Protocol Review & Monitoring System (PRMS)

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Project Summary/Abstract: Protocol Review & Monitoring System The Fred and Pamela Buffett Cancer Center (FPBCC) has established a process by which proposed FPBCC clinical and population science protocols undergo internal peer review for scientific merit and prioritization prior to University of Nebraska Medical Center (UNMC) Institutional Review Board approval. Reviews by the FPBCC Scientific Review Committee (SRC) are to confirm the scientific validity of the proposed study, and to assess the feasibility of the study relative to the availability of human subjects and current protocols based on enrollments from that same patient and/or subject population. The FPBCC SRC review also assures that the data and safety monitoring plan for the proposed clinical trial is appropriate and in accordance with regulations, and provides feedback and recommendations to the investigator (if warranted) to enhance the scientific merit and/or the logistics of the planned study. The FPBCC SRC is a multidisciplinary committee charged with overseeing the scientific aspects of cancer-related research involving human subjects conducted by UNMC students and faculty, including FPBCC members. Cancer prevention studies, screening trials, behavioral studies, quality of life / survivorship studies, and interventional trials that rely on collection of patient-reported outcomes are reviewed by the SRC. The FPBCC SRC has the authority to approve, require modifications, or disapprove research activities that fall within its jurisdiction. FPBCC SRC members are selected to represent the broad spectrum of oncology research. The FPBCC SRC has broad expertise with representation from Medical Oncology, Surgical Oncology, Pediatric Oncology, Radiation Oncology, Pathology, and Biostatistics. The SRC has broad expertise in hematological malignancies and solid tumors, as well as in clinical research focused on supportive care and symptom management. Any Cancer Center member with expertise specific to a particular protocol may also be asked to serve as an ad hoc reviewer based on his/her unique qualifications when the relevant expertise is not available from SRC members.