Protocol Review and Monitoring System (PRMS)

点击翻译按钮获取中文摘要

Project Summary/Abstract: Protocol Review and Monitoring System The Norris Cotton Cancer Center (NCCC) has established a process by which clinical trials/population science studies proposed by Cancer Center Members undergo internal peer review. This review must occur prior to local Institutional Review Board (i.e., the Dartmouth College Committee for the Protection of Human Subjects [CPHS]) submission and review. The protocol review and monitoring system is overseen by the protocol review and monitoring committee (PRMC) which at NCCC is known as the Clinical Cancer Review Committee (CCRC). The CCRC is responsible for assessing the scientific validity of proposed studies, determining their prioritization and feasibility in light of the availability of human subjects and current protocols relying on enrollments from that same patient population, assuring that the safety monitoring plan is appropriate and in accordance with regulations, and where necessary offering constructive comments that enhance either scientific merit or implementation logistics of the proposed clinical study. The NCCC CCRC is a chartered multidisciplinary committee charged with reviewing all non-NCI Cooperative group research protocols and amendments proposed to be opened by Dartmouth Principal Investigators (PIs) for treatment of, and intervention for, cancer. Cancer prevention studies, screening trials, behavioral studies, quality of life/survivorship studies, and interventional trials that rely on collection of patient-reported outcomes that have not already undergone external peer review by NIH and its funding agencies are reviewed by the Population Science Subcommittee (PSS) of the CCRC. The CCRC has the ultimate authority to approve, require modifications, or disapprove of research activities and terminate studies that fall within its jurisdiction. Situations where CCRC will close studies include when they have a negative safety outcome, have low accrual, or if the study will not achieve its scientific objectives. CCRC members are selected to represent the broad spectrum of oncology expertise. Cadre membership includes representatives from medical oncology, hematology, surgical oncology, pediatric oncology, clinical pharmacology, biostatistics, basic science research, population science, clinical research administration, and research participant advocacy. Other disciplines, such as Radiation Oncology, Pathology, Immunology and translational biomedical engineering, are represented by members on an ad-hoc basis when a proposed clinical trial features such components in its main objectives.