<status value="draft" /> <publisher value="NFDI4Health" /> <contact> <telecom> <system value="url" /> <value value="https://www.nfdi4health.de" /> </telecom> </contact> <description value="Extension providing information about the data sharing strategy of the resource." /> <fhirVersion value="4.0.1" /> <mapping> <identity value="rim" /> <uri value="http://hl7.org/v3" /> <name value="RIM Mapping" /> </mapping> <mapping> <identity value="NFDI4Health" /> <name value="NFDI4Health to FHIR Mapping" /> </mapping> <kind value="complex-type" /> <abstract value="false" /> <context> <type value="element" /> <expression value="ResearchStudy" /> </context> <context> <type value="element" /> <expression value="Library" /> </context> <type value="Extension" /> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension" /> <derivation value="constraint" /> <differential> <element id="Extension"> <path value="Extension" /> <short value="Data sharing" /> <definition value="Group of items providing information regarding the sharing of data by the [RESOURCE]." /> <min value="1" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan" /> </mapping> </element> <element id="Extension.extension"> <path value="Extension.extension" /> <min value="1" /> </element> <element id="Extension.extension:generally"> <path value="Extension.extension" /> <sliceName value="generally" /> <short value="Is it planned to share the data?" /> <definition value="Indication whether there is a plan to make data collected in the [RESOURCE] available. In case of a [RESOURCE] with patients or other individuals, this refers to individual participant data (IPD)." /> <comment value="Short input help: Select one value from the list." /> <min value="1" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.generally" /> </mapping> </element> <element id="Extension.extension:generally.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:generally.url"> <path value="Extension.extension.url" /> <fixedUri value="generally" /> </element> <element id="Extension.extension:generally.value[x]"> <path value="Extension.extension.value[x]" /> <min value="1" /> <type> <code value="Coding" /> </type> <binding> <strength value="required" /> <description value="Value set used to respond to questions that can be answered Yes, No, or Undecided" /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-yes-no-undecided-nci" /> </binding> </element> <element id="Extension.extension:generally.value[x].system"> <path value="Extension.extension.value[x].system" /> <min value="1" /> </element> <element id="Extension.extension:generally.value[x].code"> <path value="Extension.extension.value[x].code" /> <min value="1" /> </element> <element id="Extension.extension:supportingInformation"> <path value="Extension.extension" /> <sliceName value="supportingInformation" /> <short value="Supporting documents available in addition to the data" /> <definition value="Supporting information/documents which will be made available in addition to the data collected in the [RESOURCE]." /> <comment value="Short input help: Select all that apply." /> <min value="0" /> <max value="*" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.supportingInformation" /> </mapping> </element> <element id="Extension.extension:supportingInformation.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:supportingInformation.url"> <path value="Extension.extension.url" /> <fixedUri value="supportingInformation" /> </element> <element id="Extension.extension:supportingInformation.value[x]"> <path value="Extension.extension.value[x]" /> <min value="1" /> <type> <code value="Coding" /> </type> <binding> <strength value="required" /> <description value="Value set defining codes to specify if the DataSHIELD/Opal infrastructure is available." /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sharing-plan-sup-inf-nci-local" /> </binding> </element> <element id="Extension.extension:supportingInformation.value[x].system"> <path value="Extension.extension.value[x].system" /> <min value="1" /> </element> <element id="Extension.extension:supportingInformation.value[x].code"> <path value="Extension.extension.value[x].code" /> <min value="1" /> </element> <element id="Extension.extension:timeFrame"> <path value="Extension.extension" /> <sliceName value="timeFrame" /> <short value="When and for how long will the data be available?" /> <definition value="Indication of the time period for which the data and, if applicable, supporting documents will be made available." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.timeFrame" /> </mapping> </element> <element id="Extension.extension:timeFrame.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:timeFrame.url"> <path value="Extension.extension.url" /> <fixedUri value="timeFrame" /> </element> <element id="Extension.extension:timeFrame.value[x]"> <path value="Extension.extension.value[x]" /> <type> <code value="string" /> </type> </element> <element id="Extension.extension:accessCriteria"> <path value="Extension.extension" /> <sliceName value="accessCriteria" /> <short value="Criteria for data access" /> <definition value="Indication of the access criteria by which the data will be shared, including: a) with whom; b) for which types of analyses; and c) by what mechanism." /> <comment value="Short input help: Please provide here with whom, for which types of analyses and by what mechanism the data will be shared." