Resource StructureDefinition/FHIR Server from package de.nfdi4health.mds#2.0.0 (125 ms)
Resources that use this resource
Resources that this resource uses
Source
{
"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-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" : "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:executionLanguage",
"path" : "ResearchStudy.extension",
"sliceName" : "executionLanguage",
"min" : 0,
"max" : "*",
"type" : [
{
"code" : "Extension",
"profile" : [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-execution-language"
]
}
]
},
{
"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" : [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject"
]
}
]
},
{
"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" : [
"http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure"
]
}
]
},
{
"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",
"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."
},
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.primaryPurpose"
}
]
},
{
"id" : "ResearchStudy.primaryPurposeType.coding",
"path" : "ResearchStudy.primaryPurposeType.coding",
"min" : 1,
"max" : "1"
},
{
"id" : "ResearchStudy.primaryPurposeType.coding.system",
"path" : "ResearchStudy.primaryPurposeType.coding.system",
"min" : 1
},
{
"id" : "ResearchStudy.primaryPurposeType.coding.code",
"path" : "ResearchStudy.primaryPurposeType.coding.code",
"min" : 1
},
{
"id" : "ResearchStudy.phase",
"path" : "ResearchStudy.phase",
"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."
},
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.interventional.phase"
}
]
},
{
"id" : "ResearchStudy.phase.coding.system",
"path" : "ResearchStudy.phase.coding.system",
"min" : 1
},
{
"id" : "ResearchStudy.phase.coding.code",
"path" : "ResearchStudy.phase.coding.code",
"min" : 1
},
{
"id" : "ResearchStudy.category",
"path" : "ResearchStudy.category",
"short" : "Is it an interventional or non-interventional [RESOURCE]?",
"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.",
"comment" : "Short input help: Select between non-interventional and interventional design for the given [RESOURCE].",
"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:uri",
"path" : "ResearchStudy.focus.coding.extension",
"sliceName" : "uri",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-uri"
]
}
],
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.focus.code"
}
]
},
{
"id" : "ResearchStudy.focus.coding.system",
"path" : "ResearchStudy.focus.coding.system",
"short" : "Terminology/classification",
"definition" : "Terminology/classification used for the focus area.",
"comment" : "Short Input Help: If used, name of the terminology/classification.",
"min" : 1,
"example" : [
{
"label" : "Example of a terminology/classification",
"valueCode" : "C49469"
}
],
"binding" : {
"strength" : "required",
"valueSet" : "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-conditions-classification-nci-local"
},
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.focus.classification"
}
]
},
{
"id" : "ResearchStudy.focus.coding.display",
"path" : "ResearchStudy.focus.coding.display",
"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 condition[conditions](s) or disease(s) considered in the [RESOURCE]",
"definition" : "Group of items providing information about primary health condition[conditions](s) or disease(s) considered in the [RESOURCE].",
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.conditions"
}
]
},
{
"id" : "ResearchStudy.condition.extension:uri",
"path" : "ResearchStudy.condition.extension",
"sliceName" : "uri",
"min" : 0,
"max" : "1",
"type" : [
{
"code" : "Extension",
"profile" : [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-uri"
]
}
],
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.conditions.code"
}
]
},
{
"id" : "ResearchStudy.condition.coding.code",
"path" : "ResearchStudy.condition.coding.code",
"short" : "Terminology/classification",
"definition" : "Terminology/classification used for the health condition[conditions] or disease.",
"comment" : "Short Input Help: If used, name of the terminology/classification.",
"min" : 1,
"binding" : {
"strength" : "required",
"valueSet" : "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-conditions-classification-nci-local"
},
"mapping" : [
{
"identity" : "NFDI4Health",
"map" : "Design.conditions.classification"
}
]
},
{
"id" : "ResearchStudy.condition.text",
"path" : "ResearchStudy.condition.text",
"short" : "Primary health condition[conditions] or disease name",
"definition" : "Name of primary health condition[conditions] or disease considered in the [RESOURCE].",
"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,
"example" : [
{
"label" : "Example of a primary health condition name",
"valueString" : "Hier Beispiel einfügen"
}
],
"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" : "Keyword(s) describing the [RESOURCE]",
"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",
"path" : "ResearchStudy.keyword.coding",
"max" : "1"
},
{
"id" : "ResearchStudy.keyword.coding.system",
"path" : "ResearchStudy.keyword.coding.system",
"short" : "Code of the keyword",
"definition" : "If known, the code of the keyword in a classification/vocabulary.",
"comment" : "Short input help: If found, the code from the classification/vocabulary used.",
"min" : 1,
"example" : [
{
"label" : "Hier Beschreibung einfügen",
"valueUri" : "http://id.nlm.nih.gov/mesh/D000086402"
}
],
"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" : "Start date of data collection for the [RESOURCE].",
"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 [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 reason(s) why 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: 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"
}
]
}
]
},
"text" : {
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.
FHIR