Establishment and Operation of Clinical Trial Data Monitoring Committees. Guidance for Clinical Trial Sponsors
Rockville, MD: U.S. Food and Drug Administration [FDA], 2006 March; 34 p. [Online]. Accessed: http://www.fda.gov/cber/gdlns/clintrialdmc.pdf [2006 May 3]
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On the Establishment and Operation of Clinical Trial Data Monitoring Committees: Draft Guidance. Guidance for Clinical Trial Sponsors Unknown creator (Center for Biologics Evaluation and Research [CBER] (United States) Center for Drug Evaluation and Research [CDER] (United States); Center for Devices and Radiological Health [CDRH] (United States), 2001-11)
A Proposed Charter for Clinical Trial Data Monitoring Committees: Helping Them to Do Their Job Well Grant, A.M.; Altman, D.G.; Babiker, A.G.; Campbell, M.K.; Clemens, F.; Darbyshire, J.H.; Elbourne, D.R.; McLeer, S.K.; Parmar, M.K.B.; Pocock, S.J.; Spiegelhalter, D.J.; Sydes, M.R.; Walker, A.E.; Wallace, S.A. (2005-02-19)Formal monitoring of data from randomised controlled trials (RCTs) is becoming more common. Wide variation exists in the structure and organisation of data monitoring committees (DMCs), with little guidance on how they ...