HL7 Terminology
1.0.0 - Publication

This page is part of the HL7 Terminology (v1.0.0: Release) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

ResearchSubjectState - JSON Representation

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{
  "resourceType" : "CodeSystem",
  "id" : "research-subject-state",
  "meta" : {
    "lastUpdated" : "2020-04-09T21:10:28.568+00:00"
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n            \n      <h2>ResearchSubjectState</h2>\n            \n      <div>\n              \n        <p>Indicates the progression of a study subject through a study.</p>\n\n            \n      </div>\n            \n      <p>This code system http://terminology.hl7.org/CodeSystem/research-subject-state defines the following codes:</p>\n            \n      <table class=\"codes\">\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">\n                  \n            <b>Code</b>\n                \n          </td>\n                \n          <td>\n                  \n            <b>Display</b>\n                \n          </td>\n                \n          <td>\n                  \n            <b>Definition</b>\n                \n          </td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">candidate\n                  \n            <a name=\"research-subject-state-candidate\"> </a>\n                \n          </td>\n                \n          <td>Candidate</td>\n                \n          <td>An identified person that can be considered for inclusion in a study.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">eligible\n                  \n            <a name=\"research-subject-state-eligible\"> </a>\n                \n          </td>\n                \n          <td>Eligible</td>\n                \n          <td>A person that has met the eligibility criteria for inclusion in a study.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">follow-up\n                  \n            <a name=\"research-subject-state-follow-up\"> </a>\n                \n          </td>\n                \n          <td>Follow-up</td>\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        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">ineligible\n                  \n            <a name=\"research-subject-state-ineligible\"> </a>\n                \n          </td>\n                \n          <td>Ineligible</td>\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        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">not-registered\n                  \n            <a name=\"research-subject-state-not-registered\"> </a>\n                \n          </td>\n                \n          <td>Not Registered</td>\n                \n          <td>A person for whom registration was not completed.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">off-study\n                  \n            <a name=\"research-subject-state-off-study\"> </a>\n                \n          </td>\n                \n          <td>Off-study</td>\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        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">on-study\n                  \n            <a name=\"research-subject-state-on-study\"> </a>\n                \n          </td>\n                \n          <td>On-study</td>\n                \n          <td>A person that is enrolled or registered on a study.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">on-study-intervention\n                  \n            <a name=\"research-subject-state-on-study-intervention\"> </a>\n                \n          </td>\n                \n          <td>On-study-intervention</td>\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        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">on-study-observation\n                  \n            <a name=\"research-subject-state-on-study-observation\"> </a>\n                \n          </td>\n                \n          <td>On-study-observation</td>\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 &quot;short-term follow-up&quot;.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">pending-on-study\n                  \n            <a name=\"research-subject-state-pending-on-study\"> </a>\n                \n          </td>\n                \n          <td>Pending on-study</td>\n                \n          <td>A person is pre-registered for a study.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">potential-candidate\n                  \n            <a name=\"research-subject-state-potential-candidate\"> </a>\n                \n          </td>\n                \n          <td>Potential Candidate</td>\n                \n          <td>A person that is potentially eligible for participation in the study.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">screening\n                  \n            <a name=\"research-subject-state-screening\"> </a>\n                \n          </td>\n                \n          <td>Screening</td>\n                \n          <td>A person who is being evaluated for eligibility for a study.</td>\n              \n        </tr>\n              \n        <tr>\n                \n          <td style=\"white-space:nowrap\">withdrawn\n                  \n            <a name=\"research-subject-state-withdrawn\"> </a>\n                \n          </td>\n                \n          <td>Withdrawn</td>\n                \n          <td>The person has withdrawn their participation in the study before registration.</td>\n              \n        </tr>\n            \n      </table>\n          \n    </div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "draft"
    },
    {
      "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" : "4.2.0",
  "name" : "ResearchSubjectState",
  "title" : "ResearchSubjectState",
  "status" : "draft",
  "experimental" : false,
  "date" : "2020-04-09T21:10:28+00:00",
  "publisher" : "HL7 (FHIR Project)",
  "contact" : [
    {
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://hl7.org/fhir"
        },
        {
          "system" : "email",
          "value" : "fhir@lists.hl7.org"
        }
      ]
    }
  ],
  "description" : "Indicates the progression of a study subject through a study.",
  "caseSensitive" : true,
  "valueSet" : "http://terminology.hl7.org/ValueSet/research-subject-state",
  "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."
    }
  ]
}