Good Clinical Practice (GCP) is an international ethical and scientific quality standard that provides a framework for the conduct of trials that involve human participants. Conduct of trials according to GCP ensures that the rights, safety and well-being of trial participants are protected and that the clinical trial data are credible.
Compliance with GCP is also a requirement of the Therapeutic Goods Act 1989 for conduct of CTN/CTX trails in Australia. Furthermore, it is becoming widely recognised that compliance with applicable GCP is a minimum requirement for ALL clinical research that may have an impact on the safety and well-being of human subjects.
This intensive training session will provide researchers and research staff with an overview of the fundamentals of GCP in an informal setting. The session includes practical exercises and discussion topics to highlight GCP principals and help you come up with practical, achievable solutions to your GCP challenges. This is particularly important for researchers and research staff involved in investigator initiated studies which may not have the same resourcing as large commercially-sponsored studies.
The training is Transcelerate Biopharma Inc. recognised meaning that it is portable and recognised by other sites and sponsors.
MH employees - GCP training is provided free of charge for MH employees. Please use your Melbourne Health email address to book your ticket and wear your Melbourne Health ID Badge to the session.
Students - $50 plus GST (plus Eventbrite service fee)
External persons (non-MH employees/students) - $150.00 plus GST (plus Eventbrite service fee)
MH employees - Cancellation of the booking will not attract a fee if notification is received at least 24 hours prior the session. Bookings may be transferred to another session if request to transfer is received at least 24 hours prior to commencement of the session. Non-attendance will incur a $50 fee unless the booking has been cancelled, or request to transfer is received, at least 24 hours prior to commencement of the session.
External persons and students - Cancelled booking will not receive a refund. Bookings may be transferred to another session if request to transfer is received at least 2 days prior to commencement of the session at no extra cost.