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Change in procedure competent authority

As competent authority, the CCMO has the task to check the European adverse reactions database, EudraVigilance, for suspected ...

News item | 28-09-2018 | 15:07

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 ...

News item | 09-05-2018 | 11:23

Answers to frequently asked questions about the European Clinical Trial Regulation

News item | 24-04-2018 | 10:11

Set of European guidance documents for clinical trials

Guidance documents for clinical trials are available on the website of the European Commission.

News item | 05-03-2018 | 15:37

Combining progress report with safety report in research with a medicinal product

In research with a medicinal product, the annual progress report may be combined with the annual safety report. The CCMO takes ...

News item | 20-10-2017 | 13:45

New European ethical considerations for research with minors

News item | 20-10-2017 | 09:23

New European documents with recommendations available for clinical trials

The European Commission has published three new documents with recommendations for clinical trials. The documents are the result ...

News item | 14-08-2017 | 12:36

CCMO and Paul Janssen Futurelab are developing a new online course on clinical research

On 26 June 2017 the CCMO and Paul Janssen Futurelab (a new Leiden University Medical Center initiative) signed an agreement aimed ...

News item | 14-07-2017 | 13:57

Completion EU clinical trial portal postponed to 2019

The European web portal and the European database for clinical trials will be completed in 2019 instead of October 2018, as ...

News item | 16-06-2017 | 15:43

EU regulation established on inspection procedures for clinical research with a medicinal product

News item | 21-04-2017 | 14:32