The Data and Safety Monitoring Program (DSMP) has been reviewed and approved by the UAB IRB and the NCI. It provides procedures for rigorous monitoring of all Cancer Center therapeutic clinical trials consistent with national and institutional guidelines. It utilizes three Cancer Center entities in addition to the UAB IRB - (1) the Clinical Trial Monitoring Committee (CTMC), (2) the Quality Assurance Committee (QAC), and (3) the Clinical Trial Network and Monitoring (CTNM) Office. The CTMC meets weekly to rigorously review patient data and safety by specific disease sites so that each clinical trial has oversight at least monthly with documentation of review and reports to the QAC (e.g. breast and melanoma - first Friday;Gl and GU - second Friday, etc.). The QAC meets monthly and reviews CTMC reports and reports of QAC internal audits on investigator-initiated trials not otherwise audited. These internal QAC audits average 24/year. The CTNM Office provides investigators with the capacity for IND held and/or multi-institutional trials. It provides the "sponsor" responsibilities including source document verification, monitoring, and FD/VIRB reporting as well as multi-site coordination and oversight. The DSMP of the Cancer Center provides assurance of the quality and safety of clinical trials for patient participants and clinical investigators according to federal and institutional guidelines.
The Data Safety and Monitoring Program is a critical component to coordinating high quality clinical and translational research. Thus, this program is extremely relevant to a primary mission of the Cancer Center.
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