{ "description": "Indicates the progression of a study subject through a study.", "_filename": "CodeSystem-research-subject-state.json", "package_name": "hl7.fhir.uv.xver", "date": "2020-04-10T07:10:28+10:00", "publisher": "Biomedical Research and Regulation", "jurisdiction": [ { "coding": [ { "code": "001", "system": "http://unstats.un.org/unsd/methods/m49/m49.htm", "display": "World" } ] } ], "content": "complete", "name": "ResearchSubjectState", "type": null, "experimental": "false", "resourceType": "CodeSystem", "title": "ResearchSubjectState", "package_version": "r5.r4-0.0.1-snapshot-2", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 1 }, { "url": "http://hl7.org/fhir/StructureDefinition/package-source", "extension": [ { "url": "packageId", "valueId": "hl7.fhir.uv.xver-r5.r4" }, { "url": "version", "valueString": "0.0.1-snapshot-2" } ] }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" } ], "status": "draft", "id": "498741f7-2b63-4d11-b1db-17b661eff07f", "valueSet": "http://terminology.hl7.org/ValueSet/research-subject-state|1.0.1", "kind": null, "url": "http://terminology.hl7.org/CodeSystem/research-subject-state", "concept": [ { "code": "candidate", "display": "Candidate", "definition": "An identified person that can be considered for inclusion in a study." }, { "code": "eligible", "display": "Eligible", "definition": "A person that has met the eligibility criteria for inclusion in a study." }, { "code": "follow-up", "display": "Follow-up", "definition": "A person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule." }, { "code": "ineligible", "display": "Ineligible", "definition": "A person who did not meet one or more criteria required for participation in a study is considered to have failed screening or\nis ineligible for the study." }, { "code": "not-registered", "display": "Not Registered", "definition": "A person for whom registration was not completed." }, { "code": "off-study", "display": "Off-study", "definition": "A person that has ended their participation on a study either because their treatment/observation is complete or through not\nresponding, withdrawal, non-compliance and/or adverse event." }, { "code": "on-study", "display": "On-study", "definition": "A person that is enrolled or registered on a study." }, { "code": "on-study-intervention", "display": "On-study-intervention", "definition": "The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating." }, { "code": "on-study-observation", "display": "On-study-observation", "definition": "The subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is \"short-term follow-up\"." }, { "code": "pending-on-study", "display": "Pending on-study", "definition": "A person is pre-registered for a study." }, { "code": "potential-candidate", "display": "Potential Candidate", "definition": "A person that is potentially eligible for participation in the study." }, { "code": "screening", "display": "Screening", "definition": "A person who is being evaluated for eligibility for a study." }, { "code": "withdrawn", "display": "Withdrawn", "definition": "The person has withdrawn their participation in the study before registration." } ], "caseSensitive": true, "version": "0.1.0", "contact": [ { "name": "Biomedical Research and Regulation", "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" } ] } ] }