The document discusses a webinar on practical considerations for electronic trial master file (eTMF) planning presented by Paragon Solutions. The webinar covered why organizations are moving to robust eTMF systems, the necessary people, process and technology requirements, and insights into maturity models for eTMF implementation. The presentation addressed factors driving the transition to eTMF, considerations for change management and information architecture, and the need to challenge perceptions of regulatory requirements.

1. Practical Considerations for
eTMF Planning
Industry Webinar
February 13, 2013
Fran Ross, Principal Consultant, Paragon Solutions
Michael Agard, Senior Consultant, Paragon Solutions
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2. Agenda
 Introductions
 Why the move to robust eTMF ?
 People, process, technology requirements
 Insight on eTMF maturity model
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3. Paragon Solutions’ Introduction
Paragon is an enterprise information management
solutions company that helps firms leverage
information assets to achieve better business
Corporate Facts 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
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4. Practical Considerations for eTMF Planning
Does your electronic trial master file (eTMF) …
…provide greater efficiency?
…improve quality?
…increase standardization?
…enhance collaboration?
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5. Practical Considerations for eTMF Planning
What factors drive the move
to a robust eTMF?
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6. TMF Paper to Electronic Evolution
Paper TMF Repository eTMF Trial Enabler
• Paper based, localized TMFs • Centralized, global electronic TMFs
• Myriad interpretations of requirements • Leverages TMF Reference Model
• Multiple copy / master record confusion • Sole authoritative artifacts
• Document “graveyard” • Active workflows to support study conduct
• No integration with master metadata • Robust metadata for search and retrieval
• Closed / locked environment • Open secure access
• Repetitive, error prone process • Automated workflows support CT process
• Manual Retention & Litigation Holds • Coordinated, automated RM processes
• Significant scramble for audit/inspection • Continuous readiness for audit/inspection
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7. Polling Question #1
Where are you on the eTMF continuum?
a. No eTMF
b. Electronic repository only
c. Active eTMF, without full trial enablement
d. Fully robust eTMF
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8. eTMF status
What is the status of your organization's eTMF?
We currently use eTMF
13%
3% 28% Actively Building /
10% Implementing
Evaluating
19% Actively Planning
27%
Not Considering
Unknown/Not Applicable
From TMF Reference Model working group

9. eTMF Systems Evolution
Knowledge Asset Tool
e-Filing • Workflows support CT processes (IP Release)
Cabinet • Smart alerts, actionable reports
• Shares master CT data (CTMS, EDC, IRT)
• Curated collection of email, NTF, correspondence
eTMFs on Seamless Technologies
Separate Sys. • Internal and partner eTMF in concert
Electronic SmartDocs
Scanned • Created, processed, filed electronically
• Digital signatures, fillable forms
Documents
• Prepopulated with applicable data
Balanced Document Access
Restricted • Appropriate permissions, secure content
Access • All sponsor, site, vendor and inspector roles
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Confidential – Proprietary to Paragon 9

10. Ready for a Truly Robust eTMF?
 Robust eTMF is not a technology problem, it’s a people and
process opportunity
 Reliance on current process must be abandoned
• Paper is not required, ink signatures are not needed, document
tracking tools are irrelevant
• Creators must be responsible for their content
 Perceptions of GCP “requirements” have to be challenged
 Both users and stakeholders buy into new business as usual
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13. Critical Factors When Embarking
 Organizational readiness assessment: involve all players
• Clinical, Ext team, Quality, IT, all others in trial landscape
 Change Management communications from the start
• Why will this change, WIIFM?
 Clear-eyed view of the landscape
• Critical programs, partnership/outsourcing, competitive programs,
IT roadmaps
 Thorough grasp of the Information Architecture
• Clearly defined content (TMF RM) w/definitions and
responsibilities
• Metadata, data flow, migration, integration
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14. Metadata is required for eTMF flow
 Reduce keystrokes to create new study, country, site
• Automate entry of trial personnel, roles and contact details
 Enable user-friendly navigation and search
 Manage access and control by role, status or
content type
 Relate content collection to trial milestones
 Reduce process complexity of related documents
• Protocol amendments, informed consent
 Support in-flight Investigator changes
• Trigger collection of new CV, 1572, Financial Disclosure
 Automate signals for clinical trial process via workflows
• Investigational Product release
Robust eTMF flow critically relies on authoritative and accurate metadata
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15. Clinical System Interfaces
Planning Study Conduct Reports / Submissions
IxRS
LMS /
Access Training
Management
Project Submission Submission
CTMS eTMF
Planning Repository Publishing
EDC
Templates or
Structured Authoring
Safety / PV
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16. eTMF Navigation
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17. Polling Question #2
What is the biggest impediment to using CTMS data in eTMF?
a. Data not collected early enough in the process
b. Data quality and accuracy
c. Lack of data warehouse or extraction abilities
d. Lack of expertise for interface / integration
e. Issues in sharing data between sponsor and CRO
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18. CTMS & TMF Data For Navigation
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19. CTMS & TMF Data in file names
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20. CTMS Search
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21. TMF Search Data
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22. eTMF Implementation Teams
Steering
Committee
IT Project Business
Management
Architecture & Interface & TMF Ref. Model / Communication & Compliance, SOPs,
Access & Security Process
Environments Configuration Index Training Templates
Yellow Study
Migration &
boxes are Implementation
Decommissioning
Plan
key for
initial
planning
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23. Additional factors / risk areas to address
People
• Access management
• Vendor Management / Consulting Services
• Support services, HelpDesk, Technology Transfer
Process
• Content flow for Regulatory Submissions
• Electronic and digital signatures, workflows People
• Safety document management
Technology Process
• CTMS Interface and data extraction and quality
• Platform integration / Cloud services
• Global performance
Technology
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24. eTMF Maturity Model
Archive eTMF Active eTMF Integrated eTMF
• Electronic archive of • eTMF drives business • Process and user
TMF documents processes integration with site
• Easier access for • Business users rely on for full electronic
business users eTMF for all content submission / review
• Standardized TMF needs • Inspection readiness
structure and • Structure flexibility for embedded in all
management trial requirements eTMF user behaviors
• Centralized • Improvements driven by • Process-driven trial
management and central metrics milestone completion
maintenance • Doc. mgmt . DURING • Full integration with
• Well managed, AFTER business process (i.e., IP internal systems
document completes Release Authorization) • All documents signed
business process • Clin. Systems integration electronically (digital
• Minimal transition for consistent metadata signatures), except
from paper to • E-workflow for internal legal/reg exceptions
electronic documents review / approval • Transition from
• Strong Scanning / • Moderate transition managing documents
Indexing reliance from paper to e-docs to managing data
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25. Our eTMF View
Robust eTMF allows organizations to:
 Reduce Clinical Trial process complexity
 Improve compliance by adapting or extending processes
and systems that ensure inspection readiness
 Have an authoritative source for trial documentation
 Increase authorized knowledge sharing
 Improve accuracy of research results
 Reduce records storage costs
 Determine efficient management and migration pathways for
TMF records
 Rely on eTMF as a clinical trial enabler
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26. Questions and More Information
Michael Agard, Senior Consultant, Paragon Solutions
magard@consultparagon.com
Fran Ross, Principal Consultant, Paragon Solutions
fross@consultparagon.com
Jeff Crawford, Director, Life Sciences, Paragon Solutions
jcrawford@consultparagon.com
Andy Lambros, Managing Director, Paragon Solutions, Europe
alambros@consultparagon.co.uk
Visit our website at www.consultparagon.com
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