Core C: The Data Management and Statistics Core

项目总结/文摘

PROJECT SUMMARY/ABSTRACT The Data Management and Statistics Core (DMSC) will provide the central informatics architecture for the proposed COBRE Center for Neurodegeneratation and Translational Neuroscience (CNTN). DMSC will support the core projects and their junior investigators through database management and statistical expertise. This will include database construction, data management expertise, web portal design and development, user management tools, statistical expertise, consultation to researchers on feasibility and design; consultation on bio-statistical issues throughout research activities, and perform data analyses. Data will be transmitted to the CNTN Data Center via a distributed web-based data entry system that is 21 CFR Part 11 validated and compliant. The DMSC will establish standardized systems and operational protocols and will train and certify the clinical personnel responsible for collection and entry of the data. Clinical researchers will have the option to use any device (ex. tablet, laptop, desktop) that provides secure access to the Internet. All of the goals of the CNTN and the unique translational structure of the CNTN are data-driven and require best practices in data management, cyber security and statistics. Specifics include: design and establish data flow schemes for each core group and any new pilot studies; monitor, assess, and troubleshoot deviations in established data flow schemes of research and data collection efforts; construct, update, and/or refine data collection forms; manage the CNTN software infrastructure such as SAS-based data processing; maintain a central data dictionary and document all database changes; manage the administrative and analytical inventories of DMSC; monitor validation and verification edits among cores; manage scheduling and participant tracking; manage sample inventory and tracking, including requests; design, maintain, and track usage on CNTN's websites, both Internet and Intranet; provide monthly reports to the CNTN leadership team; assist all Cores in maintaining compliance with Federal regulatory requirements; coordinate and perform required data submissions to CNTN leadership in a timely and accurate manner.