The CTIS sponsor handbook is the reference document that clinical trial sponsors should use when applying for a clinical trial authorisation through CTIS. They should also use the handbook when entering any other information in CTIS.
The handbook is aimed at:
EMA regularly updates the handbook.
The CTIS Sponsor Frequently Asked Questions (FAQ) is based on questions frequently raised by sponsors during CTIS events such as walk-in clinics, bitesize talks, and through the EMA CTIS Service Desk. It serves as complementary document to the Sponsor Handbook, which is the main operational guidance for sponsors when using CTIS.
EMA regularly updates the FAQ.
Information on clinical trials submitted in CTIS is made available on the CTIS public portal, in line with the revised CTIS transparency rules applicable as of June 2024.
Before uploading data and documents to CTIS, sponsors should be fully aware of the publication rules, see:
The roles and responsibilities of each party regarding the processing of personal data in CTIS is described by the joint controllership arrangement. For more information, see:
All reference documents on CTIS transparency rules can be found on the Accelerating Clinical Trials in the EU website. For more information, see:
EMA offers live training sessions to provide additional learning opportunities. They include bitesize talks, walk-in clinics and webinars.
Through the CTIS walk-in clinics, sponsors can ask their questions to CTIS experts and receive practical guidance about the system.
CTIS bitesize talks are themed events offering users live system demonstrations on a specific CTIS functionality. They also include question and answers on specific themes.
In addition, EMA introduced troubleshooting sessions on the Organisation Management System (OMS). They help CTIS users by clarifying outstanding issues related to registering organisation and / or location data in the OMS for use in CTIS.
The Sponsor FAQs collects the most frequently asked questions on CTIS that remain applicable across all the events listed below, consolidating reusable guidance and removing content tied to processes that are no longer current
Recordings and supporting materials become available after each event. Past events on processes that are no longer applicable are not displayed.
Select the expandable panels below to access both past and upcoming events:
Details on trainings organised externally by DIA are also included here:
For queries related to the use of the CTIS that cannot be answered through the CTIS Sponsor handbook, users should refer to the CTIS support page.
For questions on the content of clinical trial applications (structured data and documents), users should refer to the relevant Member States contact points.
For queries related to the Clinical Trials Regulation users should refer to the EudraLex CTR Q&A or to the Member States contact points.
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
26 March 2026
'Frequently asked questions for clinical trial sponsors' section added