Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles
Free Lesson Preview
This lesson is part of a complete GCP track — 2 courses, quizzes, a final exam, and a free verifiable credential. The optional $29 PDF certificate is recognized by 18+ trial sponsors.
Start learning for freeAlready enrolled? Sign in
Trace the evolution of research ethics from the Nuremberg Code through the Declaration of Helsinki and Belmont Report to understand why GCP protections exist.
Every regulation has a story. And the story behind Good Clinical Practice is not a comfortable one.
The requirements that govern clinical research today, the informed consent processes, the ethics committee reviews, the safety monitoring, none of these emerged from abstract philosophical debate. They were written in response to real events. Events in which researchers violated the trust of participants. Events in which science was used to justify cruelty. Events in which vulnerable populations were exploited in the name of knowledge.
I find that new researchers sometimes approach GCP as bureaucracy, as paperwork to complete, as boxes to check. This view changes when they understand where these requirements came from. The history of research ethics is a history of failure. GCP exists because, without explicit protections, researchers have demonstrated a capacity to harm the very people they claim to help.
This lesson examines that history. Some of what follows is disturbing. That discomfort is appropriate. The founders of modern research ethics confronted horrors that should never be repeated. Understanding those horrors is essential to understanding why every GCP requirement matters.
What you will learn5 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes
