White Paper

Operational Considerations For Readiness And Execution Of Clinical Trials Under The EU Clinical Trial Regulation

Source: TransPerfect

By Pierre-Frédéric Omnes, Executive Director, TransPerfect


The Clinical Trial Regulation (EU) 536/2014 (CTR), the latest regulatory framework for medical treatment studies, replaced the previous Clinical Trial Directive 2001/20/EC (CTD) on January 31, 2022. Since its adoption, the CTR has impacted the readiness and execution of clinical trials within the European Union (EU) and European Economic Area (EEA) Member States. In this white paper, author Pierre-Frédéric Omnesthe examines the use of “Regulation” as a legislative instrument, standardized application and reporting requirements, the centralized Clinical Trial Information System (CTIS), and heightened transparency obligations.

The paper also delves into the operational considerations for stakeholders and recommends essential areas to address in readiness plans, emphasizing the adoption of quality management systems, safeguarding confidential information, and adhering to transparency and disclosure mandates. Additionally, it underscores the significance of effective CTIS management, user allocation, and strategies for handling commercially sensitive data and personal information.

Gain a comprehensive understanding of the CTR, which has equipped stakeholders to navigate the altered regulatory landscape and prepare for conducting clinical trials in the EU/EEA by downloading this white paper.

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