Automating variations in clinical research protocols workflow

Clinical research protocols follow rigorous methodologies requiring painstaking precision in every step of the process. A variety of factors determine the required steps an individual participant will take throughout the protocol timeline. Such steps could easily become more complicated and complex in a research setting aimed at new discoveries, which require various degrees of flexibility depending on the specific conditions at various points of the study. In this paper we describe our protocol workflow system (PWS), which is designed to accommodate all of the current and potential future protocols while simultaneously providing the capability for workflow adjustments during various phases of ongoing studies. Furthermore, it is robust enough to organize and handle participants who are enrolled concurrently in multiple protocols. This automated system not only collects information at an outpatient research center, but also automates the workflow and data collection points throughout the clinic.