Definition

Statistical method to compare reporting frequency of a drug–event pair vs expected (e.g., PRR, ROR, EBGM). Used in signal detection; not proof of causation.

Example

PRR > 2 for drug X and event Y in VigiBase or internal database.

Regulatory source

GVP Module IX, EMA signal management

Common mistakes

Interpreting disproportionality as causation without clinical assessment.

Inspector question

Which disproportionality methods do you use and how do you interpret them?

Related terms