PROJECT SUMMARY/ABSTRACT—LEADERSHIP GROUP The leadership group (LG) will provide strategic and operational direction to the Center. The LG consists of a director, a senior project manager, the disease-specific group leaders, the centralized group leaders, an operations team, and various other Center committees. DAIT staff representing each of the three disease areas, bioinformatics, regulatory, and statistics (as needed) will also be considered part of the larger, external leadership group. The proposed LG steering committee provides consistency and clear communication across multiple studies and functional groups. The LG structure is designed to meet the following primary objectives: • Centralize and facilitate open lines of communication between Center group leaders and DAIT • Standardize processes and procedures across the entire program • Address high-level issues regarding study design, implementation, and analysis • Keep the Center current with industry and NIH standards • Provide administrative support to the Center • Allocate resources across the Center • Manage the financial aspects of the Center Members of the LG will build on our past success with coordinating DAIT studies to develop effective collaboration and communication channels for the Center. These same channels will be used for decision- making and issue resolution. We have found through our work with large multi-protocol NIH coordinating centers that effective communication requires a combination of approaches, including scheduled and ad hoc meetings and teleconferences, use of a collaboration portal to share documents and status information, and other tools and processes we have developed over time. Ongoing monitoring and tracking of LG functions and progress is essential to maintaining timely, high quality work across the Center. Activities must be monitored at the group level and across the Center. The LG director and senior project manager assume responsibility for monitoring work across the Center. With the goal of providing all stakeholders with the information needed to evaluate progress and identify issues and monitor resources, Rho utilizes a number of standard processes, tools, and activities that can be tailored to the needs of individual projects. As new needs arise, Rho refines these items to continuously improve our tracking and monitoring methods.