February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Data safety
monitoring committee
Independent
advisory committee which meets periodically to review
·Conduct of
the study
·Interim
analysis of study data
-Safety and
efficacy data
·Secular
trends in clinical setting
-Changes in
diagnosis of disease
-Changes in
treatment of disease
-Changes in
treatment of adverse events