Managing users and prepare results in EudraCT

1. Managing users and prepare results in EudraCT • Noémie Manent • Compliance and Inspection

2. Agenda • Introduction • Manage users • Prepare results in EudraCT • Q&A

3. Introduction • Launch of EudraCT V9 in October 2013: • initial step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR) • Clinical-trial sponsors can register on the EudraCT website to start uploading summary results • Guidance on posting and publication of result-related information on clinical trials in relation to the implementation http://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf 3

4. Manage assigned users

5. Manage assigned users • This functionality allows the primary user (already assigned to a trial) to assign other users (who are results users) to a clinical trial. • Other users can be added with one of the following roles: • -Back up : same role as the primary • -Preparer and poster : prepare and post result but cannot manage users • -Preparer : can only prepare results

6. Step 1: log in * • * The user is a primary user or a back up user

7. Step 2: Click “Manage assigned users” 7

8. Step 3: Use this screen to manage the users assigned to prepare results for a trial

9. Manage assigned users: Add user

10. Manage assigned users: select user (1)

11. Manage assigned users: select user (2)

12. Manage assigned users: select user (3)

13. Manage assigned users

14. Q&A