Clinical Trials Highlights - July 2022

On 25 July 2022 the EMA published the Clinical Trials Highlights, issue 10.

In this issue, the following topics are included:

  • ACT EU multi-stakeholder events
  • Survey on the implementation of the Clinical Trials Regulation
  • Article published: ‘Estimators for handling COVID-19 related Intercurrent Events with a hypothetical strategy’
  • Introduction to the SAFE CT Joint Action
  • Update on the consultation on draft guidance on the protection of personal data and commercially confidential information (CCI) in CTIS
  • An academic sponsor’s first experiences with CTIS
  • CTIS release notes and known issues
  • CTIS events update
  • CTIS training material update
  • CTIS training environment (‘CTIS Sandbox’) update
  • Upcoming changes to EMA Account Management
  • New KPIs to track the European clinical trials environment published
  • Multi-factor authentication strategy at EMA
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