Clinical operations course
Foundational ICH-Good Clinical Practice (GCP) E6 (R3) - eLearning
Did you know that your clinical investigations need to comply with the ICH GCP E6 (R3) guideline? Enhance your expertise with our course on the updated ICH GCP E6 (R3) guideline.
Dates and booking
Choose your date.
Before you book:
This eLearning comes in two versions:
- Standard: you work through every module.
- Adaptive Design: each module starts with a short quiz. Pass it and you can skip that module, so you save time on what you already know.
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?
Any professional within clinical research; investigator; monitor; study coordinator or other staff that need to gain foundational knowledge about and comply with the current GCP standard.
No prior training or working experience in a GCP environment is required.
What you’ll learn
About this course.
Course Description
This course covers all the ICH-GCP in its current version (R3) and will cover the responsibilities of every stakeholder involved, as well as its implementation in practice.
Without training on the ICH-GCP requirements, or without experience in clinical research, professionals are not always aware of the legal regulations that govern clinical studies, including post-marketing trials. ICH-GCP is the guideline ruling all clinical research including its conduct, performance, monitoring and reporting of the results. This course focuses on the requirements of GCP in clinical studies with pharmaceuticals.
During the course, participants will gain a thorough understanding of the entire ICH GCP E6 (R3) guideline, focusing on both foundational principles and recent updates. You will learn how to effectively implement risk-based strategies in clinical trials, enhancing efficiency and compliance while maintaining participant safety. The course also delves into quality management principles, emphasizing the importance of data integrity and governance in today’s digital landscape.
This training is ideal for all clinical research professionals who are committed to maintaining compliance and excellence in their work. By the end of the course, you will be well-prepared to navigate regulatory requirements confidently and implement effective strategies that improve trial outcomes.
Join us to deepen your understanding of ICH GCP E6 (R3) and elevate your contributions to clinical research.
Learning objectives
By the end of this course, participants will be able to:
- Understand and explain the key changes in ICH GCP E6 (R3)
- Apply risk-based quality management principles to clinical trial processes
- Implement strategies to ensure data integrity and governance
- Navigate the new structure of the R3 guideline, including annexes and appendices
- Adapt clinical trial practices to align with updated sponsor and investigator responsibilities
- Incorporate flexibility and adaptability in trial design while maintaining compliance
- Evaluate and update existing processes to meet R3 requirements
- Demonstrate proficiency in applying GCP principles in various clinical trial scenarios
Programme highlights
- Comprehensive overview of ICH GCP E6 (R3) guideline
- In-depth exploration of new sections and structural changes
- 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
- Practical application of updated GCP principles
- Case studies and interactive sessions on implementing R3 guidelines
Your trainer
Your trainer.
Format
How the course runs.
eLearning
Online, at your own pace.
Competencies
What this course builds.
How many competencies of the ECCRT Competency Framework this course covers, by area.
- Data Management and Informatics5
- Ethical & Participants Safety Considerations3
- Investigational Product Development and Regulation3
- Study and Site Management2
- Leadership and Professionalism1
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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