Details
- Organisation Name: Caloundra Hospital
- HHS: Sunshine Coast
- Services Offered: Clinical trials site; Investigator Initiated Trials; 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
- Contact: Ms Helen Rodgers- helen.rodgers2@health.qld.gov.au
- Other Affiliated Research Sites: Sunshine Coast University Hospital
Location
-26.8002 - 153.1207
Initiating study activities approval
No
Review required
1 week
Site Overview
Caloundra Health Service is located in the southern end of the Sunshine Coast Hospital and Health Service region; approximately 8km southeast of the Sunshine Coast University Hospital (SCUH) and 40km south of Nambour General Hospital; with a population of approximately 42;000
HREC
- HREC Committee Name: Metro North HREC B
- 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: 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:
- 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: Internal
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Internal
Investigational product storage Capabilities
- Refrigerator (2 to 8 Degrees C): Yes
- Freezer (-20 to -30 Degrees C): No
- Investigational Freezer (-70 to -80 Degrees C): No
- 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): No
- Investigational Freezer (-70 to -80 Degrees C): No
- 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
Palliative Care & Renal
Renal
Study Types
Academic
Industry
Investigator
Source Document Types
Paper
Average time to start study (in calendar days)
Greater than 120
How long prior to HREC meeting does the application need to be submitted?
1 week
Support in-patient admissions
Yes
PK & PD specimens
No
Study Phase Capability
Phase II
Phase III
Patient Population
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards