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Practical Application of theTMF Reference ModelIndustry WebinarNovember 14, 2012Fran Ross, Principal Consultant, Paragon S...
AgendaIntroductionsTMF Reference Model•   What is it and why do I need it?•   Where can I find the model and related infor...
Paragon Solutions’ Introduction                            Paragon is an enterprise information management                ...
Polling Question #11A. Level of involvement in TMF Reference Model?    a) Active member    b) Interested follower    c) Kn...
Why a TMF Reference Model?  •    ICH GCP Section 8 identifies “The minimum list of essential documents....”  •    Does not...
TMF Reference Model backgroundIndustry-wide effort (via DIA EDM SIAC) on content required for TMF inspection• More than 15...
TMF Success Strategies - Information ArchitectureRobust TMF information architecture base is mission critical• Delivers ma...
Survey the landscape   Survey the   landscapeSet the table • Sell project to sr. mgmt, secure one exec sponsor • Gather th...
Differentiate the issuesSurvey the    Differentiatelandscape      the IssuesCan do!                                       ...
Level the Playing Field   Survey the      Differentiate               Level the   landscape        the Issues             ...
Prepare the Tools   Survey the      Differentiate               Level the                              Prepare the   lands...
Get the Job Done      Survey the      Differentiate               Level the                              Prepare the   Get...
Get the Job Done   Survey the      Differentiate               Level the                              Prepare the   Get th...
Polling Question #22. What is the status of your organization’s eTMF?   a) We currently use eTMF   b) Actively building / ...
Core/ Recommended, Signatures, Versioning                           Signature or                            Electronic    ...
Document Lifecycle Management                                                                                 Where to    ...
Specific Artifact Considerations                             Artifact                                                     ...
Suggested Additions to the TMF Reference Model• Accountability – chain of custody, audit trail• File locations – central, ...
Metadata MadnessMetadata Functions:                                                         Creation Considerations:•  Sea...
Questions and More InformationMichael Agard, Senior Consultant, Paragon Solutionsmagard@consultparagon.comFran Ross, Princ...
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Practical Application of the TMF Reference Model Webinar

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Practical Application of the TMF Reference Model Webinar

  1. 1. Practical Application of theTMF Reference ModelIndustry WebinarNovember 14, 2012Fran Ross, Principal Consultant, Paragon SolutionsMichael Agard, Senior Consultant, Paragon Solutions Paragon Solutions, Inc. Proprietary and Confidential
  2. 2. AgendaIntroductionsTMF Reference Model• What is it and why do I need it?• Where can I find the model and related information?• How do I get involved?Applying the Model• Practical steps to implementation at your organizationContent Considerations• Specific content type considerations for your eTMF improvements Paragon Solutions, Inc. Proprietary and Confidential -2-
  3. 3. Paragon Solutions’ Introduction Paragon is an enterprise information management solutions company that helps firms leverage Corporate Facts information assets to achieve better business results.• Privately owned, 30-year history• Professional Services and Solutions Divisions• US-Based, NJ Headquarters - 8 domestic and international offices - Overseas development center• Dual-shore Delivery Paragon Solutions, Inc. Proprietary and Confidential -3-
  4. 4. Polling Question #11A. Level of involvement in TMF Reference Model? a) Active member b) Interested follower c) Know a little d) News to me1B. Is your organization using the TMF Reference Model? a) Yes, fully adopted b) Working on it c) Wishful thinking d) Not likely e) Dont yet know Paragon Solutions, Inc. Proprietary and Confidential -4-
  5. 5. Why a TMF Reference Model? • ICH GCP Section 8 identifies “The minimum list of essential documents....” • Does not provide the comprehensive contents required for TMF inspectionMinimum list of essential The Trialdocuments from ICH e.g. protocol, ICF, MVR, Master File drug shipmentOther trial-relatedrecords that “permitevaluation of the conduct Supporting recordsof the trial and quality of generally outside TMF e.g. IP manufacturingdata produced” records e.g. safety monitoring, EDC, data mgmt, biostats Other business records e.g. incorporation papers
