Details
- Organisation Name: Gold Coast University Hospital
- HHS: Gold Coast
- Services Offered: Clinical trials site; Investigator Initiated Trials; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: www.goldcoast.health.qld.gov.au/hospitals-and-centres/gold-coast-univer…
- Contact: Nurse Research Manger- GCHClinicalTrialServices@health.qld.gov.au
- Other Affiliated Research Sites: N/A
Location
-27.958375 - 153.38178
Initiating study activities approval
No
Review required
2 weeks
HREC
- HREC Committee Name: Gold Coast HHS
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Central Acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: Monthly
- 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: Vertical laminar flow hood (chemo/hazardous drugs);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 system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor, TGA
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor, TGA
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
Cytomegalovirus
Hepatitis A
Herpes Simplex
Herpes Zoster
HIV – AIDS
HMT1
Human Papilloma Virus
Infectious Diseases
Mycoses
Parasitic Diseases
Seasonal Flu
Vaccines
Study Types
Academic
Industry
Investigator
Source Document Types
Electronic
How long prior to HREC meeting does the application need to be submitted?
2 weeks
Support in-patient admissions
Yes
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
ECG/EKG Electrocardiogram
FLRO Fluoroscopy
MAMMO Mammography
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MRS Magnetic Resonance Spectroscopy
NMED Nuclear medicine e.g. Bone scan
Other
Perfusion CT
PET Positron Emission Tomography Scan
SPECT
Thallium cardiac stress test
Thyroid scan
X-Ray
Patient Population
Paediatrics
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards