Definition

The document used to determine expectedness of adverse reactions for regulatory reporting purposes, typically the company core safety information (CCSI) for marketed products or Investigator's Brochure for clinical trials.

Example

For a global marketed product, the company maintains a CCSI that serves as RSI. A reaction is 'expected' if it appears in the RSI, regardless of whether it's in individual country labels.

Regulatory source

EU GVP Module VI, ICH E2D

Common mistakes

Using different expectedness references inconsistently across regions or not updating RSI when new safety information emerges.

Inspector question

What document do you use as RSI? How often is it reviewed and updated?

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