The short version
- An adverse event is any unwanted medical event during a study, related or not.
- Teams track them to learn what is connected to the product being studied.
- Participants are usually told whom to contact if something happens.
A broad definition
An adverse event covers a headache, a fall or a hospital stay alike, so researchers do not miss patterns. Most are mild.
Related or not
The study team assesses whether an event might be linked to what is being studied. The listing and consent form describe known and possible effects.
Serious events
Some events meet a definition of seriousness, such as hospitalization. These have stricter reporting requirements to the sponsor, the review board and, in many cases, regulators.
If something happens
The consent form states who to call. For anything urgent, call your doctor or 911. We cannot receive medical reports.
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