National Clinical Trials Governance Framework implementation workshop

The Australian Commission on Safety and Quality in Health Care (the Commission), on behalf of all jurisdictions, developed the National Clinical Trials Governance Framework (Governance Framework) as the first step towards a nationally consistent approach to the accreditation of health services for the conduct of clinical trials.

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.

In February 2022, all jurisdictions agreed to implement the National Clinical Trials Governance Framework in health service organisations as an embedded approach under the Australian Health Service Safety and Quality Accreditation Scheme.

Implementation will commence in early 2023, in alignment with assessment of health service organisations to the National Safety and Quality Health Service Standards.

Over the next few months, the Commission will be hosting online implementation workshops to assist health service organisations prepare for assessment against the actions as provided in the Governance Framework.