Details
- Organisation Name: Wide Bay Hospital Health Service
- HHS: Wide Bay
- Services Offered: Clinical trials site;Investigator Initiated Trials;Satellite Site;Trial Patient Recruitment;Treatment of patients
- Website Address: www.health.qld.gov.au/services/widebay/wb-bundaberg
- Contact: Mr Darren Nicholls - [email protected]
- Other Affiliated Research Sites: Cancer Care Centre Hervey Bay
Location
-24.87291 - 152.32397
Initiating study activities approval
No
Review required
2 weeks
HREC
- HREC Committee Name: Metro North HREC A and B
- 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: 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;Others
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor
- EMR/EHR systems: In-house system;Others
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor
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
Allied Health
Basal Cell Carcinoma
Bladder Cancer
Bone Cancer
Brain Cancer
Breast Cancer
Cervical Cancer
Chronic Lymphocytic Leukaemia
Chronic Myelogenous Leukaemia
Colorectal Cancer
Follicular Lymphoma
Gastro Intestinal Solid Tumours
Haemic and Lymphatic Diseases
Head and Neck Cancer
Hepatocellular Carcinoma
Hereditary Angioedema
HR Prostate Cancer
Islet Cell Tumours
Liver Cancer
Lung Cancer
Lymphocytic Leukaemia
Lymphoma
Malignant Pleural Mesothelioma
Mantle Cell Lymphoma
Melanoma
Multiple Myeloma
Neoplasms
Neuroma
Non- Hodgkin's Lymphoma
Non-Small Cell Lung Cancer
Oncology
Ovarian Epithelial Carcinoma
Pancreatic Cancer
Prostate Cancer
Renal Cell Carcinoma
Sarcoma
Soft Tissues Sarcomas
Telemedicine
Source Document Types
Electronic
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
Yes
PK & PD specimens
Yes
Study Phase Capability
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
Adults 18 and onwards
Geriatrics 65 and onwards