Introduction to Good Clinical Practice
Course Overview
This are TransCelerate accredited GCP workshops. The modules 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.
The program consists of 5 sessions (all completed in this workshop), covering the following topics:
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
