<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 studies, substudies." /> <fhirVersion value="4.0.1" /> <mapping> <identity value="BRIDG5.1" /> <uri value="https://bridgmodel.nci.nih.gov" /> <name value="BRIDG 5.1 Mapping" /> </mapping> <mapping> <identity value="v2" /> <uri value="http://hl7.org/v2" /> <name value="HL7 v2 Mapping" /> </mapping> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="clinicaltrials-gov" /> <uri value="http://clinicaltrials.gov" /> <name value="ClinicalTrials.gov Mapping" /> </mapping> <mapping> <identity value="w5" /> <uri value="http://hl7.org/fhir/fivews" /> <name value="FiveWs Pattern Mapping" /> </mapping> <mapping> <identity value="NFDI4Health" /> <name value="NFDI4Health to FHIR Mapping" /> </mapping> <kind value="resource" /> <abstract value="false" /> <type value="ResearchStudy" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchStudy" /> <derivation value="constraint" /> <differential> <element id="ResearchStudy"> <path value="ResearchStudy" /> <constraint> <key value="category-interventional-a" /> <severity value="error" /> <human value="Cardinality: 1..*, if Design.primaryDesign == 'C98388'" /> <expression value="category.coding.where(code = 'C98388').exists() implies category.extension.extension.where(url='interventional').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="category-interventional-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.primaryDesign != 'C98388'" /> <expression value="category.coding.where(code = 'C98388').exists().not() implies category.extension.extension.where(url='interventional').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="category-nonInterventional-a" /> <severity value="error" /> <human value="Cardinality: 1..*, if Design.primaryDesign == 'C142615''" /> <expression value="category.coding.where(code = 'C142615').exists() implies category.extension.extension.where(url='nonInterventional').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="category-nonInterventional-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.primaryDesign != 'C142615'" /> <expression value="category.coding.where(code = 'C142615').exists().not() implies category.extension.extension.where(url='nonInterventional').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-mortalityData-a" /> <severity value="error" /> <human value="Cardinality: 0..1, if Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-mortalityData-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.studyType.nonInterventional != ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311'))" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-statusWhenIntervention-a" /> <severity value="error" /> <human value="Cardinality: 0..1, if Design.primaryDesign == 'C98388'" /> <expression value="category.coding.where(code = 'C98388').exists() implies extension.extension.where(url='statusWhenIntervention').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-statusWhenIntervention-b" /> <severity value="error" /> <human value="Cardinality: 0..1, if Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05')" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-statusWhenIntervention-c" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.primaryDesign != 'C98388'" /> <expression value="category.coding.where(code = 'C98388').exists().not() implies extension.extension.where(url='statusWhenIntervention').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-statusWhenIntervention-d" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.administrativeInformation.status != ('01' OR '02' OR '03' OR '04' OR '05')" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-recruitmentStatusRegister-a" /> <severity value="error" /> <human value="Cardinality: 0..1, if Resource.provenance.dataSource != '06'" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-recruitmentStatusRegister-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Resource.provenance.dataSource == '06'" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="probabilityMethod-a" /> <severity value="error" /> <human value="0..1, if Design.sampling.method == '034'" /> <expression value="extension.extension.where(url='method').valueCoding.where(code = '034').exists() implies extension.extension.where(url='probabilityMethod').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="probabilityMethod-b" /> <severity value="error" /> <human value="0..0, if Design.sampling.method != '034'" /> <expression value="extension.extension.where(url='method').valueCoding.where(code = '034').exists().not() implies extension.extension.where(url='probabilityMethod').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="nonProbabilityMethod-a" /> <severity value="error" /> <human value="0..1, if Design.sampling.method == 'C127781'" /> <expression value="extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists() implies extension.extension.where(url='nonProbabilityMethod').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="nonProbabilityMethod-b" /> <severity value="error" /> <human value="0..0, if Design.sampling.method != 'C127781'" /> <expression value="extension.extension.where(url='method').valueCoding.where(code = 'C127781').exists().not() implies extension.extension.where(url='nonProbabilityMethod').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </constraint> <constraint> <key value="masking-roles-a" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.interventional.masking.general == true" /> <expression value="extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='roles').