Definition

Document that defines expectedness of AEs for expedited reporting (e.g., IB for trials, SmPC/PL for marketed products).

Example

Company core SmPC used as RSI for post-marketing expedited reporting.

Regulatory source

ICH E2D, GVP Module VI

Common mistakes

Using outdated or wrong RSI for a region.

Inspector question

What is your RSI for each product and how do you keep it current?

Related terms