NSW Government
NSW Health and Medical Research

Quality Recognition Scheme

Recognises high-quality clinical trial units and supports building clinical trials capability across NSW

The Quality Recognition Scheme assesses the quality conduct of trial units delivering clinical trials in NSW. The Office for Health and Medical Research 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. At first, the Scheme will focus on trial units running early phase trials, but it will be open to all trial units.

The Scheme 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:

  1. Clinical and medical governance oversight
  2. Quality Management Systems (QMS) and/or equivalent procedures
  3. Risk management procedures
  4. Appropriately experienced research teams
  5. Adequate infrastructure and resources to respond to medical emergencies.

From February 2025, the Scheme will be available for participation by public and private trial units.

A successful trial unit will get a certificate from NSW Health which recognises their high-quality clinical trials. This recognition will be valid for up to three years. It will be displayed on the Office for Health and Medical Research website.

The process

The Scheme operates in two parts:

  • A desktop review via an application form – reviewing the trial unit’s current standard operating procedures and processes, and
  • An on-site audit to verify the clinical trial unit’s personnel, facilities, equipment and documents support high quality trial conduct and protect participant safety.

To find out more:

Register for the next information webinar on 10 December 2024 at 1:30pm.

Register here

Eligibility criteria

To be assessed under the QRS, a site must:

  • be based in NSW
  • operate within public or private organisations
  • have demonstrated experience in conducting clinical trials
  • demonstrate GCP compliance, with no unresolved critical or major findings from previous GCP audits or regulatory inspections
  • have current and active Standard Operating Procedures (SOPs), policies, and relevant associated documents.
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Key dates

*Tentative dates – to be confirmed. Three sites will be assessed per round.

Scheme Rounds 2025   2025 Round visit dates (week starting)
Round 1 3 February to 23 May 2025 24 February
24 March
28 April
Round 2 26 May to 5 September 2025 16 June
14 July
11 August
Round 3 8 September to 19 December 2025 29 September
27 October
24 November

 

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Application forms

Application guidance will be available prior to expression of interest release. 

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Frequently asked questions

Why take part in the Quality Recognition Scheme?

The Quality Recognition Scheme 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 the support of the Office for Health and Medical Research. 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.

What makes the Quality Recognition Scheme different to other national regulatory programs?

The Scheme is a voluntary program focused on site operations, facilities, and the clinical trial team’s skills and experience. The Quality Recognition Scheme 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

Will the Quality Recognition Scheme cover all clinical trial units within the organisation? 

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.

 

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Updated 1 week ago

For any enquiries, please reach out to the team:

Contact the Quality Recognition Scheme central office