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
Upcoming Short-Notice Accreditation
If you have an active clinical trial running at NH, your trial could be selected for review. This means the Coordinating Principal Investigator, the Principal Investigator, the SSA study contact, any member of your study team or your participants could be called upon during the accreditation for an interview.
The next assessment will not count towards the met/not met criteria of the Hospital accreditation against the standards, the Clinical Trials assessment will follow the same grading scale as the 2024 accreditation, which was assessed as: initial, growing or established systems.
Please ensure your team is informed which of your trials have been included in the pool of potential trials which could be selected for accreditation. If your trial is selected, it will be everyone’s responsibility to inform your study team and ensure your site files are ready for review. For example, the list of all delegated team members (signed and dated appropriately), and screening/enrollment logs, PICFS etc or any other study related documents could be requested by the assessors.
Accreditation Ready
Clinical leaders support clinicians to understand and perform their delegated safety and quality roles, and to operate within the clinical governance system to improve patient care.
Review your study using the Short Notice Accreditation Assessments and Action Cards, and consider whether an internal audit or self-check is required.
- Action Cards for Researchers Available on Prompt: Click here.
Strong research is continuously reviewed, understood, and improved.
- If you are an NH employee and wish to view the presentation or the slides from the 2024 Preparation Workshop 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 RESOURCES |
| 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/
