An agency of the European Union Get started with EudraCT to prepare and post results Noémie Manent Compliance and Inspection
An agency of the European Union Get started with EudraCT to prepare and post results Noémie Manent Compliance and Inspection.
Dec 24, 2015
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An agency of the European Union
Get started with EudraCT to prepare and post results
Noémie ManentCompliance 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 http://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf
3
How to register
4
How to register• https://eudract.ema.europa.eu/
5
Register for a EudraCT Account
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Agreement with data protection statement
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Enter personal details
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Registration
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Registration
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Registration
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Registration
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How to become a results user
13
How to become a results user
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How to become a results user
15
How to become a results user
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How to become a results user
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How to become a results user
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How to request trial assignment
19
How to request Trial Assignment20
Log in EudraCT
Request Assignment
How to request Trial Assignment21
Identify trial
How to request Trial Assignment22
Enter trial details
How to request Trial Assignment23
Attach letter
How to request Trial Assignment24
Attach letter
How to request trial assignment25
Attach letter
How to request Trial Assignment26
Attach letter
How to request Trial Assignment27
Request assignment – screen confirmation
How to request Trial Assignment28
Trial assignment processing
How to request Trial Assignment29
Your page – end of process
How to request Trial Assignment30
Once the request is approved
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Manage users
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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
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