Biostatistics and Clinical Research Core

生物统计学和临床研究核心 项目摘要 生物统计学和临床研究核心协助研究设计和物流，以及收集， 利用计算机科学技术分析和整合生物学和流行病学数据， 统计在Evan Dellon，MD，MPH的指导下，一位经验丰富的临床，流行病学和 翻译研究员，核心提供协助与数据库的实施和维护，网络 应用程序、经过验证的安全数据采集、质量控制、数据分析和统计分析。核心 在合理的统计研究设计、研究过程工程、数据模型开发方面提供全面合作， 系统设计和实施。这导致安全和准确的数据捕获和管理， 各种数据类型和来源，以及用于分析的数据提取和报告。核心提供了一个 基础科学家和信息学专家之间的接口，以支持转化研究。核心 为我们中心的大批临床流行病学家成员提供基本服务。的 核心的临床研究部分包括协助研究启动、IRB批准、IND、监管 问题、合同、临床协调员人员配备、数据和标本采集、标本处理、质量 控制和监测。核心的具体目标是：1）提供生物统计学和研究方面的咨询 在研究的设计、实施和分析阶段进行设计。2)提供数据收集和数据 管理服务，包括表格开发、注册跟踪、数据采集、数据验证、数据 安全和保密、数据库关闭、统计方案编制、应用程序开发。3)使 会员和学员可访问大型索赔数据库，如IMS Pharmetrics、MarketScan和Medicare。 4)通过咨询、监管支持、合同谈判和数据支持临床研究， 由经验丰富的研究协调员团队提供样本采集。5)提供培训和教育 关于样本量和功效计算、研究设计和分析。

BIOSTATISTICS AND CLINICAL RESEARCH CORE PROJECT SUMMARY The Biostatistics and Clinical Research Core assists with study design and logistics, as well as the collection, analysis and integration of biological and epidemiological data using techniques of computer science and statistics. Under the direction of Evan Dellon, MD, MPH, an experienced clinical, epidemiologic, and translational researcher, the core provides assistance with database implementation and maintenance, web applications, validated and secure data capture, quality control, data analysis, and statistical analysis. The core offers full collaboration on sound statistical study design, study process engineering, data model development, system design and implementation. This leads to secure and accurate data capture and management, linking of various data types and sources, and data extraction and reporting for analytics. The Core provides an interface between basic scientists and informatics specialists to support translational research. The Core provides essential services to the large group of clinical epidemiologists who are members of our center. The clinical research component of the core includes assistance with study start-up, IRB approval, IND, regulatory issues, contracting, clinical coordinator staffing, data and specimen collection, specimen processing, quality control and monitoring. The specific aims of the core are: 1) To provide consultation on biostatistics and study design during the design, conduct and analysis phases of research. 2) To offer data collection and data management services including forms development, enrolment tracking, data capture, data validation, data security and confidentiality, database closure, statistical programming, application development. 3) To enable members and trainees access to large claims databases such as IMS Pharmetrics, MarketScan and Medicare. 4) To support clinical research through consultation, regulatory support, contract negotiations, and data and specimen collection provided by a team of experienced study coordinators. 5) To deliver training and education about sample size and power calculations, study design and analysis.