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Early Phase Clinical Trials

Supporting quality Phase I and First-in-Human clinical trials

Dr Martina Sanderson-Smith and Dr David De Oliveira at IHMRI. Photo credit: Todd Hardingham


The Office for Health and Medical Research developed the Early Phase Clinical Trials Framework for New South Wales (NSW) to support the conduct of early phase clinical trials across the State. The scope of this framework encompasses all early phase clinical trials up to, but not including Phase II trials. It is one component of a broader suite of initiatives to build capacity to make NSW a global leader in clinical trials.

The Early Phase Clinical Trials Framework consists of two initiatives:

The Early Phase Clinical Trials Human Research Ethics Committees Scheme

The HREC Scheme was established to enhance consistent, high quality scientific and ethics review and approval process for early phase clinical trials in NSW, whilst prioritising a focus on the welfare and safety of trial participants.

Read more on the HREC Scheme

Quality Recognition Scheme

The voluntary Quality Recognition Scheme is designed to recognise high quality early phase trial sites and support clinical trials capability building across NSW. It defines the conduct criteria for early phase trials and provides guidance and support for sites working to meet the quality standards.

The scheme was modelled on the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) phase I site accreditation scheme and tailored to meet the diverse range of early phase trials operating in NSW.

It operates in two parts:

  • an application reviewing the trial site’s current standard operating procedures and processes
  • a site visit to verify the appropriate staff, facilities, equipment and documents are available at site to support high quality trial conduct and protect participant safety.

If your site is interested in participating, contact the clinicaltrialsNSW team.

Updated 4 months ago