CEU Credits: 0.1
Course Code: ELM-153
Duration: 40 mins
Skill Level: Intermediate
Language: Chinese (Simplified), English, French (France), Italian, Japanese, Spanish (Spain)
Final Exam: Yes
Certification: Yes
Version: V1.3
Effective Date: 08/13/2021
Curriculum for this course
Course Introduction
Learning Objectives
Overview: Data Integrity Awareness
Who Should Take This Program?
What are the Key Reasons for Maintaining Good Documentation?
The Regulators: FDA/Eudralex/WHO
Documents within the Scope of GDP
GDP Example: Zhejiang Hisun Pharmaceutical Co. FDA Warning Letter
GDP: Attributable (Signatures)
GDP: Legible (Clear, Complete, Legible)
GDP: Contemporaneous (Time of Occurrence)
GDP: Original (First capture)
GDP: Accurate (Data is Correct)
Date Format
Time Format
Signatures
Language – Correct Grammar
Use Indelible Ink
Scrap Paper and Post-Its
Transcribing
Late Entries
Corrections
Corrections – Example 1
Corrections – Example 2
Blank Fields
Additional Pages / Attachments
Instrument Printouts
Logbooks
Interactive Scenario
Conclusion
Final Assessment
Certification
v1.3 Minor update on 10/21/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.2 Minor update on 07/21/2024 to update resource links and ensure resources tab is accessible throughout the course. Removed malfunctioning interactive scenario slides.
v1.1 Minor update on 04/30/2023 to improve design quality and increase diversity representation of people. Changes made to on-screen text related to the GdocP characteristic “attributable” for clarity. Assessment updated to better reflect learner experience.
v1.0 Course released in 2021