Navigating Governance in the context of the Clinical Trials
ACHS Consulting can support your quality improvement journey
Clinical Governance: The Foundation of Quality and Safety
In the context of clinical trials, clinical governance ensures that research activities are integrated into the organisation’s broader safety, quality, and risk management systems.
A clinical trials governance framework needs to include:
- Leadership and Accountability: Clear lines of responsibility for clinical trial oversight, from the governing body to frontline staff, are essential. This includes defining who is accountable for the conduct, safety, and ethical compliance of trials.
- Risk Management: Clinical trial risks should be identified, assessed, and managed within the organisation’s existing risk management framework. This includes the inclusion of trial-specific risks in the risk register and the development of mitigation strategies.
- Quality Assurance: Clinical trial processes should be subject to routine quality audits, performance monitoring, and incident reporting, in line with other clinical activities.
- Continuous Improvement: There must be systems for learning from adverse events, protocol deviations, and audit findings, with a focus on ongoing improvement in trial conduct and participant safety.
- Consumer Involvement: Partnering with consumers—patients and trial participants—is a core element of clinical governance. Their perspectives should inform trial design, conduct, and evaluation.
With the introduction of the National Clinical Trials Governance Framework by the Australian Commission on Safety and Quality in Health Care (the Commission), key questions for health services include:
- Who is responsible for oversight?
- Are risks associated with clinical trials identified in your risk register, with effective monitoring and mitigation strategies?
Supporting Effective Clinical Governance
ACHS Consulting brings together expert knowledge and long-standing experience to support healthcare organisations in complex processes, internal audits, continuous improvement, and clinical governance. The support we offer can involve:
- Gap Analysis: Assess your current systems against the Framework and NSQHS Standards, identifying areas for improvement.
- Mock Assessments: Prepare your team with simulated assessments and practical feedback.
- Governance and Risk Support: Help you integrate clinical trials into your organisational risk register and governance structures, ensuring clear lines of responsibility and robust monitoring.
- Continuous Improvement: Guide you in establishing ongoing audit and review processes to maintain high standards and respond proactively to incidents or deviations.
Whether you need to strengthen adverse event monitoring, manage protocol deviations, or simply measure if your clinical trials align to the highest standards of safety and quality, ACHS Consulting is here to help.
Contact us today to discover how we can support your quality improvement journey.
