All jurisdictions have agreed to implement the Governance Framework in health service organisations as an embedded approach (as clinical research is core health service business) 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.
To give health service organisations time to implement the Governance Framework, for the first three-year accreditation cycle, they will be assessed against a maturity scale. That is, having either Established, Growing or Initial systems in place for clinical trial service provision.
Beyond the first three-year accreditation cycle, health service organisations will transition fully to the assessment of their clinical trial services under the AHSSQA Scheme, and be assessed as either having met or not-met the actions within the National Safety and Quality Health Service (NSQHS) Clinical Governance Standard and Partnering with Consumers Standard (as provided in the Governance Framework) and receive 90 days to remediate.
Implementation will commence in the second half of 2022, in alignment with health service organisations assessment to the NSQHS Standards.
The Governance Framework is currently undergoing final design and will be published on the Commission’s website shortly.
The Governance Framework is recognised as a significant reform for the clinical trials sector. It embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators that deliver clinical trials. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.
The Australian Commission on Safety and Quality in Health Care 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.
More information
Contact the Health and Medical Research Team on HMR@safetyandquality.gov.au or visit the Governance Framework web page.