Data and Safety Monitoring/Quality Assurance Committee The University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC) Data and Safety Monitoring and Quality Assurance Committee (DSM/QAC) serves the monitoring function of the Protocol Review and Monitoring System. It monitors patient safety and timely accrual of patients entering three categories of clinical trials at UMGCC: investigator-initiated trials of any Phase;all Phase I trials irrespective of sponsor;and NCI-sponsored or corporate Phase II trials where an independent DSM committee is not active. Cooperative group trials and industry-sponsored Phase III trials do not routinely fall under the purview of DSM/QAC, because these trials have established DSM programs. UMGCC's DSM/QAC is available for use by trials for which a DSM program is absent. According to a timeline that predates submission of a clinical trial's Annual Report to UM's Institutional Review Board (IRB), the DSM/QAC reviews accrual, determines if the rate of accrual allows for completion of the trial within 3-5 years from inception, and examines external and internal severe adverse events and new information from the sponsor to determine if a change in informed consent is warranted. DSM/QAC also performs other activities, including (a) reviewing, through a safety monitor, dose escalations contemplated during Phase I trials at UMGCC, irrespective of sponsor;(b) reviewing, every 6 months, clinical trials that the Clinical Research Committee deems to be of """"""""highest risk"""""""";(c) reviewing monthly reports of external adverse events (AEs) that are received from sponsors to define whether expedited reporting to UM's IRB is warranted and/or altering informed consent is warranted;and (d) collaborating as requested by UM's IRB for prospective monitoring of specific trials or considering the outcome of audits by the IRB. In Fiscal Year 2007, 108 protocols were reviewed;of these, 21 were safety reviews. Of 76 protocols reviewed for continuance, the committee approved 47 (61 percent) as is, approved 10 (13 percent) pending corrective action, closed 8 (11 percent), suspended and/or required 5 (7 percent) to undergo additional review, and deferred 6 (8 percent) until receipt of more information.
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