Fundamentals Series

The Fundamentals of Data Integrity

In this course, we will explore the foundations of data integrity. We first start with the importance of data integrity before learning the principles of ALCOA++. In the second half of the course, we follow the journey of data from the laboratory to the patient and learn about the data integrity priorities in each step.

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CEU Credits: 0.1

Course Code: ELM-221

Duration: 15 mins

Skill Level: Basic

Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)

Final Exam: Yes

Certification: Yes

Version: V4.3

Effective Date: 02/23/2024

Curriculum for this course

Welcome

Course Introduction

What is Data Integrity?

The Importance of DI

Consequences of DI Failures

Regulatory Framework

What's the News?

ALCOA+ Principles of DI

ALCOA+ Continued

ALCOA++

In the Headlines Again

Journey of Life Science Data

In the Lab

In the Clinical Trial

In Manufacturing

More News!

ISO

Ongoing Monitoring

A Transformational Device

Conclusion

Summary

Test Your Knowledge

Revision History

v4.3 Minor update on 12/02/2024 to collapse the navigation menu when course begins

v4.2 Minor update on 04/24/2024 to improve clarity of quiz answer choices and updated images and media

v4.0 Major update on 02/23/2024. This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.

v3.0 Minor update on 10/19/2023 to improve content/clarity

v2.2 Minor update on 09/19/2023 to improve course functionality

v2.1 Minor update on 04/19/2023 to fix assessment question issue

v2.0 Minor update on 03/27/2023 to fix assessment question issue

v1.2 Minor update on 01/03/2023 to fix assessment functionality, improve navigation and update to current standards

v1.0 Course released in 2021