Blog Posts
TMF University: Accredited TMF Training for Clinical Trial Professionals
TMF University: Build the Next Version of Your TMF Career Clinical trial teams are being asked to do more than manage TMF records. They are expected to understand the “why” behind TMF processes, support inspection readiness throughout the study lifecycle, and make decisions that strengthen quality, oversight, and accountability. That is where TMF University comes…
Read MoreCelebrating Clinical Trials Day: The Story Behind the TMF
Every May 20, the clinical research community pauses to recognize Clinical Trials Day, a global celebration of the people, processes, and progress that make medical advancement possible. The history of this day traces back to May 20, 1747, when James Lind, a surgeon in the British Royal Navy, began what is often considered one of…
Read MoreTMF Talks Series: Document QC Beyond the Checklist
TMF Talks is a live, interactive webinar series built around real questions from the TMF community. Pooja Brahmbhatt and Ben Rogers will discuss what meaningful QC looks like in practice, including how to document findings, trends, and follow up actions. Attendees will gain insight into how strong QC practices strengthen accountability and provide credible evidence of oversight when teams are questioned during inspections.
Read More8 Practical Next Steps for Stronger TMF Indexing
Based on the discussion in Practical TMF Indexing for Real World Scenarios featuring Janice del Rosario and Ben Rogers, here are eight practical steps teams can take next. 1. Confirm who owns the TMF index Make sure one person or group is responsible for leading updates, resolving ambiguity, and coordinating cross functional input. Shared responsibility…
Read MoreTMF Talks Series: Practical TMF Indexing for Real-World Scenarios
Janice del Rosario and Ben Rogers will share practical examples and decision-making approaches that help teams create consistent, defensible indexing across studies. The discussion will emphasize how clear indexing supports retrieval, oversight, and the ability to confidently explain TMF structure during audits and inspections.
Read MoreA Reminder of Why This Work Matters
This weekend, I drove two hours to visit my dad. I hadn’t seen him in a while, and he had just celebrated another birthday. As our parents get older, those visits start to mean a little more. We were sitting in the living room talking when he casually said, “Did you know I’ve had three…
Read MoreRare Disease Day: Why Every Document Matters More
Rare Disease Day is a reminder that behind every protocol number is a person. A family. A timeline that feels urgent. In rare disease research, there are no redundant trials. There are no “we’ll fix it next time” opportunities. Many studies involve small patient populations, global site distribution, accelerated pathways, and heightened regulatory attention. That…
Read MoreHow to Demonstrate Effective Oversight in Your TMF Part 2
The discussion will cover how to select metrics that show quality and risk rather than volume, how to trend data to demonstrate continuous oversight, and how documentation and metadata work together to support a clear inspection narrative. Attendees will gain practical guidance on preparing evidence that inspectors can follow without additional explanation.
Read MoreHow to Demonstrate Effective Oversight in Your TMF Part 1
This session will explore how to define oversight responsibilities, align TMF practices with current regulatory expectations including ICH E6 R3, and avoid common gaps that weaken inspection narratives. Attendees will gain practical insight into building an oversight framework that supports quality decision-making and stands up to regulatory scrutiny.
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