SOP: Transition of Clinical Trials from EU Clinical Trial Directive to EU Clinical Trial Regulation

This standard operating procedure (SOP) is recommended for transitioning clinical trials from the EU CTD to the EU CTR using the Clinical Trials Information System CTIS. It applies to all ongoing interventional clinical trials authorized under the CTD with at least one active site in the EU/EEA as of Jan. 30, 2025, as well as those trials on EudraCT requiring an amendment subject to approval by the member states (e.g., adding sites in a new member state) before Jan. 30, 2025.