The Data Safety Monitoring (DSM) Plan outlines the policies established by the University of Chicago Medicine Comprehensive Cancer Center for the appropriate oversight and monitoring of the conduct of cancer clinical trials at the University of Chicago. Adherence to these guidelines is a requirement of Cancer Center membership.
Failure to comply with the policies and procedures outlined in this document will result in suspension of Comprehensive Cancer Center membership privileges including lack of access to, or discounts on, shared facilities as well as other Cancer Center resources (e.g., services of the Cancer Clinical Trials Office (CCTO), or review by the Clinical Trials Review Committee (CTRC, required for institutional review board (IRB) approval)).
The purpose of these policies is to ensure the safety of participants, the validity of data, and the scientific progress of studies including termination of studies for which significant risks have been uncovered or when it appears that the trial cannot be conducted successfully. These policies apply to all cancer clinical trials regardless of study sponsorship or source of support.