European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on August 24, 2022, by adding new versions for the below documents in Module 23- Transitional trials:
- FAQs: Transition of trials from EudraCT to CTIS – Module 23 (v1.2): The European Commission reference links and links for training materials were updated.
- Sponsors’ guide: Transition of trials from EudraCT to CTIS – Module 23 (v1.2): The section for ‘create, submit and search a transitional trial’ was updated by adding more information on the two advanced search functionalities ‘trial advance search’ and ‘application advance search’ that can be used to search a transitional trial. Also, a EudraCT number cannot be changed once the transitional trial is submitted. The European Commission reference links were also updated along with CTIS insights.
- Member states’ guide: Transition of trials from EudraCT to CTIS – Module 23 (v1.2): More information has been added in the overview of transition trials about things to do before transitioning a clinical trial. A new section for evaluation of transitional trials was also added with screenshots and CTIS insights.