Signal Detection Report

Type: Information Object

Status: Planned
Industry Sector: Pharmaceuticals & Life Sciences
Sensitivity Level: Restricted
Personal Information: No PII

Description:
Aggregate safety data analysis identifying potential new risks associated with a medicinal product.

Accessed by Application(s):

• Drug Safety Management System

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Report ID	Unique identifier for the signal detection report	GUID	Mandatory
2	Product ID	Reference to the medicinal product analyzed	Reference	Mandatory
3	Signal Term	Potential risk or medical concept under review	String	Mandatory
4	Data Period	Reporting period covered by the analysis	String	Mandatory
5	Case Count	Number of cases included in the analysis	Integer	Optional
6	Disproportionality Measure	Statistical measure used to detect signal strength	Decimal	Optional
7	Evaluation Outcome	Outcome of signal evaluation	Enumeration	Mandatory
8	Review Date	Date when the signal was reviewed	Date	Mandatory

 Yes
 
 Planned
 No PII
 Restricted
 Pharmaceuticals & Life Sciences
 Aggregate safety data analysis identifying potential new risks associated with a medicinal product.

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