The Kimmel Cancer Center Protocol Review and Monitoring System (PRMS) consists of a Clinical Cancer Research Review Committee (CCRRC). This committee is lead by Dr. George Lewis, an oncologist who was the co-founder of the Gynecologic Oncology Group. Day to day coordination of CCRRC activities is provided by Steven Mervis, CTSO director. The CCRRC reviews all cancer-related information protocols for scientific merit, to assign study priorities, and monitor the scientific progress of trials. Since the last PRMS approval, the CCRRC has been reorganized, protocol review criteria have been formalized. PRMS policies and procedures have been established. The streamlined CCRRC now consists of 19 members representing all clinical KCC programs and all specialties in clinical oncology, biostatistics, basic science, and population-based research. During monthly meetings, the committee performs a scientific review of all cancer-related clinical protocols with approval required prior to review by the Institutional Review Boards [IRB] of Thomas Jefferson University. 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 CCRRC establishes protocol properties 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 give three months to increase accrual. The CCRRC terminates studies that do not show increased accrual, demonstrate an increased number of adverse events, or fail to meet accepted standards of quality control base on formal audits.
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