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Compliance with GCP and GCP training is required by

  1. National Statement
  2. Good Clinical Practice
  3. Therapeutic Goods Administration
  4. The new National Clinical Trials Governance Framework

For clinical trials involving a procedure, medicine and/or biological, the training must be delivered by a TransCelerate accredited provider and is valid for three years.  Please refer the TransCelerate website for approved courses.

TransCelerate training is universally accepted and covers all the principles of GCP.

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 Principal Investigators of clinical trials must have completed GCP training and advised the Eye and Ear Research Office.

All Associate Investigators of clinical trials must have completed GCP training and advised the Eye and Ear Research Office.

By 31 December 2021, all team members of clinical trials 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 TransCelerate approved 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/

Orygen – 4 hour (9am-1pm) zoom broadcast – 2022 dates are Wed 23 Feb, Thu 31 Mar, Mon 9 May, Tue 21 Jun, Wed 17 Aug, Thu 29 Sept, Mon 14 Nov. For further details, please contact the Research Office.

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.