All jurisdictions have agreed to implement the National Clinical Trials Governance Framework (Governance Framework) in health service organisations as an embedded approach under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. That is, health service organisations will be assessed concurrently for clinical and corporate services and clinical trial service provision.
It is mandatory for all public and private Australian hospitals, day procedure services and public dental services to be assessed through an independent accreditation process to determine whether they have implemented the National Safety and Quality Health Service (NSQHS) Standards. Therefore, the actions in the Governance Framework are also mandatory for health service organisations that provide a clinical trial service.
For the first three-year accreditation cycle, health service organisations will be assessed against a maturity scale as either having Established systems, Growing systems, or Initial systems in place to meet the NSQHS Standards for clinical trial service provision using the Governance Framework.
Assessments will commence in May 2023, in alignment with assessment of health service organisations to the NSQHS Standards
The National Clinical Trials Governance Framework
The National Clinical Trials Governance Framework builds on the National Model Clinical Governance Framework and the NSQHS Standards, providing:
- Roles and functions for identified positions relating to clinical trial service provision within a health service organisation
- Actions against which health service organisations with a clinical trial service will be assessed for accreditation
- Suggested strategies health services may implement to meet the actions within the NSQHS Standards
- Examples of evidence a health service organisation may provide that demonstrate they have met the actions within the NSQHS Standards for clinical trial service provision.
Reflecting the NSQHS Standards, the Governance Framework has five components:
- Governance, leadership and culture
- Patient safety and quality improvement systems
- Clinical performance and effectiveness
- Safe environment for the delivery of care
- Partnering with consumers.
Consistent with the NSQHS Standards, the Governance Framework does not specify how a health service organisation or trial site should develop or implement its governance systems. Rather, it describes the systems and processes that should be in place to implement an effective Governance Framework considering local needs, values and the context in which services are provided.
The Australian Commission on Safety and Quality in Health Care (the Commission) will update the supporting resources to implement the Governance Framework, and will continue to provide advice to health services through the Safety and Quality Advice Centre.
Publication, report or update
To support the delivery of high-quality clinical trial services the Commission has developed the National Clinical Trials Governance Framework on behalf of all jurisdictions in collaboration with the Australian Government Department of Health.
You can find further information on the Governance Framework on the resources page. More information about the development and launch is available in Background.