Red Nucleus Training Institute

Providing on-demand training solutions

GCP Regulations, Guidance & Informed Consent

~0.50 hrs | GCP - Regulations, Guidance, & Submissions

This module provides a summary of FDA and EU regulations and ICH guidance for good clinical practice.

Module Details

After completing this module, you will be able to:
• Recognize the differences between regulations and guidance
• Examine the Code of Federal Regulations (CFR) & EudraLex versus The International Council for Harmonisation (ICH)
• Identify the importance of informed consent and the implications of implementation

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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