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 service delivery. The Commission has developed the Clinical Trials portal to support health service organisations with implementation of the Governance Framework within their local service context.

Self-assessment tool

The self-assessment tool assists health service organisations assess their own capacity to meet the actions in the Governance Framework (where applicable), identify gaps and track their progress. The tool allows health service organisations to:

• Determine whether they meet the requirements of the actions (where applicable)
• Create a local action plan of any tasks that are needed to meet the action, including identifying roles and allocating responsibilities within the health service organisation.

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).

Guidance

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

Resources to support health services with implementation of the Governance Framework including fact sheets, flow charts and case studies are available here.

The Commission are currently scoping the requirements to support a re-design of the clinical trials portal. At this time, users will not be able to upload evidence to demonstrate that an individual action if the Governance Framework has been met (where applicable). Alternatively, users are advised to input data in reference to the location where these documents are stored within the health service and retain copies in a safe and secure location which can be produced as example evidence in the instance of an accreditation assessment.

Any queries, including user feedback, can be directed to the Health and Medical Research team via email at hmr@safetyandquality.gov.au.

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