Details
- Organisation Name: Metro South Health
- HHS: Metro South
- Services Offered: Investigator Initiated Trials; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: www.metrosouth.health.qld.gov.au/princess-alexandra-hospital
- Contact: [email protected]
- Other Affiliated Research Sites: PAH
Location
-27.49737 - 153.03352
Initiating study activities approval
Yes
Review required
2 weeks
Site Overview
Princess Alexandra Hospital is a tertiary health care centre; providing care in most major adult specialties. One of Australia's leading academic and research health centres. Provide acute medical; surgical; mental health; cancer; rehabilitation and allied health services. Nationally recognised for expertise in trauma management and a major transplantation centre for livers; kidneys; bone; cartilage; and corneas. Responsibility for a number of state-wide services including: Acquired Brain Injury Outreach Service Queensland Spinal Cord Injury Service Queensland Liver Transplant Service Queensland Eye Bank Queensland Bone Bank. Aeromedical retrieval service which transports patients to hospital via helicopter or fixed wing aircraft; a road accident response service and a major trauma retrieval service managed by our Emergency Department and Intensive Care Unit.
HREC
- HREC Committee Name: Metro South HHS HREC
- 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):
- 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):
- 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
ADHD (Attention Deficit Hyperactivity Disorder)
Alzheimers
Anxiety
Bipolar Disorder
Dementia
Depression
Mental Disorders
Migraine
Schizophrenia
Smoking Addiction
Substance Abuse
Study Types
Academic
Industry
Investigator
Source Document Types
Electronic
Paper and Electronic
Has your Clinical Trials Site or Service been audited by:
Sponsor
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
No
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
MRI Magnetic Resonance Imaging
Other
X-Ray
Patient Population
Adults 18 and onwards