Real-World Examples of eCOA Compliance & Audit Trail Review Using Advanced Statistical Methodology

As eCOA data becomes a dominant component of clinical trial datasets, regulators are placing increased emphasis on systematic, risk-based audit trail review. Guidance from ICH E6 (R3) and the EMA makes it clear: audit trails must be decipherable, analyzable, and reviewed as a planned activity tailored to trial risk. Yet traditional, site-centric monitoring approaches lack the context and scalability needed to deliver meaningful oversight of eCOA data.

This white paper brings together industry expertise to show how advanced statistical and analytical techniques enable centralized, fit-for-purpose audit trail review. Drawing on real-world examples from investigative sites, it demonstrates how established monitoring methods and newer analytical approaches can uncover atypical site and patient behavior, identify protocol non-compliance earlier, and strengthen data integrity across studies.