Details
- Organisation Name: The Prince Charles Hospital
- HHS: Metro North
- 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.metronorth.health.qld.gov.au/tpch/
- Contact: Ms Maricel Roxas- [email protected]
- Other Affiliated Research Sites: RBWH
Location
-27.388547 - 153.02271
Initiating study activities approval
No
Review required
2 weeks
Site Overview
The Cardiology Clinical Research Centre (CCRC) is one of the leading sites in Australia for coordinating and conducting clinical trials and investigator initiated research. . The Cardiology Research team is comprised of experienced and dynamic Cardiologists encompassing all cardiac sub-specialities; Clinical Research Nurse Coordinators and Administration Officers.
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: 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): 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
Acute Coronary Syndrome
Adult Coronary Syndrome
Anaemia
Anaemic Infarcts
Angina
Aortic
Arteriosclerosis
Atherosclerosis
Atrial Fibrillation
Atypical Haemolytic
Brain Ischemia
Cardiology
Cardiovascular Diseases
Chronic Heart Failure
Congestive Heart Failure
Coronary Artery Disease
Heart Failure
Hypotension
Ischemic Heart Disease
Mitral
Mitral Valve Prolapse
Pericarditis
Phlebitis
Stroke
Structured Heart
Thromboembolic Disease
Transcather Implantation
Tricuspid Valves LAA Occluders
Uremic Syndrome
Vascular Disease
Venous Thromboembolism
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
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MRS Magnetic Resonance Spectroscopy
Other
Patient Population
Adults 18 and onwards
Geriatrics 65 and onwards