Good Clinical Practices (cGCP)

ICH E6 (R3) – What’s New in R3?

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: v1.2
Effective Date: 01/23/2025

Curriculum for this course

Course Introduction
A Note on Document Structure
Risk-based Approaches
Innovation and Flexibility
Sponsor Roles
Data Quality
Computerised Systems
Informed Consent
Safety Reporting
Test Your Knowledge
v1.2 Minor update on 06/04/2025 to update resources to R3 documents.
v1.1 Minor update on 3/14/2025 to fix typo on Slide 1.9 Data Quality
v1.0 Course released on 02/25/2025

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