Tracing Data Elements through a Standard Data Flow

AbstractEver wondered where a data point came from? Ever been looking through some Tables, Figures and Listings (TFLs) and thought 'I wonder how this number came to be here?'. Chances are you are wondering about the traceability through your data collection, management, and reporting process. Where do you start tracing the data? Where do you finish? How am I going to trace this data effectively? This paper looks into the 'breadcrumb trail' through the data management and reporting cycle of clinical trials. Is there a simple solution out there to manage the traceability of the data in your trial? What will you do when the FDA come knocking and want to see the links through the steps in your process? These questions will soon be answered.