Release 5 R6 Ballot (3rd Draft)

This page is part of the FHIR Specification (v5.0.0: R5 - STU v6.0.0-ballot3: Release 6 Ballot (3rd Draft) (see Ballot Notes ). This is the The current published version in it's permanent home (it will always be available at this URL). is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.25.7 8.26.8 Resource ResearchSubject - Detailed Descriptions

Biomedical Research and Regulation icon Work Group Maturity Level : 0   Trial Use Security Category : Patient Compartments : Device , Group , Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

CodeableConcept Comments Requirements See the requirement on the start date. Alternate Names true
ResearchSubject
Element Id ResearchSubject
Definition

A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.

Short Display Participant or object which is the recipient of investigative activities in a 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 ResearchSubject.period
Element Id ResearchSubject.progress ResearchSubject.period
Definition

The current state (status) of dates the subject began and resons for status change where appropriate. ended their participation in the study.

Short Display Subject status Start and end of participation
Cardinality 0..1
0..* Type Period
Alternate Names timing
Summary true
false To Do .effectiveTime.
ResearchSubject.study
Comments Element Id ResearchSubject.study
Definition

This is intended Reference 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 study the milestone is achieved subject 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. participating in.

It is likely that more than one "state" pattern will be recorded for a
Short Display Study subject and a type has been introduced to allow this simultaneous recording. is part of
Cardinality 1..1
Type Reference ( ResearchStudy )
Summary true
ResearchSubject.progress.type ResearchSubject.subject
Element Id ResearchSubject.progress.type ResearchSubject.subject
Definition

Identifies the aspect The record of the subject's journey that person, animal or other entity involved in the state refers to. study.

Short Display state | milestone Who or what is part of study
Cardinality 0..1 1..1
Terminology Binding Type Research Subject State Type Reference ( Example Patient | Group | Specimen | Device | Medication | Substance | SubstanceDefinition | BiologicallyDerivedProduct )
Type Summary true
ResearchSubject.subjectState
Element Id ResearchSubject.subjectState
Definition

A duration in the lifecycle of the ResearchSubject within a ResearchStudy.

Short Display A duration in the lifecycle of the ResearchSubject within a ResearchStudy
Cardinality 0..*
Summary false
ResearchSubject.progress.subjectState ResearchSubject.subjectState.code
Element Id ResearchSubject.progress.subjectState ResearchSubject.subjectState.code
Definition

The current state Identifies the aspect of the subject. subject's journey that the state refers to.

Short Display candidate | eligible | follow-up in-prescreening | ineligible in-screening | not-registered eligible | off-study ineligible | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening in-follow-up | withdrawn off-study
Cardinality 0..1 1..1
Terminology Binding Research Subject State ( Required Example )
Type CodeableConcept
Summary false
ResearchSubject.progress.milestone ResearchSubject.subjectState.startDate
Element Id ResearchSubject.progress.milestone ResearchSubject.subjectState.startDate
Definition

The milestones the date a research subject has passed through. entered the given state.

Short Display SignedUp | Screened | Randomized The date a research subject entered the given state
Cardinality 0..1 Terminology Binding Research Subject Milestone ( Example ) 1..1
Type CodeableConcept dateTime
Summary false
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.subjectState.endDate ResearchSubject.progress.reason
Element Id ResearchSubject.progress.reason ResearchSubject.subjectState.endDate
Definition

The reason for the state change. If coded it should follow the formal date a research subject state model. exited or left the given state.

Short Display State change reason The date a research subject exited or left the given state
Cardinality 0..1
Terminology Binding StateChangeReason ( Example ) Type CodeableConcept dateTime
Summary false
ResearchSubject.progress.startDate ResearchSubject.subjectState.reason
Element Id ResearchSubject.progress.startDate ResearchSubject.subjectState.reason
Definition

The date when reason for the new status started. state change. If coded it should follow the formal subject state model.

Short Display State change date reason
Cardinality 0..1
Type Terminology Binding dateTime StateChangeReason icon ( Example )
Requirements Type 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. CodeableConcept
Summary false
Comments

This is NOT Example, if the date milestone is "Randomized" then the change in state was recorded. reason could be "sponsor IVRS randomization code allocated".

ResearchSubject.progress.endDate ResearchSubject.subjectMilestone
Element Id ResearchSubject.progress.endDate ResearchSubject.subjectMilestone
Definition

The date when A significant event in the state ended. progress of a ResearchSubject.

Short Display State change date A significant event in the progress of a ResearchSubject
Cardinality 0..1 0..*
Type Summary dateTime false
ResearchSubject.subjectMilestone.milestone Summary false ResearchSubject.period
Element Id ResearchSubject.period ResearchSubject.subjectMilestone.milestone
Definition

The dates the subject began and ended their participation A specific event in the research subjects journey through a research study.

Short Display Start and end of participation SignedUp | Screened | Randomized
Cardinality 0..1 1..*
Type Terminology Binding Period Research Subject Milestone ( Example )
Type timing CodeableConcept
Summary To Do .effectiveTime. false
ResearchSubject.study ResearchSubject.subjectMilestone.date
Element Id ResearchSubject.study ResearchSubject.subjectMilestone.date
Definition

Reference to the study the subject is participating in. The date/time when this milestone event was completed.

Short Display Study subject is part of The date/time when this milestone event was completed
Cardinality 1..1 0..1
Type Reference ( ResearchStudy dateTime )
Summary true false
ResearchSubject.subject ResearchSubject.subjectMilestone.reason
Element Id ResearchSubject.subject ResearchSubject.subjectMilestone.reason
Definition

The record of A rationale that provides additional clarification for the person, animal milestone that was captured or other entity involved in the study. documented.

Short Display Who or what is part of study Cardinality 1..1 0..1
Type Reference ( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct CodeableConcept )
Summary true false
ResearchSubject.assignedComparisonGroup
Element Id ResearchSubject.assignedComparisonGroup
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 id
Summary false
Comments

Maybe this is really PlanDefinition.

To Do This ought to have an identifer identifier as well as a name OR - allocation is to a Group which is part of a planDefinition which represents an Arm.
ResearchSubject.actualComparisonGroup
Element Id ResearchSubject.actualComparisonGroup
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 id
Summary false
To Do This ought to have an identifer identifier 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..*
Type Reference ( Consent )
Summary false