Safety and Quality in Clinical Trials

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National Clinical Trials Governance Framework

The Australian Commission on Safety and Quality in Health Care (the Commission) has developed the National Clinical Trials Governance Framework on behalf of all jurisdictions in collaboration with the Australian Government Department of Health.

The National Clinical Trials Governance Framework builds on the National Model Clinical Governance Framework and the National Safety and Quality Health Service (NSQHS) Standards. The National Clinical Trials Governance Framework is aligned with the NSQHS Standards, in particular, the Clinical Governance Standard (Standard 1) and the Partnering with Consumers Standard (Standard 2), and outlines:

  • Roles and functions for identified positions relating to clinical trial service provision within a health service organisation
  • Actions against which health service organisations with a clinical trial service will be assessed for accreditation
  • Suggested strategies health services may implement to meet the actions within the NSQHS Standards
  • Examples of evidence a health service organisation may provide that demonstrate they have met the actions within the NSQHS Standards for clinical trial service provision.

For further information, visit, www.safetyandquality.gov.au/standards/clinical-trials or download the National Clinical Trials Governance Framework FAQs and fact sheets

Reporting a Safety Event

To report a Safety Event, refer to the Research Governance Documents for the Safety Event Form.

If you have concern about a clinical trial

If you are a Consumer and have a concern about a clinical trial or research project refer to the section on For Consumers