The Data Management and Statistical Core

项目总结（见说明）： 生物统计学、流行病学和研究设计（BERD）专业知识对于成功开展临床和转化（CT）研究至关重要。由于最近在计算能力和数据驱动的决策过程中取得了非凡的进步，CT研究的统计技术和研究设计方法的数量有了显着增长。数据管理和统计核心（DSMC）将 与P01研究者就拟议项目进行合作，利用资源提供研究设计、数据管理和统计支持。灾害管理服务中心的具体目标包括： 1.提供研究设计和方法论支持的规划，进行，和数据分析从所有拟议的项目。 2.建立和监控数据收集、管理、处理、质量控制、数据保证、安全、通信、文件和数据长期存储的系统。 3.为本研究的研究人员提供统计分析支持，并为复杂的研究设计开发创新的研究设计解决方案，鼓励研究之间的合作，促进出版，并传播研究结果 在实现这些目标的过程中，我们的DMSC将在数据收集表格的标准化、数据输入、数据清理、进行数据质量检查以及建立报告和分析数据的程序方面确保各项研究的及时性和一致性。我们的DMSC将负责整体数据管理、质量保证程序、研究设计和数据统计分析，并作为数据的长期储存库。此外，DMSC的教师将有很好的机会实施方法改进，以进行复杂的临床和遗传研究。数据库设计和计算机程序开发将按照公认的最佳做法进行。

PROJECT SUMMARY (See instructions): Biostatistics, Epidemiology, and Research Design (BERD) expertise is essential to the successful conduct of clinical and translational (CT) studies. Due to extraordinary recent advancement in computational capabilities and data-driven decision processes, there has been significant growth in the number of statistical techniques and research design methodology for CT studies. The Data Management and Statistical Core (DSMC) will collaborate with the P01 investigators on the proposed projects by leveraging resources to provide study design, data management, and statistical support. DMSC specific aims include: 1. To provide research design and methodological support in the planning, conduct, and analysis of data from all proposed projects. 2. To establish and monitor systems for data collection, management, processing, quality control, data assurance, security, communication, documentation, and long term storage of data. 3. To provide statistical analysis support for researchers in this study and develop innovative study design solutions for complex study designs, encourage collaboration across studies, facilitate publications, and disseminate findings In achieving these aims, our DMSC will ensure timeliness and consistency across studies with respect to standardization of data collection forms, data entry, data cleaning, conducting data quality checks and setting up procedures for reporting and analyzing data. Our DMSC will be responsible for the overall data management, quality assurance procedures, study design and statistical analysis of the data as well as be the long-term repository of the data. Furthermore, the faculty in the DMSC will have an excellent opportunity to implement methodological improvements for conducting complex clinical and genetic studies. Database design and computer program development will be conducted in accordance with accepted best practices.