Details
- Organisation Name: Sunshine Coast University Hospital
- HHS: Sunshine 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/sunshinecoast/services-and-facilities/facilities/…
- Contact: Clinical Trials Team– sc-research-admin@health.qld.gov.au
- Other Affiliated Research Sites: Only Sunshine Coast HHS facilities
Location
-26.746786 - 153.113756
Initiating study activities approval
No
Review required
2 weeks
Site Overview
Sunshine Coast Hospital and Health Service (SCHHS) is the major provider of public health services, health education and research in the Sunshine Coast, Gympie, and Noosa local government areas. The Health Service comprises of 5 hospitals, Sunshine Coast University Hospital, Nambour General Hospital, Gympie Hospital, Maleny Soldiers Memorial Hospital and Caloundra Health Service. SCHHS covers about 10,020 square kilometres, providing health services to both coastal and hinterland areas with a population of over 400,000. The Clinical Research Unit manages commercially sponsored, collaborative group and investigator led trials across all disciplines of medicine. The Unit manages many clinical trials across various disciplines of medicine. It is staffed by a team of Study Coordinator Nurses who provide holistic management of clinical trials. In addition we have a large Oncology Trials unit that covers medical , radiation and haematology trials . This unit is also staffed with a team of Study Coordinator nurses.
HREC
- HREC Committee Name: All NMA HRECs
- 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
Diabetes
Endocrine
Endocrine System Diseases
Endocrinology
Insulin
Thryroid
Study Types
Industry
Investigator
Source Document Types
Paper and 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?
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
Phase II
Phase III
Type of Diagnostic Equipment
DXA Dual-Energy X-ray Absorptiometry or Bone Densitometry
ECG/EKG Electrocardiogram
FLRO Fluoroscopy
MAMMO Mammography
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
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
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards