EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency
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.
You may also be interested in...
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.
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.
The European Commission has come up with a workaround to address a current lack of functionality in the Clinical Trial Information System, while the European Medicines Agency has addressed technical queries on CTIS and the Clinical Trials Regulation.