Being Audit Ready

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A Resource Pack to support you as prepare your site for clinical trials audits.

Under the National Clinical Trials Governance Framework, all health services are required to be assessed and accredited for the conduct of clinical trials, alongside clinical and corporate services, every three years.

Making sure your site is audit-ready well in advance is crucial to the success of your site's accreditation.

Sydney Health Partners, NSW Regional Health Partners and Maridulu Budyari Gumal (SPHERE) have developed a suite of resources to support NSW clinical trial operational staff and investigators through the audit process.

Conducting a ‘friendly project review’

Undertaking a high-level review of a project ahead of an external audit will help you better prepare and identify potential areas of improvement.  The Friendly Project Review Tool includes a project questionnaire and report template to help a reviewer (not directly involved with the project) provide an independent assessment of processes and operations.  This resource can also be used as a quality improvement or study onboarding tool.

Audit Ready?

The following resources guide you through the external audit process:

The Audit Ready Checklist – ensuring you have everything in place and the necessary documentation (xlsx)

Guideline - Developing Standard Operating Procedures for an external audit (PDF)

Presentation - How to apply Good Clinical Practice to clinical trial audits (PDF)

Want to Learn More About Audits and Monitoring?

Check out the Clinical Trials In Focus Podcast Series to hear senior researchers explore the audit and monitoring process. You can tune into the podcast on Spotify or onYouTube.

  • Episode 1 - explores all things audits – what they are, why they’re important, and how to prepare.
  • Episode 2 - delves into the how and why of running a clinical trial monitoring system for investigator-initiated trials.