Clinical Trials Information System
A joint controllership arrangement describes the processing of personal data in CTIS, in accordance with the General Data Protection Regulation and EU Data Protection Regulation.
A range of actors may need to enter personal data into CTIS as part of clinical trial authorisation and supervision processes, including clinical trial sponsors, marketing authorisation applicants or holders, the European Commission, EMA, EU Member States and EEA countries.
The joint controllership arrangement describes the roles and responsibilities of each party regarding the processing of personal data in CTIS. It sets out the measures they must put in place to ensure that personal data in CTIS is securely processed, and covers how the parties are to handle any personal data breaches.
When accessing CTIS for the first time, CTIS workspace users will be made aware of the contents of the joint controllership arrangement before proceeding.
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