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.accessCriteria" /> </mapping> </element> <element id="Extension.extension:accessCriteria.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:accessCriteria.url"> <path value="Extension.extension.url" /> <fixedUri value="accessCriteria" /> </element> <element id="Extension.extension:accessCriteria.value[x]"> <path value="Extension.extension.value[x]" /> <type> <code value="string" /> </type> </element> <element id="Extension.extension:description"> <path value="Extension.extension" /> <sliceName value="description" /> <short value="Additional information about data sharing" /> <definition value="Additional descriptive information providing more details about data sharing, e.g. indication of which data in particular will be shared or why the data will not be shared or why it is not yet decided." /> <comment value="Short input help: Please indicate here which data in particular will be shared, or the reasons why it will not be shared or it is not yet decided." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.description" /> </mapping> </element> <element id="Extension.extension:description.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:description.url"> <path value="Extension.extension.url" /> <fixedUri value="description" /> </element> <element id="Extension.extension:description.value[x]"> <path value="Extension.extension.value[x]" /> <type> <code value="string" /> </type> </element> <element id="Extension.extension:datashield"> <path value="Extension.extension" /> <sliceName value="datashield" /> <short value="DataSHIELD/Opal infrastructure available?" /> <definition value="Indication whether the DataSHIELD/Opal infrastructure is available." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.datashield" /> </mapping> </element> <element id="Extension.extension:datashield.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:datashield.url"> <path value="Extension.extension.url" /> <fixedUri value="datashield" /> </element> <element id="Extension.extension:datashield.value[x]"> <path value="Extension.extension.value[x]" /> <min value="1" /> <type> <code value="Coding" /> </type> <binding> <strength value="required" /> <description value="Value set defining codes to specify if the DataSHIELD/Opal infrastructure is available." /> <valueSet value="https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sharing-plan-ds-sct-nci" /> </binding> </element> <element id="Extension.extension:datashield.value[x].system"> <path value="Extension.extension.value[x].system" /> <min value="1" /> </element> <element id="Extension.extension:datashield.value[x].code"> <path value="Extension.extension.value[x].code" /> <min value="1" /> </element> <element id="Extension.extension:requestData"> <path value="Extension.extension" /> <sliceName value="requestData" /> <short value="Link to data request application" /> <definition value="If existing, a link to the web page where the data request form and/or information on data reuse can be found." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.requestData" /> </mapping> </element> <element id="Extension.extension:requestData.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:requestData.url"> <path value="Extension.extension.url" /> <fixedUri value="requestData" /> </element> <element id="Extension.extension:requestData.value[x]"> <path value="Extension.extension.value[x]" /> <type> <code value="url" /> </type> </element> <element id="Extension.extension:url"> <path value="Extension.extension" /> <sliceName value="url" /> <short value="Web page with additional information about data sharing" /> <definition value="If existing, a link to the web page where additional information about data sharing can be found." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.url" /> </mapping> </element> <element id="Extension.extension:url.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:url.url"> <path value="Extension.extension.url" /> <fixedUri value="url" /> </element> <element id="Extension.extension:url.value[x]"> <path value="Extension.extension.value[x]" /> <type> <code value="url" /> </type> </element> <element id="Extension.extension:recordLinkage"> <path value="Extension.extension" /> <sliceName value="recordLinkage" /> <short value="Record linkage possible?" /> <definition value="Indication if record linkage with other data sources is possible." /> <comment value="Additional Information: Record linkage refers to the merging of data on the same person from different databases." /> <min value="0" /> <max value="1" /> <mapping> <identity value="NFDI4Health" /> <map value="Design.dataSharingPlan.recordLinkage" /> </mapping> </element> <element id="Extension.extension:recordLinkage.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:recordLinkage.url"> <path value="Extension.extension.url" /> <fixedUri value="recordLinkage" /> </element> <element id="Extension.extension:recordLinkage.value[x]"> <path value="Extension.extension.value[x]" /> <type> <code value="boolean" /> </type> </element> <element id="Extension.url"> <path value="Extension.url" /> <fixedUri value="https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-data-sharing-plan" /> </element> <element id="Extension.value[x]"> <path value="Extension.value[x]" /> <max value="0" /> </element> </differential> </StructureDefinition>