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The EU Clinical Trial Regulation (CTR) 536/2014 will apply in 2020.
The EU regulations for medical devices and in vitro diagnostics will apply in 2020 and 2022 respectively.
29-07-2019 | 15:32
Sponsors are required to publish results of research subject to the WMO (Medical Research involving Human Subjects Act) in ...
22-07-2019 | 09:55
The CCMO as competent authority currently has a delay in reviewing substantial amendments.
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 ...
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 ...
31-01-2019 | 09:44
The Template subject information, which helps researchers to write a concise and clear information letter for research subjects, ...
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 ...
