ICH E6(R3)
Good Clinical Practice
ICH E6(R3), finalised in January 2025, is the international standard for the design, conduct and reporting of clinical trials. This online, self-paced course covers the updated principles and how to apply them, including for practitioners contributing to real-world evidence and product evaluation.
Course Overview
self-paced
6 modules
no practical
on passing
SoMUK £60
The course takes four to six hours and covers the regulatory context, sponsor and investigator responsibilities, risk-based quality management, essential documents and data integrity, informed consent and decentralised trials, and applying GCP in practice.
Who Can Attend
If you are unsure whether this course meets a requirement from a sponsor or employer, please ask us before booking.
Including clinical researchers, pharmacists and nurses involved in clinical research
Who contribute to clinical research, real-world evidence or product evaluation
The course is open to anyone who needs a working knowledge of GCP
Course Fees
A single fee for online, self-paced study. There is no one-to-one option. All prices exclude VAT.
What You Will Learn
By the end of the course you will be able to:
- Explain the regulatory context and the principles of ICH E6(R3).
- Describe sponsor and investigator responsibilities.
- Apply risk-based quality management and identify critical-to-quality factors.
- Manage essential documents and maintain data integrity using ALCOA+.
- Obtain informed consent, including in decentralised trials.
- Apply GCP in everyday research practice.
How the Course Works
The course is six modules, completed online in your own time, with no attendance required.
Regulatory context and the E6(R3) principles
Sponsor and investigator responsibilities
Risk-based quality management and critical-to-quality factors
Essential documents and data integrity (ALCOA+)
Informed consent and decentralised trials
Applying GCP in practice
Your three steps
What Is Included
Book Your Course
Book online and you will receive your login and course materials. Complete the modules and assessment whenever suits you.
Further Information and FAQs
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