Biostatistics and Data Management Core

生物统计和数据管理核心

• 批准号: 9130286
• 负责人: Ivo D Dinov
• 金额: $ 19.2万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9130286
• 关键词: Adverse event; Biological Markers; Biometry; Case Report Form; Clinical Data; Collaborations; Common Data Element; Communities; Consultations; Data; Data Aggregation; Data Collection; Data Quality; Databases; Deposition; Development; Electronics; Elements; Ensure; Experimental Designs; Formulation; Functional disorder; Gait; Goals; Human; Image; Imagery; Industry; Informatics; Link; Maintenance; Manuscripts; National Institute of Neurological Disorders and Stroke; Online Systems; Parkinson Disease; Phase; Procedures; Process; Protocols documentation; Quality Control; Reporting; Research; Research Assistant; Research Design; Research Infrastructure; Research Personnel; Research Training; Resources; Sampling; Services; Standardization; Statistical Methods; Statistical Models; Testing; Training; Update; Validation; Vocabulary; Work; abstracting; cholinergic; clinical biomarkers; dashboard; data archive; data integrity; data management; data sharing; design; dissemination research; experience; experimental analysis; federated computing; high standard; meetings; programs; relational database; repository; research study; statistics; success; web site

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.

核心 C：总结/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 管理尤德尔中心并为国家尤德尔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的广泛和可靠的支持 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氏症社区。第一个 核心的具体目标是为中心项目提供计算和统计支持，包括 实验设计，使用现代最先进的统计模型和方法进行统计分析，以及 对分析的解释导致手稿和科学中研究成果的传播 演示文稿。第二个目标是开发一个用于影像、临床和生物标志物数据的联合数据库 支持中心内和全国尤德尔地区的研究、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。核 研究人员将协助 Udall 研究人员、合作者和学员进行制定、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 解释。 为了确保统一的格式和词汇，以促进分析和共享结果数据，NINDS 帕金森病通用数据元素，CDE，(www.CommonDataElements.ninds.nih.gov/PD.aspx) 将被使用。电子病例报告表 (eCRF) 将纳入 21 CFR 第 11 部分合规性 基于网络的关系数据库 OpenClinica®（有关更多信息，请参阅设施和资源 OpenClinica®）。去识别化的数据将存入成像数据档案 (IDA) 和 NINDS 数据 管理资源 (DMR)。 IDA 数据管理服务 (http://ida.loni.usc.edu) 将利用 建立 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) 可促进数据聚合，而无需暴露/传输个人身份信息 信息。数据标准化将符合 NINDS 帕金森病生物标志物计划 (PDBP) 存储和访问协议。临床数据将通过 ProForRMS 界面输入 PDBP DMR 以便通过 NINDS PDBP DMR 与研究人员广泛共享数据。该中心网站将 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协议。 生物统计和数据管理核心的影响将增强 Udall 的成功 项目，促进当地与帕金森病相关的研究，并贡献独特的临床、生物标志物和影像数据 到国家存储库供广泛社区使用。