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From 13 March 2020, submission of research dossiers for gene therapy and medicinal products containing GMOs takes place directly to the relevant authority
From 13 March 2020, research dossiers in the field of gene therapy and medicinal products containing GMOs must be submitted ...
Accessibility CCMO due to coronavirus outbreak
The measures taken by the Cabinet as a result of the outbreak of the new coronavirus (SARS-CoV-2/COVID-19) also have an impact on ...
Consequences of the medical device regulation on clinical investigations
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
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 ...
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 ...