Data Ctr for the Cooperative Neonatal Research Network

描述(由申请人提供)：三角研究所(RTI)建议继续担任合作多中心新生儿研究网络(NRN)的数据协调中心(DCC)。为这一持续努力建议的高级工作人员与过去4年来领导DCC的工作人员相同。此外，他们指导其他数据协调中心已有30年之久，已经完成或正在进行七项关于孕产妇/围产期/新生儿研究的主要研究。目前的研究有三个网络，包括目前提议的一个，在新生儿学和妇幼保健方面进行多点、多方案研究。W.Kenneth Poole博士，拟议的首席调查员(PI)，曾担任DCC 12个主要项目的首席调查员或联合调查员。特别是，他是NRN疾病预防控制中心的现任PI，是全球妇女和儿童健康研究网络的协议统计师，一直是高频呼吸机(HiFi)和呼吸窘迫综合征(RDS)研究的PI，是阴道感染与早产(VIP)研究的共同PI，还是NICHD早期儿童保育(SECC)研究和DC倡议研究的高级统计师。此外，普尔博士和我们的一些拟议员工在接管NRN的DCC之前，曾与四名当前的网络PI一起进行高保真和RDS研究。我们所有拟议的工作人员都在DCC项目上合作多年，包括母体/围产期/新生儿研究。RTI在马里兰州罗克维尔设有办事处，毗邻NICHD。一名协调员、一名高级分析师、三名统计员(包括联合PI)和一名支助人员设在罗克维尔的这个设施内。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品供应和标本等领域为该网络发挥领导作用。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、网站和与研究合作者的互联网链接。技术创新中心的矩阵管理结构使个别工作人员可以被分配到几个项目，在需求高峰期为项目分配额外资源提供了相当大的灵活性。研究所工作人员在与现场绩效指标和统计学家合作开发手稿以供出版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.