Core--Data management and statistical

(申请人摘要)数据管理和统计核心 负责接收、编辑、质量监控、存储、分析 在拟议的临床试验过程中产生的所有数据。DCC 将负责创建和维护所有数据库和数据录入 系统。 一般功能包括： 1.与首席临床核心医生调查人员合作，以 开发操作手册和所有案例报告表(CRF)工具； 2.制定随机分配给每个治疗组的制度 患者有资格并愿意参与试验，并使 临床部开展随机分配的必要安排 中心； 3.积累和维护适当的数据文件，同时确保 这些数据文件的机密性和安全性(包括清理和 编辑，所有数据)； 4.制定适当的数据分析和列报方法 在研究过程中收集，供临床和实验室使用 研究； 5.编写每半年一次的科学报告，说明 前六个月的项目，以及累计进度。 这项研究的结果。这些报告将描述每个项目的每月应计历史 临床中心，中期分析，临床和病理数据，不良反应 质量控制措施的效果和结果； 6.与世界银行合作编写研究报告以供出版 临床核心医师调查员； 7.参加各部门数据收集人员的培训 参与临床中心； (八)提供研究表和其他文件的长期保管； 9.操作计算机设施：所使用的计算机硬件设施 该项目的范围从中央主机IBM ES/9000到 微型计算机网络。本地服务器支持PC、扫描仪和HP激光 平特斯。Microsoft Access还将用于数据管理和 登记、随机化和表格收集。对于数据分析，SAS和 将使用S+。 10.确保所有活动符合以下方面的联邦法规 保护人类受试者。

(Applicant's Abstract) The Data Management and Statistical Core will be responsible for receiving, editing, quality monitoring, storing, and analyzing all data generated during the course of the proposed clinical trial. The DCC will be responsible for creating and maintaining all databases and data entry systems. General functions are: 1. Working with the principal clinical core physician investigators, to develop the Operations Manual and all Case Report Form (CRF) Instruments; 2. Developing a system of random assignment to the treatment groups for each patient eligible and willing to participant in the trial, and making the necessary arrangements for carrying out the random assignment at the Clinical Centers; 3. Accumulating and maintaining appropriate data files while ensuring confidentiality and security of these data files (including cleaning and editing, all data); 4. Developing appropriate methods of analysis and presentation of data collected during, the course of the study for the clinical and the laboratory studies; 5. Preparing semi-annual scientific reports describing the progress of the project during the previous six months, as well as the cumulative proloress. of the study. These reports will describe the monthly accrual history of each clinical center, interim analysis, clinical and pathology data, adverse effects, and results of quality control measures; 6. Preparing reports of the study for publication in collaboration with the Clinical Core physician investigators; 7. Participating in the training of data collection personnel at each participating clinical center; 8. Providing long-term storage of the study forms and other documents; 9. Operating the computer facilities: The computer hardware facilities used for this project range from a central main frame IBM ES/9000 to a microcomputer network. The local server supports PCs, scanners, and HP laser pninters. Microsoft Access will also be used for data management and for registration, randomization, and forms collection. For data analysis, SAS and S-Plus will be used. 10. Ensuring that all activities conform to federal regulations regarding protection of human subjects.