A physical entity which is the primary unit of operational and/or administrative interest in a study. For example, a person who is registered in a study as a recipient of an investigational product or as a control. May also include individuals who are being screened for studies, or individuals participating in observational or other studies. Other examples may include a devicess such as a pacemaker or a fuse that can be used in medical devices, a cow, a farm, a pen of pigs, a tissue sample from a tissue bank, etc. Note that the subject might not be an entire entity but a part of one, for exaample, a patch of person's skin where dermatological products are tested. The one person may have multiple areas of skin being tested simultaneously for different products - in this case, each area of skin would be a separate research subject. Note also that study subjects within a study are all of the same type.
"A physical entity which is the primary unit of operational and/or administrative interest in a study." - HL7 FHIR, ResearchSubject

Attributes
String	actualStudyArm	A study arm is "a group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins" (ClinicalTrials.gov). This property identifies the study arm in which the research subject actually took part (as opposed to the arm to which the subject was originally assigned) "The name of the arm in the study the subject actually followed as part of this study." - HL7 FHIR, ResearchSubject.actualArm
String	assignedStudyArm	A study arm is "a group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins" (ClinicalTrials.gov). This property identifies the study arm to which the research subject is assigned. "The name of the arm in the study the subject is expected to follow as part of this study." - HL7 FHIR, ResearchSubject.assignedArm
ConsentDirective	consent	"A record of the patient's informed agreement to participate in the study." - HL7 FHIR, ResearchSubject.consent
Entity	entity	"The record of the person or animal who is involved in the study." - HL7 FHIR, ResearchSubject.individual Note that FHIR points to Patient, which is good for Persons and Animals, but the FHIM points to Entity in order to handle other types of subjects such as a barnyard, or a device.
«II» Id	identifier	"Identifiers assigned to this research study by the sponsor or other systems." - HL7 FHIR, ResearchSubject.identifier
«IVL_TS» TimeInterval	period	"The dates the subject began and ended their participation in the study." - HL7 FHIR, ResearchSubject.period
«CS» Code	status	"The current state of the subject." - HL7 FHIR, ResearchSubject.status
ResearchStudy	study	"Reference to the study the subject is participating in." - HL7 FHIR, ResearchSubject.study

 actualStudyArm

Public String actualStudyArm

A study arm is "a group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins" (ClinicalTrials.gov). This property identifies the study arm in which the research subject actually took part (as opposed to the arm to which the subject was originally assigned)
"The name of the arm in the study the subject actually followed as part of this study." - HL7 FHIR, ResearchSubject.actualArm

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	actualStudyArm
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::actualStudyArm
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public

 assignedStudyArm

Public String assignedStudyArm

A study arm is "a group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins" (ClinicalTrials.gov). This property identifies the study arm to which the research subject is assigned.
"The name of the arm in the study the subject is expected to follow as part of this study." - HL7 FHIR, ResearchSubject.assignedArm

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	assignedStudyArm
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::assignedStudyArm
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public

 consent

Public ConsentDirective consent

"A record of the patient's informed agreement to participate in the study." - HL7 FHIR, ResearchSubject.consent

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	consent
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::consent
Stereotype
Template Parameter
Type	ConsentDirective
Upper	1
Upper Value	(1)
Visibility	Public

 entity

Public Entity entity

"The record of the person or animal who is involved in the study." - HL7 FHIR, ResearchSubject.individual
Note that FHIR points to Patient, which is good for Persons and Animals, but the FHIM points to Entity in order to handle other types of subjects such as a barnyard, or a device.

Constraints:

Properties:

Aggregation	None
Alias
Association	researchSubject_entity
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	1
Lower Value	(1)
Multiplicity	1..*
Name	entity
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::entity
Stereotype
Template Parameter
Type	Entity
Upper	*
Upper Value	(*)
Visibility	Public

 identifier

Public «II» Id identifier

"Identifiers assigned to this research study by the sponsor or other systems." - HL7 FHIR, ResearchSubject.identifier

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	*
Name	identifier
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::identifier
Stereotype
Template Parameter
Type	«II» Id
Upper	*
Upper Value	(*)
Visibility	Public

 period

Public «IVL_TS» TimeInterval period

"The dates the subject began and ended their participation in the study." - HL7 FHIR, ResearchSubject.period

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	0
Lower Value	(0)
Multiplicity	0..1
Name	period
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::period
Stereotype
Template Parameter
Type	«IVL_TS» TimeInterval
Upper	1
Upper Value	(1)
Visibility	Public

 status

Public «CS» Code status

"The current state of the subject." - HL7 FHIR, ResearchSubject.status

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	ResearchSubject
Terminologies	[ HL7_FHIR_R4 ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status ]
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	1
Lower Value	(1)
Multiplicity	1
Name	status
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::status
Stereotype	ValueSetConstraints
Template Parameter
Type	«CS» Code
Upper	1
Upper Value	(1)
Visibility	Public

 study

Public ResearchStudy study

"Reference to the study the subject is participating in." - HL7 FHIR, ResearchSubject.study

Constraints:

Properties:

Aggregation	None
Alias
Association	researchSubject_study
Association End
Class	ResearchSubject
Datatype
Default
Default Value
Is Composite	false
Is Derived	false
Is Derived Union	false
Is Leaf	false
Is Ordered	false
Is Read Only	false
Is Static	false
Is Unique	true
Keywords
Lower	1
Lower Value	(1)
Multiplicity	1
Name	study
Name Expression
Namespace	ResearchSubject
Opposite
Owner	ResearchSubject
Owning Association
Owning Template Parameter
Qualified Name	FHIM::Person::ResearchSubject::study
Stereotype
Template Parameter
Type	ResearchStudy
Upper	1
Upper Value	(1)
Visibility	Public