Details
- Organisation Name: Sunshine Coast University Hospital
- HHS: Sunshine Coast
- Services Offered: Preclinical device design; Clinical trials site; Bench research; 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/sunshinecoast/university-hospital
- Contact: [email protected]
- Other Affiliated Research Sites: Nambour Hospital;Royal Brisbane and Women's Hospital;Queensland Children's Hospital
Location
-26.74542 - 153.11354
Initiating study activities approval
No
Review required
Greater than 2 weeks
Site Overview
Sunshine Coast University Hospital (SCUH) is a tertiary; teaching hospital servicing all parts of the Sunshine Coast and Gympie regions. SCUH saw its first patients on 21 March 2017 and was officially opened on 19 April 2017 by the Queensland Premier and Minister for Health and Minister for Ambulance Services. Active member of the ANZICS Clinical Trials Group (ANZICS CTG)
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
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor
- EMR/EHR systems: In-house system
- 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
Bacterial Infections and Mycoses
Cardiovascular Diseases
Chemically-induced Disorders
Critical Care
ICU
Respiratory Tract Diseases
Sedation
Sepsis
Trauma
Virus Diseases
Study Types
Academic
Industry
Investigator
Source Document Types
Electronic
Average time to start study (in calendar days)
Greater than 120
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?
Yes
Support in-patient admissions
Yes
PK & PD specimens
Yes
Study Phase Capability
Device Pilot
Device Pivotal
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