AdverseEvent - Section 9.9.1

For clinical research, I think it's important to mention that there's a regulatory requirement to communicate serious adverse events (e.g., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32#:~:text=Adverse%20event%20means%20any%20untoward,life%2Dthreatening%20suspected%20adverse%20reaction.) 

Verbatim:
"In the clinical research setting, the event is additionally tracked and evaluated as part of the clinical research process for the research study, since the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment."

Addition:
"In clinical research trials, serious adverse events are required to be reported to the respective health authorities (e.g., U.S. FDA)"