What is the ASAP and what you should know about it
The Effective Statistician - in association with PSI
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FDA DSUR: Enhancing Safety in Clinical Trials
This chapter introduces the speaker Greg, who discusses the FDA DSUR and its role in identifying and managing potential risks in clinical trials. It highlights the expanded scope of the new safety summary regulation and emphasizes the importance of reporting adverse reactions and conducting aggregate program level safety assessments.
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