Introduction to ICH-GCP

Good Clinical Practice is an international Ethical and Scientific Quality Standard for Designing, Conducting, Recording and Reporting trials that involve the participation of Human Subjects.


Key learning objectives

This module is designed to:

  • Understand why clinical research is so highly regulated
  • Understand the need for harmonization and the birth of ICH Good Clinical Practice (GCP)
  • Understand the general process of a clinical trial
  • Recognize the importance of good documentation

Key message

As laid out by the international standards and requirements, a basic understanding of Good Clinical Practice is a pre-requisite for anyone carrying out, or involved with, clinical research and clinical trials. The course is therefore relevant to:

  • Investigators and all persons assisting with the trial (e.g. Research nurses)
  • Members of ethics committees
  • Clinical trials support staff (e.g. Clinical Research Organization (CRO) staff)

Source documents

The Introduction to ICH-GCP source document for this chapter has been adapted from UCB Pharma

Last update: Monday, July 18, 2011
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