COVID-19 – GCP Arrangements for 2020
You will find the latest info on Good Clinical Practice Intro and Refresher Training dates and times for 2020, HERE.
What is the training?
‘Introduction to GCP Training’ involves a six-hour face-to-face interactive workshop is suitable for staff with and without previous ICH GCP training, and is designed for all those involved in pharma 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, involves a two-hour workshop, is available to staff with current accredited GCP training which is due to expire. (Proof of completion must be provided)
Run by trained GCP facilitators, Monash Partners offers the training at two sites: The Alfred and the Monash Health Translation Precinct (MHTP), Clayton campus. 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 Monash Partners employees 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 the Monash Partners member organisation who have opted in to this training – Alfred Health, Baker Institute, Burnet Institute, Cabrini Health, Eastern Health, Epworth HealthCare, Monash Health, Monash University and Peninsula Health.