Good Clinical Practice - Online - Module Code C5.01

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. Our GCP courses are up-to-date with current ICH regulations E6 (R2).

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.

This course takes on average 2-4 hours to complete.

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.

You can begin at any time. This module is always open to enrolments as it is part of the Research Essentials training model.

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