To support the delivery of high-quality clinical trial services the Australian Commission on Safety and Quality in Health Care (the Commission) has developed the National Clinical Trials Governance Framework (Governance Framework) on behalf of all jurisdictions in collaboration with the Australian Government Department of Health. The Governance Framework provides the first step toward the accreditation of health services for the conduct of clinical trials. The Commission has developed the Clinical Trial portal to support the pilot and implementation of the Governance Framework.

Self-assessment tool

The self-assessment tool assists health service organisations assess their readiness to meet the actions in the Governance Framework, identify gaps and track their progress. The tool allows health service organisations to:

• Determine whether they meet the requirement of the actions
• Document the evidence that demonstrates each action has been met
• Create an action plan of any tasks that are needed to meet the action, including allocating responsibility

Operational metrics tool

The operational metrics tool will support trial units, clinical departments, hospitals and health networks to collect and review their clinical trial service operational performance through a series of automated reports. These reports can be used to assist your health service organisation with strategic planning to deliver a clinical trial service. The operational reports items are aligned with the National Aggregate Statistics (NAS).

For help with navigating the Clinical Trials portal, you can access the Clinical Trials portal user guide here.

Any queries can be directed to the Commission Clinical Trials team via email at CTgovernance@safetyandquality.gov.au.