Getting Ready for ICH E6(R3): What You Need to Know About Data Governance

Background

The ICH Harmonised Guideline for Good Clinical Practice (GCP) E6 third revision was drafted in 2023 and will be effective in 2025. COVID-19 inspired this revision, driving the need for modern, flexible clinical trials that embrace Quality-by-Design and Risk-based approaches. While patient safety and data integrity remain fundamental, the guidance emphasizes digital transformation and risk-proportionate policies for computerized systems. ICH E6 (R3) mandates traceability in data processing and analysis, reflecting the complex ecosystem of systems that now generate and store trial data.

Key Changes in Data Requirements

A major update in ICH E6 (R3) is expanding Data Governance requirements to both Sponsor and Investigator levels. The guidance mandates robust data management practices focusing on integrity, traceability, and security. Key requirements include system-to-system data transfer protocols, metadata management, and comprehensive audit trail review. This evolution emphasizes protecting both trial participant experience and the data generated throughout their journey.

Expanded Data Governance Scope

From data capture to final archive, Sponsors and Investigators must now attest to data quality, security, and integrity. Clinical teams need to consider both participant experience and data lifecycle management in trial designs. Implementing comprehensive data governance strategies and standards will improve data quality while delivering enhanced insights and value.

Technology Solutions

Modern platforms must support these requirements through:

• Automated PHI/PII identification and protection
• Standardized data retention policies
• Streamlined user access management
• Integration with eClinical systems
• Comprehensive audit capabilities

The Egnyte platform addresses these needs by providing out-of-the-box policies for sensitive data identification, retention management, and seamless eClinical ecosystem integration. Its intuitive interface and built-in training simplify data governance without compromising functionality.

Looking Ahead

As organizations prepare for ICH E6 (R3), selecting the right technology partner becomes essential. Solutions like Egnyte offer more than just tools; we provide a partnership that ensures data confidence throughout the trial lifecycle. Organizations can meet new requirements with comprehensive governance capabilities and continuous support while enhancing clinical research efficiency. 

Egnyte for Life Sciences can seamlessly work with various data structures and eClinical ecosystems to deliver thorough data governance. It includes ready-to-use policies capable of identifying Protected Health Information (PHI), Personally Identifiable Information (PII), or other sensitive data. System administrators can easily manage user access and activity while delegating data oversight responsibilities to data owners for issue resolution. 

Its user-friendly interface and built-in training resources simplify data governance without sacrificing functionality.

If you would like to learn more about Egnyte for Life Sciences, Click Here.