Guideline for developing a SOPs for an external audit of an NSW clinical trial site

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 guidance on the process of facilitating an external audit and how to develop appropriate Standard Operating Procedures to guide the process.