Core C: The Data Management and Statistics Core

项目摘要/摘要 数据管理和统计核心(DMSc)将为 建议建立科布雷神经退行性变和转化神经科学中心(CNTN)。DMSc将 通过数据库管理和统计专业知识支持核心项目及其初级调查人员。 这将包括数据库建设、数据管理专业知识、门户网站设计和开发、用户 管理工具、统计专业知识、向研究人员咨询可行性和设计；咨询 在整个研究活动中处理生物统计问题，并进行数据分析。数据将被传输到 CNTN数据中心通过基于Web的分布式数据录入系统，该系统已通过21 CFR Part 11验证和 顺从。DMSc将建立标准化系统和操作协议，并将培训和认证 负责数据收集和录入的临床人员。临床研究人员将有权选择 要使用任何设备(例如平板电脑、笔记本电脑、台式机)，提供对互联网的安全访问。世界银行的所有目标 CNTN和CNTN独特的转换结构是数据驱动的，需要数据方面的最佳做法 管理、网络安全和统计。具体内容包括：设计和建立数据流程方案 核心组和任何新的试点研究；监控、评估和排除已建立的数据流中的偏差 研究和数据收集计划；构建、更新和/或改进数据收集表格；管理 CNTN软件基础设施，如基于SAS的数据处理；维护中央数据词典和 记录所有数据库更改；管理DMSc的行政和分析库存；监控 核心间的确认和验证编辑；管理日程安排和参与者跟踪；管理样本 清点和跟踪，包括请求；设计、维护和跟踪CNTN网站上的使用情况，两者 互联网和内联网；向CNTN领导团队提供月度报告；协助所有核心维护 遵守联邦法规要求；协调并执行所需的数据提交 及时准确地领导CNTN。

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.