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