Protocol Review and Monitoring System

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM The Buffett Cancer Center (BCC) has established a process by which proposed BCC clinical and population science research protocols undergo internal peer review for scientific merit and prioritization prior to University of Nebraska Medical Center (UNMC) Institutional Review Board approval. The BCC SRC is a multidisciplinary committee charged with overseeing the scientific aspects of cancer-related research involving human subjects conducted by members of the UNMC faculty and students, and BCC 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 BCC SRC has the authority to approve, require modifications, or disapprove research activities that fall within its jurisdiction. The SRC confirms the scientific validity of the proposed study, and assesses the feasibility of the study relative to the availability of human subjects and ongoing protocols based on enrollments from that same or patient and/or subject population. The BCC 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, to enhance the scientific merit and/or the logistics of the planned study. Initial review includes two stages, beginning with preliminary review and approval by the Disease Focused Teams (DFTs) followed by the SRC review. National, Externally Peer Reviewed and Multi-Institutional studies with an approved NCI Designated or Comprehensive Center as the lead site, received expedited review, which focuses on priority and feasibility. The BCC SRC members are selected to represent the broad spectrum of oncology research. The BCC SRC has broad expertise with representation from Medical, Surgical, Pediatric and Radiation Oncology, Pharmacology, Pathology, Nursing and Biostatistics. The Committee also has broad expertise in hematological malignancies and solid tumors, as well as in clinical research in supportive care and symptom management. Any Cancer Center member with expertise specific to a particular protocol may also be asked to serve as an at-large or ad-hoc reviewer based on their unique qualifications or when expertise is not available from SRC members.