Clinical Research Glossary

adverse event adverse event


Any health problem that happens during the study.

Example of adverse event in a sentence

The study team needs to know about all adverse events that happen during the study.

More Info

Researchers track adverse events for safety reasons. They also want to find out whether any issues could be related to the study treatment.

Participants should tell the study team about any health problem that happens while they are in a study. Any event such as a fever, headache, cold, a mood change, or falling, should be reported.

Other info to think about when joining a study

You may see references to “adverse event” during the consent process when discussing procedures since many studies include specific time points to ask participants if they have experienced any health problems.

You may also see references to “adverse event” when discussing the risks of the study. Depending on the type of study you join, the risks you learn about are based on information participants in previous studies reported. It is important that you tell the study team about any health problem that happens during the study, even if you don’t think it’s related to the research.

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