?? The Long-Awaited CTIS Update: A New Era for Transparency
Mat Parowicz
Freelance Senior Consultant Clinical Regulatory Affairs & Study Start-Up, Founder, CTR/CTIS Master Trainer, Speaker and your Rock in the surf
As a Freelance Clinical Regulatory Affairs Expert and Study Start-Up Specialist, I've witnessed the complexities of navigating regulatory requirements in several submissions in CTIS with the huge burden of choosing the right deferral times and/or redacting documents in the right way. Recently, the European Medicines Agency (EMA) announced a significant update that will reshape the landscape of clinical trial submissions in Europe.
On 18 June, the long-awaited CTIS update will go live, marking the implementation of the revised CTIS transparency rules. This update, detailed in the Revised CTIS Transparency Rules published on 05 October 2023, prioritizes key documents of interest and eliminates deferral functionality. Which results that documents like IB and IMPD will no longer be made publicly available. This strategic shift aims to strike a balance between transparency requirements and operational efficiency.
?? How do you like the upcoming changes? Any thoughts?
Personally, I believe these changes will not only streamline processes but provide a good balance between EU's transparency efforts on the one hand and the burden of redacting documents on the other hand.
To learn more about the implications of these changes and their impact on clinical trial operations, visit my blog at www.regulatory.rocks.
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