Data Safety and Monitoring

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The Data & Safety Monitoring Plan (DSMP) adopted by the H. Lee Moffitt Cancer Center & Research Institute originally in 2002 ensures that all clinical research conducted or coordinated by the Cancer Center is scientifically well designed, responsibly managed, appropriately reported, and that it protects the rights and welfare of human participants. The institutional plan conforms to NIH and NCI policies and guidelines regarding data and safety monitoring. The characteristics and degree of monitoring is individualized for each study according to the degree of risk involved to the individual participants and the complexity of the clinical research. As the specific types of monitoring and reporting will vary by the nature of the individual trial, the responsibility for ensuring that monitoring is appropriate, timely and effective includes a number of Cancer Center groups. The Associate Center Director for Clinical Investigations holds overall responsibility for data and safety monitoring. Other entities that have a role in data and safety monitoring include: Principal Investigators (PI) and study teams; the Clinical Research Operations (CRO) department; the Institutional Protocol Monitoring Committee (PMC); External Data Safety Monitoring Board (DSMB) (if applicable); the Research Compliance - Corporate Compliance Office; and the University of South Florida Institutional Review Board (USF IRB). The PMC, chaired by Dr. Pamela Munster, reviews all interim reports submitted by the study team to ensure that the study is being conducted as written. The PMC also review audit reports submitted by clinical trial auditors in the Research Compliance Division of the Corporate Compliance Department to assure compliance with protocol treatment and adherence to regulatory requirements. The monitoring and auditing functions report to two different entities in the Cancer Center to ensure appropriate checks and balances.