GCP Audit Report Template | Good Clinical Practice ICH E6 Compliance | Editable Word PDF | Clinical Trials Internal Audit

GCP audits require structured documentation of protocol compliance, informed consent, data integrity, subject safety, deviation management, and CAPA—because inspection readiness depends on how clearly findings and evidence are recorded. This GCP Audit Report Format helps you streamline the audit process by capturing audit scope, observations, nonconformities, and corrective actions in one professional report—so your audit reporting stays consistent, complete, and inspection-ready.

This is a ready-to-use, professionally designed, and fully customizable audit report created to streamline your audit process. It supports internal audits, vendor/site audits, and regulatory readiness by providing a standardized structure aligned with GCP expectations. Everything is organized to help auditors document checks faster, reduce reporting gaps, and improve closure of audit findings.

Whether you audit clinical trial sites, CROs, sponsors, vendors, or trial documentation systems, this format supports stronger compliance documentation, smoother management review, and better readiness for inspections.

What’s Included:

• Audit cover page and report header (study/site/vendor, audit type, date, auditor details)
• Audit scope, objectives, criteria, and GCP reference section
• Study overview and audit plan summary (protocol, sponsor, site details—customizable)
• Findings and evidence recording fields (process-wise / requirement-wise)
• Subject safety and informed consent verification section
• Data integrity and source data verification (SDV) summary fields (customizable)
• Deviation, AE/SAE reporting, and documentation review section
• Nonconformity/observation log with classification fields (customizable)
• CAPA section (root cause, corrective action, owner, target date, verification)
• Closing meeting summary, audit conclusion, management sign-off, follow-up timeline

Key Benefits:

• Streamlines GCP audit reporting with a standardized, ready-to-use format
• Improves inspection readiness with consistent evidence documentation
• Reduces reporting time with structured sections for findings and CAPA
• Supports faster corrective action closure with ownership and due dates
• Strengthens protocol compliance, documentation, and data integrity reporting
• Improves audit trail quality for sponsors, CROs, and regulators
• Fully customizable for sites, vendors, and trial process scope
• Ideal for internal audits, site audits, vendor audits, and GCP readiness audits

Get your GCP Audit Report audit report format today and streamline your audit process.