Details
- Organisation Name: The Prince Charles Hospital
- HHS: Metro North
- 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.metronorth.health.qld.gov.au/tpch/
- Contact: Dr Sandra Miles - sandra.miles@health.qld.gov.au or sandra.miles@acu.edu.au
- Other Affiliated Research Sites: N/A
Location
-27.388642 - 153.022796
Initiating study activities approval
No
Review required
2 weeks
Site Overview
Located 8km from Royal Brisbane Womens Hospital . The Prince Charles Hospital is a major teaching hospital in Brisbane's northside with an emphasis in cardiac and respiratory medicine and cardio-thoracic surgery. It also has geriatric and rehabilitation services; elective orthopaedic services and cardiothoracic services; an in-patient psychiatric unit and a 16 bed palliative care unit.
HREC
- HREC Committee Name: Metro North HREC A and 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? No
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
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
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Quality
- EMR/EHR systems: In-house
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Quality
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): Yes
- 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): Yes
- 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
Nursing
Nursing Research
Wound care and Pressure injury prevention
Study Types
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
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 Pivotal
Phase II
Phase III
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
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
Adults 18 and onwards
Geriatrics 65 and onwards