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="masking-roles-b" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.interventional.masking.general == false" /> <expression value="extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='roles').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="masking-description-a" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.interventional.masking.general == true" /> <expression value="extension.extension.extension.where(url='general').where(value=true).exists() implies extension.extension.extension.where(url='description').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="masking-description-b" /> <severity value="error" /> <human value="Cardinality: 0..*, if Design.interventional.masking.general == false" /> <expression value="extension.extension.extension.where(url='general').where(value=true).exists().not() implies extension.extension.extension.where(url='description').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="interventional-a" /> <severity value="error" /> <human value="Cardinality: 0..1, Design.primaryDesign == 'Interventional'" /> <expression value="category.coding.where(code = 'C98388').exists() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="interventional-b" /> <severity value="error" /> <human value="Cardinality: 0..0, Design.primaryDesign != 'Interventional'" /> <expression value="category.coding.where(code = 'C98388').exists().not() implies extension.where(url='https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional').exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="nonInterventional-a" /> <severity value="error" /> <human value="Cardinality: 0..1, Design.primaryDesign == 'Non-interventional'" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="nonInterventional-b" /> <severity value="error" /> <human value="Cardinality: 0..0, Design.primaryDesign != 'Non-interventional'" /> <expression value="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 value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-stageStopped-a" /> <severity value="error" /> <human value="Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')" /> <expression value="extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.coding.exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-stageStopped-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')" /> <expression value="extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.coding.exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-reasonStopped-a" /> <severity value="error" /> <human value="Cardinality: 0..1, if Design.administrativeInformation.status == ('06' OR '07')" /> <expression value="extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists() implies reasonStopped.text.exists()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </constraint> <constraint> <key value="study-reasonStopped-b" /> <severity value="error" /> <human value="Cardinality: 0..0, if Design.administrativeInformation.status != ('06' OR '07')" /> <expression value="extension.extension.where(url='status').valueCoding.where(code = '06' or code = '07').exists().not() implies reasonStopped.text.exists().not()" /> <source value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-study" /> </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-study" /> </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-study" /> </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-study" /> </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-study" /> </constraint> <mapping> <identity value="NFDI4Health" /> <map value="Design" /> </mapping> </element> <element id="ResearchStudy.extension"> <path value="ResearchStudy.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="5" /> </element> <element id="ResearchStudy.extension:descriptions"> <path value="ResearchStudy.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="ResearchStudy.extension:mortalityData"> <path value="ResearchStudy.extension" /> <sliceName value="mortalityData" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-mortality-data" /> </type> </element> <element id="ResearchStudy.extension:administrativeInformation"> <path value="ResearchStudy.extension" /> <sliceName value="administrativeInformation" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-admin-info" /> </type> </element> <element id="ResearchStudy.extension:subject"> <path value="ResearchStudy.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="ResearchStudy.extension:dataSource"> <path value="ResearchStudy.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="ResearchStudy.extension:recruitment"> <path value="ResearchStudy.extension" /> <sliceName value="recruitment" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-recruitment-backport-r5" /> </type> </element> <element id="ResearchStudy.extension:comparisonGroup"> <path value="ResearchStudy.extension" /> <sliceName value="comparisonGroup" /> <min value="0" /> <max value="*" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-comparison-group-backport-r5" /> </type> </element> <element id="ResearchStudy.extension:outcomes"> <path value="ResearchStudy.extension" /> <sliceName value="outcomes" /> <min value="0" /> <max value="*" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/StructureDefinition/nfdi4health-ex-mds-outcomemeasure-backport-r5" /> </type> </element> <element id="ResearchStudy.extension:assessments"> <path value="ResearchStudy.