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.
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 […]