Resources for the National Clinical Trials Governance Framework
The Australian Commission on Safety and Quality in Health Care has developed resources for health services to support implementation of the National Clinical Trials Governance Framework.
National Clinical Trials Governance Framework Implementation Workshops
Individual health service organisation sessions are available to facilitate and support implementation of the Governance Framework, contact the Clinical Trials Team at HMR@safetyandquality.gov.au for more information and to arrange a session.
In February 2022, all jurisdictions agreed to implement the Governance Framework in health service organisations as an embedded approach (as clinical research is a core health service business) under the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. That is, health service organisations will be assessed concurrently for clinical and corporate services and clinical trial service provision.
The Governance Framework is recognised as a significant reform for the clinical trials sector. The Governance Framework embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators that deliver clinical trials. Importantly, it will do so in a way that will reduce duplication and increase efficiency, cohesion and productivity across the clinical trials sector.