Details
- Organisation Name: Cairns Hospital
- HHS: Cairns & Hinterland Hospital and Health Service
- Services Offered: Clinical Research Unit
- Website Address: www.health.qld.gov.au/services/cairns-hinterland/cairns_cairns_hosp
- Contact: Clinical Research Unit - Nurse Unit Manager- CairnsCRU@health.qld.gov.au
- Other Affiliated Research Sites: Townsville
Location
-16.9124 - 145.76831
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 Clinical Research Unit supports the Teletrials model across many disciplines and can act as the Primary or Satellite site.
HREC
- HREC Committee Name: Far North Queensland Human Research Ethics Committee
- Meeting frequency: 5 weekly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Central Acting as Local
- Mandate distribution of safety: Yes
- Meeting frequency: 5 weekly
- 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? No
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
Equipment
- Investigational Product: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes
Patient Records
- Record Archiving: Yes
- EMR/EHR systems: Yes
- Has your Clinical Trial Site or Service been accredited? Yes
- EMR/EHR systems: Yes
- 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): No
- Investigational Freezer (-70 to -80 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): No
- Investigational Freezer (-70 to -80 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
#N/A
Study Types
Academic
Industry
Investigator
Has your Clinical Trials Site or Service been audited by:
Other
Average time to start study (in calendar days)
91-120
Does the HREC committee require contract /budget approval prior to release final approval documents?
Yes
Does your Facility support in-patient admissions?
No
PK & PD specimens
Yes
Study Phase Capability
Device Pilot
Device Pivotal
Device Post Approval
Phase II
Phase III
Phase IV
Type of Diagnostic Equipment
#N/A
Patient Population
All age groups