Administrative Core

行政核心

• 批准号: 10247037
• 负责人: Elizabeth J Shpall
• 金额: $ 19.04万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-22 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247037
• 关键词: Address; Biometry; Biotechnology; Blood Banks; Budgets; Cancer Center; Cell Therapy; Cells; Child; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Communication; Data Collection; Development; Disputes; Ensure; Equilibrium; Evaluation; Freezing; Funding; Funding Agency; Goals; Grant; Group Meetings; Health system; Human Resources; Individual; Infrastructure; Institution; Institutional Review Boards; Investigation; Investigational Drugs; Jordan; Lead; Leadership; Measurement; Medicine; Operations Research; Oranges; Patients; Principal Investigator; Productivity; Program Research Project Grants; Publications; Recombinant DNA; Recommendation; Regulatory Affairs; Reporting; Research; Research Personnel; Research Project Grants; Resource Sharing; Services; Structure; Supervision; Translations; Umbilical Cord Blood; United States Food and Drug Administration; United States Health Resources and Services Administration; United States National Institutes of Health; Universities; Validation; Visit; Washington; college; meetings; novel; operation; pre-clinical; preclinical study; programs; recruit

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.

项目摘要 行政核心负责运营，通讯，监管和 该计划的财务监督以及拟议赠款的行为的监督。 该计划高度整合，临床前和科学研究直接影响 开发转化临床研究方案。行政核心监督 该计划的运营并促进了报告，调查人员与 访问我们的内部和外部顾问以及外部调查人员。为此进行临床试验 PO1仅在两个主要机构Anderson Cancer Center（MDACC）进行。 在伊丽莎白·谢帕尔博士和儿童国家卫生系统（CNHS）的领导下 在凯瑟琳·鲍拉德（Catherine Bollard）博士的领导下。临床前研究将在另一个 三个PO1机构与包括哈佛大学在内的PO1项目负责人一起 （Robert Sackstein Project 1-Dr。 道格拉斯·尼克松（Douglas Nixon）和鲍拉德（Bollard）博士）和贝勒医学院（BCM）（项目3-乔丹博士 奥兰治和凯蒂·雷兹瓦尼博士）。两个核心A领导者Drs。 Shpall和Bollard一直 自2004年以来紧密合作。他们已经发展了一个持续的和深度 合作，始于Bollard博士在BCM，并无缝转移到 CNHS在2012年被招募时。核心支持机构审查委员会 （IRB），食品和药物管理局（FDA）研究性新药（IND），研究 生物安全委员会（IBC）和国立卫生研究院生物技术活动 重组DNA委员会（NIH/OBA/RAC）提交和临床所需的报告 P01中的协议。核心管理计划人员，帐户和预算 赠款部分，包括正在进行的调查人员帐户余额的报告。这 核心负责为资助机构和研究准备必要的报告 项目和出版物。这种共享资源核心是该PO1的重要组成部分。 拟议的服务将促进调查人员与我们的沟通 顾问；通过采购所有 除了向机构提供持续的报告外，IND和RAC的必要批准以及 将为所有四个项目以及核心C提供CB单位，以实现拟议的目标 和PO1的目标。集中化这些功能可确保最大效率，整合， 一致性和监督，如果每个项目和核心都是 单独负责执行服务。