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Implementing the TMF Reference Model
The document outlines a webinar discussing the implementation of the TMF Reference Model and its relevance in managing clinical trial documentation. It covers topics such as adapting the model for trial organizations, electronic TMF systems, and the TMF Exchange Mechanism Standard. The session also features insights from professionals in the life sciences industry and emphasizes the framework's benefits for compliance and efficiency.
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Implementing the TMF Reference Model
- 1. How to Implement theTMF Reference Model 1
- 2. House Keeping About thecompany • This webinar is being recorded and will be made available after this session • Feel free to use the chatbox to submit your questions at anytime • Q&A will take place at the end of the webinar • We will send these slides to your email at the end of the webinar
- 3. 3 Agenda LIVE WEBINAR • TMFReference Model overview and organization • Adapting the Model for any trial organization • Applying the Model in eTMF • Enabling the TMF Exchange Mechanism Standard
- 4. 4 Meet Your Speakers Paul Fenton— Presidentand CEO, Montrium Fran Ross— Consultant, CGI
- 5. • Montrium wasfounded in 2005 • Headquartered in Montreal, Canada • EU HQ in Brussels • Clients in North America, Europe & Asia • Work exclusively in the Life Sciences Industry • We have over 8000 Users in 20+ Countries • Leading Content Management Platform • Experienced Professional Services Group 5 About Montrium Connecting People, Processes & Technology About the company
- 6. 6 Electronic Content Management &Business Intelligence for Clinical Trials connect platform Regulatory Document Management & Submission Planning for Drugs and Devices Integrated and Data Driven Quality Management Solutions for Life Sciences
- 7. © 2019 CGIConfidential Range of services High-end IT and business consulting Systems integration IT and business process outsourcing Differentiators 7 Client-proximity model Industry domain expertise Intellectual Property Global delivery network CGI is global end-to-end IT and business services provider $8.7 billion revenue 74,000 professionals 40 countries 400 locations 5,000 clients 150 IP-based solutions
- 8. 8 POLL A B OU T T H E C O M P A N Y What is your highest priority TMF challenge today? a) Leveraging the TMF Reference Model b) Improving our eTMF system c) Exchanging TMF records d) Getting through an inspection e) All of them!
- 9. TMF Reference Model Overview SE C T I O N # 1
- 10. 10 What is the TMF Reference Model? AB O U T T H E C O M P A N Y Industry consensus catalog of all TMF records ICH E6 Section 8 Essential Documents plus Adjudication, EDC, Data Mgmt, Statistics, etc. Drives clarity on the records to protect for clinical trial inspection Rigorous, extensive, collaborative and exhaustive life science community effort Positive feedback by Regulatory Authorities (not regulation nor requirement) Most recent version = TMF RM v3.1 TMF Ref Model By the Numbers • >400 members on team • 60% US, 35% EU, 5% AP • >400 Companies • Pharma • CRO • Vendor • Regulatory agencies MHRA FDA EMA JPMA Tech/ Other Pharma CRO/ Consult. Consortium Companies
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- 12. TMF Ref Model Participation CommunityMeetings every other month Insights exchanged via LinkedIn and Yahoo groups Join (or start) community initiatives: - Change Control Board, eTMF-EMS - Document Date Conventions, TMF Plan Template, TMF Metrics ALL WELCOME TO JOIN! www.tmfrefmodel.com
- 13. How is theTMF Ref Model structured? 13 Zone # Zone Name Typical Functions Zone 1 Trial Management Clinical Operations Zone 2 Central Trial Documents Clin Ops, Med Writing Zone 3 Regulatory Regulatory Affairs Zone 4 IRB / IEC Clin Operations Zone 5 Site Management Clin Operations Zone 6 IP and Trial Supplies Clin Operations, IP Supply Zone 7 Safety Management Safety Zone 8 Central and Local Testing Clin Operations, Bioanalytics Zone 9 Third Parties Legal, Procurement, Operations Zone 10 Data Management Data Management Zone 11 Statistics Statistics
- 14. 14 Poll Where are youon the TMF Reference Model continuum? a. Using version 3.0 or later b. Using version 2.0 or earlier c. Working on TMF RM adoption d. Thinking about adoption e. Need more information
- 15. Adapting the Modelfor any trial organization S E C T I O N # 2
