National One Stop Shop and National Clinical Trials Front Door
From Research GEMS to the National One Stop Shop - the evolution of the health and medical research platform in South Australia.
The Australian Commission on Safety and Quality in Health Care has been engaged by the Australian Government Department of Health, in partnership with all jurisdictions (including SA Health) via the Clinical Trials Project Reference Group, to conduct consultations to develop the requirements and specifications of the National One Stop Shop for health-related human research approvals and the National Clinical Trials Front Door.
To make it easier for patients, researchers, industry representatives and sponsors to find, conduct, participate and invest in high quality and ethical research in Australia.
- To address long-standing challenges with duplication, delays, navigation and fragmentation as a result of different research ethical approval and local site authorisation systems in the jurisdictions; separate processes for Therapeutic Goods Administration (TGA) notifications; a separate process for registration on the Australian and New Zealand Clinical Trials Registry; separate processes for other jurisdiction- specific and therapy-specific approvals and authorisations and, the absence of individualised and fragmented operational monitoring and reporting approaches
- Enhance patient access to state-of-the-art treatments
- Improve health outcomes
- Contribute to the innovation economy and a self-improving health system
- Strengthen Australia’s global positioning in health and medical research.
Creating sustainable efficiencies within the clinical trials and research sector through a single national, interconnected, rapid and streamlined world-leading approvals platform in collaboration with all jurisdictions that will:
- Provide a cross-jurisdictional ethics approval and site-specific authorisation platform that incorporates key application, notification and approval systems
- Incorporate the Clinical Trials Notification and Clinical Trials Approval schemes administered by the TGA
- Include an embedded and automated next-generation national clinical trials registry
- Provide sophisticated monitoring and reporting functionality for different users.
Options for improving research participation through a related community volunteer portal, the National Clinical Trials Front Door will also be considered through the consultation process. This includes mechanisms that facilitate access to third party participant recruitment providers.
Additionally, the One Stop Shop will:
- Embed the National Clinical Trials Governance Framework accreditation obligations and automate data/reports/processes to support the accreditation process
- Assist all governments to respond to areas of need in a rapid, coordinated and strategic manner based on real-time, accurate information regarding trial activity and site capability
- Aim to extend beyond the public and private hospital sector to incorporate the university, primary care and independent medical research sectors
- Protect data integrity and adhere to data security requirements.
One Stop Shop Consultation update – June 2022
The Australian Commission on Safety and Quality in Health Care (the Commission) has been conducting consultations on the National One Stop Shop for health-related human research approvals.
The Commission has undertaken a two-phased consultation on the National One Stop Shop - a national platform for health-related human research. This approach is to ensure high impact stakeholders receive information on the evidence for a national platform and can share their information and preferences.
In the first phase, beginning September 2021, the Commission conducted more than 70 consultations sessions. The second phase of consultations provided an update to the research community on the work undertaken to date and refined user requirements for the national platform.
As part of the second phase of consultations, the Commission developed a demonstration tool (Proof of Concept). The Proof of Concept is a high-level interactive prototype with a subset of core functions, which was demonstrated as part of the second phase of consultations.