The P2C National Resource Center for High-Impact Clinical Trials in Medical Rehabilitation (High-Impact Trials Center, HITC) will serve as a catalyst for the design and implementation of rigorous, high-impact clinical trials to advance medical rehabilitation research. Oversight of the Center will be provided by the Administrative Oversight Component (Admin-C) directed by Marcas Bamman, PhD and Associate Directors (ADs) Gary Cutter, PhD and Amie McLain, MD. Assisting the Director and ADs on Center oversight will be three additional Executive Committee members: S. Louis Bridges, Jr., MD, PhD, Kenneth Saag, MD, MSc, and David Standaert, MD, PhD. The central purpose of Admin-C is to oversee all components of the Center; ensuring the needs of medical rehabilitation researchers seeking to conduct clinical trials are met with widely disseminated, open access to the highest of quality resources and services: 1) in clinical trials training and education; 2) in trials planning, implementation, management, and reporting; and 3) to maximize trial efficiency and potential impact by facilitating use of HITC core facilities, databases, and/or existing multicenter networks. Admin-C will also be responsible for the effectiveness of two HITC programs designed to facilitate the development and design of future, high-impact trials: 1) the HITC national Pilot Studies program; and 2) the HITC Validation Laboratory. Admin-C will define the overall direction based on input from the Component Directors, the Center's Internal and External Advisory Panels, and on responses from the investigator base. Admin-C will achieve its central purpose via the following specific aims:
Aim 1. Set priorities and the overall strategic plan of the Center and its Components.
Aim 2. Oversee and evaluate the effectiveness of the four research and service Components (Promo-C, Collab-C, Tech-C, and Pilot-C) to assure that they continuously function in a productive and cost efficient manner to meet the needs of the user base of medical rehabilitation researchers.
Aim 3. Stimulate the continued evolution of the Components to develop new services and resources that will meet the needs of the investigator base.
Aim 4. Oversee the educational enrichment programs designed to bolster the clinical trials knowledge and skills of the user base, leading to higher quality trials.
Aim 5. Ensure effective dissemination of HITC services, resources, funding, educational, and training opportunities to the user base.
Aim 6. Create strategic approaches to expand the HITC user base.
Aim 7. Seek and respond to HITC evaluation by the Internal and External Advisory Panels, and ensure that the recommendations of these panels are instituted.
Aim 8. Seek and respond to HITC evaluation by the user base to: 1) gauge the Center's impact on the medical rehabilitation research community; and 2) ensure continued improvement in both engagement and the quality of services and resources provided.
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