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），作为合作多中心生殖医学网络（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；协调该网络的行政活动，包括组织、信息、后勤和管理方面的支持，以便对生殖疾病的治疗进行临床试验。作为RMN的一部分，我们将以合作的方式参与临床站点和NICHD在本RFA中概述的网络研究的各个方面，并为其提供重要支持。例如，我们将定期与NICHD项目管理员、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报告；安排RMN相关会议及电话会议；为RMN委员会和DSMC会议和电话、实地考察、跟踪样本准备和分发会议议程、会议记录和行动项目；监测不良事件，进行实地考察，协助RMN满足监管要求；并将提供完成行动项目的时间表，并根据需要提供行动项目的最新状态。我们将与RMN的研究人员合作制定协议，参与包括SC在内的委员会，并与其他站点、咨询委员会（AC）和DSMC进行互动。我们已经组建了一支优秀的研究团队，他们在DCC和RMN的所有领域都有丰富的经验，一些研究人员正在与PI合作，为由NICHD资助的早产研究基因组和蛋白质组学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，并准备在开展生殖疾病临床试验的这一重要联合努力中与RMN的临床研究地点建立新的伙伴关系。我们承诺履行《区域合作协定》所规定的发展协调委员会的作用和责任，并在这方面得到机构的充分支持。

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.