Details
- Organisation Name: University of Sunshine Coast
- HHS: N/A
- Services Offered: Clinical trials site; GP trials; Trial Patient Recruitment; Completion of study documentation as per ICH GCP and contract
- Website Address: www.usc.edu.au/connect/usc-clinical-trials-centre
- Contact: Ms Jessica Baird- Jbaird@usc.edu.au
- Other Affiliated Research Sites: Other University of Sunshine Coast sites
Location
-26.711328 - 153.064315
Initiating study activities approval
No
Review required
2 weeks
Site Overview
Primary care trials. Our facility has three locations: at Sippy Downs on the Sunshine Coast, at Morayfield in the Moreton Bay Region and at Southbank in the Brisbane CBD
HREC
- HREC Committee Name: Bellberry
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Central Acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Central Acting as Local
- Mandate distribution of safety: Yes
Facility staffing and training
- Handling Investigational Product: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: Yes
Licenses to receive, store, dispense and return controlled substances
- Required Licenses or Registrations: Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? Yes
Equipment
- Investigational Product: Horizontal laminar flow hood (non-hazardous drug preparation)
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: In-house
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Other
- EMR/EHR systems: In-house
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Other
Investigational product storage Capabilities
- Refrigerator (2 to 8 Degrees C): Yes
- Freezer (-20 to -30 Degrees C): Yes
- Investigational Freezer (-70 to -80 Degrees C): Yes
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? Yes
- Does this equipment provide Min/Max Temperature Monitoring? Yes
- Do you have the ability to generate a temperature monitoring log for this equipment? Yes
- Does this equipment have a temperature alarm? Yes
- Do you have an SOP which supports calibration of this equipment? Yes
- Freezer (-20 to -30 Degrees C): Yes
- Investigational Freezer (-70 to -80 Degrees C): Yes
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? Yes
- Does this equipment provide Min/Max Temperature Monitoring? Yes
- Do you have the ability to generate a temperature monitoring log for this equipment? Yes
- Does this equipment have a temperature alarm? Yes
- Do you have an SOP which supports calibration of this equipment? Yes
Specialty Research Area
Bacterial Infections and Mycoses
Cardiovascular Diseases
Digestive System Diseases
Endocrine System Diseases
Eye Diseases
Female Urogenital Diseases and Pregnancy Complications
Haemic and Lymphatic Diseases
Immune System Diseases
Male Urogenital Diseases
Musculoskeletal Diseases
Nervous System Diseases
Nutritional and Metabolic Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Skin and Connective Tissue Diseases
Vaccine Development
Virus Diseases
Wounds and Injuries
Study Types
Academic
Industry
Source Document Types
Paper and Electronic
Average time to start study (in calendar days)
30-60
How long prior to HREC meeting does the application need to be submitted?
2 weeks
Support in-patient admissions
No
PK & PD specimens
Yes
Study Phase Capability
Phase I
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
DXA Dual-Energy X-ray Absorptiometry or Bone Densitometry
Other
X-Ray
Patient Population
Adults - Ages 18-64
Healthy Volunteers