20 May 2022

New podcast series supports clinical trial site audits

A new podcast, launched by Maridulu Budyari Gumal, the Sydney Partnership for Health, Education, Research and Enterprise (SPHERE) together with Sydney Health Partners and NSW Regional Health Partners, aims to support researchers and clinicians preparing for clinical trial audits as a new national framework comes into effect.

“Audits are perceived to be quite scary; but they don’t have to be,” said Rebekah Freckleton, Manager of Research Strategy and Partnerships at Northern Sydney Local Health District, speaking on the first episode of Clinical Trials in Focus.

The podcast explores all things audits: what they are, why they’re important, and how to prepare.

“Preparing for an audit does take time, but if you have good processes in place, and follow your SOPs you should be good to go,” said Clinical Nurse Consultant (Surgical Research) at John Hunter Hospital and podcast guest, Rosemary Carroll.

In July 2022, the National Clinical Trials Governance Framework comes into effect. Developed by the Australian Commission for Safety and Quality in Health Care, it’s the first step towards a nationally consistent approach to the accreditation of health services conducting clinical trials.

Under the framework, ensuring clinical trials meet required standards will have implications for the ongoing accreditation of public health services.

“Audits have become increasingly common, but they’ve helped us drive improvements in Standard Operating Procedures (SOPs) and processes,” added Robert Kent, Research Operations Manager at the Kinghorn Cancer Centre.

“They also make everything simpler for the next audit.”

To help sites prepare for audits, we have also developed an Audit-Ready Resource Pack, that includes:

a presentation introducing the concepts of clinical trials audits and Good Clinical Practice,
an audit visit checklist, and
guidelines for developing Standard Operating Procedures for external clinical trial audits.

These resources can be downloaded from Auditing Resources  

To learn more about audits, and being-audit ready, listen to the first episode here 

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