Data and Safety Monitoring

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PROJECT SUMMARY (See Instructions): The Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) ensures the safety of patients who are subjects in clinical research at the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). UMGCC's DSM/QAC reviews in an ongoing fashion Severe Adverse Events (SAEs), internal and external, to define whether expedited reporting to the Institutional Review Board (IRB) ofthe University of Maryland School of Medicine (UMSOM) and/or altering informed consent is warranted. UMGCC's DSM/QAC is recognized by IRB as the DSM body of record for UMGCC protocols that do not have a freestanding, independent DSM process. DSM/QAC reviews in that capacity the following types of protocols: investigator-initiated trials of any phase, all Phase I trials irrespective of sponsor, and NCI-sponsored or corporate Phase II trials for which an independent DSM committee is not active. On at least an annual basis, this entails reviewing the currency and accuracy of the consent form, the protocol regulatory binder, response rates, audit results, and whether accrual during the review period is within the allowed enrollment according to the latest IRB review. DSM/QAC will review audits contracted to and performed by UMSOM's IRB of 50 percent of patients accrued to the protocol types under its purview. DSM/QAC may also direct its own audits, as necessary, of trials under DSM/QAC purview. The timing of the DSM/QAC review is prior to the annual IRB review. Finally, in pursuing its institutional mandate to provide real-time governance of the conduct of early-phase clinical trials, DSM/QAC will also assess Phase I studies for dose-limiting toxicities after each cohort, before dose escalation, and semiannually. DSM/QAC meets monthly and requires a quorum of three members. For calendar year 2009, 129 actions occurred at DSM/QAC meetings. Of these, 93 were annual reviews of protocols, 9 were safety reviews, 13 were reviews of responses from principal investigators to previous queries from DSM/QAC, and 12 were reviews of internal safety reviews or IRB conducted audits, with two protocols suspended as a result (counted as distinct actions). Of the 93 annual reviews, 78 were approved for continuance; 12 remained open but had corrective actions prescribed; and 3 were referred for consideration of closure by the Clinical Research Committee, all with poor accruals.