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 - [email protected]
- 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? No
- Does the Facility have the ability to handle radio-labelled Investigational Products? No
Equipment
- Investigational Product: N/A
- 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
Specialty Research Area
Bacterial Infections and Mycoses
Cardiovascular Diseases
Digestive System Diseases
Endocrine System Diseases
Male Urogenital Diseases
Musculoskeletal Diseases
Nervous System Diseases
Nutritional and Metabolic Diseases
Occupational Diseases
Renal
Respiratory Tract Diseases
Virus Diseases
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
Study Phase Capability
Phase II
Phase III
Type of Diagnostic Equipment
CT Scan Computerized Tomography Scan
ECG/EKG Electrocardiogram
MRI Magnetic Resonance Imaging
Other
X-Ray
Patient Population
Adults 18 and onwards
Geriatrics 65 and onwards