Straightforward But Technical: Transferring Existing Studies To EU Clinical Trial Portal

 
• By Vibha Sharma

At a webinar organized by the European Medicines Agency, EU member states discussed their experiences with reviewing the requests made by trial sponsors to switch existing studies to the Clinical Trial Regulation.

Macro photo of tooth wheel mechanism with arrows and PRIVATE, PUBLIC letters
Studies authorized under Clinical Trial Regulation benefit from increased transparency • Source: Shutterstock/EtiAmmos

Although there is plenty of time until the 31 January 2025 deadline for ensuring that ongoing trials in the EU that were approved under the Clinical Trials Directive (CTD) comply with the Clinical Trial Regulation (CTR), sponsors are being urged to plan early for this making this switch.

The procedure for transitioning a trial from the CTD to the CTR is quite straightforward but “rather technical by nature,”...

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