Data Management and Reporting Group

数据管理和报告组

• 批准号: 9927578
• 负责人: Lasonia Morgan
• 金额: $ 284.36万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9927578
• 关键词: Access to Information; Allergic Disease; Archives; Area; Back; Clinical; Clinical Data; Clinical Management; Clinical Research; Clinical Trials; Code; Collection; Communicable Diseases; Data; Data Element; Data Management Resources; Data Reporting; Database Management Systems; Disease; Enrollment; Ensure; Environment; Human Resources; Immune System Diseases; Individual; Industry; Industry Standard; Information Systems; International; Laboratories; Lead; Libraries; Management Information Systems; Medidata; Meta-Analysis; Methods; Monitor; National Institute of Allergy and Infectious Disease; Notification; Observational Study; Online Systems; Participant; Procedures; Process; Protocols documentation; Randomized; Regulation; Reporting; Research Personnel; Safety; Secure; Serious Adverse Event; Services; Standardization; Study Subject; System; Technology; Therapeutic; Time; Training; United States National Institutes of Health; Validation; Visit; Voice; Work; base; computerized; data archive; data cleaning; data management; data portal; data quality; data sharing; data standards; experience; flexibility; innovation; meetings; prevent; randomized trial; response; rho; sample collection; success; tool; transmission process

PROJECT SUMMARY/ABSTRACT—DATA MANAGEMENT AND REPORTING GROUP High-quality clinical data management has been a cornerstone of Rho services since its inception. Over the last 2 decades, Rho has served as the coordinating center for numerous NIH-sponsored observational studies and clinical trials, which has given us extensive experience developing, implementing, and maintaining innovative and reliable data systems for clinical research. In anticipation of the consolidation of study coordination activities across DAIT consortia, Rho has worked over the last year to standardize methods and processes across our current consortia. The Data Management and Reporting Group Component will provide—across the 3 disease groups— high-quality, integrated, and secure information management systems and well-developed procedures for the collection of clinical and mechanistic data, the randomization of study subjects, the tracking of specimen collection and distribution, and the reporting of safety data. New DAIT studies coordinated by the Center will use the following systems for data management and reporting: • Medidata Rave (an industry-leading, state-of-the-art, web-based data management tool) for the receipt, entry, verification, processing, correcting, storage, tracking, transmission and reporting on all clinical data and clinical laboratory data. Medidata Rave minimizes routine data entry errors and boosts efficiency through robust data validation functionality that effectively turns data capture and data cleaning into 1 process. • RhoRAND™ for 24-7 access to participant registration and randomization using web-based or interactive voice response technology. Non-computerized methods will be available if needed. • Oracle Argus safety data system for entering, tracking, coding, reporting, analyzing, and archiving SAE data for clinical studies in accordance with federal and international regulations. Rho will carefully and comprehensively monitor accruing study data for enrollment status, visit and procedure completion status, and safety triggers. RhoPortal will be used across the DAIT Consortia to provide near real-time access to information about study progress. Any data quality or study progress metric that the Consortia Investigators or DAIT personnel wish to see routinely can be made available via RhoPortal. We will use the CDISC CDASH standard for clinical data management for new studies managed by the Center. CDASH provides a study with a library of data elements that are also an industry standard and is an excellent starting point for efficiently setting up a clinical data management system. Rho has already begun the process of developing standards for forms and variables that do not exist in CDASH, but which are common across our studies and therapeutic areas. This “RhoDASH” global library will grow organically over time, and will allow us to store final study data in a standard format that can be uploaded to data sharing portals.

项目摘要/摘要 - 数据管理和报告小组 自成立以来，高质量的临床数据管理一直是RHO服务的基石。超过 在过去的20年中，Rho一直担任众多NIH赞助的观察性的协调中心 研究和临床试验为我们提供了丰富的发展，实施和维护的经验 用于临床研究的创新和可靠的数据系统。预期研究的巩固 在过去的一年中，Rho跨越了Dait联盟的协调活动，以标准化方法和 我们当前财团的过程。 数据管理和报告组组件将提供3个疾病组的范围 - 高质量，集成和安全的信息管理系统以及完善的程序 收集临床和机械数据，研究对象的随机化，标本的跟踪 收集和分发以及安全数据的报告。由中心协调的新的DAIT研究将 使用以下系统进行数据管理和报告： •Medidata Rave（一种行业领先，最先进的基于网络的数据管理工具） 收据，输入，验证，处理，纠正，存储，跟踪，传输和报告 临床数据和临床实验室数据。 Medidata狂欢最小化常规数据输入错误，并且 通过强大的数据验证功能提高效率，该功能有效地转动数据捕获和 数据清洁为1个过程。 •使用基于Web或 交互式语音响应技术。如果需要，将可用非计算方法。 •用于输入，跟踪，编码，报告，分析和归档SAE的Oracle Aracus Argus安全数据系统 根据联邦和国际法规的临床研究数据。 RHO将仔细，全面地监视应计研究数据，以确定注册状态，访问和 程序完成状态和安全触发器。若port体将在整个涉及联盟中使用 几乎实时获取有关学习进度的信息。任何数据质量或研究进度指标 财团调查员或dait人员希望常规查看，可以通过摘要提供。 我们将将CDISC CDASH标准用于临床数据管理，以进行由 中心。 CDASH提供了一项研究库的研究库，这些数据要素也是行业标准的，并且是 有效建立临床数据管理系统的绝佳起点。 Rho已经开始 为CDASH中不存在的形式和变量制定标准的过程，但它们很常见 在我们的研究和治疗领域。随着时间的流逝，这个“ Rhodash”的全球图书馆将有机地增长，并且 我们将允许我们以标准格式存储最终研究数据，该数据可以上传到数据共享门户。