Refresher ICH Good Clinical Practice

Note: These GCP courses are only available to PAID EMPLOYEES of the Monash Partners organisations.

Overview

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.

View course flyer

Course outline

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, and 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.