National Clinical Trial Governance Framework (NCTGF)

National Clinical Trials Governance Framework (NCTGF) at St Vincent’s Hospital Melbourne

The National Clinical Trials Governance Framework (NCTGF) provides a national standard for the safe and high-quality conduct of clinical trials. It builds on the National Model Clinical Governance Framework and NSQHS Standards to ensure research is conducted safely, ethically, and effectively.

At SVHM, the NCTGF guides the design, approval, and monitoring of clinical trials, promoting transparency, accountability, and excellence in research. In August 2023, SVHM achieved a full 3 out of 3 maturity rating in its initial assessment, reflecting our commitment to world-class clinical research and improved health outcomes for our community.

Moving forward, the NCTGF will be assessed as part of hospital accreditation, meaning all health services conducting clinical trials are required to comply with its standards.

Purpose and Scope

The NCTGF ensures clinical trials are conducted in a safe and high-quality environment, improving outcomes for patients and the community. Embedding clinical trial services into routine hospital practices under the NSQHS Standards delivers operational efficiencies across multiple therapeutic areas, including:

  • Pre-trial assessment of a trial site (site selection, feasibility assessment)
  • Pre-recruitment activities (ethical and local site approvals)
  • Recruitment and trial management
  • Workforce training and engagement
  • Trial-related business and financial management

 

What is a Clinical Trial?

A clinical trial is any research study that prospectively assigns participants to one or more health-related interventions to evaluate effects on health outcomes. This includes, but is not limited to:

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

Departmental Checklist

The Research Directorate has developed the NCTGF Departmental Checklist, a self-assessment tool within SAGE for all departments currently active, or planning to be active, in any clinical trial.

Based on the NCTGF User Guide and associated action points, the checklist assists departments with compliance, including documenting evidence required for hospital accreditation.

Purpose of the Checklist

The checklist enables departments to:

  • Identify gaps and opportunities for improvement in clinical trial service delivery
  • Enhance integration within hospital systems and resources
  • Document evidence demonstrating compliance with the NCTGF

 

Frequency of Completion
Departments should update the checklist At least twice annually (every 6 months), or whenever significant changes occur in clinical trial operations.

 

Recommendations and Resources
Departments may adopt processes that best suit their operations, provided they comply with institutional policies and legislative requirements, NCTGF standards, and other applicable research standards, including:

    • NHMRC Guidelines
    • International Council for Harmonisation – Good Clinical Practice (ICH-GCP)
    • Australian Code for the Responsible Conduct of Research

Guidance materials and templates are available to assist with planning and documentation. If documentation is not currently available, departments should provide comments outlining steps being taken or planned to achieve alignment. Evidence of effort and forward planning will be considered as part of the assessment.

 

How to Access

Each departmental checklist has a unique CTW (Clinical Trial Workforce) ID in SAGE. The Head of Department is the owner of the checklist. If you cannot locate your checklist in SAGE, please contact research.directorate@svha.org.au to request access.

How to Access Departmental Checklist in SAGE

Clinical Trials Management System (CTMS)

From July 2025, SVHM has implemented a Clinical Trial Management System (CTMS) for all interventional trials. The CTMS provides a central platform to track trial milestones and finances, manage participant enrolment, monitor compliance, oversee ethics and governance approvals, and maintain up-to-date trial information. By standardising trial processes and improving oversight, the CTMS directly supports NCTGF compliance, enhancing transparency, ensuring data integrity, streamlining reporting, and aligning operations with national clinical trial governance standards.

How CTMS Works

The CTMS secure, centralised platform within SVHM that manages every stage of an interventional trial. At SVHM, it works by:

  • Capturing trial set-up information in a structured format based on governance documents (site-specific protocol, CTRA/RCA, and PICFs).
  • Tracking participant activity – from enrolment and consent to treatment, follow-up, and trial completion.
  • Streamlining communication – allowing researchers, governance staff, and other stakeholders to work from the same up-to-date information.
  • Monitoring trial progress – with dashboards that show milestones, timelines, and potential risks in real time (coming soon).
  • Managing compliance – ensuring that all trial documentation, reporting, and monitoring align with NCTGF and institutional requirements.

 

Resources

More resources are available on the SVHM Intranet. Please contact research.directorate@svha.org.au for any queries.

 

Consumer Engagement in Research

SVHM ResearchFriends_website banner

SVHM @ ResearchFriends is a new way to connect researchers and consumers while supporting NCTGF requirements for consumer engagement and feedback in clinical trials. Whether you’re a researcher seeking lived-experience insights or a community member wanting to help shape real-world research, ResearchFriends makes it easy to collaborate, provide input on study design, recruitment materials, and participant information, and make a meaningful impact.
Sign up for ResearchFriends here: https://svhm.researchfriends.org

Clinical Trial Participation Experience Survey

Launched in November 2024, this automated survey is designed to gather valuable feedback from trial participants, enhance patient experience, and support the continuous improvement of our clinical trials.

The survey is automatically distributed every six months to active trial participants and consists of three distinct question sets, tailored to the participant’s stage in the trial.

Questions focus on key areas such as patient satisfaction, comfort level, understanding of the trial, and communication with the study team.

Key Objectives:

  • Foster stronger engagement and transparency to improve overall participant experience and satisfaction
  • Use participant feedback to enhance trial monitoring, identify opportunities for quality and safety improvements, and support participant retention
  • Ensure compliance with NCTGF standards for hospital accreditation, specifically in Patient Safety and Quality Improvement Systems and Partnering with Consumers