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Accreditation

Below is some information taken from the ACSQHC website:

The National Clinical Trials Governance Framework

Jurisdictional endorsement of the National Clinical Trials Governance Framework (Governance Framework) and recommendations for implementation.

In February 2022, all jurisdictions 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 Scheme (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, health service organisations will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the National Safety and Quality Health Service (NSQHS) Standards (as provided in the Governance Framework) 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 NSQHS Standards 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 the year, in alignment with assessment to health service organisations 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. The Governance Framework 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 (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.

Attachment Size
CT Accreditation Evidence Bank Spreadsheet updated 4.4.2022.xlsx 26.39 KB
ACSQHC National Clinical Trials Governance Framework and User Guide_0.pdf 1.1 MB
Standard 1 - 1.15 to 1.20
Standard 2 full recording
Standard 1 - Clinical Governance
Standard 2 - Partnering with Consumers