EMA Clinical Trial Information System (CTIS): The Future User Perspective-Virtual Information Day

The European Commission confirmed 31 January 2022 as the date of entry into application of the Clinical Trials Regulation EU No 536/2014 and the go-live of the Clinical Trial Information System (CTIS).

The objectives of this virtual information day are to help prepare users for the new way of submitting Clinical Trial Applications (CTA) through CTIS.

It will provide –on a high level- an overview of key aspects of CTIS for future users to consider.

Ample time is foreseen for a live demo presenting users an overview of the two restricted workspaces for sponsors and authorities.

Furthermore, current status and experience with sponsor users’ preparedness will be shared.

The information day will close with an update on access to CTIS training material and EMA support.

The information day will not cover aspects of the registration process nor user access management in CTIS. More information on those topics can be found on the dedicated EMA CTIS webpages.

• The Clinical Trials Regulation and key aspects for users to consider when preparing for CTIS
• CTIS live demo of sponsor and authority workspaces: how to navigate the system
• Sponsor perspective on user preparedness
• Update on Access to CTIS training material and support

This EMA CTIS Virtual Information Day is aimed at all CTIS users:

• Clinical Trial Sponsors
• CROs
• Member State NCAs
• Ethics Committee Members