Biostatistical and Data Management Core Resource

生物统计和数据管理(BDM)核心构成了该方案项目所有统计和数据管理需求的中央资源。每个研究项目产生的数据将被转移到数据库部分，以便在综合SIR2002数据管理系统中录入和存储，该系统旨在满足项目在清理、组织和检索数据以进行计划分析和临时分析方面的所有需要。这些活动将由一名数据管理员和一名数据录入员在核心主任的监督下在一个由工作站和镜像文件服务器组成的防火墙保护的联网系统上进行。统计部门将负责协调执行调查人员在临床试验、功能成像研究以及教育和行为干预中进行的所有计划分析。核心将根据随机对照试验的最高行为标准，不断提供建议，从而提高两项临床试验的性能：将保持适当的方法，以确保随机性、盲目性和受试者遵从性。将应用最先进的成像数据统计分析技术。每名统计员将与一个项目的公共投资司密切合作，通过业务数据管理核心与首席调查员和项目调查员定期安排的会议，对所有项目进行全面的统计和与数据有关的审查。BDM核心还将在招募患者方面与核心A密切合作，在整合血液和组织样本分析结果方面与核心D密切合作。

The Biostatistics and Data Management (BDM) Core consitutes the central resource for all statistical and data management needs of the program project. Data generated by each of the research projects will be transferred to the Database Component for entry and storage in an integrated SIR2002 data management system designed to meet all the needs of the projects with respect to cleaning, organization and retrieval of data for planned and ad hoc analyses. These activities will be carried out by a data manager and a data entry clerk working under the supervision of the Core director on a fire-wall protected networked system of work stations and mirrored file servers. The Statistics Component will be responsible for coordinating the implementation of all planned analyses conducted by investigators in the clinical trials, functional imaging study and the educational and behavior intervention. The core will advise continually on and thereby enhance, the performance of the two clinical trials according to the highest standard of conduct for randomized controlled trials: appropriate methods to ensure randomization, blinding and subject compliance will be maintained. State-of-the-art techniques for the statistical analysis of imaging data will be applied. Each statistician will work closely with the P.I. of one project, with overall statistical and data-related review of all projects provided through regularly scheduled meetings of the BDM Core with the Principal Investigator and project investigators. The BDM Core will also work closely with Core A with respect to patient recruitment, and with Core D with respect to integration of results obtained from analysis of blood and tissue specimens.