Biostatistics and Data Management Core

核心C：摘要/摘要 尤德尔中心生物统计和数据管理核心将提供重要的生物统计支持和数据 Udall中心的管理，并为国家Udall计划和更广泛的帕金森病做出贡献 研究社区。核心的两个具体目标旨在确保所有人都得到广泛和可靠的支持 尤德尔中心的研究人员，以及外部合作者和更广泛的帕金森社区。第一 核心项目的具体目标是为中心项目提供计算和统计支持，包括 设计实验，使用现代、最先进的统计模型和方法进行统计分析，以及 对导致研究成果在手稿和科学中传播的分析的解释 演示文稿。第二个目标是开发一个联合数据库，用于影像、临床和生物标记物数据 支持中心内和全国所有Udall的研究研究和协作互动 中心，并确保数据管理和质量控制适用于所有项目。堆芯 调查人员将协助Udall调查人员、合作者和受训人员进行制定、测试和验证 适当的研究假设，以及数据收集、管理、处理、可视化和 释义。 为确保统一的格式和词汇表，以便于分析和共享结果数据，NINDS 帕金森氏病通用数据元素、CDE、(www.CommonDataElements.ninds.nih.gov/PD.aspx) 将会被使用。电子案例报告表格(ECRF)将纳入符合21 CFR Part 11的标准 基于Web的关系数据库OpenClinica®(有关以下方面的详细信息，请参阅工具和资源 OpenClinica®)。未识别的数据将被存入成像数据档案(IDA)和NINDS数据 管理资源(DMR)。开发协会数据管理服务(http://ida.loni.usc.edu)将利用 建立了PPMI数据模式(www.ppmi-info.org)。NINDS DMR存储库需要使用全局 唯一标识符(GUID)，无需暴露/传输个人身份即可促进数据聚合 信息。数据标准化将符合NINDS帕金森氏病生物标记物计划(PDBP) 用于存储和访问的协议。临床数据将通过ProFoRMS接口输入PDBP DMR 为了通过NINDS PDBP DMR与调查人员广泛共享数据。该中心的网站将 提供访问摘要统计数据(数据仪表板)的直接链接，管理社区对样本的请求 和数据，并传播研究成果和计算方案。 生物统计和数据管理核心的影响将是加强Udall的成功 项目，以促进当地与帕金森病相关的研究，并提供独特的临床、生物标记物和成像数据 提供给国家储存库，供社区广泛使用。

Core C: Summary/Abstract The Udall Center Biostatistics and Data Management Core will provide vital biostatistical support and data management for the Udall Center and contribute to the national Udall program and wider Parkinson's disease research community. The two specific aims of the Core are designed to ensure broad and reliable support of all Udall Center investigators, as well as external collaborators and the wider Parkinson's community. The first specific aim of the Core is to provide computational and statistical support of the Center projects, including design of experiments, statistical analyses using modern, state-of-the-art statistical models and methods, and interpretation of analyses leading to dissemination of research findings in manuscripts and scientific presentations. The second aim is to develop a federated database for imaging, clinical, and biomarker data that supports the research studies, collaborative interactions within the Center and nationally across all Udall Centers, and ensures that data management and quality controls are applied for all projects. Core investigators will assist Udall investigators, collaborators, and trainees with formulation, testing and validation of appropriate research hypotheses, and data collection, management, processing, visualization and interpretation. To ensure uniform formats and vocabularies that facilitate analyses and sharing of resulting data, the NINDS Parkinson's Disease Common Data Elements, CDEs, (www.CommonDataElements.ninds.nih.gov/PD.aspx) will be used. Electronic case report forms (eCRFs) will be incorporated into the 21 CFR Part 11-compliant web-based relational database OpenClinica® (see Facilities and Resources for more information on OpenClinica®). De-identified data will be deposited into the Imaging Data Archive (IDA) and the NINDS Data Management Resource (DMR). The IDA data management service (http://ida.loni.usc.edu) will utilize the established PPMI data schema (www.ppmi-info.org). The NINDS DMR repository requires the use of a Global Unique Identifier (GUID) that facilitates data aggregation without exposing/transferring Personally Identifying Information. Data standardization will comply with NINDS Parkinson's Disease Biomarkers Program (PDBP) protocols for storage and access. Clinical data will be entered into the PDBP DMR via the ProFoRMS interface in order to broadly share data with investigators through the NINDS PDBP DMR. The Center web-site will provide direct links to access summary statistics (data dashboard), manage community requests for samples and data, and disseminate research findings and computational protocols. The impact of the Biostatistics and Data Management Core will be to enhance the success of the Udall projects, to facilitate PD-related research locally, and to contribute unique clinical, biomarker and imaging data to national repositories for broad community use.