Today’s News

1. Today’s News

2. Overview • Mayo’s Institutional Review Board’s Quality Journey • Mayo’s Cancer Center “ACTION” Project • Quality Infrastructure Building in the areas supporting Research at Mayo • Emergence of CREEM

3. Motivating Factors • PI whining……never underestimate • Concern about compliance gaps • Philosophical shift in Research Leadership • CTSA RFA • Regulatory/infrastructure “Tower of Babel” • Etc. etc. etc……

4. Bruegel the Elder 1563

5. Research Roadmap to Excellence Timeline Phases Phase I Research Visionand Strategic Priorities Phase 2 ResearchInfrastructure Compliance Phase 3 Research Infra-structure Process Improvement Phase 4 Research InfrastructureService 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 2007 - 2008 2008 forward 2006 - 2007 2005 -2006 2005

6. Mayo IRB’s Quality Journey

7. 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

8. Current Status of Mayo’s 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

9. Research Roadmap to Excellence Phase III Accomplishments

10. 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

11. Mayo’s “ACTION Project” Accelerating Clinical Trial Integration & Overcoming Non-value-added activities

12. 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

13. 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

14. Research Roadmap to Excellence Phase III Accomplishments

15. 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

16. Quality Infrastructure Building in the Areas Supporting Research

17. 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

18. Quality Infrastructure Building Current Areas

19. Comprehensive Research Electronic Environment for Mayo (CREEM)

20. Bruegel the Elder 1563

21. 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

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

23. 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.

24. Questions Rosenblum