As part of Grampians Health’s commitment to undertake high-quality, ethical and health service-relevant research, it is strongly recommended that all researchers get ICH Good Clinical Practice (GCP) certification.
For clinical trials, GCP certification is mandatory, and principal investigators must also complete further training – please see more information below.
From 1 May 2024, members of clinical trials at Grampians Health must present certificates of completion for the following training courses.
| All members of the clinical trial team (including principal investigators, associate investigators, study coordinators, clinical trials pharmacists, etc.) | ICH GCP certification (GCP certificates must be submitted with SSA) |
| Principal investigators of clinical trials (mandatory) Other clinical trial team members (recommended) |
Australian Clinical Trials Education Centre (AC-TEC) course Trials Essentials for Investigators* (course completion certificate must be submitted with SSA) |
*Principal Investigators please note: completion of the AC-TEC Trial Essentials for Investigators course includes ICH GCP certification. However, ICH GCP certification must be renewed every three years (several providers of this training), while the Trial Essentials for Investigators course only needs to be completed once.
About the Trial Essentials for Investigators course
This introductory package of five courses equips trial investigators with foundational knowledge about overseeing and managing clinical trials in Australia.
Course elements:
- Trial regulatory requirements in Australia
- Trial feasibility and start-up process
- Safety monitoring and reporting in trials
- Protocol compliance and serious breaches
- PI oversight and trial management
Completion of this course is equivalent to 10 active learning hours towards CPD points and satisfies the requirements of ICH GCP.
Many of our staff have already completed the A-CTEC training packages as part of their own education program. If you have already completed the course please advise the Research Ethics and Governance Office (researchethics@gh.org.au).
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