Explore insights on ICH E6(R3), ICH E8(R1), and related guidelines shaping today’s clinical research landscape. Learn how evolving regulations impact risk management, quality oversight, and sponsor responsibilities
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 […]