Definition

Practice of validating signals using internal methodology and documentation without using the formal EMA signal validation form; acceptable when equivalent rigor is applied.

Example

Internal signal validation report with same elements (data, methodology, conclusion) as EMA form.

Regulatory source

EMA PRAC guidance, GVP Module IX

Common mistakes

Skipping validation or using ad-hoc undocumented approach.

Inspector question

How do you validate signals when not using the EMA validation form?

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