The Protocol Review and Monitoring System (PRMS) of the CCC consists of a Clinical Scientific Review Committee [CSRC] and its Executive Committee which act together to review all cancer-related clinical protocols for scientific merit, to assign study priorities, and to monitor the scientific progress of trials. Since the last PRMS approval, the CSRC has been reorganized, protocol review criteria have been formalized, PRMS policies and procedures have been established and AN Executive Committee has been created. The streamlined CRC now consists of 18 members (including 2 ex officio) representing all clinical CCC programs and all specialties in clinical oncology, biostatistics, basic science, and population-based research. During monthly meetings, t he committee performs a scientific review of all cancer-related clinical protocols with approval required prior to review by the Institution Review Boards [IRB] of OSU and Columbus Children's Hospital. Primary and secondary reviewers are required to include at a minimum a clinical oncologist [physician] and a biostatistician. Reviews adhere to a review form to assure that all review criteria are addressed. Based on scientific merit and institutional patient resources, the CSRC establishes protocol priorities for accrual in the event that study eligibility criteria may overlap. Ongoing studies are monitored for scientific progress every six months. Investigators of studies that fail to maintain accrual are warned and given three months to increase accrual The CSRC terminates studies that do not show increased accrual, demonstrate an increased number of adverse events, or fail to meet accepted standards of quality control based on formal audits. The Executive Committee of seven CSRC members meets monthly to assign reviews to submitted studies and to assist the CSRC in determining study priorities and in monitoring scientific progress.
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