National Clinical Trials Governance Framework

National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework (the Framework) provides a consistent nationwide approach to managing clinical trials in Australia. The Framework is designed to enhance the governance of clinical trial services by providing clarity to governments, health service organisations, hospital administrators, clinicians, and other stakeholders involved in running clinical trials.

The Framework establishes a uniform set of principles and expectations for the ethical, safe and effective conduct of clinical trials in accordance with the Australian Code for the Responsible Conduct of Research and the National Statement on Ethical Conduct in Human Research. The Framework covers topics such as ethics approval, risk management, and data management, along with reporting, monitoring, and auditing.

The Framework is governed by the Australian Commission on Safety and Quality in Health Care (the Commission’s) and forms part of the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme. The Framework also builds on the National Safety and Quality in Health Services (NSQHS) Standards.

QIP is approved as an accrediting agency under the AHSSQA Scheme to accredit against the National Clinical Trials Governance Framework.

Recognising the need to pair assessment of the Framework with that of the NSQHS Standards, the QIP Team is on hand to support health service organisations meet these requirements to ensure a streamlined accreditation experience

Initial assessment – requirements and process

All health service organisations and trial sites providing clinical trials must implement the Framework in line with the NSQHS Standards under the AHSSQA Scheme.

Accreditation will commence on 30 May 2023, using a maturity scale to formulate the assessment for the first three-year accreditation cycle. This assessment pathway provides health service organisations with time to implement the Framework. 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 using the Framework.

It’s important to note that the Framework does not specify how a health organisation or trial site should develop or implement its governance systems. Rather, it describes the systems and processes that should be in place to implement an effective Governance Framework considering local needs, values and the context in which services are provided.

A range of resources are available via the Commission’s website to support the implementation of the Framework, along with personalised support from the QIP Team.

National Clinical Trials Governance Framework background

The implementation of the National Clinical Trials Governance Framework is a significant reform for the clinical trials sector.

In 2016, Health Ministers acknowledged that, despite efforts from states and territories to advance clinical trials, there were still fragmentation and inefficiency issues that prevented Australia from being a preferred location for such trials.

In 2018, the Commission, on behalf of the Australian Government Department of Health and all states and territories, began work on a Governance Framework.

In February 2022, all the jurisdictions consented to embed the Governance Framework in health service organisations as part of the Australian Health Service Safety and Quality Accreditation (AHSSQA) Scheme.

In March 2022, the Governance Framework was launched by the Australian Government Department of Health.

By embedding clinical trials into routine health service provision, duplication and inefficiency will be reduced, providing greater cohesion and productivity across the sector.

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