Data Coordination Center for the RMN

描述（由申请人提供）：本申请是对RFA-HD-06-008的回应，旨在建立一个数据协调中心（DCC），作为多中心生殖医学合作网络（RMN）的一部分。根据RFA的要求，我们将负责研究设计、中央数据库管理、统计领导;以及协调网络的行政活动，包括向RMN提供组织、信息、后勤和监管支持，以开展生殖疾病治疗的临床试验。作为RMN的一部分，我们将与临床研究中心和NICHD合作，并在本RFA中概述的网络研究的各个方面为临床研究中心和NICHD提供重要支持。例如，我们将定期与NICHD计划管理员、指导委员会（SC）、数据安全和监测委员会（DSMC）、网络调查员进行沟通并及时向其报告;将安排RMN相关会议和电话会议;将为RMN委员会和DSMC会议和电话会议、现场访问、跟踪样本准备和分发会议议程、会议记录和行动项目;将监测不良事件，进行研究中心访视，协助RMN满足监管要求;并将根据需要提供完成行动项目的时间表和行动项目状态的更新。我们将与RMN的研究者合作制定方案，参与包括SC在内的委员会，并与其他研究中心、咨询委员会（AC）和DSMC进行互动。我们已经组建了一个在DCC和RMN的所有领域都具有丰富经验的优秀研究人员团队，一些研究人员正在与PI合作，为NICHD资助的早产研究基因组和蛋白质组网络提供类似的支持。我们有最好的设施和信息技术。我们决心加强与NICHD的伙伴关系，并准备与RMN的临床研究中心建立新的伙伴关系，共同努力开展生殖疾病的临床试验。我们致力于RFA中规定的DCC的作用和责任，并在这奋进得到充分的机构支持。

DESCRIPTION (provided by applicant): This application is in response to RFA-HD-06-008 to establish a Data Coordination Center (DCC) as a part of the Cooperative Multicenter Reproductive Medicine Network (RMN). As requested by the RFA, we will be responsible for study design, central database management, statistical leadership; and coordination of the administrative activities of the Network including organizational, informational, logistic, regulatory support to the RMN in order to conduct the clinical trials on treatments for reproductive disorders. As a part of the RMN, we will participate in a cooperative manner with and provide vital support to the Clinical Sites and the NICHD in all aspects of Network research as outlined in this RFA. For example, we will communicate regularly with and report timely to the NICHD Program Administrators, the Steering Committee (SC), the Data Safety and Monitoring Committee (DSMC), the Network investigators; will arrange RMN related meetings and conference calls; will prepare and distribute meeting agendas, minutes, and action items for the RMN committee and DSMC meetings and calls, site visits, track samples; will monitor adverse events, conduct site visits, assist RMN with regulatory requirements; and will provide timelines for the completion of action items and updates on the status of action items as required. We will collaborate with investigators in RMN in the protocol development, participate in the committees including the SC, and interact with other sites, the Advisory Committee (AC), and the DSMC. We have assembled a team of outstanding investigators with extensive experience in all of areas of the DCC and RMN, and several investigators are collaborating with the PI in providing the similar support for the Genomic and Proteomic Network for Preterm Birth Research funded by the NICHD. We have the best facilities and information technologies. We are determined to strengthen our partnership with the NICHD and are ready to establish new partnerships with clinical research sites in the RMN in this important joint effort to conduct clinical trials for reproductive disorders. We are committed to the role and responsibilities of the DCC as stated in the RFA and have full institutional support in this endeavor.