An agency of the European Union
Managing users and prepare results in EudraCT
Noémie ManentCompliance and Inspection
Agenda
• Introduction
• Manage users
• Prepare results in EudraCT
• Q&A
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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
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Manage assigned users
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Manage assigned users
This functionality allows the primary user (already assigned to a trial) to assign other users (who are results users) to a clinical trial.
Other users can be added with one of the following roles:
-Back up : same role as the primary
-Preparer and poster : prepare and post result but cannot manage users
-Preparer : can only prepare results
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Step 1: log in *
6* The user is a primary user or a back up user
Step 2: Click “Manage assigned users”
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Step 3: Use this screen to manage the users assigned to prepare results for a trial
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Manage assigned users: Add user
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Manage assigned users: select user (1)
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Manage assigned users: select user (2)
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Manage assigned users: select user (3)
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Manage assigned users
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Q&A
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