Good Clinical Practice: An Introduction

Define Good Clinical Practice and explain its dual purpose

Identify the 11 principles of ICH GCP E6(R3) and their significance

Explain how GCP protects trial participants and ensures data quality

Describe the relationship between GCP and regulatory compliance

Recognize the evolution of GCP from E6(R1) to E6(R3)

Prepare for deeper GCP study through understanding foundational concepts

A standard for the planning, initiating, performing, recording, oversight, evaluation, analysis and reporting of clinical trials that provides assurance that the data and reported results are reliable and that the rights, safety and well-being of trial participants are protected.

Source: ICH E6(R3) Guideline, Glossary

Define Good Clinical Practice and explain its dual purpose

Identify the 11 principles of ICH GCP E6(R3) and their significance

Explain how GCP protects trial participants and ensures data quality

Describe the relationship between GCP and regulatory compliance

Recognize the evolution of GCP from E6(R1) to E6(R3)

Prepare for deeper GCP study through understanding foundational concepts

Source: ICH E6(R3) Guideline, Glossary

Good Clinical Practice: An Introduction

Good Clinical Practice: An Introduction

Good Clinical Practice: An Introduction

What you will learn

Definition: Good Clinical Practice (GCP)

You're already ahead of most

What you will learn

Definition: Good Clinical Practice (GCP)

You're already ahead of most