Systems engineering and software development for the NIH fetal saturation (FOX) trial

NIH-NICHD plans to analyze electronic fetal monitoring signals and data recorded from 10000 pregnant women to assess the efficacy of the fetal oxygen saturation modality. The FOX project involves a systems engineering effort to determine the necessary fetal monitor configurations and interfaces, and a software development effort to design and implement an application to manage the study and collect the physiologic data from the monitors and store it on a PC. Major activities were the development of a project requirements document, a test plan, a requirements/design specification, a functioning prototype and final product, and to perform design reviews. Milestones included the delivery of a project requirements document and requirements specification, a prototype, completion of user acceptance testing on the final design, and beta site and full site deployments.