Good Clinical Practice

Free training for Monash Partners researchers!

Monash Partners is pleased to offer free TransCelerate-accredited training in Good Clinical Practice (GCP) to all paid employees of its 10 partner organisations.

Do I need this training?

The training is compulsory for Monash Partners researchers who plan to conduct any non-commercial or commercially sponsored clinical trial through the following organisations: Alfred Health, Baker Heart and Diabetes Institute, Burnet Institute, Cabrini, Epworth, Monash University, Hudson Institute of Medical Research, Monash Health, Peninsula Health and Eastern Health.

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 can do this training?

To help researchers meet these requirements, Monash Partners is offering all investigators and sub-investigators the opportunity to undergo recognised GCP training before conducting any phase of a clinical trial or interventional study. Researchers involved in human research other than clinical trials and interventional studies are not required to undergo GCP certification.

Run by trained GCP facilitators, Monash Partners offers the training at two sites: Alfred Medical Research and Education Precinct (AMREP), and the Monash Health Translation Precinct (MHTP). It may also be available at other sites, depending on demand.

The ‘Introduction to GCP Training’ involves a five-hour face-to-face interactive workshop designed for those involved in pharmaceutical or 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, involving a two-hour workshop, is also available to staff who have completed accredited GCP training in the past three years. (Proof of completion must be provided.)

Still want to know more about GCP?

You’ll find the nitty gritty of Monash Partners GCP here, and the Declaration of Helsinki here.

Email our GCP team

You can  find out more about our Good Clinical Practice training courses by sending an email or checking the timetable below.