February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Overview: 39
Ethical Issues
Data safety monitoring committee (cont.)
Membership: Usually 3 or 4 members independent of study sponsor and investigators
·Scientists, clinicians
-Experts in disease
-Experts in treatment
-Experts in anticipated adverse events
·Statisticians
·Ethicists
·Patient advocates