Template

Friendly Project Review Tool

This tool is designed to support clinical trial teams in preparing for formal audits by providing an independent, high-level review of project operations.

Who is this for?

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

Key Takeaways

  • Understand how to undertake or participate in a Friendly Project Review
  • Identify which studies could be reviewed and at what stage of the project
  • Learn how the review process works
  • Know what happens after the review

Friendly Project Reviews are designed to assist clinical trial teams better prepare for external audits undertaken by clinical trial sponsors or other bodies such as the Therapeutic Goods Administration (TGA), Food and Drug Authority (FDA) or National Clinical Trials Governance Framework (NCTGF).

This resource includes details of how to undertake or participate in a review, as well as a project questionnaire and report template.