Using Verified Clinical Trials’ Database Registry to Determine the Prevalence of and Prevent Inclusion/Exclusion Related Protocol Violations in Early Phase Clinical Trials

Yulan Zhang from Verified Clinical Trials presenting a poster at ASCPT2019 “Using Verified Clinical Trials’ Database Registry to Determine the Prevalence of and Prevent Inclusion/Exclusion Related Protocol Violations in Early Phase Clinical Trials”. VCT prevents duplicate subjects in clinical trials.

The data demonstrates how VCT prospectively determines the prevalence of and prevent inclusion/exclusion related protocol violations (IEPVs) in early phase trials at United States (US) Clinical Pharmacology Units (CPUs) using a global research subject database registry (GRSDR). IEPVs are preventable protocol deviations that can affect participant safety and data integrity. IEPVs result from subject forgetfulness, deception or researchers’ inability to reliably verify subject research history. The prevalence of IEPVs has historically not been well understood because methods to collect the information were previously retrospective or unreliable. Prospective prevention of IEPVs provides cost savings to both sponsors and sites. VCT has similar data in other regions of the world.