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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
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="research-subject-state"/> <meta> <lastUpdated value="2022-09-07T11:58:29.429+11:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <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 is 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 responding, 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> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="draft"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="1"/> </extension> <url value="http://terminology.hl7.org/CodeSystem/research-subject-state"/> <identifier> <system value="urn:ietf:rfc:3986"/> <value value="urn:oid:2.16.840.1.113883.4.642.4.2007"/> </identifier> <version value="5.0.0-ballot"/> <name value="ResearchSubjectState"/> <title value="ResearchSubjectState"/> <status value="draft"/> <experimental value="false"/> <date value="2020-12-28T16:55:11+11:00"/> <publisher value="HL7 (FHIR Project)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <telecom> <system value="email"/> <value value="fhir@lists.hl7.org"/> </telecom> </contact> <description value="Indicates the progression of a study subject through a study."/> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/research-subject-state"/> <content value="complete"/> <concept> <code value="candidate"/> <display value="Candidate"/> <definition value="An identified person that can be considered for inclusion in a study."/> </concept> <concept> <code value="eligible"/> <display value="Eligible"/> <definition value="A person that has met the eligibility criteria for inclusion in a study."/> </concept> <concept> <code value="follow-up"/> <display value="Follow-up"/> <definition value="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."/> </concept> <concept> <code value="ineligible"/> <display value="Ineligible"/> <definition value="A person who did not meet one or more criteria required for participation in a study is considered to have failed screening or is ineligible for the study."/> </concept> <concept> <code value="not-registered"/> <display value="Not Registered"/> <definition value="A person for whom registration was not completed."/> </concept> <concept> <code value="off-study"/> <display value="Off-study"/> <definition value="A person that has ended their participation on a study either because their treatment/observation is complete or through not responding, withdrawal, non-compliance and/or adverse event."/> </concept> <concept> <code value="on-study"/> <display value="On-study"/> <definition value="A person that is enrolled or registered on a study."/> </concept> <concept> <code value="on-study-intervention"/> <display value="On-study-intervention"/> <definition value="The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating."/> </concept> <concept> <code value="on-study-observation"/> <display value="On-study-observation"/> <definition value="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"."/> </concept> <concept> <code value="pending-on-study"/> <display value="Pending on-study"/> <definition value="A person is pre-registered for a study."/> </concept> <concept> <code value="potential-candidate"/> <display value="Potential Candidate"/> <definition value="A person that is potentially eligible for participation in the study."/> </concept> <concept> <code value="screening"/> <display value="Screening"/> <definition value="A person who is being evaluated for eligibility for a study."/> </concept> <concept> <code value="withdrawn"/> <display value="Withdrawn"/> <definition value="The person has withdrawn their participation in the study before registration."/> </concept> </CodeSystem>
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.