Guided Notes

Audit Trails & Data Integrity Review

What audit trails contain, risk-based audit trail review, spotting suspicious patterns (late changes, frequent edits, off-hours entries, backdating), user access reviews and integrity investigations.

What an audit trail records

Slide 1 / 5

For every data point in a validated EDC: • who created/changed it (unique user), • when (server timestamp), • old and new values, • reason for change, • related queries. Audit trails must be secure, computer-generated, and unchangeable by users. Regulators increasingly expect sponsors to REVIEW them, not just keep them.

← CDM Metrics & Status Reporting