Launch Of EU Clinical Trial Portal Moves A Step Closer
Key Audit To Check Full Functionality Of CT System Gets Underway
An independent audit of the new EU Clinical Trials Information System has finally commenced, indicating that plans are on track for the EU Clinical Trial Regulation to be implemented from December 2021.
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A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
The European Medicines Agency’s management board has agreed a revised go-live date for the new clinical trial information system. The new date is 'aspirational' and might change again depending on how the system fares in an ongoing independent audit to ascertain its full functionality.
From the end of this year, clinical trial sponsors of all shapes and sizes will be able to use the EU’s new centralized trial submissions portal and database. In view of the complexity of the system, practical training sessions as well as online informational materials will be on offer.