International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The Fundamentals of GCP Deviations

In clinical trials, minor errors can sometimes have significant consequences. In the Fundamentals of Deviations for GCP,  we’ll follow a team as they discover a critical error and conduct an investigation to uncover the root cause. Along the way, we’ll examine the tools they used and the steps they took to identify the deviation, determine its scope and impact, and best practices for the process. We’ll focus intensely on the importance of investigations in ensuring patient safety and data integrity. We’ll conclude with an overview of key protocol deviation investigation closeout steps.

CEU Credits: 0.1
Course Code: ELM-265
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 09/19/2025

Curriculum for this course

A Missing Report
Risk and Issue Monitoring
Issue Identification
Immediate Actions
Issue Identification: Data Collection and Steps
Investigation
Root Cause Analysis (RCA)
RCA Characteristics
5 Whys
Fishbone Diagram
Root Cause Determination
Investigation Closure Documentation
Investigation Closure Approvals
Post-Investigation Process
Deviations and Compliance
The importance of a Defined Process
A Strong QMS
Test your Knowledge!
v1.0 Course Released on 01/27/26

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