Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Patient Compartments: Device, Patient

Detailed Descriptions for the elements in the ResearchSubject resource.

ResearchSubject
Element IdResearchSubject
Definition

A physical entity which is the primary unit of operational and/or administrative interest in a study.

Cardinality0..*
TypeDomainResource
Alternate NamesStudy Subject
Summaryfalse
Comments

Need to make sure we encompass public health studies.

ResearchSubject.identifier
Element IdResearchSubject.identifier
Definition

Identifiers assigned to this research subject for a study.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
ResearchSubject.status
Element IdResearchSubject.status
Definition

The publication state of the resource (not of the subject).

Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (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)
Summarytrue
ResearchSubject.progress
Element IdResearchSubject.progress
Definition

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

Cardinality0..*
Summaryfalse
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 IdResearchSubject.progress.type
Definition

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

Cardinality0..1
Terminology BindingResearchSubjectStateType (Example)
TypeCodeableConcept
Summaryfalse
ResearchSubject.progress.subjectState
Element IdResearchSubject.progress.subjectState
Definition

The current state of the subject.

Cardinality0..1
Terminology BindingResearchSubjectProgresss :
TypeCodeableConcept
Summaryfalse
ResearchSubject.progress.milestone
Element IdResearchSubject.progress.milestone
Definition

The milestones the subject has passed through.

Cardinality0..1
Terminology BindingResearchSubjectMilestone (Example)
TypeCodeableConcept
Summaryfalse
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 IdResearchSubject.progress.reason
Definition

The reason for the state change. If coded it should follow the formal subject state model.

Cardinality0..1
Terminology BindingStateChangeReason (Example)
TypeCodeableConcept
Summaryfalse
ResearchSubject.progress.startDate
Element IdResearchSubject.progress.startDate
Definition

The date when the new status started.

Cardinality0..1
TypedateTime
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.

Summaryfalse
Comments

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

ResearchSubject.progress.endDate
Element IdResearchSubject.progress.endDate
Definition

The date when the state ended.

Cardinality0..1
TypedateTime
Requirements

See the requirement on the start date.

Summaryfalse
ResearchSubject.period
Element IdResearchSubject.period
Definition

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

Cardinality0..1
TypePeriod
Alternate Namestiming
Summarytrue
To Do.effectiveTime.
ResearchSubject.study
Element IdResearchSubject.study
Definition

Reference to the study the subject is participating in.

Cardinality1..1
TypeReference(ResearchStudy)
Summarytrue
ResearchSubject.subject
Element IdResearchSubject.subject
Definition

The record of the person, animal or other entity involved in the study.

Cardinality1..1
TypeReference(Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct)
PatternsReference(Patient,Group,Specimen,Device,Medication,Substance,BiologicallyDerivedProduct): No common pattern
Summarytrue
ResearchSubject.assignedArm
Element IdResearchSubject.assignedArm
Definition

The name of the arm in the study the subject is expected to follow as part of this study.

Cardinality0..1
Typestring
Summaryfalse
Comments

Maybe this is really PlanDefinition.

To DoThis 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 IdResearchSubject.actualArm
Definition

The name of the arm in the study the subject actually followed as part of this study.

Cardinality0..1
Typestring
Summaryfalse
To DoThis 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 IdResearchSubject.consent
Definition

A record of the patient's informed agreement to participate in the study.

Cardinality0..1
TypeReference(Consent)
Summaryfalse