Good Clinical Practice training

In accordance with the National Clinical Trials Governance Framework, clinical trial investigators and their clinical teams must undertake training in GCP.

More broadly, the Office for Research requires GCP training as part of Research Governance approval.

This applies to all research studies conducted at the Royal Melbourne Hospital (RMH) except for Quality Assurance studies.

What are the RMH's requirements?

• The RMH research personnel must hold and maintain a current, valid GCP training certificate before commencement of delegated study activities in a research project. This includes Principal and Associate Investigators, Research Nurses, Research Coordinators and Managers.
• The GCP training course undertaken must meet the minimum criteria set out by the TransCelerate Biopharma Inc. Mutual Recognition Program and appear on this website.
• Face-to-face GCP training is encouraged whether it is in-person or remotely delivered. For example, remotely delivered as part of an interactive webinar.
• Australian based GCP training is strongly preferred.
• Confirmation of valid GCP training must be provided to the Office for Research for all staff before the start of a research study at the RMH
• TransCelerate GCP certification is accepted for a maximum of three (3) years unless a shorter timeframe is specified on the certificate.