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The World Health Organization defines a clinical trial as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes."
The National Health and Medical Research Council (NHMRC) states that clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.
Following the pilot, it is anticipated that clinical trial services will be assessed using a maturity scale to the actions identified in the National Clinical Trials Governance Framework (NCTGF). The framework has been accepted by all Australian jurisdictions and assessment to the framework will be conducted as part of hospital accreditation.
If you work in clinical trials, this video provides you with useful information on the implementation of the Governance Framework and will help you understand how to prepare for accreditation.
Governing bodies are responsible for ensuring all clinical trials undertaken within their organisation comply with the requirements of national and local legislation and for ensuring appropriate research governance personnel, systems and structures are in place. Governing bodies are required to attest to this in the health service organisation’s Attestation Statement which is sent to their chosen accreditation assessment company.
Implementation of the National Clinical Trials Governance Framework (NCTGF) published by the Australian Commission on Safety and Quality in Health Care has been endorsed by Metro South Health. To date, a gap analysis has been completed against the NCTGF and a related implementation plan is pending.
Implementing the National Clinical Trials Governance Framework in MSH - video recording
The Australian Government’s generous Research & Development (R&D) Tax Incentive encourages more industry investment in R&D.
The Incentive provides businesses investing in eligible R&D with generous tax offsets:
Other benefits under the new R&D Tax Incentive include:
Above all, the new system provides a globally competitive tax incentive for conducting R&D activities in Australia.