Data Coordination Center for the RMN

RMN 数据协调中心

• 批准号: 7935595
• 负责人: HEPING ZHANG
• 金额: $ 756.53万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7935595
• 关键词: Administrative Coordination; Administrator; Adverse event; Advisory Committees; Area; Biological; Cataloging; Catalogs; Collaborations; Collection; Commit; Communication; Computer Assisted; Conduct Clinical Trials; Data; Data Base Management; Data Collection; Data Coordinating Center; Data Set; Databases; Development; Disease; Equipment; Funding; Genomics; Human Resources; Information Technology; Institution; Interview; Joints; Leadership; Letters; Logistics; Manuals; Manuscripts; Monitor; Nail plate; National Institute of Child Health and Human Development; Participant; Perception; Performance; Premature Birth; Preparation; Procedures; Proteomics; Protocols documentation; Publications; Quality Control; Reporting; Reproductive Medicine; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Role; Safety; Sampling; Secure; Site; Site Visit; Specimen; Summary Reports; System; Telephone; TimeLine; Training; Update; base; clinical research site; cost; data management; design; experience; improved; meetings; member; programs; protocol development; quality assurance; reproductive; response; sample collection; symposium; tool; web page; web site

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.

描述(申请人提供)：本申请是对RFA-HD-06-008的响应，目的是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。应RFA的要求，我们将负责研究设计、中央数据库管理、统计领导；以及协调该网络的行政活动，包括为RMN提供组织、信息、后勤和监管支持，以便进行生殖疾病治疗的临床试验。作为RMN的一部分，我们将以合作的方式参与临床站点和NICHD，并在本RFA概述的网络研究的方方面面提供重要支持。例如，我们将与NICHD项目管理人、指导委员会(SC)、数据安全和监测委员会(DSMC)、网络调查员定期沟通并及时报告；将安排与RMN相关的会议和电话会议；将为RMN委员会和DSMMC会议和电话会议准备和分发会议议程、纪要和行动项目；将进行现场访问、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；并将根据需要提供完成行动项目的时间表和行动项目状态的最新信息。我们将与RMN的调查人员合作制定方案，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在DCC和RMN的所有领域都具有丰富经验的杰出研究人员团队，几名研究人员正在与PI合作，为NICHD资助的早产研究基因组和蛋白质网络提供类似的支持。我们拥有最好的设施和信息技术。我们决心加强与NICHD的伙伴关系，并准备在这一重要的联合努力中与RMN的临床研究地点建立新的伙伴关系，以进行生殖障碍的临床试验。我们致力于履行《区域合作框架》中所述的发改委的作用和责任，并在这一努力中得到充分的机构支持。