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.
Read MoreUtilisation of artificial intelligence (AI) to transform key steps in clinical trials to increase clinical trial efficiency, improve patient safety and the patient experience.
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