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Documentation Checklist for Clinical Trial Audits

Documentation Checklist for Clinical Trial Audits

This checklist is designed to support clinical trial teams in preparing for external clinical trial audits.

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Who is this for?

Researchers and research operations and support staff wanting to better prepare for clinical trial audits.

Key Takeaways

  • Facilitates consistent audit preparation at trial sites
  • Covers seven key documentation categories
  • Identifies gaps or issues, allowing teams to prioritise follow-up actions
  • Supports documentation of audit findings, strengths, weaknesses, and recommendations

Developed in alignment with Good Clinical Practice (GCP), ethical and regulatory standards, the checklist helps ensure that essential clinical trial documentation, procedures, and compliance measures are in place and up to date. It helps maintain audit readiness, which is especially important given that inspections may be unannounced.

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