SERVICE
Good Clinical Practice - Online - Module Code C5.01
Course Overview
This TransCelerate endorsed, fully online module will introduce you to the internationally recognised and endorsed Good Clinical Practice standards (E6 R2) and the roles and responsibilities of all those involved in conducting research involving humans. It will also help you to understand the importance of ethically sound research design and conduct and how applying the principles GCP promotes excellence in science, data quality, and supports the safety and wellbeing of research participants.
This module is suitable for providing evidence of Introduction to GCP certification requirements as well as Refresher GCP.
Participants can claim 3 CPD points on completion of this module.
PRAXIS maintains course content to ensure all information is current.
ICH E6 (R3) Updates
The ICH E6 (R3) draft Guideline was endorsed by ICH in January 2025. This means that the Guideline is formally endorsed and now ready to be adopted by the regulatory bodies. The Guideline aims to harmonise the framework for conducting clinical studies
Further information can be found via the below links:
here and ICH endorses E6 (R3) guideline on GCP
The changes are anticipated to be implemented across the sector later in 2025. The timeline is yet to be confirmed.
Further updates to GCP, E6 (R3) are anticipated to be confirmed in late 2025/2026.
PRAXIS will be updating course content when the changes are made.
How long will it take to complete?
This course takes on average 2-4 hours to complete.
Will I get a certificate of completion?
Yes! A certificate will be automatically issued once a minimum of 80% is achieved in the final quiz section of the module. You can download it immediately . The certificate will show evidence of this modules compliance with TransCelerate requirements.
When can I start?
You can begin at any time. This module is always open to enrolments as it is part of the Research Essentials training model.
What will be covered?
In accordance with TransCelerate requirements, our courses cover the following core areas of ICH GCP (E6R2) and include a variety of online short assessment tasks and case studies, designed to enhance the learning experience of our students.
- Session 1 - The GCP standards and why we have them
- Session 2 - Study set up
- Session 3 - Informed consent
- Session 4 - Case report forms and data entry
- Session 5 - Safety reporting
Note: Add Module Code C5.01 to the enrolment form where prompted
Price
Individual Enrolment
$99pp plus GST
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.