Definition

The comprehensive assessment of a validated signal including analysis of all available data to characterize the risk and determine appropriate actions.

Example

Evaluation of a hepatotoxicity signal includes: case series review, literature analysis, mechanism assessment, population risk factors, dose relationship, and comparison with similar drugs.

Regulatory source

EU GVP Module IX

Common mistakes

Limiting evaluation to spontaneous data without incorporating clinical trial data, literature, and epidemiological studies.

Inspector question

Show me a signal evaluation report. How do you integrate data from multiple sources?

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