an agency of the european union managing users and prepare results in eudract noémie manent...

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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