Details
- Organisation Name: Queensland Eye Institute
- HHS: N/A
- Services Offered: Clinical trials site
- Website Address: www.qei.org.au
- Contact: clinical.trials@qei.org.au
- Other Affiliated Research Sites: N/A
Location
-27.49128433889171, 153.0346458615373
Is your Facility able to initiate study activities prior to Ethics Committee protocol approval?
No
How long before Ethics Committee review is the Submission Packet required?
1 week
Site Overview
QEI conducts clinical trials, both Sponsor and Investigator initiated, for a range of different ocular related pathologies.
HREC
- HREC Committee Name: Bellberry 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
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: Vertical laminar flow hood (chemo/hazardous drugs), Horizontal laminar flow hood (non-hazardous drug preparation); Extemporaneous 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): 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
Eye Diseases
Study Types
Academic
Industry
Investigator
Source Document Types
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?
1 week
Does the HREC committee require contract /budget approval prior to release final approval documents?
Yes
Does your Facility support in-patient admissions?
No
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
#N/A
Patient Population
Adults - Ages 18-64