Red Nucleus Training Institute

Providing on-demand training solutions

Good Documentation Practices in a Clinical Environment

~0.50 hrs | GCP - Documents & Data Integrity

Good Documentation Practices (GDocP) are a critical portion of the clinical trial process, inclusive of document authoring, change control, access, and archiving. The Good Documentation Practices in a Clinical Environment module summarizes standard practices for good clinical documentation.

Module Details

At the completion of this module, you will be able to:
• Describe data integrity and the data life cycle while applying current regulations and industry standards (ALCOA, etc) within the good practices (GxP) environment
• Identify methods to assess quality documentation to support inspection of clinical trials (authoring, archiving, and validating systems)
• Summarize an actionable plan for Title 21 Part 11 compliance

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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