Training
Peter Mac Good Clinical Practice (GCP) Training Requirements
It is a requirement of the Australian Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA) and European Regulators that Principal Investigators (PIs), Co-Investigators (CIs) and other trial coordination staff undergo recognised Good Clinical Practice (GCP) training to conduct clinical trials.
Our Office of Cancer Research provides an accredited GCP training course in house that delivers tailored training that is acceptable to most clinical trial sponsors. For further information and bookings please email This email address is being protected from spambots. You need JavaScript enabled to view it.
We expect that:
- All current Principal Investigators on prospective interventional studies have successfully completed GCP training
- All Principal Investigators and all staff on delegation logs undertake accredited GCP training appropriate to their role and delegation
- Researchers on all other human research projects undertake GCP training
As a rule, in addition to the Peter Mac GCP training course, we will accept any single FDA/TGA accredited GCP training program as satisfying the mandated requirements. You should provide records demonstrating attendance and successful completion of GCP training conducted externally or on-line to the Office of Cancer Research where a central registry of GCP staff is being maintained.
The recommended Peter Mac GCP training is valid for three years from the date of issue. We expect that staff will ensure that their training is always up to date. The Office of Cancer Research will send reminders to staff when refresher training falls due and will advertise GCP training dates to clinical research staff.
We expect that Investigators and Trial Coordinators also keep records of their GCP training (in the form of a copy of their training certificate) and that the date of the most recent update is recorded in their CV.
Ethics and Governance
If your department is interested in receiving training on submitting ethics and governance applications or on other ethics and governance topics, please email This email address is being protected from spambots. You need JavaScript enabled to view it. or call (03) 8559 7540 to discuss your requirements.
NHMRC
NHMRC provide training modules that introduce the clinical trials environment, clinical research ethics and ethical review and research governance processes.
