Data and Safety Monitoring Plan
The University of Kentucky Markey Cancer Center (MCC) places the highest priority on ensuring the safety of subjects participating in clinical trials and on the quality of data obtained from clinical and translational research. The Data and Safety Monitoring Plan describes the procedures for all therapeutic and non-therapeutic cancer clinical trials conducted by MCC investigators.
All clinical trials involving humans and human specimens are monitored commensurate with the degree of risk involved with participation in the study. The MCC has implemented a process for routine real-time data monitoring and safety review of all trials, with a special focus upon investigator-initiated trials (IITs), which is based upon the Essential Elements of the National Cancer Institute (NCI) guidelines, the Food and Drug Administration (FDA) monitoring regulations, and Good Clinical Practice Guidelines. The MCC DSMP is maintained by the Associate Director for Clinical Research and the Chair of the MCC Data and Safety Monitoring Committee (DSMC) and approved by the Director of the MCC. The MCC DSMP is reviewed and revised at least annually.
Download the complete DSMP (PDF, 1 MB) or the Provost's outline for monitoring and oversight of cancer-related clinical trials (PDF, 160 KB) at the University of Kentucky.
Download a list (PDF, 41 KB) of the committee members who serve on Markey's Data Safety and Monitoring Committee, Protocol Review and Monitoring Committee, and Audit Committee.