Biostatistics and Data Management Core

生物统计和数据管理核心

• 批准号: 9329505
• 负责人: Ivo D Dinov
• 金额: $ 19.68万
• 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/9329505
• 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; Elements; Ensure; Experimental Designs; Formulation; Functional disorder; Gait; Goals; Human; Image; Imagery; Industry; Informatics; Inosine Dialdehyde; Link; Maintenance; Manuscripts; Modernization; National Institute of Neurological Disorders and Stroke; Online Systems; Parkinson Disease; Phase; Procedures; Protocols documentation; Quality Control; Reporting; Research; Research Assistant; Research Design; Research Infrastructure; Research Personnel; Research Support; Research Training; Resources; Sampling; Services; Standardization; Statistical Data Interpretation; Statistical Methods; Statistical Models; Testing; Training; Update; Validation; Vocabulary; Work; cholinergic; clinical biomarkers; dashboard; data archive; data integrity; data management; data sharing; design; dissemination research; experience; experimental analysis; experimental study; federated computing; high standard; meetings; programs; relational database; repository; research data dissemination; 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：摘要/摘要 Udall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Udall中心，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得到广泛和可靠的支持， Udall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 对分析结果的解释，从而传播研究成果的手稿和科学 介绍。第二个目标是为成像、临床和生物标志物数据开发一个联合数据库 支持研究，中心内的合作互动和全国各地的所有尤德尔 中心，并确保数据管理和质量控制适用于所有项目。核心 研究人员将协助Udall研究人员、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 解释。 为了确保统一的格式和词汇，以便于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） 将用于电子病例报告表（eCRF）将纳入21 CFR第11部分-合规性 基于Web的关系数据库OpenClinica®（有关详细信息，请参阅设施和资源 OpenClinica®）。去识别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（Unique Identifier，缩写为REQ），可促进数据聚合，而不会暴露/传输个人身份 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ProFoRMS界面输入PDBP DMR 通过NINDS PDBP DMR与研究者广泛共享数据。中心网站将 提供直接链接以访问汇总统计数据（数据仪表板），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。 生物统计学和数据管理核心的影响将是提高Udall的成功 项目，以促进当地与PD相关的研究，并提供独特的临床，生物标志物和成像数据 供社区广泛使用。