Refresher ICH Good Clinical Practice
Note: These GCP courses are only available to PAID EMPLOYEES of the Monash Partners organisations.
This TransCelerate-accredited GCP short course will provide participants with an update of how to conduct a study in accordance with ICH GCP. Suitable 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.
The course consists of 5 modules:
- The Standards
- Study Set Up
- Informed Consent
- Case Report Form and Data Entry
- Safety Reporting
Who should attend?
This course is offered at no charge and only to paid employees of the Monash Partners organisations:
- Alfred Health
- Baker IDI Heart
- Burnet Institute
- Cabrini Health
- Eastern Health
- Epworth Healthcare
- Monash Health
- Monash University
- Peninsula Health
Only staff that have previously completed GCP training and can provide evidence of course completion within the last 3 years are eligible for GCP refresher training. Staff are required to upload their certificate of completion during the registration process.
Previous GCP training can encompass any of the following:
- Any training (face to face or online) that meets the criteria for ICH GCP investigator site personnel training as identified by Transcelerate Biopharma Inc, including:
- Research Excellence Training (RXT), ARCS, Peter MacCallum Cancer Centre or Murdoch Childrens Research Institute GCP training programs
- Any of the TransCelerate accredited or accredited Pharmaceutical sponsor GCP training programs
- US National Institute of Health (NIH) GCP training
- Formal clinical research training (which includes GCP training) through a university or research institute
Successful completion of this course will provide attendees with a certificate of accredited ICH GCP training.
While the information contained herein was correct at the date of publication, Monash University reserves the right to alter procedures, fees and regulations should the need arise.
Click on the session date to register for that session:
Once a course has reached maximum 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. 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. Training may be available for a charge. With reasonable notice, you may be able to defer your place, subject to availability. 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 the GCP team on firstname.lastname@example.org.