NAPS2 Data Management and Statistics Core

摘要：NAPS2数据库管理和统计(DMS)核心 北美先兆综合征的数据管理和统计(DMS)核心 RBD第二阶段联盟(NAPS2)将成为以下方面的合作者和宝贵资源 Cores和该项目的重点是预测表观转化。DMS核心将协助应用 适当的统计和方法技术以及领导和协作的数据分析和 报告所有岩芯和项目的准备情况。我们将与行政和临床核心合作 以及学习站点，以确保实现目标招生并对收集的数据进行最高级别的审查 质量控制(QC)标准，包括关于第11部分合规系统和程序、数据的培训 监控、查询和清理。我们将与其他核心合作，整合其收集的数据，提供 通过两年一次的数据冻结的其他QC。特别需要DMS核心的协助来分析 所有疾病标记物的纵向消长和症状转化模式之间的关系。 要提供中央标准数据集，DMS核心势在必行，两者都可以追溯到现有的 NAPS1数据，以及在NAPS2中预期收集的数据，这将避免研究的不一致和不同 接近了。通过使用这种集中和标准化的方法，并提供深度学习方面的专业知识 通过跨核心的分析和机器学习，我们可以提供最高质量的数据，这反过来将创建 该项目最可靠的结果。NAPS2 DMS核心将作为所有调查人员的资源，包括 NAPS2联合体以外的人员协助进行可靠和可重复的数据分析。这是我们的使命 以加强和支持NAPS2联盟的研究目标，提供及时的 可靠的数据管理和适当的分析专业知识，最终将导致最佳试验 RBD参与者联合核病的规划和未来临床试验。

ABSTRACT: NAPS2 DATABASE MANAGEMENT AND STATISTICS (DMS) CORE The Data Management and Statistics (DMS) Core of the North American Prodromal Synucleinopathy Consortium on RBD, Stage 2 (NAPS2) will serve as both a collaborator and a valuable resource for the Cores and the Project focused on predicting phenoconversion. The DMS Core will assist in the application of appropriate statistical and methodological techniques as well as leading and collaborating data analysis and report preparations for all Cores and the Project. We will work with the Administrative and Clinical Cores and study sites to ensure target enrollment is achieved and the data collected is scrutinized with the highest quality control (QC) standards which include training on Part 11 compliance systems and procedures, data monitoring, queries and cleaning. We will work with the other Cores to integrate their collected data, providing additional QC through bi-annual data freezes. The DMS Core’s assistance is specifically needed for analysis of associations among longitudinal growth/decline and symptomatic conversion patterns of all disease markers. The DMS Core is imperative for providing a central standard data set, both retrospectively from the existing NAPS1 data, and prospectively collected data in NAPS2 which will avoid study inconsistencies and varying approaches. By using this centralized and standardized approach and providing expertise in deep learning analysis across cores and machine learning, we can offer the highest quality data which in turn will create the most reliable results for the Project. The NAPS2 DMS Core will act as a resource to all investigators, including those outside of the NAPS2 Consortium to assist with reliable and reproducible data analysis. It is the mission of the DMS Core to enhance and support the research objectives of the NAPS2 Consortium by providing timely and reliable data management and appropriate analytic expertise which will ultimately lead to optimal trial planning and future clinical trials for synucleinopathies in RBD participants.