Audit Trail is a chronological and secure record of activities, actions, and changes made within a clinical trial's data management or electronic systems. It serves to track and document any modifications, additions, or deletions to ensure data integrity, compliance with regulatory requirements, and transparency. The audit trail provides a detailed history of data alterations and the identity of the individuals responsible for those changes.
Definitions
ICH E6
Documentation that allows reconstruction of the course of events [1].
See also
Links to this page
- Glossary:Audit Trail (redirect page) (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf