Coral Sea Clinical Research Institute

-21.1276,149.1658

No

2 weeks

Coral Sea Clinical Research Institute is a clinical research facility in Northern Queensland. Specialising in Phase II and III Gastroenterology trials, Coral Sea Clinical Research Institute work alongside a team of leading, internationally recognised Gastroenterologists to deliver high quality clinical trials.
CSCRI conducts all trials in alignment with ICH Good Clinical Practice and in accordance with local, national and international guidelines and regulatory bodies (Declaration of Helsinki, TGA (Australia), FDA (USA), National Health and Medical Research Council (NHMRC) and Medicines Australia).

- HREC Committee Name: Bellberry Human Research Ethics Committee
- Meeting frequency: Twice a Month
- Types of HREC (IRB/ERB/ETHICS) Committee that are used: Local
- Mandate distribution of safety: No

- Handling Investigational Product: Yes
- Training program for the research staff: Yes
- Include GCP: Yes
- Facility written sop during transportation to satellite site: N/A

- Required Licenses or Registrations: Not Applicable
- Does the Facility have the ability to handle radio-labelled Investigational Products? No

- Investigational Product: Horizontal laminar flow hood (non-hazardous drug preparation)
- Centrifuge: Yes
- Refrigerated Centrifuge: Yes

- Record Archiving: Yes
- EMR/EHR systems: In-house system
- Has your Clinical Trial Site or Service been accredited? No
- Audit Type: N/A

- 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? No
- 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