Core A: Administrative Core

核心A：行政核心

• 批准号: 8072679
• 负责人: CHUL W AHN
• 金额: $ 19.7万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8072679
• 关键词: Acute; Adverse event; Basic Science; Biological Markers; Biometry; Biostatistics Core; Clinical; Clinical Data; Clinical Trials Data Monitoring Committees; Communication; Computer software; Confidentiality of Patient Information; Consult; Data; Data Analyses; Data Base Management; Data Collection; Data Quality; Data Security; Database Management Systems; Databases; Dissection; Elements; Ensure; Epidemiology; Experimental Designs; Genetic; Grant; Human Resources; Image; Laboratories; Management Information Systems; Methodology; Monitor; Online Systems; Publications; Publishing; Quality Control; Reporting; Research; Research Design; Research Ethics Committees; Research Personnel; Resources; Role; Sample Size; Secure; Services; Statistical Methods; Statistical Models; System; Testing; Time; data acquisition; data integration; data management; design; innovation; novel; patient safety; pre-clinical; programs; repository; research study; sound

The Biostatistics and Data Management Core (BDMC) will serve as a centralized resource to the investigators of the proposed SCCOR Acute Aortic Dissection Project grant to insure that the dispersed elements of program remain synchronized, and to providing database management and biostatistical services as needed. The core will seve as a centralized resource for data acquisition and management, designing clinical and basic science experiments, developing innovative statistical methodology, statistical analysis, and publishing research results generated by the SCCOR projects. The specific aims of the BDMC are: 1. To assist in the planning and study design of the grant projects, including sample size and power calculations and data analysis plans. 2. To facilitate data collection, entry, quality control, and data integration among SCCOR projects which include basic science, pre-clinical, clinical and epidemiologic projects. 3. To develop a secure, web-based database management system for tracking, distribution and central repository of genetic, socio-demographic, laboratory, biomarker, imaging and clinical data. 4. To provide study monitoring that would ensure patient safety by timely reporting of adverse events to IRBs and the Data Monitoring Committee. 5. To conduct statistical analyses including descriptive analyses, hypothesis testing, estimation, and construction of statistical models. 6. To develop and apply innovative statistical methods pertienent to acute aortic dissection studies. 7. To generate statsitical reports and to collaborate in publication of scientific results.

生物统计和数据管理核心（BDMC）将作为研究者的集中资源 拟议的SCCOR急性主动脉夹层项目赠款，以确保分散的元素， 程序保持同步，并根据需要提供数据库管理和生物统计服务。 核心将作为数据采集和管理的集中资源，设计临床和基础 科学实验，开发创新的统计方法，统计分析和出版 SCCOR项目产生的研究成果。不丹灾害管理委员会的具体目标是： 1.协助计划及设计研究项目，包括样本量及研究功效 计算和数据分析计划。 2.促进SCCOR项目之间的数据收集、输入、质量控制和数据集成， 包括基础科学、临床前、临床和流行病学项目。 3.开发一个安全的网上数据库管理系统，用于跟踪、分发和 遗传学、社会人口统计学、实验室、生物标志物、成像和临床数据库。 4.提供研究监查，通过及时向IRB报告不良事件来确保患者安全性 和数据监测委员会。 5.进行统计分析，包括描述性分析、假设检验、估计和 建立统计模型。 6.发展和应用与急性主动脉夹层研究相关的创新统计方法。 7.生成统计报告，并合作发表科学成果。