Audit Trails & Transparency: Tracking Changes In Clinical Data

By Ben Baumann

Audit trails are essential to safeguarding data integrity and ensuring regulatory compliance in clinical research, particularly as trials grow in complexity and scale. An audit trail is a secure, time-stamped digital record that documents every action performed on trial data—capturing who made a change, what was changed, when it occurred, and why. This traceable history not only fulfills requirements under FDA 21 CFR Part 11, GDPR, and ICH E6(R2), but also provides the foundation for transparency, accountability, and trust in electronic records. As demonstrated in large-scale adaptive studies such as the I-SPY 2 trial.

OpenClinica’s audit trail capabilities deliver real-world benefits by offering site-agnostic tracking, centralized dashboards, and real-time monitoring across decentralized and hybrid trials. This approach enables faster query resolution, improved sponsor confidence, and reduced operational risk while ensuring compliance. By combining comprehensive traceability with user-friendly visibility, OpenClinica empowers research teams to maintain true oversight, detect discrepancies early, and support efficient trial execution. Ultimately, audit trails are not simply a regulatory necessity, but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.