reasonStopped-b",
"human": "Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()"
}, {
"key": "recordLinkage-a",
"human": "Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "recordLinkage-b",
"human": "Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"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()"
}, {
"key": "legalBasisDetails-a",
"human": "Cardinality: 1..1, if RecordLinkage.legalBasis == 'True'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()"
}, {
"key": "legalBasisDetails-b",
"human": "Cardinality: 0..0, if RecordLinkage.legalBasis == 'False'",
"source": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study",
"severity": "error",
"expression": "extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()"
} ]
}, {
"id": "ResearchStudy.extension",
"min": 5,
"path": "ResearchStudy.extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
}
}, {
"id": "ResearchStudy.extension:executionLanguage",
"max": "*",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-execution-language" ]
} ],
"sliceName": "executionLanguage"
}, {
"id": "ResearchStudy.extension:descriptions",
"max": "1",
"min": 1,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions" ]
} ],
"mapping": [ {
"map": "Resource.descriptions",
"identity": "NFDI4Health"
} ],
"sliceName": "descriptions"
}, {
"id": "ResearchStudy.extension:mortalityData",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data" ]
} ],
"sliceName": "mortalityData"
}, {
"id": "ResearchStudy.extension:administrativeInformation",
"max": "1",
"min": 1,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info" ]
} ],
"sliceName": "administrativeInformation"
}, {
"id": "ResearchStudy.extension:subject",
"max": "1",
"min": 1,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject" ]
} ],
"sliceName": "subject"
}, {
"id": "ResearchStudy.extension:dataSource",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source" ]
} ],
"sliceName": "dataSource"
}, {
"id": "ResearchStudy.extension:recruitment",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5" ]
} ],
"sliceName": "recruitment"
}, {
"id": "ResearchStudy.extension:comparisonGroup",
"max": "*",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5" ]
} ],
"sliceName": "comparisonGroup"
}, {
"id": "ResearchStudy.extension:outcomes",
"max": "*",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure" ]
} ],
"sliceName": "outcomes"
}, {
"id": "ResearchStudy.extension:assessments",
"max": "*",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments" ]
} ],
"sliceName": "assessments"
}, {
"id": "ResearchStudy.extension:dataSharingPlan",
"max": "1",
"min": 1,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan" ]
} ],
"sliceName": "dataSharingPlan"
}, {
"id": "ResearchStudy.extension:nonInterventional",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional" ]
} ],
"sliceName": "nonInterventional"
}, {
"id": "ResearchStudy.extension:interventional",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional" ]
} ],
"sliceName": "interventional"
}, {
"id": "ResearchStudy.extension:groupsOfDiseases",
"max": "1",
"min": 1,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases" ]
} ],
"mapping": [ {
"map": "Design.groupsOfDiseases",
"identity": "NFDI4Health"
} ],
"sliceName": "groupsOfDiseases"
}, {
"id": "ResearchStudy.extension:sampling",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling" ]
} ],
"sliceName": "sampling"
}, {
"id": "ResearchStudy.extension:recordLinkage",
"max": "1",
"min": 0,
"path": "ResearchStudy.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage" ]
} ],
"sliceName": "recordLinkage"
}, {
"id": "ResearchStudy.identifier",
"path": "ResearchStudy.identifier",
"short": "Alternative identifiers",
"mapping": [ {
"map": "Resource.idsAlternative",
"identity": "NFDI4Health"
} ],
"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."
}, {
"id": "ResearchStudy.identifier.type",
"min": 1,
"path": "ResearchStudy.identifier.type",
"short": "Type of the registry",
"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": [ {
"map": "Resource.idsAlternative.scheme",
"identity": "NFDI4Health"
} ],
"definition": "Type/name of the system where the given [RESOURCE] is already registered."
}, {
"id": "ResearchStudy.identifier.value",
"min": 1,
"path": "ResearchStudy.identifier.value",
"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": [ {
"map": "esource.idsAlternative.identifier",
"identity": "NFDI4Health"
} ],
"definition": "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",
"short": "Primary purpose of the [RESOURCE]",
"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."
},
"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.",
"mapping": [ {
"map": "Design.primaryPurpose",
"identity": "NFDI4Health"
} ],
"definition": "Specification of the main purpose of the [RESOURCE]."
}, {
"id": "ResearchStudy.primaryPurposeType.coding",
"max": "1",
"min": 1,
"path": "ResearchStudy.primaryPurposeType.coding"
}, {
"id": "ResearchStudy.primaryPurposeType.coding.system",
"min": 1,
"path": "ResearchStudy.primaryPurposeType.coding.system"
}, {
"id": "ResearchStudy.primaryPurposeType.coding.code",
"min": 1,
"path": "ResearchStudy.primaryPurposeType.coding.code"
}, {
"id": "ResearchStudy.phase",
"path": "ResearchStudy.phase",
"short": "Numerical phase",
"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."
