Administrative Core

项目总结 行政核心负责运营、通信、监管和 对该计划的财务监督，以及对拟议拨款行为的监督。 该计划是高度整合的，临床前和科学研究直接影响 转化型临床研究方案的制定。行政核心监督 该计划的运作，并促进报告，调查人员和 我们的内部和外部顾问以及外部调查人员的访问。这方面的临床试验 PO1只在两个主要机构进行，MD安德森癌症中心(MDACC) 在伊丽莎白·施波尔博士和儿童国家卫生系统(CNHS)的领导下 在凯瑟琳·博拉德博士的领导下。临床前研究将在另一家进行 与包括哈佛大学在内的PO1项目负责人合作的三个PO1机构 (项目1--Dr。Robert Sackstein和Shpall博士)、乔治华盛顿大学(项目2--Dr.Shpall)。 Douglas Nixon和Bollard博士)和贝勒医学院(项目3--Jordan博士 奥兰治和凯蒂·雷兹瓦尼博士)。两位Core A领导者Shpall博士和Bollard博士 自2004年以来一直密切合作。他们已经发展了持续和深入的 合作，开始于Bollard博士在BCM时，并被无缝转移到 2012年她在那里被招募时，她在CNHS。核心支持机构审查委员会 (IRB)，食品和药物管理局(FDA)新药研究(IND)，调查 生物安全委员会(IBC)和美国国立卫生研究院生物技术活动办公室 临床所需的重组DNA委员会(NIH/OBA/RAC)提交和报告 P01中的协议。核心管理每个项目的人员、账户和预算 赠款部分，包括调查人员账户余额的持续报告。这个 CORE负责为研究准备必要的报告给资助机构 项目和出版物。该共享资源核心是该PO1的基本和关键部分。 建议的服务将有助调查人员与本署 顾问；促进临床前项目向临床的翻译，通过采购所有 除了向各机构提供持续的报告外，还必须获得IND和RAC的批准，以及 将为所有四个项目提供CB单元以及核心C，以实现拟议目标 和PO1的目标。集中这些职能可确保实现最高效率、集成度、 一致性和监督，如果每个项目和核心都是 个人负责执行服务。

PROJECT SUMMARY The Administrative Core is responsible for the operations, communications, regulatory and financial oversight of the program, as well as supervision of the conduct of the proposed grant. The program is highly integrated and the preclinical and scientific studies impact directly on development of the translational clinical research protocols. The Administrative Core supervises the operations of the program and facilitates reports, communication between investigators and visits of our internal and external advisors as well as outside investigators. Clinical trials for this PO1 are only conducted at the two lead institutions, MD Anderson Cancer Center (MDACC) under the leadership of Dr. Elizabeth Shpall and Children's National Health System (CNHS) under the leadership of Dr. Catherine Bollard. Pre-clinical studies will be performed at the other three PO1 institutions in conjunction with the PO1 Project leaders including Harvard University (Project 1-Dr. Robert Sackstein and Dr. Shpall), George Washington University (Project 2- Dr. Douglas Nixon and Dr. Bollard) and Baylor College of Medicine (BCM) (Project 3- Dr Jordan Orange and Dr. Katy Rezvani). The two Core A leaders, Drs. Shpall and Bollard have been working together closely since 2004. They have developed a sustained and in depth collaboration, which began when Dr Bollard was at BCM and was transferred seamlessly to CNHS when she was recruited there in 2012. The core supports the Institutional Review Board (IRB), Food and Drug Administration (FDA) Investigational New Drug (IND), Investigational Biosafety Committee (IBC), and National Institutes of Health Office of Biotechnology Activities Recombinant DNA Committee (NIH/OBA/RAC) submissions and reporting required for clinical protocols in the P01. The core manages program personnel, accounts and budgets for each section of the grant, including ongoing reports of account balances for the investigators. The core is responsible for preparing the necessary reports to the funding agency, for the research projects and publications. This shared resource core is an essential and critical part of this PO1. The proposed services will facilitate the communication between the investigators and our advisors; facilitate the translation of the pre-clinical projects to the clinic by procuring all the requisite IND and RAC approvals in addition to providing on-going reports to the agencies, and will provide CB units to all four projects as well as Cores C to accomplish the proposed goals and objectives of the PO1. Centralizing these functions assures maximal efficiency, integration, consistency and oversight, which would not be possible if each Project and Core were individually responsible for performing the services.