European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 02, 2022, by adding the updated documents in Module 02- High-level overview of CTIS workspaces and common system functionalities:
- Section 1: A diagram for CTIS cross-system in the ‘Summary of CTIS cross-system buttons’ was added. The format of the table for key functionalities of buttons was updated by adding new icons for each button.
- Section 2: A new section for ‘Access and Practicality’ to the existing information for ‘CTIS Cross-system buttons’ was added, providing information on access routes for both the workspaces and the public website. It also enlists good practices recommendations.
- FAQs: Overview of CTIS workspaces and common system functionalities – Module 02 (v1.2): The questions and answers that are added or revised in this version are –
- Sections 1.9: This section was revised by adding links for both, authority and sponsor workspaces
- Sections 1.10, 1.11, and 1.12: These sections are added newly and provide information on password recovery, browser recommendations, and session time out limit
- Section 3.4: This section was added newly and provides information on turning off or re-directing notices and alerts
- Section 4.2: This section was revised by adding more information on how administrator roles are assigned. It also explains the types of administrator roles and provides the reference link for training module 07
- Section 4.3: This section was revised by adding more information for the option of ‘My roles’
- Section 5.4: This section was added newly and provides steps for searching an annual safety report