The new theme Mandatory Review procedure of Medical Research explains when the WMO act applies to clinical research and which reviewing systems are in place when the WMO does not apply. This is the second theme of the course Clinical research in the Netherlands - Legislation and Procedures. The first theme Explaining the Dutch Review System addresses legislation and review procedures in the Netherlands (including reviewing committee, tasks of the CCMO and MREC accreditation) has been freely available since July 2017. More themes will become available later this year.

The themes are developed by Paul Janssen Futurelab Leiden in collaboration with CCMO (Dutch Central Committee on Research Involving Human Subjects) and is intended for national and international clinical researchers, Clinical Research Associates (CRAs), company employees, and (candidate) members of the Dutch Medical Research Ethics Committees (Dutch abbreviation METC’s) who are interested in the current legal and regulatory framework for clinical research in the Netherlands. With our courses, we try to inspire and engage participants by using a repertoire of educational tools such as animations, readings, articles, infographics, tools, videos and quizzes.

As part of the course, a free Committee Finder has been created and new features have been implemented for the second theme. The tool allows you to quickly find the reviewing committee and competent authority where to submit your research file and which other organisations are involved in the approval process. The tool may be used for free independently of the course. The entire course is freely available on the Paul Janssen Futurelab Leiden website.

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