Global Network Data Coordinating Center

全球网络数据协调中心

• 批准号: 7941611
• 负责人: Tyler D Hartwell
• 金额: $ 14.24万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-17 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7941611
• 关键词: Accounting; Address; Behavioral; Biological; Biometry; Books; Child Care; Child health care; Clinical; Clinical Trials Data Monitoring Committees; Collection; Communication; Computer Systems Development; Computer software; Computers; Conduct Clinical Trials; Congresses; Contracts; Data; Data Analyses; Data Collection; Data Coordinating Center; Databases; Development Plans; Distributed Databases; Doctor of Philosophy; Enrollment; Ensure; Equipment; Event; Funding; Guidelines; HIV; HIV/STD; Human Resources; Incidence; Individual; Institutes; International; Intervention; Interviewer; Kenya; Laboratories; Language; Leadership; Logistics; Mails; Male Circumcision; Manuals; Manuscripts; Master of Business Administration; Maternal and Child Health; Measures; Minority; Monitor; Multicenter Studies; Multicenter Trials; NCI Scholars Program; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; National Institute of Mental Health; Neonatal; Network-based; Online Systems; Operative Surgical Procedures; Participant; Pathway Analysis; Patient Monitoring; Performance; Pharmaceutical Preparations; Pharmacy facility; Phase; Policies; Population; Preparation; Prevention; Procedures; Production; Protocols documentation; Publications; Publishing; Quality Control; Questionnaire Designs; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Reporting; Research; Research Activity; Research Design; Research Institute; Research Methodology; Research Personnel; Research Project Grants; Research Training; Resources; Running; Scientist; Secure; Services; Site; Specialist; Structure; Summary Reports; System; Time; TimeLine; Training; Translations; United States National Institutes of Health; Update; Visit; Woman; Work; Writing; cost; data management; design; distributed data; drug testing; experience; flexibility; follow-up; laptop; meetings; member; methionylmethionine; mortality; pill; protocol development; research study; sample collection; skills; statistics; stillbirth; symposium; tool; transmission process; web site

DESCRIPTION (provided by applicant): Research Triangle Institute (RTI) proposes to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women's and Children's Health Research (GN). The strong, experienced team of scientists who have led the GN DCC for the past 5 years will continue this effort. Responsibilities of the DCC will include (1) coordinating overall study activities; (2) providing biostatistical and data management leadership; (3) participating in study design and protocol development; (4) developing data management systems (DMSs); (5) collaborating in developing study materials (e.g., data forms) and overseeing translation of these materials into appropriate languages; (6) developing and implementing quality control systems; (7) assisting in training Research Unit (RU) personnel in study procedures, including use of the DMSs; (8) developing capacity for research at the RUs by training RU staff in research methodology, data management, and statistical analysis and assisting them in writing DMSs and in publishing study results; (9) continuing to manage study-wide communications and logistics; (10) assisting RUs (if appropriate) in biological specimen collection; (11) organizing and coordinating Steering Committee (SC) and Data and Safety Monitoring Board (DSMB) meetings; (12) producing routine and special reports that meet the needs of the RUs, NICHD, the SC, and the DSMB; and (13) assisting in disseminating results of the GN studies through publication and presentations. All proposed RTI staff have been involved in carrying out the above responsibilities for the GN, including the PI, Tyler Hartwell, Ph.D., and Co-Pis Vijaya Rao, Ph.D., and Elizabeth McClure, M.Ed. Drs. Hartwell and Rao each have over 30 years of experience in leading DCCs for NIH multicenter studies, including international studies. We will use an Internal Management Committee to oversee the DCC operations and assign a DCC Protocol Team to work with GN investigators on each new protocol. We will use the existing IT structures, developed over the past 5 years, to collect and transmit study data to RTI from RU sites continuing in the Network, including hardware, software, and the on-site IT expert and data manager to assist in maintaining the systems. For new RUs, we will assist in purchasing the computer equipment required for data collection, management, and transmission and will help train new RU site staff to manage the systems developed. Our communications network will again be built around conference calls, e-mail, and the project website that disseminates project reports and study materials. During the first year of the project, RTI will collaborate with RU staff and NICHD to finish publications from single site protocols from the first phase of the study, complete data collection on the FIRST BREATH multicenter protocol, and begin developing additional common protocols for randomized clinical trials.

描述（由申请人提供）：研究三角研究所（RTI）建议作为NICHD全球妇女和儿童健康研究（GN）的数据协调中心（DCC）。在过去的5年中，领导GN DCC的坚强，经验丰富的科学家团队将继续这一努力。 DCC的责任将包括（1）协调整体研究活动； （2）提供生物统计学和数据管理领导； （3）参与研究设计和协议开发； （4）开发数据管理系统（DMS）； （5）合作开发研究材料（例如，数据表格），并监督这些材料转化为适当的语言； （6）开发和实施质量控制系统； （7）协助培训研究部门（RU）人员进行研究程序，包括使用DMS； （8）通过培训RU研究人员在研究方法，数据管理和统计分析中培训RUS研究能力，并协助他们编写DMS和发布研究结果； （9）继续管理整个学习的沟通和物流； （10）协助RUS（如果适当）进行生物标本收集； （11）组织和协调指导委员会（SC）以及数据与安全监测委员会（DSMB）会议； （12）制作常规和特别报告，以满足RUS，NICHD，SC和DSMB的需求； （13）通过出版和演讲协助传播GN研究的结果。所有拟议的RTI工作人员都参与了对GN的上述职责，包括PI，Tyler Hartwell，Ph.D。和Co-Pis Vijaya Rao，Ph.D。和Elizabeth McClure，M.Ed。博士。 Hartwell和Rao各自在领先的DCC进行NIH多中心研究（包括国际研究）方面拥有30多年的经验。我们将使用一个内部管理委员会来监督DCC运营，并指派DCC协议团队与GN调查人员合作，以实现每个新协议。我们将使用过去5年来开发的现有IT结构，从继续在网络中持续的RU站点收集和传输研究数据，包括硬件，软件以及现场IT专家和数据经理，以协助维护系统。对于新的RUS，我们将协助购买数据收集，管理和传输所需的计算机设备，并将帮助培训新的RU站点工作人员管理开发的系统。我们的通信网络将再次围绕电话会议，电子邮件以及传播项目报告和研究材料的项目网站构建。在项目的第一年中，RTI将与RU员工和NICHD合作，从研究的第一阶段完成单个站点协议的出版物，对第一个呼吸多中心协议的完整数据收集，并开始为随机临床试验开发其他常见协议。