Administration Core

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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.