SIDS Data Coordinating and Analysis Center

描述（由申请人提供）：在多中心研究或合作项目中，一个具有强大领导，组织和分析能力的集中数据协调和分析中心（DCAC）是项目成功的关键。DMSTAT公司提议作为产前酒精暴露和婴儿猝死综合征（SIDS）多学科研究网络的DCAC，该网络将通过对RFA HD- 03-004的响应而建立。DM-STAT作为NICHD和NIAAA赞助的多中心试验和合作的指定DCAC，具有良好的成功记录。我们的目标是让参与的员工生活更轻松，这样他们就可以专注于自己的专业领域。为了实现这一目标，DM-STAT将建立和维护一个全研究范围的基础设施，以支持网络成员，包括NICHD、NIAAA和管理委员会之间的活动和促进信息共享。这个基础设施将围绕一个包含行政和数据管理组件的网络网站。该网站将提供对所有项目文件和材料、数据管理报告、统计分析摘要的即时访问，并将提供一个论坛（会议中心）来分享想法和问题。第一阶段（共两个阶段）要求在综合临床站点（CCS）、发育生物学和病理学中心（DBPC）和DCAC之间建立一个正式的合作结构，以调查产前酒精暴露与婴儿猝死综合征（SIDS）和不良妊娠结局（如死胎和胎儿酒精综合征（FAS））风险之间的关系。此外，该网络还将调查可能与女性在怀孕和哺乳期间决定饮酒有关的社会和行为因素。第一阶段将需要制定可检验的假设，对核心和具体地点的规程进行试点试验，并根据这些试点研究的结果编写一份载有建议的执行摘要，以评估第二阶段的可行性和理由。DM-STAT将在研究设计、协议开发、数据管理和统计分析方面为网络提供领导和指导。有了一个有凝聚力的网络，DM-STAT将负责协调核心协议的安全和一致实施，监测关键质量指标，并对试点数据进行分析。DM-STAT致力于质量；这是我们所做的一切的焦点。我们积极主动，而不是被动被动，在精简和组织流程和程序方面具有创新性，能够与各级学习人员进行教育和沟通，我们充满激情，致力于第一次就把工作做好。我们认为，DM-STAT最有能力以高效率和有效的方式满足该网络的需要。

DESCRIPTION (provided by applicant): In multi-center studies or collaborative projects, a centralized Data Coordinating and Analysis Center (DCAC) with strong leadership, organization and analytic skills is critical to the success of the project. DMSTAT, Inc. proposes to serve as the DCAC for the multi-disciplinary research network on prenatal alcohol exposure and sudden infant death syndrome (SIDS) that will be established through responses to RFA HD- 03-004. DM-STAT has a proven track record of success as the designated DCAC on NICHD and NIAAA sponsored multi-center trials and collaborations. Our goal is to make life easier for participating staff so that they can focus on their areas of expertise. To achieve that goal, DM-STAT will create and maintain a study-wide infrastructure to support the activities of and facilitate information sharing between members of the Network, including the NICHD, NIAAA, and governing boards. This infrastructure will revolve around a Network website containing administrative and data management components. The website will provide instant access to all project documentation and materials, data management reports, statistical analysis summaries, and will provide a forum (the Meeting Center) for sharing ideas and issues. The first phase (of two phases) calls for formalizing a collaborative structure between, Comprehensive Clinical Sites (CCS), Developmental Biology and Pathology Center(s) (DBPC) and the DCAC to investigate the relationship between prenatal alcohol exposure and the risk for sudden infant death syndrome (SIDS) and adverse pregnancy outcomes (e.g., stillbirth and fetal alcohol syndrome (FAS)). In addition, the Network will investigate social and behavioral factors that may be related to a woman's decision to drink alcohol during pregnancy and lactation. Phase I will require development of testable hypotheses, pilot testing of the core and site-specific protocols and producing an executive summary with recommendations based upon the results of these pilot studies in order to assess feasibility and justification for Phase II. DM-STAT will provide leadership and guidance to the network with respect to study design, protocol development, data management and statistical analysis. With a cohesive Network in place, DM-STAT will then be responsible for coordinating safe and consistent implementation of the core protocol, monitoring key indicators of quality, and performing analysis of pilot data. DM-STAT is committed to quality; it is the focal point of everything we do. We are proactive as opposed to reactive, innovative in streamlining and organizing processes and procedures, able to educate and communicate with study staff at all levels, and we are passionate and committed to getting the job done right the first time. We believe that DM-STAT is best positioned to serve the needs of this Network in an efficient and effective manner.