Protocol Review and Monitoring (PRMS)

点击翻译按钮获取中文摘要

Project Summary/Abstract (Description): Protocol Review & Monitoring System Norris Cotton Cancer Center (NCCC) has established a process by which Cancer Center Members undergo internal peer review of the scientific merit and prioritization of proposed clinical trials and population science protocols prior to Institutional Review Board review (i.e., Dartmouth's Committee for the Protection of Human Subjects [CPHS]). These NCCC reviews are to confirm the scientific validity of the proposed study, to assess the feasibility of the study in light of the availability of human subjects and current protocols relying on enrollments from that same population, to assure the safety monitoring plan is appropriate and in accordance with regulations, and to offer comments that could enhance either scientific merit or implementation logistics of the planned study. NCCC's Clinical Cancer Research Committee (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 CCRC Population Science Subcommittee (PSS). The CCRC has the authority to approve, require modifications in, or disapprove research activities that fall within its jurisdiction. CCRC members are selected to represent the broad spectrum of oncology research. Cadre membership includes representatives from medical oncology, hematology, surgical oncology, pediatric oncology, clinical pharmacology, biostatistics, basic science research, population science, clinical research administration, and patient advocacy. Other disciplines such as Radiation Oncology, Pathology and Immunology are represented by members on an ad-hoc basis when a clinical trial features such components in its main objectives.