Early Phase Clinical Trials

Framework

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 aims to recognise high quality clinical trial units. It also supports building clinical trials capability across NSW. It sets the conduct criteria for early phase trials and provides guidance and support for sites in meeting the quality standards.

Please visit the Quality Recognition Scheme page for further information.