The Clinical Trial Unit (CTU) is based at Barwon Health – University Hospital Geelong. The unit is supported by a team of up to 18 investigators in endocrinology, infectious diseases. and paediatrics.
The CTU has been in operation for approximately 20 years, conducts pharmaceutically sponsored clinical trials, investigator initiated clinical trials, and assists with the design, planning and execution of clinical trials with collaborators.
The experience across the range of Clinical Trial Coordinators includes Division 1 Registered Nurses, Scientists, Diabetes Educators and a Bone Density Technologist.
The unit has designated clinical trial consulting space, waiting area, a laboratory that meets physical containment 2 requirements (PC2) and administrative areas. A range of equipment is available to conduct clinical trials, including equipment for clinical assessments, ECGs, venipuncture, IV infusions, centrifuges, fridge, -20oC and -80oC freezers.
The Barwon Health Pharmacy department manages the storage, accountability and dispensing of all investigational products for trials conducted within the unit.
The unit conducts both outpatient and inpatient trials accessing a wide range of participants across the Barwon South West region.
The CTU operates in accordance with the International Conference on Harmonisation Guidance on Good Clinical Practice (CPMP/ICH/135/95) and the National Statement of Ethical Conduct in Human Research and all staff have current GCP training.
Barwon Health has signed the memorandum of understanding to be part of the mutual acceptance of ethical review and the CTU regularly performs the role of lead site, with one of the investigators appointed Chief Principal Investigator (CPI) for centralised ethics submissions. The length of time to approval is depended on the ethics committee chosen for submission. Local governance approval is submitted in parallel with ethics, however governance approval can only be granted once final EC approval has been obtained. This takes up to 2 weeks.
Therapeutic Areas: Endocrinology, Infectious Diseases, Paediatrics