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 and V10 in May 2014: –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. Step 1: Identify trial (up to 50) How to request Trial Assignment 22

23. Step 2: select the request method Presentation title (to edit, click View > Header and Footer) 23

24. Step2A: Requested method: via a letter from the sponsor Presentation title (to edit, click View > Header and Footer) 24

25. Step2A: Requested method: via a letter from the sponsor - Enter trial details How to request Trial Assignment 25

26. Step2A: Requested method: via a letter from the sponsor - Attach letter How to request Trial Assignment 26

27. Step2A: Requested method: via a letter from the sponsor - Attach letter How to request trial assignment 27

28. Step2A: Requested method: via a letter from the sponsor - Attach letter How to request Trial Assignment 28

29. Step2A: Requested method: via a letter from the sponsor - Attach letter How to request Trial Assignment 29

30. Step2A: Requested method: via a letter from the sponsor - Request assignment – screen confirmation How to request Trial Assignment 30

31. Step2A: Requested method: via a letter from the sponsor - processing How to request Trial Assignment 31

32. Step2A: Requested method: via a letter from the sponsor - End of process How to request Trial Assignment 32

33. Step2A: Requested method: via a letter from the sponsor - Once the request is approved 33

34. Step2B: Requested method: based on protocol information A user, for whom the email address was included in the CTA submitted to the national competent authority, can request the trial assignment by selecting the option “request assignment based on protocol information”. This request will be automatically granted if the email address of the requestor/user matches the one included in the CTA. This method is fast and effective and if there is a match between the email addresses, the requestor has immediate access to the result user interface for the trial. Presentation title (to edit, click View > Header and Footer) 34

35. Step2B: Requested method: based on protocol information The following CTA fields are verified against the requestor email during this process: B.1.6 Sponsor Contact email B.2.6 Legal Representative email C.1.4.6 Request for the competent authority email C.2.5.6 Request for the ethics committee email Presentation title (to edit, click View > Header and Footer) 35

36. Step2A: Requested method: via a letter from the sponsor - Request assignment – screen confirmation How to request Trial Assignment 36

37. Step2B: Requested method: based on protocol information – click confirm Presentation title (to edit, click View > Header and Footer) 37

38. Step2B: Requested method: based on protocol information – outcome of assignment request Presentation title (to edit, click View > Header and Footer) 38

39. Step2B: Requested method: based on protocol information–end of process return to your page Presentation title (to edit, click View > Header and Footer) 39

40. Manage users 40

41. 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 41

42. Q&A 42