Resources for the National Clinical Trials Governance Framework

The Commission has developed the following web-based tools to assist HSOs monitor their clinical trial service operations and self-assess their capacity to meet the actions within the NSQHS Standards, as provided in the NCTGF. 

• The self-assessment tool
• The operational metrics tool.

Across 2025 the Commission will undertake enhancements against the self-assessment and monitoring tools to support health services and accreditation agencies prepare for assessment to the Governance Framework. Feedback on development opportunities can be shared directly with the Health and Medical Research Team via HMR@safetyandquality.gov.au.

Access the Clinical Trials Portal

User guide for the Clinical Trials Portal

2024

Guide, user guide or guidelines

Self-assessment tools

This self-assessment tool assists health services assess their capacity to meet the actions in the Governance Framework. The tool enables health services to:

• Determine whether they meet the actions
• Document the evidence that demonstrates each action has been met
• Create an action plan of any tasks to meet the actions, including allocating a person responsible for completing the tasks.

Actions within the Governance Framework are aligned with the NSQHS Clinical Governance Standard and Partnering with Consumers Standard. Speak with your hospital quality officer about the systems and processes currently in place to meet the actions within the NSQHS Standards and use the tool to assess your clinical trial service.

Operational metrics tool

The operational metrics tool enables the workforce within trial units, clinical departments, hospitals and health networks to report on their clinical trial service operations. This information enables health service organisations to review their clinical trial services operating in multiple departments using a series of automated reports.

The operational metrics tool is aligned with the reporting requirements for the National Aggregate Statistics (NAS).

The Commission have published a resource to support health services navigate the Clinical Trials Portal. View the webinar below.

The Commission is committed to the protection of personal information in accordance with the Privacy Act 1988 (Privacy Act). The Commission aims to ensure that all personal information is managed in accordance with the Australian Privacy Principles (APPs) contained in the Privacy Act. 

Further information can be found at the Commission's Privacy Policy.

The Commission have worked with the VCCC to refine the MDS to support reporting requirements of governing bodies and clinical trial workforce in relation to the NCTGF. 

The MDS provides a series of baseline operational metrics (indicators) relevant to national priority indicators and regulatory requirements, such as those provided in Actions 1.1, 1.8 and 1.9 of the NCTGF, in addition to workforce and trial participant experience. 

An updated version of the MDS is available at VCCC Alliance Metrics.

This National Clinical Trials Governance Framework: Orientation for Assessors course aims to support assessors in assessing service providers for implementation of the National Clinical Trials Governance Framework (download this document before commencing the course).

There are 4 modules in this course as listed below. The modules vary in length. An estimated time for completion is provided below:

1. Introduction to clinical trials (Completion time: 60 minutes)
2. Clinical trials regulation and legislation (Completion time: 30 minutes)
3. National Clinical Trials Governance Framework (Completion time: 90 minutes)
4. Assessing service providers to the Governance Framework (Completion time: 60 minutes)

Each module includes interactive content, knowledge check activities and ends with a quiz.

The course requires an 80% pass in the quiz to receive a completion certificate.

Clinical trials provide early access to innovative treatments and interventions for patients, and improve the overall standard of medical care provided in Australian hospitals through the uptake of evidence into practice. Data suggest that improved outcomes for patients participating in clinical trials are due in part to the increased clinical surveillance a trial provides and greater clinician adherence with evidence-based care. 

A clinical trial is 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.¹ Clinical trials include but are not limited to:

• Surgical and medical treatments and procedures
• Experimental drugs and diagnostics²
• Biological products
• Medical devices
• Health-related service changes
• Health-related preventative strategies
• Health-related educational interventions.

All trials undergo rigorous evaluation to make sure that the intervention being tested is effective, safe and feasible for use more broadly in the community. 

Clinical trials generate evidence to inform best-practice ways of providing care and treatment to patients. A thriving clinical trials environment is essential for a robust and self-improving healthcare system.

1. World Health Organisation - http://www.who.int/topics/clinical_trials/en/
2. In the Australian context, this includes novel treatments and interventions

Self–improving health system

Governance is the set of relationships and functions established by a health service organisation or trial service between its state or territory department of health, governing body, executive, workforce, patients, consumers, and other stakeholders to ensure good clinical trial service provision.

