Todays News

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Todays News
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Overview

• Mayos Institutional Review Boards Quality
  Journey
• Mayos Cancer Center ACTION Project
• Quality Infrastructure Building in the areas
  supporting Research at Mayo
• Emergence of CREEM

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Motivating Factors

• PI whiningnever underestimate
• Concern about compliance gaps
• Philosophical shift in Research Leadership
• CTSA RFA
• Regulatory/infrastructure Tower of Babel
• Etc. etc. etc

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Bruegel the Elder 1563
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Research Roadmap to Excellence Timeline
Phases
Phase 4 Research InfrastructureService Excellence
Phase 3 Research Infra-structure Process
Improvement
Phase 2 ResearchInfrastructure Compliance
Phase I Research Visionand Strategic Priorities

• Financial management systems
• Written policies and procedures
• Roles and responsibilities
• Compliance training and education
• NIH Response Circle Back

• Vision
• Strategic priorities
• Strategic initiatives
• Scorecard metrics

• 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

• Management systems design
• Policy system
• Protocol management system
• Pre-award system
• Legal contracting system
• IRB process
• Quality Management Systems
• Comprehensive Training Program

2008 forward
2007 - 2008
2006 - 2007
2005 -2006
2005
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• Mayo IRBs Quality Journey

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IRB Performance Improvement Plan

• Purpose The IRB Performance Improvement Plan
  initiative was designed to evaluate and improve
  the core operational elements of the IRB,
• Quality Management
• Business Systems / Applications
• Organizational Structure
• Job Core Competencies and Staffing Strategy
• Establish a foundation for managing operational
  efficiency and continuous improvement
• Evaluate performance through measurement
• Prepare the IRB for AAHRPP Accreditation

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Current Status of Mayos IRB

• Able to Proactively Manage Operations
• Decisions Made using Data from Operational
  Measurements
• Regulatory Compliant
• Continuous Improvement, Understood - Engrained in
  the Culture
• Staff Equipped with Required Skills and
  Competencies
• Ability to Effectively Address Customer Concerns

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Research Roadmap to Excellence Phase III
Accomplishments
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Mayo IRB Remainder of 2009

• AAHRPP Accreditation Readiness Work
• Improvement Projects
• Reducing Rework for IRB Applications
• Facilitating the IRB Scientific Committee Members
  Experience
• Consent Form Template Improvement
• Standardized Scientific Review Process
• IRBe Notifications/Navigation Improvements
• Integrated IRB/RRRP Review Process
• Complete Implementation of Quality Management
  System (QMS) and Quality Plan
• Enhanced Training Program with Competency
  Assessment

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Mayos ACTION Project

• Accelerating Clinical Trial Integration
  Overcoming Non-value-added activities

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ACTION Project Overview

• Purpose Improve performance of key processes
  associated with conducting clinical trials
• Scope Study concept to patient enrollment
• Reduce timeline and expense for clinical trial
  development and activation
• Integrate the process between MCA, MCF and MCR
• 10 continuous improvement teams formed
• 56 projects developed

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Current vs. Future State

• Current State Investigator-initiated trials with
  industry support
• Timeframe from concept approval until protocol
  activation Mean 12.6 months Median 10.3
  months
• Future state process can be accomplished in as
  few as 98 days

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Research Roadmap to Excellence Phase III
Accomplishments
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ACTION Benefits

• Patient satisfaction
• Faster activation of trials for our patients
• Increased access to clinical trials with
  innovative treatments
• Enhanced financial performance
• Lower personnel costs due to faster turnaround
  time
• Enhanced revenue creation through quicker
  participant enrollment
• Enhanced employee satisfaction and retention
• Elimination of rework and errors
• Enhanced employee performance
• Enhanced researcher satisfaction

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• Quality Infrastructure Building in the Areas
  Supporting Research

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Quality Management Infrastructure

• Provides the foundation for proactive quality
  management, fact based decision making and
  process improvement
• Quality Management Systems (QMS)
• define and integrate the various internal
  processes within a work unit supporting research
• facilitate continuous improvement of the core
  business processes,
• improve business performance - meeting and
  exceeding customer requirements

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Quality Infrastructure Building Current Areas
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• Comprehensive Research Electronic Environment for
  Mayo
• (CREEM)

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Bruegel the Elder 1563
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Emergence of CREEM

• The electronic Tower of Babel
• Multiple redundant and overlapping systems
• Regulatory and operational support for research
• Business owners vs. IT operating in a vacuum

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CREEM Oversight Organization
Research Committee
CREEM Sponsorship Group
Research IT Subcommittee
CREEM Program Steering Group
CREEM Implementation Team
Meta Data Mgmt
CTSA Bioinform. Core
Service Catalog
DLMP I.T.
RLIMS
CTMS
PI Portal
MIRIS
Omics
ReAIMS
CRIMS
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What Have We Learned ?

• Process not an Event
• Executive Sponsorship
• Empowered administrators
• Ongoing infrastructure
• IRBs are not slow in isolation
• Resistances in series
• The enforcement mind set has to go
• Electronification of a bad process leads to an
  electronified bad process
• Communication/coordination among process owners
• Internal amplification of external
  regs..sedimentary rock
• Our single legal entity is likely an advantage
• Etc. etc. etc.

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Questions
Rosenblum