Details
- Organisation Name: Queensland Children's Hospital
- HHS: Children's Health Queensland
- Services Offered: Clinical trials site; Investigator Initiated Trials; Trial Patient Recruitment; Treatment of
patients; Completion of study documentation as per ICH GCP, contract and, Preclinical device
design - Website Address: www.health.qld.gov.au/services/childrenshealthqld/childrenshealth-qch
- Contact: CHQ Clinical Trials Team- [email protected]
- Other Affiliated Research Sites: All Queensland hospitals; National and International
Location
-27.4837 - 153.02652
Initiating study activities approval
No
Review required
2 weeks
Site Overview
The Queensland Children's Hospital is a tertiary-level teaching hospital and offers the full range of specialist services for children and adolescents.
HREC
- HREC Committee Name: Children's Health Queensland 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: N/A
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? Yes
- Audit Type: N/A
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
Cardiovascular Diseases
Dermatology
Fragile X
Genetic Disease
Hypophosphatasia
Infection
Medicine
Metabolic Diseases
Sleep
Study Types
Academic
Industry
Investigator
Source Document Types
Paper and Electronic
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
Support in-patient admissions
Yes
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
Other
Patient Population
Paediatrics