Data Management and Statistical Support

数据管理和统计支持

• 批准号: 7900787
• 负责人: Kiat Ruxrungtham
• 金额: $ 16.73万
• 依托单位: HIV-NAT, THE THAI RED CROSS AIDS RCH CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7900787
• 关键词: Address; Area; Biometry; Cambodia; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Computer software; Computers; Data; Data Collection; Doctor of Philosophy; Epidemiology; HIV; Head; Human Resources; Individual; Laws; Licensing; Methods; Monitor; Nurses; Paper; Patients; Physicians; Printing; Protocols documentation; Records; Research; Resources; Site; Statistical Data Interpretation; Supervision; Thailand; Time; Training; Work; data management; database design; design; experience; facsimile; member; programs; statistics

Objectives The objective of this Core is to provide additional facilities and manpower in the areas of data management and statistical support for the proposed CIPRA projects. To address the statistical needs of both Thai and Cambodian CIPRA projects, this core targets building capacity and training within both new and existing staff. A data safety monitoring board will be constituted to oversee the progress of each of the projects. Specific aims 1. to employ a full-time data manager to supervise all aspects of data collection and centralized data entry 2. to employ two study monitors, two data entry clerks and a clinical research assistant 3. to employ a Ph.D. statistician part-time as core leader in the first two years of the CIPRA projects 4. to employ a local Ph.D. bio-statistician on-site part-time in the first two years of the CIPRA projects 5. to employ a master's level bio-statistician 6. to train a current master's level Thai bio-statistician to the PhD level and to employ her as full-time core leader beginning in the third year of the CIPRA projects 7. to design, print and distribute study protocols and documentation for use in all CIPRA projects 8. to provide necessary hardware and software to allow transfer, storage and statistical analysis of data, including facsimile machines, new computers, statistical software, photocopier and CD writer (for data backup), and document storage cabinets for patient and study records 9. to establish a data safety monitoring board (DSMB) Methods This core will be led by Dr Matthew Law, who has 10 years of experience as head of the biostatistics department at National Centre in HIV Epidemiology and Clinical Research (NCHECR) in Sydney. The current data manager at HIVNAT, with six years experience, will head the data management component of the core. The current biostatistician at HIV-NAT has commenced PhD training in NCHECR under the supervision Mathew Law. She will return to HIV-NAT to be core leader following her training. Thirty plain paper facsimile machines will be installed at the study sites in Thailand and Cambodia and at HIV-NAT to facilitate data transfer. A license for SPSS software will be purchased. A DSMB will be constituted, comprising members from Thai

目标 该核心的目的是在数据管理领域提供其他设施和人力， 对拟议的CIPRA项目的统计支持。满足泰国和柬埔寨的统计需求 CIPRA项目，该核心针对新员工和现有员工的建筑能力和培训。数据安全 监视委员会将构成监督每个项目的进度。 具体目标 1。雇用全日制数据经理来监督数据收集和集中数据输入的所有方面 2。雇用两个研究监视器，两个数据输入文员和一名临床研究助理 3。攻读博士学位统计学家在CIPRA项目的头两年中兼职为核心领导者 4。雇用当地博士学位在CIPRA项目的头两年 5。雇用硕士级生物统计学家 6。要培训现任大师级的泰国生物统计学家，并聘请她为全职核心领导者 从CIPRA项目的第三年开始 7。设计，打印和分发研究方案和文档用于所有CIPRA项目 8。提供必要的硬件和软件以允许数据传输，存储和统计分析，包括 FACSIMILE机器，新计算机，统计软件，影印器和CD作者（用于数据备份），以及 病人和研究记录的文档储藏柜 9。建立数据安全监控委员会（DSMB） 方法 该核心将由Matthew Law博士领导，Matthew Law博士拥有10年的经验 悉尼的艾滋病毒流行病学与临床研究（NCHECR）国家中心。 Hivnat的当前数据经理， 凭借六年的经验，将负责核心的数据管理部分。当前的生物统计学家 HIV-NAT已在Mathew Mathew Law的监督下开始在NCHECR进行博士学位培训。她会回到艾滋病 在训练后成为核心领导者。将在泰国的研究地点安装30张平原纸传真机 和柬埔寨和HIV-NAT，以促进数据传输。将购买SPSS软件的许可证。 DSMB会 由泰国人组成，由成员组成