The Quality Recognition Scheme (QRS) assesses the quality conduct of trial units delivering clinical trials in NSW. We developed the Scheme to ensure clinical trials have high standards of research practice, trial quality and a focus on participant safety.
The Scheme is based on the UK’s Medicines and Healthcare Products Regulatory Agency Phase I accreditation scheme of early phase sites. The QRS will be open to all trial units, however, will use a risk-based method for the order of participation selection. Early phase trial units will be on the prioritisation list.
The QRS sets the conduct criteria for clinical trials and provides guidance and support for sites working to meet the quality standards. Trial units will be assessed against quality recognition standards from five key risk areas:
- clinical governance
- quality systems
- risk management
- research teams, and
- infrastructure.
If successful, recognition will be valid for up to three years.
Expressions of interest for 2026 are now open
Expressions of interest from clinical trial units wishing to participate in the QRS are now open. This is a valuable opportunity to engage in a structured quality assessment process and work towards formal recognition of your clinical trial operations.
Application resources
- NSW Clinical Trials QRS High Level Assessment Standards – preliminary version (PDF 332.4 KB)
- NSW Clinical Trials QRS Application Guide 2025 – preliminary version (PDF 535.9 KB)
- NSW Clinical Trials QRS Information Webinar Slides – 10 December 2024 (PDF 1.8 MB)
Frequently asked questions
The QRS aims to boost confidence in clinical trial conduct in NSW. It is an opportunity for all trial units, new or established, to improve site quality management practices with our support. A single set of standards give clear and consistent expectations for trial operations across NSW.
Participating in the Scheme can also help in preparation for national health service accreditation.
The Scheme is a voluntary program focused on site operations, facilities, and the clinical trial team’s skills and experience. The QRS assessment standards complement current mandatory national programs. They assess health services at the organisational level, and clinical trials at the project level. Participating in the Scheme supports trial units meet these requirements. The two mandatory programs in Australia are:
- the Australian Commission on Safety and Quality in Health Care’s National Clinical Trial Governance Framework
- Therapeutic Goods Administration’s Good Clinical Practice Inspection Program.
As the safety, infrastructure, and training needs will vary across therapeutic areas, review will occur at a clinical trial unit level. Thus, recognition under the Scheme will not cover the entire health service/hospital nor trials performed outside the named site, although, processes related to the entire health service/hospital may be requested during assessment.
Recognised trial units
Status: Full recognition - this unit has met all five standards of the Quality Recognition Scheme, demonstrating excellence in clinical trial operations.
Recognised Capabilities
- Early phase clinical trials
- First in Human/Patient studies
Awarded: 13 May 2025
Status: Full recognition - this unit has met all five standards of the Quality Recognition Scheme, demonstrating excellence in clinical trial operations.
Recognised Capabilities
- Early phase clinical trials
- Medical devices
Awarded: 13 October 2025