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Codesystem-research-subject-status.json

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw JSON (canonical form + also see JSON Format Specification)

Definition for Code System ResearchSubjectStatus

{
  "resourceType" : "CodeSystem",
  "id" : "research-subject-status",
  "meta" : {
    "lastUpdated" : "2019-09-18T23:14:37.696+00:00"
  },
  "text" : {
    "status" : "generated",
    "div" : "<div>!-- Snipped for Brevity --></div>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 0
  }],
  "url" : "http://hl7.org/fhir/research-subject-status",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.1.830"
  }],
  "version" : "4.1.0",
  "name" : "ResearchSubjectStatus",
  "title" : "ResearchSubjectStatus",
  "status" : "draft",
  "experimental" : false,
  "date" : "2019-09-18T23:14:37+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://hl7.org/fhir/ValueSet/research-subject-status",
  "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."
  }]
}

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.