Problem
In the FDA's guidance document "Safety Reporting Requirements for INDs and BA/BE Studies," the FDA outlines the importance of identifying and characterizing adverse events that arise during the course of clinical trials.
Importantly, the FDA outlines the types of events such as (Adverse Event (21 CFR 312.32(a), Suspected Adverse Reaction (21 CFR 312.32(a)), Adverse Reaction, Unexpected, Serious, Life threatening) that MUST be reported to the FDA in the form of IND Safety Reports. Describe each of these events and explain how and when these types of events must be reported to the FDA. How are they reported?