The State of TMF

TMF Standard Model V1: From Reference Model to Digital Standard

Two years in development, the TMF Standard Model V1 draft opens for community review on October 19. What changes for your team? Paul Carter and Christina Mantzioros explain what V1 is and how it differs from the TMF Reference Model. You'll hear why V1 is a digital, evidence-based standard built around ICH E6(R3). You'll also hear about the features that set V1 apart: record groups and record types, stable unique identifiers, and one model covering drugs, biologics, medical devices, IVDR, RWE, and the investigator site file. You'll learn how V1 gives you consistent, machine-readable TMF content you exchange across systems and organizations. You'll also learn the steps your team should take now to prepare. Learn more about community review and compare your current TMF structure against the new record groups and types: https://www.cdisc.org/public-review/cdisc-tmf-standard-model-v1-community-review Signup to our upcoming product showcase where we'll perform a live demo of AI-assisted indexing in eTMF Connect: https://montrium.registration.goldcast.io/webinar/a9580101-3715-4c26-8d88-f6154a53a77d CHAPTERS: 0:00 Why regulators say less is more 0:59 Welcome to Episode 28 1:27 Why the TMF Reference Model needed to change 10:00 Will a standard mean less flexibility? 13:51 The new V1 structure 17:38 From 246 artifacts to 557 record types 21:30 From documents to records and evidence 22:38 How V1 maps to ICH E6(R3) 24:14 Why Core and Recommended go away 26:32 Poll on V1’s impact on the industry 29:28 Poll on when teams plan to adopt V1 34:02 Q&A on the TMF as an essential records ecosystem 38:15 Q&A on visualizing record groups and record types 39:08 Q&A on using metadata to tell the story of a study 42:46 Q&A on getting functional areas to own their records 46:04 No more record type for relevant communications and notes to file 48:57 Wrap up 49:49 November 18 product showcase on AI-assisted indexing (check the description to sign up)

Documents without a plot: why your inspector can't follow your TMF

A complete TMF doesn't always mean a clear one. In this episode, we dig into one of the most common and underappreciated inspection risks: the TMF that technically has everything, but still can't tell you what actually happened. We break down the two root causes that derail TMF narratives: missing context (the "why" behind decisions and deviations) and missing connections (how documents relate and sequence into a coherent study story). We'll also look at how inspectors actually read a TMF, and what they're really looking for when they try to follow the thread. 0:00 - The inspector confidence problem 0:53 - Welcome and introductions 2:35 - From paper TMF to digital overload 5:00 - What ICH E6(R3) really means 10:30 - Why more documents is riskier 13:30 - Relevant communications: what to file and what to cut 19:30 - How inspectors actually read a TMF 23:30 - Records living outside the TMF 34:30 - How AI helps with curation and essentiality 44:00 - The mindset shift: from filing to narrating 46:00 - What's coming next

The CRO TMF Handoff: The solution to hidden compliance gaps in CRO to sponsor TMF transfers

This is no April Fools joke...The State of TMF podcast is back for a new season and we're jumping into a hot topic. The end-of-study TMF transfer shouldn't be a black box. But for too many sponsors it is, until they're staring down a list of inspection findings. In this episode, Paul Carter and Christina Mantzioros share tried and tested ways to identify TMF problems before your CRO sends the final package, and how AI-powered risk models can help you verify completeness and quality without manually checking thousands of documents. CHAPTERS: 0:00 Introduction 1:00 Season 4 Premiere & Episode Overview 2:00 Sponsor Oversight Challenges When CROs Manage the TMF 7:00 When the CRO Hands the TMF Back: What to Expect 10:00 Archiving the TMF: Where to Store It and What's in Scope 13:00 TMF Plans, Data Transfer Agreements, and Authoritative Source 17:00 Evaluating TMF Quality at Handover: Evidence of Oversight 20:00 Risk-Based Oversight and ICH E6(R3) Requirements 23:00 Q&A: Contract Timing, Cost Pressure, and CRO Access 27:00 What Regulators Expect: Proactive vs. Reactive Oversight 30:00 Q&A: Transferring Documents and Audit Trails 35:00 How AI Can Improve TMF Oversight 41:00 Q&A: Using AI Securely and Deterministically 46:00 Closing & Season 4 Episode 2 Preview

