Details
- Organisation Name: Gympie Hospital
- HHS: Sunshine Coast
- Services Offered: Clinical trials site; Investigator Initiated Trials; Satellite Site; Trial Patient Recruitment; Treatment of patients; Completion of study documentation as per ICH GCP and contract
- Website Address: www.health.qld.gov.au/services/sunshinecoast
- Contact: Ms Helen Rodgers - Helen.Rodgers2@health.qld.gov.au
- Other Affiliated Research Sites: Sunshine Coast University Hospital
Location
-26.18419 - 152.65832
Initiating study activities approval
No
Review required
1 week
Site Overview
Gympie Hospital provides acute regional services to approximately 21;000 residents in the Gympie; Cooloola and Kilkivan areas.
HREC
- HREC Committee Name: Metro North HREC A (MNHA), Metro North HREC B (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?
- Does the Facility have the ability to handle radio-labelled Investigational Products?
Equipment
- Investigational Product:
- Centrifuge: No
- Refrigerated Centrifuge: No
- Centrifuge: No
- Refrigerated Centrifuge: No
Patient Records
- Record Archiving:
- EMR/EHR systems:
- Has your Clinical Trial Site or Service been accredited?
- Audit Type: Other
- EMR/EHR systems:
- Has your Clinical Trial Site or Service been accredited?
- Audit Type: Other
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): No
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? No
- Does this equipment provide Min/Max Temperature Monitoring? Yes
- Do you have the ability to generate a temperature monitoring log for this equipment? No
- Does this equipment have a temperature alarm? No
- Do you have an SOP which supports calibration of this equipment? No
- Freezer (-20 to -30 Degrees C): No
- Investigational Freezer (-70 to -80 Degrees C): No
- Investigational Freezer (Liquid Nitrogen -135 Degrees C): No
- Does this equipment have back-up power? No
- Does this equipment provide Min/Max Temperature Monitoring? Yes
- Do you have the ability to generate a temperature monitoring log for this equipment? No
- Does this equipment have a temperature alarm? No
- Do you have an SOP which supports calibration of this equipment? No
Study Types
Academic
Industry
Investigator
Source Document Types
Paper
Average time to start study (in calendar days)
30-60
How long prior to HREC meeting does the application need to be submitted?
1 week
Support in-patient admissions
Yes
PK & PD specimens
No
Patient Population
Adults 18 and onwards
Geriatrics 65 and onwards