Clinical operations course
ICH-GCP E6 (R3) Refresher
Do you need to update and to refresh your knowledge on the current ICH-GCP E6 (R3) and its implementation and you want to do it in a very practical and useful way?
Dates and booking
Choose your date.
All fees exclude VAT. Booking for several colleagues? Choose the number of participants, or ask about an in-house session.
Who it’s for
Is this course for you?
Everyone who needs to refresh their knowledge of the current rules of GCP in clinical studies. Prior training or working experience in a GCP environment is required.
What you’ll learn
About this course.
Course Description
This interactive course is designed for professionals who already have knowledge of the International Council on Harmonization and Good Clinical Practice (ICH-GCP) standard but need to be up to date. It is designed as a refresher and will cover the responsibilities of all stakeholders in the clinical research field. This refresher session is a very innovative course which will allow you to verify the extend of your knowledge on ICH-GCP and complete the potential gap.
Interactive quizzes and exercises are included in our course that give you feedback on your comprehension. This will help you to maximise your learning journey. You will be able to test your comprehension with a final grading test. Extra information, updates and your globally recognised certification can be found on our Virtual Campus.
If you'd like to see our complete Foundational GCP course then you can find it here.
Learning objectives
By the end of this course, participants will be able to:
- Describe the new principles of ICH GCP E6 (R3)
- Discuss risk-based quality management principles in clinical trial processes
- Recognize strategies to ensure data integrity and governance
- Identify the new structure of the R3 guideline, including annexes
- Outline updated sponsor and investigator responsibilities
- Describe approaches for incorporating flexibility in trial design while maintaining compliance
- Recognize areas where existing processes may need updates to meet R3 requirements
Programme highlights
- Comprehensive overview of ICH GCP E6 (R3) guideline
- In-depth exploration of the new structure, including principles and annexes
- Analysis of key differences between R2 and R3
- Focus on risk-based approaches and quality management
- Discussion on data integrity and governance in clinical trials
- Examination of updated responsibilities for IRB/IEC, investigators, and sponsors
Your trainer
Your trainer.
Format
How the course runs.
Live online
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Data Management and Informatics3
- Investigational Product Development and Regulation2
- Study and Site Management2
- Ethical & Participants Safety Considerations1
Good to know
Questions about this course.
Can I book for several colleagues?
Yes. Choose the number of participants next to a date. For a group of 4 or more, an in-house session tailored to your SOPs may suit you better.
What if I need to cancel?
Cancelling more than 30 calendar days before the course is free of charge. Between 21 and 30 days before, 50% of the fee is due, and the full fee within 21 days. A €50 administration fee applies per cancellation. You can also send a colleague in your place by letting us know in writing.
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