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.
Does Everyone Use the CDISC 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 CDISC TMF Reference Model has become the most widely recognized framework for organizing the Trial Master File (TMF) — the collection of essential […]
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 […]
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 records that ensure compliance with Good Clinical Practice (GCP). […]
Hidden TMF Clinical Compliance Risks The Risk Of Inspectable Content Housed Outside the TMF In the fast-paced world of clinical trial compliance, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection readiness clinical trials. Yet, many sponsors inadvertently overlook critical good clinical practice (GCP) documentation. This oversight can create unnecessary stress […]
Clinical Trial Master File Trends from 2024 As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations. These are being driven by technological advancements and evolving regulatory requirements. At Just in Time GCP, we work with TMFs of all shapes and sizes, and this year, we have identified several clear […]
TMF Management in Clinical Trials: Ensuring Quality, Compliance, and Oversight Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her insights in The Clinical Trial Vanguard article titled The Trial Master File: A Window into the Quality of Any Clinical Study. The article underscores the TMF’s essential role in maintaining compliance, oversight, and data […]