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Clinical Trials Regulation (EU CTR 536/2014)

CTR TRAINING COURSE INFORMATION

CTR Online Course
£49
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This online European Clinical Trials Regulation (EU CTR 536/2014) training course provides a practical introduction to the requirements governing clinical trials in the European Union. This self-paced course explores clinical trial authorisation and CTIS, safety reporting, transparency, ethics and participant protection, regulatory oversight, TMF management, risk-based quality management and end-of-trial responsibilities. You’ll gain the knowledge and confidence to understand how the CTR applies throughout the clinical trial lifecycle and support compliant, well-managed clinical research.

Current Status

Not Enrolled

Price

£49.00

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KEY FEATURES OF OUR ONLINE CTR 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 helps sponsors, investigators, and service providers understand the CTR framework and how to apply it throughout the clinical trial lifecycle. Focusing on real-world scenarios rather than theory, it covers trial authorisation, safety reporting, transparency obligations, ethics and participant protection, TMF management, risk-based monitoring, and end-of-trial responsibilities.

Through interactive examples, you will see how to maintain regulatory compliance, ensure participant safety, and manage trials efficiently under the CTR.

By the end of the course, you will have the confidence and knowledge to run EU clinical trials responsibly, ensuring quality, safety, and full compliance with current regulations. 

 

Course Content

Clinical Trials Regulation (EU CTR 536/2014) Module 1
Clinical Trials Regulation (EU CTR 536/2014) Module 2

Course Support

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WHAT WILL I LEARN FROM THIS CTR TRAINING COURSE?

Explain the purpose, scope and key requirements of the European Clinical Trials Regulation (EU CTR 536/2014).

Describe the requirements for clinical trial authorisation, CTIS, substantial modifications, safety reporting and transparency.

Apply CTR requirements relating to ethics, informed consent, participant protection, data protection and the roles and responsibilities of key stakeholders.

Apply CTR requirements for trial oversight, risk-based quality management, TMF management, service provider oversight and end-of-trial activities.

FAQs

Why should I choose this online European Clinical Trials Regulation training course?

Our online European Clinical Trials Regulation training course provides a practical introduction to the rules and requirements that apply to clinical trials conducted in the EU. Designed for sponsors, investigators and service providers, the course covers key areas including CTIS, trial authorisation, safety reporting, transparency, participant protection, regulatory oversight, TMF requirements and risk-based quality management. Using practical examples, you’ll develop a clear understanding of how the CTR applies throughout the trial lifecycle and the knowledge to support compliant and responsible clinical trial conduct.

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.