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 ...
20-09-2019 | 16:35
For investigator-initiated research, a special template is now available for the clinical trial agreement.
20-09-2019 | 10:25
An update of the Investigational Medical Device Dossier (IMDD) is available.
29-07-2019 | 15:32
Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...
22-07-2019 | 09:55
The CCMO as competent authority currently has a delay in reviewing substantial amendments.
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 ...
01-03-2019 | 13:42
It is currently uncertain when the United Kingdom (UK) is going to leave the European Union (EU), whether an agreement is going ...
31-01-2019 | 09:44
The Template subject information, which helps researchers to write a concise and clear information letter for research subjects, ...
31-01-2019 | 09:26
In response to an initiative of UMC Utrecht, the CCMO has made a template available for the annual safety report for ...
14-01-2019 | 16:22
To help investigators write a short and clear subject information letter, the CCMO published two examples of subject information ...
05-11-2018 | 00:00
On 5 November 2018 the CCMO launched a new version of its corporate website ccmo.nl.
08-10-2018 | 17:29
The United Kingdom (UK) is leaving the European Union (EU) on 30 March 2019. There will be a 'no-deal Brexit' if, at that moment, ...
08-10-2018 | 13:03
The EU portal and database for clinical trials are expected to go live in 2020. This was announced by the European Medicines ...
28-09-2018 | 15:07
As competent authority, the CCMO has the task to check the European adverse reactions database, EudraVigilance, for suspected ...
09-05-2018 | 11:23
The template for the Informed Consent Form has been updated. The immediate cause for this is the amendment of the General Data ...
24-04-2018 | 10:11
05-03-2018 | 15:37
Guidance documents for clinical trials are available on the website of the European Commission.
20-10-2017 | 13:45
In research with a medicinal product, the annual progress report may be combined with the annual safety report. The CCMO takes ...
