<status value="draft" /> <publisher value="NFDI4Health" /> <contact> <telecom> <system value="url" /> <value value="https://www.nfdi4health.de" /> </telecom> </contact> <description value="Group of items applicable only to registries." /> <fhirVersion value="4.0.1" /> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="workflow" /> <uri value="http://hl7.org/fhir/workflow" /> <name value="Workflow Pattern" /> </mapping> <mapping> <identity value="w5" /> <uri value="http://hl7.org/fhir/fivews" /> <name value="FiveWs Pattern Mapping" /> </mapping> <mapping> <identity value="objimpl" /> <uri value="http://hl7.org/fhir/object-implementation" /> <name value="Object Implementation Information" /> </mapping> <mapping> <identity value="NFDI4Health" /> <name value="NFDI4Health to FHIR Mapping" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="Library" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Library" /> <derivation value="constraint" /> <differential> <element id="Library"> <path value="Library" /> <constraint> <key value="biosamples-a" /> <severity value="error" /> <human value="0..*, if Design.dataSource.general == 'C70699'" /> <expression value="extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists() implies extension.extension.where(url='biosamples').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="biosamples-b" /> <severity value="error" /> <human value="0..0, if Design.dataSource.general != 'C70699'" /> <expression value="extension.extension.where(url='general').valueCoding.where(code = 'C70699').exists().not() implies extension.extension.where(url='biosamples').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="imaging-a" /> <severity value="error" /> <human value="0..*, if Design.dataSource.general == '031'" /> <expression value="extension.extension.where(url='general').valueCoding.where(code = '031').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-radiomics').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="imaging-b" /> <severity value="error" /> <human value="0..0, if Design.dataSource.general != '031'" /> <expression value="extension.extension.where(url='general').valueCoding.where(code = '031').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-radiomics').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="omics-a" /> <severity value="error" /> <human value="0..*, if Design.dataSource.general == '033'" /> <expression value="extension.extension.where(url='general').valueCoding.where(code = '033').exists() implies extension.extension.where(url='omics').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="omics-b" /> <severity value="error" /> <human value="0..0, if Design.dataSource.general != '033'" /> <expression value="extension.extension.where(url='general').valueCoding.where(code = '033').exists().not() implies extension.extension.where(url='omics').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="supportingInformation-a" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'" /> <expression value="extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='supportingInformation').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="supportingInformation-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'" /> <expression value="extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='supportingInformation').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="timeFrame-a" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'" /> <expression value="extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='timeFrame').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="timeFrame-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'" /> <expression value="extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='timeFrame').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="accessCriteria-a" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.dataSharingPlan.generally == '373066001'" /> <expression value="extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists() implies extension.extension.where(url='accessCriteria').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="accessCriteria-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.dataSharingPlan.generally != '373066001'" /> <expression value="extension.extension.where(url='generally').valueCoding.where(code = '373066001').exists().not() implies extension.extension.where(url='accessCriteria').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="recordLinkage-a" /> <severity value="error" /> <human value="Cardinality: 1..1, if Design.dataSharingPlan.recordLinkage == 'Yes'" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="recordLinkage-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.dataSharingPlan.recordLinkage == 'No'" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="legalBasisDetails-a" /> <severity value="error" /> <human value="Cardinality: 1..1, if RecordLinkage.legalBasis == 'True'" /> <expression value="extension.extension.where(url='legalBasis').where(value=true).exists() implies extension.extension.where(url='legalBasisDetails').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <constraint> <key value="legalBasisDetails-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if RecordLinkage.legalBasis == 'False'" /> <expression value="extension.extension.where(url='legalBasis').where(value=false).exists() implies extension.extension.where(url='legalBasisDetails').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-registry" /> </constraint> <mapping> <identity value="NFDI4Health" /> <map value="Design" /> </mapping> </element> <element id="Library.extension"> <path value="Library.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="5" /> </element> <element id="Library.extension:groupsOfDiseases"> <path value="Library.extension" /> <sliceName value="groupsOfDiseases" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-groups-of-diseases" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Design.groupsOfDiseases" /> </mapping> </element> <element id="Library.extension:ethicsCommitteeApproval"> <path value="Library.extension" /> <sliceName value="ethicsCommitteeApproval" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-ethics-approval" /> </type> </element> <element id="Library.extension:keywords"> <path value="Library.extension" /> <sliceName value="keywords" /> <min value="0" /> <max value="*" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-keywords" /> </type> </element> <element id="Library.extension:descriptions"> <path value="Library.extension" /> <sliceName value="descriptions" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-descriptions" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Resource.descriptions" /> </mapping> </element> <element id="Library.extension:dataSource"> <path value="Library.extension" /> <sliceName