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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:

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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: • 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. Identify trial How to request Trial Assignment

  23. Enter trial details How to request Trial Assignment

  24. Attach letter How to request Trial Assignment

  25. Attach letter How to request trial assignment

  26. Attach letter How to request Trial Assignment

  27. Attach letter How to request Trial Assignment

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

  29. Trial assignment processing How to request Trial Assignment

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

  31. Once the request is approved

  32. Manage users

  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

  34. Q&A

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