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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 NSW early phase clinical trials framework includes all Phase I and First-in-Human clinical trials.


The Office for Health and Medical Research developed the Early Phase Clinical Trials Framework for New South Wales (NSW) to support early phase clinical trials across the State. The framework is one component of a broader suite of initiatives to build capacity to make NSW a global leader in clinical trials.

HREC Scheme

The Early Phase Clinical Trials Human Research Ethics Committees (HRECs) Scheme was established to further support NSW’s consistent, high quality scientific and ethics review and approval process for early phase clinical trials in NSW, while supporting 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 criteria.

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
  • a site visit to verify the appropriate staff, facilities, equipment and documents to support high quality trial conduct and protect participant safety.

The scheme is being piloted in late 2019 and will implemented across NSW in early 2020.


Updated 3 years ago