Details
- Organisation Name: Royal Brisbane and Women's Hospital
- HHS: Metro North
- Services Offered: Clinical trials site; Investigator Initiated Trials; Satellite Site; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: https://metronorth.health.qld.gov.au/rbwh/research/our-services/cahr
- Contact: Dr Adrienne Young- [email protected]
- Other Affiliated Research Sites: N/A
Location
-27.44627303451125, 153.02822471534208
Initiating study activities approval
No
Review required
2 weeks
Site Overview
The Royal Brisbane and Women's Hospital is a hospital located in Herston in Brisbane; Queensland; Australia. The hospital has 929 beds; and it is estimated that 65% of the patients served come from within 15 kilometres (9.3 min) of the hospital. It is the largest hospital in Queensland.
HREC
- HREC Committee Name: Metro North HREC A and B
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Cental acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Cental acting as Local
- 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: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: 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? Not Applicable
- Does the Facility have the ability to handle radio-labelled Investigational Products? Not Applicable
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: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Other
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: Other
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): No
- 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): No
- 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
Allied Health
Occupational Diseases
Study Types
Academic
Industry
Investigator
Source Document Types
Paper and Electronic
Average time to start study (in calendar days)
Greater than 120
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
Yes
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Patient Population
Adults 18 and onwards
Geriatrics 65 and onwards