NAPS2 Data Management and Statistics Core

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ABSTRACT: NAPS2 DATABASE MANAGEMENT AND STATISTICS (DMS) CORE The Data Management and Statistics (DMS) Core of the North American Prodromal Synucleinopathy Consortium on RBD, Stage 2 (NAPS2) will serve as both a collaborator and a valuable resource for the Cores and the Project focused on predicting phenoconversion. The DMS Core will assist in the application of appropriate statistical and methodological techniques as well as leading and collaborating data analysis and report preparations for all Cores and the Project. We will work with the Administrative and Clinical Cores and study sites to ensure target enrollment is achieved and the data collected is scrutinized with the highest quality control (QC) standards which include training on Part 11 compliance systems and procedures, data monitoring, queries and cleaning. We will work with the other Cores to integrate their collected data, providing additional QC through bi-annual data freezes. The DMS Core’s assistance is specifically needed for analysis of associations among longitudinal growth/decline and symptomatic conversion patterns of all disease markers. The DMS Core is imperative for providing a central standard data set, both retrospectively from the existing NAPS1 data, and prospectively collected data in NAPS2 which will avoid study inconsistencies and varying approaches. By using this centralized and standardized approach and providing expertise in deep learning analysis across cores and machine learning, we can offer the highest quality data which in turn will create the most reliable results for the Project. The NAPS2 DMS Core will act as a resource to all investigators, including those outside of the NAPS2 Consortium to assist with reliable and reproducible data analysis. It is the mission of the DMS Core to enhance and support the research objectives of the NAPS2 Consortium by providing timely and reliable data management and appropriate analytic expertise which will ultimately lead to optimal trial planning and future clinical trials for synucleinopathies in RBD participants.