Data Coordination Center for the RMN

描述(由申请人提供)：为响应RFA-HD-14-018，我们将重新竞争数据协调中心(DCC)作为合作多中心生殖医学网络(RMN)的一部分，并将负责研究设计、实施、分析和发布；数据管理；现场监测；监管要求；以及财务管理，作为我们当前工作的继续。我们将以高度合作的方式参与，并在RMN的各个方面向临床站点和NICHD提供至关重要的支持。例如，我们将定期与NICHD项目管理者、指导委员会(SC)、数据和安全监测委员会(DSMB)、咨询委员会(AB)和RMN调查员沟通并及时报告；积极参与方案制定的所有方面；为RMN相关会议和电话会议安排后勤；为RMN委员会和董事会准备和分发会议和电话会议议程、会议纪要和行动项目；进行现场监测访问；监督生物监测管理；监测不良事件；协助RMN满足法规要求；与研究药物和生物库代表合作；为研究人员提供或协调培训；促进数据和资源共享并检索外部调查人员使用的RMN样本产生的数据；执行数据质量控制、分析和报告；管理与议定书有关的成本；以及最重要的是，在科学出版物方面发起和/或合作。RMN经历了前所未有的生产力，在许多领域超过了我们的目标。作为这一成功的关键贡献者，我们的DCC“与最优秀的人站在一起”。RMN非常享受我们的存在和贡献并从中受益，反之亦然。我们得到了我们机构的全力支持，包括世界知名的设施和信息技术。我们决心推进RMN和NICHD的使命，以改善不孕不育的治疗，以及更广泛的公共卫生政策和实践。

DESCRIPTION (provided by applicant): In response to RFA-HD-14-018, we are re-competing for the Data Coordination Center (DCC) as a part of the Cooperative Multicenter Reproductive Medicine Network (RMN) and will be responsible for Study Design, Conduct, Analyses and Publications; Data Management; Site Monitoring; Regulatory Requirements; and Financial Administration as a continuation of our current work. We will participate in a highly cooperative manner and provide vital support to the Clinical Sites and the NICHD in all aspects of the RMN. For example, we will communicate regularly with and report in a timely manner to the NICHD Program Administrators, Steering Committee (SC), Data and Safety Monitoring Board (DSMB), Advisory Board (AB) and RMN investigators; actively participate in all aspects of protocol development; arrange logistics for RMN-related meetings and teleconferences; prepare and distribute meeting and teleconference agendas, minutes, and action items for the RMN committees and boards; conduct site monitoring visits; oversee biospecimen management; monitor adverse events; assist RMN with regulatory requirements; collaborate with study drug and biorepository representatives; provide or coordinate training for study personnel; facilitate data and resource sharing and retrieve the data generated from the RMN samples used by outside investigators; perform data quality control, analysis and reporting; manage the protocol-related costs; and most importantly, initiate and/or collaborate in scientific publications. The RMN has experienced unprecedented productivity, exceeding our goals in many areas. As a key contributor to this success, our DCC "stands tall with the best of the best." The RMN has greatly enjoyed and benefited from our presence and contribution, and vice versa. We have full support from our institution, including world renowned facilities and information technology. We are determined to advance the RMN and NICHD mission for improving infertility treatment, and more broadly, public health policy and practice.