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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.
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.
Here you will find our news items following the coronavirus outbreak.
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.
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 ...
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 ...
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 ...
08-04-2022 | 16:48
Based on the Central Review of Medical Research Involving Human Subjects Decree ( Besluit Centrale Beoordeling), the assesment ...
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 ...
