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Running of clinical trials in the EU under the 2014 Clinical Trial Regulation: things are moving a step forward

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France

The long-awaited independent audit on the European clinical trial information system, also called CTIS, has just been started.

This is a key time, because it is one of the major steps in the implementation of the Clinical Trial Regulation (CTR) of 16 April 2014, which was meant to have occurred much sooner and is still not in force. Without this audit, formally defined in the CTR, the CTR and the system of centralised procedure to apply for a clinical trial authorisation, cannot enter into force.

Pursuant to the CTR, the latter should have been fully applicable by 28 May 2016. Thanks to this current audit, CTIS could be effective in December 2021.

The purpose of the audit is to verify that the CTIS works well, with full functionality, like the public portal and the data submission. The functional specifications to be checked are defined in a paper issued by the EMA on 25 mars 2015.

The audit results are expected for Q2 2021.

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