  6. 6. TMF Reference Model backgroundIndustry-wide effort (via DIA EDM SIAC) on content required for TMF inspection• More than 150 companies and 250 individuals• No agency endorsement or requirement, reviewed with positive feedback• Offers standard content, structure, naming, definitions and metadata Core or Recommen ICH Unique ID Sponsor Investigator TMF Zone Section Artifact name Alternate names Definition / Purpose ded Code EDM RM Number Document Document To describe the objective(s), design, Central Trial Trial Clinical Investigation methodology, statistical considerations, 1.4.4 Full02 Documents 02.01 Documents 02.01.02 Protocol Plan (Devices) and organization of a trial..... Core 8.2.2 Protocol 032 X XGThoroughly detailed and fairly complex• By the numbers: 244 artifact rows, 30 columns• Organized by Zones and Sections• Covers trial files for biopharm and device sponsors, sites, IIS• Details include ICH, EDM, trial process, file level, more…. Paragon Solutions, Inc. Proprietary and Confidential -6-
  7. 7. TMF Success Strategies - Information ArchitectureRobust TMF information architecture base is mission critical• Delivers many faceted dividends, and is foundational for both paper and electronic TMF inspection readiness• Generates “do it better” ideation, comprehension and enthusiasmRobust TMF information architecture base is hard work• Invest the time nailing the content, classifications, metadata• Include and align with all content creators, content stewards, trial and senior managementRobust TMF information architecture is worth it• Ensure your TMF is accurate, robust + inspection ready• Mitigate the TMF effort in M&A, partnerships, outsourcing• Enable team focus on trial completion, not wheel reinvention or post-study scramble OK! I’m ready….now what? Paragon Solutions, Inc. Proprietary and Confidential -7-
  8. 8. Survey the landscape Survey the landscapeSet the table • Sell project to sr. mgmt, secure one exec sponsor • Gather the team – represent all roles involved in trial processes Harvest the materials • Collect all SOPs and instructions on trial processesIdentify your company’s TMF issues • Artifact handoff confusion • Two or more “original” filing locations • Issues with TMF audits / inspections • Record retention clarity Know thyself! Paragon Solutions, Inc. Proprietary and Confidential -8- Drug Information Association www.diahome.org
  9. 9. Differentiate the issuesSurvey the Differentiatelandscape the IssuesCan do! • Avoid black holes • Artifact source – Turf wars • Content definition – Creationism • Filing responsibility – Legal holds • Timing requirements – System revamps • SOP identification – Other improvement initiatives • Other metadata Regions of space from which nothing, not even light, can escape Paragon Solutions, Inc. Proprietary and Confidential -9-
  10. 10. Level the Playing Field Survey the Differentiate Level the landscape the Issues Playing FieldGet the buy-in • What are we doing and why?Don’t assume TMF comprehension or standard vocabulary • Standards and definitions – template, final, index, artifact • TMF 101s for all participants Respect the learning curve • Ramp up time for model comprehension and ingestion WIIFM??? Paragon Solutions, Inc. Proprietary and Confidential - 10 -
  11. 11. Prepare the Tools Survey the Differentiate Level the Prepare the landscape the Issues Playing Field ToolsCopy TMF RM for Master TMF Index, adjust columns • Rename headers and add additional columns • Lock unique number column for mappingCreate work plan, meeting schedule and deliverablesPrepare all participants for rigorous discussionAgree on scope and conflict resolution • Content lifecycle: final document filing, not creation or destruction • Predetermine where the buck stops • Process for resolving disagreements Paragon Solutions, Inc. Proprietary and Confidential - 11 -
  12. 12. Get the Job Done Survey the Differentiate Level the Prepare the Get the Job landscape the Issues Playing Field Tools DoneBe vigilant for squirrels and black holes• Structure / buckets / containers do not matter, don’t let it break the stride• Agree to and use the parking lot (outdated SOPs, immature/broken processes)Keep inspection readiness at forefront • Laser focus: is it required for a future inspection? Do our SOPs say we produce it? If requested, who would be responsible and where would they have it? • Make it personal: “If you’re in the room with an inspector…” Paragon Solutions, Inc. Proprietary and Confidential - 12 -
