{ "resourceType": "CodeSystem", "id": "research-subject-status", "meta": { "lastUpdated": "2019-11-01T09:29:23.356+11:00" }, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode": "brr" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode": "trial-use" }, { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger": 1 } ], "url": "http://hl7.org/fhir/research-subject-status", "identifier": [ { "system": "urn:ietf:rfc:3986", "value": "urn:oid:2.16.840.1.113883.4.642.4.830" } ], "version": "4.0.1", "name": "ResearchSubjectStatus", "title": "ResearchSubjectStatus", "status": "draft", "experimental": false, "date": "2019-11-01T09:29:23+11:00", "publisher": "HL7 (FHIR Project)", "contact": [ { "telecom": [ { "system": "url", "value": "http://hl7.org/fhir" }, { "system": "email", "value": "fhir@lists.hl7.org" } ] } ], "description": "Indicates the progression of a study subject through a study.", "caseSensitive": true, "valueSet": "http://hl7.org/fhir/ValueSet/research-subject-status", "content": "complete", "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." } ] }