New EU legislation
General Data Protection Regulation (GDPR)
As of 25 May 2018 the General Data Protection Regulation (GDPR) is effective. Here you can read about the consequences of this regulation for collecting and processing personal data in medical research.
EU Clinical Trial Regulation (CTR)
The EU Clinical Trial Regulation (CTR) 536/2014 will apply in 2020.
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 ...