- 16. 16 TMF Information Architecture A B OU T T H E C O M P A N Y • TMF IA = organization’s baseline for: • Trial audits and inspections • eTMF configuration • SOPs • Clinical system interoperability • IA is a crucial component of GCP inspection surety, and cornerstone for clinical trial technology initiatives • Without a thorough TMF IA, organizations cannot transform TMF management from a burden to an asset
- 17. TMF Information Architecture •Refine TMF Ref Model to organization specificity • Ensure enterprise transformation from “their TMF” to our TMF • Full view to all clinical inspection record types TMF Information Architecture TMF SOP Index Other critical records (systems, process) TMF Reference Model v3.1 Goal: TMFs autonomously demonstrate the full study story and prove compliance: • Protocol followed • Subjects protected • Data solid
- 18. TMF Information Architecture TMFIA is: • Adopted from TMF Reference Model • Global TMF baseline for all studies • Clarifies standard “systems of record” • Details initial eTMF config insights • Used as starting point for each study’s TMF structure TMF IA requires governance to stay aligned to: • Health Authority changes • New clinical practices • Your SOP landscape • eTMF Capabilities 18 TMF Master Index eTMF Config Systems of Record • EDC • Safety • IRT
- 19. 19 How do youstart it? Prepare - do the ground work • Join the TMF Reference Model community, understand the landscape • Know your TMF issues, find the applicable colleagues, ensure sponsorship Clarify - differentiate the mission • What will your TMF IA deliver, what will it not solve • Share “TMF Basics”, ensure common terms and language • Complete a current SOP gap analysis, create your baseline IA workbook
- 20. 20 How do youfinish it? Gather – drive the discussion • Set meeting norms, parking lot, expectations • Conquer non-controversial records first (zone two before zone nine) • Acknowledge gaps, track issues and move on • Defer black holes – content creation complexity, third party differences, intra- department sore spots • Answer any question with an inspection view “So fifteen years from now, the inspector…” Accomplish – apply the results • Celebrate the effort and the wins • Inform everybody about everything • Apply results –SOPs, change management, eTMF config, etc. • Safeguard the IA workbook
- 21. TMF Master –example column types 21 Record Name Expires (Y/N) Signature (Y/N) Restricted (Y/N) System of record Accountable TMF Plan N N N eTMF Clin Ops Study Operations Manual N Y N eTMF Clin Ops Master Randomization List N N Y IRT Biostats Third Party Contracts Y Y Y eContract Legal
- 22. How long doesTMF IA take? Good enough is great! • Complete v1.0 mastery can take 4 to 12+ months • Achieve as much specificity as possible o Expect clarity on the majority of critical record decisions o Defer items needing future attention • Drive just over the speed limit o Request forbearance, appreciate cooperation • Keep the laser focus on inspection “So twelve years from now, the inspector would find ….” 22
- 23. 23 TMF Reference Model Benefits Benefits of usingthe Model • Tested and vetted by scores of life science organizations • Industry Interoperability with trial third parties (CROs) • Clinical partnerships and M&A • OOTB alignment across the eTMF Vendor community The Model is the START, not the FINISH • Consensus, group-sourced Model = inherent compromise (record buckets, trial type records) • Results should vary: your TMF needs specificity for your organization, your SOPs and your users • Clarity in TMF IA drives excellence in eTMF
- 24. Applying the Modelin eTMF S E C T I O N # 5
- 25. The reference modelwas designed for both paper and electronic systems…
- 26. Implementing the modelin an eTMF There are certain considerations that need to be taken in to account when implementing it in an electronic system: • Compliance – Does the vendor of the system already provide a configuration which is aligned with the TMF RM • Document types – there could be many more than the artifacts within the model, use of sub-artifact names could be useful • Versioning – how to manage/update RM versions within your system • Completeness calculations – using the core or recommended column to define what is required
