In the context of a clinical trial, if the investigator ‘s brochure is not a summary of product characteristics, it shall contain a clearly identifiable section called the ‘Reference Safety Information’ (RSI). … the RSI shall contain product information on the investigational medicinal product and on how to determine what adverse reactions are to be considered as expected adverse reactions, and on the frequency and nature of those adverse reactions [Reg (EU) No 536/2014 Annex 1.E.30]