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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 ...

News item | 16-03-2020 | 11:45

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 ...

News item | 13-03-2020 | 11:57

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 ...

News item | 20-12-2019 | 11:29

Template clinical trial agreement available for investigator-initiated research

For investigator-initiated research, a special template is now available for the clinical trial agreement.

News item | 20-09-2019 | 16:35

Update Investigational Medical Device Dossier (IMDD) available

An update of the Investigational Medical Device Dossier (IMDD) is available.

News item | 20-09-2019 | 10:25

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 ...

News item | 29-07-2019 | 15:32

Review of substantial amendments by competent authority delayed

The CCMO as competent authority currently has a delay in reviewing substantial amendments.

News item | 22-07-2019 | 09:55

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 ...

News item | 21-05-2019 | 13:29

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, ...

News item | 31-01-2019 | 09:44

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 ...

News item | 31-01-2019 | 09:26