Data Integrity (ALCOA)

Data Governance

With increasing use of digital systems for clinical trial activities, maintaining data integrity is essential for compliance, patient safety, and regulatory approval. That’s why data governance is a critical component of Good Clinical Practice (GCP) as outlined in ICH E6 (R3), Section 4. In this course, you will be guided through practical ways to follow these guidelines during clinical trials, applying them to common situations.

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CEU Credits: 0.1
Course Code: ELM-981
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 06/17/2025

Curriculum for this course

Course Introduction
Introduction to ICH E6 R3
Maintaining Data Integrity through Data Governance
Key Processes and Expectations
Fundamental Requirements for Data Quality
Designing Systems for Data Blinding
Tailoring Blinded and Unblinded Roles
Applying Data Blinding Guidelines
Overview of the Data Lifecycle
Data Capture
Data Review
Data Corrections
Data Transfers and Migrations
Data Analysis
Data Destruction
Applying Data Lifecycle Guidelines
Overview of Considerations
Security
Validation
Additional Validation Considerations
System Failure
Technical Support
User Management
Summary
Test your Knowledge
v1.0 Course released on 08/26/2025

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