Quality by Design: Bridging the TMF - Quality Gap in Your Study

In this episode, our experts will be diving into QbD and how this proactive approach is shaping clinical trial management. From ensuring compliance to improving overall trial efficiency, we’ll explore why embedding quality from the start is critical for clinical success. Joining us for this discussion is our President & CEO, Paul Fenton-Carter, and our Head of eTMF Services, Donatella Ballerini. Together, they’ll break down how QbD principles can enhance TMF quality, reduce risks, and future-proof trial documentation. ------------------------------------- CHAPTERS: 00:00 Hot Take w/ Paul Fenton-Carter 00:40 Speaker Intros 01:39 It's a Jurassic World when it comes to quality (topic intro) 05:32 The importance of quality in clinical trials 08:58 Processes (SOPs) for quality 14:45 How to define the list of essential records? 19:22 Where QMS meets TMF & SOP 33:20 Agile TMF vs the current TMF situation 33:04 Benefits of the integration, Manual integration and the future 41:03 QbD is a mindset not just a methodology & questions 49:24 Sign up for TMF Week 2025 & wrap up 52:11 Outro ---------------------------------------- Sign up to TMF Week 2025: https://www.tmfweek.com/ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

ICH E6(R3): The Birth of the (Digital) Record

In this episode, our experts will be diving into ICH E6(R3) and the shift from documents to truly digital, regulatory-compliant records. Clinical trial management is evolving, and this discussion will explore what that means for the future. Joining us for this conversation is our President & CEO, Paul Fenton-Carter, , alongside Karen Roy from Epista and Joanne Malia from Regeneron. Together, they’ll discuss what we know about ICH E6(R3) now, what's to come in the future, and how this shift will impact the industry. _____________________________________________ CHAPTERS: 00:00 Hot Take w/ Joanne Malia 00:30 Welcome and topic intro 01:03 Guest intros (Joanne Malia and Karen Roy) 03:53 Important changes to the final version of ICH E6 R3 06:39 Areas where risk-based approach is useful 08:05 ICH M11 & digital protocol 10:21 Names changes, terminology & guidance documents 13:26 Question from the audience (Nomenclature) 15:20 ICH and the TMF Reference Model 17:25 Criteria /decisionguide 20:14 Timeline for TMF Ref Model V4 22:45 Essential records table & Records that go across studies 27:05 Questions from the audience 41:33 Wrap up 44:41 Outro _____________________________________________ Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Joanne Malia: https://www.linkedin.com/in/jsmalia2008/ Karen Roy: https://www.linkedin.com/in/karenjroy/ _____________________________________________ TMF Reference Model V4 Refresh: https://www.cdisc.org/standards/trial-master-file-reference-model Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Bridging Files - A look at the ISF Reference Model

Host Paul Fenton-Carter of Montrium is joined by Jamie Toth of BeiGene and Matt Lowery of The Pathways Group, two key contributors deeply involved in shaping this groundbreaking project. Together, they explore the progress made so far, the challenges faced, and what the future holds for the ISF Reference Model. From aligning global teams to addressing practical implementation hurdles, this episode offers valuable insights for anyone invested in improving clinical trial documentation practices. CHAPTERS: 00:00 Hot Take w/ Matt Lowery 00:35 Guest intros (Jamie Toth and Matt Lowery) 01:55 Topic Intro & History of ISF 04:20 ISF Initiative Overview and Timeline 10:32 ISF Facts 12:28 ISF Structure 21:09 A snapshot of final draft of the ISF Reference Model 22:39 Quiz Time 23:38 Final draft snapshot continued 25:25 Matt's take on packages and sub-packages 26:24 How does the TMF Reference Model align with the ISF 29:30 The three additional ISF artifacts 34:09 ISF Initiative ongoing and future activities & questions 48:51Wrap up and final thoughts 50:49 Outro ------------------------------------------------------------ Connect with Host and Guests: Paul Fenton-Carter: https://www.linkedin.com/in/paul-fenton-carter-360b531/ Jamie Toth: https://www.linkedin.com/in/jamie-marie-t-759772/ Matt Lowery: https://www.linkedin.com/in/mattlowery/ ------------------------------------------------------------ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Ask Paul - Our CEO Answers Your Most Pressing TMF Questions

Get ready for an engaging and interactive episode of The State of TMF! Montrium’s CEO, Paul Fenton-Carter, takes center stage for a no-holds-barred AMA (Ask Me Anything) session. Paul will be answering questions submitted by the audience, diving into key topics shaping the TMF industry today, from current challenges in clinical documentation to the future of TMF management in a rapidly evolving landscape. Whether you’re curious about his vision for the industry, best practices for TMF management, or insights into upcoming trends, this is your chance to hear directly from one of the leading voices in the field. CHAPTERS: 00:00 Topic Teaser w/ Paul Fenton-Carter 00:28 Speaker and topic intros 01:36 Exploring how the role of the TMF manager is evolving 06:05 Examining the industry's progress in adopting risk-based TMF management 12:40 Insights on the rapid incorporation of AI and its impact on TMF management 18:02 Discussing the challenges of accurately measuring completeness 24:25 Understanding the importance of ICH M11 and its impact on TMF 31:00 Key considerations around ICH E6(R3) and its implications for TMF 37:39 Addressing common misconceptions about TMF 38:40 Wrap up 39:20 Outro _______________________________________________ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Setting New Standards: What's in V4 of the TMF Reference Model?

