Applying GCP to audits of Clinical Trials

In 2022, the Federal government is introducing a new National Clinical Trials Governance Framework, whereby all health services will be assessed and accredited for the conduct of clinical trials, alongside clinical and corporate services, every 5 years.

Maridulu Budyari Gumal (SPHERE), Sydney Health Partners and NSW Regional Health Partners have developed a series of resources to support NSW clinical trials sites as they prepare for upcoming audits.

Target Audience: Clinical Trials site staff and investigators

Objective: To provide participants with a comprehensive understanding of:

• The objectives of conducting a Clinical Trial
• What Good Clinical Practice is and how to apply it in practice
• What a Clinical Trial audit involves
• What is commonly reviewed in a Clinical Trial audit
• Common audit findings