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Posts tagged Clinical Safety
Clinical Trials Regulation (EU) No 536/2014 Questions and Answers Document Version 7.3

Substantial amendments have been made to Chapter 7 on Safety Reporting, including  the restructuring of Chapter 7 into distinct sub-chapters. Upon review, the comprehensive updates range from the total rewording of some questions and answers with little change in underlying principle, to the addition of new questions and requirements for safety reporting.

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