CCMO and Paul Janssen Futurelab have jointly developed a free e-learning about the review procedure and the legislation for clinical research in the Netherlands.
The e-learning Clinical Research in the Netherlands - Legislation & Procedures is intended for translational and clinical researchers, research nurses, clinical research associates (CRAs), employees of companies involved in setting up and/or conducting clinical research with human subjects and (candidate) members of accredited MRECs and CCMO.
A 'Committee Finder' tool is also available to determine to which review committee the research file must be submitted, what the legal review timelines are and – depending on the product – which other organisations are also involved in the review process.
Please note! The content of the e-learning has not yet been updated following the entry into force of the EU regulations for research with a medicinal product (CTR), clinical investigations with medical devices (MDR) and performance studies using in vitro diagnostics (IVDR). This means that the information in this e-learning is not completely up-to-date anymore. A revised version of the e-learning will follow at a later date.