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
- Safety reports, medical care, and safety of your subjects (AE, SAE, DSMB)
- Trial amendments, deviations and changes in protocol
- Documentation and data management
- Monitoring, Auditing, and inspections
- Quality Assurance and Risk Management
- Progress Reports
DESCRIPTION
The Introductory WMO GCP course is the ideal introduction to Good Clinical Practice (GCP) and conducting clinical trials in the Netherlands. It gives you the tools you need to deal with amendments, deviations, and changes in protocol and research, adding new research locations and researchers, ensure a high level of quality and risk management, and have all safety measurements and reports in place.
This course is specifically tailored to the Dutch regulatory (WMO) framework and helps anyone involved in the conduct phase of clinical trials in the Netherlands. It is an ideal introductory course for students, research coordinators, site staff, CRAs, data managers, and research nurses.
- 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 Conduct 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: Conduct
- Amendments, deviations, and changes in protocol and trial
- Adding new research sites and investigators
- Safety reports (AE / SAE / SUSAR)
- Safety subjects medical care and DSMB
- Documentation and data management (source, CRF, database)
- Monitoring/ Auditing/ Inspection
- Quality assurance and risk management (R2 Addendum)
- Progress reports
matyas@igina.net –
The course has been very helpful in making me understand the key concepts of the WMO GCP and the focus points.