National Clinical Trials Governance Framework

The National Clinical Trials Governance Framework (NCTGF) was implemented in May 2023 across all Australian jurisdictions. Its purpose is to enhance the governance arrangements for clinical trials within health services. Here’s why it matters: 

Safety and Quality Assurance: 

• The NCTGF ensures that clinical trials adhere to rigorous safety and quality standards. 
• Patients and consumers participating in trials can trust that their wellbeing is a priority. 

Ethical Conduct: 

• The framework emphasises ethical practices throughout the trial process. 
• Participants’ rights, dignity, and privacy are respected. 

Access to Innovative Treatments: 

• Clinical trials are an avenue for advancing medical knowledge and developing new treatments. 
• Patients benefit from access to innovative therapies that are not yet available through standard care. 

Informed Decision-Making: 

• Clear communication about trial objectives, risks, and benefits allows informed choices. 
• Patients actively engage in discussions with healthcare providers. 

Transparency and Accountability: 

• The NCTGF promotes transparency in trial processes and accurate reporting of results. 
• Accountability mechanisms ensure organisations uphold responsibilities. 

Community Engagement: 

• Engaged communities foster trust and collaboration between researchers, healthcare providers, and the public. 

• Patients and consumers participate in shaping research priorities. 

In implementing the NCTGF, Eastern Health will prioritise patient safety, ethical treatment, and access to cutting-edge therapies. By adhering to the framework, Eastern Health aims to enhance healthcare outcomes for all. This involves strong governance, transparent processes, and community engagement, ensuring that clinical trials are conducted with integrity and benefit both patients and the broader healthcare system.  

 

Information for Eastern Health Departments

The NCTGF serves to ensure that clinical trials are conducted in a safe environment and with high-quality standards. This commitment will ultimately lead to improved health outcomes for patients and the broader community. 

Below are the key points regarding the NCTGF implementation: 

Integration into Routine Practices: The NCTGF encourages health services to embed clinical trial services into their routine practices. By aligning with The NSQHS Standards | Australian Commission on Safety and Quality in Health Care, operational efficiencies can be achieved across areas involved in clinical trial services. 

Operational Efficiencies: The NCTGF impacts several critical aspects of clinical trials, that will lead to operational efficiencies by impacting workforce training and engagement, trial-related financial management and recruitment activities. 

Five Components of the NCTGF: The NCTGF consists of the five following components: Governance, Leadership, and Culture; Patient Safety and Quality Improvement Systems; Clinical Performance and Effectiveness; Safe Environment for Care Delivery; Partnering with Consumers; Roles and Functions. 

Workforce Training and Engagement: Detailed information about the roles and functions of the governing body, managers (clinical and non-clinical), principal investigators, clinical trials workforce, accrediting agencies and consumers can be found under Fact sheets at Resources for the National Clinical Trials Governance Framework | Australian Commission on Safety and Quality in Health Care. 

 

The Office of Research and Ethics is committed to supporting the Eastern Health Research Workforce through the implementation of the National Clinical Trials Governance Framework (NCTGF). Compliance with the NCTGF requires each department conducting clinical trials to provide evidence of compliance with the action points outlined in the NCTGF User Guide. 

To help investigators with this, we encourage them to use the Short Notice Self-Assessment Checklist Tool to assess each clinical trial that is carried out in your department. The purpose of this checklist is to assist each Clinical Trial Unit in conducting self-assessments and demonstrating departmental alignment with the Framework. 

The checklist aligns with the action points required for Framework Accreditation. 

These Actions include: 

• Clinical Trial Workforce Register and Training 

• Departmental Policies and Standard Procedures for Clinical Trials Operations 
• Aboriginal and Torres Strait Islander People in Clinical Trials 
• Trial Participants Engagement and Feedback 

By adhering to this process, Eastern Health aims to improve clinical trial governance and ensure alignment with the NCTGF, benefiting both patients and research.