FDA - Use of Data Monitoring Committees in Clinical Trials

14th February 2024

FDA - Use of Data Monitoring Committees in Clinical Trials 

This guidance provides recommendations to help sponsors of clinical trials determine (1) when a data monitoring committee (DMC) (also known as a data and safety monitoring board DSMB) or a data and safety monitoring committee (DSMC) or an independent data monitoring
committee (IDMC)) would be useful for trial monitoring and (2) what procedures and practices
should be considered to guide their operation.

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