ICH E6(R3) – Metadata records that allow reconstruction of the course of events by capturing details on actions (manual or automated) performed relating to information and data collection and, where applicable, to activities in computerized systems. The audit trail should show activities, initial entry, and changes to data fields or records, by whom, when and, where applicable, why. In computerized systems, the audit trail should be secure, computer generated and timestamped.
CDISC-Gloss – A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. [after ICH E6, CSUICI]