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

Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD），校内人口健康研究部（DIPHR）需要为妊娠和新生儿健康研究（SPAN）提供数据协调服务。SPAN是一项前瞻性妊娠队列研究，招募妊娠早期女性，并在整个妊娠期间保留她们，并有可能进行长期随访。这项研究有三个具体目标： 第一章 父亲对DOHaD的贡献（DAD目的）：确定父亲心血管风险和与胎儿生长、新生儿人体测量和胎盘特征相关的精液表观遗传因素; （二） 胎儿生长和胎盘衰老的遗传学（gGAP目标）：确定胎儿生长、新生儿人体测量和胎盘表观遗传衰老的遗传机制; 第三章 GDM（妊娠期糖尿病）的分娩时机（TIME aim）：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周的最佳分娩时机，相对于新生儿发病率和死亡率。 该计划旨在提供数据协调服务，最终提供SPAN研究中收集的数据的最终数据集和统计分析。本研究涉及负责招募和入组的多个研究中心。数据协调中心（DCC）（本任务指令）负责组织试验部分的数据安全和监查委员会（DSMB）。基于网络的数据收集系统将由NICHD的临床试验数据库（CTDB，https：//ctdb.nichd.nih.gov/ctdb/）建立。 范围 为"妊娠和新生儿健康研究"提供数据协调服务。"这项任务订单的目的是采购一个数据中心的服务，以便为SPAN研究进行准备、培训活动、登记和数据收集和数据分析。DCC应协助实施NICHD CTDB的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，编制完整的数据文件，清理和验证数据， 处理、跟踪（研究访视、数据录入和生物标本）、支持行政和监管要求以及统计分析。此外，DCC负责审查研究网站，并与临床研究中心密切合作，以监查和监督研究。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，并提供试验结果中期分析计划。此外，DCC将负责根据需要为时事通讯开发、研究网站和社交媒体（例如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.