The conduct and oversight of the progress of trials and safety of participants is achieved in many ways through development, review and performance throughout the lifecycle of the research study. In addition to the important role of the principal and co-investigator(s), the research team(s) and the individual Cancer Center Disease Programs to this endeavor, the Clinical Protocol Scientific Review and Monitoring Committee (CPSRMC) of the Cancer Center is at the core of this process. The scope and responsibilities of this Committee have evolved over time to provide rigorous and supportive review and monitoring of clinical investigations within the Cancer Center. Initially established in 1992 as the Scientific Review Board and following the then current NCI guidelines, the committee initially focused on scientific validity, study design and appropriates of statistical endpoints of protocols that did not have external peer review. Based on a desire to extend this review to all protocols in the Cancer Center, the scope and responsibilities of the committee were expanded in 1995 with a new charter and newly appointed members. More recently additional changes to enhance the process include a requirement for submission to the CPSRMC of a programmatic protocol review;adoption of a risk-based model for monitoring of clinical trials and strengthening the committee membership with additional senior researchers. In its current functions the CPSRMC reviews the scientific rationale, feasibility, study and biostatistical designs, and provides oversight to the progress of all institutional protocols to ensure adherence to initial study design, timely accruals, stopping criteria are followed and that patient safety is maintained. In addition, the CPSRMC is empowered to modify study conduct or close studies.

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National Cancer Institute (NCI)
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St. Jude Children's Research Hospital
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Wu, Jianrong (2015) Power and sample size for randomized phase III survival trials under the Weibull model. J Biopharm Stat 25:16-28
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