The Fundamentals of Good Clinical Practices (ICH E6 R2)

In this course we will discuss the fundamentals of Good Clinical Practices, or GCP. Good Clinical Practice sounds like an obvious part of any development, manufacturing, research or life science industry. However, this has not always been the case and not until relatively recently has there been an accepted and agreed upon standard for conducting clinical trials in a safe and ethical way.

Picture yourself in the early 1900’s and a traveling salesman pitches you a miracle serum that is guaranteed to cure any ailment. Maybe you’ve had a lingering cough or an arm injury and this medicine is sure to fix you. But at that time, you wonder, was the medicine held to any standards? Was it safe to consume? Was it tested on people safely and ethically?

These issues, and many more, are the reason for the creation of Good Clinical Practices. So let’s take a journey through the history, roles and essential elements of Good Clinical Practice as laid out by ICH E6 R2.