Adverse Event Wheel—Easy AE Look-Up

Adverse events share a commonality in definition regardless of the clinical trial venue.

For example, adverse events (AEs) are always unwanted medical occurrences; whereas adverse device effects (ADEs) are always device related adverse events.

Serious events are tricky, but we are always on firm ground if we use the ISO 14155 definition, with the statistically most common characteristic being increased hospital stay. It follows that serious adverse device effects (SADEs) are device related, while serious adverse events (SAEs) are not.

Unanticipated serious adverse device effects (USADEs or simply UADEs) are device effects that have changed in nature, severity, or frequency of occurrence from what was described in the protocol.

Then there are near incidents (NIs) and new information (NIs) and situations that may cause us to terminate a trial early.

It’s complicated to keep it straight in your head, but easy with the pocket-sized, laminated, FDA and ISO consistent Adverse Event Wheel. This easy AE look-up tool takes you or your study coordinators to uniform first-cut categorizations of adverse events so they are reported on time, just as defined in your protocol.

Available in March for $15. Order HERE.

Comments

[Nancy J Stark]

Hello Janice,
It could be. It is designed for medical devices, meaning it uses medical device terminology, but an adverse event is an adverse event whether it is part of a clinical trial or part of regular clinical practice. Nancy

[Janice Hinsey]

Will this wheel be useful in understanding serious injuries not related to a clinical study?