The reference safety information (RSI) contained in the IB provides an important reference point for expedited reporting of suspected unexpected serious adverse reactions (SUSARs) in the clinical trial. This RSI should include a list of adverse reactions, including information on their frequency and nature. This list should be used for determining the expectedness of a suspected serious adverse reaction and subsequently whether reporting needs to be expedited in accordance with applicable regulatory requirements (see section 3.13.2(c)).
The IB also provides insight to support the clinical management of the participants during the course of the clinical trial. The information should be presented in a concise, simple, objective, balanced and
non-promotional form that enables a clinician or potential investigator to understand it and make their own unbiased risk-benefit assessment of the appropriateness of the proposed trial. For this reason, a medically qualified person should be involved in the generation of an IB, but the contents of the IB should be approved by the disciplines that generated the described data.