Center Management Operations: Administrative Core The Administrative Core, centered at the University of Minnesota will manage, coordinate, and supervise the entire range of Center activities, monitoring progress, ensuring the data are shared securely and ensuring that a strategic plan is carried out effectively and efficiently. The PI (Dr. Patterson) and Administrative Core staff will be responsible for ensuring that appropriate systems are in place to provide for biosafety and security of materials, data, facilities and compliance with U.S., DHHS and NIH laws and regulations. The Administrative core staff will include Dr. Patterson (Pi/Director), Dr Robert Vince (Co-Director), Dr. Herbert Nagasawa (consultant for scientific coordination), Rebbecca Moen (Minnesota Research Services Organization and Office of Clinical Research) and Wanda Lee (Accounting/Administrative Coordination). Dr. Nagasawa, Professor Emeritus of the University of Minnesota and principal inventor of the mercaptopyruvate prodrugs, now resides in Irvine, California, which is close to the U C Irvine and U C San Diego campuses. Therefore, he is geographically ideally situated to coordinate the sharing of research and other information among the research groups. Dr. Nagasawa is in continual contact with Dr. Patterson by telephone, e-mail or fax, and meets twice yearly with him. This will continue. In addition,he will met quarterly with with Drs Boss and Brenner (or more often if needed) and will coordinate the experimental data sharing among the three projects. The scientific personnel of the Administrative core (Drs Patterson, Vince and Nagaswa) will assist in developing a data sharing agreement between the individual institutions involved in the grant (Minnesota, U C Irvine and U C san Diego). This should allow the individual project Pis to publish results jointly or independently in peer reviewed journals and present at scientific conferences in a timely manner as required by the NIH data sharing policy without compromise of sensitive information. Private sharing of sensitive data among the individual projects will be will be handled through a secure server located at the Center for Drug Design and information will be transferred to the server via secure FTP. Additional support is available through the University of Minnesota Office of Clinical Research (OCR). The OCR will assist investigators by supporting Data and Safety Monitoring Boards (DSMB), for clinical trials that require one. The OCR will coordinate scheduling of DSMB meetings, recording of minutes, dissemination of data, committee member identification, DSMB reports, and submission of reports to the IRB and other entities as required. The Office of Clinical Research in the Academic Health Center of The University of Minnesota provides full service clinical research support and will serve in this role for any clinical trials conducted within the proposed projects. Specifically, the Office will provide project management, assistance with IND applications, monitoring of clinical trials for regulatory compliance, and support for any Data and Safety Monitoring Boards necessary.
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