Protocol Review and Monitoring System

$38,797P30FY2018CANIH

Beckman Research Institute/City Of Hope, Duarte CA

Investigators

Linked publications & trials

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Abstract

PROJECT SUMMARY (See instructions): The COHCCC Protocol Review and Monitoring System is implemented through the activities of its Cancer Protocol Review and Monitoring Committee (CPRMC). The CPRMC focuses on scientific merit, scientific priorities, and scientific progress of Cancer Center clinical research, working collaboratively with the Data and Safety Monitoring Committee (DSMC) in accordance with the COHCCC Data and Safety Monitoring Plan. The role of the CPRMC is to: 1) maintain and improve the quality of institutional clinical research; 2) prioritize clinical research conducted by Cancer Center members; and 3) provide a pathway for innovative clinical cancer research to access Cancer Center shared resources and protocol specific research support. Committee review and voting is required for all new trials, amendments, and annual continuation reviews. The scientific review process for new trials includes an evaluation of study design, scientific rationale, feasibility and biostatistical methodology. Annual continuation reviews include an examination of actual vs. expected accrual and continued relevance of the research question. The CPRMC provides a centralized mechanism for evaluating the scientific merit of all cancer clinical trials and prioritizes studies for access to COHCCC clinical trial resources. Funding is requested for partial salary support for the Chair of the CPRMC, the Director of Scientific and Safety Review, two Protocol Analysts and a Clerical Specialist supporting the work of protocol review and monitoring. All other remaining costs are covered by institutional funds.

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