Details
- Organisation Name: Royal Brisbane and Women's Hospital
- HHS: Metro North
- Services Offered: Clinical trials site; Investigator Initiated Trials; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: www.metronorth.health.qld.gov.au/researc
- Contact: Ms Susan Heggie - Susan.Heggie@health.qld.gov.au
- Other Affiliated Research Sites: N/A
Location
-27.446135 - 153.027784
Initiating study activities approval
No
Review required
2 weeks
Site Overview
Motor Neurone Disease Research conducts both investigator-led and clinical trails research in motor neurone disease within the Neurology Department; Royal Brisbane and Women's Hospital under Neurologist A/Prof. Robert Henderson and Prof. Pam McCombe.
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
- 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): 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
Chronic Idiopathic Demyelinating Polyneuropathy
Motor Neurone Disease
Musculoskeletal Diseases
Nervous System Diseases
Neurology
Other Neurological Condition including Pompe Disease
Study Types
Academic
Industry
Investigator
Source Document Types
Paper and Electronic
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
Patient Population
Adults 18 and onwards