},
"comment": "Short input help: Select one value from the list.",
"mapping": [ {
"map": "Design.interventional.phase",
"identity": "NFDI4Health"
} ],
"definition": "If applicable, numerical phase of the [RESOURCE]."
}, {
"id": "ResearchStudy.phase.coding.system",
"min": 1,
"path": "ResearchStudy.phase.coding.system"
}, {
"id": "ResearchStudy.phase.coding.code",
"min": 1,
"path": "ResearchStudy.phase.coding.code"
}, {
"path": "ResearchStudy.category",
"min": 1,
"definition": "Non-interventional design refers to a [RESOURCE] that does not aim to alter its outcomes of interest. Interventional design refers to a [RESOURCE] that aims to alter its outcomes of interest.",
"short": "Is it an interventional or non-interventional [RESOURCE]?",
"mapping": [ {
"map": "Design.primaryDesign",
"identity": "NFDI4Health"
} ],
"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."
},
"max": "1",
"id": "ResearchStudy.category",
"comment": "Short input help: Select between non-interventional and interventional design for the given [RESOURCE]."
}, {
"id": "ResearchStudy.category.extension",
"min": 1,
"path": "ResearchStudy.category.extension"
}, {
"id": "ResearchStudy.category.extension:studyType",
"max": "1",
"min": 1,
"path": "ResearchStudy.category.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type" ]
} ],
"sliceName": "studyType"
}, {
"id": "ResearchStudy.focus",
"path": "ResearchStudy.focus",
"short": "Primary focus of the [RESOURCE]",
"mapping": [ {
"map": "Design.focus",
"identity": "NFDI4Health"
} ],
"definition": "Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.)."
}, {
"id": "ResearchStudy.focus.coding.extension:uri",
"max": "1",
"min": 0,
"path": "ResearchStudy.focus.coding.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-uri" ]
} ],
"mapping": [ {
"map": "Design.focus.code",
"identity": "NFDI4Health"
} ],
"sliceName": "uri"
}, {
"path": "ResearchStudy.focus.coding.system",
"min": 1,
"definition": "Terminology/classification used for the focus area.",
"short": "Terminology/classification",
"mapping": [ {
"map": "Design.focus.classification",
"identity": "NFDI4Health"
} ],
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-conditions-classification-nci-local"
},
"id": "ResearchStudy.focus.coding.system",
"comment": "Short Input Help: If used, name of the terminology/classification.",
"example": [ {
"label": "Example of a terminology/classification",
"valueCode": "C49469"
} ]
}, {
"id": "ResearchStudy.focus.coding.display",
"min": 1,
"path": "ResearchStudy.focus.coding.display",
"short": "Focus area",
"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).",
"mapping": [ {
"map": "Design.focus.label",
"identity": "NFDI4Health"
} ],
"definition": "Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.)."
}, {
"id": "ResearchStudy.condition",
"path": "ResearchStudy.condition",
"short": "Primary health condition[conditions](s) or disease(s) considered in the [RESOURCE]",
"mapping": [ {
"map": "Design.conditions",
"identity": "NFDI4Health"
} ],
"definition": "Group of items providing information about primary health condition[conditions](s) or disease(s) considered in the [RESOURCE]."
}, {
"id": "ResearchStudy.condition.extension:uri",
"max": "1",
"min": 0,
"path": "ResearchStudy.condition.extension",
"type": [ {
"code": "Extension",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-uri" ]
} ],
"mapping": [ {
"map": "Design.conditions.code",
"identity": "NFDI4Health"
} ],
"sliceName": "uri"
}, {
"id": "ResearchStudy.condition.coding.code",
"min": 1,
"path": "ResearchStudy.condition.coding.code",
"short": "Terminology/classification",
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-conditions-classification-nci-local"
},
"comment": "Short Input Help: If used, name of the terminology/classification.",
"mapping": [ {
"map": "Design.conditions.classification",
"identity": "NFDI4Health"
} ],
"definition": "Terminology/classification used for the health condition[conditions] or disease."
}, {
"id": "ResearchStudy.condition.text",
"min": 1,
"path": "ResearchStudy.condition.text",
"short": "Primary health condition[conditions] or disease name",
"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).",
"example": [ {
"label": "Example of a primary health condition name",
"valueString": "Hier Beispiel einfügen"
} ],
"mapping": [ {
"map": "Design.conditions.label",
"identity": "NFDI4Health"
} ],
"definition": "Name of primary health condition[conditions] or disease considered in the [RESOURCE]."
