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 ...
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 ...
CCMO launches a new website
05-11-2018 | 00:00
On 5 November 2018 the CCMO launched a new version of its corporate website ccmo.nl.
Possible consequences of Brexit for clinical research
08-10-2018 | 17:29
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
08-10-2018 | 13:03
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
28-09-2018 | 15:07
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
09-05-2018 | 11:23
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
24-04-2018 | 10:11
Set of European guidance documents for clinical trials
05-03-2018 | 15:37
Guidance documents for clinical trials are available on the website of the European Commission.
Combining progress report with safety report in research with a medicinal product
20-10-2017 | 13:45
In research with a medicinal product, the annual progress report may be combined with the annual safety report. The CCMO takes ...
New European documents with recommendations available for clinical trials
14-08-2017 | 12:36
The European Commission has published three new documents with recommendations for clinical trials. The documents are the result ...
CCMO and Paul Janssen Futurelab are developing a new online course on clinical research
14-07-2017 | 13:57
On 26 June 2017 the CCMO and Paul Janssen Futurelab (a new Leiden University Medical Center initiative) signed an agreement aimed ...
Completion EU clinical trial portal postponed to 2019
16-06-2017 | 15:43
The European web portal and the European database for clinical trials will be completed in 2019 instead of October 2018, as ...
EU regulation established on inspection procedures for clinical research with a medicinal product
21-04-2017 | 14:32