Reporting on safety during the course of a research study is one of the most important tasks of the Principal Investigator and research coordinator. The regulations in this area can be confusing because two regulatory agencies, HHS and the FDA, have different, but conceptually overlapping, reporting requirements. For reference, please utilize the subheadings that relate to the event that requires reporting. If you need further assistance in assessing your reporting responsibilities, please contact the IRB Research Monitor or submit an inquiry through IRBmail.