An Opinion and Practice Survey on the Structure and Management of Data and Safety Monitoring Boards
Tereskerz, Patti M
Guterbock, Thomas M
Kermer, Deborah A
Moreno, Jonathan D
Accountability in research 2011 Jan; 18(1): 1-30
There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.
Showing items related by title, author, creator and subject.
Tereskerz, Patricia M. (2010-01)Those charged with assuring research accountability have little guidance as to how to best structure and manage data safety monitoring boards (DSMBs). One major concern is increased litigation surrounding human subject ...
Reitsma, A.M.; Closen, M.L; Cunningham, M.; Lombardo, P.A.; Minich, H.N.; Moreno, J.D.; Nichols, R.L.; Pearson, R.D.; Sawyer, R.G.; Wispelwey, B.; Tereskerz, P.M. (2005-07-01)
Tereskerz, Patricia M.; Hamric, Ann B.; Guterbock, Thomas M.; Moreno, Jonathan D. (2009-01)Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to ...