in Clinical Trials
Good Clinical Practice
What is Good Clinical Practice training?
Monash Partners ‘Introduction to Good Clinical Practice (GCP) Training’ involves a six-hour face-to-face interactive workshop and is fully accredited. The training is suitable for staff with and without previous International Council on Harmonisation (ICH) GCP training, and is designed for all those involved in pharma or interventional clinical research.
It is comprised of the following five modules:
- The standards
- Study set-up
- Informed consent
- Case report form and data entry
- Safety reporting.
The ‘GCP Refresher’ course, involves a two-hour workshop and is accredited. It is available to staff with current accredited GCP training which is due to expire. (Proof of completion must be provided).
Run by experienced facilitators, Monash Partners offers Introduction and Refresher training at two sites: The Alfred and Monash Health Translation Precinct (MHTP), Clayton campuses. It may also be available at other sites, depending on demand.
Learning materials will be emailed to all participants before the course date, please ensure you have access to a suitable device (laptop or iPad) to view the documents.
Do I need this training?
The training is compulsory for employees of Monash Partners member organisations who plan to conduct, or are involved in, a clinical trial. The Good Clinical Practice guidelines apply to clinical research and detail the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants. Accredited training in this area is expected by pharmaceutical companies that initiate commercially sponsored clinical trials, and this course is recognised as acceptable for this purpose.
In Australia, the Therapeutic Goods Administration (TGA) has adopted the European version of the guidelines, with specific comments relevant to Australia. Researchers in Australia are required to have adequate experience, qualifications or be supervised under the Australian Code, National Statement and ICH Good Clinical Practice guidelines.
Who is eligible to attend?
All paid employees of Monash Partners member organisation who have opted in to this training – Alfred Health, Baker Institute, Burnet Institute, Cabrini Health, Eastern Health, Epworth HealthCare, La Trobe University, Latrobe Regional Hospital, Monash Health, Monash University and Peninsula Health.
Still want to know more about GCP?
Please contact our GCP team.
Click register to register for that session:
More events coming soon
Once a course has reached maximum capacity a waiting list will commence.
This course is offered free of charge. It is in high demand and places are extremely limited. If you have registered for a course, but are unable to attend and fail to notify us, you will forfeit your once only no-cost place. Training may be available for a charge. With reasonable notice, you may be able to defer your place, subject to availability. Failure to cancel your registration less than 24 hours prior to course commencement may incur a $50 fee.
If you have registration queries please contact our GCP team.
GCP training COVID-19 update
Due to the ongoing COVID-19 situation, we are currently unable to offer our face-to-face Introduction to GCP training. In light of this, we have identified two online training options for our Partner members:
Western Australian Health Translation Network
As a Monash Partner Organisation employee, select AHRA-Partners to access discounted modules. Should you have any queries, please contact the RETProgram Support Team or call them on (08) 6151 0878.
This course is offered at a small cost of $10.
Please note, that neither of these training programs have been co-designed by Monash Partners.
We will provide an update when we are in a position to resume our face-to-face Introduction to Good Clinical Practice training.
As a Monash Partner Organisation employee, select AHRA-Partners to access discounted modules, should you have any queries please contact our GCP team.