This
page
is
part
of
the
FHIR
Specification
(v3.0.2:
STU
3).
(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
|
|
Maturity Level : N/A | Ballot Status : Informative |
Definition for Code System ResearchSubjectStatus
{
"resourceType": "CodeSystem",
"id": "research-subject-status",
"meta": {
"lastUpdated": "2019-10-24T11:53:00+11:00"
"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": "Informative"
"valueString": "Draft"
},
{
"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"
"value": "urn:oid:2.16.840.1.113883.4.642.1.830"
},
"version": "3.0.2",
"version": "3.3.0",
"name": "ResearchSubjectStatus",
"status": "draft",
"experimental": false,
"date": "2019-10-24T11:53:00+11:00",
"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": "The subject has been identified as a potential participant in the study but has not yet agreed to participate"
"definition": "An identified person that can be considered for inclusion in a study."
},
{
"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": "eligible",
"display": "Eligible",
"definition": "A person that has met the eligibility criteria for inclusion in a study."
},
{
"code": "active",
"display": "Active",
"definition": "The subject is currently being monitored and/or subject to treatment as part of the 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": "suspended",
"display": "Suspended",
"definition": "The subject has temporarily discontinued monitoring/treatment as part of the study"
"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": "withdrawn",
"display": "Withdrawn",
"definition": "The subject has permanently ended participation in the study prior to completion of the intended monitoring/treatment"
"code": "not-registered",
"display": "Not Registered",
"definition": "A person for whom registration was not completed"
},
{
"code": "completed",
"display": "Completed",
"definition": "All intended monitoring/treatment of the subject has been completed and their engagement with the study is now ended"
"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.