Monash Partners offers two Good Clinical Practice (GCP) programs: An Introduction to GCP Workshop and a GCP Refresher course which is available to paid employees of the Monash Partners organisations only.

‘Introduction to Good Clinical Practice Training’ involves a 6-hour Face to Face 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 or 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: The Alfred Medical Research Alliance in Melbourne and The Monash Health Translation Precinct (MHTP) in Clayton. It may also be available at other sites, depending on demand.

The ‘GCP Refresher course’ involves a 2-hour Online interactive workshop. 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.

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.

Please contact our GCP team via email - gcp@monashpartners.org.au