This part of the application form relates to aspects of medical ethical assessment by the CCMO (Central Committee on Research involving Human Subjects).
The CCMO will assess the research proposal according to the criteria of the Medical Research Involving Human Subjects Act (WMO (Medical Research Involving Human Subjects Act)) and according to the criteria of Regulation (EU) No 536/2014 (CTR). The application procedure is through an EU portal and database (CTIS).
All necessary information for researchers on submission and assessment under the CTR can be found on the CCMO website - Clinical trials with medical products (CTR).