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Practical Steps to Selecting and Implementing an eTMF
This webinar presentation provided an overview of practical steps for selecting and implementing an electronic trial master file (eTMF). It began with an introduction and housekeeping items. It then covered the changing regulatory landscape around eTMF requirements. Key challenges and the future of eTMF were discussed. The presentation outlined the process for eTMF vendor selection and provided tips for a successful implementation. It emphasized the importance of planning, change management, and adopting the TMF Reference Model.
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Practical Steps to Selecting and Implementing an eTMF
- 2. Practical Steps to Selectingand Implementing an eTMF eTMF Bootcamp Webinar Series Thursday, 16 May 2019 2
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- 4. 4 House Keeping L I VE W E B I N A R • 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
- 5. 5 Meet Your Speakers Paul Fenton Presidentand CEO, Montrium Sholeh Ehdaivand Founder & President LMK Clinical Research
- 6. • Founded in2005 • Working Exclusively in the Life Sciences • Headquartered in Montreal, Canada • EU HQ in Brussels • Clients in North America, Europe & Asia • Leading Content Management Platform • Over 8000 Users in 20+ Countries • Experienced Professional Services Group 6 About Montrium Connecting People, Processes & Technology A B O U T T H E C O M P A N Y
- 7. 7 Electronic Content Management &Business Intelligence for Clinical Trials C O N N E C T P L A T F O R M Regulatory Document Management & Submission Planning for Drugs and Devices Integrated and Data Driven Quality Management Solutions for Life Sciences
- 8. State of theIndustry 8
- 9. 9 Regulatory evolution – EMA Guideline Guidelineon the content, management and archiving of the clinical trial master file (paper and/or electronic) EMA/INS/GCP/856758/2018 Released 6 December 2018 • Legislation does not differentiate between paper and electronic TMF • TMF content should be collated in a timely manner • GCP Inspectors will require direct access to the eTMF system as used by the organization • There should be a primary TMF system for holding essential documents • Information contained within other systems may also be considered part of the TMF
- 10. 10 Regulatory Evolution - New EUDirective • EU Regulation 536/2014 originally released in 2014, will likely come into effect in 2019 • The sponsor and investigator shall keep a clinical trial master file….it shall be readily available and directly accessible upon request. • The sponsor and the investigator shall archive the content of the clinical trial master file for at least 25 years after the end of the clinical trial
- 11. 11 Regulatory Evolution - ICH E6Addendum R2 • Currently in step 4 (consultation) of the ICH process and is currently being implemented by ICH members • The sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents. The storage system (irrespective of the media used) should provide for document identification, search and retrieval.
- 12. 12 Regulatory Evolution - ICH E6Addendum R2 • SOPs should cover system setup, installation and use. The SOPs should describe: System validation and functionality testing Data collection and handling System maintenance System security measures Change control Data backup and recovery Contingency planning Decommissioning • The responsibilities of the sponsor, investigator and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in the use of the systems
- 13. ü That theeTMF is able to demonstrate compliance with the protocol and GCP ü That the eTMF is up to date and readily available for inspection directly within the system ü That minimal training is required to access the system and find eTMF content ü That a clear inventory of eTMF content exists and identifies what content is being maintained where ü That systems are adequately validated and controlled ü That copies of paper records maintained within the eTMF are certified copies 13 What the Regulators Expect from eTMF
- 14. • Approach canvary between different inspectorates • In EU, inspectors want to be able to access the complete eTMF in the organizations system • They should be able to search for content, and review eTMF preferably in a book like fashion • They want to be able to flag documents for later review • They want to be able to see documents on- screen easily • They potentially want to perform remote review of documents • They will expect to be able to access other systems that may contain eTMF data 14 How the regulators will inspect eTMF
