Glossary Term

Audit Trail

Data & Safety

Also known as: electronic audit trail, Part 11 audit trail

A secure, computer-generated, time-stamped electronic record that allows reconstruction of the events relating to the creation, modification, or deletion of an electronic record.

Audit trails are required by 21 CFR Part 11 for regulated electronic systems (EDC, eTMF, eConsent). They support data integrity (ALCOA+) and are routinely reviewed during inspections.

Need IRB review for your study?

Elemental IRB provides fast, transparent ethical oversight for commercial and academic research.

See pricing → How it works →