1. Managing Complexity Through Innovation
A Case Study for a Paperless Solution
David Mitchell, CRM
Assistant Director, E-Records Management

2. Objectives Learn about CGIRB’s integrated paperless solution
Planning and implementation
Compliance and quality
Examples of efficiencies and ROI

3. Background of paperless initiative
Brief overview of IRB role
IRB work is paper intensive
96% of incoming documents born digital
20 – 25 linear feet produced internally every week
Fileroom requests
Average of 6800+/year ( )

4. Background of paperless initiative
Regulatory Considerations:
21 CFR Part 11
Electronic Signatures and Electronic Records
System validation
Accurate and complete copies (Trustworthiness)
Limiting system access
21 CFR Parts 50 and 56
Protection of Human Subjects (FDA) & Institutional Review Board Composition

5. Background of paperless initiative
Regulatory Considerations:
ICH Guidelines for Good Clinical Practice, section E6
45 CFR Part 46
Protection of Human Subjects (DHHS)
IRB Records
What to maintain
Records retention

6. Background of paperless initiative
Started as project to handle e-documents only
Realized review process could be streamlined
Compliance module and 21 CFR Part 11 capabilities and e- signature
Customization and integration options with Protocol Tracking System (PTS) and client-facing portal
Flexible automated workflow options
Size of system and cost

7. Background of paperless initiative
Initial meetings in late 2006 to plan the concept of paperless system
Proof of Concept document with Xerox DocuShare® as solution
Business process requirements
Tasks to measure success
21 CFR Part 11 scenarios & checks
Tentative configuration schedule
Process flow diagrams
Design specifications
Testing and validation

8. Background of paperless initiative
Why it made sense for CGIRB
Confidential nature of our business
Use “closed systems” as defined in 21 CFR Part 11
“…an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.”
Excellent case for e-signatures
Lots of print & scan functions to eliminate
Pre-existing technical architecture lent itself to integration with EDMS

9. Background of paperless initiative
Goal:
To develop a 21 CRF Part 11 compliant document management system with workflow, archives, version control and electronic/digital signatures to handle incoming electronic documents.
Objectives:
Increase organizational responsiveness
Reduce time associated with file requests, audits and submissions
Enable full-text search of all live and archived documents
Enforce security
Provide regulatory compliance surety
Protect and archive institutional knowledge
Conserve personnel resources
Reduce the need for paper (cost, shipping, storage)

10. Testing & Validation Time consuming but essential (and valuable)
Testing requirements
Functional walkthroughs
Test cases documented

11. Implementation – Phase I
Out-of-the-box functionality introduced to staff
Training on:
System navigation
User interface
Collections
Searching – basic and advanced
Permissioning of folders and documents
All documents were read only
Regulated decisions still based on paper documents

12. Implementation – Phase II
Bulk import utility implemented to upload images
Compression and OCR
Documents in DocuShare available to staff for reference
Regulated decisions still based on paper documents

13. Implementation – Phase III
Implemented May 18, 2009
Paperless workflows
Integration with tracking database
Tasking for teams based on submission type
E-signature functionality with all staff receiving training
Revised SOPs and policies
Regulated decisions made from electronic document of record
Centralized team for intake

14. Implementation – Phase III
By the numbers:
923,000+ study documents
556,000+ submission documents
Since 5/18/2009:
21,000+ submissions entered
34,000+ fax submissions entered
2300+ hardcopy submissions entered

15. More about integration
CGIRB ConnexusTM
Integrated e-document management web portal
Paperless document repository – window into DocuShare
Secure online access to files and forms
Submission tracking
Fully validated, with complete audit trails
Integration impossible without core EDMS

16. Compliance and Quality
Regulations affecting system
E-signature functionality?
DocuShare CPX – compliance module
Testing and validation – required?
Security – users trained and authorized
Records retention & disposition
Quality audits
Content – who will audit content? Process for correcting?
External audits – security features for giving access to system
12 client audits in 2010
FDA routine inspection
AAHRPP accreditation inspection

17. Efficiencies and ROI Investment in compliance is priceless
E-signatures replace wet ink and day-long signing duty
Board reviews – keyword searches for pharmaceutical or medical terminology enables more efficient review
Shipping costs
Clients accessing Connexus for approvals can save $15-$20 per site
CGIRB shipping and courier expenses were ~$200/week to send meeting materials to Board members

18. Efficiencies and ROI Efficiencies realized in 3 primary areas:
File requests

19. Efficiencies and ROI Efficiencies realized in 3 primary areas: Audits
14 paper-based audits in 2009
Approx. 80 hours prep time (2 FTEs)
12 electronic audits in 2010
Approx. 1-2 hours prep time (1 FTE)

20. Efficiencies and ROI Efficiencies realized in 3 primary areas:
Submissions (104 minutes v. 3.4 minutes, N = 100)

21. Efficiencies and ROI Equipment and supplies
Paper purchases decreased over 75%
Photocopier surplused - $1700/month savings
Annual savings on office supplies estimated to be $101,000+
Personnel reductions

22. Lessons Learned Unrealistic timeline expectations
Processes change over time
Need good communications and documentation
Phased in implementation

23. Conclusion
Still tracking impact of CGIRB ConnexusTM on submissions, turnaround time, shipping
Technical know-how of staff must increase
Empower and train to “own” data
Staff may want to mirror paper-based methods in e-system
Others will want to automate everything

24. Questions?