Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4B in FHIR STU3 - Downloaded Version null See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:CodeSystem ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "research-subject-status"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n \n \n <h2>ResearchSubjectStatus</h2>\n \n \n <div>\n \n \n <p>Indicates the progression of a study subject through a study.</p>\n\n \n \n </div>\n \n \n <p>This code system http://hl7.org/fhir/research-subject-status defines the following codes:</p>\n \n \n <table class=\"codes\">\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">\n \n \n <b>Code</b>\n \n \n </td>\n \n \n <td>\n \n \n <b>Display</b>\n \n \n </td>\n \n \n <td>\n \n \n <b>Definition</b>\n \n \n </td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">candidate\n \n \n <a name=\"research-subject-status-candidate\"> </a>\n \n \n </td>\n \n \n <td>Candidate</td>\n \n \n <td>An identified person that can be considered for inclusion in a study.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">eligible\n \n \n <a name=\"research-subject-status-eligible\"> </a>\n \n \n </td>\n \n \n <td>Eligible</td>\n \n \n <td>A person that has met the eligibility criteria for inclusion in a study.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">follow-up\n \n \n <a name=\"research-subject-status-follow-up\"> </a>\n \n \n </td>\n \n \n <td>Follow-up</td>\n \n \n <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>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">ineligible\n \n \n <a name=\"research-subject-status-ineligible\"> </a>\n \n \n </td>\n \n \n <td>Ineligible</td>\n \n \n <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>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">not-registered\n \n \n <a name=\"research-subject-status-not-registered\"> </a>\n \n \n </td>\n \n \n <td>Not Registered</td>\n \n \n <td>A person for whom registration was not completed.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">off-study\n \n \n <a name=\"research-subject-status-off-study\"> </a>\n \n \n </td>\n \n \n <td>Off-study</td>\n \n \n <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>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">on-study\n \n \n <a name=\"research-subject-status-on-study\"> </a>\n \n \n </td>\n \n \n <td>On-study</td>\n \n \n <td>A person that is enrolled or registered on a study.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">on-study-intervention\n \n \n <a name=\"research-subject-status-on-study-intervention\"> </a>\n \n \n </td>\n \n \n <td>On-study-intervention</td>\n \n \n <td>The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">on-study-observation\n \n \n <a name=\"research-subject-status-on-study-observation\"> </a>\n \n \n </td>\n \n \n <td>On-study-observation</td>\n \n \n <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>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">pending-on-study\n \n \n <a name=\"research-subject-status-pending-on-study\"> </a>\n \n \n </td>\n \n \n <td>Pending on-study</td>\n \n \n <td>A person is pre-registered for a study.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">potential-candidate\n \n \n <a name=\"research-subject-status-potential-candidate\"> </a>\n \n \n </td>\n \n \n <td>Potential Candidate</td>\n \n \n <td>A person that is potentially eligible for participation in the study.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">screening\n \n \n <a name=\"research-subject-status-screening\"> </a>\n \n \n </td>\n \n \n <td>Screening</td>\n \n \n <td>A person who is being evaluated for eligibility for a study.</td>\n \n \n </tr>\n \n \n <tr>\n \n \n <td style=\"white-space:nowrap\">withdrawn\n \n \n <a name=\"research-subject-status-withdrawn\"> </a>\n \n \n </td>\n \n \n <td>Withdrawn</td>\n \n \n <td>The person has withdrawn their participation in the study before registration.</td>\n \n \n </tr>\n \n \n </table>\n \n \n </div>"^^rdf:XMLLiteral ]
] ; #
fhir:extension ( [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status> ] ;
fhir:value [
a fhir:Code ;
fhir:v "trial-use" ]
] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm> ] ;
