Details
- Organisation Name: University of Queensland
- HHS: N/A
- Services Offered: Clinical trials site, Pre-clinical, Phase 1 unit
- Website Address: www.uqccr.uq.edu.au
- Contact: Chris Shannon- [email protected]
- Other Affiliated Research Sites: N/A
Location
-27.44841401091926, 153.02854474232797
Initiating study activities approval
No
Review required
2 weeks
Site Overview
UQCCR is a state-of-the-art research facility located within the Herston Health Precinct in Brisbane, Queensland, which includes the Royal Brisbane and Women's Hospital (RBWH), one of Australia's largest, the Pathology Queensland Central Laboratory, NATA accredited laboratories and uniquely co-located with Herston Imaging Research Facility (HIRF).
UQCCR provides space and equipment to support researchers and industry partners to deliver on the four major clinical research themes of: Clinical Neurosciences, Fertility, women's Cancer and Infectious Diseases.
UQCCR 's purpose-built clinical research facility which facilitates ICH-GCP aligned phase II to phase IV investigator initiated and commercially sponsored clinical trials for investigation medicinal product, device and health-intervention trials. In addition to hosting research-based outpatient clinics, and research projects, the Clinical Research Facility facilitates trial design, protocol and database development and supports research ethics, governance and regulatory applications within Queensland Health, The University of Queensland. and TGA. The UQCCR clinical research team have the knowledge and
proven track record of conducting high impact national and international randomised clinical trials with professional services to meet internal and external client's needs.
UQCCR supports a dynamic research culture, and is equipped with a range of facilities, interdisciplinary teams purpose-fit, with proximity to specialty services for clinical trial conduct. Co-location and accessibility to specialist services and expertise facilitates bespoke project delivery within a framework of
governance and quality.
UQCCR provides space and equipment to support researchers and industry partners to deliver on the four major clinical research themes of: Clinical Neurosciences, Fertility, women's Cancer and Infectious Diseases.
UQCCR 's purpose-built clinical research facility which facilitates ICH-GCP aligned phase II to phase IV investigator initiated and commercially sponsored clinical trials for investigation medicinal product, device and health-intervention trials. In addition to hosting research-based outpatient clinics, and research projects, the Clinical Research Facility facilitates trial design, protocol and database development and supports research ethics, governance and regulatory applications within Queensland Health, The University of Queensland. and TGA. The UQCCR clinical research team have the knowledge and
proven track record of conducting high impact national and international randomised clinical trials with professional services to meet internal and external client's needs.
UQCCR supports a dynamic research culture, and is equipped with a range of facilities, interdisciplinary teams purpose-fit, with proximity to specialty services for clinical trial conduct. Co-location and accessibility to specialist services and expertise facilitates bespoke project delivery within a framework of
governance and quality.
HREC
- HREC Committee Name: MNHHS-RBWH, TPCH, Children's Health Queensland HHS, UQ - UQR & I, Office of Research and Ethics
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local, Sponsor Provided Central
- Mandate distribution of safety: Yes
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local, Central Acting as Local, Sponsor Provided Central
- 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: N/A
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N/A
Licenses to receive, store, dispense and return controlled substances
- Required Licenses or Registrations: No
- 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: Other
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor
- EMR/EHR systems: Other
- 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): 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
Bacterial Infections and Mycoses
Cardiovascular Diseases
Chemically-induced Disorders
Endocrine System Diseases
Immune System Diseases
Mental Disorders
Musculoskeletal Diseases
Neoplasms
Nervous System Diseases
Otorhinolaryngologic Diseases
Parasitic Diseases
Respiratory Tract Diseases
Virus Diseases
Wounds and Injuries
Source Document Types
Paper and Electronic
Average time to start study (in calendar days)
61-90
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?
No
Support in-patient admissions
No
PK & PD specimens
Yes
Study Phase Capability
Device Pilot
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MAMMO Mammography
MRI Magnetic Resonance Imaging
Other
Perfusion CT
PET Positron Emission Tomography Scan
X-Ray
Patient Population
Geriatrics 65 and onwards
Adolescents/Adults 16 and onwards
Adults 18 and onwards