Course Overview:

This eLearning course offers a comprehensive and practical introduction to the updated ICH Good Clinical Practice (GCP) Guideline E6(R3). Designed for clinical research professionals across sponsors, CROs, and investigative sites, the course outlines the current expectations for conducting ethical, scientifically sound, and high-quality clinical trials.

With modules focusing on core principles, roles and responsibilities, informed consent, safety reporting, data governance, and essential records, learners will gain a solid understanding of how to effectively apply the E6(R3) guidelines in everyday clinical research activities. This course provides foundational knowledge and practical insights to ensure compliance with the latest international standards.

Duration:
Approx. 90-120 minutes (self-paced)

Format:
Self-paced eLearning with engaging modules, interactive elements, real-world examples, and assessments designed to ensure learners can effectively apply the knowledge gained in practical clinical research settings.

Target Audience:
This course is intended for clinical trial staff, sponsor personnel, CRO professionals, monitors, and anyone involved in the planning, conduct, oversight, or analysis of interventional clinical trials. It is also ideal for anyone looking to familiarize themselves with Good Clinical Practice (GCP) and its application in modern clinical research.

Prerequisites:
The course is open to all learners. While prior experience in clinical research is beneficial, it is not required to complete the course.

Assessment & Certification:

The course includes short knowledge checks at the end of each module, followed by a final graded multiple-choice quiz (pass mark: 80%). Upon successful completion, learners can download a Certificate of Completion.

Learning Objectives:

Upon completion of the course, learners will be able to:

• Explain the foundational principles of ICH GCP E6(R3)
• Understand the roles and responsibilities of investigators, sponsors and IRBs
• Apply GCP principles in informed consent and safety reporting
• Ensure data integrity and compliance throughout clinical trials
• Identify and maintain essential records throughout the trial lifecycle