Details
- Organisation Name: Griffith University Clinical Trial Unit
- HHS: N/A
- 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/griffith-health/clinical-trial-unit
- Contact: Prof Evelin Tiralongo - clinicaltrialunit@griffith.edu.au
- Other Affiliated Research Sites: N/A
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? No
- EMR/EHR systems: Others
- Has your Clinical Trial Site or Service been accredited? No
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? 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): 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
Acute and Chronic Cardiac Diseases
Aged
Allergic Rhinitis
Allergy
Allied Health
Alzheimers
Amyloidosis
Anxiety
Arrhythmia
Arteriosclerosis
Asthma
Atherosclerosis
Atrial Fibrillation
Autoimmune
Back and Neck Pain
Bacterial Infections
Bacterial Infections and Mycoses
Benign Prostatic Hyperplasia
Cardiac
Cardiac Devices
Cardiology
Cardiovascular
Cardiovascular Diseases
Congestive Heart Failure
Coronary Artery Disease
Crohn's Disease
Cystic Fibrosis
Cystitis
Cytomegalovirus
Dementia
Dementia and Ageing
Depression
Depression and Anxiety
Devices
Diabetes
Diabetic Kidney Disease
Digestive System Diseases
Diverticulitis
Ear Nose Throat (ENT)
Early Onset Dementia
Emphysema
Endocrine
Endocrine System Diseases
Endocrinology
Endometriosis
Eye Diseases
Female
Female Urogenital Diseases and Pregnancy Complications
Frontotemporal Dementia
Gastro Oesophageal Refulx Disease (GERD)
Gastroenterology
Gastroenterology Hepatology
General Medicine
Genetic Disease
Geriatric Medicine
Glomerulonephritis
Gynaecology
Heart Failure
Hepatic
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatology
Herpes Zoster
Human Papilloma Virus
Hypertension
Hypotension
Idiopathic Pulmonary Fibrosis
Immune System Diseases
Infection
Infection and Inflammation
Infectious
Infectious Diseases
Inflammatory Bowel
Inflammatory Bowel Diseases
influenza
Insulin
Iron Deficiency Anaemia
Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS)
Ischemic Heart Disease
Joint
Kidney Disease
Kidney Health and Nephrology
Kidneys
Liver
Liver Disease
Lung and Allergy
Medical Devices
Mental Disorders
Mental Health Psychiatry and CNS
Metabolic Diseases
Migraine
Mild Cognitive Impairment
Muscle/Tendon Strain
Musculoskeletal Diseases
Mycoses
NASH
Nephrology
Nephrology Renal And Urology
Nervous System Diseases
Neurological
Neurology
Nutrition
Nutritional and Metabolic Diseases
Older Persons
Ophthalmology
Orthopaedics
Outpatient Clinics
Pain
Pericarditis
Pneumonia
Psychiatry
Renal
Renal Medicine
Renal Research
Respiratory
Respiratory and Sleep
Respiratory Tract Diseases
Rheumatoid
Rheumatoid Arthritis
Rheumatology
Seasonal Flu
Sexual Diseases
Sexual Health
Sinusitis
Skin and Connective Tissue Diseases
Sleep
Strep
Telehealth
Telemedicine
Teletrials
Thryroid
Upper GI Disorders
Urinary Tract Infection
Urinary Tract Infections
Vaccine Development
Vaccines
Virology
Virus Diseases
Women
Wound care and Pressure injury prevention
Study Types
Industry
Investigator
Source Document Types
Paper and Electronic
Has your Clinical Trials Site or Service been audited by:
Sponsor
TGA
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
No
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