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

Technical Resources International, Inc., Bethesda MD

Investigators

Abstract

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.