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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchSubjectState
{ "resourceType" : "CodeSystem", "id" : "research-subject-state", "meta" : { "lastUpdated" : "2022-09-10T05:52:37.223+11:00", "profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"] }, "text" : { "status" : "generated", "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This code system <code>http://terminology.hl7.org/CodeSystem/research-subject-state</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">candidate<a name=\"research-subject-state-candidate\"> </a></td><td>Candidate</td><td>An identified person that can be considered for inclusion in a study.</td></tr><tr><td style=\"white-space:nowrap\">eligible<a name=\"research-subject-state-eligible\"> </a></td><td>Eligible</td><td>A person that has met the eligibility criteria for inclusion in a study.</td></tr><tr><td style=\"white-space:nowrap\">follow-up<a name=\"research-subject-state-follow-up\"> </a></td><td>Follow-up</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">ineligible<a name=\"research-subject-state-ineligible\"> </a></td><td>Ineligible</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">not-registered<a name=\"research-subject-state-not-registered\"> </a></td><td>Not Registered</td><td>A person for whom registration was not completed.</td></tr><tr><td style=\"white-space:nowrap\">off-study<a name=\"research-subject-state-off-study\"> </a></td><td>Off-study</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">on-study<a name=\"research-subject-state-on-study\"> </a></td><td>On-study</td><td>A person that is enrolled or registered on a study.</td></tr><tr><td style=\"white-space:nowrap\">on-study-intervention<a name=\"research-subject-state-on-study-intervention\"> </a></td><td>On-study-intervention</td><td>The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.</td></tr><tr><td style=\"white-space:nowrap\">on-study-observation<a name=\"research-subject-state-on-study-observation\"> </a></td><td>On-study-observation</td><td>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".</td></tr><tr><td style=\"white-space:nowrap\">pending-on-study<a name=\"research-subject-state-pending-on-study\"> </a></td><td>Pending on-study</td><td>A person is pre-registered for a study.</td></tr><tr><td style=\"white-space:nowrap\">potential-candidate<a name=\"research-subject-state-potential-candidate\"> </a></td><td>Potential Candidate</td><td>A person that is potentially eligible for participation in the study.</td></tr><tr><td style=\"white-space:nowrap\">screening<a name=\"research-subject-state-screening\"> </a></td><td>Screening</td><td>A person who is being evaluated for eligibility for a study.</td></tr><tr><td style=\"white-space:nowrap\">withdrawn<a name=\"research-subject-state-withdrawn\"> </a></td><td>Withdrawn</td><td>The person has withdrawn their participation in the study before registration.</td></tr></table></div>" }, "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" : 1 }], "url" : "http://terminology.hl7.org/CodeSystem/research-subject-state", "identifier" : [{ "system" : "urn:ietf:rfc:3986", "value" : "urn:oid:2.16.840.1.113883.4.642.4.2007" }], "version" : "5.0.0-ballot", "name" : "ResearchSubjectState", "title" : "ResearchSubjectState", "status" : "draft", "experimental" : false, "date" : "2020-12-28T16:55:11+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-state", "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." }] }
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Sat, Sep 10, 2022 04:55+1000.
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