1. A Case Study Transforming Research Management Systems at Mayo Clinic
Presented by:
Steven C. Smith, Chair, Research Administration
Leon G. Clark, Vice-Chair, Research Administration
Gary C. Cseko, Operations Administrator, Research Administration
Susan M. Uhlenkamp, Chair, Research Finance
NCURA Annual Conference, Washington DC
Washington Hilton, Washington, DC
11:00 – 12:00pm, November 7, 2012

2. Disclosure
The presenters do not have any relevant financial relationships with any commercial interests.

3. Presentation Outline Learning Objectives Overview Questions
Describe the Mayo quality improvement framework and how this framework can be applied in their own organizations to improve the quality and transform business processes.
Explain that transformation is a process that advances through a series of stages that build upon one another.
Describe the eight stages of change, the critical action steps to take and the common problem to avoid.
Select a change of strategic importance currently underway in your own organization and complete a brief assessment tool to identify critical action steps to take and common problems to avoid enhancing the likelihood of a successful transformation.
Summarize a Mayo Clinic Case Study highlighting the transformation of Research Management Systems at Mayo Clinic currently underway.

4. Learning Objectives
Describe the Mayo quality improvement framework and how this framework can be applied in their organizations to improve the quality and transform business processes.
Explain the transformation is a process that advances through a series of stages that build upon one another.
Describe the eight stages of changes, the critical action steps to take and the common problems to avoid.

5. Overview Mayo Clinic Overview Mayo Quality Framework
Comprehensive Research Management System
Stages of Transformation

6. Mayo Clinic Health System
Mayo Clinic Locations
Mayo Clinic
Mayo Clinic Health System
Rizza
Mayo Clinic
in Arizona
Mayo Clinic
in Florida
©2011 MFMER | slide-6

7. Mayo Clinic Research is…
National research program
Arizona, Florida, Minnesota
In top 20 NIH-funded AMC’s
365 awards from 27 institutes
Over 8,000 active human studies
Over 3,000 staff employed in research
©2011 MFMER | slide-7

8. Research: Overview Mayo Clinic research partnerships
Translational research
Bedside
Bench
Population
Over 90% of Mayo physicians are involved in research-related activities
$600 million research budget
Mayo Clinic research partnerships

9. Mayo Clinic Research is…
Enterprise-wide governance
Enterprise-wide leadership & management
Physician/administrator partnership
Committed to creating ‘world-class’ systems
Continuing growth of programs
Evolution from ‘cottage industries’ to systems approach
Infrastructure not up to Mayo standards
Recognition of risks
Commitment to implementing quality systems
©2011 MFMER | slide-9

10. Mayo Clinic Quality Framework
The best care for every patient every day I
Quality Academy Leader Training
Champions training
Articulate roles and expectations
Commitment to transparency
Communications plan
Culture
III
Practice (e.g. - pressure ulcers, right-site surgery)
Education (e.g. – Ask Mayo Expert)
Research (e.g. – IRB, OSPA,etc)
Engineering IV
Demonstrate business case
Active visible leadership
Process owners
Frontline empowerment
Common scorecard + targets
100-day discipline
Execution V
Infrastructure II
Quality Academy
Systems implementation
Enterprise Learning System
Spread simulation practices
December 6, 2007
Adapted from Bisognano, Plsek. 10 More Powerful Ideas for Improving Patient Care. Chicago: Health Administration Press & Institute for Healthcare Improvement; 2006.
©2010 MFMER |

11. Research Management System Transformation CRMS Vision
Imagine we will…
Create optimal research administrative services to advance research from knowledge generation through delivery to our patients
…that is our vision

12. CRMS Key Strategic Objectives
Creating an Optimal Clinical Trials Management System
Implementing Quality Management Systems across all Research Business Units
Developing Scalable Infrastructure to serve MCHS, APN and clients globally

13. Comprehensive Research Management System
New Treatments
New Lab Procedures
New Analysis Capabilities
New Care Delivery Methods
End of study report
Drop out, screen failure, outcomes reporting
Produce publications
Present discoveries
Assign staff/resources
Patient search, screening, scheduling
Patient treatment & education
Collect/test/track samples data analysis
Meeting preparation
Meeting execution
Document/forms review
Scientific review
Establish study plan
Create protocol
Complete/initiate docs and forms
Qualify staff and/or organizations
Creation of aims
Literature search
Preliminary reviews
Create concept docs
Identify teams
Translation
Analysis & Reporting 
Protocol Execution 
Protocol Review 
Protocol Development 
Concept Development 
Pre-award Activities
Study Activities
Post-study Activities
RESEARCH PROCESS 
Planning & Strategy Services
Research Governance, Research Leadership, Strategic Planning, Operational Planning, Portfolio Management, Quality Planning,
Financial Planning & Analysis, Benchmarking, Competitive Intelligence,
Research Collaborations & Partnerships, Research Funding Model, Research Review Process
Business Management Services
Research Policy Management, Process and Procedure Management, Quality Management and Process Improvement, Administrative Support Activities, e-Research – (Research Web, Clinical Trials Management System, Lawson), New Process Design, Performance Management & Reporting, Business Analysis, Project Management
◄ Research Services 
Funding Services
Identification of Funding Opportunities, Proposal Submission Services, Budgeting and Forecasting, Contracting, Fundraising, Intellectual Property Disclosures & Licensing
Training & Education Services
Compliance Training & Education, A.H. Staff Education & Development, Leadership Development, Change Management
Scientific Support Services
Pharmacy Support, Study Coordination, Direct Scientific Support for Cellular-Animal-Human Studies, Biostatistics, Informatics, Computing, Epidemiology, Bio-repository, Health Services Research, Bio-specimens, Survey Research
Regulatory Support Services
Billing Compliance, Human Subjects Protection, Animal Care and Use, Research Safety, Conflict of Interest

