Data Coordination Center for the RMN

此应用程序响应RFA-HD-06-008建立数据协调中心(DCC)作为一部分 合作多中心生殖医学网络(RMN)。按照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，包括组织、信息、后勤和监管方面的支助 RMN，以便进行生殖障碍治疗的临床试验。 作为RMN的一部分，我们将以合作的方式参与并为RMN提供至关重要的支持 临床站点和NICHD在网络研究的所有方面，如本RFA所概述的。例如，我们 将定期与NICHD项目管理员沟通并及时向其报告，指导 委员会(SC)、数据安全和监测委员会(DSMC)、网络调查人员；将 安排与RMN相关的会议和电话会议；准备和分发会议议程、会议纪要、 以及RMN委员会和DSMC会议和电话会议的行动项目、现场访问、跟踪样本；将 监测不良事件，进行现场访问，协助RMN满足法规要求；并将提供 完成行动项目的时间表，并根据需要更新行动项目的状态。我们会 与RMN的调查人员合作制定方案，参与委员会，包括 SC，并与其他站点、咨询委员会(AC)和DSMC互动。 我们已经组建了一支优秀的调查团队，在所有领域都有丰富的经验 DCC和RMN，以及几名调查人员正在与PI合作，为 由NICHD资助的早产研究基因组和蛋白质组网络。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 并准备在这个重要的联合中与RMN的临床研究站点建立新的合作伙伴关系 努力进行生殖障碍的临床试验。我们致力于发挥以下作用和承担责任 如《区域合作框架》所述，发展合作委员会在这一努力中得到了充分的机构支持。

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.