GOVERNANCE AND QUALITY

Governance and quality for research at Icon continues to be a strength and focus. 2022 saw continued evolutions of a global governance framework and the implementation of the Investigator Initiated Trials Framework.

Research governance and quality is governed by the Icon Group Executive who set the strategic and operational plans for all research activities at Icon and has specific responsibilities to:

• Provide managerial leadership in delivering care and supporting the strategic direction and the culture set by the Board for the research division

• Approve the approach to planning, implementing, evaluating, and improving of research practice and quality

• Enable the provision of support, resources, training, information, and opportunities to the workforce to provide safe and quality care for research participants

Discuss clinical quality and safety data from research participants with the Global Research Committees and the Executive Leadership Team about matters including consumers feedback, audit results, accreditation reports, incidents, compliments, and complaints

• Monitor and evaluate implementation progress of research clinical governance and quality activities and take further action, as needed

Icon’s research and cancer division’s quality teams have established a working relationship to ensure all accreditation standards are met. The working group was established in 2022 to review and integrate the National Clinical Trials Governance Framework into Icon Group’s Clinical Governance Framework through the support of existing documentation and processes.

The National Clinical Trials Governance Framework

In 2022, the Australian Health Service Safety and Quality Accreditation (NSQHS) scheme implemented the National Clinical Trials Governance Framework. As a result, all health service organisations in Australia will be assessed concurrently for clinical, corporate services and clinical trial service provision.

To provide health service organisations time to implement the National Clinical Trials Governance Framework, for the first three-year accreditation cycle, the organisation will be assessed on a maturity scale. The maturity scale is assessed from having established systems, growing systems, or initial systems in place to meet the NSQHS standard for clinical trial service provision.

Beyond the first three-year accreditation cycle, health service organisations will transition fully to the assessment of clinical trial services under the AHSSQA (Australian Health Service Safety and Quality Accreditation) Scheme and be assessed as either having met or not met the actions within the NSQHS Standards Clinical Governance Standard and Partnering with Consumer Standards and receive 60 days to remediate.

IIT Framework

The IIT Framework outlines the process for development, management, and maintenance of the Icon IIT portfolio. The IIT Framework allows for Icon to provide a clear pathway for study concept development and provide an end-to-end service. This IIT Framework underwent a major revision to streamline processes and ensure studies were being managed with a high focus on quality. This framework also allows for Icon to partner with external organisations to develop and produce a high quality IIT program anywhere in the world.