Definition

The systematic process of analyzing safety data to identify potential new risks or changes in known risks associated with a medicinal product.

Example

Routine disproportionality analysis of the safety database identifies an unexpectedly high reporting ratio for cardiac arrhythmia. This triggers signal validation activities.

Regulatory source

EU GVP Module IX, ICH E2E

Common mistakes

Relying solely on statistical methods without clinical review, or conversely, ignoring statistical signals without proper evaluation.

Inspector question

Describe your signal detection methodology. What data sources and analytical methods do you use?

Related terms