Compliance with GCP and GCP training is required by
- National Statement
- Therapeutic Goods Administration
- Eye and Ear Clinical Trials Governance Framework
For clinical trials involving a procedure, medicine and/or biological, the training must be delivered by a TransCelerate listed provider and is valid for three years. Please refer the TransCelerate website for a list of content compliant courses.
For clinical trials involving a device, the training must be delivered by a TransCelerate accredited provider and is valid for three years.
Eye and Ear Hospital requirements
All team members of clinical trials (including Principal Investigators, Associate Investigators and other team members) will be required to provide evidence of current Good Clinical Practice (GCP) training to the Research Office.
When you have successfully completed or renewed a GCP training course (this will be included on the training certificate), please send a copy to the Research Office at ethics@eyeandear.org.au.
Current Training opportunities
The Research Office does not recommend specific courses as each individual has their own requirements. Eye and Ear staff have participated in the following courses:
Genesis Research Services – https://genesisresearchservices.com/education/gcp-ich-course/
ARCS Australia – Online training (arcs.com.au)
The Global Health Network – https://globalhealthtrainingcentre.tghn.org/
Praxis Australia – https://praxisaustralia.com.au/services/good-clinical-practice/
World Medical Device Organization – https://wmdo.org/
The Research Office will consider other training providers – please send the details to the Research Office for verification.
