{ "description": "Extension providing information about the data sharing strategy of the study.", "_filename": "StructureDefinition-nfdi4health-ex-mds-study-data-sharing-plan.json", "package_name": "de.nfdi4health.mds", "date": null, "derivation": "constraint", "publisher": "NFDI4Health", "fhirVersion": "4.0.1", "name": "NFDI4Health_EX_MDS_Study_Data_Sharing_Plan", "mapping": [ { "uri": "http://hl7.org/v3", "name": "RIM Mapping", "identity": "rim" }, { "name": "NFDI4Health to FHIR Mapping", "identity": "NFDI4Health" } ], "abstract": false, "type": "Extension", "experimental": null, "resourceType": "StructureDefinition", "title": "NFDI4Health EX MDS Study Data Sharing Plan", "package_version": "1.0.0", "status": "draft", "id": "542c64cb-47b0-4326-8793-56b7bc5a6b41", "kind": "complex-type", "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-data-sharing-plan", "context": [ { "type": "element", "expression": "ResearchStudy" } ], "version": "0.9", "differential": { "element": [ { "id": "Extension", "max": "1", "min": 1, "path": "Extension", "short": "Information about data sharing", "mapping": [ { "map": "1.17.35 Resource.studyDesign.dataSharingPlan", "identity": "NFDI4Health" } ], "definition": "Group of items providing information about the data sharing strategy of the study." }, { "id": "Extension.extension", "min": 1, "path": "Extension.extension" }, { "path": "Extension.extension", "min": 1, "definition": "Indication whether there is a plan to make data collected in the study available. In case of studies with patients or other individuals, this refers to individual participant data (IPD).", "short": "Is it planned to share the data?", "mapping": [ { "map": "1.17.35.1 Resource.studyDesign.dataSharingPlan.generally", "identity": "NFDI4Health" } ], "sliceName": "generally", "max": "1", "id": "Extension.extension:generally", "comment": "Short input help: Select one value from the list." }, { "id": "Extension.extension:generally.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:generally.url", "path": "Extension.extension.url", "fixedUri": "generally" }, { "id": "Extension.extension:generally.value[x]", "min": 1, "path": "Extension.extension.value[x]", "type": [ { "code": "Coding" } ], "binding": { "strength": "required", "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-yes-no-undecided-snomedct-nci", "description": "Value set used to respond to questions that can be answered Yes, No, or Undecided" } }, { "id": "Extension.extension:generally.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:generally.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "path": "Extension.extension", "min": 0, "definition": "Supporting information/documents which will be made available in addition to the study data.", "short": "Supporting documents available in addition to the data", "mapping": [ { "map": "1.17.35.2 Resource.studyDesign.dataSharingPlan.supportingInformation", "identity": "NFDI4Health" } ], "sliceName": "supportingInformation", "max": "*", "id": "Extension.extension:supportingInformation", "comment": "Short input help: Select all that apply." }, { "id": "Extension.extension:supportingInformation.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:supportingInformation.url", "path": "Extension.extension.url", "fixedUri": "supportingInformation" }, { "id": "Extension.extension:supportingInformation.value[x]", "min": 1, "path": "Extension.extension.value[x]", "type": [ { "code": "Coding" } ], "binding": { "strength": "required", "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sharing-plan-sup-inf-umls-local", "description": "Value set defining codes to specify if the DataSHIELD/Opal infrastructure is available." } }, { "id": "Extension.extension:supportingInformation.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:supportingInformation.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "id": "Extension.extension:timeFrame", "max": "1", "min": 0, "path": "Extension.extension", "short": "When and for how long will the data be available?", "mapping": [ { "map": "1.17.35.3 Resource.studyDesign.dataSharingPlan.timeFrame", "identity": "NFDI4Health" } ], "sliceName": "timeFrame", "definition": "Indication when the data and, if applicable, supporting documents will become available and for how long." }, { "id": "Extension.extension:timeFrame.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:timeFrame.url", "path": "Extension.extension.url", "fixedUri": "timeFrame" }, { "id": "Extension.extension:timeFrame.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "string" } ] }, { "path": "Extension.extension", "min": 0, "definition": "Indication by what access criteria data will be shared, including: a) with whom, b) for what types of analyses, and c) by what mechanism.", "short": "Criteria for the data access", "mapping": [ { "map": "1.17.35.4 Resource.studyDesign.dataSharingPlan.accessCriteria", "identity": "NFDI4Health" } ], "sliceName": "accessCriteria", "max": "1", "id": "Extension.extension:accessCriteria", "comment": "Short input help: E.g., with whom, for what types of analyses and by what mechanism the data will be shared." }, { "id": "Extension.extension:accessCriteria.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:accessCriteria.url", "path": "Extension.extension.url", "fixedUri": "accessCriteria" }, { "id": "Extension.extension:accessCriteria.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "string" } ] }, { "path": "Extension.extension", "min": 0, "definition": "Additional descriptive information providing more details about the data sharing, e.g. indication what data in particular will be shared or why the data will not be shared or why it is not yet decided.", "short": "Additional information about data sharing", "mapping": [ { "map": "1.17.35.5 Resource.studyDesign.dataSharingPlan.description", "identity": "NFDI4Health" } ], "sliceName": "description", "max": "1", "id": "Extension.extension:description", "comment": "Short input help: E.g., indication what data in particular will be shared or why the data will not be shared or why it is not yet decided" }, { "id": "Extension.extension:description.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:description.url", "path": "Extension.extension.url", "fixedUri": "description" }, { "id": "Extension.extension:description.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "string" } ] }, { "id": "Extension.extension:datashield", "max": "1", "min": 0, "path": "Extension.extension", "short": "Is the DataSHIELD/Opal infrastructure available?", "mapping": [ { "map": "1.17.35.6 Resource.studyDesign.dataSharingPlan.datashield", "identity": "NFDI4Health" } ], "sliceName": "datashield", "definition": "Indication, whether the DataSHIELD/Opal infrastructure is available." }, { "id": "Extension.extension:datashield.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:datashield.url", "path": "Extension.extension.url", "fixedUri": "datashield" }, { "id": "Extension.extension:datashield.value[x]", "min": 1, "path": "Extension.extension.value[x]", "type": [ { "code": "Coding" } ], "binding": { "strength": "required", "valueSet": "https://www.nfdi4health.de/fhir/metadataschema/ValueSet/nfdi4health-vs-mds-study-data-sharing-plan-ds-snomedct-umls", "description": "Value set defining codes to specify if the DataSHIELD/Opal infrastructure is available." } }, { "id": "Extension.extension:datashield.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:datashield.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "id": "Extension.extension:url", "max": "1", "min": 0, "path": "Extension.extension", "short": "Web page with additional information about data sharing", "mapping": [ { "map": "1.17.35.7 Resource.studyDesign.dataSharingPlan.url", "identity": "NFDI4Health" } ], "sliceName": "url", "definition": "If existing, a link to the web page where additional information about data sharing can be found." }, { "id": "Extension.extension:url.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:url.url", "path": "Extension.extension.url", "fixedUri": "url" }, { "id": "Extension.extension:url.value[x]", "path": "Extension.extension.value[x]", "type": [ { "code": "url" } ] }, { "id": "Extension.url", "path": "Extension.url", "fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-data-sharing-plan" }, { "id": "Extension.value[x]", "max": "0", "path": "Extension.value[x]" } ] }, "contact": [ { "telecom": [ { "value": "https://www.nfdi4health.de", "system": "url" } ] } ], "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension" }