Details
- Organisation Name: Torres and Cape HHS
- HHS: Torres Cape
- Services Offered: Clinical Trial Site; Clinical Trial Administration
- Website Address: www.health.qld.gov.au/services/torres-cape/capeyork_weipa_hosp
- Contact: TCHHS-clinical-trials@health.qld.gov.au
- Other Affiliated Research Sites: Townsville
Location
-12.6248 - 141.8774
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
Weipa is a multipurpose health service facility providing 24-hour inpatient; outpatient; residential aged care; emergency and primary healthcare services. Located 815km from Cairns Hospital.
HREC
- HREC Committee Name: N/A
- Meeting frequency: N/A
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: N/A
- Mandate distribution of safety: N/A
- Meeting frequency: N/A
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: N/A
- Mandate distribution of safety: N/A
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: Extemporaneous Preparation
- Centrifuge: Yes
- Refrigerated Centrifuge: No
- Centrifuge: Yes
- Refrigerated Centrifuge: No
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): No
- 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): No
- 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
Telehealth
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 your Facility support in-patient admissions?
Yes
PK & PD specimens
Yes
Study Phase Capability
Phase II
Phase III
Type of Diagnostic Equipment
Other
Patient Population
Adults - Ages 18-64
Geriatrics 65 and onwards