If the adverse reaction or event occured while the patient was participating in a study (e.g., a clinical trial), this class will contain identifying information about that study.

Attributes
«CS» Code	category	"This information should be provided if the "Type of Report" (C.1.3) has been populated with "Report from study"." - ICH E2B(R3), C.5.4. Possible values include: Clinical trials; Individual patient use (e.g. "compassionate use" or "named patient basis"); Other studies (e.g. pharmacoepidemiology, pharmacoeconomics, intensive monitoring).
«II» Id	identifier	"This repeatable data element should be populated with the study registration number as assigned in a reporting region." - ICH E2B(R3), C.5.1.r.1.
String	name	Name of the Study. From ICH E2B(R3), C.5.2.
String	sponsorsStudyId	"This data element should be completed only if the sender is the study sponsor or has been informed of the study number by the sponsor." - ICH E2B(R3), C.5.3.

 category

Public «CS» Code category

"This information should be provided if the "Type of Report" (C.1.3) has been populated with "Report from study"." - ICH E2B(R3), C.5.4. Possible values include: Clinical trials; Individual patient use (e.g. "compassionate use" or "named patient basis"); Other studies (e.g. pharmacoepidemiology, pharmacoeconomics, intensive monitoring).

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	Study
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	category
Name Expression
Namespace	Study
Opposite
Owner	Study
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::Study::category
Stereotype
Template Parameter
Type	«CS» Code
Upper	1
Upper Value	(1)
Visibility	Public

 identifier

Public «II» Id identifier

"This repeatable data element should be populated with the study registration number as assigned in a reporting region." - ICH E2B(R3), C.5.1.r.1.

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	Study
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	identifier
Name Expression
Namespace	Study
Opposite
Owner	Study
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::Study::identifier
Stereotype
Template Parameter
Type	«II» Id
Upper	1
Upper Value	(1)
Visibility	Public

 name

Public String name

Name of the Study. From ICH E2B(R3), C.5.2.

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	Study
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	name
Name Expression
Namespace	Study
Opposite
Owner	Study
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::Study::name
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public

 sponsorsStudyId

Public String sponsorsStudyId

"This data element should be completed only if the sender is the study sponsor or has been informed of the study number by the sponsor." - ICH E2B(R3), C.5.3.

Constraints:

Properties:

Aggregation	None
Alias
Association
Association End
Class	Study
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	sponsorsStudyId
Name Expression
Namespace	Study
Opposite
Owner	Study
Owning Association
Owning Template Parameter
Qualified Name	FHIM::AdverseEventReporting::Study::sponsorsStudyId
Stereotype
Template Parameter
Type	String
Upper	1
Upper Value	(1)
Visibility	Public