Global Network Data Coordinating Center

全球网络数据协调中心

基本信息

批准号：
7777615
负责人：
Tyler D Hartwell
金额：
$ 41万
依托单位：
RESEARCH TRIANGLE INSTITUTE
依托单位国家：
美国
项目类别：
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/7777615
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

项目摘要

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）：三角研究所 (RTI) 提议充当 NICHD 全球妇女和儿童健康研究网络 (GN) 的数据协调中心 (DCC)。过去 5 年领导 GN DCC 的强大、经验丰富的科学家团队将继续这一努力。 DCC 的职责包括 (1) 协调整体研究活动； (2) 提供生物统计和数据管理领导；（3）参与研究设计和方案制定； (4) 开发数据管理系统（DMS）； (5) 合作开发学习材料（例如数据表格）并监督这些材料翻译成适当的语言；（六）制定并实施质量控制体系； (7) 协助对研究单位 (RU) 人员进行研究程序方面的培训，包括 DMS 的使用； (8) 通过对研究方法、数据管理和统计分析方面的研究人员进行培训，并协助他们撰写 DMS 和发布研究结果，发展研究中心的研究能力； (9) 继续管理研究范围内的通讯和后勤； (10) 协助RU（如适用）进行生物标本采集；（十一）组织协调指导委员会（SC）和数据与安全监测委员会（DSMB）会议； (12) 制作满足 RU、NICHD、SC 和 DSMB 需要的例行报告和特别报告； (13) 通过出版物和演示协助传播 GN 研究结果。所有拟议的 RTI 工作人员都参与了 GN 的上述职责，包括 PI Tyler Hartwell 博士、Co-Pis Vijaya Rao 博士和 Elizabeth McClure 教育硕士。博士。 Hartwell 和 Rao 各自在领导 NIH 多中心研究（包括国际研究）的 DCC 方面拥有超过 30 年的经验。我们将使用内部管理委员会来监督 DCC 的运营，并指派一个 DCC 协议团队与 GN 研究人员就每个新协议进行合作。我们将使用过去 5 年开发的现有 IT 结构，从网络中持续存在的 RU 站点收集研究数据并将其传输到 RTI，包括硬件、软件以及现场 IT 专家和数据管理员，以协助维护系统。对于新的 RU，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 站点工作人员来管理所开发的系统。我们的通讯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建立。在该项目的第一年，RTI 将与 RU 工作人员和 NICHD 合作，完成研究第一阶段的单中心协议的出版物，完成 FIRST BREATH 多中心协议的数据收集，并开始为随机临床开发其他通用协议试验。