Practical strategies for maintaining a complete, accurate, and inspection-ready Trial Master File. Topics include records processing, QC methods, metadata, reconciliation, and telling the full story of the study.
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, […]
Lessons from the 2025 CDISC US + TMF Interchange — By Kathleen Mellet, Business Analyst at Just in Time GCP and Project Manager for The CDISC TMF Standard Model How the TMF Community Is Shaping the Next Era of Standardization At this year’s CDISC US Interchange in Nashville, the Trial Master File (TMF) community came […]
The Next Era of TMF: Strategic Planning for the Digitization of the CDISC TMF Standard (formerly known as the CDISC TMF Reference Model) The Trial Master File (TMF) is entering a new era. As clinical research becomes more digital, decentralized, and data-driven, the way we structure and manage essential trial records must evolve too. That […]
Announced on October 13, 2025 – Learn More Here Does Everyone Use the TMF Reference Model? The short answer: no — not everyone uses it. But nearly every sponsor, CRO, and vendor in clinical research is influenced by it. The TMF Reference Model has become the most widely recognized framework for organizing the Trial Master […]
FDA Warning Letters aren’t just regulatory formalities—they’re red flags signaling oversight gaps that can jeopardize patient safety, trial integrity, and sponsor credibility.
Just in Time GCP Spotlight: Veeva R&D and Quality Summit 2025 The Just in Time GCP team attended the Veeva R&D Quality Summit in Boston, where we proudly served as a Gold Sponsor. The Summit was an exciting experience. It offered a chance to engage with Veeva experts, partners, and users, and to see innovations […]
Free Tools to Assess eTMF Health Practical, No-Cost Resources for TMF Oversight and Inspection Readiness Your Trial Master File (TMF) is more than a clinical record / document repository—it’s the official story of your study. And under the finalized ICH E6(R3) guideline, it must be managed with risk-proportionate oversight that extends beyond completeness to include […]
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, […]
Reclaiming Your Trial Master File: A Strategic Move Toward Stronger Clinical Compliance As clinical trial complexity grows and regulatory expectations continue to evolve—particularly with the release of ICH E6(R3)—more sponsors are rethinking how their Trial Master File (TMF) is managed. While Contract Research Organizations (CROs) remain essential partners in trial execution, many organizations are choosing […]
Just Announced October 13, 2025 – Read More Here Why the CDISC TMF Reference Model is Important for Smaller Companies Executing Clinical Trials If you’re a small or emerging life sciences company, navigating the complexities of clinical trials can be daunting. A key element to understand is the Trial Master File (TMF)—a collection of essential […]