European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 09, 2022, by adding the below updated document in Module 07- Management of registered users and role matrix:
FAQs: Management roles and permissions – Module 07 (v1.3): The questions and answers that are added or revised in this version are –
- Section 1.1: This section was revised by updating the process to register in CTIS
- Sections 2.1, 2.2, 2.3, 2.4, 2.6, 2.7, and 2.9: These sections were revised by changing the number of roles for overall CTIS and in both workspaces, providing more information on ‘all trials’ under the scope available for a role, administrator roles, high-level administrators, the documents to request high-level administrator roles for the first time, and the number of user administrator a sponsor or a member state can have.
- Section 5.3: This section was newly added explaining the reason for the distinction between sponsors (Industry and Academia) and marketing authorization holder (MAH) roles.
- Section 5.4: This section was revised by updating the information for ‘submitters’
- Section 5.5: This section was newly added explaining how the ethics committee can be both CT Coordinator and National Organization Administrator (NOA)
- Section 6.1: This section was revised by adding a note for users to click on ‘Search’ for viewing the roles