The Clinical Protocol Office (CPO) is the coordinating center for all UNC Lineberger Comprehensive Cancer Center sponsored local and multi-center trials and the majority of Cooperative Group and pharmaceutical company supported cancer research. The CPO consists of 30 professionals responsible for assisting in protocol development, contract acquisition and management, regulatory oversight and compliance, 9reparation and submission of INDs for novel studies and novel compounds, internal and external study tudits and quality control, and data acquisition and preparation, and management. Since the last critique, the CPO has implemented the ProTrack database, an effective and reliable data storage and retrieval system for managing clinical trials. This database facilitates the timely and accurate submission of numerous INDs to the FDA, as well as expansion of capacity for managing novel institutional and multi-center studies. At the urging of external advisors, the Center has also added a Protocol Office Executive Committee that provides oversight, advice, and direction for policy, study prioritization, and resource allocation. These improvements plus continued staff expansion have enabled the CPO to support increasinly complex, innovative studies such as the Phase I bortezomib (LCCC 9804), a GSK sponsored EGFR trials, and multi-center, Phase III studies such as LCCC 9719. Mark Socinski, MD is the CPO Faculty Director; Joy Ostroff, RN, BBSN, OCN, is the Facility Director. The CPO reports to Dr. Richard Goldberg, Associate Director for Clinical Research. The majority of the proposed increase provides infrastructure to support increased quality (including audit), growing demands for regulation and oversight, and accrual outreach, particularly to minorities.
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