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Developing a Standard Operating Procedure for Clinical Trial Audits

This guideline provides an overview of the key steps involved in developing a Standard Operating Procedure (SOP) for hosting external audits at a clinical trial site in NSW.

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Key Takeaways

  • Understand the development, training and compliance requirements for a SOP
  • Gain a high-level overview of the audit process and what should be included in a SOP
  • Learn what happens after an audit and how to respond to audit findings

Who is this for?

Researchers and research operations and support staff wanting to better understand the clinical trials audit process and what procedures need to be in place.

This resource introduces the key concepts involved in hosting external trial audits and provides guidance on developing a SOP to support that process.

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