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.
Template research protocol for CTR studies available on CCMO website
21-07-2022 | 10:44
As of 21 July 2022, the template research protocol for studies falling under the CTR is available on the CCMO website.
New Subject Information Sheet (SIS) template now available on the CCMO website
15-07-2022 | 12:57
A new template (in Dutch) for the Subject Information Sheet (SIS) for subjects aged 16 and over (adults) is now available on ...
Dutch Trial Register (NTR) no longer available
24-06-2022 | 10:13
The Dutch Trial Register (NTR) is no longer available. The National Trial Register, in which the CCMO Register and the former NTR ...
MREC NedMec ready for review of research files
15-04-2022 | 12:24
As of 15 April 2022, MREC NedMec, the result of the merger of MREC AVL and MREC Utrecht on 1 January 2022, offers review of ...
Therapeutic vaccines now only reviewed by MRECs
08-04-2022 | 16:48
Based on the Central Review of Medical Research Involving Human Subjects Decree ( Besluit Centrale Beoordeling), the assesment ...
New online tool makes CTR scope more transparent
23-12-2021 | 17:12
The new Clinical Trial Decision Tool helps you to determine whether your study with a medicinal product falls within the scope of ...