{ "description": "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.", "_filename": "CodeSystem-research-study-registration-activity.json", "package_name": "hl7.fhir.uv.extensions.r5", "date": "2022-05-15T16:55:11.085+11:00", "meta": { "profile": [ "http://hl7.org/fhir/StructureDefinition/shareablecodesystem" ], "lastUpdated": "2022-05-15T16:55:11.085+11:00" }, "publisher": "HL7 International / Biomedical Research and Regulation", "jurisdiction": [ { "coding": [ { "code": "001", "system": "http://unstats.un.org/unsd/methods/m49/m49.htm" } ] } ], "content": "complete", "name": "ResearchStudyRegistrationActivity", "type": null, "experimental": "true", "resourceType": "CodeSystem", "title": "ResearchStudy Registration Activity Code System", "package_version": "5.3.0-ballot-tc1", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "draft" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 0 } ], "status": "draft", "id": "f0ae5df8-9198-49b0-955b-0f84f77e95c8", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-registration-activity", "kind": null, "url": "http://hl7.org/fhir/research-study-registration-activity", "identifier": [ { "value": "urn:oid:2.16.840.1.113883.4.642.4.2124", "system": "urn:ietf:rfc:3986" } ], "concept": [ { "code": "record-verification", "display": "Record Verification", "definition": "Record has been verified." }, { "code": "primary-outcome-data-collection", "display": "Primary outcome data collection", "definition": "The data has been obtained for the primary outcomes from all participants." }, { "code": "registration-submission", "display": "Registration submission", "definition": "The initial record has been submitted for registration." }, { "code": "registration-submission-qc", "display": "Registration submission Quality Check", "definition": "The initial record submission has been confirmed to meet acceptance criteria for registration." }, { "code": "registration-posting", "display": "Registration posting", "definition": "The initial record has been registered and published." }, { "code": "results-submission", "display": "Results submission", "definition": "Study results have been submitted." }, { "code": "results-submission-qc", "display": "Results submission Quality Check", "definition": "The submitted study results have been confirmed to meet acceptance criteria for publication." }, { "code": "results-posting", "display": "Results posting", "definition": "Study results have been published in the registry." }, { "code": "disposition-submission", "display": "Disposition submission", "definition": "A request for deferral of study submission requirements has been submitted." }, { "code": "disposition-submission-qc", "display": "Disposition submission Quality Check", "definition": "The submitted request for deferral of study submission requirements has been confirmed for acceptance for publication." }, { "code": "disposition-posting", "display": "Disposition posting", "definition": "The request for deferral of study submission requirements has been published in the registry." }, { "code": "update-submission", "display": "Update submission", "definition": "An update to the record has been submitted." }, { "code": "update-posting", "display": "Update posting", "definition": "An update to the record has been published in the registry." } ], "caseSensitive": true, "version": "5.3.0-ballot-tc1", "contact": [ { "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" } ] } ] }