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27 news items
Template clinical trial agreement available for investigator-initiated research
For investigator-initiated research, a special template is now available for the clinical trial agreement.
Update Investigational Medical Device Dossier (IMDD) available
An update of the Investigational Medical Device Dossier (IMDD) is available.
Publish your clinical trial results in ToetsingOnline and in EudraCT database
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
The CCMO as competent authority currently has a delay in reviewing substantial amendments.
Changes regarding submission of clinical trial agreement
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
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
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
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
To help investigators write a short and clear subject information letter, the CCMO published two examples of subject information ...
CCMO launches a new website
On 5 November 2018 the CCMO launched a new version of its corporate website ccmo.nl.