National Clinical Trials Governance Framework Update

ACHS is approved by ACSQHC (the Commission) to assess healthcare organisations to the National Clinical Trials Governance Framework

The Australian Commission on Safety and Quality in Health Care, on behalf of all jurisdictions, developed the National Clinical Trials Governance Framework as the first step towards a nationally consistent approach to the accreditation of health services for the conduct of clinical trials. Assessments will commence 30 May 2023, in alignment with assessment of health service organisations to the NSQHS Standards

The World Health Organization (WHO) definition for a clinical trial is: "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes."

Who does the Clinical Trials Governance Framework apply to? 
This mandatory framework applies to all healthcare organisations that provide a clinical trial service, including public and private Australian hospitals, day procedure services and public dental services. The assessment is designed to ensure that clinical trials are conducted in a manner that is consistent and transparent across Australia. 

How is the Clinical Trials Governance Framework assessed? 
Healthcare organisations are to be assessed against 27 identified actions under the Governance Framework aligned with the National Safety and Quality Health Service (NSQHS) Standards.  

As an approved accrediting agency, ACHS will work with Members throughout the Assessment Process in two stages. In the first stage of implementation, health service organisations will be assessed against a maturity scale as either having Established systems, Growing systems, or Initial systems in place. This occurs within the first three years of the accreditation cycle and will allow time for organisations to implement the Governance Framework. 

Beyond the first, three-year accreditation cycle, healthcare organisations will transition fully to the assessment of their clinical trial services 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).

For organisations that are already accredited to the NSQHS Standards with ACHS, assessment against the Governance Framework will occur in alignment with the NSQHS Standards assessment.

Next steps

If your health service organisation conducts clinical trials, contact your Customer Services Manager via or 02 9281 9955 to discuss when your health service will be assessed to the National Clinical Trials Governance Framework and what information you will need to provide in relation to the clinical trials being conducted by your health service.

For further information visit our website here.