General introduction to the online course
Before a new clinical research study can begin in the Netherlands, the research file must be reviewed and approved by an official reviewing committee. In most (but not all) cases, the reviewing committee is one of the 20 or so accredited Medical Research Ethics Committees (MRECs; in Dutch: METC) in the Netherlands. In rare cases, the reviewing committee is not an accredited MREC but the Central Committee Involving Human Subjects (in Dutch: CCMO). In addition, for some clinical research with gene therapy and cell therapy medicinal products, also the Ministry of Infrastructure & Watermanagement is involved.
In the European Union (EU), all proposals for clinical research using medicinal products must be submitted both to a reviewing committee and to the member state’s Competent Authority. In the Netherlands, most (but not all) clinical studies using medicinal products are submitted to an accredited MREC, and the CCMO serves as the Dutch Competent Authority; however, the situation changes when the reviewing committee is the CCMO and not an accredited MREC.
We can imagine that all of this must seem quite complicated. But don’t worry; during the online course, we will explain the submission and review process and the responsibilities of the various parties involved using clear language.