Starting June 18, 2024, the revised transparency rules Clinical Trials Information System (CTIS) will become applicable with the launch of a new version of the CTIS public portal.
The updated rules strike a balance between transparency of information and protection of Commercially Confidential Information (CCI). They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data.
Key Change: Say goodbye to the deferral mechanism! Under the updated rules, sponsors are no longer permitted to delay the publication of certain data for up to 7 years post-trial. This significant change ensures that trial information is made available to the public in a timelier manner, enhancing transparency and accountability in clinical research.
What to Expect?
Increased transparency: With the removal of the deferral mechanism, more trials will be publicly available on the new CTIS portal. This means that stakeholders, including patients, researchers, and regulatory authorities, will have access to a broader range of trial data, fostering greater transparency and trust in the clinical research process.
Data disclosure timelines aligned with the updated rules: The revised transparency rules will establish clear timelines for the disclosure of trial information, ensuring consistency and adherence to regulatory requirements. This alignment will streamline the process for sponsors and improve accessibility to critical trial data for all stakeholders.
What You Can Do Now:
Explore the quick guide: Take advantage of the quick guide, which provides a comprehensive breakdown of the timelines for publishing trial information. This resource will help sponsors understand their obligations under the updated rules and plan accordingly.
Watch the CTIS Bitesize talks: Gain valuable insights into the rule changes by watching the CTIS Bitesize talks. These informative sessions will offer practical guidance and best practices for navigating the updated transparency requirements.
Mark your calendars: Don’t miss the follow-up talk scheduled for June 20, 2024. This session will provide further support and clarification on the revised rules, helping sponsors adapt their business processes effectively.
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