Definition

AE listed in RSI (e.g., SmPC) for the relevant population and dose; affects expedited reporting (usually not expedited if expected).

Example

Nausea listed in SmPC—reported nausea may be expected.

Regulatory source

ICH E2D, GVP Module VI

Common mistakes

Using wrong RSI or wrong population (e.g., pediatric vs adult).

Inspector question

How do you determine expectedness for each report?

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