New Podcast Series Launches to Support Clinical Trial Site Audits

A new podcast has been launched by three NSW Research Translation Centres to support researchers and clinicians prepare 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 in the first episode of Clinical Trials in Focus.

The podcast, produced by Sydney Health Partners, Maridulu Budyari Gumal (SPHERE) and NSW Regional Health Partners 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 podcast guest Rosemary Carroll, who is a Clinical Nurse Consultant (Surgical Research) at John Hunter Hospital.

In July 2022, the National Clinical Trials Governance Framework comes into effect. Developed by the Australian Commission for Quality and Safety in Healthcare, 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, the three Translation Centres have also developed an Audit Ready Resource Pack, that includes a presentation about how to apply Good Clinical Practice (GCP) to audits of clinical trials, a site audit checklist, and guidelines for developing Standard Operating Procedures (SOP) for external clinical trial audits.

These resources can be downloaded from the Translation Centres’ websites:

• Sydney Health Partners
• SPHERE
• NSW Regional Health Partners