February 2023: CTIS Newsflash

On February 17, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications. All CTIS newsflash updates are posted on the Development of the Clinical Trials Information System page.

This encompasses the key data and trends from the week of February 07 to 13, 2023, regarding CTA submissions, CTAs with a decision, and CTAs with a decision per RMS, when compared to the previous week.

In the upcoming CTIS “Hotfix,” Member States will be able to unlock database locks that have occurred in a limited number of trials and a small group of sponsors, enabling them to respond to Request for Information (RFI). This update will also permit sponsors to modify an application via an RFI.

Moreover, the upcoming release of CTIS is scheduled for the week of February 20, 2023, and is anticipated to bring several enhancements that will enhance the user experience. These enhancements consist of displaying Notices and Alerts for Union controller roles and EMA Admin, improving search functionality, rectifying the error message that appears when trying to submit an RFI response, boosting the efficiency of the Substantial Modification detail review process, and ensuring that the data download encompasses the latest entries.

For more information, please refer to our previous post on CTIS Newsflash.