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- Update on the consultation on draft guidance on the protection of personal data and commercially confidential information (CCI) in CTIS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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