Biostatistics/Data Management

项目总结（见说明）： 生物统计和数据管理核心将为SPOTRIAS项目范围内进行的研究提供统计、系统和数据管理支持。这将包括在研究设计和规划、电子数据采集（EDC）系统开发和维护、数据质量控制和研究监测以及数据分析和解释的统计方面的合作和咨询。核心小组将确保遵守良好统计和数据管理做法的最高标准。该核心的具体目标是： 1.为与合作伙伴SPOTRIAS项目相关的实验室实验、成像研究、观察性研究和临床试验的设计、规划、实施、分析和报告提供统计和计算专业知识。 2.为SPOTRIAS的整个团队提供随时可用的统计和计算专业知识 调查人员通过"开门"咨询。 3.在电子病例报告表（eCRF）设计、数据收集、电子数据采集和数据管理系统（ECD & DM）设计和开发以及数据质量控制方面为SPOTRIAS研究者提供建议和支持。 4.与生物统计学家合作，向研究主要研究者、医学监查员和数据安全和监查委员会（DSMB）提供报告。

PROJECT SUMMARY (See instructions): The Biostatistics and Data Management Core will provide the statistical, systems and data management support for research conducted within the scope of SPOTRIAS projects. This will include collaboration and consultation on the statistical aspects of study design and planning, electronic data capture (EDC) system development and maintenance, data quality control and study monitoring as well as data analysis and interpretation. The Core will ensure adherence to the highest standards of good statistical and data management practice. The specific aims of this Core are: 1. To provide statistical and computational expertise for the design, planning, conduct, analysis, and reporting of laboratory experiments, imaging studies, observational studies, and clinical trials associated with the Partners based SPOTRIAS Projects. 2. To provide ready access to statistical and computational expertise to the entire group of SPOTRIAS investigators through "open door" consultation. 3. To advise and support SPOTRIAS investigators in the areas of electronic case report forms (eCRFs) design, data collection, electronic data capture and data management system (ECD&DM) design and development, and data quality control. 4. To collaborate with Biostatisticians on provision of reports to study principal investigators, medical monitor, and the Data Safety and Monitoring Board (DSMB).