Good Clinical Practice (GCP) in Australia
A TransCelerate Mutually Recognised ICH GCP E6 Investigator Site Training.
About This 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 R2 GCP Training, targeted at investigator site personnel.
With the ability to exit and resume the course at any point, participants will have the flexibility to fit the course into their busy schedules and gain valuable insights into this critical aspect of clinical trials.
Pricing
Free
WAHTN Partners have free access to this course
$40
Participants from the AHRA partner organisations have discounted access to this course.
$120
Any person from the public can gain access to the course.
Course Objectives
GCP 1: Overview and Principles
Understand the origins and rationale for Good Clinical Practice (GCP) principles.
Understand the principles of GCP and 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.
GCP 2: Data, Record and Investigational Product Management
Identify and understand the purpose of essential documents that are required to conduct a research project, in particular clinical trials.
Understand data and record management requirements and investigational product accountability.
GCP 3: Research Ethics and Governance
Understand the role of a Research Governance Framework in the application of GCP principles.
Identify the role of a Human Research Ethics Committee in the ethical review and approval of a research project.
Understand ethical considerations and participant consent requirements for different types of research and populations.
Identify the role of Research Governance in the governance review and authorisation of a research project at an institution/site.
GCP 4: Monitoring, Reporting and Project Closure
Identify the roles and responsibilities of the sponsor, investigators, Human Research Ethics Committee and institution/site in the monitoring of a research project.
Understand the data management and amendment processes during the conduct of a project.
Understand the progress, compliance and safety reporting requirements for a research project in particular, for clinical trial and clinical investigation research.
Understand the requirements for closing a project.
Feedback From Participants
"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 self-assessments complement well with the comprehensive lesson content."