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="ResearchStudy.extension:dataSharingPlan"> <path value="ResearchStudy.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="ResearchStudy.extension:nonInterventional"> <path value="ResearchStudy.extension" /> <sliceName value="nonInterventional" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-non-interventional" /> </type> </element> <element id="ResearchStudy.extension:interventional"> <path value="ResearchStudy.extension" /> <sliceName value="interventional" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-interventional" /> </type> </element> <element id="ResearchStudy.extension:groupsOfDiseases"> <path value="ResearchStudy.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="ResearchStudy.extension:sampling"> <path value="ResearchStudy.extension" /> <sliceName value="sampling" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-sampling" /> </type> </element> <element id="ResearchStudy.extension:recordLinkage"> <path value="ResearchStudy.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="ResearchStudy.extension:imaging"> <path value="ResearchStudy.extension" /> <sliceName value="imaging" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-imaging" /> </type> </element> <element id="ResearchStudy.identifier"> <path value="ResearchStudy.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="ResearchStudy.identifier.type"> <path value="ResearchStudy.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="ResearchStudy.identifier.value"> <path value="ResearchStudy.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="esource.idsAlternative.identifier" /> </mapping> </element> <element id="ResearchStudy.status"> <path value="ResearchStudy.status" /> <comment value="The item does not exist in NFDI4Health' MDS. Fixed to 'active' for all studies." /> <fixedCode value="active" /> </element> <element id="ResearchStudy.primaryPurposeType"> <path value="ResearchStudy.primaryPurposeType" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.primaryPurpose" /> </mapping> </element> <element id="ResearchStudy.primaryPurposeType.coding"> <path value="ResearchStudy.primaryPurposeType.coding" /> <short value="Primary purpose of the [RESOURCE]" /> <definition value="Specification of the main purpose of the [RESOURCE]." /> <comment value="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 value="required" /> <description value="Value set defining codes to specify the primary purpose of a (sub-)study in a ResearchStudy resource." /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-purpose-hl7-nci" /> </binding> </element> <element id="ResearchStudy.phase"> <path value="ResearchStudy.phase" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.interventional.phase" /> </mapping> </element> <element id="ResearchStudy.phase.coding"> <path value="ResearchStudy.phase.coding" /> <short value="Numerical phase" /> <definition value="If applicable, numerical phase of the [RESOURCE]." /> <comment value="Short input help: Select one value from the list." /> <binding> <strength value="required" /> <description value="Value set defining codes to specify the phase of a (sub-)study in a ResearchStudy resource." /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-phase-nci" /> </binding> </element> <element id="ResearchStudy.category"> <path value="ResearchStudy.category" /> <short value="Is the study design non-interventional or interventional?" /> <min value="1" /> <max value="1" /> <binding> <strength value="required" /> <description value="Value set defining codes for primary designs of (sub-)studies in a ResearchStudy resource." /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-primary-design-nci" /> </binding> <mapping> <identity value="NFDI4Health" /> <map value="Design.primaryDesign" /> </mapping> </element> <element id="ResearchStudy.category.extension"> <path value="ResearchStudy.category.extension" /> <min value="1" /> </element> <element id="ResearchStudy.category.extension:studyType"> <path value="ResearchStudy.category.extension" /> <sliceName value="studyType" /> <min value="1" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-type" /> </type> </element> <element id="ResearchStudy.focus"> <path value="ResearchStudy.focus" /> <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="ResearchStudy.focus.coding.extension"> <path value="ResearchStudy.focus.coding.extension" /> <min value="1" /> </element> <element id="ResearchStudy.focus.coding.extension:codeableConcept"> <path value="ResearchStudy.focus.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="ResearchStudy.focus.text"> <path value="ResearchStudy.focus.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="ResearchStudy.condition"> <path value="ResearchStudy.condition" /> <short value="Primary health conditions or diseases considered in the [RESOURCE]" /> <definition value="Group of items providing information about primary health conditions or diseases considered in the [RESOURCE]." /> <mapping> <identity value="NFDI4Health" /> <map value="Design.conditions" /> </mapping> </element> <element id="ResearchStudy.condition.coding.extension"> <path value="ResearchStudy.condition.coding.extension" /> <min value="1" /> </element> <element id="ResearchStudy.condition.coding.extension:codeableConcept"> <path value="ResearchStudy.condition.