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 on 31 January. The provisions of the regulation are being implemented via CTIS, whose default setting is to make public almost all data and documents submitted as part of a clinical trial application at the first opportunity, unless a deferral is agreed