ResearchSubject - FHIR v5.0.0-ballot

Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). 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: R5 R4B R4 R3

8.23.7 Resource ResearchSubject - Detailed Descriptions

Biomedical Research and Regulation icon

Work Group

Maturity Level: 0

Trial Use

Security Category: Patient

Compartments: Device, Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Element Id	ResearchSubject
Definition	A physical entity which is the primary unit of operational and/or administrative interest in a study.
Short Display	Physical entity which is the primary unit of interest in the study
Cardinality	0..*
Type	DomainResource
Alternate Names	Study Subject
Summary	false
Comments	Need to make sure we encompass public health studies.
ResearchSubject.identifier
Element Id	ResearchSubject.identifier
Definition	Identifiers assigned to this research subject for a study.
Short Display	Business Identifier for research subject in a study
Note	This is a business identifier, not a resource identifier (see discussion)
Cardinality	0..*
Type	Identifier
Summary	true
ResearchSubject.status
Element Id	ResearchSubject.status
Definition	The publication state of the resource (not of the subject).
Short Display	draft \| active \| retired \| unknown
Cardinality	1..1
Terminology Binding	PublicationStatus (Required)
Type	code
Is Modifier	true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
Summary	true
ResearchSubject.progress
Element Id	ResearchSubject.progress
Definition	The current state (status) of the subject and resons for status change where appropriate.
Short Display	Subject status
Cardinality	0..*
Summary	false
Comments	This is intended to deal with the confusion routinely created by haing two conflated concepts of being in a particular state and having achieved a particular milestone. In strict terms a milestone is a point of time event that results in a change from one state to another. The state before the milestone is achieved is often given the same name as the milestone, and sometimes the state may have the same description. For instance "Randomised" and "Visit 1" may be different milestones but the state remains at "on study" after each of them. It is likely that more than one "state" pattern will be recorded for a subject and a type has been introduced to allow this simultaneous recording.
ResearchSubject.progress.type
Element Id	ResearchSubject.progress.type
Definition	Identifies the aspect of the subject's journey that the state refers to.
Short Display	state \| milestone
Cardinality	0..1
Terminology Binding	ResearchSubjectStateType (Example)
Type	CodeableConcept
Summary	false
ResearchSubject.progress.subjectState
Element Id	ResearchSubject.progress.subjectState
Definition	The current state of the subject.
Short Display	candidate \| eligible \| follow-up \| ineligible \| not-registered \| off-study \| on-study \| on-study-intervention \| on-study-observation \| pending-on-study \| potential-candidate \| screening \| withdrawn
Cardinality	0..1
Terminology Binding	ResearchSubjectState (Required)
Type	CodeableConcept
Summary	false
ResearchSubject.progress.milestone
Element Id	ResearchSubject.progress.milestone
Definition	The milestones the subject has passed through.
Short Display	SignedUp \| Screened \| Randomized
Cardinality	0..1
Terminology Binding	ResearchSubjectMilestone (Example)
Type	CodeableConcept
Summary	false
Comments	There can be multiple entries but it is also valid to just have the most recent. This should npt be rlied upon as the full path the subject has taken.
ResearchSubject.progress.reason
Element Id	ResearchSubject.progress.reason
Definition	The reason for the state change. If coded it should follow the formal subject state model.
Short Display	State change reason
Cardinality	0..1
Terminology Binding	StateChangeReason (Example)
Type	CodeableConcept
Summary	false
ResearchSubject.progress.startDate
Element Id	ResearchSubject.progress.startDate
Definition	The date when the new status started.
Short Display	State change date
Cardinality	0..1
Type	dateTime
Requirements	This was originally defined as the date when the change in status occurred. This assumed all states were recorded which is not true. Hence the need to track the end of the state.
Summary	false
Comments	This is NOT the date the change in state was recorded.
ResearchSubject.progress.endDate
Element Id	ResearchSubject.progress.endDate
Definition	The date when the state ended.
Short Display	State change date
Cardinality	0..1
Type	dateTime
Requirements	See the requirement on the start date.
Summary	false
ResearchSubject.period
Element Id	ResearchSubject.period
Definition	The dates the subject began and ended their participation in the study.
Short Display	Start and end of participation
Cardinality	0..1
Type	Period
Alternate Names	timing
Summary	true
To Do	.effectiveTime.
ResearchSubject.study
Element Id	ResearchSubject.study
Definition	Reference to the study the subject is participating in.
Short Display	Study subject is part of
Cardinality	1..1
Type	Reference(ResearchStudy)
Summary	true
ResearchSubject.subject
Element Id	ResearchSubject.subject
Definition	The record of the person, animal or other entity involved in the study.
Short Display	Who or what is part of study
Cardinality	1..1
Type	Reference(Patient \| Group \| Specimen \| Device \| Medication \| Substance \| BiologicallyDerivedProduct)
Summary	true
ResearchSubject.assignedArm
Element Id	ResearchSubject.assignedArm
Definition	The name of the arm in the study the subject is expected to follow as part of this study.
Short Display	What path should be followed
Cardinality	0..1
Type	string
Summary	false
Comments	Maybe this is really PlanDefinition.
To Do	This ought to have an identifer as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm.
ResearchSubject.actualArm
Element Id	ResearchSubject.actualArm
Definition	The name of the arm in the study the subject actually followed as part of this study.
Short Display	What path was followed
Cardinality	0..1
Type	string
Summary	false
To Do	This ought to have an identifer as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm.
ResearchSubject.consent
Element Id	ResearchSubject.consent
Definition	A record of the patient's informed agreement to participate in the study.
Short Display	Agreement to participate in study
Cardinality	0..1
Type	Reference(Consent)
Summary	false