The Good Clinical Practice (GCP) guideline is the international ethics and scientific quality standard for conducting clinical trials
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.
Fee schedule for GCP training
The following fees and conditions apply to face-to-face (may be delivered remotely) training provided by the Office for Research.
|Fee (excl. GST)*
|Royal Melbourne Hospital employee
|External person (non-RMH employee)
* Note: Fees incur GST and a service fee from Eventbrite. Fees may change without notice.
Upcoming GCP training sessions
For RMH employees
- Cancellation of the booking will not attract a fee if notification is received at least 24 hours before the session
- Bookings may be transferred to another session if request to transfer is received at least 24 hours before the start of the session.
- Non-attendance will incur a $50 fee unless the booking was cancelled, or request to transfer was received, at least 24 hours before the start of the session.
For external persons and students
- Cancelled bookings will not be refunded
- Bookings may be transferred at no extra cost to another session if the request is received at least two days before the start of the session.