NAPS2 Data Management and Statistics Core

NAPS2 数据管理和统计核心

• 批准号: 10187089
• 负责人: CHENGJIE XIONG
• 金额: $ 98.99万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10187089
• 关键词: American; Clinical; Clinical Data; Clinical Trials; Clinical assessments; Collection; Data; Data Analyses; Data Analytics; Data Reporting; Data Set; Database Management Systems; Databases; Dictionary; Disease Marker; Enrollment; Ensure; Freezing; Future; Genetic; Goals; Growth; Individual; Intervention; Lead; Length; Machine Learning; Manuscripts; Medidata; Methodology; Mission; Modality; Monitor; Participant; Pattern; Polysomnography; Preparation; Procedures; Process; Publications; Quality Control; REM Sleep Behavior Disorder; Reproducibility; Research; Research Personnel; Research Support; Resources; Sample Size; Signal Transduction; Site; Specimen; Standardization; System; Techniques; Time; Training; Work; base; data management; data repository; data sharing; data standards; deep learning; design; longitudinal design; neuroimaging; programs; prospective; relational database; statistics; synucleinopathy

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.

摘要：NAPS 2数据库管理和统计（DMS）核心 北美前驱突触核蛋白病的数据管理和统计（DMS）核心 RBD第二阶段（NAPS 2）联盟将作为合作者和宝贵的资源， 核心和项目侧重于预测表型转化。DMS核心将协助应用 适当的统计和方法技术，以及领导和合作的数据分析， 汇报所有核心和项目的准备情况。我们将与行政和临床核心 和研究中心，以确保实现目标入组，并以最高的标准审查收集的数据 质量控制（QC）标准，包括第11部分合规系统和程序的培训，数据 监控、查询和清理。我们将与其他核心合作，整合他们收集的数据， 通过一年两次的数据冻结进行额外的QC。DMS核心的协助特别需要分析 所有疾病标志物的纵向生长/下降和症状转换模式之间的相关性。 DMS核心对于提供中央标准数据集至关重要，无论是从现有的 NAPS 1数据和NAPS 2中前瞻性收集的数据，这将避免研究不一致和变化 接近。通过使用这种集中化和标准化的方法并提供深度学习方面的专业知识， 通过跨核心分析和机器学习，我们可以提供最高质量的数据，从而创建 为项目提供最可靠的结果。NAPS 2 DMS核心将作为所有调查人员的资源，包括 NAPS 2 Consortium之外的其他人，以协助进行可靠和可重复的数据分析。这是我们的使命 通过提供及时的信息，加强和支持NAPS 2联盟的研究目标 可靠的数据管理和适当的分析专业知识，最终将实现最佳试验 计划和未来的临床试验，在RBD参与者的突触核蛋白病。