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Get started with EudraCT to prepare and post results

Get started with EudraCT to prepare and post results. Noémie Manent Compliance and Inspection. Agenda. Introduction How to register How to become a results user How to request trial assignment Manage users Q&A. Introduction. Launch of EudraCT V9 in October 2013 and V10 in May 2014:

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Get started with EudraCT to prepare and post results

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  1. 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

  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 3

  4. How to register

  5. How to register • https://eudract.ema.europa.eu/ 5

  6. Register for a EudraCT Account

  7. Agreement with data protection statement

  8. Enter personal details

  9. Registration

  10. Registration

  11. Registration

  12. Registration

  13. How to become a results user

  14. How to become a results user

  15. How to become a results user

  16. How to become a results user

  17. How to become a results user

  18. How to become a results user

  19. How to request trial assignment

  20. Log in EudraCT How to request Trial Assignment

  21. Request Assignment How to request Trial Assignment

  22. Step 1: Identify trial (up to 50) How to request Trial Assignment

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

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

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

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

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

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

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

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

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

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

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

  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)

  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)

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

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

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

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

  40. Manage users

  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

  42. Q&A

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