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
- Regular study completion and report end of the trial
- Early termination
- Requirements for Clinical Study Report
- Archiving of trial documentation and retention period
DESCRIPTION
The Introductory WMO GCP course is the ideal introduction to Good Clinical Practice (GCP) and archiving (closing out) clinical trials in the Netherlands. It gives you the tools you need to deal with the completion of your trial, report the end of your trial, requirements of the final report/ clinical study report, and archiving and retention periods of your research documents.
This course is specifically tailored to the Dutch regulatory (WMO) framework and helps anyone involved in the archiving (close-out) phase of clinical trials in the Netherlands. It is an ideal introductory course for students, research coordinators, CRAs, 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 Close-out 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: Archiving (Close-out)
- Regular completion of a trial
- Preliminary closing of a trial
- Report end of the trial
- Requirements for Clinical Study Report
- Storage and archiving trial documentation
- Retention deadlines for trial documentation
matyas@igina.net –
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