What does the audit trail include?

Every action that touches a clinical record is logged: who, what, when, where, the prior state, the new state, and the cryptographic signature. Logs include the AI model identifier used for each suggestion, the citation source sentence, the CTCAE criterion, the per-drug attribution scores, the rater, the adjudicator (if applicable), the e-signature hash, and the regulatory cascade flags. Retention is 6 years, the FDA standard for clinical trial records, on dedicated time-series infrastructure.