Administration

中心管理运营：管理核心 以明尼苏达大学为中心的行政核心将管理、协调和监督 整个中心活动范围，监控进度，确保数据安全共享，并确保 有效、高效地实施战略部署。PI(帕特森博士)和行政核心人员 将负责确保适当的系统到位，以提供生物安全和 材料、数据、设施以及对美国、国土安全部和美国国立卫生研究院法律法规的遵守情况。 行政核心工作人员将包括Patterson博士(PI/主任)、Robert Vince博士(联席主任)、Herbert博士 长泽(科学协调顾问)，Rebbecca Moen(明尼苏达研究服务 临床研究组织和办公室)和万达·李(会计/行政协调)。 明尼苏达大学荣誉退休教授、长泽博士 硫代丙酮酸前药，现在位于加利福尼亚州的欧文，靠近加州大学欧文和加州大学圣迭戈分校 迭戈校园。因此，他的地理位置非常理想，可以协调研究和 研究小组中的其他信息。长泽博士一直与帕特森博士保持联系 电话、电子邮件或传真，每年与他见两次面。这种情况将继续下去。此外，他还将每季度会晤一次 与DRS Boss和Brenner(如果需要，更经常)合作，并将协调实验数据共享 在这三个项目中。 行政核心的科学人员(帕特森博士、文斯博士和长崎博士)将协助 在参与赠款的各个机构之间制定数据共享协议(明尼苏达州，加利福尼亚州 欧文和加州大学圣地亚哥分校)。这应该允许单独的项目PI联合或独立发布结果 在同行评议的期刊上发表，并按照NIH数据的要求及时在科学会议上发表 在不损害敏感信息的情况下共享策略。 各个项目之间敏感数据的私人共享将通过安全的服务器进行处理 位于药物设计中心，信息将通过安全的FTP传输到服务器。 其他支持可通过明尼苏达大学临床研究办公室(OCR)获得。这个 OCR将通过支持数据和安全监控委员会(DSMB)来协助调查人员进行临床试验 需要一个。OCR将协调DSMB会议的日程安排、记录、分发 数据、委员会成员身份、DSMB报告以及向IRB和其他实体提交报告 视需要而定。 明尼苏达大学学术健康中心临床研究办公室提供了完整的 为临床研究提供支持，并将在建议的临床试验中担任这一角色 项目。具体地说，该厅将提供项目管理、协助IND申请、监测 监管合规性的临床试验，以及对任何必要的数据和安全监测委员会的支持。

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.