Release 5 FHIR CI-Build

This page is part of the Continuous Integration Build of FHIR Specification (v5.0.0: R5 - STU ). This is the current published version in it's permanent home (it will always (will be available incorrect/inconsistent at this URL). For a full list of available versions, see times).
See the Directory of published versions icon . Page versions: R5 R4B R4 R3

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

Detailed Descriptions for the elements in the ResearchSubject resource.

0..1 Comments Alternate Names
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.

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
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
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..* 0..1
Summary Type false Period
Alternate Names Comments timing
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. Summary true
To Do .effectiveTime.
Element Id ResearchSubject.progress.type ResearchSubject.study
Definition

Identifies the aspect of Reference to the subject's journey that study the state refers to. subject is participating in.

Short Display state | milestone Study subject is part of
Cardinality 0..1 1..1
Terminology Binding Type Research Subject State Type Reference ( Example ResearchStudy )
Type Summary CodeableConcept true
Element Id ResearchSubject.progress.subjectState ResearchSubject.subject
Definition

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

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

The milestones A duration in the subject has passed through. lifecycle of the ResearchSubject within a ResearchStudy.

Short Display SignedUp | Screened | Randomized A duration in the lifecycle of the ResearchSubject within a ResearchStudy
Cardinality Terminology Binding Research Subject Milestone ( Example ) 0..*
Type Summary CodeableConcept false
Element Id ResearchSubject.progress.reason ResearchSubject.subjectState.code
Definition

The reason for Identifies the state change. If coded it should follow aspect of the subject's journey that the formal subject state model. refers to.

Short Display State change reason candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study
Cardinality 0..1 1..1
Terminology Binding StateChangeReason ResearchSubjectState icon ( Example )
Type CodeableConcept
Summary false
Element Id ResearchSubject.progress.startDate ResearchSubject.subjectState.startDate
Definition

The date when a research subject entered the new status started. given state.

Short Display State change The date a research subject entered the given state
Cardinality 0..1 1..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
Element Id ResearchSubject.progress.endDate ResearchSubject.subjectState.endDate
Definition

The date when a research subject exited or left the state ended. given state.

Short Display State change The date a research subject exited or left the given state
Cardinality 0..1
Type dateTime
Requirements See the requirement on the start date. Summary false
Element Id ResearchSubject.period ResearchSubject.subjectState.reason
Definition

The dates reason for the subject began and ended their participation in state change. If coded it should follow the study. formal subject state model.

Short Display Start and end of participation State change reason
Cardinality 0..1
Type Terminology Binding Period StateChangeReason icon ( Example )
Type timing CodeableConcept
Summary true false
To Do Comments .effectiveTime.

Example, if the milestone is "Randomized" then the reason could be "sponsor IVRS randomization code allocated".

Element Id ResearchSubject.study ResearchSubject.subjectMilestone
Definition

Reference to the study A significant event in the subject is participating in. progress of a ResearchSubject.

Short Display Study subject is part A significant event in the progress of a ResearchSubject
Cardinality 1..1 0..*
Type Summary Reference ( ResearchStudy ) false
Element Id ResearchSubject.subject ResearchSubject.subjectMilestone.milestone
Definition

The record of the person, animal or other entity involved A specific event in the research subject's journey through a research study.

Short Display Cardinality Who or what is part of study 1..1
Cardinality Terminology Binding 1..1 ResearchSubjectMilestone icon ( Example )
Type Reference ( Patient | Group | Specimen | Device | Medication | Substance | BiologicallyDerivedProduct CodeableConcept )
Summary true false
Element Id ResearchSubject.assignedComparisonGroup ResearchSubject.subjectMilestone.date
Definition

The name of the arm in the study the subject is expected to follow as part of date/time when this study. milestone event was completed.

Short Display What path should be followed The date/time when this milestone event was completed
Cardinality 0..1
Type id dateTime
Summary false
Comments Element Id ResearchSubject.subjectMilestone.reason
Definition

Maybe this is really PlanDefinition. A rationale that provides additional clarification for the milestone that was captured or documented.

To Do Cardinality 0..*
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. Terminology Binding StateChangeReason icon ( Example )
Type CodeableConcept
Summary false
Element Id ResearchSubject.actualComparisonGroup ResearchSubject.comparisonGroup
Definition

The name of the arm in the study A group to which the subject actually followed as part of this study. is assigned. This group assignment is used for administration or analysis.

Short Display What path was followed A group to which the subject is assigned
Cardinality 0..*
0..1 Terminology Binding Example Comparison Group ( Example )
Type id CodeableReference ( Group )
Summary false
To Do Comments

This ought to have an identifer as well as a name OR - allocation grouping is used for study administration (such as assignment to arms in a Group which is part of a planDefinition which represents an Arm. trial) or study analysis (such as groupings for observational studies or sensitivity analyses).

Element Id ResearchSubject.consent
Definition

A record of the patient's informed agreement Agreement to participate in the study. a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies.

Short Display Agreement to participate in study
Cardinality 0..*
Type Reference ( Consent )
Summary false