Harnessing ICH GCP E6(R3): Empowering Sites and Sponsors for the Future of Clinical Trials
On January 6, 2025, the International Council for Harmonisation (ICH) took a decisive step forward with the finalization of ICH E6(R3), marking a significant evolution in the global regulation of interventional clinical trials. With the principles and Annex 1 now in Step 4, regulatory adoption by ICH member countries is imminent.
ICH E6(R3) preserves the foundational ethos of its predecessor while embracing the realities of decentralized trials, technology-enabled collaboration, and risk-based thinking. Critically, it emphasizes sponsor-site partnership, underscoring the importance of mutual accountability, effective communication, and proactive support to uphold Good Clinical Practice (GCP).
Florence is helping the industry move from passive compliance to active enablement – making ICH E6(R3) not just a regulatory requirement but a strategic advantage.
What Sponsors Need to Know – and Do
ICH E6(R3) emphasizes that sponsors must actively support their sites. It’s not enough to hand off responsibilities. Instead, sponsors must foster a dynamic, tech-enabled partnership to ensure quality, participant protection, and data reliability.
Key Sponsor Responsibilities Under E6(R3):
- Promote Quality by Design : Sponsors should embed quality into study planning and operational design. This includes leveraging historical site performance data to select fit-for-purpose sites and defining processes that minimize unnecessary burden.
- Enable Remote Oversight: Real-time, remote access to site documentation and activity logs is now essential. Sponsors must move beyond static monitoring visits to continuous, centralized oversight that flags risks proactively.
- Collaborate Transparently: E6(R3) requires effective communication between sponsors and sites. Tools that facilitate shared access to essential documents, monitoring feedback, and action items are critical to meeting this expectation.
- Use of Technology and Digital Systems: ICH E6(R3) sets clear expectations for validating and managing digital systems, emphasizing data integrity, access controls, and security. Sponsors must ensure oversight of both sponsor- and site-owned systems and establish processes for timely issue reporting across all technologies used in the trial.
Florence SiteLink® empowers sponsors to meet these demands with:
- Centralized, real-time monitoring dashboards across all trial sites and CROs
- Incomplete documents, and site performance anomalies
- Automated, compliant audit trails of all activity across folders and documents
- Seamless generation and storage of certified electronic copies with robust permission controls
Don’t simply comply with the new ICH GCP E6(R2) guidelines, harness them to accelerate your clinical trials.
What Sites Need to Know to Stay Compliant – and Empowered
Sites play an equally critical role in ICH E6(R3)’s collaborative model. The guideline reinforces that sites maintain control over their own documentation while also participating in quality planning and execution.
Key Site Expectations Under E6(R3):
- Own Your Essential Documents: Sites must maintain visibility and control of their trial records before, during, and after the study, ensuring integrity and accessibility throughout.
- Facilitate Inspection Readiness: Whether for internal quality checks or external audits, sites should be able to demonstrate data completeness, accuracy, and traceability—at any time.
- Engage in Continuous Quality Improvement: Sites are encouraged to proactively identify operational risks and communicate them with sponsors, CROs, or regulatory authorities.
Florence SiteLink® is designed with site enablement in mind, providing:
- Site-owned digital workspaces where all essential documents are housed
- Built-in version control and audit trails to ensure data provenance
- Powerful search functionality for inspection readiness at a moment’s notice
- SOP-backed infrastructure that ensures integrity even during system upgrades
Beyond Compliance: Operationalizing ICH E6(R3) with Florence SiteLink®
Florence SiteLink® doesn’t just check the regulatory boxes – it operationalizes ICH E6(R3) principles into every workflow:
|
E6(R3) Expectation |
SiteLink® Capability |
|
Remote oversight (3.11.4) |
Real-time monitoring of sites and CROs |
|
Centralized essential documents (Appendix C). |
Unified platform for all trial stakeholders |
|
Data integrity and audit trails (4.2) |
Always-on tracking of document lifecycle |
|
Risk-based quality management (3.10) |
Alerts and analytics for early issue detection |
| Investigator record control (2.12, C.3.3) |
Investigator-led document management |
Looking Ahead: R3 as a Catalyst for Collaboration
ICH E6(R3) is more than an update – it’s a call to reimagine how sponsors and sites work together. The days of fragmented, reactive trial oversight are over. With Florence, sponsors and sites gain the tools to build a shared foundation of trust, transparency, and performance.
By adopting technology that enshrines the principles of ICH E6(R3), your teams can reduce protocol deviations, accelerate timelines, and improve participant safety – all while staying fully inspection-ready.
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