Awardee OrganizationUNIVERSITY OF NEBRASKA MEDICAL CENTER
Description
Abstract Text
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.
No Sub Projects information available for 5P30CA036727-31 5724
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
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Patents
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Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
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Clinical Studies
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History
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