Learning Outcomes

In this free course, you will learn how to:

• Define the meaning of Good Clinical Practice in research.
• Describe the ethical foundation of Good Clinical Practice.
• Identify the purpose of ICH and its guidelines.
• Identify the ethical principles guiding clinical research practice.
• Explain the sponsor’s responsibilities in trial oversight.
• List examples of documents required for inspection readiness.
• Generate strategies to strengthen data integrity in studies.
• Evaluate how risk-based oversight enhances trial efficiency.
• Illustrate examples of protocol deviations and their impact.