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Introductory WMO GCP Course to Prepare Clinical Trials in the Netherlands

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


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  • ICH GCP and ICH GCP R2 Addendum
  • EU Directives (2001 and 2005)
  • Dutch legislation: Medical Research Involving Human Subjects Act (WMO), WGBO, and Wet BIG
  • Roles in clinical research
  • Abbreviations and terminology
  • Preparation of product information (IB/IMPD)
  • Creation of patient information (PIF/IC form)
  • Compensation and insurance
  • Agreements



The Introductory WMO GCP course is the ideal introduction to Good Clinical Practice (GCP) and preparing clinical trials in the Netherlands. It gives you the tools you need to prepare product information, arrange the required insurances, setup Patient Information documentation, and have all necessary contracts and agreements in place.

This course is specifically tailored to the Dutch regulatory (WMO) framework and helps anyone involved in the preparation phase of clinical trials in the Netherlands. It is an ideal introductory course for students, research coordinators, CRAs, CRO staff, and pharmacists.

  • 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 Preparation 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, the EU Directives, and the WMO. 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 WMO GCP training package.

After you have completed all components of the Introductory GCP elearning 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.



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)
  • Legal framework for clinical research in the Netherlands (WMO, WGBO, Wet BIG, AVG) and scope
  • The roles in clinical research: sponsor, METC, competent authority CCMO or Ministry of Health (VWS), monitor, auditor, researcher, 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

Module: Preparation

You’ll learn the following in this module:

  • Package, label, import and deliver a research product
  • Drafting product information (Investigators Brochure, IMPD)
  • Drafting patient information and informed consent with Model Subject Information 2019
  • Contracts and agreements
  • Privacy legislation (AVG)
  • Insurance (subject insurance and liability)

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 WMO GCP Course to Prepare Clinical Trials in the Netherlands

  1. matyas@igina.net

    I am happy to have been part of this training. It has helped me build my capacity in the processes.

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