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National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework is an Australian framework established to integrate clinical trial service provision into the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. It mandates that health service organizations, including public and private hospitals, day procedure services, and public dental services, be independently assessed for compliance with the National Safety and Quality Health Service (NSQHS) Standards in relation to clinical trial service provision.

Overview

The Governance Framework is a component of a broader effort to ensure the safety and quality of health services in Australia. It builds upon the National Model Clinical Governance Framework and the NSQHS Standards, aiming to provide a structured approach to clinical trial service provision within health service organizations. The framework outlines roles and functions for identified positions, actions for accreditation assessment, suggested strategies for meeting the standards, and examples of evidence demonstrating compliance.

Components

Reflecting the NSQHS Standards, the Governance Framework comprises five key components:

1. Governance, Leadership, and Culture: Establishing a governance structure that promotes safe and quality clinical trial service provision.
2. Patient Safety and Quality Improvement Systems: Implementing systems to continuously improve the safety and quality of clinical trials.
3. Clinical Performance and Effectiveness: Ensuring clinical trials are performed effectively and yield reliable results.
4. Safe Environment for the Delivery of Care: Providing a safe physical and psychological environment for clinical trial conduct.
5. Partnering with Consumers: Engaging with consumers to inform and improve the planning, design, delivery, and evaluation of clinical trials.

Implementation and Assessment

The implementation of the Governance Framework is mandatory for health service organizations providing clinical trial services. For the initial three-year accreditation cycle, organizations will be assessed on a maturity scale, categorized as having Established, Growing, or Initial systems to meet the NSQHS Standards using the Governance Framework. The first assessments are scheduled to commence in May 2023.

Development and Support

The Australian Commission on Safety and Quality in Health Care is responsible for updating the supporting resources for the Governance Framework and provides ongoing advice to health services through the Safety and Quality Advice Centre.