Details
- Organisation Name: Royal Brisbane 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: www.metronorth.health.qld.gov.au/rbwh/
- Contact: Professor Leonie Callaway- leonie.callaway@health.qld.gov.au
- Other Affiliated Research Sites: N/A
Location
-27.446583 - 153.027796
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?
2 weeks
Site Overview
The RBWH is a tertiary referral teaching hospital; providing services to patients throughout the State; Northern New South Wales and the Northern Territory; incorporating all major health specialties including medicine; surgery; psychiatry; oncology; women's and newborn services; trauma services and more than 30 subspecialties
Women's and Newborn Services offer a diverse range of healthcare services to women and their babies across Queensland and beyond.
The service line is dedicated to quality multidisciplinary healthcare and is actively involved in the advancement in services in research and education and has a strong connection with multiple universities and training organisations in the provision of a tertiary service.
Women's and Newborn Services offer a diverse range of healthcare services to women and their babies across Queensland and beyond.
The service line is dedicated to quality multidisciplinary healthcare and is actively involved in the advancement in services in research and education and has a strong connection with multiple universities and training organisations in the provision of a tertiary service.
HREC
- HREC Committee Name: Metro North 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
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? Yes
- Does the Facility have the ability to handle radio-labelled Investigational Products? Yes
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): 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
Cystitis
Endometriosis
Female Urogenital Diseases and Pregnancy Complications
Fertility
Gynaecology
Neonatal Obstetrics
Obstetric Medicine
Study Types
Academic
Industry
Investigator
Source Document Types
Paper and Electronic
Has your Clinical Trials Site or Service been audited by:
Sponsor
Average time to start study (in calendar days)
61-90
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
Does your Facility support in-patient admissions?
Yes
PK & PD specimens
Yes
Study Phase Capability
Phase II
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
MRI Magnetic Resonance Imaging
PET Positron Emission Tomography Scan
X-Ray
Patient Population
Pediatrics - Less than or equal to 17
Adolescents/Adults 16 and onwards
Adults - Ages 18-64