- 15. 15 POLL A B OU T T H E C O M P A N Y Have you undergone an inspection that involved your eTMF? • Yes and I provided guided access • Yes and the inspector accessed the eTMF directly • No, we have never been inspected or were inspected using paper
- 16. Documents vs Data how to manage •Recent inspection in the UK identified over 40 electronic systems that contained data that were relevant to the TMF • More and more study information which could be used to demonstrate compliance is contained within other systems i.e. - MVRs in CTMS - Safety reports in PVS - SAE data in EDC • Need to clearly identify what you consider to be TMF relevant in the inventory • Ensure that you can provide access to information contained within these systems to inspectors
- 17. Documents vs Data how to manage •Avoid producing PDF outputs of data if possible or practical • Evaluate ways of presenting information in a more holistic way across systems • Ensure that there is uniformity across systems in relation to identifiers and metadata • Ensure that you have a clear process for each of the areas that is generating eTMF content
- 18. • Changing regulatoryrequirements and expectations in relation to TMF inspection readiness • Increased complexity in study design and study operations • Benefit of centralizing content in one location • Ability to improve traceability and execution of clinical processes • Improved information management and access • Risk based clinical trials and clinical metrics 18 What is driving eTMF adoption
- 19. 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 2011 2012 20132014 2015 2016 2017 2018 ResponsePercent Survey year What percentage of current Phase II/III trials are fully outsourced to CROs 100% 76-99% 51-75% 26-50% 0-25%
- 20. 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 2012.5 2013 2013.52014 2014.5 2015 2015.5 2016 2016.5 2017 2017.5 ResponsePercent Survey year What format is your TMF? All Inspectable TMF / ISF in paper All Inspectable eTMF / eISF Combination Other
- 21. 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 2011 2012 20132014 2015 2016 2017 2018 ResponsePercent Survey year What is the status of your eTMF/eISF? We currently use eTMF / eISF Evaluating Actively Planning Actively Building/Implementing Not Considering Not Applicable / Unknown
- 22. 22 POLL A B OU T T H E C O M P A N Y What is the status of eTMF in your organization: 1. We are still using paper 2. We have a hybrid paper/electronic TMF 3. We use our CROs eTMF 4. We are fully electronic 5. We don’t have a TMF
- 23. What are the keychallenges • TMF complexity with many stakeholders • Cost of acquisition and implementation of eTMF systems • Ability to fully eradicate paper • TMF completeness calculation complexity • Multiple repositories and systems hold TMF content • Organizational change
- 24. What does the future hold..... 24 •Documents will become data • eTMF completeness and QC will be data and event driven • Standards for content and metadata • Improvements in eTMF content interchange • Remote inspections
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- 26. 26 POLL A B OU T T H E C O M P A N Y In your opinion how long does it take to fully implement an eTMF solution? a) Less than a month b) 1-3 months c) 3-6 months d) 6-12 months e) More than a year
- 27. 27 Process A B OU T T H E C O M P A N Y • Try and keep requirements to the point and avoid stating the obvious • Decide if you are looking for a cloud based or on premise solution • Think about internal and external usage as well as how inspectors will access the eTMF Establish Clear Requirements Identify vendors Evaluate systems Contract Plan Resources Implement
- 28. 28 Process A B OU T T H E C O M P A N Y • Try to keep the number of vendors to a minimum • Establish high level criteria that you will use to select the vendors for evaluation i.e. geographic presence, level of eTMF specialization, company size, high level system features (from product literature), delivery model (cloud vs on premise) Establish Clear Requirements Identify vendors Evaluate systems Contract Plan Resources Implement
- 29. 29 Process A B OU T T H E C O M P A N Y • Establish objective criteria based on system functionality and alignment with your future process • Avoid complex scoring schemes based on requirements • Involve the right people to evaluate • Ask vendors to show how your process would look (avoid too many scenarios) Establish Clear Requirements Identify vendors Evaluate systems Contract Plan Resources Implement
- 30. 30 Process A B OU T T H E C O M P A N Y • Ensure that roles and responsibilities are clearly defined • Ensure storage limits and costs are clearly defined especially in relation to archiving • Perform adequate due diligence before signing contracts • Pre-agree deployment and go-live timeline Establish Clear Requirements Identify vendors Evaluate systems Contract Plan Resources Implement
