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EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency

 
• By Vibha Sharma

A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.

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Sponsors Can Use A Mix Of Redaction And Deferral Processes To Protect Commercial Data • Source: Shutterstock

EU regulators have issued a keenly awaited guideline explaining how study sponsors can protect commercially confidential and personal data in dossiers submitted to the Clinical Trials Information System (CTIS) under the provisions of the Clinical Trials Regulation. Compliance with the legislation became mandatory for all new trials on 31 January.

The guideline, developed under the Accelerating Clinical Trials in the EU (ACT EU) initiative, addresses a number of questions on transparency aspects that were raised by sponsors during a survey...

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