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
CP1336232-1
Disclosure
The presenters do not have any relevant financial relationships
with any commercial interests.
CP1336232-2
Presentation Outline
 Learning Objectives
 Overview
 Questions
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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.
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Overview
 Mayo Clinic Overview
 Mayo Quality Framework
 Comprehensive Research Management System
 Stages of Transformation
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Mayo Clinic
Locations
Mayo Clinic
Mayo Clinic Health System
Mayo Clinic
in Arizona
Mayo Clinic
in Florida
©2011 MFMER | slide-6
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
Research: Overview
Translational research
Bedside
 Over 90% of Mayo
physicians are involved in
research-related activities
Bench
Population
 $600 million research
budget
Mayo Clinic research partnerships
©2011 MFMER | slide-8
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
Mayo Clinic Quality Framework
I
III
•
•
•
•
•
The best care for every patient every day
Culture
Quality Academy Leader Training
Champions training
Articulate roles and expectations
Commitment to transparency
Communications plan
IV
Engineering
• Practice (e.g. - pressure ulcers,
right-site surgery)
• Education (e.g. – Ask Mayo
Expert)
• Research (e.g. – IRB, OSPA,etc)
V
•
•
•
•
•
•
Execution
Demonstrate business case
Active visible leadership
Process owners
Frontline empowerment
Common scorecard + targets
100-day discipline
Infrastructure
II
• Quality Academy
• Systems implementation
December 6, 2007
• Enterprise Learning System
• Spread simulation practices
Adapted from Bisognano, Plsek. 10 More Powerful Ideas for Improving Patient Care.
Chicago: Health Administration Press & Institute for Healthcare Improvement; 2006.
©2010 MFMER | 3065532-10
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
CRMS Key Strategic Objectives
1) Creating an Optimal Clinical Trials Management System
2) Implementing Quality Management Systems across all
Research Business Units
3) Developing Scalable Infrastructure to serve MCHS, APN
and clients globally
Comprehensive Research Management System
Pre-award Activities
◄ Research Services 
RESEARCH
PROCESS 
Study Activities
Post-study Activities
Concept
Development 
Protocol
Development 
Protocol
Review 
Protocol
Execution 
Analysis
& Reporting 
 Creation of
aims
 Literature
search
 Preliminary
reviews
 Create concept
docs
 Identify teams
 Establish study
plan
 Create protocol
 Complete/initiate
docs and forms
 Qualify staff
and/or
organizations
 Meeting
preparation
 Meeting
execution
 Document/forms
review
 Scientific review
 Assign
staff/resources
 Patient search,
screening,
scheduling
 Patient treatment
& education
 Collect/test/track
samples data
analysis
 End of study
report
 Drop out, screen
failure, outcomes
reporting
 Produce
publications
 Present
discoveries
Translation
 New
Treatments
 New Lab
Procedures
 New Analysis
Capabilities
 New Care
Delivery
Methods
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
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
Research Management System Transformation
CRMS Roadmap to Excellence
Phase I
Phase 2
Phase 3
Phase 4
Research Vision
and Strategic
Priorities
Research
Infrastructure
Compliance
Research Infrastructure Process
Improvement
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
14
The Stages of Change
8 Steps to Transforming Your Organization
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
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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
Develop a scalable global Affiliated Research Network
Optimize Clinical Trials
Integrate research administrative services and systems
CRMS Phase 4
2012-2017
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
2006-2011
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
Questions
CP1336232-17
Appendix
CP1336232-18
Step 1 – Establish a sense of urgency
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Examine market and competitive
realities
 Identify and discuss crises and major
opportunities
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-19
Step 1 – Establish a sense of urgency
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Understanding difficulty of driving people
from their comfort zones
 Becoming paralyzed by risks
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-20
Step 2 – Form a powerful guiding coalition
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Assemble a group with enough power
to lead change
 Encourage the group to work together
as a team
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-21
Step 2 – Form a powerful guiding coalition
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 No prior experience in teamwork at the top
 Relegating team leadership to HR, quality,
or strategic-planning executive rather than a
senior line manager
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-22
Step 3 – Create a vision
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Create a vision to help direct the change
 Develop strategies to achieve the vision
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-23
Step 3 – Create a vision
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Presenting a vision that’s too complicated or
vague to be communicated succinctly
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-24
Step 4 – Communicate the vision
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Use every vehicle possible to communicate
 Teach new behaviors by leaders setting
an example
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-25
Step 4 – Communicate the vision
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Under communicating the vision
 Behaving in ways antithetical to the vision
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-26
Step 5 – Empower others to act
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Get rid of obstacles to change
 Change systems or structures that seriously
undermine the vision
 Encourage risk taking and unconventional
thinking
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-27
Step 5 – Empower others to act
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Failing to remove powerful individuals who resist
the change effect
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-28
Step 6 – Plan for and create short-term wins
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Plan for visible performance improvements
 Create visible performance improvements
 Recognize and reward employees involved
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-29
Step 6 – Plan for and create short-term wins
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Leaving short-term successes up to chance
 Failing to achieve successes early enough
(12-24 months into change effort)
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-30
Step 7 – Consolidate improvements
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 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
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-31
Step 7 – Consolidate improvements
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Declaring victory too soon—with the first
performance improvement
 Allowing resistors to convince “troops” that the
war has been won
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-32
Step 8 – Institutionalize new approaches
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Articulate the connections between the new
behaviors and corporate success
 Develop the means to ensure leadership
development and succession
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-33
Step 8 – Institutionalize new approaches
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
 Not creating new social norms and shared values
consistent with changes
 Promoting people into leadership positions who
don’t personify the new approach
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-34
The Stages of Changing
8 Steps to Transforming Your Organization
Step 1
Step 2
Step 3
Establish Form
Create
urgency coalition vision
Step 4
Convey
vision
Step 5
Step 6
Step 7
Empower ShortProduce
staff
term win change
Step 8
Institutionalize
approach
Source: “Leading Change: Why Transformation Efforts Fail”,
Kotter, John P., Harvard Business Review, January, 2007.
CP1336232-35