Module 3 – How is compliance with GCP ensured?

This is the third and final module of the Good Clinical Practice course.

Once you have completed this course, you’ll be able to print your certificate.

This module covers the following chapters:

Chapter 7 – Patient Safety

  • What is patient safety?
  • Who is responsible for patient safety?
  • Safety Reporting

Chapter 8 – Informed Consent 

  • What is Informed Consent?
  • How is Informed Consent acquired?

Chapter 9 – Investigational Product (IP)

  • What is IP
  • IP responsibilities

Chapter 10 – Protocol and Investigator Brochure 

  • Clinical Trial Protocol
  • Investigator Brochure

Chapter 11 – Essential Documents

  • Essential Documents
  • Electronic Records and Trial Master File (TMF)



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