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National Clinical Trials Governance Framework implementation begins

From March 2023, all heath service organisations conducting clinical trials will need to implement the National Clinical Trials Governance Framework in alignment with assessment to the National Safety and Quality Health Service Standards.

Accreditation timeframe

To give health service organisations time to implement the Framework, for the first three years, or one accreditation cycle, health services will be assessed against a maturity scale.

Health service organisations will be assessed as either having Established systems, Growing systems, or Initial systems in place to meet the NSQHS Standards for clinical trial service provision.

Support

To assist implementation, the Commission has developed new resources, including a tool to conduct a self-assessment, manage examples of evidence and report on trial operations.

Organisations can also access direct support through the Safety and Quality Advice Centre, and join preparatory information sessions to learn more. If you'd like to join a session please email the clinical trials team at HMR@saftyandquality.gov.au.

Background

The Framework is recognised as a significant reform for the clinical trials sector. It embeds clinical trials into routine health service provision under the NSQHS Standards. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.

More information

Visit safetyandquality.gov.au/ctgf and join the NCTGF mailing list by emailing your contact details to HMR@safetyandquality.gov.au.

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