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.

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.

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.

Please contact our GCP team.