About the NOSS
The NOSS is a state-of-the-art system that will offer a consistent, national approach for health and medical research – including clinical trials – from start to finish.
The NOSS will be available to any organisation conducting health and medical research in Australia. It will be essential for clinical trial activities required by the:
It will replace the existing state and territory research application systems, reducing duplication by:
- more than 50% in the application process
- 35% in the Clinical Trials Notification process
- 60% in trial registration.
Users will be able to track the progress of a clinical trial – from research application to ethics approval and site authorisation.
The NOSS is part of a suite of important national reforms to strengthen, harmonise and streamline health and medical research in Australia.
Why it is important
The current regulatory and operating environment for clinical trials is fragmented and inefficient, with different rules, systems and processes, in each state and territory.
This puts a large administrative and regulatory burden on the medical research sector, especially for research that crosses state and territory borders.
By streamlining approvals and processes into a single national system, the NOSS will:
- make it easier for patients, researchers and sponsors to find, conduct and participate in clinical trials and research
- help more Australians get early access to potential lifesaving and life-changing treatments
- enable governments to quickly respond to areas of need in a coordinated and strategic way
- make the process more efficient
- uphold data security
- protect commercial-in-confidence information
- position Australia as a global leader for clinical trials.
How it will work
All public, private, not-for-profit, universities and aged care organisations conducting health and medical research will have access to the NOSS. It will enable:
- researchers to
- submit a clinical trial application
- apply for ethics approval
- select the Human Research Ethics Committees of their choice
- register their clinical trial
- publish the results of their clinical trial
- healthcare professionals to
- find clinical trials relevant to their patients
- seek clear information about clinical trials for discussing with patients
- health services to
- measure and manage performance on metrics that matter to both commercial and investigator-initiated research
- meet their reporting obligations for clinical trials under the National Clinical Trials Governance Framework
- promote their capability to sponsors and researchers, to attract clinical trials and research
- sponsors to find clinical trials seeking sponsorships
- patients to
- search for available clinical trials relevant to their condition
- register to receive notifications on clinical trials and research of interest to them.
The NOSS will provide relevant information at jurisdictional and national levels to:
- inform performance
- take a quality improvement approach to the sector
- inform key national initiatives
- help position Australia as a preferred destination for research.
A secure system
The system will ensure the privacy, confidentiality, integrity and availability of information.
Best-practice protections and access controls will ensure maximum data security and user permissions. It will comply with:
- the National eHealth Access Framework (IS027000)
- the Protective Security Policy Framework
- Australian Government Information Security.
Before users can access the system and information in it, they will require authentication, including multi-factor authentication. Authorised users will only have access to documents and information relevant to them.
The system will include built-in and best-practice security capabilities that improve on the options, systems and processes available to select users.
Users will also be able to:
- lock down some information to sites
- restrict access to specific user profiles.
Who we work with
To ensure the NOSS meets the needs of all stakeholders, we work with:
- state and territory governments
- Australian Government agencies and regulators
- patients, consumers and industry representatives
- sponsors and researchers
- healthcare providers.
Status
Following significant consultation and testing, a proof of concept has been developed.
We are now holding discovery workshops from April 2025 with experts and stakeholders to:
- define detailed system requirements by user type
- finalise the design of the user-centric platform.
Once this discovery work is complete, we will work towards translating the platform vision into a detailed technical solution.
Get involved
Contact us to get involved in the next wave of design and delivery workshops.
Learn more
To learn more:
- register your interest to receive updates
- find previous updates.
Contact
Contact us for more information about the reforms to improve the health and medical research regulatory and operating environment.