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Launch Of EU Clinical Trial Portal Moves A Step Closer

Key Audit To Check Full Functionality Of CT System Gets Underway

Executive Summary

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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Long-Awaited EU Clinical Trials Portal Meets Major Milestone

A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.

EU Clinical Trial System Launch Delayed To Jan 2022

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.

How To Use The EU’s New Clinical Trial Submission System

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.

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