National Clinical Trials Governance Framework

Northern Health is currently undertaking the implementation of the National Clinical Trials Governance Framework (NCTGF), aiming to fortify the clinical trial space within our healthcare system.

This framework serves as a structure for developing a culture of excellence in clinical research, ensuring that patients in the North have access to leading treatments and interventions while bolstering the overall quality of care provided across Australian hospitals by integrating evidence-based practices. Clinical trials play a pivotal role in advancing medical knowledge and enhancing patient care.

Aligned with the National Safety and Quality in Healthcare Service Standards, particularly Standards 1 and 2 – Clinical Governance and Partnering with Consumers, the NCTGF promotes the seamless integration of clinical trial services into routine hospital care. By adhering to these standards, we aim to elevate patient outcomes and enrich the healthcare experience through collaborative partnerships between clinicians, researchers, and patients.

Links below to the NSQHS website:

• Standard 1 – Clinical Governance
• Standard 2 – Partnering with Consumers

WORKSHOP 12FEB2024

If you are an NH employee and wish to view the presentation or the slides please see click the link to be taken to the intranet: NH Intranet page

NCTGF Clinical Trial Definition

The framework defines a Clinical Trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials include but are not limited to:

• Surgical and medical treatments and procedures
• Experimental drugs and diagnostics
• Biological products
• Medical devices
• Health-related service changes
• Health-related preventative strategies
• Health-related educational interventions

MACH Workbooks

Your actions:

• Read MACH Workbook Part One – a 15 page introduction
• Review the Checklist relevant to your role in MACH Workbook Part Two.
• Review the Checklist relevant to your role in MACH Workbook Part Three

Resources for your review

Australian Commission on Safety and Quality in Health Care (ACSQHC)

NCTGF AND USERGUIDE

NCTGF OVERVIEW

NCTGF FAQ

NCTGF INVESTIGATORS

NCTGF WORKFORCE

NCTGF Update from sites that have been through accreditation

The Australian Clinical Trials Alliance (ACTA) held a webinar in February titled: NCTGF Update from sites that have been through accreditation, where NH Research Director Nik Zeps was a speaker, watch a recording of the webinar here.

Australian Clinical Trials Alliance is the national peak body supporting and representing networks of clinician-researchers conducting investigator-initiated clinical trials, maintaining clinical quality registries, and operating clinical trial coordinating centres within the Australian healthcare system.

Until ACTA, there was no single, coordinated mechanism to connect clinical researchers with governments, healthcare policymakers and consumers on issues that impact the conduct of investigator-led clinical trials across the Australian health system.

More information available on their website: https://clinicaltrialsalliance.org.au/