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Australian Government clinical trials initiative

Consultation Report – National One Stop Shop – a national platform for health-related human research 

The Australian Commission on Safety and Quality in Health Care (ACSQHC), in partnership with the Australian Government Department of Health and Aged Care and all jurisdictions via the Clinical Trials Project Reference Group, were engaged to undertake Australian-wide consultations on a national health-related human research Information and Communication Technology platform – a National One Stop Shop, hosted in the secure Commonwealth environment.

This National One Stop Shop for all health and medical research will make it easier for researchers, industry representatives and sponsors to find, conduct, participate and invest in research in Australia.

The National One Stop Shop presents a significant opportunity to achieve a national, interconnected, rapid and streamlined approvals platform that will:

  • include a cross-jurisdictional ethics and governance approvals platform that incorporates key application, notification and approval systems
  • incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the Therapeutic Goods Administration
  • include an embedded and automated next-generation national clinical trials registry
  • provide sophisticated monitoring and reporting functionality for different users
  • improve patient recruitment through a related National Clinical Trials Front Door.

Consultations commenced in July 2021 to gather the requirements for the National One Stop Shop and the National Clinical Trials Front Door.

Consultation participants included jurisdictional health departments, health service organisations, industry, universities, medical research institutes, government agencies, Aboriginal and Torres Strait Islander groups, consumers and other individuals with an interest in the Clinical Trials sector.

National consultations have recently been completed and the consultation report has been endorsed for publication by all health ministers. Access the report and addenda via the links below:

You can find out more about this initiative on the ACSQHC website.

If you have any questions, please contact