Clinical Trials Information System (CTIS) Data Protection Notice

"The Clinical Trials Information System (CTIS), established under the Clinical Trials Regulation, processes personal data related to clinical trials and safety reports.

Key Points:

• System Overview: CTIS includes the EU Portal and EU Database and retains data for 25 years from 31-Jan-2022.
• Data Controllers: The European Commission, EMA, Member States, commercial and non-commercial organizations, and academia jointly manage data processing.
• User Access & Transparency:
• Access levels vary based on user profiles.
• A public module provides transparency but excludes personal data unless otherwise specified.
• Data Handling & Third Parties:
• Third parties support CTIS development, maintenance, and data quality assurance.
• Personal data may be included in official documents, with investigators and sponsor signatories' identities made public.
• Data subjects can exercise their rights under applicable regulations with any of the joint controllers.

Region: European Union

Source: https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-regarding-personal-data-processing-clinical-trials-information-system-ctis_en.pdf-0