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INFORMATION FOR

Office of Quality Assurance and Monitoring

Yale Cancer Center has partnered with the Yale Center for Clinical Investigation to create a quality assurance and safety monitoring system to support investigators and improve the quality of clinical research at Yale. The Office of Quality Assurance and Monitoring is an administrative arm of Yale Cancer Center dedicated to the management and coordination of the Center’s Protocol Review and Monitoring (PRMS) and Data and Safety Monitoring (DSM) functions in order to support, facilitate, and assure the highest quality clinical research at Yale.

Three major components provide for clinical research review and oversight: the Protocol Review Committee (PRC), the Protocol Lifecycle Subcommitte (PLCS) of the PRC, and the Data and Safety Monitoring Committee (DSMC), and OPRM manages and tracks all committee and related activities. These committees are responsible for reviewing and monitoring all Cancer clinical protocol science, designs and analyses, use of Center resources, continued progress, and data and safety compliance.

The Office of Quality Assurance and Monitoring has partnered with the Yale Center for Clinical Investigation to create a quality assurance and safety monitoring system to support investigators and improve the quality of clinical research at Yale. The Office of Quality Assurance and Monitoring is an administrative arm of Yale Cancer Center dedicated to the management and coordination of the Center’s Protocol Review and Monitoring (PRMS) and Data and Safety Monitoring (DSM) functions in order to support, facilitate, and assure the highest quality clinical research at Yale.

Three major components provide for clinical research review and oversight: the Protocol Review Committee (PRC), the Protocol Lifecycle Subcommittee (PLCS) of the PRC, and the Data and Safety Monitoring Committee (DSMC), and OPRM manages and tracks all committee and related activities.These committees are responsible for reviewing and monitoring all Cancer clinical protocol science, designs and analyses, use of Center resources, continued progress, and data and safety compliance.

The Office of Quality Assurance and Monitoring also provides an ongoing training and education program for clinical research staff to assist them in managing clinical trials and complying with regulatory requirements.

Protocol Review Committee I (PRC I)

Chair: Barbara Burtness, MD
Vice-Chair: Hari Deshpande, MD
Contact: Niece Hanna, MS
Phone: 203-785-7408 or prc.ycc.committees@yale.edu

Protocol Review Committee II (PRC II)

Chair: Antonio Omuro, MD
Vice-Chair: Stacey Stein, MD
Contact: Niece Hanna, MS
Phone: 203-785-7408 or prc.ycc.committees@yale.edu

Protocol Life Cycle Subcommittee (PLCS) of the PRC

Chair: Steven Gore, MD
Contact: Dismayra Martinez, MHE, CCRP
Phone: 203-737-3537 or prc.ycc.committees@yale.edu

Data and Safety Monitoring Committee (DSMC)

Chair: Daniel Petrylak, MD
Vice-Chair: Edward Snyder, MD and Amer Zeidan, MBBS
Contact: Dismayra Martinez, MHE, CCRP
Phone: 203-737-3537 or dsmc.ycc.committees@yale.edu

The Office of Quality Assurance and Monitoring operates under guidelines determined by the National Cancer Institute’s requirements for funding within the Cancer Center Support Grant (CCSG).