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| AdverseEventReporting UML Documentation |
AdverseEventReporting
Class ICRRInformationReporter
"The primary source of the information is the person who provides the facts about the ICSR. In case of multiple sources, the "Primary Source for Regulatory Purposes" (C.2.r.5) is the person who first reported the facts to the sender. The primary source should be distinguished from senders and retransmitters; the latter is captured in Section C.3." - ICH E2B(R3), C.2.r.
| Attributes |
| «AD» Address |  address |
The address of the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.2.3 - C.2.r.2.6.
|
| ReportedTo | alsoReportedTo |
This property indicates whether the Initial Reporter also reported the adverse event / reaction to the the manufacturer, user facility, or distributor/importer.Medwatch 3500 form question G.4.
|
| String | departmentName |
The name of the department (if any) with which the Person who provided facts about the ICSR is associated. From ICH E2B(R3), C.2.r.2.2.
|
| Boolean | doNotDiscloseIdentity |
This property is set to true if the Initial Reporter indicated that he/she does NOT want his/her identity disclosed to the manufacturer.Medwatch 3500 form question G.5.
|
| «TEL» ContactPoint | email |
The email address that a person uses while at their place of business. First choice for business related contacts during business hours.
|
| Boolean | isHealthProfessional |
Is the person reporting the Adverse Event is a Health Care Provider? Medwatch 3500A form question E.2.
|
| Boolean | isPrimarySource |
"Identifies which primary source to use for regulatory purposes and in case of multiple sources, it identifies the source of the World Wide Case Unique Identification number; this source should identify where the case occurred." - ICH E2B(R3), C.2.r.5.
|
| «PN» PersonName | name |
The name of the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.1.1 - C.2.r.1.4.
|
| String | occupation |
The occupation of the person reporting the Adverse Event. May be used to determine the qualification property identified by ICSR.Medwatch 3500A form question E.3.
|
| String | organizationName |
The name of the organization with which the Person who provided facts about the ICSR is associated. From ICH E2B(R3), C.2.r.2.1.
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| «TEL» ContactPoint | phone |
The telephone number of the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.2.7.
|
| «CS» Code | qualification |
Provides an indication of the level of professional training held by the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.4. Possible values include: Physician; Pharmacist; Other health professional; Lawyer; Consumer or other non health professional; Unknown (null flavor).
|
Properties:
| Alias | |
| Classifier Behavior | |
| Is Abstract | false |
| Is Active | false |
| Is Leaf | false |
| Keywords | |
| Name | ICRRInformationReporter |
| Name Expression | |
| Namespace | AdverseEventReporting |
| Owned Template Signature | |
| Owner | AdverseEventReporting |
| Owning Template Parameter | |
| Package | AdverseEventReporting |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter |
| Representation | |
| Stereotype | |
| Template Parameter | |
| Visibility | Public |
address
Public «AD» Address address
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The address of the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.2.3 - C.2.r.2.6.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | address |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::address |
| Stereotype | |
| Template Parameter | |
| Type | «AD» Address |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
alsoReportedTo
Public ReportedTo alsoReportedTo
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This property indicates whether the Initial Reporter also reported the adverse event / reaction to the the manufacturer, user facility, or distributor/importer.Medwatch 3500 form question G.4.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | alsoReportedTo |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::alsoReportedTo |
| Stereotype | |
| Template Parameter | |
| Type | ReportedTo |
| Upper | * |
| Upper Value | (*) |
| Visibility | Public |
departmentName
Public String departmentName
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The name of the department (if any) with which the Person who provided facts about the ICSR is associated. From ICH E2B(R3), C.2.r.2.2.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | departmentName |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::departmentName |
| Stereotype | |
| Template Parameter | |
| Type | String |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
doNotDiscloseIdentity
Public Boolean doNotDiscloseIdentity
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This property is set to true if the Initial Reporter indicated that he/she does NOT want his/her identity disclosed to the manufacturer.Medwatch 3500 form question G.5.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | doNotDiscloseIdentity |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::doNotDiscloseIdentity |
| Stereotype | |
| Template Parameter | |
| Type | Boolean |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
email
Public «TEL» ContactPoint email
-
The email address that a person uses while at their place of business. First choice for business related contacts during business hours.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | email |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::email |
| Stereotype | |
| Template Parameter | |
| Type | «TEL» ContactPoint |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
isHealthProfessional
Public Boolean isHealthProfessional
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Is the person reporting the Adverse Event is a Health Care Provider? Medwatch 3500A form question E.2.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | isHealthProfessional |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::isHealthProfessional |
| Stereotype | |
| Template Parameter | |
| Type | Boolean |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
isPrimarySource
Public Boolean isPrimarySource
-
"Identifies which primary source to use for regulatory purposes and in case of multiple sources, it identifies the source of the World Wide Case Unique Identification number; this source should identify where the case occurred." - ICH E2B(R3), C.2.r.5.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | isPrimarySource |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::isPrimarySource |
| Stereotype | |
| Template Parameter | |
| Type | Boolean |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
name
Public «PN» PersonName name
-
The name of the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.1.1 - C.2.r.1.4.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | name |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::name |
| Stereotype | |
| Template Parameter | |
| Type | «PN» PersonName |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
occupation
Public String occupation
-
The occupation of the person reporting the Adverse Event. May be used to determine the qualification property identified by ICSR.Medwatch 3500A form question E.3.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | occupation |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::occupation |
| Stereotype | |
| Template Parameter | |
| Type | String |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
organizationName
Public String organizationName
-
The name of the organization with which the Person who provided facts about the ICSR is associated. From ICH E2B(R3), C.2.r.2.1.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | organizationName |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::organizationName |
| Stereotype | |
| Template Parameter | |
| Type | String |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
phone
Public «TEL» ContactPoint phone
-
The telephone number of the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.2.7.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | phone |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::phone |
| Stereotype | |
| Template Parameter | |
| Type | «TEL» ContactPoint |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
qualification
Public «CS» Code qualification
-
Provides an indication of the level of professional training held by the Person who provided facts about the ICSR. From ICH E2B(R3), C.2.r.4. Possible values include: Physician; Pharmacist; Other health professional; Lawyer; Consumer or other non health professional; Unknown (null flavor).
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | ICRRInformationReporter |
| 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 | qualification |
| Name Expression | |
| Namespace | ICRRInformationReporter |
| Opposite | |
| Owner | ICRRInformationReporter |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::ICRRInformationReporter::qualification |
| Stereotype | |
| Template Parameter | |
| Type | «CS» Code |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
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| AdverseEventReporting UML Documentation |