FAIRsharing record for: Clinical Trials Information System

This FAIRsharing record describes: The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorisation and supervision of clinical trials in the European Union and the European Economic Area. From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022.