Clinical trial service governance is an integrated component of the corporate and clinical governance of HSOs. It ensures that everyone, including frontline trial investigators undertaking clinical trials and members of governing bodies such as Boards, is accountable to patients and the community for assuring the delivery of clinical trials is of high quality, integrated into clinical care and continuously improving.

The cost of delays in trial start-up impact on clinical trial budgets and are frequently related to strategic and operational barriers. Improved organisational governance of trial services enables health administrators to oversight trial operations including (complex) contract negotiation (including financial schedules), use of national forms and standard contracts, determine work force arrangements and optimise organisational strategic planning to deliver clinical trial services. It is anticipated that, accreditation to the actions within the NCTGF will remove barriers to the following clinical trial processes.

• Trial site feasibility assessment
• Timely ethical and site-specific assessment approval timeframes
• Participant screening and recruitment activities
• Trial management
• Workforce planning and staff training
• Trial related financial management and reporting.

Systems and processes currently in place in health service organisations that underpin strategic planning to deliver clinical trial services include: organisational leadership; policies and procedures; risk management; incident management and open disclosure; workforce safety and quality training and infrastructure to deliver clinical trials.

The Commission has developed resources to support health services implement the NCTGF. Once implemented, health service administrators will have visibility of trial related activity within their organisation. Clinical trial operations will be measured and reported by trial; trial site; health service organisation and jurisdiction. Measures of operational efficiency will align with the National Aggregate Statistics (NAS) currently reported only at the jurisdictional level for public health organisations.

HSOs accredited to the National Safety and Quality Health Service (NSQHS) Standards conducting clinical trials will be assessed against the actions in the NCTGF.

For HSOs that are already accredited to the NSQHS Standards, the accreditation process will remain unchanged. However, assessment against the actions in the NCTGF will be included.

HSOs will continue to select their accrediting agency, from among approved agencies, to assess their performance.

The National Clinical Trials Governance Framework and User Guide provides detailed information and strategies to assist HSOs with implementing the improvements required by the NCTGF. Suggested strategies to meet the actions within the NCTGF, and examples of evidence an HSO might provide to demonstrate they have met the actions are also provided.

The Commission has developed resources (including a self-assessment tool, case studies, fact sheets, video tutorial and online operational metrics tool) to support implementation.

The Commission has a NSQHS Standards Advice Centre available for support and, if required, mediation between HSOs and accreditation agencies during assessment. Support will be provided by telephone 1800 304 056 and email accreditation@safetyandquality.gov.au.

Additional support will be provided by the Commission to health service organisations throughout the first assessment cycle.

For the first assessment cycle, HSOs will be assessed using a maturity scale for each applicable action to provide an indicator of success. This approach recognises that HSOs are at different stages of maturity in implementation of the actions and provides HSOs with a unique quality improvement opportunity to implement safety and quality enhancements ahead of the transition to the NSQHS Standards rating system. It is expected that improvements should be achievable over a health services standard planning cycle of three years.

Figure 1: Maturity scale for health service organisation assessment

One of the underpinning principles of health service provision is equity. HSOs are required to provide equitable access to the community as part of routine health care. The NCTGF extends this responsibility to clinical trials (both commercially sponsored and investigator-initiated). HSOs providing a clinical trials service are required to:

• Ensure patients and consumers can access to clinical trials in a timely manner
• Observe cultural safety, competence and respect in providing clinical trial services to meet the needs and priorities of First Nations peoples
• Provide appropriate resourcing to allow patients and consumers from different demographics, geographics and culturally diverse background to participate in all available trials within and across HSOs
• Maintain a skills and reputable clinical trials workforce in accordance with Action 1.20

The NCTGF also provides guidance for HSOs when they act as the trial sponsor. For investigator-initiated trials, the HSO or trial site that is the approving authority may also be the trial sponsor. In such cases, the governing body ensures that its overarching governance and quality management systems separates its responsibilities as a trial sponsor from its responsibilities as a trial site and ensures that the requirements of sponsorship can be met. For example, implementation of organisational strategies to meet Actions 1.7, 1.11, 1.12. 

Clinical trial networks and ARHTCs could work with their member organisations to build capacity in a number of ways including, but not limited to: clinical trial education and training for the workforce and consumers; providing advice and support to trial investigators and researchers on good clinical trial practice relating to protocol development; data management and analytics; report writing; navigating ethical processes; participant recruitment and project management.

AHRTCs could also support HSOs in the review of clinical trial outcomes and contribute to guideline development and evidence translation into clinical practice.