Data Management and Statistical Core

摘要- ALLFTD -数据管理和统计核心 数据管理和统计核心支持ARTFL LEFFTDS纵向的目标 额颞叶变性（ALLFTD）通过维护一个安全的，最先进的关系数据库 收集参与者数据，与ALLFTD核心、项目和研究者共享这些数据， 以及各种国家数据储存库，并通过协助 在ALLFTD中进行统计规划和分析。使用先前构建的符合21 CFR Part 11标准的 核心将使用和改进现有的数据库，并为真实的实时数据开发新的自动化工具 输入和检查，向核心和临床中心报告数据问题，并帮助教育 如何确保未来数据输入的更高质量。核心将继续使用和开发新的工具 在可行的情况下进行电子数据采集。这样，核心将与其他核心密切合作， 临床中心确保有效和准确的数据输入和采集。核心将协助患者 跟踪、招募和保留研究参与者有助于参与者样本的交换， 在ALLFDTD联盟和其他研究小组，包括国家阿尔茨海默氏症 协调中心（NACC），阿尔茨海默病和相关痴呆症国家集中储存库 （NCRAD）、神经影像学实验室（LONI）和FTD疾病登记研究（FTDDR）。（Allftd将共同- 在FTDDR中招募合格患者。）核心将在核心之间以及与项目之间共享数据 作为ALLFTD的内部和外部研究者。核心小组将向所有核心小组提供统计支助， 项目，协助研究设计，统计规划，分析和解释结果，并与 在需要时开发和实施新方法，如开发新的 用于推导ALLFTD中使用的心理测量指标的改进标准值的方法，以及 贝叶斯混合效应模型，以更好地估计全脑结构轨迹， 纵向数据在审查ALLFTD联盟研究者的数据请求时，核心将审查 这些应用程序不仅用于数据事务，还将审查研究设计和分析计划，并将提供 在有利的情况下提供统计指导。

ABSTRACT – ALLFTD – DATA MANAGEMENT AND STATISTICAL CORE The Data Management and Statistical Core supports the goals of the ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) by maintaining a secure, state-of-the art relational database for the collection of participant data, by sharing these data with ALLFTD Cores, Projects and investigators both internal and external to ALLFTD as well as various national data repositories, and by assisting with the statistical planning and analysis across ALLFTD. Using the previously constructed, 21 CFR Part 11 Compliant database the Core will use and improve upon existing and develop new automated tools for real time data entry and checking, reporting back to the Cores and Clinical Centers with data issues, and help educate on how to assure higher quality for future data entries. The Core will continue to work with and develop new tools for electronic data capture when feasible. In this way the Core will work closely with the other Cores and Clinical Centers to assure efficient and accurate data entry and capture. The Core will assist with patient tracking and recruitment and retention of study participants assist with exchange of participant samples and data within the ALLFDTD consortium and with other research groups including the National Alzheimer’s Coordinating Center (NACC), National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD), the Laboratory of Neuroimaging (LONI) and the FTD Disorders Registry (FTDDR). (ALLFTD will co- enroll eligible patients in FTDDR.) The Core will share data between the Cores and with the Projects as well as investigators internal and external to ALLFTD. The Core will provide statistical support to all Core and Projects, assisting with study design, statistical planning, analysis and interpretation of results, and work with the development and implementation of new methods when needed, like with the development of new methods for the derivation of improved normative values for the psychometric measures used in ALLFTD, and Bayesian Mixed Effects Models to obtain better estimates of whole-brain structural trajectories from longitudinal data. When reviewing data requests from ALLFTD consortium investigators the Core will review the applications not only for data matters, but also review study design and analyses plans and will offer statistical guidance when beneficial.