Official Definitions, Made Understandable

Understand how adverse events and adverse device effects are defined across FDA, ICH E6, and ISO 14155—with direct links to the original sources and guidance.

What Counts as an AE (and When)

Learn how adverse events can occur throughout a study—including screening and procedures—not just after a drug or device is administered.

Built for Real-World Site Practice

Designed for coordinators, investigators, and site staff who need practical clarity before tackling reporting timelines and responsibilities.

Understand adverse events without the confusion.

Adverse event definitions are one of the most misunderstood areas of clinical research. FDA regulations, ICH guidance, and ISO standards all use slightly different language—and that’s where uncertainty creeps in. This short, foundational session breaks adverse events down clearly and consistently across drug, biologic, and medical device trials in the United States. You’ll learn how adverse events are defined, what “untoward” really means in practice, and how to recognize adverse events whether they occur during screening, study procedures, or after exposure to the investigational product. Designed for real-world site practice, this session focuses on clarity—not memorization—so you can apply definitions confidently in documentation, reporting, and decision-making. If you’ve ever paused and thought, “Wait… is this actually an AE?”—this session is for you.

Want to keep building your safety reporting foundation?

This session is part of the Safety Reporting for Sites: A Foundations Series bundle, which brings four safety reporting sessions together into one cohesive learning path—available in the ClinIQ Academy catalog.

Curriculum

1 Chapter · 1 Lesson

  1. 1

    Understanding Adverse Events and Adverse Device Effects in Drug and Device Studies

    1. (Included in full purchase)

      Understanding AEs and ADEs in Drug and Device Studies

Start learning on your path to clinical research confidence. 

Clear definitions are the foundation of good safety reporting. Start with clarity and build confidence you can carry into every study.

$10.00

Enroll now