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.
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 ...
CCMO closed during Ascension weekend
21-05-2019 | 13:24
During the Ascension weekend, the CCMO is closed on Thursday 30 May and Friday 31 May 2019.
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 ...