Details
- Organisation Name: Cairns Hospital
- HHS: Cairns
- Services Offered: Clinical trials site, Satellite Site, Completion of study documentation as per ICH GCP and contract
- Website Address: www.health.qld.gov.au/services/cairns-hinterland/cairns_cairns_hosp
- Contact: Research Manager- [email protected]
- Other Affiliated Research Sites: Townsville
Location
-16.9124 - 145.76831
Initiating study activities approval
No
Review required
Greater than 2 weeks
Site Overview
The Clinical Research Unit conducts clinical trials for Cardiology, Respiratory, Oncology. Renal, Emergency, Infectious Diseases, Intensive care, Sexual health and diabetes also conduct clinical trials.
HREC
- HREC Committee Name: Far North Queensland Human Research Ethics Committee
- Meeting frequency: Every 5 weeks
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Central Acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: Every 5 weeks
- 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: No
- Include GCP:
- Facility written sop during transportation to satellite site: N/A
- Training program for the research staff: No
- Include GCP:
- Facility written sop during transportation to satellite site: N/A
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? No
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
Equipment
- Investigational Product: Vertical laminar flow hood (chemo/hazardous drugs)
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving:
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: FDA ( Food Drug Administration), CRO ( Clinical Research Organisation), Sponsor
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: FDA ( Food Drug Administration), CRO ( Clinical Research Organisation), 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
Cardiovascular Diseases
General Medicine
Neoplasms
Nutritional and Metabolic Diseases
Respiratory Tract Diseases
Virus Diseases
Study Types
Academic
Industry
Investigator
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?
Greater than 2 weeks
Does the HREC committee require contract /budget approval prior to release final approval documents?
No
Support in-patient admissions
No
PK & PD specimens
Yes
Study Phase Capability
Device Pilot
Device Pivotal
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
MAMMO Mammography
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
NMED Nuclear medicine e.g. Bone scan
PET Positron Emission Tomography Scan
Thallium cardiac stress test
Thyroid scan
X-Ray
Patient Population
Adults 18 and onwards