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8.26.8 8.24.9 Resource ResearchSubject - Detailed Descriptions

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.

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.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.subject
Element Id ResearchSubject.subject
Definition

The record of the person, animal 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 | SubstanceDefinition | BiologicallyDerivedProduct )
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.subjectState.code
Element Id ResearchSubject.subjectState.code
Definition

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

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

The date a research subject entered the given state.

Short Display The date a research subject entered the given state
Cardinality 1..1
Type dateTime
Summary false
ResearchSubject.subjectState.endDate
Element Id ResearchSubject.subjectState.endDate
Definition

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

Short Display The date a research subject exited or left the given state
Cardinality 0..1
Type dateTime
Summary false
ResearchSubject.subjectState.reason
Element Id ResearchSubject.subjectState.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
Comments

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

ResearchSubject.subjectMilestone
Element Id ResearchSubject.subjectMilestone
Definition

A significant event in the progress of a ResearchSubject.

Short Display A significant event in the progress of a ResearchSubject
Cardinality 0..*
Summary false
ResearchSubject.subjectMilestone.milestone
Element Id ResearchSubject.subjectMilestone.milestone
Definition

A specific event in the research subjects subject's journey through a research study.

Short Display SignedUp | Screened | Randomized Cardinality 1..* 1..1
Terminology Binding Research Subject Milestone ResearchSubjectMilestone icon ( Example )
Type CodeableConcept
Summary false
ResearchSubject.subjectMilestone.date
Element Id ResearchSubject.subjectMilestone.date
Definition

The date/time when this milestone event was completed.

Short Display The date/time when this milestone event was completed
Cardinality 0..1
Type dateTime
Summary false
ResearchSubject.subjectMilestone.reason
Element Id ResearchSubject.subjectMilestone.reason
Definition

A rationale that provides additional clarification for the milestone that was captured or documented.

Cardinality 0..1 0..*
Terminology Binding StateChangeReason icon ( Example )
Type CodeableConcept
Summary false
ResearchSubject.assignedComparisonGroup ResearchSubject.comparisonGroup
Element Id ResearchSubject.assignedComparisonGroup ResearchSubject.comparisonGroup
Definition

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

Short Display What path should be followed A group to which the subject is assigned
Cardinality 0..1 Type id 0..*
Summary Terminology Binding false Comments Maybe this is really PlanDefinition. To Do This ought to have an identifier as well as a name OR - allocation is to a Example Comparison 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 ( Example 0..1 )
Type id CodeableReference ( Group )
Summary false
To Do Comments

This ought to have an identifier 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).

ResearchSubject.consent
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