Learning Objectives:

• List the key drivers that led to the formation of International Council for Harmonisation (ICH) and Good Clinical Practice Guideline (GCP).
• Describe the 13 principals of ICH GCP.
• Define key terms used in the ICH GCP Guideline.
• Explain the roles and responsibilities of a sponsor, an investigator, and the IRB/IEC.
• List the core requirements for obtaining the informed consent of study participants.
• Define the purpose of various documents and templates that professionals use in the clinical trial process.

Audience:
Primary: Physicians and Nurses engaged in the care of patients within a clinical research trial.
Secondary: All Clinical Research Personnel

Knowledge level (basic, intermediate, advanced): Basic

Related to the following Core Competencies:
Ethical and Participant Safety Considerations
Clinical Trial Operations (GCPs)
Scientific Concepts and Research Design
Medicines Development and Regulation