Red Nucleus Training Institute

Providing on-demand training solutions

Introduction to Good Clinical Practices

~0.50 hrs | GCP - Clinical Operations & Process

The Introduction to Good Clinical Practices module provides an overview of the rules, regulations, and guidelines that companies must or should follow during clinical trials to ensure the protection of human participants.

Module Details

After completing this module, you will be able to:
• Define Good Clinical Practices (GCPs) and their use in the pharmaceutical and life sciences industries
• State the application of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP E6 (R2) in the pharmaceutical and life sciences industries
• State the role the Code of Federal Regulations (CFR) Title 21 Part 11 plays in GCP
• Recall the 13 ICH Principles
• Identify key historical moments that played a role in developing GCP and ICH GCP E6 (R2)

Features

• Audio narration with on-demand full-text transcript
• Module-level interactive learning exercises and
self-check questions
• Fully cited and sourced from a blend of Red Nucleus
best practices and global health authority regulations
and guidance
• Updated annually
• SCORM compliant

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