in Clinical Trials
Good Clinical Practice (Accredited ICH GCP Training)
Monash Partners offers two Good Clinical Practice (GCP) programs:
- Introduction to GCP - full day, in-person workshop for staff with and without previous training
- GCP Refresher course- 2 hour, Zoom workshop, available to staff with current accredited GCP training which
is due to expire within 6 months (proof of completion must be provided)
Both courses are available to paid employees of the Monash Partners organisations only.
In addition to this, we endorse the free online GCP course offered by the Australian Clinical Trials Education Centre
A-CTEC is a not for profit, Australia wide, member-based education platform, hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs. To learn more about their courses, please click on the link below.
A-CTEC Home Page: https://actec.myopenlms.net/
For A-CTEC GCP queries, please contact the Helpdesk Support via email - A-CTEC@unimelb.edu.au
What is Good Clinical Practice training?
Good Clinical Practice (GCP) is an International Ethical and Scientific Quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trails. It also serves to protect the rights, integrity and confidentiality of trial subjects.
Monash Partners Introduction to Good Clinical Practice Training is a 6-hour, in-person, interactive workshop and is fully accredited. The training is suitable for staff with and without previous International Council for Harmonisation (ICH) GCP training, and is designed for all those involved in pharma, interventional clinical research.
It is comprised of the following 5 modules:
- The Standards
- Study Set-up
- Informed Consent
- Case report Form & Data Entry
- Safety Reporting
Run by experienced facilitators, Monash Partners offers the Introduction to Good Clinical Practice at two sites:
- Alfred Research Alliance in Melbourne
- Monash Health Translation Precinct (MHTP) in Clayton
Note: It may also be available at other sites, depending on demand.
The GCP Refresher course involves a 2-hour interactive workshop delivered via Zoom. It is available to staff with current accredited GCP training which is due to expire within 6 months and should be refreshed every 3 years (proof of completion must be provided)
Once a participant is registered they shall receive a confirmation followed by the Course Resources emailed closer to the date of the program. We recommend you have access to a suitable device (Laptop/iPad) to view the PDF documents during the course.
Do I need this training?
The training is compulsory for employees of MP member organisations who plan to conduct or are involved in, a clinical trial. Some MP member organisations may also require this training for people involved in other forms of research.
The GCP 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 Good Administration (TGA) has adopted the International 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, the National Statement and ICH Good Clinical Practice Guidelines.
Who is eligible to attend?
All paid employees of Monash Partners member organisation.
Still want to know more about GCP?
Please contact our GCP team via email - email@example.com
Click register to sign up for one of our 2023 sessions:
Once a course has reached max. capacity a waiting list will commence. Please note this course is available at no individual charge. It is in high demand and places are extremely limited. Within reasonable notice, you may be eligible to defer your place, subject to availability.
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. 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.