Administration Core

项目概要/摘要-管理核心（核心A） 在这一更新申请中，我们提出了推进一个全新的 肾结石的治疗方法有哪些？在下一个财政年度，我们将 开发并提供一种多功能集成的基于超声的治疗系统， 分离并排出结石。这将是一项重要的工作。研究将在五点进行 该研究所是一个由50多名研究人员、工作人员、顾问和顾问组成的团队。整体研究 战略是复杂的。项目和核心之间的许多协同作用需要仔细考虑， 协同由于这些原因，一个强大的管理核心是必不可少的计划的成功。 我们在这个PPG的第24年。在这段时间里，我们在国际社会中享有显著的稳定， 参与机构和我们的主要人员。目前的建议包括两个项目（项目1和2）， 应用物理实验室（APL）-华盛顿大学（UW）， 加州理工学院，以及华盛顿大学泌尿系和机械工程系。第三个项目（项目3）在 印第安纳州大学（IU）与IU健康，牛津大学和伊利诺伊大学分包合同。的 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C）将在APL-UW。 核心（核心B）将为IU。我们有一个董事会来监督临床影响，一个外部顾问 委员会，以确保严格性和可重复性，数据安全监测委员会的安全审查的临床试验，和 研究监查以确保法规遵从性。 根据我们的经验，在管理像我们这样的多机构项目时， 使各个团队保持在正确的轨道上，不断努力完成共同的目标和目的。 我们在这方面取得了巨大的成功。我们所取得的成就的关键在于 几个基本要素。我们的研究人员擅长合作科学，我们工作得非常好。 作为个人，我们共同致力于集团的整体成功，我们通过保持 沟通在一个非常高的水平。这是一种成功的团队科学，由强有力的行政领导推动。 具体而言，核心A为计划项目提供以下财政、科学和监管领导： ·目标1。提供财政管理; ·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， 利用核心资源; ·目标4。与PPG顾问、安全性和研究监查员以及NIDDK联络; ●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.