57  Inspection Readiness & Audit Defense

57.1 Purpose

This module defines how CRAs support inspection readiness, regulatory audits, and inspection responses across the clinical trial lifecycle. Inspection readiness spans the entire lifecycle, as illustrated in the Trial Lifecycle Map.

57.2 CRA Accountability (Practical)

• Maintain inspection-ready documentation at all times
• Support sites during audits and inspections
• Verify completeness and consistency of trial records
• Track findings and remediation actions
• Contribute to CAPA effectiveness

57.3 Why This Matters

Inspections determine: - Regulatory trust - Sponsor credibility - Trial validity - Site eligibility for future studies