Sponsors Under Fire For Excessive Data Redactions & Deferrals In EU Clinical Trials Portal
An analysis of publicly available information in the EU Clinical Trials Information System shows how commercial and academic sponsors differ in their approach to transparency. There are also concerns around the lack of “push back” from EU member states to address potential non-compliance.
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Updated EU CTIS Guide Offers Workaround To Protect ‘Commercially Confidential’ Dosing Data
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CTIS: EMA Consults On Transparency Rules & Simplifications For Clinical Trials Portal
The European Medicines Agency says that any changes it makes to its transparency rules on the information that is submitted through the Clinical Trials Information System will be implemented before the end of 2023.