Data Ctr for the Cooperative Neonatal Research Network

描述（由申请人提供）：三角研究所（RTI）提议继续作为多中心新生儿合作研究网络（NRN）的数据协调中心（DCC）。为这一持续努力提议的高级工作人员与过去4年来领导发展协调委员会的人员相同。此外，他们还指导其他数据协调中心30年，并已完成或正在进行7项关于产妇/围产期/新生儿研究的重大研究。目前的研究是三个网络，包括目前提议的一个，在新生儿学和妇幼保健方面进行多地点、多协议研究。W. Kenneth Poole博士，拟任首席研究员（PI），曾担任12个DCC主要项目的PI或Co-PI。特别是，他是NRN DCC的现任PI，是全球妇女和儿童健康研究网络的协议统计学家，曾担任高频通气（HIFI）和呼吸窘迫综合征（RDS）研究的PI，是阴道感染和早产（VIP）研究的共同PI，以及NICHD早期儿童保育研究（SECC）和DC倡议研究的高级统计学家。此外，在接手NRN的DCC之前，Poole博士和我们提议的一些工作人员与目前的四个网络pi一起进行了HIFI和RDS研究。我们提议的所有工作人员都在DCC项目上合作多年，包括孕产妇/围产期/新生儿研究。RTI在马里兰州罗克维尔的办公室就在NICHD的隔壁。一名协调员、一名高级分析师、三名统计人员（包括联合负责人）和一名支助人员位于罗克维尔的这个设施。RTI在统计设计和分析、数据收集程序、数据管理和处理、质量控制、随机化、研究后勤、网络通信以及跟踪药物供应和样本等领域承担网络的领导作用。我们使用最先进的数据收集、处理和管理方法，包括计算机辅助数据收集方法、电子数据传输、网站以及与研究合作者的互联网连接。RTI的矩阵式管理结构可将个别工作人员分配到若干项目，在最需要的时候为项目分配额外资源提供了相当大的灵活性。研究所工作人员与现场pi和统计学家在出版手稿开发方面有着令人印象深刻的记录。

DESCRIPTION (provided by applicant): Research Triangle Institute (RTI) proposes to continue serving as the Data Coordinating Center (DCC) for the Cooperative Multicenter Neonatal Research Network (NRN). The senior staff proposed for this continued effort are the same as those who have directed the DCC for the last 4 years. In addition, they have directed other data coordinating centers for 30 years and have completed or are now conducting seven major studies in maternal/perinatal/neonatal research. Current studies are three networks, including the currently proposed one, that conduct multisite, multiprotocol studies in neonatology and maternal and child health. Dr. W. Kenneth Poole, the proposed Principal Investigator (PI), has been the PI or Co-PI of 12 major DCC projects. In particular, he is the current PI of the DCC for the NRN, is a protocol statistician for the Global Network for Women's and Children's Health Research, has been the PI of the High Frequency Ventilation (HIFI) and Respiratory Distress Syndrome (RDS) studies, was Co-PI of the Vaginal Infection & Prematurity (VIP) study, and was senior statistician on NICHD's Study of Early Child Care (SECC) and DC Initiative studies. Also, Dr. Poole and some of our proposed staff worked with four of the current Network PIs on the HIFI and RDS studies prior to taking over the DCC for the NRN. All of our proposed staff have worked together for many years on DCC projects including the studies in maternal/perinatal/neonatal research. RTI has Rockville, MD offices next door to NICHD. A coordinator, a senior analyst, three statisticians (including the Co-PI), and a support person are located in this Rockville facility. RTI assumes a leadership role for the Network in the areas of statistical design and analysis, data collection procedures, data management and processing, quality control, randomization, study logistics, Network communications, and tracking drug supplies and specimens. We use state-of-the-art methods of data collection, processing, and management, including computer-assisted data collection methods, electronic data transfer, a web site, and Internet linkages with the study collaborators. RTI's matrix management structure, whereby individual staff may be assigned to several projects, provides considerable flexibility in allocating additional resources to projects at times of peak needs. Institute staff have an impressive track record working with site PIs and statisticians in the development of manuscripts for publication.