Skip to main content

Adverse Event (AE)

« Back to Glossary Index

Also referred to an adverse experience or side effects, an adverse event is any health problem experienced by a participant during a studyClinical Research Glossary – Plain Language Definitions (

An AE is defined by the Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), and the International Council for Harmonisation (ICH) as follows:

Adverse Event (DHHS OHRP): Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research; whether or not considered related to the subject’s participation in the research. OHRP: Unanticipated Problems Involving Risks & Adverse Events Guidance

Adverse Event (FDA IND): Any untoward medical occurrence associated with the use of a drug in humans; whether or not considered drug related. FDA: 21 CFR 312.32, IND Safety Reporting; FDA: Safety Reporting Requirements for INDs and BA/BE Studies

Adverse Event (ICH GCP): Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An Adverse Event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product; whether or not related to the investigational product. ICH GCP, 1.2

« Back to Glossary Index