LEARNING OBJECTIVES
- 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
- 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
DESCRIPTION
The Introductory WMO GCP course is the ideal introduction to Good Clinical Practice (GCP) and designing clinical trials in the Netherlands. 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 Dutch regulatory (WMO) framework and helps anyone involved in the design phase of clinical trials in the Netherlands. 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, 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 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.
COURSE CONTENTS
Module: Introduction
- 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: Design
- 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
Module: VGO
- The process
- Visualization of the Local Feasibility procedure
- For which types of research does the VGO apply?
- The 4 steps of the Local Feasibility procedure
- Part A and Part B of the VGO
- Relationship between VGO and other documents
- The timelines of the Local Feasibility procedure
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