HL7 Terminology (THO)
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HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 7.4.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

: ResearchSubjectState

Active as of 2024-04-24 Maturity Level: 1

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{
  "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\"><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</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>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.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">in-prescreening<a name=\"research-subject-state-in-prescreening\"> </a></td><td>In-Prescreening</td><td><div><p>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.</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">in-screening<a name=\"research-subject-state-in-screening\"> </a></td><td>In-Screening</td><td><div><p>A subject (ResearchSubject) undergoing a full evaluation to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy).</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 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).</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 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).</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 subject (ResearchSubject) who is enrolled in a study (ResearchStudy).\nIn a retrospective study context: the start of the period during which a subject's data is included, observed, or considered as part of the study analysis.</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>A subject (ResearchSubject) who is in an intervention phase of a study (ResearchStudy).</p>\n</div></td></tr><tr><td style=\"white-space:nowrap\">in-follow-up<a name=\"research-subject-state-in-follow-up\"> </a></td><td>In-Follow-Up</td><td><div><p>A subject (ResearchSubject) who has completed planned study (ResearchStudy) procedures and tests and is being monitored based on a protocol-prescribed schedule.</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 subject (ResearchSubject) who is no longer participating in a study (ResearchStudy).\nIn a retrospective study context: the end of the period during which a subject's data is included, observed, or considered as part of the study analysis.</p>\n</div></td></tr><tr style=\"background-color: #ffeeee\"><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 style=\"background-color: #ffeeee\"><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 style=\"background-color: #ffeeee\"><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 style=\"background-color: #ffeeee\"><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 style=\"background-color: #ffeeee\"><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 style=\"background-color: #ffeeee\"><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 style=\"background-color: #ffeeee\"><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" : "2.0.0",
  "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" : "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."
    },
    {
      "code" : "in-prescreening",
      "display" : "In-Prescreening",
      "definition" : "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."
    },
    {
      "code" : "in-screening",
      "display" : "In-Screening",
      "definition" : "A subject (ResearchSubject) undergoing a full evaluation to determine if they are eligible or ineligible for inclusion in a study (ResearchStudy)."
    },
    {
      "code" : "eligible",
      "display" : "Eligible",
      "definition" : "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)."
    },
    {
      "code" : "ineligible",
      "display" : "Ineligible",
      "definition" : "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)."
    },
    {
      "code" : "on-study",
      "display" : "On-Study",
      "definition" : "A subject (ResearchSubject) who is enrolled in a study (ResearchStudy).\nIn a retrospective study context: the start of the period during which a subject's data is included, observed, or considered as part of the study analysis."
    },
    {
      "code" : "on-study-intervention",
      "display" : "On-Study-Intervention",
      "definition" : "A subject (ResearchSubject) who is in an intervention phase of a study (ResearchStudy)."
    },
    {
      "code" : "in-follow-up",
      "display" : "In-Follow-Up",
      "definition" : "A subject (ResearchSubject) who has completed planned study (ResearchStudy) procedures and tests and is being monitored based on a protocol-prescribed schedule."
    },
    {
      "code" : "off-study",
      "display" : "Off-Study",
      "definition" : "A subject (ResearchSubject) who is no longer participating in a study (ResearchStudy).\nIn a retrospective study context: the end of the period during which a subject's data is included, observed, or considered as part of the study analysis."
    },
    {
      "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.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    },
    {
      "code" : "not-registered",
      "display" : "Not Registered",
      "definition" : "A person for whom registration was not completed.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    },
    {
      "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'.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    },
    {
      "code" : "pending-on-study",
      "display" : "Pending on-study",
      "definition" : "A person is pre-registered for a study.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    },
    {
      "code" : "potential-candidate",
      "display" : "Potential Candidate",
      "definition" : "A person that is potentially eligible for participation in the study.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    },
    {
      "code" : "screening",
      "display" : "Screening",
      "definition" : "A person who is being evaluated for eligibility for a study.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    },
    {
      "code" : "withdrawn",
      "display" : "Withdrawn",
      "definition" : "The person has withdrawn their participation in the study before registration.",
      "property" : [
        {
          "code" : "status",
          "valueCode" : "retired"
        },
        {
          "code" : "retirementReason",
          "valueString" : "Replaced by newer terminology in version 2.0"
        }
      ]
    }
  ]
}