Red Nucleus Training Institute

Providing on-demand training solutions

Managing Data Integrity and the Electronic Record Life Cycle

~0.50 hrs | GCP - Documents & Data Integrity

The integrity of data and documents is a critical component to running a clinical study. In this module, you will learn how to ensure your data is accurate and secure, and review key components of document and data storage and change control. Finally, you will learn about the different types of data, documents, systems, and how they all tie in to study submissions.

Module Details

After completing this module, you will be able to:
• Describe data integrity (DI) compliance components within electronic health records (EHRs), informed consent, and signatures
• Cite essential documentation characteristics and methods required to generate certified copies
• Recognize the application of ALCOA+ to paper and electronic documentation

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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