News - Latest
23 news items
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.
Possible consequences of Brexit for clinical research
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
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 ...