We're involved in a range of research projects and clinical trials including:
- commercially sponsored trials
- collaborative trials with multi-centre networks
- local investigator-led trials.
Site overview
- PC2 Research laboratory with constantly monitored and alarmed -80°C and -20°C freezers and 4°C refrigerators, centrifuges and biological safety hood
- ECG machines, pulse oximetry, scales and thermometers
- all supporting calibration and certification documentation
- a dedicated Clinical Trials Pharmacist
- local pathology access using Pathology Queensland
- local Research Governance Unit and Principal Governance Officer (Research)
- advanced standardised budgeting templates and trial costing support tools
- extensive standard operating procedure library
- experienced clinical trial Registered Nurses and Clinical Nurses with knowledge of trial data management and reporting requirements, and supporting laboratory processing procedures
- local access to the integrated electronic Medical Record system (ieMR)
- twice yearly Good Clinical Practice (GCP) training compliance and up to date clinical staff CV library
Clinical Research Unit ward
At Sunshine Coast University Hospital, we have a dedicated clinical trials ward with 8 fully-equipped consultation rooms. The ward has plenty of office space for visiting clinical research associates to work in.
The ward is restricted to research staff only. This provides security for trial documentation, data and any other investigational products.
Trial participants can stay in their own private room with a bed, recliner, TV, and ensuite bathroom. They can also have meals provided as required.
Clinical pharmacy services
Our clinical pharmacy provides an experienced, high quality, and efficient service to trials involving medicines. It:
- supports and promotes the safe and ethical use of medicines
- maintains our compliance with relevant legislation, standards and guidelines
- supports the safety and welfare of participants, including protection of their rights, confidentiality and privacy.
Our clinical trials pharmacists are trained in Good Clinical Practice (GCP) and have strong backgrounds in clinical pharmacy. We provide:
- high quality, efficient investigational drug service
- dispensing and drug accountability
- maintenance of trial-specific preparation and dispensing records
- liaison with trial sponsors, investigators, study coordinators, study participants, their families and carers, medical, nursing and other pharmacy staff
- investigational drug compatibility, drug interactions, contraindications, monitoring
- aseptic preparation of sterile and cytotoxic medication through Slade in Brisbane
- secure, temperature-monitored storage
- on-site drug disposal
- study design and randomisation
- sourcing investigational medicines.
Pharmacy fees
The Pharmacy Department must support all clinical trials involving medication. You should discuss the study and the support required with the Clinical Pharmacy team.
Fees may apply. These are based on the service provided using a cost recovery model, and depend on study design.
We support local investigator-initiated research by providing a trial service at reduced charge.
Study participants receive clinical trial medications at no charge.
When you're planning to conduct a clinical trial, contact the Clinical Pharmacy team for feasibility assessment and to request a fee proposal.
Pharmacy approval of your site-specific assessment application
Your site-specific assessment (SSA) evaluates whether a study is suitable to commence on site.
The Director of Pharmacy will sign off the SSA Pharmacy project support documentation on the recommendation of the Pharmacy Clinical Trial Support Service.
Medical imaging
Our medical imaging teams provide a full range of diagnostic and interventional imaging services for research projects and clinical trials.
We provide services at Sunshine Coast University Hospital (SCUH), Nambour General Hospital, Gympie Hospital, and Caloundra Health Service. The exact services provided at each site vary.
We use the following imaging modalities:
- X-ray
- Computerised Tomography (CT)
- Magnetic Resonance Imaging (MRI)
- Ultrasound, Mammography
- Nuclear Medicine
- Positron emission tomography (PET)
- Fluoroscopy Bone Mineral Densitometry (BMD).
Our radiologists are familiar with many reporting criteria used specifically for monitoring of treatment response including RECIST and PCWG3.
If you're interested in using diagnostic medical imaging for your research project, get in touch with our medical imaging research coordination team.
Pathology
Pathology Queensland provides a comprehensive range of pathology services for Sunshine Coast University Hospital.
Our clinical trials team will work with you to engage Pathology Queensland. You'll also need to apply for Pathology Queensland services for each project.
Clinical trials laboratory pathology services
The clinical trials nurses prepare all samples for central pathology. There is a dedicated PC2 research laboratory for the clinical trial coordinators to prepare specimens for shipping. The laboratory is approved by the Office of the Gene Technology Regulator, and is equipped with:
- refrigerated centrifuges
- biological safety hood
- 4°C fridge
- -20°C and -80°C freezers.
All clinical trials nursing staff get an induction to our laboratory, with regular training and competency assessments.
We have calibration certificates for all items of equipment.
Support for external clinical trials sponsors
We have a number of processes and procedures specific to clinical trials. Contact the Research Governance and Development Unit or Clinical Trials team for these resources.
You should also refer to Apply for research governance to see our schedule of fees and approval procedure.
If you're submitting a site-specific assessment (SSA) for governance review on behalf of a Principal Investigator, contact the Research Governance and Development Unit for support and more information.
Support for Principal Investigators
Approval for a clinical trial must follow the same process as for all research governance approval. Refer to the procedures on Apply for research governance.
Current staff members should refer to our clinical trials procedural documents on our intranet (QHEPS). This includes information about your responsibilities as a Principal Investigator.
All staff involved in clinical trials need to be Good Clinical Practice (GCP) Certified. If you need support to find a suitable GCP training course, contact the Clinical Trials unit.
Our clinical trials support and coordination teams can provide you with all the support required for preparing clinical trials budgets and documentation.