New Guidance To Clarify Transparency Provisions In EU Clinical Trials Portal
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.
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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.
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.