DATA COORDINATING CENTER FOR THE STUDY OF PREGNANCY AND NEONATAL HEALTH (SPAN)

SPAN是一个预期怀孕队列，招募怀孕早期的女性，并在整个怀孕期间保留她们，并有可能进行长期随访。这项研究有三个具体目标： 1)父亲对DOHaD的贡献(DAD的目的)：确定父亲的心血管风险和精液表观遗传因素与胎儿生长、新生儿人体测量和胎盘特征相关； 2)胎儿生长和胎盘老化的遗传学(gGAP目标)：确定胎儿生长、新生儿人体测量和胎盘表观遗传老化的遗传机制；以及 3)妊娠期糖尿病(妊娠期糖尿病)的分娩时间(时间目标)：使用适应性试验设计进行临床试验，以确定妊娠期糖尿病合并妊娠38-39周的最佳分娩时间相对于新生儿发病率和死亡率。 这一举措是为了数据协调服务，这些服务最终将提供将从SPAN研究中收集的数据的最终数据集和统计分析。这项研究涉及多个负责招聘和招生的学习地点。数据协调中心(DCC)(本任务单)负责组织试验部件的数据安全与监控委员会(DSMB)。基于网络的数据收集系统将由美国国立卫生研究院临床试验数据库(CTDB，https://ctdb.nichd.nih.gov/ctdb/).)建立 作用域 为《妊娠与新生儿健康研究》提供数据协调服务。本任务单的目的是为SPAN研究的准备、培训活动、注册、数据收集和数据分析采购DCC的服务。数据协调中心应协助从NICHD CTDB实施基于网络的数据管理系统。主要职责包括协调和管理数据收集，确保数据质量和完整性，编制全面的数据文件，清理和核实数据， 处理、跟踪(研究访问、数据录入和生物检疫)，支持行政和监管要求以及统计分析。此外，疾病预防控制中心负责审查研究网站，并与临床站点密切合作，以监测和监督研究。DCC还负责为研究的临床试验部分提供随机化方案和组织DSMB，并为试验结果的中期分析提供计划。此外，DCC将负责根据需要为时事通讯开发、学习网站和社交媒体(如Facebook帖子)提供图形专业知识。

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Division of lntramural Population Health Research (DIPHR) requires data coordinating services for the Study of Pregnancy And Neonatal health (SPAN). SPAN is a prospective pregnancy cohort recruiting women in early pregnancy and retaining them throughout pregnancy with potential for long-term follow-up. The Study has three specific aims - 1) Paternal Contribution to DOHaD (DAD aim): Determine paternal cardiovascular risk and semen epigenetic factors associated with fetal growth, neonatal anthropometry, and placental characteristics; 2) Genetics of fetal Growth And Placental aging (gGAP aim): Identify genetic mechanisms underlying fetal growth, neonatal anthropometry, and placental epigenetic aging; and 3) Timing of delivery for GDM (Gestational Diabetes Mellitus) (TIME aim): Perform a clinical trial using an adaptive trial design to determine the optimal timing of delivery for gestational diabetes complicated pregnancies between 38-39 weeks relative to neonatal morbidity and mortality. This initiative is for the data coordinating services that will ultimately provide the final dataset and statistical analyses of the data that will be collected from the SPAN Study. This study involves multiple study sites that are responsible for recruitment and enrollment. The data coordinating center (DCC) (this task order) is responsible for organizing a data safety and monitoring board (DSMB) for the trial component. The web-based data collection system will be established by the NICHD's Clinical Trial Database (CTDB, https://ctdb.nichd.nih.gov/ctdb/). SCOPE To provide data coordinating services for "the Study of Pregnancy And Neonatal Health." The purpose of this task order is to procure the services of a DCC for preparation, training activities, enrollment and data collection and data analysis of the SPAN study. The DCC shall aid in implementing a web-based data management system from the NICHD CTDB. Major responsibilities include coordination and management of data collection, assuring data quality and integrity, producing thorough data documentation, cleaning and verifying the data, processing, tracking (study visits, data entry and biospecimens), supporting administrative and regulatory requirements and statistical analyses. In addition, the DCC is responsible for reviewing the study website and working closely with the clinical sites to monitor and oversee the study. The DCC is also responsible for providing a randomization scheme and organizing a DSMB for the clinical trial component of the study and providing a plan for the interim analysis of trial findings. Moreover, the DCC will have the responsibility of providing graphic expertise for newsletter development, study website, and social media (e.g. Facebook posts), as needed.