fhir:value [
a fhir:Integer ;
fhir:v 1 ]
] [
( fhir:extension [
fhir:url [
fhir:v "packageId"^^xsd:anyURI ;
fhir:l fhir:packageId ] ;
fhir:value [
a fhir:Id ;
fhir:v "hl7.fhir.uv.xver-r4b.r3" ] ] [
fhir:url [
fhir:v "version"^^xsd:anyURI ;
fhir:l fhir:version ] ;
fhir:value [
a fhir:String ;
fhir:v "0.1.0" ] ] [
fhir:url [
fhir:v "uri"^^xsd:anyURI ;
fhir:l fhir:uri ] ;
fhir:value [
a fhir:Uri ;
fhir:v "http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r3"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4b.r3> ] ] ) ;
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/package-source"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/package-source> ]
] [
fhir:url [
fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg> ] ;
fhir:value [
a fhir:Code ;
fhir:v "brr" ]
] ) ; #
fhir:url [
fhir:v "http://hl7.org/fhir/research-subject-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/research-subject-status>
] ; #
fhir:version [ fhir:v "4.3.0"] ; #
fhir:name [ fhir:v "ResearchSubjectStatus"] ; #
fhir:title [ fhir:v "ResearchSubjectStatus"] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:experimental [ fhir:v false] ; #
fhir:date [ fhir:v "2021-01-16T14:06:13-06:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] )
] ) ; #
fhir:description [ fhir:v "Indicates the progression of a study subject through a study."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [
fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm> ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:caseSensitive [ fhir:v true] ; #
fhir:valueSet [
fhir:v "http://hl7.org/fhir/ValueSet/research-subject-status|3.0.2"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/ValueSet/research-subject-status?version=3.0.2>
] ; #
fhir:content [ fhir:v "complete"] ; #
fhir:concept ( [
fhir:code [ fhir:v "candidate" ] ;
fhir:display [ fhir:v "Candidate" ] ;
fhir:definition [ fhir:v "An identified person that can be considered for inclusion in a study." ]
] [
fhir:code [ fhir:v "eligible" ] ;
fhir:display [ fhir:v "Eligible" ] ;
fhir:definition [ fhir:v "A person that has met the eligibility criteria for inclusion in a study." ]
] [
fhir:code [ fhir:v "follow-up" ] ;
fhir:display [ fhir:v "Follow-up" ] ;
fhir:definition [ fhir:v "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." ]
] [
fhir:code [ fhir:v "ineligible" ] ;
fhir:display [ fhir:v "Ineligible" ] ;
fhir:definition [ fhir:v "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." ]
] [
fhir:code [ fhir:v "not-registered" ] ;
fhir:display [ fhir:v "Not Registered" ] ;
fhir:definition [ fhir:v "A person for whom registration was not completed." ]
] [
fhir:code [ fhir:v "off-study" ] ;
fhir:display [ fhir:v "Off-study" ] ;
fhir:definition [ fhir:v "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." ]
] [
fhir:code [ fhir:v "on-study" ] ;
fhir:display [ fhir:v "On-study" ] ;
fhir:definition [ fhir:v "A person that is enrolled or registered on a study." ]
] [
fhir:code [ fhir:v "on-study-intervention" ] ;
fhir:display [ fhir:v "On-study-intervention" ] ;
fhir:definition [ fhir:v "The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating." ]
] [
fhir:code [ fhir:v "on-study-observation" ] ;
fhir:display [ fhir:v "On-study-observation" ] ;
fhir:definition [ fhir:v "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\"." ]
] [
fhir:code [ fhir:v "pending-on-study" ] ;
fhir:display [ fhir:v "Pending on-study" ] ;
fhir:definition [ fhir:v "A person is pre-registered for a study." ]
] [
fhir:code [ fhir:v "potential-candidate" ] ;
fhir:display [ fhir:v "Potential Candidate" ] ;
fhir:definition [ fhir:v "A person that is potentially eligible for participation in the study." ]
] [
fhir:code [ fhir:v "screening" ] ;
fhir:display [ fhir:v "Screening" ] ;
fhir:definition [ fhir:v "A person who is being evaluated for eligibility for a study." ]
] [
fhir:code [ fhir:v "withdrawn" ] ;
fhir:display [ fhir:v "Withdrawn" ] ;
fhir:definition [ fhir:v "The person has withdrawn their participation in the study before registration." ]
] ) . #
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r4b.r3#0.1.0 based on FHIR 3.0.2. Generated 2026-03-20
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