Data Management and Statistical Suppport

数据管理和统计支持

• 批准号: 7668253
• 负责人: Kiat Ruxrungtham
• 金额: $ 5.91万
• 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: 2008
• 资助国家: 美国
• 起止时间: 2008-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7668253
• 关键词: Address; Area; Biometry; Cambodia; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Computer software; Computers; Country; Data; Data Collection; Doctor of Philosophy; Epidemiology; HIV; Head; Human Resources; Individual; Laws; Licensing; Medicine; Methods; Monitor; Nurses; Paper; Patients; Physicians; Printing; Protocols documentation; Records; Resources; Site; Statistical Data Interpretation; Supervision; Thailand; Time; Training; Universities; Work; data management; database design; design; experience; facsimile; member; professor; 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 Thailand, Cambodia and other countries, to be chaired by Scott Hammer, Professor of Medicine at Columbia University.

目标 该核心的目标是在数据管理领域提供额外的设施和人力， 为拟议的CIPRA项目提供统计支持。满足泰国和柬埔寨的统计需求 该中心的核心目标是在新的和现有的工作人员中进行能力建设和培训。数据安全 并会成立监察委员会，监察每项工程的进度。 具体目标 1.聘请一名全职数据经理，监督数据收集和集中数据输入的各个方面 2.雇用两名研究监查员、两名数据录入员和一名临床研究助理 3.聘请一位博士在CIPRA项目的头两年，兼职统计员担任核心领导人 4.聘请当地的博士生物统计学家在CIPRA项目的头两年兼职现场 5.聘请一名硕士生物统计学家 6.将一名泰国生物统计学硕士培养到博士水平，并聘请她为全职核心领导人 从CIPRA项目的第三年开始， 7.设计、打印和分发研究方案和文件，供所有CIPRA项目使用 8.提供必要的硬件和软件，以便传输、存储和统计分析数据，包括 传真机、新电脑、统计软件、影印机及光碟烧录机（用作数据备份），以及 用于患者和研究记录的文件存储柜 9.建立数据安全监测委员会（DSMB） 方法 该核心将由Matthew Law博士领导，他在生物统计学系担任主任已有10年经验， 国家艾滋病毒流行病学和临床研究中心（NCERR）。HIVNAT目前的数据管理员， 拥有六年经验，将领导核心数据管理部分。现任生物统计学家， HIV-NAT已开始在Mathew Law的监督下在尼泊尔进行博士培训。她将返回艾滋病毒-NAT， 在她的训练下成为核心领导者。泰国的研究中心将安装30台普通纸传真机 柬埔寨和艾滋病毒-NAT，以促进数据传输。将购买SPSS软件的许可证。DSMB将 成立一个由泰国、柬埔寨和其他国家的成员组成的委员会，由斯科特·哈默担任主席， 哥伦比亚大学医学教授。