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National Clinical Trials Governance Framework

Clinical trials provide early access to innovative treatments and interventions for patients and help to improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice.

Pilot of the National Clinical Trial Governance Framework

The Australian Commission on Safety and Quality in Health Care has developed the National Clinical Trials Governance Framework as a first step toward implementing the National Safety and Quality Health Service (NSQHS) Standards and achieving accreditation of health services for the conduct of clinical trials.

The Framework aims to ensure that clinical trials are conducted in a safe environment and in a high-quality manner for improved health outcomes for patients and the community. The Framework supports health services to reduce trial start up times, optimise pre-approval and participant recruitment timeframes, better engage trial sponsors and improve consistency in trial service delivery.

Selection of Bendigo Health as a pilot

In July 2020 Bendigo Health was among a handful of health services selected by the Commission to pilot the National Clinical Trials Governance Framework. This presented a valuable opportunity for Bendigo Health to be assessed in implementing the Framework.

It is expected that improvements will be achievable over a planning cycle of three years. A comprehensive action plan to address the outstanding items has been drafted and disseminated for further review by relevant stakeholders throughout the organisation to ensure the Framework is fully implemented to meet Bendigo Health’s accreditation in 2024.

The Department of Research and Innovation would like to thank everybody who provided support in preparing for the pilot assessment and who continue to help us work towards implementation of the National Clinical Trial Governance Framework for safe and quality clinical trials provision at our organisation.

Video

For those who work in clinical trials, this video provides useful information on the implementation of the Governance Framework and will help you understand how to prepare for accreditation.

Further Reading

  • National Clinical Trials Governance Framework and User Guide
  • National Clinical Trials Governance Framework Literature Review
  • National Clinical Trials Governance Framework Mapping Exercise
  • FAQs- National Clinical Trials Governance Framework
  • Fact sheet 1 - National Clinical Trials Governance Framework and accreditation overview
  • Fact sheet 2 - National Clinical Trials Governance Framework - Clinical Governance Standard
  • Fact sheet 3 - National Clinical Trials Governance Framework - Partnering with Consumers Standard
  • Fact sheet 4 - National Clinical Trials Governance Framework - Roles and functions of the governing body
  • Fact sheet 5 - National Clinical Trials Governance Framework - Roles and functions of managers (clinical and non-clinical)
  • Fact sheet 6 - National Clinical Trials Governance Framework - Information for consumers
  • Fact sheet 7 - National Clinical Trials Governance Framework - Roles and functions of clinical trial sponsors
  • Fact sheet 8 - National Clinical Trials Governance Framework - Roles and functions for site principal investigators
  • Fact sheet 9 - National Clinical Trials Governance Framework - Roles and functions for the clinical trials workforce
  • Fact sheet 10 - National Clinical Trials Governance Framework - Information for accrediting agencies   

Resources