Module 2 – Key people and their responsibilities

This is the module two of our Good Clinical Practice Course.

This module covers the following chapters.

Chapter 4 – Investigator

  • Who is an Investigator?
  • Investigator Responsibilities
  • Investigator Non-Compliance
  • Investigator Scenario

Chapter 5 – Sponsor

  • Who is a Sponsor?
  • Sponsor Responsibilities
  • Quality Management, Risk, QA, QC
  • Delegation
  • Trial Management, Data Handling and Record Keeping
  • Investigator and Monitor Selection
  • Sponsor Scenario

Chapter 6 – Monitor

  • What is monitoring and why is it necessary?
  • Monitoring Approaches
  • Monitoring Visits and Reporting
  • Monitoring Scenario


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