The IGPRG, formerly the Clinical Trials Project Reference Group (CTPRG), was established in October 2023. It involves senior officials from:
- the Australian Government
- state and territory governments
- the National Health and Medical Research Council (NHMRC)
- the Therapeutic Goods Administration (TGA)
- the Office of Gene Technology Regulator (OGTR)
- the Australian Commission on Safety and Quality in Health Care (ACSQHC).
The IGPRG takes a strategic evidence-based focus and engages with industry and networked partners. It also engages with other key stakeholders, including registry groups and the general public.
The IGPRG’s key objectives are to:
- provide effective and enduring cross-jurisdictional governance arrangements
- enable effective ongoing cross-jurisdictional and cross-agency collaboration
- collectively develop, implement, oversee and administer the National One Stop Shop
- embed research as essential health system business via the National Clinical Trials Governance Framework
- streamline coordination units and innovation
- harness national networks and partnerships
- improve clinical trials data and knowledge systems
- enhance capacity and consistency of ethics approvals.
Work of the group
A National One Stop Shop for health and medical research
The ACSQHC delivered consultations to develop the requirements for the National One Stop Shop. This was done on behalf of the Australian Government Department of Health and Aged Care and in partnership with all jurisdictions via the CTPRG (now the IGPRG).
Learn more about the National One Stop, including its goals and consultation reports, on the ACSQHC website.
National governance framework
- strengthens governance arrangements for clinical trial services
- provides clarity to those responsible for delivering clinical trials, including
- health service organisations
- hospital administrators
Best practice principles and processes which are consistent with existing regulations for the conduct of clinical trials in Australia underpin the framework.
Under the framework, all Australian health services must follow National Safety and Quality Health Service (NSQHS) Standards for accreditation, from May 2023. Health services include all public and private Australian hospitals, day procedure services and public dental services.
The framework ensures that:
- clinical trial service is embedded in routine health service clinical and corporate governance systems and is considered core health service business
- clinical trials governance is a fundamental part of the health services governing body’s responsibilities and accountabilities
- clinical trials are conducted in a safe environment that is continually improving, for the best possible outcomes for participants and the community.
Learn more about the framework, including its core principles of governance for clinical trial services on the ACSQHC website.
National teletrials compendium
In Australia, all public and private health service employees involved in clinical trials, including teletrials, must follow standard operating procedures and principles. These are outlined in the National Teletrials Compendium.
The compendium assists organisations engaged in conducting clinical trials in Australia to standardise their procedures. We review it every 2 years.
IGPRG initiatives have produced these publications.
Please contact us for more information about the IGPRG.