Designing an Institutional Database for Auditing and Monitoring of Clinical Research

Background: Good Clinical Practice (GCP) and the US Food and Drug Administration (FDA) regulations require auditing and monitoring of clinical trials to assure regulations, policies and the protocol are being followed. This improves the quality and reliability of a study. Objective: Virginia Commonwealth University (VCU) has implemented an auditing and monitoring tracking and reporting system within OnCore® a Clinical Trial Management System. Having an institutional process for collecting and tracking study specific findings allows for reporting on a particular study but also allows for trends in deficiencies to be recognized within investigative teams and the institution. Looking at these deficiencies then allows for education across the university. This article will highlight the steps used to develop the checklists and results of the first 18 months of utilization. Conclusion: Expansion and creation of a VCU specific checklist have allowed for standardization, tracking, reporting and education around compliance with regulations, policies, and best practices. Keywords: Auditing, clinical research, clinical trial, Clinical Trial Management System (CTMS), education, Good Clinical Practice (GCP), quality, monitoring.