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| AdverseEventReporting UML Documentation |
AdverseEventReporting
Class Sender
The person and/or organization that sent the ICSR. From ICH E2B(R3), C.3.
| Attributes |
| «AD» Address |  address |
The address of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.1 - C.3.4.5.
|
| «CS» Code | category |
"Captures the type of sender organisation or individual." - ICH E2B(R3), C.3.1. Possible values include: Pharmaceutical Company; Regulatory Authority; Health Professional; Regional Pharmacovigilance Centre; WHO collaborating centres for international drug monitoring; Other (e.g. distributor or other organisation); Patient/Consumer.
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| String | departmentName |
The name of the organizational department (if any) under whose auspices the ICSR was sent. From ICH E2B(R3), C.3.3.1.
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| «TEL» ContactPoint | email |
The email address of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.8.
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| «TEL» ContactPoint | fax |
The facsimile number of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.7.
|
| 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 person in the company or agency who is responsible for the authorisation of report dissemination. This would usually be the same person who signs the covering memo for paper submissions." - ICH E2B(R3), C.3.3.1 - C.3.3.5.
|
| String | organizationName |
The name of the organization (e.g., company name or regulatory authority name) under whose auspices the ICSR was sent. From ICH E2B(R3), C.3.2.
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| «TEL» ContactPoint | phone |
The telephone number of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.6.
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Properties:
| Alias | |
| Classifier Behavior | |
| Is Abstract | false |
| Is Active | false |
| Is Leaf | false |
| Keywords | |
| Name | Sender |
| Name Expression | |
| Namespace | AdverseEventReporting |
| Owned Template Signature | |
| Owner | AdverseEventReporting |
| Owning Template Parameter | |
| Package | AdverseEventReporting |
| Qualified Name | FHIM::AdverseEventReporting::Sender |
| Representation | |
| Stereotype | |
| Template Parameter | |
| Visibility | Public |
address
Public «AD» Address address
-
The address of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.1 - C.3.4.5.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::address |
| Stereotype | |
| Template Parameter | |
| Type | «AD» Address |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
category
Public «CS» Code category
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"Captures the type of sender organisation or individual." - ICH E2B(R3), C.3.1. Possible values include: Pharmaceutical Company; Regulatory Authority; Health Professional; Regional Pharmacovigilance Centre; WHO collaborating centres for international drug monitoring; Other (e.g. distributor or other organisation); Patient/Consumer.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::category |
| Stereotype | |
| Template Parameter | |
| Type | «CS» Code |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
departmentName
Public String departmentName
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The name of the organizational department (if any) under whose auspices the ICSR was sent. From ICH E2B(R3), C.3.3.1.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::departmentName |
| Stereotype | |
| Template Parameter | |
| Type | String |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
email
Public «TEL» ContactPoint email
-
The email address of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.8.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::email |
| Stereotype | |
| Template Parameter | |
| Type | «TEL» ContactPoint |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
fax
Public «TEL» ContactPoint fax
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The facsimile number of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.7.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | fax |
| Name Expression | |
| Namespace | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::fax |
| Stereotype | |
| Template Parameter | |
| Type | «TEL» ContactPoint |
| 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 | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::isPrimarySource |
| Stereotype | |
| Template Parameter | |
| Type | Boolean |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
name
Public «PN» PersonName name
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"The name of person in the company or agency who is responsible for the authorisation of report dissemination. This would usually be the same person who signs the covering memo for paper submissions." - ICH E2B(R3), C.3.3.1 - C.3.3.5.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::name |
| Stereotype | |
| Template Parameter | |
| Type | «PN» PersonName |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
organizationName
Public String organizationName
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The name of the organization (e.g., company name or regulatory authority name) under whose auspices the ICSR was sent. From ICH E2B(R3), C.3.2.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::organizationName |
| Stereotype | |
| Template Parameter | |
| Type | String |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
phone
Public «TEL» ContactPoint phone
-
The telephone number of the person or organization who sent the ICSR. From ICH E2B(R3), C.3.4.6.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | Sender |
| 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 | Sender |
| Opposite | |
| Owner | Sender |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::Sender::phone |
| Stereotype | |
| Template Parameter | |
| Type | «TEL» ContactPoint |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
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| AdverseEventReporting UML Documentation |