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72 news items
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 ...
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.
EU clinical trial portal expected to go live in 2020
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
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
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