title: Statistical approaches and policies for the operations of Data and Safety Monitoring Committees.
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: R M
authors.initials: RM
authors.lastname: Califf
authors.forename: S S
authors.initials: SS
authors.lastname: Ellenberg
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D003627:Data Interpretation, Statistical; D006801:Humans; D017410:Practice Guidelines as Topic; D017751:Safety Management / Q000592:standards / Q000706:statistics & numerical data*