1. An agency of the European Union Managing users and prepare results in EudraCT Noémie Manent Compliance and Inspection

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

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 http://ec.europa.eu/health/files/eudralex/vol- 10/2012_302-03/2012_302-03_en.pdf 3

4. Manage assigned users 4

5. 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 5

6. Step 1: log in * 6 * 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 8

9. Manage assigned users: Add user 9

10. Manage assigned users: select user (1) 10

11. Manage assigned users: select user (2) 11

12. Manage assigned users: select user (3) 12

13. Manage assigned users 13

14. Q&A 14