Regulatory issues for Data and Safety Monitoring Committees.
Fisher
L
L
Department of Biostatistics, University of Washington, PO Box 82026, Kenmore, WA 98155-0086, USA. lloyd_fisher@alum.mit.edu
Klibaner
M
M
D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D009316:National Institutes of Health (U.S.); D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration