FDA Audit Checklist for Clinical Trials Template | FREE PDF

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FDA audit checklist for clinical trials template

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Use this template with Lumiform

Customize this template or build your own
Fill out templates via mobile app
Get reports and analyse your data

Prices start from ░░░ per month

Book a demo

Learn more

The FDA audit checklist for clinical trials template helps you prepare for regulatory inspections with confidence. This comprehensive checklist covers all critical areas the FDA examines during site visits, including protocol adherence, informed consent documentation, investigational product accountability, and data integrity verification.

When a major pharmaceutical company faced an unexpected FDA inspection, their quality team used this structured checklist to quickly identify and address documentation gaps in their clinical trial master files, allowing them to pass the inspection without major findings. According to FDA inspection data, issues with data integrity and protocol compliance account for Form 483 observations in clinical trials. We created this template to help you avoid these common pitfalls and maintain continuous inspection readiness.

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Preview of the template

Page 1

Trial Documentation

Are all trial-related documentation and records maintained in an organized manner?

Do the records accurately reflect the conduct of the trial?

Are all protocol amendments documented and approved?

Are the informed consent forms properly documented?

Compliance with Protocol

Are all trial procedures being carried out per the approved protocol?

Are any protocol deviations properly documented?

Are the inclusion/exclusion criteria being followed?

Are investigational product accountability records maintained?

Participant Safety

Are adverse events and serious adverse events being properly reported?

Are participant safety measures, such as stopping rules, being followed?

Are participant privacy and data confidentiality being maintained?

Are participants being properly monitored for safety throughout the trial?

Frequently asked questions

Can this checklist help prepare for unannounced FDA inspections?

Yes, this checklist is specific to maintain continuous inspection readiness. By conducting regular internal audits using this template, you’ll ensure critical documentation is always organized, complete, and readily accessible—essential for responding confidently to unannounced FDA inspections with minimal disruption to ongoing trial activities.

Who should be responsible for completing this FDA audit checklist for clinical trials template at our research site?

The clinical research coordinator or quality assurance manager typically leads the audit process, but input should come from multiple team members including the principal investigator, regulatory specialist, and study nurses. This collaborative approach ensures comprehensive review across all operational areas that FDA inspectors will evaluate.

How does this FDA audit checklist for clinical trials template help address common Form 483 observations?

This checklist targets the most frequent Form 483 citation areas including protocol deviations, informed consent documentation, investigational product accountability, and record-keeping practices. By systematically reviewing these high-risk areas, you can identify and correct potential compliance issues before they become regulatory findings during an FDA inspection.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.