ICH E6 (R3) – What’s New

The goal of this course is to explore the new GCP guideline. At the end of the course, you’ll be able to identify the updated principles of GCP and discuss overarching themes present in ICH E6 R3 Good Clinical Practice guideline document.

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CEU Credits: 0.1
Course Code: ELM-932
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 08/22/2023

Curriculum for this course

Course Introduction
What You Will Learn
A Note on Document Structure
Risk-based Approaches
Innovation and Flexibility
Sponsor Roles
Data Quality
Computerized Systems
Informed Consent
Safety Reporting
What We Covered
Test Your Knowledge

Author

Nick Cohen

GxP Quality Assurance Expert

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