Administration Core

项目摘要/摘要--管理核心(核心A) 在这次续订申请中，我们提出了推进一个全新的 肾结石非侵入性外科治疗的概念。在下一个资助期内，我们会 开发和提供基于超声的多功能集成治疗系统，该系统可以成像、破裂、 分离并驱逐石头。这将是一项重大的任务。研究将在5点进行。 该团队由50多名研究人员、工作人员、顾问和顾问组成。整体研究 战略是复杂的。项目和核心之间的众多协同作用将需要仔细考虑 协调。出于这些原因，一个强有力的行政核心对该方案的成功至关重要。 我们现在是这个PPG的第24年。在这段时间里，我们在 参与机构和我们的关键人员。目前的提案包括两个项目(项目1和项目2) 应用物理实验室(APL)-华盛顿大学(UW)，分包合同/分项预算 加州理工学院，以及威斯康星州大学泌尿系和机械工程系。第三个项目(项目3)在 印第安纳大学(IU)，分包给IU-Health、牛津大学和伊利诺伊大学。这个 行政核心(核心A)和工程核心(核心C)将在APL-UW，而统计 核心(核心B)将在Iu。我们有一个董事会来监督临床影响，一个外部咨询 确保严密性和重复性的委员会，用于临床试验安全审查的数据安全监测委员会，以及 研究监控以确保法规遵从性。 根据我们的经验，管理像我们这样的多机构项目的主要挑战是 使各个团队保持在正轨上，不断努力实现共同的目标和目的。 我们在这方面取得了巨大的成功。我们所能做到的蒸馏的关键是 几个基本要素。我们的研究人员擅长协作科学，我们工作得非常好 作为个人，我们共同致力于集团的全面成功，我们通过不断 在非常高的层次上进行沟通。这是一种成功的团队科学，得到了强有力的执行领导力的推动。 具体地说，核心A为计划项目提供财政、科学和监管领导，具体如下： 目标1.提供财务管理； 目标2.促进科学进步和生产力； 目标3.促进和监测项目之间的协同合作，并使 核心资源的利用； 目标4.与PPG顾问、安全和研究监督员以及NIDDK保持联系； 目标5.保持监管批准和合规性。

PROJECT SUMMARY/ABSTRACT - Administration Core (Core A) In this renewal application, we propose the basic and applied research needed to advance an entirely new concept for the non-invasive surgical management of kidney stones. During the next funding period, we will develop and deliver a multifunctional integrated ultrasound-based therapy system that images, breaks, detaches and expels stones. This will be a significant undertaking. The research will be performed at five institutions and involve a team of over 50 researchers, staff, consultants, and advisors. The overall research strategy is complex. The numerous synergistic interactions among the Projects and Cores will require careful coordination. For these reasons a robust Administration Core is essential to the success of the Program. We are in Year-24 of this PPG. Over this time, we have enjoyed remarkable stability among the participating institutions and our key personnel. The current proposal includes two Projects (Projects 1 & 2) at the Applied Physics Laboratory (APL)-University of Washington (UW) with subcontracts/sub-budgets to CalTech, and the UW Departments of Urology and Mechanical Engineering. A third Project (Project 3) is at Indiana University (IU) with subcontracts to IU-Health, Oxford University, and the University of Illinois. The Administration Core (Core A) and the Engineering Core (Core C) will be at the APL-UW, while the Statistical Core (Core B) will be at IU. We have a Board of Directors to oversee clinical impact, an External Advisory Board to assure rigor and reproducibility, a Data Safety Monitor Board for safety review of clinical trials, and a study monitor to assure regulatory compliance. In our experience the main challenge seen in administering a multi-institutional Program such as ours is in keeping the individual teams on track, working continually toward completion of shared goals and objectives. We have had tremendous success at this. The key to what we have been able to accomplish distills down to several essential elements. Our investigators are skilled at collaborative science, we work extremely well together, as individuals we are dedicated to the overall success of the group, and we build by keeping communication at a very high level. This is successful team science facilitated by strong executive leadership. Specifically, Core A provides fiscal, scientific, and regulatory leadership for the Program Project as follows: ● Aim 1. Provide fiscal stewardship; ● Aim 2. Facilitate scientific progress and productivity; ● Aim 3. Promote and monitor synergistic collaboration among the Projects and enable productive utilization of Core resources; ● Aim 4. Liaise with PPG advisors, safety and study monitors, and the NIDDK; ● Aim 5. Maintain regulatory approval and compliance.