- 27. Implementing the modelin an eTMF cont’d • Referencing – Use the artifact number and unique ID • Structure – leverage the process zone and section structure to facilitate navigation • Date conventions – leverage the date conventions in the model to provide a basis for calculating timeliness • Import/Export – The RM can provide a baseline to facilitate the identification of TMF content that needs to be exported/imported between 2 parties – eTMF-EMS takes this further • Metadata – align with the eTMF-EMS where possible
- 28. 28 POLL Have you implementedan eTMF which integrates the TMF Reference Model? a) Yes, we implemented an eTMF which uses the Model as is without any modifications b) Yes, but we made some changes to the RM c) No, it was impossible to implement the RM in our eTMF d) We don’t current have an eTMF
- 29. Enabling the TMF Exchange MechanismStandard S E C T I O N # 6
- 30. • An extensionof the TMF RM which focuses on the transfer of content, metadata, audit trail and eSig information • A TMF metadata standard • A mechanism for exchanging TMF content between systems • A method for describing TMF artifacts which is comprehensible by both humans and machines What is the eTMF-EMS Electronic Trial Master File – Exchange Mechanism Standard
- 31. What are wetrying to solve • More electronic systems are being used to manage TMF • Most systems use the TMF RM to organize artifacts • At the end of the study, the TMF needs to be transferred back to the sponsor • This often requires a significant amount of mapping and manipulation to be able to import the content Solution: A transport protocol which facilitates exchange of eTMF content…The eTMF Exchange mechanism Standard
- 32. • Prior tothe TMF RM, organization of TMF content was a free-for-all • Since then, we have seen massive uptake of the TMF RM across the industry and globally • The TMF RM provides us with structure and a certain level of ‘standardization’ • Focus is still very much on the organization of the artifacts rather than describing artifacts through metadata • This is a challenge for systems…the eTMF-EMS is aiming to solve this Where we have come from
- 33. • The eTMF-EMSsubgroup is composed of around 25 members from pharma, CROs, vendors and consultants • The group is overseen by the TMF RM steering committee • Active for around 2.5 years and meets weekly • Significant interest and support from industry • Vendor and Business round tables working on implementation Who is involved?
- 34. How it works TransferID ProcessZone Section Section Section Artifact Artifact Content Export XML Exchange File XML XSD Checksum
- 35. How could itbe used? 35 • Final eTMF transfer to sponsor from CRO for archiving • Interim transfer of eTMF content to central eTMF or other trial management system • Migration of eTMF content following merger and acquisition • Migration of eTMF content following upgrade or change of eTMF system • Long term archiving of eTMF content and associated metadata • Transfer of shadow copies to sponsors
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- 37. 37 How does itlink to the RM? • The eTMF-EMS is linked to the RM through the following cross references: - Artifact Number i.e. 01.01.01 - Unique ID i.e. 001 - RM version number • When an artifact is exchanged it must be cross referenced with the above information • This allows the receiving system to properly identify and file it within it RM based structure
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- 41. Exchange Agreements allowtwo parties to define how content exchanges will occur as well as organizational specific information and standards
- 42. 42 Exchange Agreements -Identification • Identification of exchanging parties • Identification of computerized systems • Identification of version(s) of the TMF Reference Model being used
- 43. 43 Exchange Agreements -Methodology • Method of transfer and verification • Frequency of transfer • Convention on updates and modifications
- 44. 44 Exchange Agreements -Conventions • Type of artifacts being transferred i.e. Data Management documents, entire TMF etc. • Folder structure specification (e.g. TransferID > Process Zone > Section) • Organization specific sub-artifact definitions • Organization specific non-standard metadata definitions • Organization specific data conventions
- 45. QUESTIONS? 45A B OU T T H E C O M P A N Y
- 46. Are you interestedin receiving more information about Montrium’s eTMF Connect? 1) Yes, could be useful 2) No, not interested 46 POLL A B O U T T H E C O M P A N Y