Obstetrical Pharmacology Research Network - Data Coordination and Analyses Center

描述(由申请人提供)：RTI国际(RTI)建议为产科药理学研究网络(OPRU)建立数据协调和分析中心(DCAC)。RTI在超过25个多站点临床、流行病学和行为研究中担任DCAC长达31年的经验，其中许多研究涉及妇幼保健领域，这使我们能够认识到并解决DCAC必须承担的各种责任，以成功满足多站点研究的不断变化的需求。OPRU DCAC有几个独特的要求：(1)DCAC将与多个正在进行的方案整合到一个运行网络中，(2)收集的生物标本包括不寻常的组织，如胎盘和脐带血，以及(3)可能向FDA提交一些数据以支持药物标签，这对方案中的质量保证和控制具有影响。特别值得注意的是，这项研究涉及到推进药代动力学和药效学建模领域的机会。因此，我们建议在DCAC项目以及统计建模和动物和临床研究方面具有经验的关键人员。我们推荐Rick Williams博士担任PI(DCAC管理和统计建模)和联合调查员，RTI的Timothy Fennell博士和Claude Hughes博士(临床试验和转化医学)，以及加州大学圣地亚哥分校的Edmund Capparelli博士(儿科药代动力学分析)。DCAC的其他职责包括但不限于：(1)参与制定方案；(2)开发和实施全研究范围的通信网络；(3)提供数据收集和管理系统，以满足研究的新需求；(4)根据需要支持研究的后勤；(5)协助培训现场人员的标准研究程序；(6)协助制定和实施质量控制程序和质量保证程序；(7)支持生物标本的收集、运输和跟踪；(8)提供生物统计和数据管理领导；(9)编写符合研究网站、指导委员会和数据安全和监测委员会需要的常规报告和特别报告；以及(10)在协调传播计划的范围内，通过出版物和专题介绍，帮助传播研究结果。随着网络需求的变化，我们将能够从具有不同背景的大量工作人员中补充我们的基地工作人员，以满足研究的预期需求。RTI位于马里兰州罗克维尔靠近NICHD的办公室，根据需要为指导委员会会议提供互动和当地支持的会议空间。

DESCRIPTION (provided by applicant): RTI International (RTI) proposes to establish the Data Coordinating and Analysis Center (DCAC) for the Obstetrical Pharmacology Research Network (OPRU). RTI's 31 years of experience serving as DCAC for over 25 multi-site clinical, epidemiologic, and behavioral studies, many in the field of maternal and child health, enable us to recognize and address the various responsibilities that must be undertaken by a DCAC to successfully meet the ever-changing needs of a multi-site study. The OPRU DCAC has several unique requirements: (1) the DCAC will integrate into an operational Network with multiple ongoing protocols, (2) the biospecimens collected include unusual tissues such as placenta and cord blood, and (3) some data may be submitted to the FDA in support of drug labeling, which has implications for quality assurance and control in the protocols. Of particular note, the research involves the opportunity to advance the field of pharmacokinetic and pharmacodynamic modeling. Consequently, we propose key persons with experience in DCAC projects, as well as statistical modeling and animal and clinical research. We propose Dr. Rick Williams as PI (DCAC management and statistical modeling) and Co-Investigators Drs. Timothy Fennell (animal toxicology) and Claude Hughes (clinical trial and translational medicine) from RTI and Dr. Edmund Capparelli (pediatric pharmacokinetic analysis) at the U of California, San Diego. Other responsibilities for the DCAC include, but are not limited to: (1) participating in protocol development; (2) developing and implementing a study-wide communications network; (3) providing data collection and management systems that are responsive to the emerging needs of the study; (4) supporting the logistics of the study as needed; (5) assisting in training site personnel in standard study procedures; (6) assisting in developing and implementing quality control and quality assurance procedures; (7) supporting the collection, shipping, and tracking of biospecimens; (8) providing biostatistical and data management leadership; (9) producing both routine and ad hoc reports that meet the needs of the Research Sites, the Steering Committee, and the Data Safety and Monitoring Board; and (10) helping to disseminate the results of the study through publications and presentations within the context of a coordinated dissemination plan. As the demands of the Network change, we will be able to supplement our base staff with needed expertise from our large staff with varied backgrounds that address the anticipated needs of the study. RTI's office near to NICHD in Rockville, MD, provides meeting space as needed for interaction and local support for Steering Committee meetings.