The Yale Cancer Center is committed to ensuring the safety of patients participating in clinical trials and requires all clinical trials conducted at the YCC to include provisions for data and safety monitoring. The development of protocol monitoring plans and reporting requirements are dependent upon the overall risk to patients, the nature of the agent, the phase of the trial and prior safety data with the proposed treatment regimen, the role of the Yale principal investigator and the institution, and the study sponsor. The original NCI approved Yale Cancer Center (YCC) Data and Safety Monitoring Plan was recently revised and approved by NCI in July of 2011. The plan outlines the scope of protocol oversight which is operationalized by the YCC Data and Safety Monitoring Committee (DSMC). While each investigator is responsible for the day to day monitoring of a study, the initial scientific review conducted by the YCC Protocol Review Committee (PRC) includes the assignment of a more detailed protocol specific plan requiring additional oversight provided by the DSMC. For studies without external monitoring this includes a protocol specific schedule for safety review and internal auditing. The Office of Protocol Review and Monitoring (OPRM), headed by Susan Anderson, is the administrative arm of the DSMC. 12.2 PURPOSE OF THE DSMC

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