Release 4 5

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8.23.6 8.25.7 Resource ResearchSubject - Detailed Descriptions

Biomedical Research and Regulation icon Work Group Maturity Level : 1 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 ResearchSubject is a participant or object which is the primary unit recipient of operational and/or administrative interest 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 current publication state of the subject. resource (not of the subject).

Short Display draft | active | retired | unknown
Cardinality 1..1
Terminology Binding ResearchSubjectStatus 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
To Do Element Id Should this 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 common code system 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 Research Subject State Type ( 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 Research Subject State ( 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 Research Subject Milestone ( 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 icon ( 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 events? 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.individual ResearchSubject.subject
Element Id ResearchSubject.individual ResearchSubject.subject
Definition

The record of the person or person, animal who is 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 ResearchSubject.assignedComparisonGroup
Element Id ResearchSubject.assignedArm 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 string id
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 ResearchSubject.actualComparisonGroup
Element Id ResearchSubject.actualArm 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 string id
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 0..*
Type Reference ( Consent )
Summary false