EU Clinical Trial Regulation (CTR)
On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply with new rules for research with medicinal products in the European Union.
EU Medical Device Regulation (MDR)
On May 26, 2021, the EU Medical Device Regulation 2017/745 (MDR) has come into effect with specific rules for the submission, review and conduct of clinical investigations with medical devices.
CCMO develops patient-friendly Subject Information Sheet (SIS)
21-03-2023 | 00:00
CCMO considers an accessible SIS for both participants and researchers to be of great importance. Therefore, CCMO has started the ...
Revision of the Site Suitability Declaration (VGO)
23-02-2023 | 10:22
The Dutch Clinical Research Foundation (DCRF) has revised the Site Suitability Declaration (VGO). The aim of this revision is to ...
Patient participation in the research file from 1 March 2023
05-01-2023 | 16:10
As part of its Patient Participation programme, CCMO has developed a set of questions on patient participation that will be ...
New Dutch Trial Register online
19-12-2022 | 14:32
The website of the new Dutch Trial Register (‘Landelijk Trial Register’; LTR) is available. The ultimate aim of the LTR is to ...
Availability CCMO during holiday season
13-12-2022 | 17:20
Due to the holiday season, CCMO will be closed on December 26, 2022. CCMO’s availability is reduced from Tuesday December 27 ...
Rates 2023: assessment of research under CTR, MDR and IVDR
20-10-2022 | 14:44
The Ministry of Health, Welfare and Sport has set the rates for 2023 for medical ethical review in the Netherlands of research ...