Details
- Organisation Name: Gold Coast University Hospital
- HHS: Gold Coast
- Services Offered: Clinical trials site; Investigator Initiated Trials; Satellite Site; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: www.health.qld.gov.au/services/goldcoast/gcoast_gcoast_hosp
- Contact: Nurse Research Manager- CBDclinicaltrials@health.qld.gov.au
- Other Affiliated Research Sites: Robina Hospital
Location
-27.95859 - 153.38251
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: Local;Central Acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local;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 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
Acquired Haemophilia
Acute Lymphoblastic Leukaemia
Acute Myelogenous Leukaemia
Aplastic Anaemia
Basal Cell Carcinoma
Bladder Cancer
Bone Cancer
Brain Cancer
Breast Cancer
Cervical Cancer
Chronic Lymphocytic Leukaemia
Chronic Myelogenous Leukaemia
Colorectal Cancer
Febrile Neutropenia
Follicular Lymphoma
Gastro Intestinal Solid Tumours
Gastrology
Haemic and Lymphatic Diseases
Haemophilia
Head and Neck
Head and Neck Cancer
Hepatocellular Carcinoma
Hereditary Angioedema
HR Prostate Cancer
Hypocalcaemia
Iron Deficiency Anaemia
Iron Overload
Islet Cell Tumours
Leukopenia
Liver
Liver Cancer
Lung
Lung Cancer
Lymphocytic Leukaemia
Lymphoma
Malignant Pleural Mesothelioma
Mantle Cell Lymphoma
Melanoma
Multiple Myeloma
Myelodysplastic Syndrome
Neoplasms
Neuroma
Non- Hodgkin's Lymphoma
Non-Small Cell Lung Cancer
Ovarian Cancer
Ovarian Epithelial Carcinoma
Pancreatic Cancer
Prostate Cancer
Refractory Anaemia
Renal Cell Carcinoma
Sarcoma
Sickle Cell Anaemia
Soft Tissues Sarcomas
Squamous & Non Squamous Sarcomas
Throat Cancer
Thrombocytopenia
Thyroid Cancer
Vasculitis
Study Types
Academic
Industry
Investigator
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
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
Other
Perfusion CT
PET Positron Emission Tomography Scan
SPECT
X-Ray