Glossary

Adverse Event of Special Interest (AESI)

A noteworthy event for a product or class of products that a sponsor wants to monitor carefully. It can be serious or non-serious, or it be potential precursor or prodrome for more serious medical conditions in susceptible individuals. It should be described in protocols and instructions provided for investigators as to how and when to report it to the sponsor.

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Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.