Information on how EMA processes personal data is available on EMA’s website:
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Clinical Trials Information System (CTIS)
The Clinical Trials Information System (CTIS) is the system that stores the information on clinical trials that you can find using this website.
The CTIS, in its secure domain, contains personal data relating to:
- registered users of the CTIS;
- clinical trial sponsors and their staff;
- experts working for national authorities in EU Member States;
- principal investigators of clinical trials;
- sponsors’ legal representatives in the European Union;
- senior representatives of clinics and institutions carrying out clinical trials.
Some of these personal data may be visible to you when using this website’s search function.
For information on how we protect personal data in the CTIS:
Joint controllership arrangement
The joint controllership arrangement describes the allocation of respective roles, responsibilities and practical arrangements between the parties for compliance with their respective data protection obligations as part of the authorisation and supervision of clinical trials in CTIS.
These parties include:
- clinical trial sponsors;
- marketing authorisation applicants and holders;
- EU Member States and EEA countries;
- the European Commission;
When registered users access CTIS for the first time, they have to accept the terms of the joint controllership arrangement before they can proceed.