Clinical trials conducted in the European Union (EU) and European Economic Area (EEA) are governed by the Clinical Trials Regulation, also known as CTR (Regulation (EU) No 536/2014). CTR was implemented on January 31, 2022 along with the launch of the Clinical Trials Information System (CTIS). CTIS acts as a centralized EU portal and database for clinical trials by supporting the flow of information between clinical trial sponsors, EU Member States, EEA countries, and the European Commission. It has provisions for both protocol registration and results posting activities for clinical trials conducted in EU/EEA. Results posting also includes submission of lay langauge summary. CTIS is not a World Health Organization (WHO) recognized primary registry.
|Registries at a Glance|
|Registry||PHUSE Categorization||Information to be Entered By||Route of Data in Registry||Study Type||Language|
|EU CTIS||Not Applicable||Competent authority, Sponsor||Clinical Trial Application||
|Registration and Results Requirements|
|Prior to enrollment|
|Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies)|
- November 2022: CTIS Training Update - European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support on November 30, 2022, by adding a new version of the CTIS – Sponsor handbook (v3.0). The below sections were newly added in version 3.0 of the CTIS – Sponsor handbook: Section 3.5: Marketing Authorization Holder (MAH) group of users – This section gives … Continue reading "November 2022: CTIS Training Update"
- November 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions - European Medicines Agency updated the event pages Organisation Management System (OMS) Trouble Shooting Session for CTIS users- October 2022 and OMS Trouble Shooting Session for CTIS users- November 2022 on November 29, 2022, with the following information: A video recording of the session held on October 2022 was made available. A Presentation from the session … Continue reading "November 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions"
- November 2022: CTIS Update - European Medicines Agency updated the event page, Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 2 over the What’s New Section on November 23, 2022: The presentation for the CTIS bitesize talk held on November 23, 2022, is now available on the event page. It explains, in brief, different kinds of circumstantial events … Continue reading "November 2022: CTIS Update"