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.

1. A Case Study of an
eTMF Implementation
at a Small Biotech
Adair Turner, MSc, RAC
Regulatory Affairs Manager
Mission3, Inc.

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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.
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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.
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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.
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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.
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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 required
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8. Program Plan - 5 Projects
1. eTMF Structure, Setup, and Implementation
2. Ongoing Clinical Trial Document Processing
3. Legacy Clinical Trial Data Processing
4. EDM Regulatory Structure, Setup, and Implementation
5. NDA Project Planning and eCTD Document Processing
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9. eTMF Solution
Together, we developed a flexible process:
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10. Process Definition
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11. Technology Setup – 5 months
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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 Vendor
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13. Scanning Vendor Process
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14. eTMF Vendor Process
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15. eTMF Vendor QC Checklist
Verify:
•Page count
•Naming convention
•Metadata
•Location
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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 documentation
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17. Document Naming Convention
• Partner went through the DIA TMF RM and
added the naming convention they wanted for
each item.
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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.
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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.
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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.
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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.
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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.”
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23. Legacy Document Transfer
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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.
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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.
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26. Let me know if you have any questions!
aturner@mission3.com
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