For all clinical trials to be conducted in the EU/EEA, all applications are submitted via a single entry point: the European portal CTIS.
Information and access to CTIS can be found on the EMA website.
The EMA has developed a training programme for CTIS users. The training page contains a link to the CTIS handbook for sponsors, including Frequently Asked Questions, and contains various training modules on basic CTIS functionalities.
To create an application in CTIS, users have to be registered (EMA account) and given roles and permissions. Organisations have to be registered in the organisation management system (OMS) and medicinal products have to be registered in the medicinal product dictionary (XEVMPD). These essential steps are explained further in this section.
Please note! Make sure that 'Scientific Contact Point' and 'Public Contact Point' are entered in the Sponsor section of Part I of the application, otherwise the application will not pass the final check on submission application in CTIS.