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Identifying an adverse event (AE) can be tricky for those new to research (and even sometimes for experienced researchers).  It is easy to confuse the terms “adverse event” and “side effect” but in research these have very different meanings.  An AE is defined as “any untoward medical occurrence” and includes new signs, symptoms or diseases, or abnormal lab or vital results.  The easiest way to identify an AE is to report any change from baseline.

AEs should be assessed at every visit and can be reported by anyone (even the patient) but grade and relationship to the investigational product must be determined by an Investigator.  Each study protocol will provide guidance on how to determine grade and causality.

Adverse event logs are an easy way track ongoing AEs.  Click here to download a free Adverse Event Log template.

Unwell

Affinity Clinical Research Services Newsletter

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