Reference safety information (RSI)

In Safety & pharmacovigilance

Reference safety information is the specific, clearly identified section of a document — usually the investigator's brochure — used to decide whether a reaction is expected. It must be a defined list, not the whole document, and it is approved and version-controlled. Using the wrong version can turn a correctly handled case into a reporting failure.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.