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 Manager- GCHClinicalTrialServices@health.qld.gov.au
- Other Affiliated Research Sites: N/A
Location
-27.95859 - 153.38251
Initiating study activities approval
No
Review required
2 weeks
HREC
- HREC Committee Name: Gold Coast HHS HREC
- 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
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
Adult Coronary Syndrome
Anaemia
Anaemic Infarcts
Angina
Aortic
Arteriosclerosis
Atherosclerosis
Atrial Fibrillation
Atypical Haemolytic
Brain Ischemia
Cardiovascular Diseases
Chronic Heart Failure
Congestive Heart Failure
Coronary Artery Disease
Endocrinology
Hypotension
Infection and Inflammation
Interventional Cardiology and Cardiothoratics
Ischemic Heart Disease
Medical Devices
Mitral Valve Prolapse
Pericarditis
Phlebitis
Stroke
Thromboembolic Disease
Uremic Syndrome
Vascular Disease
Venous Thromboembolism
How long prior to HREC meeting does the application need to be submitted?
2 weeks
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
Interventional/Angio Suites and Operating Theatre
MAMMO Mammography
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MRS Magnetic Resonance Spectroscopy
NMED Nuclear medicine e.g. Bone scan
Perfusion CT
PET Positron Emission Tomography Scan
SPECT
Thallium cardiac stress test
Thyroid scan
X-Ray