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 adhere to the Yale Cancer Center (YCC) Data and Safety Monitoring Plan (DSMP). The original NCI approved./YCC DSMP 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 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 development of protocol specific 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 purpose of the DSMC is to provide ongoing data and safety monitoring for all interventional cancer clinical trials. The DSMC reviews all studies at least annually and has the authority to intervene in the conduct of these studies as necessary to ensure the safety of the participants and to maintain the highest quality in the clinical research performed at YCC. The Committee reviews safety data, audit findings, reports of unanticipated events, protocol deviations and requests for specific reviews from faculty, staff or study participants. The DSMC is chaired by Michal Rose, MD, Associate Professor of Medicine, and the Vice Chair is Ed Snyder, MD Professor of Laboratory Medicine each with over 13 years of clinical trials experience. The Office of Protocol Review and Monitoring (OPRM), headed by Susan Anderson, is the administrative arm of the DSMC which coordinates all DSMC activities, maintains records of all DSMC actions and provides staffing for internal audits and follow up on actions required as a resiJit of DSMC review or finding. OPRM also coordinates training programs for faculty and research staff, including. Good Clinical Practices (GCP), IRB Basics, Research Ethics and Misconduct, as well as specific topics key to the understanding of compliance and safety as they are identified and addressed as required.

Public Health Relevance

The DSMC is able to provide frequent checks on the activities of each therapeutic protocol in order to identify existing or potential problems that could affect patient safety and require corrective action plans to address such issues.

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