ABSTRACT
During clinical studies, subjects always have undesirable experiences. These may or may not be related to the study drug or device. These experiences are known as adverse events (AEs) or adverse experiences and may be considered adverse effects or adverse drug reactions if there is a relation to the treatment. The strict de—nitions of what is an adverse event, an unexpected adverse event, and a serious adverse event are found in the Code of Federal Regulations (21 CFR), and the International Conference on Harmonization (ICH) topic. Data managers typically do not make judgments about what is an adverse event and what is a serious adverse event, but they do need to understand enough about the data to process and store it properly.
