Components of the National One Stop Shop
Consultations revealed broad support and a sense of genuine enthusiasm and anticipation for the proposed National One Stop Shop. It is seen as a rare transformational opportunity for Australia to address longstanding challenges. It would assist all governments to respond to areas of need in a rapid, coordinated and strategic manner based on real-time, accurate information.
The objective is to integrate key approval processes and existing national systems for trials and research to reduce administration and navigation burden for investigators, sponsors, sites and administrators. This would streamline and improve application and approval processes, as well as management, monitoring, and reporting across the full project life cycle.
It embeds new accreditation requirements for trial sites under the National Clinical Trials Governance Framework from 31 May 2023.
National consultations have sought feedback on the requirements of the proposed platform and the potential for a National One Stop Shop that at its core would:
- Provide all components of a national cross-government approvals platform within a central platform
- Provide an embedded next generation national clinical trials and research registry with automated registration to facilitate best-practice access to trials for patients and strategic capability for governments and stakeholders.
- Incorporate national clinical trials / research systems such as the clinical trial notification (CTN) and clinical trials approvals (CTA) schemes, relevant aspects of other systems such as the Good Clinical Practice Site Inspection Program and processes of the Gene Technology Regulator
- Embed the National Clinical Trials Governance Framework accreditation obligations and automated data, reports and processes to support the accreditation process
- Provide relevant research management, monitoring and compliance reporting functionality for different users, including safety and adverse event reporting, and annual human research ethics committee reporting, with dashboards for different users.
Following implementation, this platform would replace other national and jurisdictional systems. To achieve the desired reform outcomes, cross-jurisdictional governance arrangements with representation from all jurisdictional health departments, or their equivalent, and the TGA, the OGTR, the NHMRC and the Commission, will be needed to harmonise the approvals processes nationally. Such governance arrangements were strongly supported by key stakeholders during the consultations. Many stakeholders expressed the view that an innovative and intuitive approvals platform combining the functionality and with jurisdictional governance arrangements would make the research process significantly easier and less burdensome in Australia.
National SSA minimum requirements consultations
As part of the second phase of consultations, the Commission conducted consultations on the core elements of the national SSA. The aim of the single national SSA is to ensure a single process for local site risk assessment and authorisation for health-related human research. The goals of the national SSA are to:
- Minimise duplication and the administrative burden related to local site research authorisation
- Include above the line (national) requirements
- Include below the line (jurisdictional) requirements (these requirements do not include the consideration of jurisdictional legislation that would be undertaken at the time of ethical review)
- Enable direct sign-off to authorising officers.
An SSA Expert Reference Group was established to guide the consultations on the national SSA core elements with members nominated by the CTPRG. The Commission conducted four targeted consultations and two public webinars to ensure engagement with the broader sector in March 2022.
A national SSA survey was developed to collect feedback on the existing draft National SSA from the research community. The survey was published on the Commission’s website for two weeks on Monday 28 February 2022 and received 582 responses. In total, more than 842 individuals and groups participated in the national SSA consultations.
The CTPRG endorsed in principle the single national SSA core elements with agreed amendments for implementation via the National One Stop Shop subject to feedback through the second phase of national consultations. The SSA consultations are now closed.
National Clinical Trials Front Door
A range of views and options were explored throughout the consultations. There is broad support for a public facing website that acts as a central access point to facilitate connectivity for health researchers, sponsors, industry, primary carers, allied health and the community.
Register to receive updates
Register here to receive updates on the National One Stop Shop project.
If you have any questions, please contact HMR@safetyandquality.gov.au.
