! Administrative Core Abstract: The Advancing Reliable Measurement in Alzheimer's Disease and cognitive Aging (ARMADA) Administrative (Admin) Core will provide overall administrative and organizational oversight. It will manage and support the Cores and the Research project to validate and norm an expanded NIH Toolbox for Assessment of Neurological and Behavioral Function (NIHTB+) focused on older adults, age 65-85 with normal cognition, amnestic mild cognitive impairment (aMCI) or early dementia due to Alzheimer's Disease (AD). Additional measures will be evaluated for inclusion in the NIHTB to enhance its value in AD research. The Admin Core will establish and implement administrative, statistical and technical support structures to enable any needed measure modification and development, and insure the efficient collection, analysis and storage of data. Additionally, the Admin Core will facilitate and support the integration of ARMADA within the National Alzheimer's Coordinating Center (NACC; PI: Kukull). Our Admin Core is comprised of professionals highly experienced in the management of large networks of scientists devoted to developing, validating, and applying outcome measures, including the NIHTB and other adult assessments. The Admin faculty and staff are at present responsible for curating the current NIHTB under funding provided by the NIH-funded Patient Centered Assessment Resource (PCAR, see www.healthmeasures.net). We have broad experience in managing and coordinating multi-component research, maintaining fiscal accountability, handling intellectual property (IP) issues, participating in FDA initiatives, regulatory compliance, self-assessment and evaluation, and overall operational, meeting, and logistical planning. We propose to parlay this experience to insure the effective and efficient support of the ARMADA team. The Admin Core will oversee legal and regulatory compliance, including data security, establishing and implementing mechanisms to protect IP, maintaining and documenting regulatory compliance, and preparing documentation to enable FDA approval of the extended NIHTB measures in clinical trials. The core will work collaboratively with the Technology Core and the Data and Statistical Analysis Core to monitor data security and backup across all ARMADA sites. The Admin Core will train and provide resources to the sites to insure successful data collection, using standardized procedures and continuous site support, and offer in-person training in utilizing didactics, simulations/role playing, demonstrations with hands-on practice, reviews, feedback, and discussions. They will visit sites annually to certify that local data collection is appropriate and consistent across all of the sites and provide sites with continuous support for technological and operational issues as well as score interpretation. !
|Besser, Lilah; Kukull, Walter; Knopman, David S et al. (2018) Version 3 of the National Alzheimer's Coordinating Center's Uniform Data Set. Alzheimer Dis Assoc Disord 32:351-358|