This collection explores current GCP regulations and guidance shaping clinical trial oversight, including ICH E6(R3) and evolving regulatory expectations. The articles focus on how trial sponsors interpret and apply regulatory requirements in practice, with attention to accountability, risk management, and quality oversight.
From Principle to Practice: Applying the FDA and EMA AI Guiding Principles in Clinical Trials How Just in Time GCP Operationalizes the FDA and EMA Guiding Principles for Good AI Practice By Kathie Clark, Industry Expert; Technology & Innovation Partner, Just in Time GCP As AI-enabled tools are increasingly adopted across clinical operations, Life Science […]
Rethinking “State of Control” in a Cloud-Driven Clinical Environment Why Annex 11 Matters for eTMF — Even Outside GMP By Kathie Clark, Industry Expert; Technology & Innovation Partner, Just in Time GCP The new draft of EMA’s Annex 11 of the EU GMP guidelines governs computerized systems used in manufacturing environments. However, its principles—lifecycle validation, […]
GCP Was Built on GMP: Why Clinical Teams Need to Understand Their Shared DNA A Shared History Many Clinical Professionals Never Learn Good Manufacturing Practices (GMP) came decades before Good Clinical Practice (GCP). When regulators began shaping GCP in the 1970s–1990s, they did not build a new quality system from scratch. Instead, they extended the […]
What EMA’s New AI and Data Integrity Guidelines Signal for Clinical Research In July 2025, the European Commission opened a public consultation on updates to EudraLex Volume 4, with revisions developed by the EMA GMDP Inspectors Working Group, in cooperation with PIC/S. The consultation covers three documents: Chapter 4 – Documentation Annex 11 – Computerized […]
ICH E6(R3) Clinical Data Integrity & Technology Governance: A Priority Update for Sponsors ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to strengthen how they govern data and technology so their teams can maintain control across complex, multi-vendor environments. At Beyond Clinical Compliance on September 9 in Philadelphia, Donna […]
ICH E6(R3) Risk Management and Oversight: A Priority Update for Sponsors ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to prioritize process updates so their teams don’t waste time or miss critical risks. At Beyond Clinical Compliance, on September 9th in Philadelphia, Donna Dorozinsky addressed this challenge in […]
Why CTQs, Clinical Data, and TMF Oversight Matter More Than Ever in Risk-Based Review Under ICH E6(R3) For years, risk review meant one thing: checking documents in the Trial Master File (TMF). In practice, this meant asking questions such as: Have the right files been uploaded? Were they signed on time? Are they in the […]
ICH E6(R3) Sponsor Oversight: What Clinical Compliance Teams Must Know With ICH E6(R3) taking effect, sponsor oversight is entering a new era. The updated guideline makes it clear: sponsors must move beyond passive documentation and adopt a proactive, risk-based model of oversight. This isn’t just a compliance requirement—it’s a fundamental shift in how trials are […]
Records vs. Documentation in Clinical Trials: A Terminology Shift Under ICH E6(R3) In clinical research, precise terminology shapes compliance strategy. One of the most important shifts in the latest ICH E6(R3) Good Clinical Practice (GCP) guideline, finalized in January 2025, is the move from referring to “documents” to using the broader term “records.”As a result, […]
ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era of clinical compliance focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes familiar […]