EU Issues More Q&As To Support Compliance With Clinical Trials Regulation
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.
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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.
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.
CTIS: EU Industry Welcomes ‘Landmark Moment’ But Says Issues Still Need Addressing
EFPIA acknowledges that while the mandatory use of the EU Clinical Trials Information System from today is a significant milestone, it says the usability and functionality of the system need to be enhanced and there are also issues with the Clinical Trials Regulation that need to be fixed.