Details
- Organisation Name: Translational Research Institute
- HHS: N/A
- Services Offered: Pre-clinical device design, Early Phase, Complementary medicines clinical trials, Clinical trials site, Pre-clinical, GP trials, Phase 1 unit, Bench research, Investigator Initiated Trials, Satellite Site, Trial Patient Recruitment, Treatment of patients, Completion of study documentation as per ICH GCP and contract
- Website Address: www.tri.edu.au/
- Contact: [email protected]
- Other Affiliated Research Sites: Yes
Location
-27.49863116542877, 153.031237842328
Initiating study activities approval
No
Review required
2 weeks
Site Overview
Translational Research Institute (TRI) has two multi-purpose clinical research facilities, the Clinical Research Facility (CRF) and TRI@Childrens (TRIC). The TRI CRF is located on the Princess Alexandra Hospital campus. TRIC is located at the Centre for Children's Health Research on the Queensland Children's Hospital Campus. These facilities are specifically designed for the conduct of adult and paediatric human research in controlled safe environments.
The TRI Translational Trials team are clinical research professionals dedicated to advancing clinical trials. Our services include feasibility assessment, protocol development, Ethics and Governance submissions, budget negotiations and the full conduct of clinical trials by our nursing, project management, pharmacy and laboratory staff.
The TRI Translational Trials team are clinical research professionals dedicated to advancing clinical trials. Our services include feasibility assessment, protocol development, Ethics and Governance submissions, budget negotiations and the full conduct of clinical trials by our nursing, project management, pharmacy and laboratory staff.
HREC
- HREC Committee Name: N/A
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local
- Mandate distribution of safety: No
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local
- Mandate distribution of safety: No
Facility staffing and training
- Handling Investigational Product:
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site:
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site:
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: Extemporaneous Preparation, Vertical laminar flow hood (chemo/hazardous drugs), Glove box (non-vented), Horizontal laminar flow hood (non-hazardous drug preparation), Glove box (vented to outside)
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving:
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? No
- Audit Type:
- EMR/EHR systems: Other
- Has your Clinical Trial Site or Service been accredited? No
- Audit Type:
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
General Medicine
Respiratory Tract Diseases
Signs and Symptoms
Skin and Connective Tissue Diseases
Stomatognathic Diseases
Virus Diseases
Wounds and Injuries
Study Types
Academic
Government
Industry
Investigator
Source Document Types
Paper and Electronic
Average time to start study (in calendar days)
Less than 30
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
Device Pivotal
Device Post Approval
Phase I
Phase II
Phase III
Phase IV
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
MRA Magnetic Resonance Angiography
MRI Magnetic Resonance Imaging
MRS Magnetic Resonance Spectroscopy
NMED Nuclear medicine e.g. Bone scan
Perfusion CT
PET Positron Emission Tomography Scan
SPECT
Thallium cardiac stress test
Thyroid scan
X-Ray
Patient Population
Paediatrics
Adolescents/Adults 16 and onwards
Adults 18 and onwards
Geriatrics 65 and onwards