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EMA Consults On Protecting Personal & Commercial Data In New Clinical Trial System

 
• By Vibha Sharma

The EMA explains how sponsors can comply with transparency requirements under the EU Clinical Trial Regulation while protecting personal data and commercially confidential information.

Closed up finger on keyboard with word CLINICAL TRIALS
The default setting in CTIS is to make data/documents public at the first opportunity • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on a draft guideline that explains how sponsors can protect personal data and commercially confidential information that they submit to the new EU Clinical Trials Information System (CTIS).

The guideline is in response to new transparency obligations introduced by the Clinical Trial Regulation (CTR), which came into force...

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