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National Clinical Trials Governance Framework


The National Clinical Trials Governance Framework is aligned with the NSQHS Standards, in particular, the Clinical Governance Standard and the Partnering with Consumers Standard.

There are five components within these two Standards:

  • Governance, leadership and culture
  • Patient safety and quality improvement systems
  • Clinical performance and effectiveness
  • Safe environment for the delivery of care
  • Partnering with consumers

The actions in the National Clinical Trials Governance Framework are mandatory for health service organisations and trial sites providing clinical trial services. The Framework's purpose is 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 National Clinical Trials Governance Framework user guide is available here:

The CALHN Clinical Program Self-Assessment tool has been designed to assist with assessing readiness to meet the actions within the Governance Framework and to track and report on progress.

The Self-Assessment tool is available by emailing us at

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