Biostatistics/Data Management

项目总结(见说明)： 生物统计和数据管理核心将为在SPOTRIAS项目范围内进行的研究提供统计、系统和数据管理支持。这将包括就研究设计和规划、电子数据采集系统的开发和维护、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进行合作和协商。核心将确保遵守良好统计和数据管理做法的最高标准。这一核心的具体目标是： 1.为设计、规划、实施、分析和报告与基于合作伙伴的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提供统计和计算专业知识。 2.向SPOTRIAS的整个小组提供随时获得统计和计算专门知识的机会 调查人员通过“敞开大门”进行咨询。 3.在电子案件报告表的设计、数据收集、电子数据采集和数据管理系统的设计和开发以及数据质量控制等领域，向南太平洋合作组织的调查人员提供咨询和支助。 4.与生物统计学家合作，提供报告，以研究主要调查人员、医疗监测员和数据安全与监测委员会(数据安全和监测委员会)。

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).