The quality and ultimate reliability of clinical data collected from investigative sites during a study depends on many factors. One area that may not get enough attention is the cycle time from subject visit through eCRF data capture, and final review and cleaning of that data.
We hear it from our customers all the time: complexity is a problem. Too many steps in the clinical process. Too many procedures. Too many doctor’s visits. Too much data. So in a recent contribution to the Data Analytics blog on Applied Clinical Trials, we decided to dig into a Medidata Insights metric that addresses one piece of the complexity puzzle: eCRF design complexity, which is a score that reflects the relative estimated work effort associated with implementing a clinical study eCRF—including eCRF build, testing and deployment—using the Medidata Rave system for electronic data capture, management and reporting.
We’ve already talked about the trend towards targeted (or “risk-based”) site monitoring and data review. Despite the growing popularity of targeted source document verification (SDV), some organizations remain concerned about the potential impact on data quality.