results information Nomie Manent Compliance and Inspection Sector - - PowerPoint PPT Presentation

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results information
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results information Nomie Manent Compliance and Inspection Sector - - PowerPoint PPT Presentation

Apr 10, 2023 165 likes •254 views

EU Clinical Trials Register: presentation of results information Nomie Manent Compliance and Inspection Sector An agency of the European Union Agenda Background Presentation of the results Usability testing 1 Background: EU

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An agency of the European Union

EU Clinical Trials Register: presentation of results information

Noémie Manent Compliance and Inspection Sector

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Agenda

  • Background
  • Presentation of the results
  • Usability testing

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Background: EU Clinical Trials Register and Results

Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 http://ec.europa.eu/health/files/eudralex/vol-10/2012_302- 03/2012_302-03_en.pdf The EudraCT database will be updated and sponsors will be able to enter and publish the results of trials they conducted.

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An agency of the European Union

https://www.clinicaltrialsregister.eu/index.html

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Usability testing

A small group including Patient Organisations and Sponsors will be asked to review the proposed display of the results to assess its usability. Further testing will be done once the system has been launched and that real data are available.