Resources for the National Clinical Trials Governance Framework

Fact sheets

These fact sheets provide details on the process and scope of assessment to the NCTGF. 

An Advisory is a formal communication issued by the Commission to accrediting agencies and health service organisations. Advisories provide guidance and direction on the interpretation and/or assessment of the NCTGF under the AHSSQA Scheme. Advisories will usually be issued when the Commission identifies that additional support is required to assist with the consistent implementation or assessment of a specific action or topic. An advisory may also be issued where the implementation of an action requires a stepwise process with long implementation timeframes.

Understanding the roles and functions of identified positions relating to clinical trial service provision within a health service is an important step in preparing for accreditation to the NCTGF. 

For example, Action 1.1 of the NCTGF requires health service organisations to ensure roles and responsibilities are clearly defined for the governing body, management, clinicians and the workforce in relation to the provision of clinical trial services. The following fact sheets are intended to support health service organisations meet this requirement. 

All HSOs and interested stakeholders (for example university staff and students, industry representatives, consumer representatives or state or territory government representatives) can register with the Commission to access the Clinical Trials Portal. Users will be required to provide a professional email domain to register.

Site contributors do not have any administrative rights so they cannot register other users on behalf of their HSO. If a HSO does not have a site administrator, all site contributors (general users) will have to register and be verified by the Commission to access the Clinical Trials Portal. 

User accounts have one of the following levels of access: 

• Basic access: users with basic access are only able to view and edit their own submissions and generate basic reports
• Clinical department access: users with clinical department access are able to view and access submissions from other users within the same clinical departments and generate reports at the clinical department level
• Health service organisation access: users with health service organisation access are able to view and access submissions from all users within the same organisation and generate reports at the clinical department level and for the whole organisation.

The Clinical Trials Portal is hosted on a secure HealthIT system. All users will be verified either by the Commission or by the designated site administrator for the HSO before they can access the Clinical Trials Portal. All users can be confident that their data is hosted in a secure environment. 

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 operation metrics tool does not collect any commercial-in-confidence information. Commercial-in-confidence information relates to the clinical trial protocol, the investigator’s brochure, study materials, early study results and the investigational product. 

The clinical trial information required for the operational metrics relates to the project title; the type of study; trial phase and sponsor type; time frame for human research ethics committee approval; local site authorisation and recruitment activity. The investment data section collects information on the expected income such as per patient payment. The financial information should be available in the clinical trial research agreement. Generally, this is the only information a trial coordinator has at hand to contribute to the organisation’s financial and business planning.

To access the Clinical Trials Portal, users are recommended to use Chrome, Microsoft Edge or Firefox. Internet Explorer is no longer a supported system.

The current system allows for manual data entry only.

It is important that clinical trial units become familiar with the actions in the NCTGF. This is because assessment to the NCTGF includes clinical trial units and ensures all actions in the NSQHS Standards have been met by the HSO. 

HSOs may wish to nominate someone to coordinate the completion of the self-assessment tool for the organisation. It is intended that this person would coordinate a whole of organisation approach inclusive of the clinical trials work force, clinical and non-clinical managers, human resources, finance and the executive to review the organisation’s readiness to meet the actions in the NCTGF.

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.