Clinical Research in the Netherlands – Legislation & Procedures
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In this online course, you are introduced to legislation and procedures on clinical research in the Netherlands. The course will contain several themes covering various topics. The first 3 themes ‘The Dutch Review System’ and 'The Mandatory Review of Medical Research' and 'Organizing and submitting a research file' are now open for you and it is free! More themes will become available later this year.
This course is for …..
This online course is for clinical researchers, research nurses, clinical research associates (CRAs), employees of companies involved in clinical research, (candidate) members of reviewing committees (accredited MREC and CCMO), and others interested to learn more on the review of clinical research in the Netherlands.
Are you planning to conduct clinical research in the Netherlands? If so, we recommend that you take some time to understand the Dutch review system and learn the practical steps involved. It will help you prepare and submit your research file efficiently.
The online course contains (amongst others) the easy-to-use ‘Committee Finder' tool that will not only help you to find the right committee (accredited MREC or CCMO) for the medical-ethics review of your research file, but it also shows the legal review timelines for these committees and explains which other organizations are involved in the various additional approval processes (if applicable). You can also use the Committee Finder tool outside this course. Go to our website and then to the Tool section where your will find the tool.
The themes for this online course are developed in collaboration with the CCMO and is in part based on the Dutch e-learning site Onderzoekswijs.nl. Paul Janssen Futurelab Leiden is solely responsible for the course content. As of December 31, 2019 the CCMO has closed the e-learning site Onderzoekswijs.nl.
As you have noticed this learning environment is pretty straightforward. Although we take great care to ensure the learning environment works on all browsers, Explorer may give suboptimal results (especially in video quality). Chrome, Safari or Firefox are recommended.
You can go back and forth in the course using the
buttons in the blue header of this learning environment. The next button is only active if all assignments of the topic are completed. The button in the header allows you to view the available course content at any time including reference to the topics you have already covered. At the bottom of each screen, you will find a button which enables you to ask for help -either with technical issues or course content related. You will be joined by other online course participants allowing you at specified times to interact and learn from each other. Use the button in the footer if you want to exit the learning environment.
During the course, you will at times be prompted to answer some self-assessment questions, perform and upload assignments and/or engage in online discussion by reflecting on your fellow learners assignment results. The scores of the self-assessments are not recorded. The self-assessments are included in this course for you conveniences to test if you comprehend the presented course content.
All videos in this course can be viewed with English subtitles. Press the CC button in the videoplayer to acces them. Some videos provide to option to naigate between chapters. Press this button to open the menu with all chapters. You will see each chapter marked as a dot on the videotimeline too.
Feel free to contact us by using the button in case you run into either technical problems or have course content related questions or issues.