AdverseEventReporting
Class Study

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 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 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

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

String sponsorsStudyId 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.


Properties:

Alias
Classifier Behavior
Is Abstractfalse
Is Activefalse
Is Leaffalse
Keywords
NameStudy
Name Expression
NamespaceAdverseEventReporting
Owned Template Signature
OwnerAdverseEventReporting
Owning Template Parameter
PackageAdverseEventReporting
Qualified NameFHIM::AdverseEventReporting::Study
Representation
Stereotype
Template Parameter
VisibilityPublic

Attribute Details

 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:

AggregationNone
Alias
Association
Association End
ClassStudy
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namecategory
Name Expression
NamespaceStudy
Opposite
OwnerStudy
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::Study::category
Stereotype
Template Parameter
Type«CS» Code
Upper1
Upper Value(1)
VisibilityPublic


 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:

AggregationNone
Alias
Association
Association End
ClassStudy
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Nameidentifier
Name Expression
NamespaceStudy
Opposite
OwnerStudy
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::Study::identifier
Stereotype
Template Parameter
Type«II» Id
Upper1
Upper Value(1)
VisibilityPublic


 name
Public String name

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

Constraints:
Properties:

AggregationNone
Alias
Association
Association End
ClassStudy
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
Namename
Name Expression
NamespaceStudy
Opposite
OwnerStudy
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::Study::name
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic


 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:

AggregationNone
Alias
Association
Association End
ClassStudy
Datatype
Default
Default Value
Is Compositefalse
Is Derivedfalse
Is Derived Unionfalse
Is Leaffalse
Is Orderedfalse
Is Read Onlyfalse
Is Staticfalse
Is Uniquetrue
Keywords
Lower0
Lower Value(0)
Multiplicity0..1
NamesponsorsStudyId
Name Expression
NamespaceStudy
Opposite
OwnerStudy
Owning Association
Owning Template Parameter
Qualified NameFHIM::AdverseEventReporting::Study::sponsorsStudyId
Stereotype
Template Parameter
TypeString
Upper1
Upper Value(1)
VisibilityPublic