The National Clinical Trials Governance Framework launched


AusBiotech welcomes the recent launch of The Australian Commission on Safety and Quality in Health Care (the Commission)’s National Clinical Trials Governance Framework.

The launch of the Governance Framework has provided the opportunity for the Commission to communicate the benefits of the Framework for the clinical trials sector and to the Australian community.

The Commission is updating the supporting resources to implement the Governance Framework and is working with accrediting agencies in preparation for assessment to the Governance Framework.

Assessments will likely commence in January 2023 under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme and the process for accreditation will apply as either having met or not met the actions within the National Safety and Quality Health Service (NSQHS) Standards Clinical Governance Standard.

The Governance Framework is recognised as a significant reform for the Australian 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, the Commission’s Governance Framework will make a concerted effort to reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.

AusBiotech is currently collaborating with its Clinical Trials Advisory Group to advise relevant members on how the Governance Framework will continue to shape future clinical trial activities in the sector.

To find out more information on The Commission’s National Clinical Trials Governance Framework, click here.