Course introduction
Welcome to The Institute of Clinical Research (ICR) eLearning programme.
We recognise that individuals need comprehensive learning materials in a flexible and easy to use method, and have developed a new series of eLearning modules with these requirements in mind.
You are now on the way to learn about the Principles of the International Conference on Harmonisation Good Clinical Practice ICH GCP. We hope that you will take away valuable information from this course, and we welcome feedback from all our learners.
The objective of ICH GCP is to provide a unified standard for the European Union (EU), Japan and the United States (US), to facilitate the mutual acceptance of clinical data by the regulatory authorities in these regions.
This module allows the learner to get an insight into the principles of ICH GCP.
Target audience
The primary audience for this module is anyone involved in the set up, conduct or reporting of a clinical trial. This module will also provide the standard principles required to satisfy the regulatory requirements and meet the exacting standards of clinical research.
You will need to refer to the ICH GCP guideline for more detailed information.
Course objectives
By the end of this session, you will be able to…
- Describe the history and purpose of GCP
- Discuss the roles and responsibilities of clinical trial staff according to ICH GCP
- Discuss the practical application of ICH GCP to the clinical trial process
- Outline the current changes to regulations
For more information about other eLearning material, visit our website or contact us.
