An agency of the European Union 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 2
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 10/2012_302-03/2012_302-03_en.pdf 10/2012_302-03/2012_302-03_en.pdf 3
How to register 4
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Register for a EudraCT Account 6
Agreement with data protection statement 7
Enter personal details 8
Registration 9
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Registration 11
Registration 12
How to become a results user 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 request trial assignment 19
How to request Trial Assignment 20 Log in EudraCT
Request Assignment How to request Trial Assignment 21
Identify trial How to request Trial Assignment 22
Enter trial details How to request Trial Assignment 23
Attach letter 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
Request assignment – screen confirmation How to request Trial Assignment 28
Trial assignment processing How to request Trial Assignment 29
Your page – end of process How to request Trial Assignment 30
Once the request is approved 31
Manage users 32
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
Q&A 34