- 31. 31 Process A B OU T T H E C O M P A N Y • Remember that system implementation is a group effort between the vendor and your team • Ensure that you have champions, super users and IT involved in implementation • Budget for internal resources and secure availability • Assign an internal project manager to keep things moving on your end Establish Clear Requirements Identify vendors Evaluate systems Contract Plan Resources Implement
- 32. 32 Process A B OU T T H E C O M P A N Y • Consider selecting a pilot project so that you can iron out the kinks before deploying on a larger scale • Try and adopt the TMF RM as much as possible • Think carefully about TMF artifacts and what will be managed in the eTMF solution versus other systems • Aim to use the solution both internally and externally so that all eTMF content is in one place Establish Clear Requirements Identify vendors Evaluate systems Contract Plan Resources Implement
- 33. 33 POLL A B OU T T H E C O M P A N Y Do you currently have a TMF Champion in your organization? a) Yes b) No
- 34. 34 Key attributes to look for •Ease of use for all stakeholders • Flexibility to accommodate different study types and ability to configure • TMF auto-classification and fast indexing tools • Use of TMF RM out of the box • Ability to evaluate TMF completeness based on study status and design • Inspector mode (easy search, review and tagging) • Ability to centralize platform for use by all stakeholders
- 35. 35 Right sizing the vendor •Not all vendors are created equal • Look for vendors that can support your volume of business • Prefer vendors with sound industry knowledge • Evaluate vendors product roadmap and their product evolution • Choose the vendor that best fits your process and budget • Look for a business partner type relationship where you are able to contribute to the evolution of the product
- 36. eTMF Implementation - Rightthe First Time! 36
- 37. 37 Plan • Have anoverall, sustainable strategy: internal implementation needs • Study assessment in the eTMF • Change and culture management • TMF Reference Model mapping • Go Live!
- 38. 38 Strategy Needs Assessment: • Howsoon do you need the eTMF to be implemented? Do you have enough time? • Understand current TMF document and content location; • Evaluate if it is possible to bring everything into one system; • According to the 2015 TMF Reference Model survey, 42% are still using multiple repositories • Potential Issues: multiple SOPs, multiple people, easily out of compliance – not knowing where documents are could raise red flags
- 39. 39 Assessment • Clinical trialassessment which studies will utilize the eTMF technology • Start with a pilot! A new study that can start in the eTMF • TMF Migration § All studies § Risk Based approach § Hybrid
- 40. 40 Change is inevitable •Culture and change management • What are your organizations values, believes and norms toward the TMF? • TMF Champion • Innovator: renew the TMF through technology, people and process; • Committed to Change: shepherd organizational change despite opposition; • New Processes: align with eTMF (technology) and people; • Change Management Network: within each department to help cascade and support the change “You must remain focused on your journey to greatness” Les Brown
- 41. 41 TMF RM Adoption •Master TMF Plan: how your organization will file TMF content • SOP Mapping: understand the required documents (Regulatory requirements, ICH GCP and your organizations SOPs) • Naming Conventions: how will documents be named in the eTMF system • Date Conventions: consistent way to associate dates to documents • TMF Plan: study specific conventions and requirements
- 42. 42 Ready, Set, Go! •Properly manage the implementation process from concept through completion • Control the process • Don’t be shy – you can change stuff – break things down – people, process and technology • Checkpoints along the way!
- 43. 43 Conclusions & Recommendations •Have a deep understanding the of regulatory environment • eTMF vendor selection – choose the one that is right for you! • Timelines and milestones should be achievable • Have a plan and be ready for Day 1 • Ask for help when needed
- 44. 44 • Facilitates exchangeof clinical trial information to all stakeholders • Accurately tracks the progress of TMF completeness • Allows you to quickly comply with regulatory requirements, audits and inspections An intuitive eTMF Platform Engineered for Growth Organizations
- 45. Are you interestedin receiving more information about Montrium’s eTMF Connect? 1) Yes, could be useful 2) No, not interested 45 POLL
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