A lot has changed since Version 3 of the TMF Reference Model was released in 2015. The growing adoption of digital technologies, combined with increasing amounts of data collection, have made for a vastly different landscape—one that requires different approaches to TMF management. Thus, enter: Version 4 of the TMF Reference Model. In this expert-led breakdown of V4, Montrium's President & CEO (and new co-chair of the TMF Reference Model) Paul Fenton-Carter is joined by the model's founder and former chair, Karen Roy. Together, they'll explore the new features and changes you'll be seeing in V4, as well as the impact these updates will have on clinical documentation management practices in the digital age. CHAPTERS: 00:00 Topic Teaser w/ Karen Roy 00:25 Topic intro 00:43 Speaker intros w/ Paul Fenton-Carter & Karen Roy 02:27 History of the TMF Reference Model 07:25 Regulatory Evolution and other factors 10:00 What is a Digital TMF 12:23 Benefits of becoming a Digital Standard 17:01 The Data Driven Approach & Digital Protocols 23:28 Heads of TMF and what they need to know about USDM 26:54 The future of TMF Reference Model V4 & Goals 35:09 The importance of standardizing Sub-Artifacts 43:51 V4 (TMF RM) Org Chart 51:15 How to get involved? 56:15 Wrap up 57:11 Outro ________________________________________________________________ CDISC Sign-In: https://www.cdisc.org/sign-in Paul Fenton-Carter email: pfenton@montrium.com Karen Roy's email: kroy@cdisc.org Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Unlocking the TMF Goldmine: Why M11 & DDF Are the Key to Digital TMF

From paper to pixels, the TMF has come a long way in its digital transformation—and so have the ways in which we manage it. In this episode, Paul Fenton of Montrium and Nick Hargaden of Moderna will explore the future of the TMF as it transitions into a fully digital landscape. We'll discuss the current gaps that prevent TMF from being truly digital and examine key industry initiatives, including ICH M11 and Digital Data Flow from Transcelerate, to understand their impact on eTMF systems. We'll also highlight the benefits of a data-driven approach in enhancing quality, timeliness, and compliance, while revealing how it can unlock the vast goldmine of information stored within the eTMF to improve oversight and streamline clinical process management. CHAPTERS 00:00 Topic Teaser 00:50 Speaker intros 03:36 Topic intro 04:30 The Heart of Digital TMF and the new standard ICH M11 17:20 How will the new standards affect Sponsors and CROs? 19:41 Functions impacted outside of TMF with the new standard 25:00 Impact on the vendor ecosystem 29:24 The regulatory impact 34:50 How can Sponsor adapt to the new standard? 37:24 Will Regulatory bodies be lenient with the changes? 40:05 Regulatory processes 42:30 Hurdles Vendors and Sponsors might face with the implementation of M11 45:45 How to prepare for the changes 48:25 Wrap up 49:15 Outro _____________________________________________ Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

• Chapters

More than an Archive - Moving to an Active TMF Management Model

Managing your TMF program effectively with outdated or inefficient processes can feel overwhelming, especially with limited resources and an evolving regulatory environment. Today, teams are transitioning away from passive TMF models that prioritize an archivist mindset towards a more modern and agile approach to TMF focused on managing and compiling the TMF in an active manner. In this session, Donatella Ballerini and Oliver Pearce of Montrium will guide you through the essential components of active TMF management. They will introduce Montrium's TMF Maturity Model, providing a structured approach to evaluate and advance your TMF processes. You'll learn how to leverage technology for real-time oversight and ensure your TMF team maintains an agile TMF mindset. --------------------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Battle of the Binders: What's the Difference Between the TMF & the ISF?

Distinguishing between the ISF and the TMF is an all-too-frequent source of confusion in clinical documentation. Are they the same? Are they different? The answer to both of those questions is yes. Join special guests Aryn Knight and Matt Lowery as they get into the nitty gritty of the great ISF-TMF debate. We'll be covering which contents are specific to the ISF vs which are specific to the TMF, who is responsible for each, their different regulatory requirements, and inspection readiness for both. --------------------------------------------------------- Aryn Knight on LinkedIn: Matt Lowery on LinkedIn: Register for for episode #9 @TMF Week 2024 Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Leaving No Stone Unturned: The TMFer’s Guide to Audit Trail Reviews

