February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Overview: 38
Ethical Issues
Data safety monitoring committee (cont.)
At periodic meetings, interim study results are reviewed and recommendations made to the sponsor
·Terminate the study early
·Modify the protocol
·Issue alerts to the investigators
·Modify study monitoring procedures
·Continue as planned