Center Management Operations: Administrative CoreThe Administrative Core, centered at the University of Minnesota will manage, coordinate, and supervise theentire range of Center activities, monitoring progress, ensuring the data are shared securely and ensuring thata strategic plan is carried out effectively and efficiently. The PI (Dr. Patterson) and Administrative Core staffwill be responsible for ensuring that appropriate systems are in place to provide for biosafety and security ofmaterials, 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. HerbertNagasawa (consultant for scientific coordination), Rebbecca Moen (Minnesota Research ServicesOrganization and Office of Clinical Research) and Wanda Lee (Accounting/Administrative Coordination).Dr. Nagasawa, Professor Emeritus of the University of Minnesota and principal inventor of themercaptopyruvate prodrugs, now resides in Irvine, California, which is close to the U C Irvine and U C SanDiego campuses. Therefore, he is geographically ideally situated to coordinate the sharing of research andother information among the research groups. Dr. Nagasawa is in continual contact with Dr. Patterson bytelephone, e-mail or fax, and meets twice yearly with him. This will continue. In addition,he will met quarterlywith with Drs Boss and Brenner (or more often if needed) and will coordinate the experimental data sharingamong the three projects.The scientific personnel of the Administrative core (Drs Patterson, Vince and Nagaswa) will assist indeveloping a data sharing agreement between the individual institutions involved in the grant (Minnesota, U CIrvine and U C san Diego). This should allow the individual project Pis to publish results jointly or independentlyin peer reviewed journals and present at scientific conferences in a timely manner as required by the NIH datasharing policy without compromise of sensitive information.Private sharing of sensitive data among the individual projects will be will be handled through a secure serverlocated 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). TheOCR will assist investigators by supporting Data and Safety Monitoring Boards (DSMB), for clinical trials thatrequire one. The OCR will coordinate scheduling of DSMB meetings, recording of minutes, dissemination ofdata, committee member identification, DSMB reports, and submission of reports to the IRB and other entitiesas required.The Office of Clinical Research in the Academic Health Center of The University of Minnesota provides fullservice clinical research support and will serve in this role for any clinical trials conducted within the proposedprojects. Specifically, the Office will provide project management, assistance with IND applications, monitoringof clinical trials for regulatory compliance, and support for any Data and Safety Monitoring Boards necessary.
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