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Introductory GCP Course to Design Clinical Trials in Europe

This course was previously called “Light EU-GCP training – Design”. Learn about basic Good Clinical Practice principles and get a thorough introduction to the design of clinical trials in Europe via this highly interactive, self-paced introductory e-learning course. Includes 2 interactive modules.


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Phase of Study

Region of Regulation


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  • Principles of ICH GCP and the ICH GCP Addendum R2
  • EU Directives 2001 & 2005
  • Roles in clinical research
  • Abbreviations and terminology
  • Protocol development and content
  • Risk management
  • Selection of research sites and staff
  • Setting up quality assurance (DSMB and SOPs)
  • Monitoring and auditing
  • Creation of essential documents



The Introductory GCP course is the ideal introduction to Good Clinical Practice (GCP) and designing clinical trials in Europe. It gives you the tools you need to develop protocols, draft essential documents, and select the right researchers and sites.

This course is specifically tailored to the European regulatory framework and helps anyone involved in the design phase of clinical trials in Europe. It is an ideal introductory course for Ph.D. students, CRO and Sponsor Staff, Clinical Trial Assistants, and research staff.

  • Efficient and interactive online learning
  • Easy accessible via smartphone, tablet or desktop
  • Self-paced and modular

The course consists of 2 online training modules: Introduction and Design of a clinical trial. It represents a total workload of 2 hours. The modules are divided into chapters of 10 minutes and consist of the guidelines which apply to clinical trials in the Netherlands, including the Declaration of Helsinki, ICH GCP E6 Addendum R2, and the EU Directives. If you require additional knowledge for the execution of other phases of the trial, you can easily add these modules by upgrading to an Expert online GCP training package.

After you have completed all components of the Introductory GCP e-learning course, you will receive a Certificate.

All training courses include one-year access to the online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.

Enroll now to get started with the online learning modules on your smartphone, tablet, or desktop computer.



[toggles title=”Module:  Introduction”]
You’ll learn the following in this module:

  • Introduction to medical research
  • Types of clinical research (interventional, therapeutic, multi/single center)
  • History of legislation and regulations clinical research (Code of Nuremberg, Declaration of Helsinki)
  • The principles of ICH GCP incl. R2 Addendum
  • Laws and regulation clinical research Europe (EU directives 2001 and 2005, EU Regulation 536/2014)
  • The roles in clinical research (sponsor, IEC, competent authority, monitor, auditor, investigator, research professional)
  • Additional requirements for clinical trials of a medicinal product
  • Phases of a clinical trial of a medicinal product
  • Abbreviations and terminology in medical scientific research


[toggles title=”Module:  Design”]
You’ll learn the following in this module:

  • Protocol development and content
  • Select research team
  • Selection of investigators and research locations
  • Selection criteria for researchers and research locations
  • Create and store essential documents (Investigator Site File)
  • Risk inventory and assessment
  • Setting up quality assurance: monitoring plan, auditing, DSMB, SOPs


Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks.  We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

1 review for Introductory GCP Course to Design Clinical Trials in Europe

  1. matyas@igina.net

    The course was interesting and the materials provided were very helpful.

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