CORE--Protocol Review Monitoring System

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DESCRIPTION (adapted from the application): All cancer-related protocols involving a UNMC faculty member or a UNMC Eppley Cancer Center member require review by the Scientific Review Committee. The mission of the Scientific Review Committee is complementary to that of the institutional Review Board (IRB). It does not duplicate or overlap the responsibilities of the IRB, which focuses on the protection of human subjects. The IRB will not issue a full approval for any cancerrelated study involving human subjects without first receiving notice of full approval from the Scientific Review Committee which attests that all scientific requirements for the study have been met. The Scientific Review Committee focuses on the scientific merit, prioritization, and progress of the research. The specific objective of the Scientific Review Committee include: ? Review scientific merit of cancer-related research involving human subjects at the UNMC Eppley Cancer Center. ? Foster development of innovative, collaborative, and scientifically sound studies which focus on the prevention, detection, diagnosis, and treatment of cancer including long-term follow-up and supportive care. ? Aid investigators in the establishment of the prioritization of studies and assure optimal allocation of the Cancer Center clinical and community resources. ? Assist investigators in the development and conduct of clinical cancer studies in conjunction with the Clinical Trials Office. ? Monitor progress of protocols relative to study objectives. ? Monitor accrual, data collection, and safety in conjunction with the Data Safety and Monitoring Committee and the Audit Committee. ? Provide a standard protocol format for submission and review.