eTMF Structure, Setup, and Implementation Case Study


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This presentation describes a case study of an eTMF structure, setup, and implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.

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eTMF Structure, Setup, and Implementation Case Study

  1. 1. A Case Study of aneTMF Implementationat a Small BiotechAdair Turner, MSc, RACRegulatory Affairs ManagerMission3, Inc.
  2. 2. Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.Drug Information Association 2
  3. 3. Agenda• This session provides a case study of an eTMF implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.• We will discuss our experience, process management, and lessons learned.Drug Information Association 3
  4. 4. Problem• Not enough resources!• The logistics of managing paper-based processes with limited resources was challenging, overwhelming, and time consuming.• Documentation was “Welcome aboard, Bob. inconsistent, incomplete, Your job is to figure out what the heck happened missing, expired, and/or here.” redundant.Drug Information Association 4
  5. 5. Objective• Prepare for an upcoming NDA eCTD submission and the subsequent GCP inspection.• Transform existing paper based processes with a centralized electronic solution that would maximize resources by using a globally available cloud-based framework.Drug Information Association 5
  6. 6. Partner’s System Requirements• DIA TMF Reference Model utilization – Clearly structured to account for documentation levels and the trial complexity (global, country, site) – The TMF RM is intended to provide a collaborative advantage to stakeholders in creating and managing their TMFs.Drug Information Association 6
  7. 7. Additional Requirements• Software as a Service delivery model in which software and associated data are centrally hosted in the cloud and available globally• Low cost and commitment• Quickly and easily implemented• Document management capabilities – Check in/check out, version control, audit trail, work flows and lifecycles, etc. – Ability to use the same system for multiple projects• Flexible• Minimal validation requiredDrug Information Association 7
  8. 8. Program Plan - 5 Projects1. eTMF Structure, Setup, and Implementation2. Ongoing Clinical Trial Document Processing3. Legacy Clinical Trial Data Processing4. EDM Regulatory Structure, Setup, and Implementation5. NDA Project Planning and eCTD Document ProcessingDrug Information Association 8
  9. 9. eTMF SolutionTogether, we developed a flexible process:Drug Information Association 9
  10. 10. Process DefinitionDrug Information Association 10
  11. 11. Technology Setup – 5 months Drug Information Association 11
  12. 12. The Process - Partner• CRA receives paper document(s) at site, identifies/verifies content, completes online transmittal form, assembles document package, and ships document package to Scanning VendorDrug Information Association 12
  13. 13. Scanning Vendor ProcessDrug Information Association 13
  14. 14. eTMF Vendor ProcessDrug Information Association 14
  15. 15. eTMF Vendor QC ChecklistVerify:•Page count•Naming convention•Metadata•LocationDrug Information Association 15
  16. 16. Documentation• Partner audited both the Scanning Vendor and the eTMF Vendor to ensure appropriate quality documentation prior to signing.• SOPs/Methodologies/Working Practices for Scanning vendor, eTMF vendor, and Partner company that cover each part of the process• Appropriate and documented training• Validation documentationDrug Information Association 16
  17. 17. Document Naming Convention• Partner went through the DIA TMF RM and added the naming convention they wanted for each item.Drug Information Association 17
  18. 18. Metadata• Beyond the metadata suggested by the DIA TMF RM, we added a field for the unique “Physical Document Locator” that corresponds to the hard copy and wet signature if needed. Drug Information Association 18
  19. 19. Current Study• We used the current Ph. 3 study as our initial project and pilot.• Together, we wrote, reviewed, and implemented Scanning Methodology and Work Practice documents.• Scanned, indexed, and filed approximately 3500 documents in 6 months.• Implemented EDMS for Regulatory documents during this timeframe as well.Drug Information Association 19
  20. 20. Legacy Process• More than 60,000 legacy documents were shipped to scanning vendor (in 80 boxes).• The shipment included a MS Excel spreadsheet that listed the documents that were in the boxes and was organized by section of a previous Trial Master File and by folder identifier.• A new methodology document was written for scanning the legacy documents.Drug Information Association 20
  21. 21. Legacy Study• The Scanning Vendor had to do a great deal of document reconciliation in order to index and scan the documents and timelines were pushed back by a couple of months.• Legacy Study #1 contains approximately 26,500 documents and must be complete in 2 months!• In order to meet timelines, documents must be reviewed and filed in under 1 min each.• A weekly status report is provided to our partner showing the status of planned completion vs. actual completion.Drug Information Association 21
  22. 22. Automated Metadata• Scanning vendor indexed documents with metadata provided on the Excel spreadsheet.• Text file indexes are uploaded with the PDF documents to a secure SFTP site.• The text file is used to populate the document metadata as the documents are automatically loaded into a “Staging Area.” Drug Information Association 22
  23. 23. Legacy Document TransferDrug Information Association 23
  24. 24. How is it better?• All study records are globally accessible, available and organized. Partner is able to easily identify gaps and assess completeness.• New processes, standards and controls ensure increased TMF quality.• Time associated with file requests, audits, and inspections have decreased. While the cost of mailing documents, searching for information and reproducing redundant documentation is significantly lowered.Drug Information Association 24
  25. 25. Lessons Learned• Establish paper document classification.• Identify document naming conventions and metadata early.• Correspondence should be relevant and organized.• Planning and communication are the keys to estimating and managing program timelines.Drug Information Association 25
  26. 26. Let me know if you have any questions! aturner@mission3.comDrug Information Association 26