Sponsor Audit Section
A Sponsor Audit section documents the independent assurance activity used to evaluate trial conduct and systems beyond routine monitoring. It should make clear that sponsor audit is not simply another name for site monitoring or operational quality control.
A Sponsor Audit section explains when and how independent sponsor audits may be performed, their scope and independence, and how findings are handled.
Key details
Important caveats
Scope Boundary
Keep sponsor audit separate from Trial Monitoring and from inspections conducted by regulatory authorities. Audit details may vary by sponsor quality system and applicable requirements.
Further guidance
Content
Describe audit independence, risk-based selection or scope, auditor qualification/authority, access to relevant records and systems, documentation of findings, escalation, and follow-up.
Purpose
Explain how independent audit provides assurance that trial processes and data systems conform to the protocol, procedures, and applicable requirements.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification
- E6(R3) Good Clinical Practice (GCP) — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current FDA final-guidance overview for ICH E6(R3), including quality by design, risk-based quality management, technology, proportionality, and clarified sponsor/investigator responsibilities