Reference Safety Information (RSI)
The section of the Investigator Brochure that lists expected serious adverse reactions for an investigational product.
What it means
Reference Safety Information is the specific list, usually in a dedicated IB section, used to judge whether a serious adverse event is expected or unexpected. It drives SUSAR classification. Translations must reproduce the RSI verbatim in tables and in the ICF's foreseeable risks section.
Why it matters for LATAM submissions
A single mistranslated adverse reaction term can flip a SUSAR classification and trigger avoidable expedited reports across every LATAM country.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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