Data Safety Monitoring Committee (DSMC) of the NYU Cancer Institute operates based on the 2001 NCI approved Charter. The DSMC reports to the NYU Cancer Institute Clinical Cancer Investigation Committee (W. Carroll, M.D. Chair;Deputy Director of NYUCI). The DSMC is responsible for monitoring safety, conduct and compliance with protocol data monitoring plans for clinical trials in the Cancer Institute that are not monitored by any other institution or agency, and review of all internal serious adverse events on clinical trials in the Cancer Institute. The scope of this internal DSMC review includes Phase I, Phase II, and Phase I/II studies that are: ? NYU Investigator - Initiated protocols ? NCI Protocols-not reviewed by NCI ? NY GOG - NYU coordinating site The DSMC is composed of clinical investigators/oncologists who are members of the NYUCI, and biostatisticians from the Biostatistics Shared Resource (BSR) who are experts in clinical trial methodology and conduct. The DSMC is supported by staff from the BSR and Clinical Trials Office (CTO). Table 1 lists the members of the DSMC and the staff. The membership of the DSMC is designed to ensure that should there be a conflict of interest for the Chair because of her role on a specific clinical trial, then the Deputy Chair takes over. The same is true for the Oncology members. Additional ad hoc members are also recruited as needed. The DSMC meets monthly to review ongoing clinical trials. This monthly review includes monitoring of three aspects of the protocol: study conduct, safety, and compliance with the data safety monitoring plan. Monitoring for study conduct includes review of: accrual rates, eligibility, compliance, protocol violations, and dropouts. Monitoring for safety includes review of: adverse events (AEs), treatment related AEs, serious adverse events (SAEs), and, for phase I studies, dose limiting toxicities (DLTs). For Phase II studies, compliance with the protocol defined stopping rules is also reviewed along with the results of planned interim analyses. All reviews are based on data provided to the Committee by the Principal Investigator and the CTO. Verification of accuracy of data is conducted by the Internal Audit Committee and editing and validation procedures implemented as part of the data management processes and procedures.

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