}, {
"id": "ResearchStudy.relatedArtifact",
"max": "1",
"path": "ResearchStudy.relatedArtifact",
"type": [ {
"code": "RelatedArtifact",
"profile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-related-artifact-resource" ]
} ],
"mapping": [ {
"map": "Resource.ids",
"identity": "NFDI4Health"
}, {
"map": "Resource.idsNfdi4health",
"identity": "NFDI4Health"
}, {
"map": "Resource.webpage",
"identity": "NFDI4Health"
} ]
}, {
"id": "ResearchStudy.keyword",
"path": "ResearchStudy.keyword",
"short": "Keyword(s) describing the [RESOURCE]",
"comment": "Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated.",
"mapping": [ {
"map": "Resource.keywords",
"identity": "NFDI4Health"
} ],
"definition": "Group of items providing information about keywords describing the [RESOURCE]."
}, {
"id": "ResearchStudy.keyword.coding",
"max": "1",
"path": "ResearchStudy.keyword.coding"
}, {
"id": "ResearchStudy.keyword.coding.system",
"min": 1,
"path": "ResearchStudy.keyword.coding.system",
"short": "Code of the keyword",
"comment": "Short input help: If found, the code from the classification/vocabulary used.",
"example": [ {
"label": "Hier Beschreibung einfügen",
"valueUri": "http://id.nlm.nih.gov/mesh/D000086402"
} ],
"mapping": [ {
"map": "Resource.keywords.code",
"identity": "NFDI4Health"
} ],
"definition": "If known, the code of the keyword in a classification/vocabulary."
}, {
"id": "ResearchStudy.keyword.text",
"min": 1,
"path": "ResearchStudy.keyword.text",
"short": "label",
"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.",
"example": [ {
"label": "Keyword label",
"valueString": "SARS-CoV-2"
} ],
"mapping": [ {
"map": "Resource.keywords.label",
"identity": "NFDI4Health"
} ],
"definition": "Keyword(s) describing the [RESOURCE]."
}, {
"id": "ResearchStudy.period.start",
"path": "ResearchStudy.period.start",
"short": "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": [ {
"map": "Design.administrativeInformation.startDate",
"identity": "NFDI4Health"
} ],
"definition": "Start date of data collection for the [RESOURCE]."
}, {
"id": "ResearchStudy.period.end",
"path": "ResearchStudy.period.end",
"short": "End date",
"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": [ {
"map": "Design.administrativeInformation.endDate",
"identity": "NFDI4Health"
} ],
"definition": "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."
}, {
"id": "ResearchStudy.site",
"max": "1",
"path": "ResearchStudy.site",
"type": [ {
"code": "Reference",
"targetProfile": [ "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-centers" ]
} ]
}, {
"id": "ResearchStudy.reasonStopped.coding",
"max": "1",
"path": "ResearchStudy.reasonStopped.coding",
"short": "Stopping stage",
"binding": {
"strength": "required",
"valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-status-halted-stage-local"
},
"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]",
"mapping": [ {
"map": "Design.administrativeInformation.stageStopped",
"identity": "NFDI4Health"
} ],
"definition": "Specification of the stage at which the [RESOURCE] was prematurely stopped."
}, {
"id": "ResearchStudy.reasonStopped.text",
"path": "ResearchStudy.reasonStopped.text",
"short": "Stopping reason",
"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": [ {
"map": "Design.administrativeInformation.reasonStopped",
"identity": "NFDI4Health"
} ],
"definition": "Specification of the reason(s) why the [RESOURCE] was prematurely stopped."
}, {
"id": "ResearchStudy.note",
"max": "1",
"path": "ResearchStudy.note"
}, {
"id": "ResearchStudy.note.text",
"path": "ResearchStudy.note.text",
"short": "Additional information about the [RESOURCE]",
"comment": "Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields.",
"mapping": [ {
"map": "Design.comment",
"identity": "NFDI4Health"
} ],
"definition": "Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields.."
}, {
"id": "ResearchStudy.objective.name",
"min": 1,
"path": "ResearchStudy.objective.name",
"short": "Research questions/hypotheses",
"mapping": [ {
"map": "Design.hypotheses",
"identity": "NFDI4Health"
} ],
"definition": "Statement of the research questions and/or hypotheses underlying the [RESOURCE]."
} ]
},
"contact": [ {
"telecom": [ {
"value": "https://www.nfdi4health.de",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
}