14. Research Management System Transformation CRMS Roadmap to Excellence
Phase I Research Vision and Strategic Priorities
Phase 2
Research Infrastructure Compliance
Phase 3
Research Infra- structure Process Improvement
Phase 4
Research Infrastructure Service Excellence
Vision
Strategic priorities
Strategic initiatives
Scorecard metrics
Financial management systems
Written policies and procedures
Roles and responsibilities
Compliance training and education
NIH Response Circle Back
Management systems design
Policy system
Protocol management system
Pre-award system
Legal contracting system
IRB process
Quality Management Systems
Comprehensive Training Program
Research strategic planning
Research policy management
Research compliance
Research management system
Research contract management
Research financial management
Sponsored projects administration
Research information services
Research communication
Research web services
Human subjects protection
Animal care and use
Research career development
Science and technology
Research Service Excellence Cycles
Research Service Center
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.

15. The Stages of Change 8 Steps to Transforming Your Organization
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

16. Research Management System Transformation CRMS Inflection Points
Create optimal research administrative services and systems
Advance entrepreneurism to the benefit of our patients and society
Accelerate the translation of discoveries to our patients
CRMS Phase 4
Develop a scalable global Affiliated Research Network
Optimize Clinical Trials
Integrate research administrative services and systems
Implement QMS in all Research business units
Implemented QMS in selected Research business units
Reduced pre-award cycle time by 351 days
Increased federal indirect revenue by $8M annually
CRMS Phases 1-3
Reduced administrative costs by 10%
Eliminated industry research write-offs by $1.8M annually
Eliminated need to outsource IRB savings $16M annually
Reduced NIH annual audit findings from 14 to 0 for last 3 years
Mitigated $65M in risk exposure
Closed 27 major research compliance gaps
Resolved 72 compliance questions raised by NIH for continued federal funding
NIH Inquiry
DOJ Settlement
©2011 MFMER | slide-16

17. Questions

18. Appendix

19. Step 1 – Establish a sense of urgency
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Examine market and competitive realities
Identify and discuss crises and major opportunities
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

20. Step 1 – Establish a sense of urgency
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Understanding difficulty of driving people from their comfort zones
Becoming paralyzed by risks
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

21. Step 2 – Form a powerful guiding coalition
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Assemble a group with enough power to lead change
Encourage the group to work together as a team
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

22. Step 2 – Form a powerful guiding coalition
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
No prior experience in teamwork at the top
Relegating team leadership to HR, quality, or strategic-planning executive rather than a senior line manager
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

23. Step 3 – Create a vision Create a vision to help direct the change
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Create a vision to help direct the change
Develop strategies to achieve the vision
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

24. Step 3 – Create a vision
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Presenting a vision that’s too complicated or vague to be communicated succinctly
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

25. Step 4 – Communicate the vision
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Use every vehicle possible to communicate
Teach new behaviors by leaders setting an example
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

26. Step 4 – Communicate the vision
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Under communicating the vision
Behaving in ways antithetical to the vision
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

27. Step 5 – Empower others to act
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Get rid of obstacles to change
Change systems or structures that seriously undermine the vision
Encourage risk taking and unconventional thinking
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

28. Step 5 – Empower others to act
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Failing to remove powerful individuals who resist the change effect
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

29. Step 6 – Plan for and create short-term wins
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Plan for visible performance improvements
Create visible performance improvements
Recognize and reward employees involved
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

30. Step 6 – Plan for and create short-term wins
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Leaving short-term successes up to chance
Failing to achieve successes early enough
(12-24 months into change effort)
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

31. Step 7 – Consolidate improvements
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Use increased credibility to change policies, systems and structures that don’t fit new vision
Hire, promote and develop employees who can implement the vision
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

32. Step 7 – Consolidate improvements
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Declaring victory too soon—with the first performance improvement
Allowing resistors to convince “troops” that the war has been won
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

33. Step 8 – Institutionalize new approaches
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Articulate the connections between the new behaviors and corporate success
Develop the means to ensure leadership development and succession
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

34. Step 8 – Institutionalize new approaches
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
Not creating new social norms and shared values consistent with changes
Promoting people into leadership positions who don’t personify the new approach
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.

35. The Stages of Changing 8 Steps to Transforming Your Organization
Establish urgency
Institu- tionalize approach
Produce change
Short- term win
Empower staff
Convey vision
Create vision
Form coalition
Step 8
Step 7
Step 6
Step 5
Step 4
Step 3
Step 2
Step 1
BPO (Business Process Opportunities)/ Quality Sponsored
Management Systems Design – Refine supervisory structure in research.
Policy System – Mechanism to standardize research policies and store in a common location.
Source: “Leading Change: Why Transformation Efforts Fail”, Kotter, John P., Harvard Business Review, January, 2007.