To enhance its ability to fortify ...

To enhance its ability to fortify the safety of clinical trial subjects--and to make secure the accuracy of data discloseed to support New medicine Applications--FDA set out to clarify its policy onward the use of Data Monitoring Committees. Also known as Data and Safety Monitoring Boards, DMC superintend safety issues and track treatment results during the course of a clinical investigation

FDA's draft Guidance for Clinical Trial Sponsors onward the Establishment and Operation of Clinical Trial Data Monitoring Committees (issued November 2001) describes the parts responsibilities, and operations of