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National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework (NCTGF) provides a set of safety and quality standards to embed clinical trials into routine health service provision and strengthen the clinical and corporate governance arrangements for health service organisations (HSOs) that deliver a clinical trial service.

This site contains information on the NCTGF only. The Australian Department of Health Disability and Ageing now leads the National One Stop Shop (NOSS) and the former National Mutual Acceptance Scheme (now the HREC accreditation scheme). Further information can be found on their Australian Clinical Trials National reforms website.

Consultation closed

Public consultation on the initial draft of the National Safety and Quality Health Service Standards (third edition) has now closed. Thank you to everyone who shared their views, experiences and expertise. Feedback will be analysed and used to refine the next draft of the Standards ahead of piloting in 2027.

About the National Clinical Trials Governance Framework

Decommissioning of the Clinical Trials Portal

The Commission is decommissioning the Clinical Trials Portal on Tuesday 29 September 2026 as part of ongoing improvements to our digital tools and services.

New registrations for access to the Clinical Trials Portal will cease on Sunday 30 August 2026.

Existing users will still be able to log in and access their information until the portal is decommissioned on Tuesday 29 September 2026.

A new National Standards Monitoring Tool with a NCTGF module is being developed and is estimated to launch on Wednesday 30 September 2026.

Users are strongly encouraged to download and save all data from their profiles before Tuesday 29 September 2026. Once the portal is decommissioned, the Commission will not be able to retrieve or provide access to any user data.
 

Download the Framework and User Guide

National Clinical Trials Governance Framework and User Guide
 

Contact us

For questions regarding implementation and feedback on the National Clinical Trials Governance Framework please contact our health and medical research team.

For questions regarding accreditation please contact the Safety and Quality Advice Centre.

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Last updated: 26 September 2026