EMA Consults On Protecting Personal & Commercial Data In New Clinical Trial System
The EMA explains how sponsors can comply with transparency requirements under the EU Clinical Trial Regulation while protecting personal data and commercially confidential information.
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Research-based drug companies believe the EU guideline on protecting confidential business and personal information in the clinical trials portal CTIS addresses some key concepts, but they point to the need for greater clarity and simplification going forward.
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.
EU regulators have developed new guidance to help companies steer through the transparency requirements in the Clinical Trials Information System and protect personal and commercially confidential information in submissions.