FHIR Release 3 (STU) R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.0.2: STU 3). (v3.5.0: 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

Vocabulary Biomedical Research and Regulation Work Group Maturity Level : N/A Ballot Status : Informative

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

Definition for Code System ResearchSubjectStatus

{
  "resourceType": "CodeSystem",
  "id": "research-subject-status",
  "meta": {
    "lastUpdated": "2019-10-24T11:53:00+11:00"

  "resourceType" : "CodeSystem",
  "id" : "research-subject-status",
  "meta" : {
    "lastUpdated" : "2018-08-19T21:48:56.559+10:00"

  },
  "text": {
    "status": "generated",
    "div": "<div>!-- Snipped for Brevity --></div>"

  "text" : {
    "status" : "generated",
    "div" : "<div>!-- Snipped for Brevity --></div>"

  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status",
      "valueString": "Informative"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 0
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "rcrim"
    }
  ],
  "url": "http://hl7.org/fhir/research-subject-status",
  "identifier": {
    "system": "urn:ietf:rfc:3986",
    "value": "urn:oid:2.16.840.1.113883.4.642.1.805"

  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"

  },
  "version": "3.0.2",
  "name": "ResearchSubjectStatus",
  "status": "draft",
  "experimental": false,
  "date": "2019-10-24T11:53:00+11:00",
  "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": "The subject has been identified as a potential participant in the study but has not yet agreed to participate"
    },
    {
      "code": "enrolled",
      "display": "Enrolled",
      "definition": "The subject has agreed to participate in the study but has not yet begun performing any action within the study"
    },
    {
      "code": "active",
      "display": "Active",
      "definition": "The subject is currently being monitored and/or subject to treatment as part of the study"
    },
    {
      "code": "suspended",
      "display": "Suspended",
      "definition": "The subject has temporarily discontinued monitoring/treatment as part of the study"
    },
    {
      "code": "withdrawn",
      "display": "Withdrawn",
      "definition": "The subject has permanently ended participation in the study prior to completion of the intended monitoring/treatment"

  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueString" : "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" : "3.5.0",
  "name" : "ResearchSubjectStatus",
  "title" : "ResearchSubjectStatus",
  "status" : "draft",
  "experimental" : false,
  "date" : "2018-08-19T21:48:56+10:00",
  "publisher" : "HL7 (FHIR Project)",
  "contact" : [{
    "telecom" : [{
      "system" : "url",
      "value" : "http://hl7.org/fhir"

    },
    {
      "code": "completed",
      "display": "Completed",
      "definition": "All intended monitoring/treatment of the subject has been completed and their engagement with the study is now ended"
    }
  ]

      "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.