CTIS for authorities

The Clinical Trials Information System (CTIS) offers a secure workspace to support EU Member States, EEA countries and the European Commission in overseeing the conduct of clinical trials in the European Union (EU) and European Economic Area (EEA).

Target CTIS authority workspace users

National competent authorities of EU Member States and EEA countries
Ethics committees of EU Member States and EEA countries (national processes regarding access to CTIS for ethics committees may vary)
European Commission

Functionalities

Manage registered users and user roles
View clinical trial application dossiers
Manage tasks related to the assessment of clinical trials
Collaborate within and between Member States
Receive alerts and notifications for ongoing trials
Download documents submitted by clinical trial sponsors
Record inspections of sites and clinical trials
Conduct union controls

Getting started

Log in

Check with your organisation’s master trainer for CTIS whether you need to use the secure workspace. If you do, you can log in using your EMA account. If you have access to any EMA-hosted websites or online applications, you already have an EMA account and you should use the same credentials.

How to register

If you do not have an EMA account, you need to create an EMA account. Once your account is registered, you should ask your organisation’s administrator to assign you the roles and permissions you need to view and collaborate on clinical trial dossiers.