  13. 13. Get the Job Done Survey the Differentiate Level the Prepare the Get the Job landscape the Issues Playing Field Tools DoneWork through the model: “trust but verify” • Complete the index grid, row by row • Quick wins, reiterations, subgroups for problem areas • Carefully consider recommended, GCP codes and your regional regs. • Keep sr. mgmt. and executive sponsor apprised of progress / problems / success Apply the new standard • New TMFs: Update TMF SOPs, WI, manual, apply to electronic systems • Current TMFs: Risk-based approach - inspection, duration • Hold mapping sessions with partners/vendorsMaintain new TMF index • Safeguard the output for reuse and future considerations, partnerships and M&AC-E-L-E-B-R-A-T-E, spread the word and thank all participants Paragon Solutions, Inc. Proprietary and Confidential - 13 -
  14. 14. Polling Question #22. What is the status of your organization’s eTMF? a) We currently use eTMF b) Actively building / implementing c) Evaluating d) Not considering e) Unknown / not applicable Paragon Solutions, Inc. Proprietary and Confidential - 14 -
  15. 15. Core/ Recommended, Signatures, Versioning Signature or Electronic Needed for Filter Version Country or Site Workflow? Startup Control? Core / Section Artifact name Definition / Purpose RecommendedTrial To describe how monitoring will be implemented duringOversight 01.01.08 Monitoring Plan the trial, including strategy for source data verification. CoreTrial To describe how medical surveillance of trial subjectsOversight 01.01.09 Medical Monitoring Plan will be assured during the trial. CoreTrial To describe the policy for publishing the trial results ifOversight 01.01.10 Publication Policy publication policy is not captured within the protocol. Recommended Optional Paragon Solutions, Inc. Proprietary and Confidential - 15 -
  16. 16. Document Lifecycle Management Where to File? CountryTemplate Specific May expand the list of core documents required at a milestone Study Site Specific Specific Paragon Solutions, Inc. Proprietary and Confidential - 16 -
  17. 17. Specific Artifact Considerations Artifact Phase II-IV ExploratoryIVRS-IWRS Training Documentation Yes NoOperational Procedure Manual Yes NoQuality Plan Yes NoAdjudication Committee Document Yes No Other Considerations and Examples: • Therapeutic Area Specific – Oncology Database Lock • Patient Population - Pediatric Informed Consent Form • Country Specific – Investigator Medical License • Controlled Substance Tracking – DEA Form 222 • Company specific – Translation Explanation or Approval • Vendor Specific – Central Lab Normals • Enhanced Access Control – Contracts Paragon Solutions, Inc. Proprietary and Confidential - 17 -
  18. 18. Suggested Additions to the TMF Reference Model• Accountability – chain of custody, audit trail• File locations – central, local, site• SOP and Template relationships• Documents requiring translation and relationship of translated document to the original• Which date(s) and formats are required / optional / system generated Paragon Solutions, Inc. Proprietary and Confidential - 18 -
  19. 19. Metadata MadnessMetadata Functions: Creation Considerations:• Search - User Entry• Filter - Look up fields• Sort - System generated / auto-fill• Labels - CTMS Interface• Reports - Mandatory / OptionalExamples:• Study and Protocol Data• Country and Site Data• Site Personnel Names and Roles – CVs, FDA Form 1572,• Text to differentiate the same artifact received multiple times – Protocol Signature Pages• Creation, Approval and Revision Dates• Vendor Name and Role• IRB/EC Name• Lab Name• Financial Disclosure Form Paragon Solutions, Inc. Proprietary and Confidential - 19 -
  20. 20. Questions and More InformationMichael Agard, Senior Consultant, Paragon Solutionsmagard@consultparagon.comFran Ross, Principal Consultant, Paragon Solutionsfross@consultparagon.comJeff Crawford, Director, Life Sciences, Paragon Solutionsjcrawford@consultparagon.comTMF Reference Model linksFollow the blog - http://tmfrefmodel.blogspot.com/LinkedIn discussion group - “TMF Reference Model”Get V2.0 of the Model / In-depth Overview / Join the Team:www.diahome.org/en/News-and-Publications/Publications-and-Research/EDM-Corner.aspx Paragon Solutions, Inc. Proprietary and Confidential - 20 -

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