New paper published in British Journal of Clinical Pharmacology

December 07, 2022 The paper is entitled “Impact of Monitoring Approaches on Data Quality in Clinical Trials - A Cross-Study Comparison of Risk-Based Monitoring and Classic Monitoring”, and is authored by: Jeppe Ragnar Andersen, Christoffer von Sehested, Inger Byrjalsen, Sara Popik, Anne Bo Follin, and Asger Bihlet.


Source Data Verification (SDV) has been reported to account for up to 25% of the budget in Clinical Trials (CT) and cost-benefit of SDV has been questioned. Guidelines for Risk-Based Monitoring (RBM) were published in 2013 by agencies and in 2016, ICH-GCP-E6-(R2) added a requirement for risk-based approaches. This report will perform a comparison of the impact of RBM versus Classic Monitoring (CM) on data quality (defined as accuracy of data reporting from source data to final trial data) and expected impact on costs of CTs.