Trial Master File
17 videos · last 6 months shuffled daily, then older videos newest first
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59:23 AI-Driven CTMS, CTFM and eTMF Workflows in One Trial
Cloudbyz walks through its CTMS, clinical trial financial management and eTMF modules in a single trial, including AI agents that extract a protocol's schedule of activities and reconcile site invoices.
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41:57 TMF Structures for Adaptive Platform Trials
An Australian Clinical Trials Alliance presentation on structuring the trial master file for adaptive platform trials, including operational issues and applying a standard TMF and ISF index in a multi-centre, multi-country trial.
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38:13 Day 1 Session 1 - TMF 101: Crash Course in Trial Master File Fundamentals
A Montrium session on what a Trial Master File is, how it fits into the ICH-GCP framework, and who is responsible for it at each stage of a trial.
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44:40 Why Most TMF Leads Struggle With Oversight (And How to Fix It)
Nicole Palmer talks to a Trial Master File lead about building the oversight systems that keep a TMF inspection-ready.
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8:11 Why Signing In and Out of a Study Matters for the TMF
A TMF Daily Podcast episode on why signing in and out of a study matters for traceability, audit findings and keeping the Trial Master File inspection-ready.
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51:40 CRA Truths: Drowning in Documentation
Five CRAs and industry professionals discuss handling documentation across the life cycle of a clinical trial, from feasibility onward.
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2:04:11 EU Clinical Trials Regulation and the TMF
A TMF Reference Model workshop led by Karen Roy, Martina Duevel and Russell Joyce on how the EU Clinical Trials Regulation changes trial master file content and process.
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43:54 AI-Driven Document Management in Clinical Research
Angie Schwab of EZ Research Solutions discusses time lost to manual document management in clinical research and how AI-driven platforms address compliance, on the TMF Daily Podcast.
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40:18 TMF Inspection Readiness with Chad Scribner
Chad Scribner, senior consultant at Epista Life Sciences, discusses TMF inspection readiness on the TMF Daily podcast, including risk-based TMF reviews, ancillary systems, meaningful metrics and the red flags inspectors spot.
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12:37 Everest CRO Experience with Flex Databases
Dana Leff Niedzielska, SVP of global clinical operations at Everest Clinical Research, on how the CRO uses Flex Databases' CTMS and eTMF in its clinical operations.
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24:02 Best Gateway into Clinical Research? The CTA
CRA Corner's Maria talks to Alexandra, a Clinical Trial Assistant working in the UK, about the CTA role and how people break into clinical research.
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43:40 This Is What’s Quietly Failing Your TMF (Monitoring Oversight & QC)
Ellie Houston on monitoring oversight and quality control in the trial master file, and why some studies stay inspection-ready while others scramble.
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38:19 Clinical Research in India and the U.S. Compared
Sanket Shah, a clinical research leader at Shine TCS, compares how trials are run in India and the United States on the TMF Daily podcast, covering operations, culture, regulation and quality systems.
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36:33 Translation Accuracy and AI in Global Clinical Trials
Duncan Shaw, President and Owner of DTS Language Services, discusses translation risk in global trials, regulatory-grade accuracy for sponsors, CROs and IRBs, and the limits of AI translation, on the TMF Daily Podcast.
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46:22 Core eTMF Features and Practices
The in-house experts explain in detail what an eTMF is, the benefits and core features of an eTMF, compliance requirements, as well as how to choose the right eTMF vendor.
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1:24:53 The Importance of Clinical Trial Master Files (TMF) with Doran Triggs, BS
Doran Triggs of the Stanford Center for Clinical Research on what a trial master file is, what it must contain, how to manage it and how to stay inspection-ready.
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43:04 Day 1 Session3 - Streamlining the TMF Reference Model for Optimal Clinical Trial Document Management
Montrium on what happened when one sponsor's use of the TMF Reference Model grew too complex, and how they streamlined it during an IT migration.