Definition

A potential signal that, after thorough evaluation, is determined not to represent a true safety concern and requires no further action.

Example

A statistical signal for stroke is identified. Evaluation reveals the reports were confounded by underlying disease, with no plausible drug mechanism. The signal is closed as refuted.

Regulatory source

EU GVP Module IX

Common mistakes

Closing signals without adequate documentation of evaluation rationale, or prematurely closing signals that warrant ongoing monitoring.

Inspector question

How do you document refuted signals? What level of evaluation is required before closure?

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