Definition

A study conducted after authorization to obtain further information on a medicine's safety, identify risks, or measure effectiveness of risk minimization.

Example

A PASS using healthcare databases aims to estimate the incidence of hepatotoxicity in routine clinical practice and identify patient risk factors.

Regulatory source

EU GVP Module VIII

Common mistakes

Designing PASS that cannot answer the specific safety questions due to inadequate sample size or data sources.

Inspector question

Describe your PASS program. How do you select study designs and data sources?

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