As part of its Patient Participation programme, CCMO has developed a set of questions on patient participation that will be included in the research file from 1 March 2023. For the time being, patient participation is not mandatory, but if patients are not involved in the study, the submitter must justify this choice. Absence of patient participation cannot lead to the rejection of a research file.
For research with medicinal products covered by CTR, you may use CCMO's English-language research protocol. In section 5.4, you are asked to indicate, as part of the study plan and design, whether patients are involved in the study. If patient participation has not been carried out, you are asked to substantiate this.
For other research subject to WMO, the questions are included in the ABR form, to be submitted as part of a research file in ToetsingOnline. For the time being, this also applies to research covered by the Medical Device Regulation (MDR) or the In Vitro Diagnostics Regulation (IVDR).
The questions become only visible in the ABR form when you indicate that your research concerns Dutch research, i.e. 'monocentre research' or 'multicentre research only in the Netherlands'.
On this page (Dutch only*) of the CCMO you will find information and a guide about patient participation for researchers. This information will help fill in the questions in the ABR form and provides examples that you can think about when completing and preparing your research file for review by the MRECs.
*The English part of the website is still under construction.