Definition

Safety data from sources outside the company's own database, including regulatory databases, literature, registries, and epidemiological studies.

Example

Signal evaluation incorporates: EudraVigilance data, FAERS data, published case reports, observational study results, and competitor product safety information.

Regulatory source

EU GVP Module IX

Common mistakes

Relying solely on internal data for signal evaluation without consulting external sources.

Inspector question

What external data sources do you use for signal detection and evaluation?

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