Good Clinical Practice (GCP) in Australia
A TransCelerate Mutually Recognised ICH GCP E6 (R2) 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 R2 (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 5.5 hours to complete.
Some feedback from our online participants on the ‘best aspects’ of this ICH GCP training:
“It was well laid out which made it easy to follow. It was good that it had the quizzes spaced out as this acted as a break type activity and meant I could really focus in on what I had just been reading and solidify that knowledge.”
“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 was easy to navigate through the course and the use of “real people” involved in research is clever.”
“The ability to download and have access to legislation and governance documents. The clear nature of the information presented made learning easy.”
“The different methods of delivering the information kept it interesting and helped to maintain concentration. I also liked the YouTube videos.”
“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.”