{ "description": "Extension informing about the status of a study.", "_filename": "StructureDefinition-nfdi4health-ex-mds-study-status.json", "package_name": "de.nfdi4health.mds", "date": null, "derivation": "constraint", "publisher": "NFDI4Health", "fhirVersion": "4.0.1", "name": "NFDI4Health_EX_MDS_Study_Status", "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 Status", "package_version": "1.0.0", "status": "draft", "id": "00b32f66-6d3f-45f5-9dcc-20cfa2853c4c", "kind": "complex-type", "url": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-status", "context": [ { "type": "element", "expression": "ResearchStudy" } ], "version": "0.9", "differential": { "element": [ { "id": "Extension", "max": "1", "min": 1, "path": "Extension", "short": "Status", "definition": "Group of items providing information about different status of a study (overall status, status of an interventional study, recruitment status, enrolling by invitation status)." }, { "id": "Extension.extension", "min": 1, "path": "Extension.extension" }, { "path": "Extension.extension", "min": 1, "definition": "Overall status of the study.", "short": "Overall study status", "mapping": [ { "map": "1.17.7 Resource.studyDesign.status", "identity": "NFDI4Health" } ], "sliceName": "overallStatus", "max": "1", "id": "Extension.extension:overallStatus", "comment": "Additional information: If at least one study site in a multicenter study has the status 'Ongoing', then the overall status for the study must be 'Ongoing'. | Short input help: Select one value from the list." }, { "id": "Extension.extension:overallStatus.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:overallStatus.url", "path": "Extension.extension.url", "fixedUri": "overallStatus" }, { "id": "Extension.extension:overallStatus.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-overall-status-umls-local", "description": "Value set defining codes to specify the overall status of a study." } }, { "id": "Extension.extension:overallStatus.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:overallStatus.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "path": "Extension.extension", "min": 0, "definition": "Specification whether study participants receive intervention or have completed it but are still being followed according to the primary objective of the study.", "short": "Do participants receive an intervention?", "mapping": [ { "map": "1.17.8 Resource.studyDesign.statusWhenIntervention", "identity": "NFDI4Health" } ], "sliceName": "statusWhenIntervention", "max": "1", "id": "Extension.extension:statusWhenIntervention", "comment": "Short input help: Select one value from the list." }, { "id": "Extension.extension:statusWhenIntervention.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:statusWhenIntervention.url", "path": "Extension.extension.url", "fixedUri": "statusWhenIntervention" }, { "id": "Extension.extension:statusWhenIntervention.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-status-when-intervention-local", "description": "Value set defining codes to specify the status of a study when it was halted." } }, { "id": "Extension.extension:statusWhenIntervention.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:statusWhenIntervention.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "path": "Extension.extension", "min": 0, "definition": "Overall recruitment status of the study as indicated in the corresponding register of clinical trials.", "short": "Overall recruitment status of the study from the register of clinical trials", "mapping": [ { "map": "1.17.12 Resource.studyDesign.recruitmentStatusRegister", "identity": "NFDI4Health" } ], "sliceName": "recruitmentStatusRegister", "max": "1", "id": "Extension.extension:recruitmentStatusRegister", "comment": "Additional information: The item applies only to studies automatically uploaded from the registers of clinical trials." }, { "id": "Extension.extension:recruitmentStatusRegister.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:recruitmentStatusRegister.url", "path": "Extension.extension.url", "fixedUri": "recruitmentStatusRegister" }, { "id": "Extension.extension:recruitmentStatusRegister.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-recruitment-status-register-umls-local", "description": "Value set defining codes to specify the study recruitment status (from a register) in a ResearchStudy resource." } }, { "id": "Extension.extension:recruitmentStatusRegister.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:recruitmentStatusRegister.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "id": "Extension.extension:statusEnrollingByInvitation", "max": "1", "min": 0, "path": "Extension.extension", "short": "Are participants enrolled by invitation?", "mapping": [ { "map": "1.17.11 Resource.studyDesign.statusEnrollingByInvitation", "identity": "NFDI4Health" } ], "sliceName": "statusEnrollingByInvitation", "definition": "Specification whether study participants have been selected from a predetermined population or enrolled by invitation." }, { "id": "Extension.extension:statusEnrollingByInvitation.extension", "max": "0", "path": "Extension.extension.extension" }, { "id": "Extension.extension:statusEnrollingByInvitation.url", "path": "Extension.extension.url", "fixedUri": "statusEnrollingByInvitation" }, { "id": "Extension.extension:statusEnrollingByInvitation.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-not-applicable-snomedct", "description": "Value set used to respond to questions that can be answered Yes, No, or Not Applicable." } }, { "id": "Extension.extension:statusEnrollingByInvitation.value[x].system", "min": 1, "path": "Extension.extension.value[x].system" }, { "id": "Extension.extension:statusEnrollingByInvitation.value[x].code", "min": 1, "path": "Extension.extension.value[x].code" }, { "id": "Extension.url", "path": "Extension.url", "fixedUri": "https://www.nfdi4health.de/fhir/metadataschema/StructureDefinition/nfdi4health-ex-mds-study-status" }, { "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" }