Good Clinical Practice (GCP) in Australia
A TransCelerate Mutually Recognised ICH GCP E6 Training Program
GCP OVERVIEW AND PRINCIPLES
This Module covers the origins, rational, principles and relevant guidelines of GCP; as well as the roles and responsibilities of those conducting/overseeing research.
DATA, RECORD AND INVESTIGATIONAL PRODUCT MANAGEMENT
This Module identifies the purpose of essential documents, data and record management requirements and investigational product accountability.
RESEARCH ETHICS AND GOVERNANCE
This Module covers the application of a research governance framework, the roles of human research ethics committees and research governance offices, and informed consent requirements.
MONITORING, REPORTING AND PROJECT CLOSURE
This Module discusses the roles and responsibilities for monitoring and closing a project, including data management, protocol amendments, safety reporting and compliance.
Why Should You Complete the Good Clinical Practice (GCP) in Australia Course?
The ‘Good Clinical Practice (GCP) in Australia’ online training course is specifically designed to assist clinical researchers within Australia understand the principles and foundations of GCP. Although the ICH Guideline for GCP E6 (ICH GCP) primarily relates to clinical trials and has an international context, all human research conducted in Australia should be undertaken in accordance with the GCP principles contained in the National Statement on Ethical Conduct in Human Research and ICH GCP (where relevant).
All researchers involved with human research within Australia, are encouraged to undertake GCP training and refresh this 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.
The Course, consisting of 4 Modules, will take approximately 4.5 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.”
“The quizzes in between to test our knowledge and the way everything was presented systematically.”
“Clear explanation, good examples, logical flow”
“The self-assessments complement well with the comprehensive lesson content.”