Quality Data in Clinical Trials: Source Data Verification Vs Risk-Based Monitoring

Early October 2023 Sonja Simon-Zoula, Head of Clinical Operations at EarlySight delivered a keynote presentation comparing Rick Based Monitoring to Source Data Verification.

A critical component of clinical trials is ensuring the quality of the collected data through careful monitoring. Historically, source data verification (SDV) has been the gold standard, with monitors verifying 100% of the data points from source documents against the case report forms. However, SDV is resource-intensive and costly, especially for large trials.

In recent years, risk-based monitoring (RBM) has emerged as an alternative approach. With RBM, risks to data quality are assessed upfront and monitoring is focused on higher risk data points. This allows for more efficient use of resources by targeting monitoring to critical areas. However, RBM requires significant planning and coordination across functions and can be subjective in risk assessments.

Since the COVID-19 pandemic limited on-site monitoring visits, many sponsors rapidly adopted RBM out of necessity. But what is the right balance moving forward? Industry data indicates an increasing number of mixed model studies incorporating elements of both SDV and RBM. Sponsors seem to be strategically combining targeted on-site SDV for high risk processes with centralized and remote monitoring of data metrics and quality indicators.

For example, a phase 3 trial evaluating a new cancer therapy may use RBM to monitor enrolment rates, data completeness, and protocol deviations across all sites. This allows issues to be quickly identified so they can be addressed proactively. But for high risk procedures, like biopsies or administration of chemotherapy, 100% SDV may still be performed to minimize risks to patient safety.

Hybrid approaches allow sponsors to take advantage of RBM’s efficiencies while still verifying source data for critical endpoints and safety measures. They provide a way to balance data quality and patient safety with cost and resource constraints. With careful planning and cross-functional coordination, sponsors can design monitoring strategies incorporating elements of both SDV and RBM to maintain data integrity and subject protections while also improving efficiency. As complexity of clinical trials increases, using the right tools for the right risks will be key to ensuring high quality evidence generation.