Details
- Organisation Name: Sunshine Coast University Private Hospital
- HHS: N/A
- Services Offered: Clinical trials site; Trial Patient Recruitment; Completion of study documentation as per ICH GCP and contract
- Website Address: www.sunshinecoastuniversityprivate.com.au/For-Doctors/Clinical-Trials
- Contact: clinicaltrials.scu@ramsayhealth.com.au
- Other Affiliated Research Sites: Ramsay Healthcare
Location
-26.744073 - 153.114366
Initiating study activities approval
Yes
Review required
2 weeks
Site Overview
The Clinical Trials Unit at the Sunshine Coast University Private Hospital (SCUPH) is part of the Ramsay Clinical Trials Network; which includes a number of Ramsay private hospitals. SCUPH offers a comprehensive range of inpatient and day services across a wide range of specialties. Medical consulting suites are located onsite together with pharmacy; pathology; radiology and cardiology services. Particular trial areas of interest include Oncology; Haematology; Cardiology and Gastroenterology.
HREC
- HREC Committee Name: Other
- 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: Not Applicable
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: Not Applicable
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: Vertical laminar flow hood (chemo/hazardous drugs)
- 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: Other
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Other
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
Digestive System Diseases
Neoplasms
Study Types
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?
2 weeks
Support in-patient admissions
No
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MAMMO Mammography
MRI Magnetic Resonance Imaging
Other
X-Ray
Patient Population
Adults 18 and onwards