UPDATE: The TGA have adopted the ICH E6(R3) Guideline for Good Clinical Practice, effective from 13 January 2026. 

A 12 month transition period from 13 January 2026 to 13 January 2027 allows stakeholders time to update processes, documentation and training to meet the R3 requirements. Further information is available on the TGA website. 

Monash Partners will now teach R3 for all Introduction to GCP and GCP Refresher courses.

Monash Partners offers two Good Clinical Practice (GCP) programs:

• Introduction to GCP - full day, in-person workshop for staff with and without previous training.
• GCP Refresher course- two hour, Zoom workshop, available to staff with accredited GCP training which is current or within six months of expiry.

Both courses are available to paid employees of the Monash Partners organisations only.

In addition to this, we endorse the free online GCP course offered by the Australian Clinical Trials Education Centre (A-CTEC).

A-CTEC is a not-for-profit, Australia-wide, member-based education platform, hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs. To learn more about their courses, please click on the link below.

A-CTEC Home Page: https://actec.myopenlms.net/

For A-CTEC GCP queries, please contact the Helpdesk Support via email - A-CTEC@unimelb.edu.au

Good Clinical Practice (GCP) is an International Ethical and Scientific Quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

GCP training is compulsory for employees of Monash Partner member organisations who plan to conduct, or are involved in, a clinical trial. Some Monash Partners member organisations may also require this training for people involved in other forms of research.

Monash Partners offers the following two Good Clinical Practice (GCP) programs:

Introduction to GCP

Six-hour, in-person, interactive workshop for staff with and without previous International Council for Harmonisation (ICH) GCP training. This course is designed for all those involved in pharma, interventional clinical research.

It is comprised of the following five modules:

1. The Standards
2. Study Set-up
3. Informed Consent
4. Case Report Form and Data Entry
5. Safety Reporting

GCP Refresher course

Two-hour, online, interactive workshop, available to staff with current ICH GCP training. Staff must provide proof of prior GCP completion and be within six months of their certification expiring. GCP training should be refreshed every three years.

The training is compulsory for employees of Monash Partners member organisations who plan to conduct or are involved in, a clinical trial. Some Monash Partner member organisations may also require this training for people involved in other forms of research.

The GCP guidelines apply to Clinical Research, and detail the requirements for trial documentation, protocol amendments, 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 Good Administration (TGA) has adopted the International 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, the National Statement and ICH Good Clinical Practice Guidelines.

All paid employees of Monash Partners member organisation.

Please contact our GCP team via email - gcp@monashpartners.org.au