Adverse Event Report

Type: Information Object

Status: Planned
Industry Sector: Pharmaceuticals & Life Sciences
Sensitivity Level: Confidential
Personal Information: Sensitive PII

Description:
Record of an unintended medical occurrence associated with use of a medicinal product.

Accessed by Application(s):

• Drug Safety Management System
• Pharmacovigilance System

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Adverse Event ID	Unique identifier for the adverse event report	GUID	Mandatory
2	Product ID	Reference to the medicinal product involved	Reference	Mandatory
3	Participant ID	Reference to the affected trial participant or patient	Reference	Optional
4	Event Term	Standardized adverse event term	String	Mandatory
5	Seriousness	Seriousness classification of the event	Enumeration	Mandatory
6	Onset Date	Date when the event started	Date	Optional
7	Reported Date	Date when the event was reported	Date	Mandatory
8	Causality Assessment	Assessment of relationship to the medicinal product	Enumeration	Optional
9	Outcome	Outcome of the adverse event	Enumeration	Optional
10	Reporting Status	Regulatory reporting status of the case	Enumeration	Mandatory

 Yes
 
 Planned
 Sensitive PII
 Confidential
 Pharmaceuticals & Life Sciences
 Record of an unintended medical occurrence associated with use of a medicinal product.

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