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Implementing Good Clinical Practice E6(R3) Annex 2

IMPLEMENTING ICH GCP E6(R3) ANNEX 2 TRAINING COURSE INFORMATION

£49
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Our online Implementing Good Clinical Practice E6(R3) Annex 2 training course has been developed for clinical research professionals who already have a foundation in GCP and need to understand how Annex 2 applies to modern clinical trial designs. This interactive, self-paced course explores decentralised and pragmatic trials, digital health technologies, real-world data, remote activities, service providers and risk-based oversight. You’ll gain practical knowledge of how to apply Annex 2 requirements while protecting participants, maintaining data integrity and supporting compliant, high-quality clinical trial conduct.

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£49.00

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KEY FEATURES OF OUR ONLINE IMPLEMENTING ICH GCP E6(R3) ANNEX 2 TRAINING COURSE:

  • 100% online and accessible anytime, anywhere
  • Developed by experts with 35+ years of experience in clinical research
  • Enhanced with interactive content and robust knowledge checks
  • Certification on completion

This online course provides a practical and accessible overview of the final ICH E6(R3) Annex 2 Guideline, adopted on 03 June 2026. You will learn what additional considerations have been introduced for modern clinical trial designs, why these expansions matter, and how they impact participant safety, data integrity, informed consent and investigational product management across a wider range of trial settings.

Through clear explanations and real-world application, the course highlights key responsibilities for investigators, sponsors, and ethics committees when implementing decentralised elements, pragmatic approaches, digital health technologies (DHTs), real-world data (RWD), and external service providers. By the end of the course, you will understand how to apply Annex 2 requirements to your processes and oversight responsibilities to ensure compliance while supporting reliable trial results.

This course is designed to provide an understanding of the considerations introduced in the ICH E6(R3) Annex 2 Guideline; it does not constitute a formal qualification. A valid, accredited GCP certificate is still required for anyone conducting clinical trial activities.

Course Content

Implementing Good Clinical Practice E6(R3) Annex 2

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WHAT WILL I LEARN FROM THIS IMPLEMENTING ICH GCP E6(R3) ANNEX 2 TRAINING COURSE?

Explain the purpose and scope of ICH GCP E6(R3) Annex 2 and its application to modern clinical trial designs.

Describe the responsibilities of investigators, sponsors and IRBs/IECs when conducting decentralised and pragmatic clinical trials.

Apply Annex 2 principles to the use of digital health technologies, real-world data, remote activities and external service providers.

Apply risk-based approaches to participant safety, data integrity, investigational product management and oversight in modern clinical trials.

FAQs

Why should I choose this online Implementing ICH GCP E6(R3) Annex 2 training course?

Our online ICH GCP E6(R3) Annex 2 training course provides practical, focused training on the additional considerations for modern clinical trial designs. Developed for clinical research professionals who already have GCP knowledge, the course explores decentralised and pragmatic trials, digital health technologies, real-world data, remote activities, service providers and risk-based oversight. Through interactive learning, practical examples and scenario-based activities, you’ll build the knowledge and confidence to apply Annex 2 requirements to real-world trial situations while maintaining participant safety, data integrity and regulatory compliance.

Can I buy this course for my team?

Yes. We offer team licences for organisations of all sizes, making it easy to enrol multiple learners, track their progress and manage training in one place. Please contact us to discuss your requirements and receive a tailored quotation.

Do I need any previous clinical research experience?

No. This course is suitable for learners with little or no previous clinical research experience, as well as professionals looking to refresh or expand their knowledge. The content is presented in a clear, practical way, making it accessible to a wide range of learners.

What makes this course different?

Our training isn’t just a tick-box exercise. Every course is written by experienced clinical research professionals, not AI, and is designed to be engaging, interactive and relevant to real-world practice. Through realistic scenarios, knowledge checks and practical examples, you’ll build confidence in applying what you’ve learned, not just remembering it.

If this course isn’t right for you, take a look at our other online clinical courses.