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Biostatistics and Data Management Core

生物统计和数据管理核心

基本信息

批准号：
7491576
负责人：
PATRICK E DUFFY
金额：
$ 20.94万
依托单位：
SEATTLE BIOMEDICAL RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7491576
关键词：
Adverse event Agreement Antimalarials Apache Indians Appointment Architecture Area Bioinformatics Biomedical Research Biometry Biotechnology Child Clinic Clinical Clinical Trials Clinical Trials Data Monitoring Committees Communication Computer Architectures Computer software Confidentiality Conflict of Interest Consult Daily Data Data Analyses Data Security Database Management Systems Databases Development Devices Digit structure Disease Economic Development Electronics Elements Ensure Failure Feedback Funding Goals Grant Guidelines Hand High Performance Computing Housing Immunity Industry Infant Infection Internet Java Journals Laboratories Lead Left Life Linux Local Area Networks Longitudinal Studies Malaria Malaria prevention Medical Medical Records Methods Monitor Mothers Numbers Online Systems Outcome Measure Paper Participant Patients Persons Placebos Predisposition Pregnancy Pregnant Women Preparation Procedures Production Proteomics Protocols documentation Publications Publishing Randomized Randomized Controlled Clinical Trials Records Recovery Recruitment Activity Reporting Research Research Design Research Ethics Committees Research Infrastructure Research Institute Research Personnel Right-On Safety Sample Size Sampling Secure Security Serious Adverse Event Services Side Site Specific qualifier value Speed Standards of Weights and Measures Statistical Methods Supervision Support of Research System Tanzania Teleconferences Testing Therapeutics Committee Time Training Treatment Protocols Tropical Medicine United States Food and Drug Administration United States National Institutes of Health Validation Work Writing authority base cluster computing comparative data integrity data management database design design digital experience infant outcome member mouse Smc1l1 protein mouse Smc1l2 protein open source prevent programs repository research study wide area network

项目摘要

The ICIDR Program is an interactive endeavor to examine the impact of malaria prevention during pregnancy on mother-infant outcomes, in the context of a randomized trial of four regimens for Intermittent Presumptive Treatment against pregnancy malaria (IPTp). The broad, long-term objectives of the program are to identify more effective treatments to prevent malaria infection and disease in pregnant women, to understand the long-term impact of malaria prevention on the acquisition of protective immunity and malaria susceptibility in pregnant women and their infants, and to develop a center of excellence in Tanzania for interventional studies of antimalarial drugs in pregnant women and children. The Data Management and Biostatistics Components will provide core services to other elements of ICIDR Program, will ensure data integrity and security, and will facilitate timely reporting and publication. The Core has the following specific aims: 1) Execute an effective, secure Database Management System in support of research and capacity-building for the ICIDR, including database design, barcode tracking system, and a system double data entry and validation. 2) Migrate the ICIDR database web-based application, that will include digital signature, audit system, internet communication and VPN, and development of SOPs for database management and training. 3) Establish a Data and Safety Monitoring Board and DSMB charter to oversee and monitor interventional clinical trials. 4) Incorporate experienced Biostatistics support for study design and reporting, and reporting to the Data & Safety Monitoring Board. The Data Core in Morogoro will be fully autonomous, with a Data Manager and data entry team under the supervision of Dr. Mutabingwa.

ICIDR计划是一项互动奋进，旨在研究妊娠期间预防疟疾对母婴结局的影响，并对四种间歇性假定治疗方案进行随机试验。该方案广泛的长期目标是确定更有效的治疗方法，以预防孕妇感染疟疾和患病，了解疟疾预防对孕妇及其婴儿获得保护性免疫力和疟疾易感性的长期影响，并在坦桑尼亚建立一个卓越中心，对孕妇和儿童进行抗疟药物的干预研究。数据管理和生物统计部分将为ICIDR计划的其他要素提供核心服务，确保数据完整性，安全，并将促进及时报告和出版。该核心有以下具体目标：1）执行一个有效、安全的数据库管理系统，以支持ICIDR的研究和能力建设，包括数据库设计、条形码跟踪系统以及双重数据输入和验证系统。2)迁移ICIDR数据库的网络应用程序，其中将包括数字签名、审计系统、互联网通信和虚拟专用网络，以及制定数据库管理和培训的标准操作程序。3)建立数据和安全性监查委员会和DSMB章程，以监督和监查干预性临床试验。4)为研究设计和报告提供经验丰富的生物统计学支持数据和安全监测委员会。Morogoro的数据核心将完全自主，在Mutabingwa博士的监督下设有数据经理和数据输入团队。