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Home » DMC, Sponsor Should Be Largely, But Not Entirely Independent
DMC, Sponsor Should Be Largely, But Not Entirely Independent
September 24, 2009
FDA regulations require sponsors to report all “serious and unexpected adverse events” to the FDA, and its guidance for data monitoring committees (DMCs) advises sponsors to inform the FDA about all recommendations related to the safety of the product under investigation, “whether or not the adverse event in question meets the definition of ‘serious.’”