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8.23.6 8.23.7 Resource ResearchSubject - Detailed Descriptions

Biomedical Research and Regulation Work Group Maturity Level : 1 0   Trial Use Security Category : Patient Compartments : 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.

Cardinality 0..*
Type DomainResource
Alternate Names Study Subject
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.

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 state of the subject.

Cardinality 1..1
Terminology Binding ResearchSubjectStatus ( 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) invalid)
Summary true
To Do Should this be a common code system for all events?
ResearchSubject.progress
Element Id ResearchSubject.progress
Definition

The current state (status) of the subject and resons for status change where appropriate.

Cardinality 0..*
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.

Cardinality 0..1
Terminology Binding ResearchSubjectStateType ( Example )
Type CodeableConcept
ResearchSubject.progress.state
Element Id ResearchSubject.progress.state
Definition

The current state of the subject.

Cardinality 0..1
Terminology Binding ResearchSubjectState ( Example )
Type CodeableConcept
ResearchSubject.progress.milestone
Element Id ResearchSubject.progress.milestone
Definition

The milestones the subject has passed through.

Cardinality 0..1
Terminology Binding ResearchSubjectMilestone ( Example )
Type CodeableConcept
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.

Cardinality 0..1
Terminology Binding StateChangeReason ( Example )
Type CodeableConcept
ResearchSubject.progress.startDate
Element Id ResearchSubject.progress.startDate
Definition

The date when the change in status occurred.

Cardinality 1..1
Type dateTime
Comments

This is NOT the date the change in state was recorded.

ResearchSubject.period
Element Id ResearchSubject.period
Definition

The dates the subject began and ended their participation in the study.

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.

Cardinality 1..1
Type Reference ( ResearchStudy )
Summary true
ResearchSubject.individual
Element Id ResearchSubject.individual
Definition

The record of the person or animal who is involved in the study.

Cardinality 1..1
Type Reference ( Patient )
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.

Cardinality 0..1
Type string
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.

Cardinality 0..1
Type string
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.

Cardinality 0..1
Type Reference ( Consent )