Details
- Organisation Name: Griffith University Clinical Trial Unit
- HHS: Gold Coast
- Services Offered: Clinical trials site; Complementary medicines clinical trials; Pre-clinical; GP trials; Bench research; Investigator Initiated Trials; Trial Patient Recruitment; Treatment of patients
- Website Address: www.griffith.edu.au/health/clinical-trial-unit
- Contact: Prof Evelin Tiralongo - e.tiralongo@griffith.edu.au
- Other Affiliated Research Sites: GCUH
Location
-27.959961 - 153.378683
Initiating study activities approval
Yes
Review required
1 week
Site Overview
Griffith University's Clinical Trial Unit comprises state-of-the-art facilities, GCP aligned facilities for phase I-IV clinical trials. As a Core Research Facility of Griffith University it supports staff and collaborators to conduct their trials. It also provides professional services to commercial clients such as the biotech, pharmaceutical, nutraceutical and complementary medicine industry across a wide range of therapeutic areas.
HREC
- HREC Committee Name: Belberry HREC
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Central Acting as Local; Sponsor Provided Central
- Mandate distribution of safety: Yes
- Meeting frequency: Weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: 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: Not Applicable
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: Not Applicable
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?
- Does the Facility have the ability to handle radio-labelled Investigational Products?
Equipment
- Investigational Product:
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: Others
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Sponsor
- EMR/EHR systems: Others
- 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): No
- Does this equipment have back-up power? Yes
- Does this equipment provide Min/Max Temperature Monitoring? No
- Do you have the ability to generate a temperature monitoring log for this equipment? No
- 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): No
- Does this equipment have back-up power? Yes
- Does this equipment provide Min/Max Temperature Monitoring? No
- Do you have the ability to generate a temperature monitoring log for this equipment? No
- 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
Digestive System Diseases
Endocrine System Diseases
Female Urogenital Diseases and Pregnancy Complications
Haemic and Lymphatic Diseases
Immune System Diseases
Male Urogenital Diseases
Musculoskeletal Diseases
Respiratory Tract Diseases
Virus Diseases
Wounds and Injuries
Study Types
Industry
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?
1 week
Support in-patient admissions
Yes
PK & PD specimens
Yes
Study Phase Capability
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
NMED Nuclear medicine e.g. Bone scan
PET Positron Emission Tomography Scan
SPECT
Thallium cardiac stress test
Thyroid scan
X-Ray
Patient Population
Healthy Volunteers