Statistics and Data Management

统计和数据管理

• 批准号: 8377345
• 负责人: Rema Raman
• 金额: $ 47.29万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-19 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8377345
• 关键词: Architecture; Archives; Area; Bioinformatics; Biometry; Case Report Form; Charge; Client; Clinical Research; Clinical Sciences; Clinical Trials; Clinical trial protocol document; Collaborations; Communities; Data; Data Files; Database Management Systems; Databases; Development; Documentation; Electronics; Environment; Exclusion Criteria; Experimental Designs; Faculty; Internet; Investigation; Leadership; Local Area Networks; Maintenance; Manuals; Manuscripts; Methodology; Methods; Monitor; Multi-Institutional Clinical Trial; National Institute of Neurological Disorders and Stroke; Newsletter; Patients; Preparation; Procedures; Process; Production; Protocols documentation; Publications; Quality Control; Randomized; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Resources; Secure; Site; TNFRSF5 gene; Therapeutic; Time; Training; Writing; acute stroke; computerized; data management; design; electronic data; firewall; inclusion criteria; interest; operation; programs; quality assurance; research study; statistics; stroke therapy

The Statistics and Data Management Core, as a centralized resource of the UCSD SPOTRIAS Center, provides expertise in study design and data management, quality control, and analysis for the entire Center's translational acute stroke research. The biostatistical responsibilities of the Core include collaborating on the experimental design of every clinical trial protocol and research project; developing and generating the randomization sequence for each study; performing interim, preliminary, and final statistical analyses on study data; and assisting with the preparation of reports and publications. All UCSD SPOTRIAS Center study data are managed through Core A. Every aspect of the data capture process, including design of case report forms, maintenance of centralized patient data files, and production of special purpose and routine statistical reports on accumulating data, is coordinated through the data management operations of the Core. The Core's computing environment consists of approximately 9 workstations connected in a client-server architecture, using TCP/IP local area network (LAN) with three servers (web, data, and archive). The network is secured behind a firewall. Data management is conducted through the PostgreSQL and Mysql relational database management systems. The quality assurance (QA) program of the Statistics and Data Management Core is extensive and comprehensive. While computerized, real-time monitoring of all study data is primary and fundamental, QA coverage extends to study initiation, project investigator and support staff training in data entry, and document development and production (e.g., training manuals, manuals of procedures, newsletters). Data entry is distributed with edit checking conducted both at the time of entry and longitudinally.

统计和数据管理核心，作为UCSD SPOTRIAS中心的集中资源， 为整个中心提供研究设计和数据管理、质量控制和分析方面的专业知识 翻译性急性卒中研究。核心的生物统计职责包括在 每个临床试验方案和研究项目的实验设计；开发和生成 每项研究的随机化序列；对以下各项执行中期、初步和最终统计分析 研究数据；协助编写报告和出版物。 所有UCSD SPOTRIAS中心研究数据都通过Core A管理。数据捕获的每个方面 流程，包括病例报告表的设计、集中患者数据文件的维护和制作 对专用统计报表和常规统计报表进行数据积累，通过数据进行协调 核心的管理运作。核心的计算环境由大约9个 在客户端-服务器体系结构中连接的工作站，使用具有三个 服务器(Web、数据和归档)。网络由防火墙保护。进行数据管理 通过PostgreSQL和MySQL关系数据库管理系统。 统计和数据管理核心的质量保证(QA)方案范围广泛， 全面性。虽然对所有研究数据的计算机化、实时监控是主要的和基础的，但QA 覆盖范围包括研究启动、项目调查员和支助人员的数据输入培训，以及 文件编制和制作(例如，培训手册、程序手册、通讯)。数据 条目被分发，在条目时和纵向上都进行编辑检查。