Good Clinical Practices (cGCP)

General Principles of Good Clinical Practices (ICH E6 R3)

In this course, we’ll be focusing on the eleven General Principles of GCP, as outlined in ICH E6 (R3). These can be grouped into three different categories based on their focus: ethical conduct and participant protection in clinical trials, maintaining scientific and operational integrity, and reliability and compliance of the data generated. In each section, learners will explore why the principles matter before going further to understand each principle.

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CEU Credits: 0.1
Course Code: ELM-983
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 03/19/2025

Curriculum for this course

Meet Devon
Good Clinical Practice - Overview
The International Council for Harmonisation
General Principles of GCP
Why It Matters: Ethical Conduct & Participant Protection
Ethical Principles
Informed Consent
Independent Review
Why it Matters: Scientific & Operational Integrity
Scientific Validity
Qualified Personnel
Build-In Quality
Risk-Based Proportionality
Clear and Feasible Protocols
Why It Matters: Data Reliability & Compliance
Reliable Results
Clear Roles and Responsibilities
Investigational Product Compliance
Summary
Test Your Knowledge
v1.0 Course released on v1.0

Author

Nick Cohen

GxP Quality Assurance Expert

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