Research Subject Status

• Official URL: http://hl7.org/fhir/research-subject-status
• Version: 6.0.0
• Status: draft
• Name: ResearchSubjectStatus
• Title: Research Subject Status
• Publisher: HL7 (FHIR Project)
• Description: Indicates the progression of a study subject through a study.
• Case Sensitive: true
• Content: complete

Concepts

CodeSystem XML

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-subject-status"/>
  <meta>
    <lastUpdated value="2021-01-05T10:01:24.148+11:00"/>

  </meta>
  <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="normative"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0"/>
  </extension>
  <url value="http://hl7.org/fhir/research-subject-status"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.4.830"/>
  </identifier>
  <identifier>
    <use value="old"/>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.1.805"/>
  </identifier>
  <version value="6.0.0"/>
  <name value="ResearchSubjectStatus"/>
  <title value="Research Subject Status"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2021-01-05T10:01:24+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-status"/>
  <content value="complete"/>
  <concept>
    <code value="candidate"/>
    <display value="Candidate"/>
    <definition value="A subject (ResearchSubject) potentially eligible for participation in a study (ResearchStudy) who has not completed an evaluation to determine whether they are eligible or ineligible for consideration."/>
  </concept>
  <concept>
    <code value="in-prescreening"/>
    <display value="In Prescreening"/>
    <definition value="A subject (ResearchSubject) undergoing an initial evaluation to determine if they are eligible or ineligible for consideration for inclusion in a study (ResearchStudy).A subject (ResearchSubject) potentially eligible for participation in a study (ResearchStudy) who has not completed an evaluation to determine whether they are eligible or ineligible for consideration."/>
  </concept>
  <concept>
    <code value="in-screening"/>
    <display value="In Screening"/>
    <definition value="A subject (ResearchSubject) undergoing a full evaluation to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy)."/>
  </concept>
  <concept>
    <code value="eligible"/>
    <display value="Eligible"/>
    <definition value="A subject (ResearchSubject) who has passed a full evaluation against the protocol specified eligibility criteria to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy)."/>
  </concept>
  <concept>
    <code value="ineligible"/>
    <display value="Ineligible"/>
    <definition value="A subject (ResearchSubject) who has failed an  evaluation against the protocol specified eligibility criteria to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy)."/>
  </concept>
  <concept>
    <code value="on-study"/>
    <display value="On-study"/>
    <definition value="A subject (ResearchSubject) who is enrolled in a study (ResearchStudy)."/>
  </concept>
  <concept>
    <code value="on-study-intervention"/>
    <display value="On-study-intervention"/>
    <definition value="A subject (ResearchSubject) who is in an intervention phase of a study (ResearchStudy)."/>
  </concept>
  <concept>
    <code value="in-follow-up"/>
    <display value="In follow-up"/>
    <definition value="A subject (ResearchSubject) who has completed planned study (ResearchStudy) procedures and tests and is being monitored based on a protocol-prescribed schedule. "/>
  </concept>
  <concept>
    <code value="off-study"/>
    <display value="Off-study"/>
    <definition value="A subject (ResearchSubject) who is no longer participating in a study (ResearchStudy)."/>
  </concept>
</CodeSystem>