R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R4B R4 R3

Codesystem-research-subject-status.json

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

Raw JSON (canonical form)

Definition for Code System ResearchSubjectStatus

{
  "resourceType": "CodeSystem",
  "id": "research-subject-status",
  "meta": {
    "lastUpdated": "2018-04-03T12:05:46.262+10:00"
  },
  "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-ballot-status",
      "valueString": "Draft"
    },
    {
      "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": "3.3.0",
  "name": "ResearchSubjectStatus",
  "status": "draft",
  "experimental": false,
  "date": "2018-04-03T12:05:46+10:00",
  "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.