TerminologyThis page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
| 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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