Global Network Data Coordinating Center

描述（由申请人提供）：三角研究所（RTI）提议作为NICHD全球妇女和儿童健康研究网络（GN）的数据协调中心（DCC）。在过去5年中领导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的领导；(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（如数据表格），并监督将这些材料翻译成适当的语言；（六）制定和实施质量管理制度；(7)协助培训研究单位（RU）人员的研究程序，包括dms的使用；(8)通过对研究所工作人员进行研究方法、数据管理和统计分析方面的培训，并协助他们编写数据管理报告和发表研究结果，发展研究所的研究能力；(9)继续管理全校的通讯和后勤工作；（10）协助RUs（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；（十二）编制符合RUs、NICHD、SC和DSMB需要的例行报告和专题报告；（13）通过出版物和报告，协助传播全球网络的研究成果。所有提议的RTI工作人员都参与了GN的上述职责，包括PI、Tyler Hartwell博士、co - PI Vijaya Rao博士和Elizabeth McClure医学博士。Drs。Hartwell和Rao分别在NIH多中心研究（包括国际研究）的领导dcc方面拥有超过30年的经验。我们将使用一个内部管理委员会来监督DCC的运作，并指派一个DCC协议小组与GN调查人员就每项新协议进行合作。我们将使用过去5年开发的现有IT结构，从网络中继续存在的RU站点收集和传输研究数据给RTI，包括硬件、软件和现场IT专家和数据管理人员，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现场工作人员管理开发的系统。我们的通讯网络将再次围绕电话会议、电子邮件和发布项目报告和研究资料的项目网站建立。在项目的第一年，RTI将与RU工作人员和NICHD合作，完成研究第一阶段单站点协议的出版，完成first BREATH多中心协议的数据收集，并开始制定随机临床试验的其他通用协议。

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.