The Ultimate Clinical Audit Tool

Comprehensive Clinical Drug Audit Checklist

I spent 14 years as an FDA Investigator, including work conducting BIMO (Bioresearch Monitoring) inspections, and issued more Form FDA-483s than I care to count. For the 13 years afterwards including part of the team that navigated J&J out of consent decree, I was directly responsible for FDA-483s received.

Clinical trial audits fail for a different reason than manufacturing audits. It's rarely that nobody knows the rule, it's that oversight of the CRO, the site, and the data trail all live in different hands, and nobody is checking whether they actually connect. This checklist is built around that gap.

[This is an employer-reimbursable professional compliance resource. Send this page to your Quality Director, Site Head, Regulatory Affairs leader or Learning and Development department for approval.]

This is a working audit tool, not a theory document. Bring it to the sponsor's office, the CRO, or the clinical site.

What's inside (19 audit items across 6 GCP domains):

• Sponsor Responsibilities and Oversight, including CRO/vendor oversight and sponsor-investigator-IRB communication
• Protocol Compliance and Execution, from inclusion/exclusion criteria through amendment approval sequencing
• Test Article Accountability and Handling, including IP storage, dispensing reconciliation, and blinding/randomization integrity
• IRB/IEC Review and Correspondence, covering approval timelines and ongoing safety reporting obligations
• Data Integrity, Source Documentation, and CRFs, including source data verification and electronic audit trail review
• Safety Reporting and Adverse Event Documentation, including AE/SAE/SUSAR timelines (7-day and 15-day reporting windows) and causality assessment documentation

Every single item includes:

• A plain-language description of the GCP expectation
• How to Verify: the specific records, correspondence, and cross-checks to conduct during the audit
• Common Deficiencies: the actual findings Investigators cite most often for that item
• A Yes / No / N/A compliance field and space for auditor comments

Plus dedicated sections for Objectionable Observations and Recommendations & Follow-Up Actions, so the completed audit functions as a standalone report.

Aligned to ICH E6(R2) and 21 CFR Parts 312 and 812.

Who this is for: Sponsors, CROs, and clinical site auditors conducting GCP compliance assessments, consultants preparing clients for a BIMO inspection, and quality leaders who need a defensible audit record covering the sponsor-site-CRO relationship, not just one party's compliance.