{
"resourceType": "StructureDefinition",
"id": "nfdi4health-pr-mds-registry",
"url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry",
"version": "0.9",
"name": "NFDI4Health_PR_MDS_Registry",
"title": "NFDI4Health PR MDS Registry",
"status": "draft",
"publisher": "NFDI4Health",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "https://www.nfdi4health.de"
}
]
}
],
"description": "Group of items applicable only to registries.",
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "rim",
"uri": "http://hl7.org/v3",
"name": "RIM Mapping"
},
{
"identity": "workflow",
"uri": "http://hl7.org/fhir/workflow",
"name": "Workflow Pattern"
},
{
"identity": "w5",
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping"
},
{
"identity": "objimpl",
"uri": "http://hl7.org/fhir/object-implementation",
"name": "Object Implementation Information"
},
{
"identity": "NFDI4Health",
"name": "NFDI4Health to FHIR Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "Library",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/Library",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "Library",
"path": "Library",
"constraint": [
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
},
{
"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-registry"
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design"
}
]
},
{
"id": "Library.extension",
"path": "Library.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"min": 5
},
{
"id": "Library.extension:groupsOfDiseases",
"path": "Library.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": "Library.extension:ethicsCommitteeApproval",
"path": "Library.extension",
"sliceName": "ethicsCommitteeApproval",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-ethics-approval"
]
}
]
},
{
"id": "Library.extension:keywords",
"path": "Library.extension",
"sliceName": "keywords",
"min": 0,
"max": "*",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-keywords"
]
}
]
},
{
"id": "Library.extension:descriptions",
"path": "Library.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": "Library.extension:dataSource",
"path": "Library.extension",
"sliceName": "dataSource",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source"
]
}
]
},
{
"id": "Library.extension:subject",
"path": "Library.extension",
"sliceName": "subject",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject"
]
}
]
},
{
"id": "Library.extension:outcomes",
"path": "Library.extension",
"sliceName": "outcomes",
"min": 0,
"max": "*",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-outcomes"
]
}
]
},
{
"id": "Library.extension:assessments",
"path": "Library.extension",
"sliceName": "assessments",
"min": 0,
"max": "*",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments"
]
}
]
},
{
"id": "Library.extension:dataSharingPlan",
"path": "Library.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": "Library.extension:dataProviders",
"path": "Library.extension",
"sliceName": "dataProviders",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-data-providers"
]
}
]
},
{
"id": "Library.extension:dataProvidersNumber",
"path": "Library.extension",
"sliceName": "dataProvidersNumber",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-data-providers-number"
]
}
]
},
{
"id": "Library.extension:population",
"path": "Library.extension",
"sliceName": "population",
"min": 1,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-population"
]
}
]
},
{
"id": "Library.extension:recordLinkage",
"path": "Library.extension",
"sliceName": "recordLinkage",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage"
]
}
]
},
{
"id": "Library.identifier",
"path": "Library.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": "Library.identifier.type",
"path": "Library.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": "Library.identifier.value",
"path": "Library.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": "Resource.idsAlternative.identifier"
}
]
},
{
"id": "Library.status",
"path": "Library.status",
"comment": "The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies.",
"fixedCode": "active"
},
{
"id": "Library.subject[x]",
"path": "Library.subject[x]",
"slicing": {
"discriminator": [
{
"type": "type",
"path": "$this"
}
],
"ordered": false,
"rules": "open"
}
},
{
"id": "Library.subject[x]:subjectReference",
"path": "Library.subject[x]",
"sliceName": "subjectReference",
"min": 0,
"max": "1",
"type": [
{
"code": "Reference",
"targetProfile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-intended"
]
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.eligibilityCriteria"
}
]
},
{
"id": "Library.subject[x]:subjectCodeableConcept",
"path": "Library.subject[x]",
"sliceName": "subjectCodeableConcept",
"min": 0,
"max": "1",
"type": [
{
"code": "CodeableConcept"
}
],
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.subject"
}
]
},
{
"id": "Library.description",
"path": "Library.description",
"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": "Library.effectivePeriod",
"path": "Library.effectivePeriod",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.administrativeInformation.startDate"
},
{
"identity": "NFDI4Health",
"map": "Design.administrativeInformation.endDate"
}
]
},
{
"id": "Library.effectivePeriod.start",
"path": "Library.effectivePeriod.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."
},
{
"id": "Library.effectivePeriod.end",
"path": "Library.effectivePeriod.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."
},
{
"id": "Library.topic",
"path": "Library.topic",
"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": "Library.topic.extension:uri",
"path": "Library.topic.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": "Library.topic.coding",
"path": "Library.topic.coding",
"short": "Terminology/classification",
"definition": "Terminology/classification used for the focus area.",
"comment": "Short Input Help: If used, name of the terminology/classification.",
"min": 1,
"max": "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"
}
},
{
"id": "Library.topic.coding.code",
"path": "Library.topic.coding.code",
"mapping": [
{
"identity": "NFDI4Health",
"map": "Design.focus.classification"
}
]
},
{
"id": "Library.topic.text",
"path": "Library.topic.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": "Library.relatedArtifact",
"path": "Library.relatedArtifact",
"max": "1",
"type": [
{
"code": "RelatedArtifact",
"profile": [
"https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-related-artifact-resource"
]
}
]
}
]
}
}