LEARNING OBJECTIVES
- Principles of ICH GCP and the ICH GCP Addendum R2
- EU Directives 2001 & 2005
- Dutch legislation: Medical Research Involving Human Subjects Act (WMO), WGBO, and Wet BIG
- Privacy in clinical trials
- Roles in clinical research
- Recruiting and informing test subjects
- Informed consent and privacy of data
- Requirements for research with vulnerable subjects
- Document and data management in research
- Monitoring and safety of test subjects
- Progress reports
DESCRIPTION
The Fundamental WMO GCP course is the ideal foundation for Good Clinical Practice (GCP), and starting and conducting clinical trials in the Netherlands. It gives you the tools you need to start your trial, recruit and inform your subjects, adhere to the requirements for research with vulnerable subjects, ensure the privacy of data, 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 start and conduct phase of clinical trials in the Netherlands. It is an ideal fundamental course for students, research coordinators, investigators, clinical trial site staff, and research nurses.
- Efficient and interactive online learning
- Easy accessible via smartphone, tablet or desktop
- Self-paced and modular
The course consists of 3 online training modules: Introduction, Start, and Conduct of a clinical trial. It represents a total workload of 4 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 Fundamental WMO/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: Start
- Delegate tasks and Initiation Visit
- Supply, storage, and use of the investigational product in a trial
- Recruitment of subjects
- Informing subjects
- Informed Consent procedure
- Randomization and coding
- Privacy of data (AVG)
- Requirements for research with vulnerable subjects
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 –
Need to explain more so that we can clearly answer questions