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 ...
Brexit and clinical research
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 ...
Template subject information from 1 April 2019 criterion for review of information letter
31-01-2019 | 09:44
The Template subject information, which helps researchers to write a concise and clear information letter for research subjects, ...
Template for annual safety report of investigator-initiated research with a medicinal product
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 ...
Examples of subject information letters available
14-01-2019 | 16:22
To help investigators write a short and clear subject information letter, the CCMO published two examples of subject information ...
CCMO launches a new website
05-11-2018 | 00:00
On 5 November 2018 the CCMO launched a new version of its corporate website ccmo.nl.
Possible consequences of Brexit for clinical research
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, ...
EU clinical trial portal expected to go live in 2020
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 ...
Change in procedure competent authority
28-09-2018 | 15:07
As competent authority, the CCMO has the task to check the European adverse reactions database, EudraVigilance, for suspected ...
Informed Consent Form template updated in line with GDPR
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 ...
Answers to frequently asked questions about the European Clinical Trial Regulation
24-04-2018 | 10:11
Set of European guidance documents for clinical trials
05-03-2018 | 15:37
Guidance documents for clinical trials are available on the website of the European Commission.
Combining progress report with safety report in research with a medicinal product
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 ...