{
"resourceType": "CodeSystem",
"id": "research-subject-state",
"meta": {
"lastUpdated": "2024-04-24T00:00:00+00:00"
},
"language": "en",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem research-subject-state</b></p><a name=\"research-subject-state\"> </a><a name=\"hcresearch-subject-state\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Last updated: 2024-04-24 00:00:00+0000; Language: en</p></div><p>This case-sensitive 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><div><p>An identified person that can be considered for inclusion in a study.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">eligible<a name=\"research-subject-state-eligible\"> </a></td><td>Eligible</td><td><div><p>A person that has met the eligibility criteria for inclusion in a study.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">follow-up<a name=\"research-subject-state-follow-up\"> </a></td><td>Follow-up</td><td><div><p>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.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">ineligible<a name=\"research-subject-state-ineligible\"> </a></td><td>Ineligible</td><td><div><p>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.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">not-registered<a name=\"research-subject-state-not-registered\"> </a></td><td>Not Registered</td><td><div><p>A person for whom registration was not completed.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">off-study<a name=\"research-subject-state-off-study\"> </a></td><td>Off-study</td><td><div><p>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.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">on-study<a name=\"research-subject-state-on-study\"> </a></td><td>On-study</td><td><div><p>A person that is enrolled or registered on a study.</p>\n</div></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><div><p>The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.</p>\n</div></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><div><p>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".</p>\n</div></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><div><p>A person is pre-registered for a study.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">potential-candidate<a name=\"research-subject-state-potential-candidate\"> </a></td><td>Potential Candidate</td><td><div><p>A person that is potentially eligible for participation in the study.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">screening<a name=\"research-subject-state-screening\"> </a></td><td>Screening</td><td><div><p>A person who is being evaluated for eligibility for a study.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">withdrawn<a name=\"research-subject-state-withdrawn\"> </a></td><td>Withdrawn</td><td><div><p>The person has withdrawn their participation in the study before registration.</p>\n</div></td></tr></table></div>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"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:2.16.840.1.113883.4.642.1.0"
}
],
"version": "1.0.1",
"name": "ResearchSubjectState",
"title": "ResearchSubjectState",
"status": "active",
"experimental": false,
"date": "2024-04-24T00:00:00+00:00",
"publisher": "Health Level Seven International",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "http://hl7.org"
},
{
"system": "email",
"value": "hq@HL7.org"
}
]
}
],
"description": "Indicates the progression of a study subject through a study.",
"copyright": "This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license",
"caseSensitive": true,
"valueSet": "http://terminology.hl7.org/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."
}
]
}
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