Good Clinical Practice GCP

Good Clinical Practice (GCP)

Refresher

ICH GCP E6 Training Program

A TransCelerate Mutually Recognised

GCP

GCP Discount for AHRA Members And

Partner Organisations

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Good Clinical Practice (GCP) Refresher

A TransCelerate Mutually Recognised – ICH GCP E6 Investigator Site Training

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of humans.

Compliance with this standard provides public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Why Should You Complete the Good Clinical Practice (GCP) Refresher Course?

The ‘Good Clinical Practice (GCP) Refresher’ online training course is specifically designed to assist clinical researchers who have already undertaken a previous GCP Course to refresh their knowledge of the basic principles of GCP and how these principles can be applied in the research setting.

The GCP Refresher course includes new and revised content relating to current regulations and guidelines for Australian clinical trials.

Although ICH GCP primarily relates to clinical trials, all human research conducted in Australia should be undertaken in accordance with the GCP principles contained in the National Statement and ICH GCP (where relevant).

Researchers are encouraged to refresh their training in line with jurisdictional requirements (e.g. every 2-3 years).

This course has been approved by the TransCelerate Site Qualification and Training Initiative, which is a Mutual Recognition Program for ICH E6 GCP Training, targeted at investigator site personnel.

For those who have not undertaken previous GCP training, the RETProgram GCP in Australia course can be found HERE.

Learning Objectives

  • Define Good Clinical Practice (GCP) and understand its principles.

  • Identify the set of guidelines, frameworks and regulations that govern the conduct of human research within Australia.

  • Define the roles and responsibilities of those responsible for the conduct and oversight of human research within Australia.

  • Understand the investigator GCP responsibilities

  • Understand how GCP should be adopted in the conduct of clinical research.

120 min

The Course, consisting of 3 parts, will take approximately 2 hours to complete.

Some feedback from our online participants on our GCP training:

“The way the material was presented was clear and interesting. I enjoyed the visuals and ‘clicking’ to access different sections for more information.”

 

“Contains a broad overview of good clinical practice but also surprisingly detailed information. This is by far one of the best online course I’ve done in a long time.”

 

“It Provides a very good overview and the parts make sense when seen in a logical way. There are many prompts to more detailed references on the topics and they can be followed up for more information. Building in breaks was a good idea.”

 

Videos, real-life examples and visuals (e.g. charts) used to support comprehension.”

“The content was well structured and allowed me to develop my understanding. Important information was consolidated well by the quiz.”

 

“The course allowed me to learn new things about why good clinical practice is important and why it is used.”

 

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