Global Network Data Coordinating Center

描述(由申请人提供)：三角研究所(RTI)建议担任NICHD全球妇女儿童健康研究网络(GN)的数据协调中心(DCC)。在过去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)协调总体研究活动；(2)领导生物统计和数据管理；(3)参与研究设计和方案制定；(4)开发数据管理系统(DMS)；(5)合作开发研究材料(如数据表格)，并监督将这些材料翻译成适当的语言；(6)开发和实施质量控制系统；(7)协助培训研究股人员进行研究程序，包括使用DMS；(8)发展研究中心的研究能力，方法是训练研究中心的工作人员撰写研究方法、数据管理和统计分析，并协助他们撰写数据管理系统和发表研究结果；(9)继续管理整个研究的沟通和后勤工作；(10)协助研究中心(如有需要)收集生物标本；(11)组织和协调指导委员会(SC)和数据与安全监测委员会(DSMB)会议；(12)编制符合研究中心、NICHD、SC和DSMB需要的例行和特别报告；以及(13)通过出版和演示协助传播GN研究的结果。所有拟议的RTI工作人员都参与了GN的上述职责，包括PIY，Tyler Hartwell，Ph.D.，Co-Pis Vijaya Rao，Ph.D.，和Elizabeth McClure，M.Ed。Hartwell博士和Rao博士在领导NIH多中心研究(包括国际研究)的DCC方面都有30多年的经验。我们将使用内部管理委员会来监督DCC的运作，并指派DCC协议团队与GN调查人员就每一项新协议进行合作。我们将使用过去5年发展的现有IT结构，从继续留在网络中的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专家和数据经理，以帮助维护系统。对于新的RU，我们将协助购买收集、管理和传输数据所需的计算机设备，并将帮助培训新的RU现场人员来管理所开发的系统。我们的通信网络将再次建立在电话会议、电子邮件以及传播项目报告和研究材料的项目网站上。在项目的第一年，RTI将与RU工作人员和NICHD合作，完成研究第一阶段的单一站点方案的发表，完成关于第一呼吸多中心方案的数据收集，并开始为随机临床试验开发额外的通用方案。

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.