One plan, every audit
Every investigator site audit run during conduct traces back to this single risk-based plan rather than a separate ad hoc decision.
What's included
How the audit plan gets built
- Risk factors drawn from the study quality plan — indication complexity, enrollment volume, site experience, and prior findings
- Audit type, scope, and cadence assigned per site and vendor based on that risk profile, not a fixed interval
- Trigger criteria defined for unscheduled or for-cause audits when a risk signal emerges mid-study
- The plan sequenced against site activation and enrollment milestones so highest-risk activity is covered first
- Periodic reassessment built in, so the plan adjusts as real risk signals change through conduct
Built on the quality plan, not around it
Scope and thresholds come directly from the study quality plan, so audit strategy and the governing QA document never drift apart.
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