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.conditions.code" /> </mapping> <mapping> <identity value="NFDI4Health" /> <map value="Design.conditions.classification" /> </mapping> </element> <element id="ResearchStudy.condition.text"> <path value="ResearchStudy.condition.text" /> <short value="Health condition or disease" /> <definition value="The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks." /> <comment value="Preferably, use terms from terminologies such as SNOMED CT." /> <min value="1" /> <example> <label value="Example of a health condition" /> <valueString value="SARS-CoV-2" /> </example> <mapping> <identity value="NFDI4Health" /> <map value="Design.conditions.label" /> </mapping> </element> <element id="ResearchStudy.relatedArtifact"> <path value="ResearchStudy.relatedArtifact" /> <max value="1" /> <type> <code value="RelatedArtifact" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-related-artifact-resource" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Resource.ids" /> </mapping> <mapping> <identity value="NFDI4Health" /> <map value="Resource.idsNfdi4health" /> </mapping> <mapping> <identity value="NFDI4Health" /> <map value="Resource.webpage" /> </mapping> </element> <element id="ResearchStudy.keyword"> <path value="ResearchStudy.keyword" /> <short value="Keywords" /> <definition value="Group of items providing information about keywords describing the [RESOURCE]." /> <comment value="Additional information: The findability of the [RESOURCE] can be significantly increased if proper keywords are stated." /> <mapping> <identity value="NFDI4Health" /> <map value="Resource.keywords" /> </mapping> </element> <element id="ResearchStudy.keyword.coding.code.extension"> <path value="ResearchStudy.keyword.coding.code.extension" /> <slicing> <discriminator> <type value="value" /> <path value="url" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> </element> <element id="ResearchStudy.keyword.coding.code.extension:code"> <path value="ResearchStudy.keyword.coding.code.extension" /> <sliceName value="code" /> <min value="0" /> <max value="1" /> <type> <code value="Extension" /> <profile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-code" /> </type> <mapping> <identity value="NFDI4Health" /> <map value="Resource.keywords.code" /> </mapping> </element> <element id="ResearchStudy.keyword.text"> <path value="ResearchStudy.keyword.text" /> <short value="label" /> <definition value="Keyword(s) describing the [RESOURCE]." /> <comment value="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 value="1" /> <example> <label value="Keyword label" /> <valueString value="SARS-CoV-2" /> </example> <mapping> <identity value="NFDI4Health" /> <map value="Resource.keywords.label" /> </mapping> </element> <element id="ResearchStudy.period.start"> <path value="ResearchStudy.period.start" /> <short value="Start date" /> <definition value="In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date." /> <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." /> <mapping> <identity value="NFDI4Health" /> <map value="Design.administrativeInformation.startDate" /> </mapping> </element> <element id="ResearchStudy.period.end"> <path value="ResearchStudy.period.end" /> <short value="End date" /> <definition value="In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date. In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit." /> <comment 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." /> <mapping> <identity value="NFDI4Health" /> <map value="Design.administrativeInformation.endDate" /> </mapping> </element> <element id="ResearchStudy.site"> <path value="ResearchStudy.site" /> <max value="1" /> <type> <code value="Reference" /> <targetProfile value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-pr-mds-centers" /> </type> </element> <element id="ResearchStudy.reasonStopped.coding"> <path value="ResearchStudy.reasonStopped.coding" /> <short value="Stopping stage" /> <definition value="Specification of the stage at which the [RESOURCE] was prematurely stopped." /> <comment value="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 value="1" /> <binding> <strength value="required" /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-status-halted-stage-local" /> </binding> <mapping> <identity value="NFDI4Health" /> <map value="Design.administrativeInformation.stageStopped" /> </mapping> </element> <element id="ResearchStudy.reasonStopped.text"> <path value="ResearchStudy.reasonStopped.text" /> <short value="Stopping reason" /> <definition value="Specification of the reasons why the [RESOURCE] was prematurely stopped, for example due to toxicity, closed due to lack of study progress, temporarily closed per study design." /> <comment value="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 value="NFDI4Health" /> <map value="Design.administrativeInformation.reasonStopped" /> </mapping> </element> <element id="ResearchStudy.note"> <path value="ResearchStudy.note" /> <max value="1" /> </element> <element id="ResearchStudy.note.text"> <path value="ResearchStudy.note.text" /> <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="ResearchStudy.objective.name"> <path value="ResearchStudy.objective.name" /> <short value="Research questions/hypotheses" /> <definition value="Statement of the research questions and/or hypotheses underlying the [RESOURCE]." /> <min value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.hypotheses" /> </mapping> </element> </differential> </StructureDefinition>