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Clinical trial audit checklist template

Clinical trial audit checklist template

The clinical trial audit checklist is essential for ensuring that clinical trials adhere to regulatory standards and protocols.

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  • Get reports and analyse your data
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Clinical trial audit checklist template

The clinical trial audit checklist is essential for ensuring that clinical trials adhere to regulatory standards and protocols.

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
or Download template as PDF

The clinical trial audit checklist template is specifically for quality assurance professionals in pharmaceutical research who need to verify compliance with Good Clinical Practice (GCP) standards. This comprehensive audit tool helps you systematically evaluate protocol adherence, informed consent processes, documentation completeness, and data integrity—all critical elements in successful regulatory inspections.

When preparing for an FDA audit, you can use this template to conduct a thorough internal review, identifying and addressing potential compliance issues before regulators arrive. With clinical trial data management audits being essential for maintaining regulatory compliance and the overall success of clinical, this template ensures you have a consistent, thorough approach to quality assurance throughout your trial lifecycle.

Related categories

Preview of the template
Page 1
Compliance Checks
Are all trial procedures being followed as per protocol?
Are there any deviations from the approved protocol?
Are adverse events being properly documented and reported?
Documentation Review
Is the informed consent process documented appropriately?
Are all required documents, such as CRFs, available and complete?
Are the study records being maintained as per regulations?
Participant Safety
Are participant eligibility criteria being followed?
Are there any reported safety issues or concerns?
Are there appropriate mechanisms in place to ensure participant safety?

Frequently asked questions

What are the most critical components to include in a clinical trial audit checklist?

Your checklist must cover protocol compliance, informed consent documentation, investigator qualifications, data integrity verification, adverse event reporting, and regulatory documentation. Focus particularly on areas where FDA commonly finds deficiencies: subject eligibility criteria, protocol deviations, and primary efficacy endpoint documentation.

How often should I conduct internal audits using this clinical trial checklist?

Conduct internal audits at key trial milestones: pre-study (before enrollment begins), mid-study (after approximately 30% of subjects enrollment), and pre-database lock. For longer studies, quarterly audits are recommended. Regular auditing helps identify and correct issues before they become regulatory findings.

How should I customize this clinical trial audit template for different trial phases?

For Phase I trials, emphasize safety monitoring and reporting sections. For Phase II/III, focus on protocol adherence and data integrity. For Phase IV, enhance sections on adverse event tracking and real-world evidence collection. Always maintain core GCP compliance sections regardless of trial phase.

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.