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EU Clarifies ‘Administrative Process’ Of Switching Trials To CTR

 
• By Vibha Sharma

The European Commission’s updated guidance on transitioning studies from the Clinical Trials Directive to the Clinical Trials Regulation reflects the agreement reached by the member state representatives in the Clinical Trials Advisory Group.

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The European Commission Says Transitioning Applications Should Not Be Reassessed • Source: Shutterstock

The European Commission has issued updated guidance that addresses concerns sponsors have had over the need to switch ongoing clinical trials authorized under the erstwhile EU Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). 

Ongoing trials that are not expected to end by 30 January 2025 must be transitioned to the CTR by submitting a “transitioning application” to the Clinical Trials Information System (CTIS)...

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