In the clinical trials arena, sponsors and CROs need ongoing access to accurate, real-time metrics to drive improvement in TMF Management and address any operational performance gaps. Metrics drive good behavior, and not taking the opportunity to learn from metrics can lead to a pattern of poor outcomes from clinical activities.
You’ve probably heard it before that the “basic” or core metrics to track and measure in our electronic trial master file (eTMF) are completeness, timeliness, and quality. Having an electronic system that can report on core metrics in real-time will help you see whether you are staying inspection ready and applying ongoing quality control. But to learn from metrics, they must be accurate, and a lot can go wrong if they aren’t (e.g. inspection findings, wasted resources, failing to reach your goals).
