Definition

A centralized system where all adverse event reports are collected, stored, and managed globally for a pharmaceutical company's products.

Example

Reports from the US, Europe, Japan, and other regions are all entered into a single global database, allowing comprehensive signal detection and regulatory reporting.

Regulatory source

ICH E2B(R3), EU GVP Module VI

Common mistakes

Maintaining separate regional databases without proper integration, leading to incomplete global safety profiles.

Inspector question

How do you ensure data integrity and consistency across your global database? Describe your data reconciliation processes.

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