value="dataSource" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-source" /> </type> </element> <element id="Library.extension:subject"> <path value="Library.extension" /> <sliceName value="subject" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-subject" /> </type> </element> <element id="Library.extension:outcomes"> <path value="Library.extension" /> <sliceName value="outcomes" /> <min value="0" /> <max value="*" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-outcomes" /> </type> </element> <element id="Library.extension:assessments"> <path value="Library.extension" /> <sliceName value="assessments" /> <min value="0" /> <max value="*" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-assessments" /> </type> </element> <element id="Library.extension:dataSharingPlan"> <path value="Library.extension" /> <sliceName value="dataSharingPlan" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan" /> </type> </element> <element id="Library.extension:dataProviders"> <path value="Library.extension" /> <sliceName value="dataProviders" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-data-providers" /> </type> </element> <element id="Library.extension:dataProvidersNumber"> <path value="Library.extension" /> <sliceName value="dataProvidersNumber" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-data-providers-number" /> </type> </element> <element id="Library.extension:population"> <path value="Library.extension" /> <sliceName value="population" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-library-population" /> </type> </element> <element id="Library.extension:recordLinkage"> <path value="Library.extension" /> <sliceName value="recordLinkage" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-record-linkage" /> </type> </element> <element id="Library.identifier"> <path value="Library.identifier" /> <short value="Alternative identifiers" /> <definition value="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 value="NFDI4Health" /> <map value="Resource.idsAlternative" /> </mapping> </element> <element id="Library.identifier.type"> <path value="Library.identifier.type" /> <short value="Type of the registry" /> <definition value="Type/name of the system where the given [RESOURCE] is already registered." /> <min value="1" /> <binding> <strength value="required" /> <description value="Value set defining codes to specify the type of a resource identifier." /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-id-type-nci-local" /> </binding> <mapping> <identity value="NFDI4Health" /> <map value="Resource.idsAlternative.scheme" /> </mapping> </element> <element id="Library.identifier.value"> <path value="Library.identifier.value" /> <definition value="Identifier" /> <min value="1" /> <example> <label value="Identifier (ID) assigned to the given [RESOURCE] by another registering system, e.g. by a registry of clinical trials or a data repository." /> <valueString value="ISRCTN91495258" /> </example> <mapping> <identity value="NFDI4Health" /> <map value="Resource.idsAlternative.identifier" /> </mapping> </element> <element id="Library.status"> <path value="Library.status" /> <comment value="The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies." /> <fixedCode value="active" /> </element> <element id="Library.subject[x]"> <path value="Library.subject[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> </element> <element id="Library.subject[x]:subjectReference"> <path value="Library.subject[x]" /> <sliceName value="subjectReference" /> <min value="0" /> <max value="1" /> <type> <code value="Reference" /> <targetProfile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-intended" /> <targetProfile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-group-actual" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Design.eligibilityCriteria" /> </mapping> </element> <element id="Library.subject[x]:subjectCodeableConcept"> <path value="Library.subject[x]" /> <sliceName value="subjectCodeableConcept" /> <min value="0" /> <max value="1" /> <type> <code value="CodeableConcept" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Design.subject" /> </mapping> </element> <element id="Library.description"> <path value="Library.description" /> <short value="Additional information about the [RESOURCE]" /> <definition value="Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields.." /> <comment value="Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields." /> <mapping> <identity value="NFDI4Health" /> <map value="Design.comment" /> </mapping> </element> <element id="Library.effectivePeriod"> <path value="Library.effectivePeriod" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.administrativeInformation.startDate" /> </mapping> <mapping> <identity value="NFDI4Health" /> <map value="Design.administrativeInformation.endDate" /> </mapping> </element> <element id="Library.effectivePeriod.start"> <path value="Library.effectivePeriod.start" /> <short value="Start date" /> <definition value="Start date of data collection for the [RESOURCE]." /> <comment value="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." /> </element> <element id="Library.effectivePeriod.end"> <path value="Library.effectivePeriod.end" /> <short value="End date" /> <definition value="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 value="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." /> </element> <element id="Library.topic"> <path value="Library.topic" /> <short value="Primary focus of the [RESOURCE]" /> <definition value="Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.)." /> <mapping> <identity value="NFDI4Health" /> <map value="Design.focus" /> </mapping> </element> <element id="Library.topic.coding.extension"> <path value="Library.topic.coding.extension" /> <min value="1" /> </element> <element id="Library.topic.coding.extension:codeableConcept"> <path value="Library.topic.coding.extension" /> <sliceName value="codeableConcept" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-codeableconcept" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Design.focus.code" /> </mapping> <mapping> <identity value="NFDI4Health" /> <map value="Design.focus.classification" /> </mapping> </element> <element id="Library.topic.text"> <path value="Library.topic.text" /> <short value="Focus area" /> <definition value="Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.)." /> <comment value="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 value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.focus.label" /> </mapping> </element> <element id="Library.relatedArtifact"> <path value="Library.relatedArtifact" /> <max value="1" /> <type> <code value="RelatedArtifact" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-related-artifact-resource" /> </type> </element> </differential> </StructureDefinition>