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How To Master The New Legal Responsibilities Introduced By The CTR

 
• By Elisabethann Wright, Henry Stewart, Sascha Grimm, Jessica Koffel and Monica Mylordou

The Clinical Trials Regulation finally entered into application on 31 January 2022, replacing the largely national, and sometimes inconsistent, rules created by the Clinical Trials Directive. In this article, law firm Cooley advises on the changes introduced by the CTR and explores ways in which firms can reduce their contractual risks and potential legal liability.  

Regulations
• Source: Shutterstock

The Clinical Trials Regulation (CTR) will replace the Clinical Trials Directive (CTD) and the related national implementing legislation of individual EU Member States over a transitional period. It introduces a single set of rules governing several aspects of clinical trials conducted within the EU.

The changes introduced by the CTR will modify, and in some instances increase, the responsibilities that trial sponsors must undertake. Provisions governing transitional periods and related obligations are particularly complex...

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