Red Nucleus Training Institute

Providing on-demand training solutions

Clinical Responsibilities for Regulatory Submission & Compliance

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

This module is an overview of the roles and responsibilities the clinical team has in ensuring compliance for key deliverables that will need to be reported in regulatory submissions.

Module Details

At the completion of this module, you will be able to:
• Describe and identify the roles and responsibilities of the key players in the regulatory compliance process
• Identify components of regulatory submissions required to conduct a clinical trial

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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