1 / 14

Managing users and prepare results in EudraCT

Learn how to manage users and prepare clinical trial results in EudraCT efficiently. Get insights into compliance and the inspection agenda, including steps to assign roles and upload summary results. Stay updated on EudraCT V9 and its impact on public availability of trial data.

macd
Download Presentation

Managing users and prepare results in EudraCT

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Managing users and prepare results in EudraCT • Noémie Manent • Compliance and Inspection

  2. Agenda • Introduction • Manage users • Prepare results in EudraCT • 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. Manage assigned users

  5. 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

  6. Step 1: log in * • * The user is a primary user or a back up user

  7. Step 2: Click “Manage assigned users” 7

  8. Step 3: Use this screen to manage the users assigned to prepare results for a trial

  9. Manage assigned users: Add user

  10. Manage assigned users: select user (1)

  11. Manage assigned users: select user (2)

  12. Manage assigned users: select user (3)

  13. Manage assigned users

  14. Q&A

More Related