FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5 - Version 0.0.1-snapshot-2. See the Directory of published versions
| Page standards status: Informative | Maturity Level: 1 |
{
"resourceType" : "CodeSystem",
"id" : "research-subject-state",
"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-fmm",
"valueInteger" : 1
},
{
"extension" : [
{
"url" : "packageId",
"valueId" : "hl7.fhir.uv.xver-r5.r4"
},
{
"url" : "version",
"valueString" : "0.0.1-snapshot-2"
}
],
"url" : "http://hl7.org/fhir/StructureDefinition/package-source"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://terminology.hl7.org/CodeSystem/research-subject-state",
"version" : "0.1.0",
"name" : "ResearchSubjectState",
"title" : "ResearchSubjectState",
"status" : "draft",
"experimental" : false,
"date" : "2020-04-10T07:10:28+10:00",
"publisher" : "Biomedical Research and Regulation",
"contact" : [
{
"name" : "Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"description" : "Indicates the progression of a study subject through a study.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"caseSensitive" : true,
"valueSet" : "http://terminology.hl7.org/ValueSet/research-subject-state|1.0.1",
"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."
}
]
}