1. An agency of the European Union Get started with EudraCT to prepare and post results Noémie Manent Compliance and Inspection

2. Agenda Introduction How to register How to become a results user How to request trial assignment Manage users 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. How to register 4

5. https://eudract.ema.europa.eu/ 5

6. Register for a EudraCT Account 6

7. Agreement with data protection statement 7

8. Enter personal details 8

9. Registration 9

10. 10

11. Registration 11

12. Registration 12

13. How to become a results user 13

14. How to become a results user 14

15. How to become a results user 15

16. How to become a results user 16

17. How to become a results user 17

18. How to become a results user 18

19. How to request trial assignment 19

20. How to request Trial Assignment 20 Log in EudraCT

21. Request Assignment How to request Trial Assignment 21

22. Identify trial How to request Trial Assignment 22

23. Enter trial details How to request Trial Assignment 23

24. Attach letter How to request Trial Assignment 24

25. Attach letter How to request trial assignment 25

26. Attach letter How to request Trial Assignment 26

27. Attach letter How to request Trial Assignment 27

28. Request assignment – screen confirmation How to request Trial Assignment 28

29. Trial assignment processing How to request Trial Assignment 29

30. Your page – end of process How to request Trial Assignment 30

31. Once the request is approved 31

32. Manage users 32

33. Manage users - Done at the trial level - Performed by the sponsor via the primary user - The primary user assigns other users (who are results users) to a trial - The other roles are: -Primary user back up -Preparer and poster -Preparer 33

34. Q&A 34