DATA SAFETY MONITORING PLAN

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Overview of DSMP: Every clinical study conducted by the Winship Cancer Institute (WCI) and its Clinical Trials Office (CTO) is required to have a data safety and monitoring plan (DSMP) that describes how the study will be audited for safety and data integrity including the reporting of adverse events. The general elements of a DSMP are (1) Adverse Event Reporting, including a description of adverse event determination/reporting procedures; proposed adverse event reporting schedules; determination regarding who is to receive adverse event reports; (2) Data, Safety and Progress Reporting with a timetable for data submission and monitoring; (3) Rules to trigger study closure including the rules and processes for implementing study closure based upon significant risks, benefits, or study futility determination and procedures and guidelines for unblinding/unmasking; (4) Methods for ensuring protection of data confidentiality and study privacy; and (5) Review of PI qualifications to conduct the particular clinical study for which DSMP is being considered. The Monitoring Office will coordinate, conduct and/or oversee all clinical trial monitoring. All investigatorinitiated interventional trials will be audited annually. The Monitoring Committee (DSMC) will review all reports of monitoring activities of active protocols annually. These reviews are in addition to the reporting requirements established by the IRB, which may include semi-annual as well as annual reports. The DSMC will also be responsible for overseeing all Phase I investigator-initiated trials.