CTIS: general information
A main characteristic of the CTR is an application procedure via a single entry point- an EU portal and database (CTIS), for all clinical trials to be conducted in the EU/EEA.
The EMA has developed a training programme for CTIS users. Guidances, instructions, videos and FAQ can be found on their website.
To create an application in CTIS, users have to be registered and given roles and permissions. Organisations have to be registered in the organisation management system and medicinal products have to be registered in the medicinal product dictionary. These essential steps are explained further in this section.
Please note! Make sure that 'Scientific Contact Point' and 'Public Contact Point' in the section sponsor are completed, otherwise the application will not pass the final check on submission application in CTIS.