In this course you will learn about:

• the principles of ICH GCP
• the rights of study participants and the safeguards to ensure their safety and well-being
• the requirements for obtaining informed consent from the study participants
• the responsibilities of the investigator
• the safety reporting requirements

ICH GCP Introduction

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”

Sneak Peak

Table of Contents:

Ethical Principles for clinical research – historical development

The Principles of ICH GCP




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