European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on April 08, 2022, by updating the below documents in Module 23- Transitional trials:
- Sponsors’ guide: Transition of trials from EudraCT to CTIS – Module 23 (v1.1): Updated the section ‘Create and submit transitional trials’ by adding information about the EudraCT number that cannot be changed after submitting the transitional trial.
- FAQs: Transition of trials from EudraCT to CTIS – Module 23 (v1.1): The questions and answers that are added or revised in this version are –
- Section 2.3: This section was newly added providing information for populating fields in a transitional trial
- Section 2.4: This section was newly added providing information for submission of transitional trial
- Section 2.7: This section was revised by adding more information for studies that requires a substantial modification after submitting it as a transitional trial.