Clinical Compliance Audit Report Example

Example Raw Findings

• Patient missed visit
• Unsigned informed consent form
• Adverse event not reported
• Missing lab metrics

1.1 Introduction

This report details findings from a routine clinical compliance audit conducted at a clinical research site. The objective of the audit is to evaluate adherence to regulatory requirements, protocol obligations, ethical standards, human subject protections, and clinical data integrity expectations.

The review included source documentation, regulatory binders, staff training records, informed consent documentation, adverse event handling processes, and standard operating procedures (SOPs).

Findings are categorized using severity levels including [CRITICAL], [MAJOR], and [MINOR].

1.2 Executive Summary

The audit identified substantial compliance risks requiring corrective action. Major deficiencies were identified in informed consent handling, subject visit management, adverse event reporting, and protocol adherence.

Unsigned Informed Consent Form

During review of study documentation, informed consent records were found incomplete before study procedures.

Severity: [CRITICAL]

Regulatory Basis: ICH-GCP E6(R2), 21 CFR Part 50 and ethics requirements.

Risk: Failure to obtain documented consent may compromise patient rights, ethics, and data validity.

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Adverse Event Not Reported

Review of source documentation revealed an adverse event documented in medical records but missing from sponsor reporting systems.

Severity: [CRITICAL]

Risk: Delayed reporting may compromise participant safety, regulatory compliance, and study integrity.