Data and Safety Monitoring Plan

The University of Kentucky (UK) 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. This document describes the data and safety monitoring plan (DSMP) for all therapeutic and non-therapeutic cancer clinical trials studying patients with cancer or those at risk for cancer conducted by MCC and MCC Research Network (MCCRN) 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 Translation 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

Other Documents

• Request Biospecimens from the Biospecimen Procurement and Translational Pathology SRF