Definition

A validated signal where evaluation has established sufficient evidence of a causal association requiring risk management action.

Example

Evaluation of a hepatotoxicity signal confirms: consistent case pattern, biological plausibility, positive dechallenge, supporting literature. Label update is recommended.

Regulatory source

EU GVP Module IX

Common mistakes

Requiring the same level of proof as a randomized trial. Signal confirmation is based on weight of evidence, not absolute certainty.

Inspector question

Walk me through a confirmed signal. What evidence supported confirmation?

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