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EU Regulators Explain How To Ensure Transitioned Trials Align With CTR

 
• By Vibha Sharma

Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.

Update Software Computer Program Upgrade Business technology Internet Concept.
Newly-transitioned trials in CTIS need to be updated at first available opportunity • Source: Shutterstock

EU regulators have issued guidance explaining what the next steps are for sponsors who moved their ongoing studies that were approved under the erstwhile Clinical Trials Directive (CTD) to the Clinical Trials Information System (CTIS) on the basis of a “minimum dossier.”

The minimum dossier mechanism was introduced in July 2023 to make it easier for sponsors to switch their trial registrations...

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