CCMO and Paul Janssen Futurelab are developing a new online course on clinical research
On 26 June 2017 the CCMO and Paul Janssen Futurelab (a new Leiden University Medical Center initiative) signed an agreement aimed at developing a new online course on clinical research. This online course, in English, offers training for national and international clinical researchers and companies, and (candidate) members of reviewing committees on the current legal and regulatory framework for clinical research in the Netherlands and does so in an inspiring way.
The first theme of the course, ‘Explaining the Dutch Review System’, was made available online today. In the next months we will gradually turn the other themes on the website Onderzoekswijs.nl into English themes that will appear on the website of Paul Janssen Futurelab. The new themes have been updated, are now more aimed at transfer of know-how and got a completely new look. The online course can be consulted free of charge without a username or a password. As soon as all themes have been uploaded, Onderzoekswijs.nl will cease to exist.
The first theme offers an introduction to the Dutch Review System for clinical research. It is not always easy for clinical researchers and industry personnel to find their way within the system. A research file will usually – but not always –be assessed by a Dutch accredited Medical Research Ethics Committee (MREC). However, accredited MRECs are not authorized to assess certain types of research in which case the research file must be assessed by the CCMO. In addition, a Competent Authority reviews clinical research with a medicinal product and sometimes even more organizations are involved in the approval process.
In order to introduce clinical researchers and industry personnel to the Dutch Review System, the first theme contains the user-friendly ‘Select the right reviewing committee’ tool. This tool enables the clinical researcher or industry employee to quickly see to which reviewing committee and Competent Authority the research file has to be submitted. The tool is also available outside of the online course.
Marcel Kenter, director of Paul Janssen Futurelab, and Cees de Heer, general secretary of the CCMO, are enthusiastic about the collaboration. The new online course with animations, readings, articles, infographics, tools, videos and quizzes will help national and international clinical researchers acquire knowledge in an appealing manner and to carry out clinical research in the Netherlands in accordance with the current legal and regulatory framework and procedures.