Details
- Organisation Name: Royal Brisbane and Women's Hospital-Cancer Care Services
- 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.health.qld.gov.au/haemophilia/html/services
- Contact: Ms Robyn Western- [email protected]
- Other Affiliated Research Sites: The Prince Charles Hospital & Caboolture Hospital & Redcliffe Hospital & Toowong & Princess Alexandra Hospital & Mount Isa Hospital & Townsville Hospital & Gin Gin & Hervey Bay Hospital & Sunshine Coast University Hospital & Bundaberg Hospital. Research Partner Collaborations with QIMR Berghofer, University of Queensland, Herston Imaging Research Facility, the Australasian Leukaemia and Lymphoma group
Location
-27.446583 - 153.027796
Initiating study activities approval
No
Review required
2 weeks
Site Overview
The Queensland Haemophilia Centre is a state-wide service based at the Royal Brisbane and Women's Hospital and it is closely associated with a similar service at the Queensland Children's Hospital. The Centre provides multidisciplinary care for those with Haemophilia, Von Willebrand disease and other inherited bleeding disorders. Haemophilia is an inherited bleeding disorder where the blood doesn't clot properly. It is caused when blood does not have enough clotting factor - a protein in blood that controls bleeding.
- Haemophilia A is the most common form, and is caused by having low levels of factor VIII (8)
- Haemophilia B is caused by having low levels of factor IX (9).
The Haematolofy and Bone Marrow Transplant Department Specialty Research Areas include: Malignant and Non-Malignant Haematology including but not limited to Hodgkins Disease, Non Hodgkins-Lymphoma, Multiple Myeloma, Acquired Haemophilia, Acute and Chronic Leukaemia's, Myelodysplastic Syndrome, Myeloproliferative Diseases, Cellular Therapy, GVHD.
Research Partner Collaborations include QIMR Berghofer, UQ, Herston Imaging Research Facility, the Australasian Leukaemia and Lymphoma Group and other medical and allied health teams within RBWH and from other health districts.
- Haemophilia A is the most common form, and is caused by having low levels of factor VIII (8)
- Haemophilia B is caused by having low levels of factor IX (9).
The Haematolofy and Bone Marrow Transplant Department Specialty Research Areas include: Malignant and Non-Malignant Haematology including but not limited to Hodgkins Disease, Non Hodgkins-Lymphoma, Multiple Myeloma, Acquired Haemophilia, Acute and Chronic Leukaemia's, Myelodysplastic Syndrome, Myeloproliferative Diseases, Cellular Therapy, GVHD.
Research Partner Collaborations include QIMR Berghofer, UQ, Herston Imaging Research Facility, the Australasian Leukaemia and Lymphoma Group and other medical and allied health teams within RBWH and from other health districts.
HREC
- HREC Committee Name: MNHA and MNHB
- 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
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
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
Acquired Haemophilia
Acute Lymphoblastic Leukaemia
Acute Myelogenous Leukaemia
Chronic Lymphocytic Leukaemia
Chronic Myelogenous Leukaemia
Haematologic Malignancies
Haematology
Haematology and Palliative Care
Haemic and Lymphatic Diseases
Haemophilia
Leukaemia
Leukemia
Leukopenia
Lymphocytic Leukaemia
Lymphoma
Mantle Cell Lymphoma
Medical Oncology and Haematology
Multiple Myeloma
Myelodysplastic Syndrome
Myeloma
Non- Hodgkin's Lymphoma
Oncology and Haematology
Oncology Malignances
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 I
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
FLRO Fluoroscopy
MRI Magnetic Resonance Imaging
MRS Magnetic Resonance Spectroscopy
Perfusion CT
PET Positron Emission Tomography Scan
SPECT
X-Ray
Patient Population
Adults - Ages 18-64