Details
- Organisation Name: Gold Coast Private Hospital
- HHS: N/A
- Services Offered: Early Phase, Clinical trials site
- Website Address: www.goldcoastprivatehospital.com.au
- Contact: Michelle Cestari- Michelle.Cestari@healthscope.com.au
- Other Affiliated Research Sites: All Healthscope Hospitals across Australia
Location
-27.960946403009714, 153.38409327671306
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
GCPH Clinical Trials Centre is a fully equipped site offering clinical project management workforce, remote monitoring capabilities and experienced principal investigators in all areas of medicine.
HREC
- HREC Committee Name: Gold Coast HHS HREC
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Sponsor Provided Central
- Mandate distribution of safety: No
- Meeting frequency: Monthly
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Sponsor Provided Central
- Mandate distribution of safety: No
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: N.A
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N.A
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, Vertical laminar flow hood (chemo/hazardous drugs), Glove box (non-vented), Horizontal laminar flow hood (non-hazardous drug preparation), Glove box (vented to outside)
- 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): 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
Study Types
Industry
Investigator
Source Document Types
Paper and Electronic
Has your Clinical Trials Site or Service been audited by:
Sponsor
Average time to start study (in calendar days)
30-60
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?
Yes
Does your Facility support in-patient admissions?
Yes
PK & PD specimens
Yes