Clinical trials at CHW are supported by a multidisciplinary network of departments including:

• Clinical Genetics
• Oncology and Haematology
• Respiratory and Sleep Medicine
• Adolescent Medicine
• Immunology and Infectious Diseases
• Neurology and Rehabilitation
• Transplant Surgery and Paediatric Intensive Care 

These departments collaborate closely with Kids Research, the research arm of SCHN, which provides infrastructure and governance for research activities.

There are dedicated paediatric facilities that support clinical trial conduct including:

• Biobanking
• Gait Lab
• Medical Imaging
• Pathology
• Cardiac Services – Electrocardiogram (ECG), Echocardiogram (ECHO)
• Spirometry
• Pharmacy
• Advanced Viral Vector Manufacturing Facility (VVMF)

CHW hosts state-of-the-art research and clinical facilities. They host a purpose-built Clinical Research Centre (CRC) facility onsite as well as clinical trials embedded within clinical services.

Equipment and services within the CHW facility includes;

• Dedicated clinical trials laboratory facilities for collection and processing of research samples
• Ambient, refrigerated, -20°C & -80°C Investigational Product (IP) storage
• Digital temperature monitoring & excursion alerts for all IP and specimen storage
• Ambient, refrigerated, -20°C & -80°C and incubated specimen storage
• Refrigerated and ambient centrifuges
• Vital signs equipment
• ECG machine
• Pharmacy drug safe
• Access to clinic rooms
• Sponsor delegate monitoring space
• Building alarms & lockable rooms
• Secure storage of IP & trial documents
• Offsite archiving at secure storage facility

All research at CHW is governed by the SCHN Human Research Ethics Committee (HREC), certified by the National Health and Medical Research Council (NHMRC) and operating under the National Mutual Acceptance scheme. The HREC reviews all levels of risk (negligible, low, and greater than low) and works in alignment with the National Statement on Ethical Conduct in Human Research and ICH-GCP guidelines. Governance oversight is provided by the SCHN Research Governance Office, ensuring compliance with NSW Health and national standards. 

Safety monitoring and reporting are conducted in accordance with NHMRC guidelines and ICH-GCP standards. CHW maintains robust systems for adverse event reporting, including independent data safety monitoring boards for high-risk trials. The SCHN HREC oversees post-approval safety and ethical compliance.

Consumer and community involvement is a core principle at CHW. The hospital engages families and carers in research design and implementation, particularly in areas such as paediatric intensive care and transition care for adolescents. The Kids Research team actively seeks and incorporates consumer feedback into trial protocols and dissemination strategies. SCHN have implemented a consumer feedback survey designed specifically for participants of clinical trials.

The following electronic systems are used at SCHN to facilitate clinical trials management:

• Clinical Trials Management System (CTMS) - all clinical trials activated at SCHN since 1 April 2024 are mandated to use CTMS. The CTMS is utilised for study tracking, site feasibility, and resource allocation.
• Electronic Investigator Site File (eISF) - all clinical trials managed at SCHN have access to an eISF for document storage and management of the clinical trials.
• REDCap is used for investigator-led studies and secure data collection.
• Electronic Data Capture (EDC) - staff working in clinical trials are trained and experienced in the use of several EDCs to facilitate data entry for clinical trials.
• Secure Email and Document Management - Microsoft Outlook and SharePoint are utlised for communication and controlled document storage.

SCHN utlises a suite of SOPs covering all aspects of clinical trials start up, management and close out that are aligned with International Council for Harmonisation Good Clinical Practice (ICH-GCP), NHMRC guidelines, the National Clinical Trials Governance Framework (NCTGF) and SCHN Research Governance requirements.

SOPs are reviewed regularly and are version-controlled in a centralised repository.

SCHN clinical trials are governed by the relevant Research Ethics, Governance, Data Privacy, Security, Risk Management and Clinical Policies, ensuring compliance with NSW Health and SCHN standards.