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EU Clinical Trial Regulation (CTR)
The EU Clinical Trial Regulation (CTR) makes the review of clinical trials a joint responsibility of all EU Member States.
Consequences of the medical device regulation on clinical investigations
20-12-2019 | 11:29
As of May 26th 2020, the European Medical Device Regulation (EU) 2017/745 (MDR) comes into effect. The MDR brings new rules for ...
Template clinical trial agreement available for investigator-initiated research
20-09-2019 | 16:35
For investigator-initiated research, a special template is now available for the clinical trial agreement.
Update Investigational Medical Device Dossier (IMDD) available
20-09-2019 | 10:25
An update of the Investigational Medical Device Dossier (IMDD) is available.
Publish your clinical trial results in ToetsingOnline and in EudraCT database
29-07-2019 | 15:32
Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...
Review of substantial amendments by competent authority delayed
22-07-2019 | 09:55
The CCMO as competent authority currently has a delay in reviewing substantial amendments.
Changes regarding submission of clinical trial agreement
21-05-2019 | 13:29
From today, the signed version of the clinical trial agreement (CTA) may be submitted to the review committee (accredited MREC or ...