Audit trail reviews may be a hot topic in the world of TMF right now, but that doesn't mean people know how to do them the right way. In this episode of The State of TMF, our experts will explain everything you need to know about audit trail reviews. We'll be going over the basics of audit trail reviews, the "why" and "how" of routine ATRs, which high-risk data points you should be reviewing, and more! ----------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/ Register for TMF Week 2024: https://www.tmfweek.com/

Finding Flexibility in a Framework: How to Build an Adaptive TMF Index for Any Study

It's important to have standards—especially when it comes to the TMF index. Aligning your TMF index to the CDISC TMF Reference Model makes it easy for organizations to speak the same language, helps you breeze through M&As, and streamlines system migrations. In this episode of the State of TMF, our host Oliver Pearce will be joined by guest Anne Ackley-Fifer from Daelight Solutions. They'll discuss how you can build a flexible and adaptive TMF index for any study, without straying from the standard ----------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/ Daelight Solutions: https://daelightsolutions.com/

Cracking the TMF Culture Code: Building Champions & Getting Non-TMF’ers engaged

If the TMF is the cornerstone of a clinical trial, then why do so many TMFers find themselves having to convince others of its importance? The answer: culture. In this episode, we crack the TMF culture code and explain how you can get stakeholder buy-in, keep non-TMFers engaged, and ensure that everyone is doing their part. Our experts will discuss tips for training, ways to gamify TMF management, the process of creating TMF champions, and more! ----------------------------------------------- Subscribe to The State of TMF Live Events: https://hubs.ly/Q01Hy0NW0 Join our community: https://hubs.ly/Q027nggP0 Join us on Instagram: https://www.instagram.com/montrium/ Join us on Facebook: https://www.facebook.com/Montrium/

Crafting a TMF Training Program for your Team

We kicked off 2024 with our most popular State of TMF episode yet! Loads of you turned up to last week to learn more about TMF training—and how to do it right. Not only did our hosts share their foolproof 5-step formula for crafting an effective TMF training program for your team, but they also got real about some of the training struggles they've faced throughout their careers. If you or your team ever struggle to understand roles, responsibilities, TMF maturity levels, and any of the other complexities that come with this line of work—then this episode is for you! ----------------------------------------------- Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/ Join us on Facebook: https -> https://www.facebook.com/Montrium/

Risk-Based TMF Management 101

Risk-based TMF management is set to be all the rage in 2024, and we want to help you hit the ground running. On the latest episode of The State of TMF, our experts shared their innovative and unique approach to risk-based TMF. They were also be joined by InSeption Group's EVP of QA & Compliance, Dawn Niccum, to discuss the past, present and what all TMF'ers need to know about the imminent future of risk-based TMF. Plus, get a FREE copy of our brand-new white paper detailing our approach to risk-based TMF management. ----------------------------------------------- Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/ Join us on Facebook: https -> https://www.facebook.com/Montrium/

Trackers & Logs in the TMF: Where to file them?

Trackers and logs are a notorious source of confusion in the TMF. But fear not, because our experts joined forces to discuss exactly where you should be filing trackers and logs in your TMF. They also shared a real (scary) story about what happens when an inspector asks to see a log that wasn't maintained 😱 and how you can avoid this happening to you. How are you enjoying The State of TMF series? We want to know what you love, what you don't love, and your suggestions for making it the most valuable podcast possible. You'll also get the chance to leave your own burning question(s) on the hot topic of risk-based TMF so we'll be sure to cover them in the next episode. You can fill out the super quick, 2-minute touchpoint by clicking this link -------------------------------------------------------------------------- Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Join us on Instagram: https -> https://www.instagram.com/montrium/ Join us on Facebook: https -> https://www.facebook.com/Montrium/

TMF Tell-all: Unveiling the State of TMF Annual Industry Report 2023

Our experts sat down to discuss the unexpected findings from our first-ever industry report and graced us with some non-stop fire insights about the TMF world of today, and tomorrow. It was the perfect way to kick off the second season of The State of TMF. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join our community -> https://hubs.ly/Q027nggP0 Read the State of TMF Industry Report 2023 -> https://hubs.ly/Q027nlrf0

Inspection readiness toolset - What tech do we need for the future?

On the final episode of Season 1 of The State of TMF, our panel of experts did a deep dive into the tools you need to be inspection-ready—today AND tomorrow. Our host, Oliver Pearce, was joined by Paul Fenton and Donatella Ballerini from Montrium, and Jamie Toth from BeiGene. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0

Is eTMF tech working for small companies?

In this "food for thought" episode, our panel of experts explored the challenges presented by the eTMF technology currently available in the life sciences industry. Paul, Christina, and Oliver offered practical and actionable recommendations that small companies can take when implementing an eTMF system. Subscribe to The State of TMF Live Events -> https://hubs.ly/Q01Hy0NW0 Join The State of TMF Community to keep learning -> https://hubs.ly/Q01DJHnL0