Good Clinical Practices Online Course & Certificate

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20 contact hours
Used For:
2 Continuing Education Units
Course and Certificate:

The ICH GCP course will give you a current and comprehensive guide to the principles of Good Clinical Practice. In 1997, the Food and Drug Administration (FDA) endorsed the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonization (ICH).The course covers the GCP guidelines of the ICH as well as the ISO standard 14155 for clinical investigations of medical devices for human subjects. Participants also learn about basic ethical principles according to the Declaration of Helsinki and local regulations that apply in their country.

GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The topics presented cover all the different aspects of the Good Clinical Practice. 

After completing Good Clinical Practices, students will be equipped with a basic understanding of the following:

  • What are the principles of Good Clinical Practices
  • What are the regulations and guidelines for studies with medical devices and pharmaceuticals
  • What are the ethical considerations?
  • What are the aspects of scientific background of clinical studies (methodological aspects)
  • What are the responsibilities of the Investigator and Sponsor
  • What is Informed Consent
  • What is Quality Control / Quality Assurance


There are no prerequisites required for this course.


 Students will be assigned 5 homework assignments, and 1 final exam. 

  1. Introduction
  2. Regulations and guidelines for studies with medical devices and pharmaceuticals
  3. The Principles of ICH GCP
  4. Ethics – Institutional Review Boards
  5. Scientific background of clinical studies (methodological aspects)
  6. Responsibilities of the Investigator
  7. Responsibilities of the Sponsor
  8. Informed Consent
  9. Data management and statistics
  10. Quality Control / Quality Assurance


 This course is Instructor-led and delivered through our award-winning online Learning Management System. 

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