{
"description": "Indicates the progression of a study subject through a study.",
"_filename": "CodeSystem-research-subject-status.json",
"package_name": "hl7.fhir.uv.xver-r4.r4b.r4",
"date": "2019-11-01T08:29:23+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": "ResearchSubjectStatus",
"type": null,
"experimental": "false",
"resourceType": "CodeSystem",
"title": "ResearchSubjectStatus",
"package_version": "0.0.1-snapshot-2",
"extension": [ {
"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/StructureDefinition/package-source",
"extension": [ {
"url": "packageId",
"valueId": "hl7.fhir.uv.xver-r4.r4b"
}, {
"url": "version",
"valueString": "0.0.1-snapshot-2"
} ]
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"status": "draft",
"id": "33c07975-3b60-41da-bd7c-041d3d6318e1",
"valueSet": "http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0",
"kind": null,
"url": "http://hl7.org/fhir/research-subject-status",
"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": "4.0.1",
"contact": [ {
"name": "Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}