About this course

This online course offers ….

In this online course, we provide the easy-to-use 'Committee Finder' tool that will help you select the appropriate reviewing committee to submit your research file, and—in the event that your study involves medicinal products or medical devices—the appropriate Competent Authority. We also clarify when additional organizations are involved in the approval of your clinical research.

In addition, we present a tool that provides an overview of the various tasks performed by the CCMO.

For example, the CCMO is also the Appeals Body; if your research proposal is rejected by an accredited MREC, you can submit an appeal to the CCMO.

This online course contains reading material, articles, animations, infographics, and tools regarding the Dutch review system, as well as self-assessment questions to test your knowledge.

The first 3 themes of the free online course are now open!

The first 3 themes describe the Dutch review system, the scope of the Dutch Medical Research Involving Human Subjects Act (Dutch: Wet Medisch-Wetenschappelijk Onderzoek met Mensen; WMO) and the submission of a research file. All three themes are now open. You are welcome to take this free part of the course whenever you like.

We do however advice you to begin at the start of theme 1 and read the articles and test your knowledge by doing the self-assessment quizzes before moving to theme 2 and then theme 3.

More themes will become available in the near future. These additional themes will explain in more detail the unique issues associated with reviewing a multicenter research study; and how, when, and to whom you need to report any adverse reactions and/or events that may occur during your clinical study.

Disclaimer

Although this online course was developed in collaboration with the CCMO, Paul Janssen Futurelab Leiden is solely responsible for the course content. Paul Janssen Futurelab Leiden strives to provide you with correct information in the online course, but cannot guarantee that all information is always correct, up to date and complete. Paul Janssen Futurelab Leiden reserves the right to change or delete any information in the online course at any time without further notice. Questions and remarks on this online course can be send to contact@PaulJanssenFuturelab.eu.

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