ICH

Clinical Trial Safety Reporting

As an Investigator Site professional, your role is pivotal. You are the first line of defense for patient well-being and the primary source for capturing reliable safety data. This involves classifying safety events as adverse events, adverse drug reactions, serious adverse events, and suspected unexpected serious adverse reactions. In this course, you’ll learn to identify and differentiate between safety events and review crucial reporting timeline requirements.

CEU Credits: 0.1
Course Code: ELM-998
Duration: 10 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 01/06/2026

Curriculum for this course

Welcome to CooperMei Clinical!
Differentiating AE from ADR
AE or ADR?
What does “serious” mean?
The hospital stay
SUSAR definition
The novel reaction
SUSAR reporting requirements
AE and ADR reporting requirements
SAE reporting
The immediate deadline
Investigator accountability
Summary
Test your knowledge

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